In April 2009, the attorneys at Burg Simpson Eldredge Hersh & Jardine, PC, filed a complaint in Federal Court in the Southern District of Ohio against Covidien, Inc., a manufacturer and distributor of medical devices, including surgical staplers. Covidien’s website indicates that the medical device at issue, its ENDO GIA Universal Stapler, “places two triple, staggered rows of titanium staples and simultaneously the knife divides the tissue in between. The instrument is designed for multiple use during a single surgical procedure . . . .”

Continue reading " Burg Simpson Eldredge Hersh & Jardine, PC Files Federal Complaint in the Southern District of Ohio Against Covidien, Inc." »

Posted by Janet G. Abaray at 02:12 PM | Permalink | Comments (0) | TrackBacks (0)

In January 2009, the attorneys at Burg Simpson Eldredge Hersh & Jardine, PC, filed a complaint in Federal Court in the Southern District of Ohio against DePuy Orthopaedics, Inc. for failure of its Limb Preservation System. According to DePuy’s website, its Limb Preservation System is designed to be used in situations involving malignant tumors (e.g., osteosarcomas) where extensive resection and replacement of the femur and tibia bones is required.

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Posted by Janet G. Abaray at 07:42 AM | Permalink | Comments (0) | TrackBacks (0)

A new risk identified while undergoing MRI has surfaced. It is by no means wide spread, but can be a concern to some. The U.S. Food and Drug Administration warned that some skin patches, such as those that deliver nicotine or other drugs, can cause skin burns if worn during an MRI scan because they contain aluminum and other metals. The metal content is not always listed as a risk on the product labeling. The skin patches include brand names as well as generic products and those that can be found over the counter. People who have used the patches during MRI scans have reported having skin burns under the patch. The FDA has received reports of five people being burned from wearing a skin patch during MRI scans. The FDA is reviewing the labeling and material content of all medicated patches to make sure those that contain metals carry a warning about the risk of wearing the patch during an MRI. They said they will tell the public when the new information is added to the label. Until then, be armed with information and tell the staff at the MRI center, both when you call to make the appointment and when you fill in the health questionnaire before you have an MRI scam, advises the FDA.

Posted by Kerry N. Jardine at 08:46 PM | Permalink | Comments (0) | TrackBacks (0)

In Copenhagen, Denmark the health minister has promised compensation to kidney patients who contracted Nephrogenic Systemic Fibrosis after being administered Omniscan, a contrast agent used in MRI to enhance tissue images. Here in the states there are also a number of lawsuits against the 5 manufacturers of gadolinium contrasting agents including the makers of Omniscan. NSF is characterized by the progressive hardening of skin and joints and sometimes internal organs that often result in the inability to move about without a wheelchair. Currently there is no treatment for the condition. Attorneys for the victims in the United States have asked for the suits to be prioritized because some of their plaintiffs are in dire circumstances while others have already perished from the debilitating disorder. As for Jakob Axel Nielson, the health minister in Denmark he says,

“The least we can do for these deeply ill people, who unfortunately became more sick after being administered Omniscan, is to identify them and offer compensation.”

Posted by Peter W. Burg at 10:50 AM | Permalink | Comments (0) | TrackBacks (0)

When reports of Salmonella and E. coli tainted food emerge the public is rightfully shocked and demands it to be set right. Often what is lost in the morass of media reports and Food and Drug Administration advisories are the personal stories of suffering. Stephanie Smith, 21, became extremely ill more than a year ago after eating a hamburger tainted with E. coli. What few know is she now suffers from seizures, brain injury and paralysis. Here mother and brother are uncomfortable leaving her alone for fear she will hurt herself further. Her brother moved back from out of state to help care for her while her mother is at work. After physical, occupational and speech therapy as well as therapy specific for a brain injury, Stephanie is now able to eat on her own. Prior to her poisoning she was a determined and talented dance instructor. Even though she misses teaching dance she keeps a positive attitude. Stephanie’s family all step in when caring for her. Her care includes three hours daily therapy, heading out for medical checkups, bathing, and washing her bedding and mattress daily to keep her from infection. What often is missed is not only the time it takes to take care of someone who has been injured by a person or a company’s negligence, but the financial cost.

Posted by Kerry N. Jardine at 09:44 AM | Permalink | Comments (0) | TrackBacks (0)

The list of peanut product recalls is growing daily in the nation’s largest salmonella tainted product recall ever. The U.S. Food and Drug Administration said that the Peanut Corporation of America, which has filed for bankruptcy, supplied the peanuts, peanut butter and peanut pasted used in the more that 1500 products that have been linked to more than 500 salmonella related illnesses and nine deaths. The FDA has assured the American consumers that major brands of peanut butter sold in jars are not affected by the recalls so far. Officials said salmonella bacteria can cause serious and sometimes fatal infections in young children, frail or elderly people and others with weakened immune systems. Healthy people infected with salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. A list of all companies recalling peanut products is available at http://www.fda.gov/oc/opacom/hottopics/salmonellatyph/recalls.html.

Posted by Kerry N. Jardine at 09:43 AM | Permalink | Comments (0) | TrackBacks (0)

The investigation into the salmonella tainted peanut butter has been stepped up a notch as the Federal Bureau of Investigations has been asked to join in the ongoing fact finding mission. The FBI was asked to assist the Food and Drug Administration because of its resources in ability and manpower. Consumer trust has been severely affected by this latest peanut butter contamination and recall. A U.S. food safety expert earlier said peanut butter makers need to be transparent about testing for salmonella before consumers will trust their products again. Peanut butter sales have dropped at least 25 percent since the salmonella outbreak linked to a PCA plant in Georgia has killed eight and sickened nearly 600, CNN reported. The FDA said major-label jarred peanut butter companies are reaching out to the public and running ads concerning the safety of their products to win back wary customers.

Posted by Kerry N. Jardine at 09:35 AM | Permalink | Comments (0) | TrackBacks (0)

Just a few weeks into history’s largest salmonella outbreak, eight deaths and 575 illnesses have occurred. It has now come to light that Peanut Corp. of America in Georgia knew as far back as 2007 that their products were probably tainted and even after tests confirmed the product contamination they elected to ship them. Federal law forbids producing or shipping foods that could be harmful to consumers' health. The U.S. Food and Drug Administration reported that in 2007 PCA shipped chopped peanuts on July 18 and 24 after salmonella was confirmed by private lab tests.

“In some instances, peanut products were shipped by (the company) prior to having assurance that the products were negative for salmonella,” said Michael Rogers, head of field investigations for the FDA.

Posted by Kerry N. Jardine at 09:30 AM | Permalink | Comments (0) | TrackBacks (0)

In the February issue of Radiology researchers raised awareness of the risk factors between gadolinium based contrast agents and the onset of Nephrogenic Systemic Fibrosis. Javier Perez-Rodriguez, of the Johns Hopkins University School of Medicine in Baltimore, and colleagues describe 33 patients diagnosed with NSF from 2003 to 2008. All the patients had advanced renal failure at the time they were given gadolinium contrasting agents prior to an MRI. The time between exposure to gadolinium and the presentation of NSF was an average of 29 days. Researchers reported before the U.S. Food and Drug Administration issued warnings about the association between gadolinium exposure and NSF, the overall incidence of the disease was 36.5 cases in 100,000 patients. After the FDA pressed for a “black box” warning on the contrasting products the amount of NSF cases dropped to 4 per 100,000 patients.

In conclusion the authors write, “In January 2007, our institution implemented policies regarding the use of GBCA in patients with severe renal dysfunction, with the aim being to reduce the incidence of NSF. These policies were associated with a significant reduction in the incidence of NSF. Besides the previously reported epidemiologic considerations of NSF associations, the success of such a policy in the reduction of NSF due to GBCA exposure strengthens the belief that there is a causal relationship between GBCA and NSF.”

Posted by Peter W. Burg at 10:54 AM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration has been informed of a recall of on lot of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles offered by Tyco Healthcare Group LP (Covidien) due to possible mislabeling. It is believed that if patients use the needles they could receive as much as 2.5 times the intended dose which could lead to hypoglycemia, serious health consequences and even death. The recall applies to Lot Number 813900, ReliOn 1cc, 31-gauge, 100 units for use with U-100 insulin. The syringes are distributed by Can-Am Care Corp and sold only by Walmart and Sam’s Club stores under the Reli-on name. The mistake was made during the packaging process. The recall includes 4,710 boxes which has a total of 471,000 bad syringes. The manufacturer has received one adverse report related to a syri nge from this product lot.

Posted by Peter W. Burg at 07:29 AM | Permalink | Comments (0) | TrackBacks (0)

A dangerous trend seems to be emerging as legislators and consumer groups pressure the U.S Food and Drug Administration to rethink their decisions on drugs and products. In the case of Wyeth vs. Levine, drug preemption is being considered by the Supreme Court that if found in favor of the drug company, will immunize pharmaceutical companies from lawsuits and give consumers no legal recourse when harmed by an FDA approved drug or product. Most recently a panel of toxicology experts said the FDA did not properly assess the potential health risks posed by the chemical bisphenol A (BPA) found in plastic bottles which some studies have linked to cancer, diabetes, heart disease and developmental delays in children. They further accuse the FDA as relying too heavily on studies funded by the chemical industry in making its decision that BPA posed no health risks. Another example is the detritus left from the Avandia mess. Congress got involved, the press had a heyday and most importantly Glaxo, the manufacturer of Avandia, had not conducted studies that could definitively disprove the allegation that is caused heart attacks. What is the link between these issues? An already overburdened and pressured agency will ultimately have sole responsibility and accountability if a drug or product is found to harm consumers. The immediate threat to the drug industry isn't lawsuits, which big pharma has shown it can beat with their large reserve of funds for such casualties. It's the fact that safety controversies, such as BPA, have demoralized the FDA, made it defensive and made it impossible to get new drugs approved. Bottom line, if preemption increases pressure on the FDA, drug companies would suffer. If drug preemption is approved it could make the FDA more vulnerable to political pressure because the politicians gave the agency the absolute word on drug safety thus the next “miracle” drug may never be approved because of the FDA’s fear. As an afterthought Canada has moved to ban plastic baby bottles containing BPA and several U.S. states are considering restricting its use.

Posted by Peter W. Burg at 12:25 PM | Permalink | Comments (0) | TrackBacks (0)

In response to rising concerns about food safety in the United States, The Government Accountability Office recently reported, “While the FDA has considered fresh produce safety a priority for many years, resource constraints and other work -- including counterterrorism efforts and unplanned events such as food borne illness outbreaks -- have caused FDA to delay key produce safety activities.” The U.S. Food and Drug Administration has been preparing for a biological attack. The repeated outbreaks of food poisoning have interfered with their efforts to improve food safety as well. What is frightening is the FDA is unclear on what it plans to do to plug up the holes. The “FDA has no formal program devoted exclusively to fresh produce and has not consistently and reliably tracked its fresh produce spending.” The fresh produce industry indicated it would welcome stronger regulation especially after outbreaks of Salmonella found in peppers from Mexico that sickened 1,400 people from April to August of this year and an E. coli epidemic in 2006, traced to California spinach that killed three. In response to the report the FDA said it is meeting with officials in Canada and Mexico, will add 327 state contract food inspections in 2009 and has approved the use of radiation to disinfect fresh spinach and lettuce. The GAO further reported that the FDA has limited resources saying, “FDA's intervention efforts have also been limited. Specifically, domestic fresh produce firms were inspected infrequently. Furthermore, FDA examined less than 1 percent of the 7.6 million fresh produce lines imported from fiscal years 2002 through 2007,” In defense the FDA is taking further steps to keep food safe and has proposed changes in its Food Protection Plan that could significantly improve its ability to oversee fresh produce. The U.S. Centers for Disease Control and Prevention estimates that each year 76 million people get some kind of food borne illness, 300,000 are hospitalized and 5,000 die.

