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.

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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.

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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."

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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.

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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.

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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.

Posted by Kerry N. Jardine at 06:07 AM | Permalink | Comments (0) | TrackBacks (0)

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.

Continue reading "Ford Explorer class action suit settled" »

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