Posted by Kerry N. Jardine at 08:18 PM | Permalink | Comments (0) | TrackBacks (0)

Canada and the United States have had their share of brushes with death and disability linked to outbreaks of Listeriosis in packaged foods, Salmonella in peanut butter, spinach and jalapenos, Clostridium difficile in hospitals and exposure to defective medicines and medical products. All of which come from improper handling, manufacturing or just plain negligence. In an environment where people are being put in danger time after time and live in a state of fear of the next contamination a line needs to be drawn. The companies, hospitals and manufacturers need to know that negligence and poor oversight cannot continue as business as usual because business as usual is killing people. Until such a time that they start to take responsibility for their product, whether it is a service or a consumable, the people need to take the lead and seek an advocate in their fight against irresponsibility. That advocate is an attorney who because of the state of affairs in the corporate arena has ample experience in fighting the giants.

Posted by Kerry N. Jardine at 07:27 AM | Permalink | Comments (0) | TrackBacks (0)

In an effort to protect American consumers the American Association for Justice, formerly known as the American Trial Lawyers Association, spent more than $1.7 million on lawsuit reform in the second quarter. The Association lobbied on proposals related to medical malpractice reform, the safety of toys and other consumer products, auto and rail safety and the pre-emption of lawsuits in state courts by federal law. This latest information demonstrates the dedication attorneys have for their clients and establishes their willingness to stand up for the protection of people against faulty products and procedures.

Posted by Michael S. Burg at 06:21 PM | Permalink | Comments (0) | TrackBacks (0)

U.S. health officials are still struggling to find the source of the salmonella outbreak in certain types of tomatoes that as of July 4th has sickened 922 people in 40 states since mid-April. The FDA and the CDC are turning their sights to produce imported from Mexico according to a CNN report last week. The Food and Drug Administration (FDA) alerted growers and brokers handling their products that, starting on Monday July 7, inspectors will stop shipments from Mexico of ingredients common to Mexican cuisine, CNN reported. Tomatoes continue to be the primary focus of the investigation but officials have expanded it to include produce commonly eaten with tomatoes. Cilantro, jalapeno peppers, serrano peppers, scallions and bulb onions are among the products to be further scrutinized. The U.S. Centers for Disease Control and Prevention says Salmonella Saintpaul, the strain involved in the outbreak, is rare. Typically, the CDC sees only about 400 cases of Saintpaul infections in humans each year. Salmonella can cause fever, diarrhea, nausea, vomiting and abdominal pain, according to the FDA.

Posted by Kerry N. Jardine at 07:12 PM | Permalink | Comments (0) | TrackBacks (0)

A Forney, Texas man was partially paralyzed when a rented U-Haul moving truck ran over him because of a faulty emergency brake and worn-down gears. A Dallas County jury agreed that U-Haul was at fault and awarded him $87 million. Talmadge Waldrip rented the U-Haul truck in September 2006 to help his daughter move. As he stopped the struck and got out, it started rolling backwards knocking him down and crushing his bladder and pelvis. Two years and more than 14 surgeries later he still cannot walk and requires 24 hour care. Many who have rented moving trucks have experienced the same type of company incompetence when reporting or experiencing problems that are ultimately ignored by the company. The attorney for the Waldrip’s and the jury agreed, “This verdict is a verdict for safety,” attorney Ted Lyon said. “U-Haul trucks are not safe. They don’s fix them.” Waldrip said his lawsuit was not about money. “I want them to know they can't treat people like this and rent a vehicle that is not roadworthy," he said.

Posted by Kerry N. Jardine at 08:30 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S Supreme court in February ruled that people affected by malfunctioning medical devices could not sue for damages because the devices had federal approval through the U.S. Food and Drug Administration. Medtronic was the defendant in the Supreme Court case. This month federal legislation is expected to be introduced to better clarify the original Medical Device Amendments from 1976. The 1976 amendments sought to block state court lawsuits because jury verdicts could interfere with FDA’s ability to regulate the design and labeling of medical devices. The new bill called the “Medical Device Safety Act” would state that existing federal law governing medical device approvals does not "modify or otherwise affect" lawsuits brought in state courts. It is being drafted by U.S. Reps. Frank Pallone, D-N.J., and Henry Waxman, D-Calif. This bill would broaden the laws terms thus opening up victims’ ability to sue over problems they or their loved ones experienced with defective medical devices, regardless of whether the FDA had approved its use.

Posted by David P. Hersh at 02:12 PM | Permalink | Comments (0) | TrackBacks (0)

When Medtronic recalled its heart defibrillator with Sprint Fidelis leads in October a study was initiated to enhance monitoring of patients currently using the implantable cardioverter defibrillator (ICD). The study was posted in late February on a website for a doctors group called the Heart Rhythm Society that reported researchers of the Minneapolis Heart Institute Foundation found that the enhanced monitoring proved “relatively ineffective in preventing adverse clinical events.” The heightened monitoring intended to detect failures did little to warn patients of potential trouble with their ICDs. About 268,000 people worldwide have been implanted with Sprint Fidelis leads and so far five deaths have been linked to malfunctions. At the time of the recall, doctors were instructed to reprogram patients’ ICDs so that an alarm would sound when something was wrong. Of the 514 Sprint Fidelis leads implanted at the Heart Institute, 17 failed 11 to 35 months after insertion, according to the study. Twelve patients received inappropriate shocks, and two did not hear the warning alarms. “What the report states is that the monitoring technique for determining when a Sprint Fidelis lead is going to fail is relatively ineffective in preventing adverse clinical events,” like inappropriate shocking, said Dr. Robert Hauser, a cardiologist at the foundation who is known nationwide for tracking safety information concerning heart devices. Overall, enhanced monitoring of the leads did not prevent shocks in two-thirds of the Heart Institute's patients that had Sprint Fidelis, the study says.

Posted by David P. Hersh at 08:10 AM | Permalink | Comments (0) | TrackBacks (0)

Dr. William Maisel, who recently criticized the medical device industry and the FDA for failing to provide consumers with timely and critical information about device malfunctions calls for further consumer protection legislation. In October Medtronic recalled their implantable defibrillators after learning that the fractures of the Sprint Fidelis leads used in the product caused five patient deaths. Dr. Maisel said that five months before Medtronic recalled the Sprint Fidelis lead wire, they submitted an application to the FDA to change the product's design and manufacturing. That request was not publicized to physicians or patients even though doctors had received letters from Medtronic in February 2007 stating that there could be a problem with the lead. He noted that after FDA approved the design changes, old versions of the Sprint Fidelis lead remained on hospital shelves for use in patients. “Often, a flawed product continues to be marketed while the manufacturer submits a revised marketing application to the FDA and awaits approval of the amended product design and manufacturing plan,” Maisel wrote in the New England Journal of Medicine editorial. “Manufacturers have repeatedly and knowingly sold potentially defective devices without public disclosure.” Dr. Robert Hauser of the Minneapolis Heart Institute, who last year helped bring the Sprint Fidelis problem to light, seconded Maisel's call for consumer protection legislation. Hauser published a medical journal article in July that suggested patients were being needlessly, and repeatedly, shocked by their Medtronic defibrillators because lead wires were fracturing at an unusually high rate. The force of a defibrillator shock is similar to being kicked in the chest by a horse, Hauser said. "When you stand back and look at this, what's so disturbing is that physicians started implanting this lead because it was FDA-approved — they thought, 'Well, it's a nice, small lead, and it's FDA-approved so it must be OK,' " said Hauser. "Just because a device is FDA-approved does not necessarily mean it is safe."

Posted by Kerry N. Jardine at 12:04 PM | Permalink | Comments (0) | TrackBacks (0)

Cardiologist Dr. William Maisal wrote in a recent issue of the New England Journal of Medicine that a recent Medtronic recall of its Sprint Fidelis leads used in its defibrillators illustrates why patients who get medical devices need more consumer protections from the government. Five deaths have been attributed to the fractures and after a 2.3 percent fracture rate over a 30 month period; Medtronic pulled them from the market in October 2007. Dr. Maisal is the director of the Medical Device Safety Institute at Beth Israel Deaconess Medical Center in Boston. He is sometimes critical of the way Medtronic and the Food and Drug Administration handled the matter. In his opinion piece he wrote that when the Sprint Fidelis lead was approved by the FDA in 2004, the device was never tested on humans, so in effect there was no clinical data to show whether it was safe. Although many cardiologists say public disclosure of a device's safety record is overwhelming and alarming to patients, Maisel argues that patients should be educated about potential risks before treatment, as part of the informed-consent process. The FDA, he adds, is failing in its mission to protect public health, saying that it does not disseminate accurate, and science-based information to the public. Maisel says that congressional action is needed, because "essential consumer protections are currently lacking." The vast majority of medical devices approved by the FDA involve no consumer input. Safety oversight shouldn't be left to device manufacturers, he argues, because they have an "inherent financial conflict of interest" and a "stronger legal obligation to their shareholders" than to patients.

Posted by Kerry N. Jardine at 08:00 PM | Permalink | Comments (0) | TrackBacks (0)

In mid January Baxter International Inc. recalled nine lots of heparin sodium injection multi-does vials due to a higher than usual number of reports of adverse reactions in patients. Baxter has expanded its recall to all lots and doses of its heparin sodium injection multi-dose, single-dose vials and HEP-LOCK heparin flush products. The reason all lots were not initially recalled was because the FDA determined there might be a shortage of heparin therapy there by increasing risk to patients needing it. Since then the FDA has concluded the recall will not jeopardize access to the drug and has informed Baxter that they may now recall its remaining lots of heparin sodium injection and flush products. Nearly all reported adverse reactions have occurred in renal dialysis, invasive cardiovascular procedures and apheresis procedures. The reactions have included a gambit of complications including hypotension that could be severe or life threatening.

Posted by Kerry N. Jardine at 08:14 PM | Permalink | Comments (0) | TrackBacks (0)

Joining the Duragesic transdermal Fentanyl patch recall is the company Actavis Inc. They announced that 14 lots of their generic version Fentanyl CII sold in the United States by subsidiary Actavis South Atlantic LLC are being voluntarily recalled from wholesalers and pharmacies. The recalled patches were manufactured by the contract manufacturer Corium International Inc. The 14 lots of the Fentanyl patch system may have a fold-over defect that can cause the patch to leak and expose patients and caregivers to the internal gel that could lead to serious side-effects such as respiratory depression and fatal overdose. Fentanyl is a potent Schedule II opiod medication. Anyone who comes in contact with the defective patches should rinse the exposed area thoroughly without the use of soap.

Posted by Kerry N. Jardine at 12:20 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA has announced a recall of a transdermal patch system, which contains the prescription painkiller Fentanyl. The patches are sold in the U.S. under the names, Duragesic by PriCara and a generic version by Sandoz Inc. In Canada, the recalled patches are sold under the Duragesic brand by Janssen-Ortho Inc. and generically by Ranbaxy Laboratories Ltd. The recall includes all 25-microgram-per-hour patches with expiration dates on or before December 2009. It has been discovered that some of the patches may have a cut in the lining of the internal reservoir where the drug is held in gel form. Fentanyl is a powerful “opiod” drug and if it leaks into the drug’s packaging, releasing into the skin it could cause difficulty breathing and a potentially fatal overdose. If skin has been exposed to an increased amount of the gel due to a cut in the reservoir the area should be thoroughly rinsed, but do not wash with soap.

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Posted by Kerry N. Jardine at 04:22 PM | Permalink | Comments (0) | TrackBacks (0)

It has recently been discovered that the recalled pre-filled Heparin syringes made by Baxter International blamed for causing allergic reactions and four deaths, was manufactured in a Chinese facility that was never inspected by the Food and Drug Administration. Both Baxter and the FDA claim it is not clear whether the product from the Chinese supplier is tied to the allergic reactions and deaths to the blood thinning drug. Baxter said February 11th that it was temporarily suspending production of Heparin because of approximately 350 negative reactions that may be a result of the drug. The allergic reactions have been mostly among patients undergoing kidney dialysis and heart surgery.

Posted by Kerry N. Jardine at 10:20 AM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration is notifying consumers about Icy Hot Heat Therapy products that have been voluntary recalled nationwide by makers Chattem Inc. This recall includes Icy Hot Heat Therapy Air Activitated Heat and the single use samples included in a limited promotion of its 3oz. Aspercreme® Pain Relieving Crème. Chattem is recalling these products because consumers have reported first, second and third degree burns as well as skin irritation resulting from consumer use.

Continue reading "FDA announces recall of Icy Hot Heat Therapy Air Activitated Heat products" »

Posted by Kerry N. Jardine at 10:08 AM | Permalink | Comments (0) | TrackBacks (0)

The latest research of Nephrogenic Systemic Fibrosis has come from the Center for Disease Control (CDC) and once again has tied NSF to exposure to Gadolinium contrast agents used in MRIs (Magnetic Resonance Images). Nephrogenic Systemic Fibrosis is a debilitating condition that leads to excessive formation of connective tissue in the skin and internal organs. It is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin; pain deep in the hip bones or ribs and muscle weakness. NSF can cause severe stiffness in joints, and can lead to death.

Continue reading "The CDC has confirmed link between Gadolinium and NSF" »

Posted by Peter W. Burg at 10:53 AM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration has recalled the SynchroMed E1 pump for potential failure in a Medtronic drug pump. The recalled Medtronic drug pumps were deemed a “class 1”, the most serious type, by the Food and Drug Administration last August. The drug pump used to treat pain, spasticity and cancer was recalled after motors failed because of gear-shaft wear. They were manufactured in Fridley and Puerto Rico before September 1999. Fortunately, no deaths or serious injuries have been reported. There are currently estimated to be 52,000 patients using the pump with about 8,000 of them that have the type that could fail. Medtronic in August informed doctors of the possible pump failure and encouraged them to monitor patients using the device.

Posted by David P. Hersh at 10:33 AM | Permalink | Comments (0) | TrackBacks (0)

Late January Baxter Healthcare Corp. voluntarily recalled thousands of pre-filled heparin injections because of questionable sterility and reports of adverse allergic events in dialysis patients. More that 50 dialysis patients in 12 states have had an allergic reaction in relation to the recalled batches of the blood thinner according federal health officials. The cases are being called the largest national outbreak of treatment-related allergic reactions ever seen in dialysis patients. The cases were reported at 19 dialysis facilities in California, Florida, Minnesota, Missouri, New Jersey, New York, North Carolina, North Dakota, Ohio, Pennsylvania, West Virginia and Wisconsin. Another 36 reports of allergic reactions are under investigation by the U.S Centers for Disease Control and Prevention. CDC officials are also looking into allergic-type reactions in seven cardiac patients in North Carolina who got Baxter-made heparin as well as looking into four cardiac cases in Florida, including one patient who died. Kidney patients receive heparin to prevent clotting of blood during the dialysis process. Allergic-type reactions occurred within minutes of starting dialysis, CDC officials said. The symptoms included facial swelling, nausea, rapid heart beat and decreased blood pressure. Baxter officials announced that some of these reactions may be severe or life threatening.

Posted by Kerry N. Jardine at 10:18 AM | Permalink | Comments (0) | TrackBacks (0)

Two new practice areas have been launched on the legal website LegalView.com. The areas address the lack of benefits when using the cholesterol drugs Vytorin and Zetia. The two drugs are used to control cholesterol levels in patients. According to a new study, Vytorin and Zetia have little success in decreasing arterial plaque and lowering a patient’s risk of heart disease compared to the generic versions. Further, Vytorin and Zetia can be up to three times more expensive. LegalView released these information portals to remind readers of the different varieties of medications available and that it is imperative that users understand the potential risks and issues associated with these drugs.

Posted by Kerry N. Jardine at 10:07 AM | Permalink | Comments (0) | TrackBacks (0)

The latest studies of the ineffectiveness of Vytorin and Zetia for reducing arterial plaque and decreasing the risk of heart disease has triggered a host of potential class-action lawsuits in several states. The suits allege that the companies Merck and Schering-Plough misled consumers into thinking the drugs were more effective than generics. Results from their ENHANCE study which ran from October 2002 to April 2006 showed Vytorin didn’t reduce plaque buildup any more than Zocor, which is available as a generic under the name simvastatin for about a third of the cost. Vytorin combines Schering-Plough’s Zetia with Merck’s Zocor. The 720-patient study was meant to show how well Vytorin limited plaque buildup in neck arteries in people whose genes gave them unusually high cholesterol levels. What the study really showed was that Vytorin was no more effective, and perhaps a bit worse, than Zocor alone.

Continue reading "Ineffectiveness of Vytorin launches a host of lawsuits" »

Posted by Kerry N. Jardine at 10:03 AM | Permalink | Comments (0) | TrackBacks (0)

A nationwide recall has been announced for NuCel Labs Eye Drops and Eye/Ear Wash. The recall is in response to a Food and Drug Administration inspection which found during product testing bacteria and particulate matter in the product. These products have been ruled non-sterile and pose an unacceptable risk of causing eye infections, which in rare cases could lead to blindness. The products are packaged in quarter ounce plastic bottles, have no lot numbers or expiration dates and approximately 500 units have been distributed nationwide through retail outlets and the internet. NuCel has ceased production and distribution and consumers are advised not to use them.

Posted by Seth A. Katz at 10:21 AM | Permalink | Comments (0) | TrackBacks (0)

Baxter has been recalling its pre-filled Heparin units and vials since January 17. The Food and Drug Administration announced the urgent nationwide recall to consumers. The recall includes nine lots of heparin sodium injection 1000 units/mL 10mL and 30mL multi-dose vials. The recall is in response to an increase in the number of reports of adverse patient reactions that may be associated with the product. The allergic-type reactions include stomach pain or discomfort, nausea, vomiting, diarrhea, decreased or low blood pressure, chest pain, fast heart rate, dizziness, fainting, unresponsiveness, burning sensation, redness or paleness of skin, abnormal sensation of the skin, mouth or lips, flushing, increased sweating, decreased skin sensitivity, headache, general feeling of illness, restlessness, watery eyes, throat swelling, thirst and difficulty opening the mouth. Some of these reaction may be severe and even life threatening. Heparin is a prescription blood thinner. The recalled units are primarily used for hemodialysis and cardiac invasive procedures. Customers have been told to discontinue use and to separate the product from their inventory.

Posted by Kerry N. Jardine at 04:33 PM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit against Medtronic by the family of a New York man has instigated the company to seek a Supreme Court ruling to protect it against future lawsuits. Medtronic has argued that since the FDA approved its medical devices it should preempt patients from bringing lawsuits against manufacturers if they are injured by the approved devices. If Medtronic succeeds in convincing the court to prevent such lawsuits, patients who are injured will lose protection against the defective medical devices that injured them.

Posted by Kerry N. Jardine at 12:55 PM | Permalink | Comments (0) | TrackBacks (0)

Rashid Hunter of Fremont, California has filed a class-action lawsuit against Medtronic on behalf of all Californians who have had the company’s defibrillator with the Sprint Fidelis leads implanted. The Sprint Fidelis leads have the potential defect of fracturing and malfunctioning at crucial moments during a cardiac event. At least five deaths have been attributed to the malfunctioning leads. Medtronic issued a recall of the defective product on October 15, 2007. Mr. Hunter’s seeks a Court order holding Medtronic responsible for all related diagnostic actions, medical charges and corrective surgical expenses caused by the defective leads. He expresses the emotional toll the recall has taken on him and his family saying, “I live in constant fear, wondering if my lead will malfunction and kill or cause me severe pain as it has done to others. My family also lives in fear that the device will fail and I won’t be able to get help in time to save my life. It would be a great relief to me and my family if Medtronic was required to fund a program to monitor the health of every patient with the recalled leads.” Hunter v. Medtronic, Inc. was filed in federal court in San Francisco alleging Medtronic misrepresented the safety of its Sprint Fidelis leads and failed to warn that the leads were prone to breakage. The Medtronic Sprint Fidelis lead has had a significantly higher than expected failure rate that appears in just the first two years after implantation.

Posted by Kerry N. Jardine at 12:49 PM | Permalink | Comments (0) | TrackBacks (0)

Nephrogenic Systemic Fibrosis (NSF), also known as Nephrogenic Fibrosing Dermopathy (NFD) is rare, but so far has only affected people with pre-existing kidney problems. The link between Gadolinium MRI dyes and NSF is gaining ground and quickly becoming irrefutable as the cause of the debilitating and sometimes deadly disease. In 2006, researchers discovered a direct association between NSF and the use of Gadolinium MRI contrast dyes. Since then, several other studies have reinforced the link between NSF and Gadolinium. The FDA in 2006 first warned doctors of the side effect. In 2007 the FDA ordered the manufactures of Gadolinium to add a black box warning, the strictest type of FDA warning, to their product labels advising of the risk of NSF to people with kidney problems. NSF leads to excessive formation of connective tissue in the skin and internal organs and is characterized by high blood pressure, burning, itching, swelling and hardening of the skin. Other symptoms include red or dark patches on the skin, pain deep in the hip bones or ribs and muscle weakness. Researchers at Yale University have reported that 95-percent of those with NSF had an MRI that involved Gadolinium two to three months before their symptoms appeared. Researchers at Massachusetts General Hospital also have found that kidney patients who had undergone MRIs with Gadolinium were 10 times more likely to develop NSF than patient who had not been exposed to such agents. Unfortunately, there are no effective treatments for NSF, although some patients have improved following a kidney transplant and there are no other alternatives to gadolinium based MRI contrast agents.

Posted by Kerry N. Jardine at 12:34 PM | Permalink | Comments (0) | TrackBacks (0)

Medtronic, Inc. announced that it has agreed to settle lawsuits relating to its Marquis line of implanted cardiac defibrillators. Under terms of the settlement, Medtronic has agreed to settle 2,682 cases for $95.6 million plus $18.5 million in attorneys' fees. The cases in the settlement are from February 2005 when Medtronic advised doctors about a potential battery problem that could cause certain implantable defibrillators in its Marquis line to fail. The settlement is a compromise and there is no admission of liability. No additional sums will be paid by Medtronic for third-party claims or attorney fees. "We are pleased to settle these cases and put the matter behind us," said Pat Mackin, senior vice president and president, Medtronic Cardiac Rhythm Disease Management. "We prefer to focus our resources on areas that are beneficial to physicians and patients, rather than prolong this litigation. We know the Marquis line of defibrillators continues to provide life-saving therapy for thousands of people around the world, and they remain among the most reliable ICDs ever manufactured by Medtronic."

Posted by Kerry N. Jardine at 06:32 AM | Permalink | Comments (0) | TrackBacks (0)

Medical syringes used by patients in home treatments for cancer and other illnesses have been contaminated with the bacteria Serratia marcescens (Sur-AY’-she-uh mar-SUH’-sens). About 40 people have fallen ill in Illinois and Texas, 20 of which were outpatients from Rush University Medical Center in Chicago. So far no deaths have been linked to the infection. The Rush doctors traced the infections to heparin-filled syringes from the company Sierra Pre-Filled in Angier, N.C. Federal investigators are inspecting the cases. Syringes from the same batch were also sent to Colorado, Florida and Pennsylvania, but at this time no infections have been reported from those states. The infections can cause fever and chills, but respond well to antibiotics. Of the 20 outpatients affected, 14 required hospitalization. The pre-filled syringe lot responsible is 070926H. Patients who think they used the recalled syringes should contact their doctors. Bacteria were found in fluid from the pre-filled syringes but it is uncertain if the original contamination was in the heparin, the saline used to dilute the drug, or the syringes themselves.

Posted by Kerry N. Jardine at 12:27 PM | Permalink | Comments (0) | TrackBacks (0)

Medtronic’s recent troubles concerning the Sprint Fidelis leads in their heart defibrillators has brought up the question among patients whether they should replace their defibrillators or not. Patients and their doctors are pondering whether they should risk another operation on the off chance that they have one of the potentially faulty wires. To complicate matters, Medtronic has agreed to provide only $800 dollars towards the replacement procedure that could exceed $12,500 dollars and take 90 minutes or more. Up until now, insurers are deciding whether to cover the operation on a case-by-case basis, unless the lead has already fractured. The number of patients with the potentially faulty wires makes this a widespread problem and the recent issue Medtronic has faced has drawn renewed scrutiny to how the medical devices are approved and regulated. In fact, this episode has led to investigations in both houses of Congress. Daniel Schultz, director of the Food and Drug Administration’s center for devices and radiological health concurs, “It seems like a good time to figure out where we are in regulating leads and what we can do better.”

Posted by Kerry N. Jardine at 06:34 AM | Permalink | Comments (0) | TrackBacks (0)

Ontario Superior Court Judge Alexandra Hoy certified a class-action lawsuit in a ruling December 6 that makes it possible for Canadians to seek Medtronic profits for damages in a lawsuit claiming the company failed to warn consumers of a defect in the batteries installed in its defibrillators. In October, Medtronic agreed to pay $130 million to settle U.S. claims against the defibrillators. In 2003 Medtronic discovered that their batteries ran out faster than the four to seven years that they were supposed to last. It wasn’t until two years later that the company advised doctors of the defective batteries. In Canada 2,416 patients had the devices implanted. Since February 2005, 613 of them had been removed or replaced as of June 2007. At this time no deaths or injuries have been reported as a result of the malfunction. The case is Between Frank Peter and Medtronic Inc., Ontario Superior Court of Justice (Toronto). Case No.: 05-CV-295910.

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In a decision Wednesday, Ford Motor Co. agreed to settle numerous class action lawsuits filed against them regarding the Ford Explorer vehicles that were prone to rollovers and tread separation on the installed Bridgestone/Firestone Inc. tires. The tread separations alone killed more than 250 people and hundreds more were injured, some catastrophically, in car accidents. The federal government began an investigation in 2000 when numerous complaints were received concerning the Bridgestone/Firestone tires installed on the Explorers. In the past several years Ford has faced wrongful death and personal injury lawsuits across the country involving the earlier models of the popular Explorer.

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Posted by Kerry N. Jardine at 06:53 AM | Permalink | Comments (0) | TrackBacks (0)

In October, Medtronic acknowledged the Sprint Fidelis wires used in their implantable defibrillators break more often than they expected. Medtronic also admits to the possibility of five deaths being linked to the defective lead wires. The wires connect defibrillator to the heart of a patient. In North Dakota, a woman is seeking a class-action suit against Minnesota based Medtronic because of the potential problems with her implanted defibrillator. Winnifred Leverson’s lawsuit allegations include emotional distress and negligence and she is seeking medical monitoring. Regardless of Medtronic’s and the FDA’s estimates that fractures have occurred in less than one percent of the wires, one death due to product defects is one too many.

Posted by Kerry N. Jardine at 03:51 PM | Permalink | Comments (0) | TrackBacks (0)

A personal injury lawsuit against Medtronic has been filed on behalf of a Kentucky woman in Minnesota state court. Kim Orange seeks damages for physical pain related to electrical shocks she suffered as well as for medical expenses she incurred and will incur for future medical care. Ms. Orange was taken to a medical center after suffering three electrical shocks caused by the defective Sprint Fidelis lead wiring that connected her heart to the defibrillator. At the medical center she suffered two additional shocks the same day and had to undergo surgery to remove the flawed device and implant a new defibrillator system. The extraction of the old and the implantation of the new lead system and defibrillator scarred her frail heart further. She expresses the pain and suffering she endured, “I felt like I was being repeatedly shot or kicked in the chest by a horse. The pain was intense and has the power to knock you down or out of a chair.” She goes on to explain, “You fear that you have a ticking time bomb inside your body that could unexpectedly explode or be triggered by a quick movement or vibration. Exertion such as bending over to make a bed, mowing the lawn and other everyday tasks have become frightening experiences.” Ms. Orange’s physician advised her to take off work. It appears the defect is attributed to the small diameter of the coil and conductors used in the leads, because of this they are subject to stress damage during and after implant. Fracturing then occurs when the conductors are strained.

Posted by Kerry N. Jardine at 12:59 PM | Permalink | Comments (0) | TrackBacks (0)

Deutsche Bank released a research report concerning additional problems on the horizon with the Sprint Fidelis lead wires used in the Medtronic defibrillator devices. Deutsche Bank analyst Tao Levy said in the report that while the impact of the recall was not as severe as anticipated, more distressing news may still be on the horizon. Nevertheless, the lead fractures could continue to require more replacements. Levy said the Fidelis lead may also offer poor sensing capabilities, ultimately leading to inappropriate shocks. "This latter concern is something new we have learned from our clinician contacts, and we could see published in medical journals," he noted in the report. "Bottom line is that while Medtronic has done a good job in managing the Fidelis recall, there will be clinicians who are not only frustrated with the number of leads affected but also by the increasingly poor performance of the lead," Levy wrote. The analyst said this could result in permanent loss of market share in implantable cardioverter defibrillators. A spokesperson for Medtronic said that the company is aware of the report but doesn't have immediate comment. In October, the medical-device maker suspended its Fidelis family of defibrillation leads because of the potential for the wires to fracture. Regardless, the company gave a report on the progress of the lead recall, which resulted in a meager 2% decline in earnings.

Posted by Kerry N. Jardine at 06:44 AM | Permalink | Comments (0) | TrackBacks (0)

Volvo Cars recently announced its decision to recall 56,000 cars because of two issues that could cause severe consequences and car accidents. Spokeswoman for Volvo Cars, Maria Bohlin confirmed that 38,000 diesel car 2006 models of S60, V 70, XC 70 and XC 90 have been linked to a material fault in the engine that could cause it to catch fire. Another recall involving 18,000 of the newer V 70 and XC70 models relates to a side air bag weakness. She goes on to explain that the fuel injector bolts, located on top of the motor cylinder are faulty and can potentially cause a diesel fuel leak into the motor, possibly causing an engine fire. It was not made immediately clear how many fire incidents there have been. Bohlin said with the air bag issues, “there’s a risk they don’t launch fast enough.” The faulty cars have been sold mainly in the U.S. Britain and Sweden.

Posted by Kerry N. Jardine at 06:47 AM | Permalink | Comments (0) | TrackBacks (0)

To resolve 2,600 claims against Medtronic and their Sprint Fidelis leads defects the company has agreed to pay around $130 million. That is up $55 million from the original proposed amount of $75 million from the initial settlement in July. The extra money will help Medtronic reach a resolution with the additional 600 claims that have since been filed over the heart defibrillators. The claims are over the battery defects in the implantable defibrillators, which send electric shocks to the heart to correct potential fatal heart rhythms. Rob Clark a spokesman for Medtronic said, “There is nothing new to report in this case. If there were a significant or material change in this case, we’d communicate that.”

Posted by Kerry N. Jardine at 12:42 PM | Permalink | Comments (0) | TrackBacks (0)

China is facing further difficulties in their relationship with the global economy when their exported toy, Aqua Dots, poisoned several children in the U.S. China’s government has suspended its worldwide export of the toy covered with a toxic chemical that metabolizes into a “date rape” drug when ingested. Nine children have been confirmed as ingesting the toy beads and sickening them, according to the Consumer Product Safety Commission. Tests showed the Aqua Dots were coated with the industrial chemical 1,4-butanediol. The “date rape” chemical is known as gamma hydroxy butyrate and may cause breathing problems, loss of consciousness, seizures, drowsiness, coma and death. In addition to the nine in the U.S., three children in Australia have also been stricken. In the U.S six of the children hospitalized came from Texas, Delaware, New Hampshire, Illinois and Utah. The U.S. recall covers 4.2 million of the Aqua Dots toys, which are colored beads that can be made into designs and then fused together when sprayed with water. The recall is the latest in a host of product quality issues that has tarnished the image of the country as an exporter of reliable goods. Australia-based Moose Enterprises, the toy’s maker has said the product was manufactured in China, but neither the company nor the Chinese government has identified the factory or factories where they were produced. Companies worldwide are increasingly outsourcing manufacturing. Often choosing Chinese factories for their cost and quality, but burgeoning competition among factories and the rising cost of labor, land and fuel are putting pressure on profits, causing some producers to cut corners. Aqua Dots were supposed to have been coated with the nontoxic 1,5-pentanediol, a chemical commonly used in computer printer ink, but that chemical generally sells for three or four times the price of the toxic compound 1,4-butanediol found on the toys.

Posted by Kerry N. Jardine at 12:37 PM | Permalink | Comments (0) | TrackBacks (0)

On October 14, 2007, Medtronic recalled the Sprint Fidelis lead wires in their product once five deaths were linked to the malfunctions. The leads are small wires which connect an implantable cardiac defibrillator to a patient's heart and deliver a jolt of electricity in order to correct an irregular heartbeat, such as during a heart attack. According to Medtronic, the Sprint Fidelis leads are more than twice as likely to break within 30 months as other lead wires manufactured by the company. Imperfections in the wires may cause a defibrillator to fail to deliver a life-saving jolt during a heart attack or may cause the device to deliver unnecessary painful and repeated shocks to the heart. The Food and Drug Administration has received at least 1,600 reports of patients who have experienced injuries or malfunctions due to problems with the Sprint Fidelis leads. Approximately one-third of these patients suffered unnecessary shocks to their hearts as a result of fractures in the lead wires. Several injured patients experienced a malfunction in their Sprint Fidelis leads and have filed lawsuits against Medtronic. These lawsuits have alleged that Medtronic continued to sell the lead wires despite the fact that they knew the product posed a greater risk for injury than its other defibrillator wires. Some experts believe that the Sprint Fidelis leads, which are known to be the thinnest made by Medtronic, may have been too fragile to be used safely with defibrillators. Medtronic is already facing more that 1,000 lawsuits over the 2005 recall of some defibrillators manufactured by the company. With more than 268,000 Sprint Fidelis leads currently in use, some financial analysts believe that the company could be facing an even greater number of lawsuits over the Sprint Fidelis recall.

Posted by Kerry N. Jardine at 12:25 PM | Permalink | Comments (0) | TrackBacks (0)

Medtronic, a company that makes pacemakers and other heart devices, has had a class action lawsuit filed against it by a man who claims to have received 47 unnecessary shocks from his implanted defibrillator. Medtronic has acknowledged some of the wires, made under the name Sprint Fidelis, in the devices have broken more often than expected and has since recalled them. The company has further added that five deaths may be linked to the faulty wires and that 235,000 people may have the faulty wires in their heart devices. The man who received the unnecessary shocks has since had his defibrillator replaced with a new set of Sprint Fidelis wires.

Posted by Kerry N. Jardine at 06:11 PM | Permalink | Comments (0) | TrackBacks (0)

Lipsticks tested by a U.S. consumer rights group found that more than half contained lead and some popular brands including Cover Girl, L'Oreal and Christian Dior had more lead than others, the group said on Oct 11th. The Campaign for Safe Cosmetics said tests on 33 brand-name red lipsticks by the Bodycote Testing Group in Santa Fe Spring, California, found that 61 percent had detectable lead levels of 0.03 to 0.65 parts per million (ppm). Lipstick, like food, is ingested. The Campaign for Safe Cosmetics, a coalition of public health, environmental and women's groups, said the FDA has not set a limit for lead in lipstick. One-third of the lipsticks tested contained an amount of lead that exceeded the U.S. Food and Drug Administration's 0.1 ppm limit for lead in candy, a standard established to protect children from ingesting lead. Lead can cause learning, language and behavioral problems such as reduced school performance and increased aggression. Pregnant women and young children are particularly vulnerable to lead exposure. Lead has also been linked to infertility and miscarriage. The FDA has set strict limits for lead levels allowed in the colors used in lipsticks and analyzes most of these to ensure they are followed. The products identified in the (CSC) report meet these standards.

Posted by Kerry N. Jardine at 12:32 PM | Permalink | Comments (0) | TrackBacks (0)

Topps Meat Co. on Oct 5th said it was closing its business, six days after it was forced to issue the second-largest beef recall in U.S. history. On Sept. 25 Topps began recalling frozen hamburger patties that may have been contaminated with the potentially fatal E. coli bacteria strain O157:H7. The recall eventually ballooned to 21.7 million pounds of ground beef. Thirty people in eight states had E. coli infections matching the strain found in the Topps patties, the Centers for Disease Control and Prevention reported. None have died. The Topps recall raised questions about whether the U.S. Agriculture Department should have acted quicker to encourage a recall. Topps conceded that much of the recalled meat had already been eaten, and on Friday expressed regret that its product had been linked to illnesses. The CDC reported the number of linked cases in these states: Connecticut, 2; Florida, 1; Indiana, 1; Maine, 1; New Jersey, 7; New York, 9; Ohio, 1; and Pennsylvania, 8.

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Posted by Kerry N. Jardine at 06:48 AM | Permalink | Comments (0) | TrackBacks (0)

The Topps Meat Co. on Saturday 29Sep expanded its recall of frozen hamburger patties to include 21.7 million pounds of ground beef that may be contaminated with E. coli bacteria that sickened more than a dozen people in eight states. The recall of products distributed to retail grocery stores and food service institutions in the United States was a drastic increase from the 332,000 pounds recalled the week prior. The recall represents all Topps products with either a "sell by date" or a "best if used by date" between Sept. 25 this year and Sept. 25, 2008. The company said this information is found on a package's back panel. All recalled products also have a USDA establishment number of EST 9748, which is located on the back panel of the package and-or in the USDA legend.

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Posted by Kerry N. Jardine at 12:31 PM | Permalink | Comments (0) | TrackBacks (0)

A package of Dole salad mix that tested positive for E. coli has triggered a recall in at least nine states, prompting new produce fears almost exactly a year after a nationwide spinach scare. The tainted bag of Dole's Hearts Delight salad mix was sold at a store in Canada, officials said. Neither Canadian health officials nor Dole Food Co. have received reports of anyone getting sick from the product. The voluntary recall, issued Monday Sep 17th, affects all packages of Hearts Delight sold in the United States and Canada with a "best if used by" date of September 19, 2007, and a production code of "A24924A" or "A24924B." The salad mix subject to the recall may have been available in the U.S. in states other than the nine already identified by Dole because in some areas a wholesaler distributed the product with clients in overlapping markets. The latest recall affects packages sold in Ontario, Quebec and the Maritime Provinces in Canad a and in Illinois, Indiana, Maine, Michigan, Mississippi, New York, Ohio, Pennsylvania and Tennessee starting around Sept. 8. Eighty-eight cases or 528 bags were distributed in Canada, and 755 cases containing 4,530 bags were distributed in the U.S.

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Posted by Kerry N. Jardine at 06:30 PM | Permalink | Comments (0) | TrackBacks (0)

An Ontario Superior Court judge has given an unprecedented green light to a class-action lawsuit against the federal government over jaw implants that disintegrated, leaving an estimated 2,600 people suffering a lifetime of intense, chronic pain. The case, which could result in settlements worth hundreds of millions of dollars, is the first in which a court has penetrated a seemingly impregnable immunity enjoyed by Health Canada regulators when it comes to faulty medical devices. The implants were manufactured in the U.S. and marketed under the trademark Proplast. A lawyer for the plaintiffs, John Legge, said in an interview that Parliament has a moral obligation to move quickly to settle the case and compensate the victims. The conduct of senior Health Canada officials in the case was unconscionable, Mr. Legge said. Despite being told the implants could break down and "cannibalize" bone and soft tissue at the base of each victim's skull, Health Canada failed to issue warnings or take action to get the devices off the market, he said. The lawsuit specifically alleges that the Health Canada employees negligently approved the Vitek TMJ implants under the Food and Drugs Act, and that they failed to warn doctors and patients of potential risks.

Posted by Kerry N. Jardine at 06:34 AM | Permalink | Comments (0) | TrackBacks (0)

A securities class action lawsuit has been filed on behalf of shareholders who purchased the common stock of Advanced Medical Optics, Inc. between January 4, 2007 and May 25, 2007. The class action lawsuit was filed for the Central District of California. The Complaint alleges that defendants violated federal securities laws by issuing a series of material misrepresentations to the market, thereby artificially inflating the price of Advanced Medical. Recently AMO voluntarily pulled their products from shelves when a rare and extremely painful infection of the cornea called acanthamoeba keratitis was linked to the use of AMO's Complete MoisturePlus Multi Purpose contact lens solution.

Posted by Kerry N. Jardine at 12:03 PM | Permalink | Comments (0) | TrackBacks (0)

An alternative theory as to the cause of chondrolysis is with the use of postoperative intra-articular pain pump catheters. A paper entitled "Post-arthroscopic Shoulder Chondrolysis with Associated Intra-articular Pain Pump Catheter Use" reports on the details. The group of investigators reviewed the charts of 152 patients who underwent 177 shoulder arthroscopies between January 1, 2003 and December 31, 2005 and looked for postarthroscopic chondrolysis. Twelve shoulders in 10 patients who underwent arthroscopic stabilization developed chondrolysis. Eighty-three percent of these required a subsequent procedure. All patients who developed chondrolysis had been treated postoperatively with an intra-articular pain pump catheter with bupivacaine containing epinephrine. Seven other patients treated with the pain pump catheters had not developed chondrolysis. All chondrolysis cases occurred after beginning the use of a larger pain pump, which infused this medication at 4.16 cc/hour over 2 or 3 days. Although the exact cause and mechanism of chondrolysis is still unknown, the study authors believe that there is a significant and previously unrecognized risk associated with the use of intra-articular pain pump catheters and bupivacaine with epinephrine. The study authors conclude that intra-articular pain pump catheters should be used with caution until the safety of constantly infusing local anesthetics intra-articularly is better defined.

Posted by Kerry N. Jardine at 03:56 PM | Permalink | Comments (0) | TrackBacks (0)

When the U.S. Food and Drug Administration approved implanting microchips in humans, the manufacturer said it would save lives, letting doctors scan the tiny transponders to access patients' medical records almost instantly. The FDA found "reasonable assurance" the device was safe, and a sub-agency even called it one of 2005's top "innovative technologies." However, neither the company nor the regulators publicly mentioned that a series of veterinary and toxicology studies, dating to the mid-1990s, stated that chip implants had induced malignant tumors in some lab mice and rats. Leading cancer specialists reviewed the research for The Associated Press and, while cautioning that animal test results do not necessarily apply to humans, said the findings troubled them. Some said they would not allow family members to receive implants, and all urged further research before the glass-encased transponders are widely implanted in people. To date, about 2,000 of the radio frequency identification, or RFID, devices have been implanted in humans worldwide, according to VeriChip Corp. The company, which sees a target market of 45 million Americans for its medical monitoring chips, insists the devices are safe, as does its parent company, Applied Digital Solutions, of Delray Beach, Fla.

Continue reading "Chip implants linked to tumors in animals" »

Posted by Kerry N. Jardine at 08:18 PM | Permalink | Comments (0) | TrackBacks (0)

Consumers and factory workers may be in danger from fumes from buttery flavoring in microwave popcorn. This was written as a warning letter to federal regulators from the leading lung research hospital, Denver’s National Jewish Medical and Research Center. A pulmonary specialist at National Jewish wrote to federal agencies saying doctors there believe they have the first case of a consumer who developed lung disease from the fumes of microwaving popcorn several times a day for years. The letter refers to a potentially fatal disease commonly called popcorn lung that has been the subject of lawsuits by hundreds of workers at food factories exposed to chemicals used for flavoring. In response to Dr. Cecile Rose 's finding, the Flavor and Extract Manufacturers Association issued a statement Tuesday Sep. 4th recommending that its members reduce "to the extent possible" the amount of diacetyl in butter flavorings they make. It noted that diacetyl is approved for use in flavors by the federal Food and Drug Administration.

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Posted by Kerry N. Jardine at 06:36 PM | Permalink | Comments (0) | TrackBacks (0)

Patients and healthcare professionals alike overestimate the safety of drug patches, according to a report in the LA Times. Pain patches containing fentanyl, including Ortho-McNeil's Duragesic, have caused overdoses, prompting the FDA to order a black box warning in 2005 that the patches should be prescribed at the lowest dose possible and not for short-term pain or post-operative pain. Other transdermal patches have also come in for questioning, including Ortho-McNeil’s Ortho Evra birth control patch, which can increase the risk of blood clots due to its higher-than-usual estrogen dose and Daytrana for ADHD, which has caused skin irritation in some users. One issue common to the transdermal patch is that while delivering a drug more steadily, it can also ultimately deliver more or too much of it. Since heat affects the rate of absorption, sunbathing or a hot shower could cause overdose. Additionally, skin thickness varies from patient to patient and thicker skins may mean lower uptake. Kenneth Sloan, a medicinal chemist at the University of Florida who has researched absorption from patches, told the LA Times: “Patches are not innocuous. One patch does not fit all.”

Posted by Seth A. Katz at 06:36 PM | Permalink | Comments (0) | TrackBacks (0)

California produce grower Metz Fresh LLC said on Wednesday August 29th, it voluntarily recalled fresh spinach in grocery stores and food service packages after a sample tested positive for salmonella. The California based company and a spokesman from the U.S. Food and Drug Administration said there have been no reports of illness or problems related to the spinach. The products were distributed in the continental United States and Canada under the Metz Fresh label. Recalled packages include 10-ounce and 16-ounce bags, as well as 2.5 and 4 pound bags shipped in cartons. The affected spinach carries tracking codes 12208114, 12208214 and 12208314. Consumers should discard any product related to the recall or return it to the place of purchase for a refund.

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Posted by Kerry N. Jardine at 10:32 AM | Permalink | Comments (0) | TrackBacks (0)

Fort Worth, Texas resident Debbie Wooten filed a personal injury lawsuit against Advanced Medical Optics, Inc. (AMO) for her suffering after the use of their Complete MoisturePlus Multi Purpose contact lens solution. The 44 year old says she suffered permanent vision loss due to Acanthamoeba keratitis, an extremely painful infection of the cornea, from use of the solution. Wooten was a regular purchaser of AMO contact lens solution, using the product as instructed. In late 2004, she began to suffer symptoms of light sensitivity, tearing, and redness. Wooten sought medical attention but her doctors were unable to accurately diagnose her condition. At the end of 2004, Wooten lost the vision in her left eye. In January 2005, Wooten was diagnosed with Acanthamoeba keratitis. She had to wait nine months for a corneal replacement surgery to make sure that after treatment of the infestation, the microorganism was dormant.

Continue reading "Texas Corneal Transplant Patient Files Lawsuit against Advanced Medical Optics " »

Posted by Seth A. Katz at 07:01 PM | Permalink | Comments (0) | TrackBacks (0)

On Aug 1st the FDA announced that many consumers may still not be aware of the May 2007 recall of Complete MoisturePlus Multipurpose Contact Lens Solution manufactured by Advanced Medical Optics (AMO) and continue to use the recalled product. Several cases of Acanthamoeba Keratitis have been reported to CDC that involves the use of the solution after the recall was announced. Individuals who wear soft contact lenses should stop using the product immediately and discard all remaining solution including partially used or unopened bottles.

Continue reading "List of AMO products recalled" »

Posted by Seth A. Katz at 06:57 PM | Permalink | Comments (0) | TrackBacks (0)

Katie was only on the Ortho Evra Patch for 10 months when she developed superficial deep vein thrombosis. Her doctor prescribed the Patch in October, 2005 as a method of birth control. After 10 months she began to have severe leg pain. She was shocked to be diagnosed with superficial deep vein thrombosis. Her doctor told her to take off the patch immediately. For the next two months she took heparin and other blood thinners. She had to stay home and rest for a week and wore a medical leg brace that keeps the blood circulating. After discovering what happened to many other young women who wore the Patch, she admitted she was very fortunate. She was surprised to find her local clinic still advertising the Ortho Evra Patch in their waiting room. So Katie ask’s “Why is the Ortho Evra Patch still on the market? Why didn't you do more testing? And what are the profits worth if you lose in people and lawsuits?"

Posted by Seth A. Katz at 02:55 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Food and Drug Administration said on Wednesday August 1st it was concerned that consumers were still using the contact lens solution Complete MoisturePlus Multipurpose solution made by Advanced Medical Optics that was recalled in May. Regulators said several new cases of the potentially deadly infection known as acanthamoeba keratitis, a parasite linked to the product, had been reported to the U.S. Centers for Disease Control and Prevention. The CDC earlier this year identified more than 20 cases of the infection in people who used the solution. The FDA reiterated its warning that people who wear soft contact lenses should stop using the solution and throw away any partially used bottles.

Posted by Seth A. Katz at 10:53 AM | Permalink | Comments (0) | TrackBacks (0)

Stores nationwide are continuing to sell recalled canned chili, stew, hash and other foods potentially contaminated with poisonous bacteria even after repeated warnings the products could kill. Thousands of cans are being removed from store shelves as quickly as investigators find them, more than a week after Castleberry's Food Co. began recalling more than 90 potentially contaminated products over fears of botulism contamination. The recall now covers two years' production at the company's Augusta, Ga., plant which includes tens of millions of cans. Spot checks by the Food and Drug Administration and state officials continue to turn up recalled products for sale in convenience stores, gas stations and family run groceries, from Florida to Alaska. The FDA alone has found them in roughly 250 of the more than 3,700 stores visited in nationwide checks, including Kentucky, Montana, New York and Indiana.

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Posted by Kerry N. Jardine at 06:17 AM | Permalink | Comments (0) | TrackBacks (0)

The FDA warned consumers to throw away 10-ounce cans of Castleberry's, Austex and Kroger brands of hot dog chili sauce with "best by" dates from April 30, 2009, through May 22, 2009. Castleberry's, owned by Bumble Bee Seafoods LLC, has recalled the products flagged by the FDA, as well as seven others produced at the same time. On Thursday July 19th, the Food and Drug Administration, Agriculture Department and Centers for Disease Control and Prevention were investigating a Castleberry's Food Co. plant in Augusta, Ga., where the suspect product was canned. An equipment malfunction may be responsible for the contamination. The company experienced a production problem about two months ago, when cans were being overheated, which can cause them to expand enough to allow in contamination, before being cooled. Production was halted until the foods being canned at the time could be checked. One food safety expert said the new outbreak was disturbing. "It raises concerns that the existing food safety programs that have been functioning are losing ground because of gaps in FDA oversight," said Caroline Smith DeWaal, director of food safety for consumer group Center for Science in the Public Interest.

Continue reading "Hot Dog Chili Sauce to Blame in Botulism Outbreak" »

Posted by Kerry N. Jardine at 08:24 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA and Baxter Healthcare Corp. have notified healthcare professionals and consumers of a Class 1 Recall of Baxter Upgraded COLEAGUE Triple Cannel Volumetric Infusion Pumps, Model numbers 2M8153, 2M8163, and 2M9163. The FDA defines a class 1 recall as "a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death." The electronic pumps are used to deliver controlled amounts of medication or other fluids to patients through and intravenous or other direct line into the bloodstream.

Continue reading "Baxter Healthcare Corp. Recalls Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps" »

Posted by Kerry N. Jardine at 06:14 PM | Permalink | Comments (0) | TrackBacks (0)

The United Food Group LLC has expanded its voluntary ground beef recall to include about 5.7 million pounds of fresh and frozen meat that may be contaminated with E. coli. David Goldman, acting administrator of the USDA Food Safety and Inspection Service, announced on Saturday that the recall would be expanded to include products with sell-by dates from April 6-April 20. The beef was sold in 11 Western states. Goldman said that none of the latest batch of suspect beef is in stores now because the product would be well past its expiration date, but consumers may still have some of the meat at home. The meat has been blamed for an E. coli outbreak in the Western states that resulted in 14 illnesses, spanning April 25 through May 18. All the patients have recovered. "It is important for consumers to look in their freezers," Goldman said.

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Posted by Kerry N. Jardine at 03:01 PM | Permalink | Comments (0) | TrackBacks (0)

A voluntary recall of ground beef processed at a Vernon, CA plant and sold in 11 states has been expanded to include an additional 370,000 pounds that may have been contaminated with a potentially deadly strain of E. coli bacteria. United Food Group LLC yesterday expanded the recall, which involved 75,000 pounds and was announced Sunday in cooperation with the U.S. Department of Agriculture and the California State Department of Health Services, based on unspecified concerns raised by the state agency, according to a company statement.

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Posted by Kerry N. Jardine at 05:26 PM | Permalink | Comments (0) | TrackBacks (0)

A voluntary recall of ground beef processed at a Vernon, CA plant and sold in 11 states has been expanded to include an additional 370,000 pounds that may have been contaminated with a potentially deadly strain of E. coli bacteria. United Food Group LLC yesterday expanded the recall, which involved 75,000 pounds and was announced Sunday in cooperation with the U.S. Department of Agriculture and the California State Department of Health Services, based on unspecified concerns raised by the state agency, according to a company statement.

Continue reading "Ground beef recall of 370,000 pounds" »

Posted by Kerry N. Jardine at 05:26 PM | Permalink | Comments (0) | TrackBacks (0)

Purdue Pharma, the company that markets OxyContin, pleaded guilty in a Virginia Federal Court today, admitting that they misled regulators, doctors and patients about the drug's risk of addiction and its potential to be abused. Three executives of the company, including its president and top lawyer, also pleaded guilty as individuals to charges of misbranding. The three agreed to pay fines totalling $34.5 million. "Misbranding" means to mislabel a drug, fraudulently promote it, or market it for an unapproved use.

Continue reading "Maker of Oxycontin Pleads Guilty, Agrees to Pay $600 Million in Fines" »

Posted by Seth A. Katz at 09:37 PM | Permalink | Comments (0) | TrackBacks (0)

Cracker Barrel and a hamburger supplier were investigated after a patron in South Carolina reported cutting her mouth on a piece of metal embedded in a patty, causing the chain to pull burgers from hundreds of restaurants. The chain has not confirmed what the object was, but they have removed burgers from more than 300 restaurants that were produced on or around the same date as those served in the Myrtle Beach restaurant where the woman was cut, said Julie Davis, spokeswoman for the Lebanon, Tenn.-based restaurants. "We are putting out a wide net," Davis said Tuesday. "We are taking this very seriously." The burgers which are delivered to the restaurants frozen and pre-formed came from Cargill Meat Solutions of Wichita, Kan., which is the chain's largest burger supplier, Davis said. "We're working to gather the information needed to come to a solid conclusion in this matter," said Mark Klein, a spokesman for Cargill's meat businesses. "No one should be jumping to conclusions until the investigation is concluded."

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Posted by Kerry N. Jardine at 09:27 PM | Permalink | Comments (0) | TrackBacks (0)

Donna Grimes is paralyzed from the neck down because the Ford Motor Co. didn't listen to its own engineers about fatal flaws its car seats pose in rear-end crashes, a Palm Beach County jury was told by her attorney James Lowe. Attorneys representing the auto manufacturer in the multimillion-dollar lawsuit say it is untrue. The mother of five is paralyzed because a car slammed into the back of her 2000 Ford Explorer at 60 mph, attorney David Kelly said. "The Explorer seat is not defective," he insisted. "The injuries were caused by the severity of this crash, and Ford did not cause the severity of this crash." The different views of the 2001 wreck are similar to those raised in lawsuits against car manufacturers throughout the nation. Grimes was alone in her Explorer, when a Toyota Solara ran into her vehicle. Her seat flew back, throwing her head-first into the back seat and breaking her neck. Witnesses said they found her seat belt around her calves. The driver of the much smaller Solara, which was heavily damaged in the crash, walked away uninjured. "She should have walked away," said her attorney James Lowe. "Donna didn't walk away because her seat broke."

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Posted by Kerry N. Jardine at 05:38 PM | Permalink | Comments (0) | TrackBacks (0)

The U.S. Consumer Product Safety Commission (CPSC) has received hundreds of complaints concerning magnets that have fallen out of a number of toys. There have been at least 33 reported cases in which children have swallowed a loose magent and had to receive emergency surgery. There has been one reported fatality of a 20-month-old-boy from Seattle, Washington. In nearly all of the cases reviewed by CPSC, each child had suffered intestinal perforations.

Continue reading "Small Magnets Found in Several Toys Dangerous to Children" »

Posted by Kerry N. Jardine at 10:32 PM | Permalink | Comments (0) | TrackBacks (0)

Researchers have recently discovered that heart patients who have stents implanted to keep their arteries open have no lasting benefit compared to those treated only with drugs. The five-year study found that patients treated with stents in addition to statins and other drugs did have a better blood flow to the heart than patients treated only with drugs, but they did not live longer or have fewer heart attacks. This study confirmed the results of previous, smaller studies.

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Posted by Kerry N. Jardine at 09:25 PM | Permalink | Comments (0) | TrackBacks (0)

A Statement from the Center for Science in the Public Interest (CSPI) Food Safety Director Caroline Smith DeWaal reports that the CDC’s latest report shows that infections from E. coli O157:H7, Salmonella, and Vibrio are all on the rise. E. coli cases reported to CDC’s FoodNet rose 50 percent since 2004, and Vibrio, another potentially deadly pathogen in shellfish, rose 78 percent since FoodNet began (1996-1998). The new data show that federal food safety agencies are failing in their job to protect Americans from foodborne illness. In the last six months outbreaks associated with spinach, tomatoes, peanut butter and lettuce have shaken the Americans confidence in the safety of the food supply. Even pet food has been recalled after an outbreak affecting thousand of cats and dogs. The Government Accountability Office recently put food safety on the list of high risk programs. Clearly, these programs are failing and need to be fixed.

Continue reading "New CDC Data Show Increases in E.coli, Salmonella and Vibrio" »

Posted by Kerry N. Jardine at 08:32 AM | Permalink | Comments (0) | TrackBacks (0)

August 2006 — First cases of Salmonella Tennessee, the rare strain linked to this outbreak, are reported.

August 2006 — Moisture invades ConAgra plant in Sylvester through a roof leak and the building's fire sprinkler system, which goes off twice because of a faulty sprinkler head. Company officials would later blame this moisture for helping salmonella bacteria grow in the plant.

Feb. 14, 2007 — The Centers for Disease Control and Prevention announce that the salmonella outbreak is linked to Peter Pan peanut butter. The CDC and state health agencies had noticed a spike in cases of people sickened with the Salmonella Tennessee strain, and interviews with victims revealed peanut butter as a link.

Feb. 14, 2007 — ConAgra announces a recall of all Peter Pan and Great Value peanut butter made at the plant. The affected jars all carried a product code beginning with "2111."

Feb. 20, 2007 — ConAgra estimates that its nationwide recall of peanut butter will cost between $50 million and $60 million.

March 7, 2007 — CDC announces that 425 people in 44 states have become ill with Salmonella Tennessee. The onset dates for most of those cases range between Aug. 1, 2006, and Feb. 16, 2007. Two-thirds of those cases were reported between Dec. 1 and Feb. 16.

April 5, 2007 — ConAgra releases findings of its investigation and blames moisture for helping salmonella spread. Company also announces plans to renovate the plant.

Posted by Kerry N. Jardine at 08:21 AM | Permalink | Comments (0) | TrackBacks (0)

Boston Scientific/Guidant and the FDA announced today that a subset of cardiac defibrillators within the Contak Renewal 3 & 4, Vitality and Vitality 2 families have been recalled. The recall includes about 73,000 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators because of faulty capacitors that may cause depletion of the batteries sooner than would normally be expected.

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Posted by David P. Hersh at 05:23 PM | Permalink | Comments (0) | TrackBacks (0)

The Food and Drug Administration said it will increase the frequency of investigations at plants that make peanut butter and similar products, saying this year's salmonella outbreak showed peanut butter is riskier than health officials had thought. "Up until this point, peanut butter has not been considered a high-risk food," said Dr. David Acheson, chief medical officer of the FDA's Center for Food Safety and Applied Nutrition. "We now know peanut butter can be a vehicle for salmonella." Peanut butter will almost certainly move up on the FDA's list of high-risk foods, and the agency bases its inspection schedule on the relative risk of foods. "For anybody who makes peanut butter, we've now learned that if there's salmonella in the environment there could be a problem," Acheson said. That's why salmonella infections could happen at other peanut butter plants, but he believes the industry has been paying attention. "I would be pretty certain that every other peanut butter producer is having the same thought we are and is paying a lot of attention to it to make sure that it doesn't happen," he said. The basic process used at all peanut butter plants is similar. They all bring raw peanuts in, roast and grind them, mix and blend them, and put the product in bottles or cans. "It's a call to all of us to be thinking about if it can happen in the ConAgra plant in Georgia, why couldn't it happen in some other peanut butter plant? And I think the answer is it could," Acheson said.

Continue reading "FDA Plans More Peanut Butter Inspections" »

Posted by Kerry N. Jardine at 07:49 AM | Permalink | Comments (0) | TrackBacks (0)

Ten attorneys were allowed inside the Sylvester, Georgia ConAgra Foods plant to see how salmonella bacteria ended up inside peanut butter jars. Lawyers, photographers and engineers walked the roof of ConAgra Foods, photographing the roof leak believed to be the source of salmonella bacteria inside the plant. "We represent almost five thousand people across the nation and we have service members in Iraq, we have people from foreign countries, we represent about half the people that are officially counted," said Seattle attorney Bill Marler. "Micro-biologists, roofing experts, engineers, lots of photographers, lots of videographers, we even have a guy in there that sort of does this laser, GPS thing to figure out where the vats are in relation to the roof to various areas," Marler said.

Continue reading "Lawyers walk through Peter Pan plant" »

Posted by Kerry N. Jardine at 07:43 AM | Permalink | Comments (0) | TrackBacks (0)

ConAgra Foods said Thursday April 5th, that moisture from a leaky roof and faulty sprinkler was the source of the salmonella bacteria that contaminated peanut butter at its Georgia plant sickening more than 400 people nationwide. The Omaha-based company conducted a nearly two-month investigation into the contamination and pledged to ensure that Peter Pan peanut butter is safe when it returns to stores in mid-July. The plant's roof leaked during a rainstorm, and the sprinkler system went off twice because of a faulty sprinkler, which was repaired. The moisture from those three events mixed with dormant salmonella bacteria in the plant that spokeswoman Stephanie Childs said likely came from raw peanuts and peanut dust. She said the plant was cleaned thoroughly after the roof leak and sprinkler problem, but the salmonella remained and somehow came in contact with peanut butter before it was packaged.

Continue reading "Moisture led to salmonella outbreak" »

Posted by Kerry N. Jardine at 10:46 AM | Permalink | Comments (0) | TrackBacks (0)

Victims of peanut butter salmonella poisoning hire Masry & Vititoe and Girardi & Keese in lawsuit against ConAgra. The lawsuit represents 76 injured individuals including two wrongful death claims. 26 different states are represented in this action including individuals from Texas, Missouri, Indiana, Florida, Kansas, and California. The team will seek, among other relief, general damages, special damages, and punitive damages.

Continue reading "Victims of Salmonella Poisoning Suing ConAgra in CA" »

Posted by Kerry N. Jardine at 10:43 AM | Permalink | Comments (0) | TrackBacks (0)

A North Dakota man has filed a federal class-action lawsuit as part of a national body parts scandal claiming he received transplanted bone tissue in South Dakota that might be diseased. Charles Geigle of Oliver County, N.D., had back surgery April 30, 2004, at Sioux Valley Hospital in Sioux Falls. He received a letter in December 2005 from a doctor at the hospital telling him the bone tissue might have been illegally acquired and that he could be at risk of getting a disease. Geigle said in his lawsuit that he and perhaps thousands of others now live in fear that they or their spouses have been exposed to a deadly disease. The now defunct New Jersey supplier was Biomedical Tissue Services and is accused of collecting body parts from cadavers without donor consent and selling them for use in transplants across the country. BTS supplied bone, skin and tendons to various processors, who in turn provided them to distributors. The Food and Drug Administration is concerned those parts could be infected with the AIDS virus, syphilis and hepatitis, but has said the risk of infection is small. The FDA will not say whether any patients have ailments that might be linked with suspect tissue. The FDA has refused to reveal how many people received BTS tissue. The FDA and Centers for Disease Control also urged people who received BTS tissue be tested for infectious disease.

Continue reading "Man files lawsuit in body parts scandal" »

Posted by Scott J. Eldredge at 08:01 PM | Permalink | Comments (0) | TrackBacks (0)

Two Palm Beach County women who became ill after eating salmonella-contaminated peanut butter are suing its manufacturer, ConAgra Foods Inc. Brian Smith, a West Palm Beach attorney with Smith & Vanture, filed separate lawsuits Thursday in Palm Beach County Circuit Court on behalf of Ruby Reilly of Palm Beach Gardens and Gloria Deleo of West Palm Beach. There are close to 400 confirmed cases of illness that have been linked to the product in 42 states, FDA officials said. ConAgra is being sued for product defects, failure to warn consumers of the product's danger, and negligence. Each woman is seeking damages in excess of $15,000.

Continue reading "Florida women who ate tainted peanut butter file suits" »

Posted by Kerry N. Jardine at 08:26 PM | Permalink | Comments (0) | TrackBacks (0)

ConAgra Foods Inc. earned $192.6 million in the third quarter despite a massive recall of all of its peanut butter products after they were linked to a salmonella outbreak, the company reported. This year's results were considerably better than a year ago, when ConAgra posted a loss of $25.2 million because of one-time charges related to restructuring. The Omaha, Nebraska based company said its earnings amounted to 38 cents per share in the quarter that ended Feb. 25, versus a loss of 5 cents a share a year ago. Its latest results included one cent a share from discontinued operations.

Continue reading "ConAgra reports 3Q profit despite peanut butter recall" »

Posted by Kerry N. Jardine at 08:01 PM | Permalink | Comments (0) | TrackBacks (0)

State officials in Tulsa Oklahoma are trying to determine whether a salmonella outbreak traced to the peanut butter recall played a role in a Tulsa man's death. Assistant laboratory director for the Oklahoma Department of Agriculture, said a peanut butter sample provided by the man's wife was tested and matched to Salmonella Tennessee (the strain that caused illnesses in hundreds of people across the country. The state is conducting more tests to determine whether the suspected organisms found in the peanut butter were present in the man's body. The director told the state Board of Agriculture the man was already suffering from an undisclosed illness before his death this month.

Continue reading "Oklahoma officials testing whether man's death linked to peanut butter" »

Posted by Kerry N. Jardine at 07:58 PM | Permalink | Comments (0) | TrackBacks (0)

In Rome, Georgia Plaintiffs' counsel Kathryn E. Barnett announced that 32 consumers, including the parents of nine children that became seriously ill after eating Peter Pan or Great Value peanut butter, spanning 16 states filed an amended class action complaint against the international food conglomerate ConAgra Foods, Inc. The proposed class consists of all persons nationwide that contracted Salmonella Tennessee from eating ConAgra's contaminated peanut butter

Continue reading "Nationwide class action lawsuit against ConAgra Foods, Inc." »

Posted by Kerry N. Jardine at 07:49 PM | Permalink | Comments (0) | TrackBacks (0)

FDA investigators have details on the location of the Salmonella outbreak that shut down the Sylvester ConAgra Foods plant five weeks ago. It could be the end of May before production resumes. The clean up will begin now that the FDA has pin-pointed the cause. "The two environmental positives that we did find were, one of them was in relation to the roaster and the other was on some cleaning equipment," said Dr. David Acheson. Since it was found twice in the environment, the FDA investigators assume it may be in other places and recommend a complete cleanup. ConAgra is working with a microbiologist on a plan to resume operations. Employees continue the clean up effort.

Continue reading "Salmonella found in roaster and cleaning supplies at ConAgra" »

Posted by Kerry N. Jardine at 08:33 PM | Permalink | Comments (0) | TrackBacks (0)

On March 21, 2007, the FDA announced new draft guidance that would lead to restrictions on who can serve on an FDA Advisory Committee in an attempt to reduce potential conflicts of interest. Advisory Committees are those committees that provide the FDA with "independent advice from outside experts" on issues relating to drugs or devices being considered by the FDA. Often the issue being considered is whether the product should be removed from the market. Thus, membership on an Advisory Committee is a prestigious position with significant influence over the continued marketability of a product.

Continue reading "FDA announces new draft guidance" »

Posted by Seth A. Katz at 08:44 PM | Permalink | Comments (0) | TrackBacks (0)

There are 13 confirmed cases of Salmonella in Indiana that have been linked to the peanut butter recall. The hospitals in and the health department have learned this is a fairly new strand of Salmonella and has people on edge. Doctors at Deaconess Hospital say they have been busy since the recall was announced. Dr. Patrick Fouts says the hospital is waiting for lab results on several other patients who had symptoms.

Continue reading "Peanut Butter Scare Keeping Doctors Busy" »

Posted by Kerry N. Jardine at 08:06 PM | Permalink | Comments (0) | TrackBacks (0)

Jars of peanut butter have the people at the Tri-State Food Bank searching for all the extra hands they can find. 35-thousand pounds of food packed and ready to ship out, but volunteers with the Tri-State Food Bank have to sort through all of the boxes, just to find the recalled peanut butter. The FDA warns the jars may be tainted with Salmonella. "One of the items we always stress that we need because it's high in protein, is peanut butter so now we're concerned we might have some peanut butter that came through and we want to make sure none of it gets out of the building," says Mary Blair, Executive Director of the Tri-State Food Bank.

Continue reading "Peanut Butter Recall Slows Down Food Bank" »

Posted by Kerry N. Jardine at 07:48 PM | Permalink | Comments (0) | TrackBacks (0)

Seven major food recalls since July inlude E. coli in spinach, Salmonella in peanut butter and Listeria in hot dogs. The Food Safety Network located at Kansas State University, is dedicated to stopping food contamination, which sickens 76 million people, one out of every four Americans and kills 5,000 each year. The network combines public awareness with an Internet-based information service and research projects in an effort to educate growers, consumers and workers. Microbiologist Doug Powell started the organization more than a decade ago at the University of Guelph in Canada. Now an associate professor of food safety in Kansas State's College of Veterinary Medicine, Powell is outspoken on good farming practices and good worker hygiene and blunt about what needs to be done. "It boils down to three words," he said. "Don't eat poop." Simple as Powell's advice sounds, food safety is far more complicated, he admits. Microbial contamination, such as E. coli or salmonella is not visible, and has no taste and no smell. It can come from any number of sources along a chain of growing, harvesting, processing, packaging and selling. It can come from water that drains from a livestock operation and runs through a field after a rain. It can come from irrigation water drawn from a contaminated pond. It can come from processing vats, storage bags, tools, or workers' hair, skin or saliva. "What needs to happen is that people need to stop the pretty talk about 'natural, locally grown, fresh, organic produce' and get serious about microbes," Powell said. "Forget about wholesome whatever and farm sunshine. What we need is bacteria-free produce."

Continue reading "Food Safety Network aims to stop food contamination" »

Posted by Kerry N. Jardine at 07:23 PM | Permalink | Comments (0) | TrackBacks (0)

The number of Oklahomans sickened by peanut butter contaminated with salmonella has increased to 12, state health officials reported. The discovery of an additional person sickened by the peanut butter prompted the state Department of Health to warn people again of the potential danger posed by the tainted product. "Nearly every family has a jar of peanut butter in their pantry, so we want Oklahomans to take this product recall very seriously," said State Health Commissioner Dr. Mike Crutcher. "If you still have jars of Peter Pan or Great Value peanut butter with the product code beginning with 2111, throw them away."

Continue reading "Oklahoman Sickened By Peanut Butter" »

Posted by Kerry N. Jardine at 09:40 AM | Permalink | Comments (0) | TrackBacks (0)

U.S. food safety authorities extended a recall of peanut butter linked to a salmonella outbreak to include products bought as early as October 2004. Initially, the U.S. Food and Drug Administration said all Peter Pan peanut butter bought since May 2006, and all of Wal-Mart Inc.'s Great Value peanut butter with the batch code 2111 should be discarded. ConAgra Foods Inc. makes both, and has recalled all potentially contaminated batches.

Continue reading "Peanut butter recall widens" »

Posted by Kerry N. Jardine at 08:04 AM | Permalink | Comments (0) | TrackBacks (0)

Law firms file their second lawsuit against ConAgra Foods Inc. on behalf of victims of salmonella poisoning derived from contaminated Peter Pan brand peanut butter. This case was filed on behalf of the daughter of a woman who died after ingesting contaminated Peter Pan peanut butter. Two firms have filed a lawsuit against ConAgra Foods Inc. on behalf of the daughter of a woman who died from Salmonella poisoning after eating Peter Pan peanut butter. The case was filed March 5, 2007 in the U.S. District Court for the Northern District of Mississippi Delta Division. The suit alleges, amongst other things, that ConAgra's negligence, and its failure to comply with the requirements of the Federal Food, Drug & Cosmetics Act contributed to the peanut butter contamination and subsequent outbreak of Salmonella. The firms have been contacted by thousands of people who became sick after ingesting contaminated peanut butter manufactured by ConAgra.

Continue reading "Woman dies after peanut butter ingestion" »

Posted by Kerry N. Jardine at 04:57 PM | Permalink | Comments (0) | TrackBacks (0)

A part-time Pinellas County Florida resident filed a $5 million class action federal lawsuit against ConAgra Foods and Wal-Mart stores because of a salmonella outbreak believed to be caused by peanut butter products three weeks ago. Marion Caldarera filed the lawsuit on behalf of her and more than 500 others who ate tainted peanut butter processed by ConAgra in Sylvester, Ga., and sold by retailers across the country. According to public records, ConAgra has been sued 12 times since the outbreak was announced and the second such filed in Florida. A Palm Beach man filed a class action lawsuit in the Southern District of Florida on Feb. 23. Caldarera’s attorney, Edward Zebersky of Hollywood said she has suffered classic symptoms of salmonella poisoning for weeks.

Continue reading "Another Lawsuit filed in peanut butter case" »

Posted by Kerry N. Jardine at 08:47 AM | Permalink | Comments (0) | TrackBacks (0)

FDA has learned that the ConAgra plant in Sylvester, GA, sent bulk Peter Pan peanut butter to its plant in Humboldt, TN. The three brands of toppings described below are part of the original Peter Pan recall. These brands have been recalled and are no longer being sold. However, some consumers may still have these products in their home. Consumers who have any of the products listed below should discard them. Individuals who are not sure if the purchased product contains the recalled peanut butter topping should contact the store where the product was purchased. The company's recall extends to products made since December 2005.

Continue reading "Peanut Butter Toppings Part of Recall" »

Posted by Kerry N. Jardine at 09:45 PM | Permalink | Comments (0) | TrackBacks (0)

The number of illnesses resulting from salmonella contamination in jars of peanut butter has climbed to 370, federal health officials said Tuesday. The number is up from 329 confirmed cases last week. Forty-two states have confirmed cases and sixty people have been hospitalized, but there have been no deaths, according to the U.S. Centers for Disease Control and Prevention. The recall has been widely reported and prompted lawsuits. It's likely that additional cases are due to raised awareness and not recent illnesses, said CDC spokesman Dave Daigle. "There may be a few weeks from when a case occurs to when it is officially reported, so we would attribute this rise in the case count to a reporting phenomenon rather than a new spike in cases," he said.

Continue reading "Salmonella cases from peanut butter rise to 370" »

Posted by Kerry N. Jardine at 09:52 PM | Permalink | Comments (0) | TrackBacks (0)

Charles Stafford is a self-acknowledged peanut butter addict, a "serious" eater of the Peter Pan brand in particular, who grew up in a poor home where "if you didn't like peanut butter, you starved." But Stafford's lifelong love of the spread was tested recently when he became infected with salmonella during a nationwide outbreak linked to the Peter Pan and Great Value brands of peanut butter, he said. Stafford bought the contaminated Peter Pan in January, ate the peanut butter every day and soon became ill, experiencing nausea, vomiting and diarrhea, the lawsuit said. His physician diagnosed him with a likely case of salmonella poisoning, according to the suit. He missed several days of work. As of Wednesday, 329 people infected with the outbreak strain had been reported to the CDC. They reside in 41 states. No deaths have been attributed to the infection.

Continue reading "Man sues maker of tainted peanut butter" »

Posted by Kerry N. Jardine at 09:43 PM | Permalink | Comments (0) | TrackBacks (0)

ConaAgra said the recall of tainted peanut butter made at a Georgia plant will cost between $50 and $60 million. Federal officials linked the peanut butter made in Sylvester to a salmonella outbreak. The salmonella has affected over 300 people nationwide including 14 reported in Georgia, since August. No deaths have been reported. Three people have already filed lawsuits claiming the peanut butter made them sick.

Continue reading "ConAgra Peanut Butter Recall Will Cost $50M" »

Posted by Kerry N. Jardine at 09:35 PM | Permalink | Comments (0) | TrackBacks (0)

Product testing by several states has now confirmed that Peter Pan peanut butter and certain Great Value brand peanut butter are the sources of the foodborne illness outbreak of Salmonella Tennessee that began in August 2006. To date 329 individuals have become ill from consuming the contaminated peanut butter, and 51 of those persons were hospitalized. The outbreak is ongoing. All products containing Peter Pan brand peanut butter and all jars of Great Value brand peanut butter bearing a product code that begins "2111" are potentially contaminated. Potentially contaminated products include 3/4 ounce and 1.1 ounce single serving packs of Peter Pan brand peanut butter. All of these products contain peanut butter that was manufactured in ConAgra's Sylvester, Georgia plant. Retailers and institutions possessing the products described should not serve or sell them. Any consumer possessing any of these products should discard them.

Continue reading "FDA Update on Salmonella Outbreak" »

Posted by Kerry N. Jardine at 09:25 PM | Permalink | Comments (0) | TrackBacks (0)

A father who says he and his son became violently ill after eating tainted Peter Pan peanut butter filed suit in Miami on Wednesday against the manufacturers and Publix, which sold him the product. Lazaro Aleman, of Cutler Bay, Fla., said the jar of peanut butter he bought was part of a batch of Peter Pan and Great Value brand peanut butter made by Nebraska-based ConAgra Foods at a Sylvester, Ga. plant. Last week, ConAgra voluntarily recalled those jars, with product code 2111 on the lid, after federal officials linked the peanut butter to a salmonella outbreak that sickened almost 300 people. Salmonella is a bacterial infection that causes fever, diarrhea and abdominal cramps. The lawsuit filed in Miami-Dade Circuit Court is at least the fourth since the recall. Aleman's attorney, John H. Ruiz, said he will ask a judge to grant class action status to include people who bought and ate the peanut butter, whether they became sick or not. Ruiz said more than 100 people from around the state, including Broward and Palm Beach counties have contacted him and might become part of the suit.

Continue reading "Florida man seeks class action in suit against peanut butter make" »

Posted by Kerry N. Jardine at 09:21 PM | Permalink | Comments (0) | TrackBacks (0)

US Health officials have confirmed the presence of salmonella bacteria in jars of peanut butter that were involved in a nationwide recall last week. The Centers for Disease Control and Prevention reported that the count of those sickened has risen to 329 in 41 states. The CDC reported that 51 of the 249 patients for whom clinical information is available have been hospitalized and that there have been no deaths. The FDA is warning consumers not to eat any Peter Pan peanut butter or Wal-Mart house brand Great Value peanut butter with a product code beginning with 2111 purchased since May 2006. Symptoms of salmonella poisoning include fever, diarrhea and abdominal cramps.

Posted by Kerry N. Jardine at 10:15 PM | Permalink | Comments (0) | TrackBacks (0)

The first class-action lawsuit against peanut butter maker ConAgra was filed by Orlando-based lawyers February 22, after floods of people reported getting sick from the tainted products and two deaths may be linked to eating the food. Lawyers with Morgan and Morgan out of Orlando filed the 12-page document in response to a flood of phone calls from peanut butter eaters. It could be legal relief for what could be at least 1,000 people in Florida who may have at one point since last summer fallen sick from Peter Pan or Great Value peanut butter. Attorneys said they are looking at two deaths possible linked to the peanut butter. "In one particular case, we have a client who ingested the peanut butter and then died as a result of a certain form of meningitis, a meningitis that can be linked to salmonella poisoning," Morgan and Morgan attorney Alexander Clem said.

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Posted by Kerry N. Jardine at 10:13 PM | Permalink | Comments (0) | TrackBacks (0)

Just when you think you have seen it all....

You can now buy a jar of Peter Pan peanut butter complete with lid coded "2111" on eBay. Yes, this is the same product that has been linked to an outbreak of Salmonella Tennessee which has sickened almost 300 people in 39 states since August, 2006. Forty six (46) patients are known to have been hospitalized; there have been no reported deaths.

Posted by Peter W. Burg at 05:34 PM | Permalink | Comments (0) | TrackBacks (0)

Certain jars of Peter Pan Peanut Butter and Great Value Peanut Butter may be contaminated with Salmonella. On February 13, the FDA received a report from the Centers for Disease Control and Prevention (CDC) in which 290 cases of a foodborne illness in 39 states was linked to consumption of varying types of Peter Pan peanut butter. The first consumer may have become ill as early as August 2006 and the outbreak appears to be ongoing.

Continue reading "Peter Pan, Great Value Peanut Butter and Salmonella" »

Posted by Peter W. Burg at 05:09 PM | Permalink | Comments (0) | TrackBacks (0)

For some time now, drug-eluting stents have been associated with a higher risk of blood clots (late stent thrombosis). Stents are tiny metal mesh cylinders which prop open a coronary artery that has been reopened by an angioplasty balloon, and drug-eluting stents go a step further by slowly releasing a drug into the artery that prevents reclogging due to tissue regrowth (restenosis).

Continue reading "Hold the Stent Please" »

Posted by Peter W. Burg at 08:09 PM | Permalink | Comments (0) | TrackBacks (0)

The Society for Cardiovascular Angiography and Interventions (SCAI) has released a clinical alert to doctors, giving practical steps they can take to reduce the risk of bloodclots in coronary artery disease patients implanted with drug-eluting stents. This alert follows hearings held by the FDA's Circulatory Systems Device Panel regarding the use of these devices. While the panel supported the continued use of drug-eluting stents, it also suggested more research to determine if they contribute to an increased risk of heart attck and death.

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Posted by Peter W. Burg at 05:58 PM | Permalink | Comments (0) | TrackBacks (0)

Defibrillator manufacturer Medtronic asked the US District Court of Minnesota to consider a motion for summary judgement. Their request was based on the claim that federal preemption barred the plaintiffs' claims. The plaintiffs' main complaint sites state law product liability claims sounding in negligence and strict liability. Other claims include violations of state Consumer Protection Statutes, violations of Minnesota false advertising and deceptive trade practices statutes, and misrepresentation by omission. The plaintiffs' seek damages for personal injuries that resulted from their use of Medtronic devices.

Continue reading "Court Denies Medtronic's Motion for Summary Judgement" »

Posted by David P. Hersh at 08:46 AM | Permalink | Comments (0) | TrackBacks (0)

According to Medtronic's website, "Medtronic is the global leader in medical technology - alleviating pain, restoring health and extending life for millions of people around the world." Medtronic manufactures cardiac resynchronization therapy defibrillators (CRT-D's) and implantable cardioverter-defibrillators (ICD's). These devices are used on patients with heart conditions and are surgically implanted into the chest. ICD's work by monitoring a patient's heart rhythm and shock the heart when the rhythm becomes abnormal to regulate the patient's heart. CRT-D's work in a similar fashion by sending electrical pulses to the heart under failure conditions.

Continue reading "Medtronic Fails to Warn Public of Malfunctioning Battery" »

Posted by David P. Hersh at 08:43 AM | Permalink | Comments (0) | TrackBacks (0)