Drug makers are starting to feel the pinch from the removal of their defective drugs from the market. It is cutting into their profits and delaying their chances of making money on new blockbuster treatments. Big Pharma is blaming the fact that it is taking longer for the Food and Drug Administration to approve their new drugs. For example Merck & Co executives, the recalled http://www.burgsimpson.com/vioxx.html manufactures, say they are facing a tough new regulatory climate that is delaying drug development. Over the last 16 months, Schering-Plough Corp. has pulled the plug on two drug development projects, one for obesity and the other for cholesterol, and considering pulling a third project. Chief Executive Fred Hassan believes the reason lies in the intensified focus on safety and the diminished tolerance for side effects. With the diabetes drug Avandia causing an increase of heart failure in some patients and the Ortho Evra birth-control patch causing blood clots and in some cases death, is it a wonder the FDA is taking longer? Drug companies are required to clear their new drugs with the FDA. If they want their products to come to market faster they need to focus their attention on screening their own products so that there is assurance that good and safe drugs are being released to the industry rather than making money.

Posted by Kerry N. Jardine at 04:36 PM | Permalink | Comments (0) | TrackBacks (0)

A warning was issued recently by the U.S. Food and Drug Administration to doctors informing them not to use Medtronic’s Infuse bone graft product in surgery on neck bones, which is considered an off-label practice the agency never approved. The Infuse powder is FDA approved for use in fusion surgeries such as in the lower back, some serious leg fractures and some oral and dental uses. The product is a genetically engineered protein that causes the body to grow its own bone. The warning issued this week also covers OP-1 brand bone graft products from Kalamazoo, Mich.-based Stryker Corp. The FDA’s warning is stating that for unknown reasons using these products in the neck can cause dangerous complications. The FDA has received at least 38 reports of complications in the past four years related to use of Infuse and OB-1 in neck fusion surgeries. The neck and throat tissue of some patients swelled, the agency said. Some patients had difficulty swallowing, breathing or speaking. Some required a second surgery to resolve the issue, and in some cases, health-care workers inserted tubes to keep them breathing, the FDA said.

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

Following on the heals of a Supreme Court decision agreeing with Medtronic’s claim that once a device is deemed safe by the FDA it preempts any lawsuits filed against them claiming injury, Johnson & Johnson is insisting the same for its controversial birth control patch Ortho Evra. In recent lawsuits filed against Johnson & Johnson evidence has been found that internal company documents and emails hid evidence that the patch delivered much more estrogen than birth control pills, potentially increasing the risk of blood clots and strokes. Now Johnson & Johnson is arguing in court that it cannot be sued by women injured by the Ortho Evra patch because the FDA had approved it. More than 3,000 women and their families have sued Johnson & Johnson after suffering heart attacks, strokes and, in 40 cases, death. From 2002 to 2006, the FDA received reports of at least 50 deaths associated with the Ortho Evra patch. The FDA did not inform the public of the potential risks until November 2005, six years after Johnson &Johnson’s own study showed the high estrogen distribution.

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Posted by Seth A. Katz at 08:37 AM | Permalink | Comments (0) | TrackBacks (0)

A lawsuit has been filed against Medtronic in Indiana alleging the defective Sprint Fidelis leads in its heart defibrillator resulted in inappropriate shocks, severe pain and hospitalization. The malfunctioning lead wires fractured causing the defibrillator to send unnecessary and painful shocks to the client’s heart. The defibrillators monitor the heart rhythm and will deliver electric shocks directly to the heart if it begins to beat erroneously. The shocks are delivered via the lead wires. The suit also claims that Medtronic concealed or downplayed the known health risks so they could continue marketing and selling the device globally. On Oct. 15, 2007, Medtronic removed its Sprint Fidelis heart defibrillator cardiac leads from the market after reports surfaced that linked the devices to patient deaths. As of now 5 deaths have been attributed to the defective medical device. The same day, the FDA concurred and said it was aware of deaths and major complications associated with the fractured leads.

Posted by David P. Hersh at 08:14 AM | Permalink | Comments (0) | TrackBacks (0)

Medtronic’s implantable infusion pumps, SynchroMed and IsoMed, have been assigned a Class I recall by the Food and Drug Administration. Physicians have been and are currently being informed about an increase in the rate of inflammatory mass cases in patients receiving drugs through Medtronic’s infusion pumps. The Food and Drug Administration defines a Class I recall as a situation in which there is a reasonable probability that use of the product will cause injury or death. In mid-January Medtronic sent an update to inform clinicians of the possibility of inflammatory mass cases. The inflammatory mass develops near the tip of the catheter attached to the pumps. Medtronic said the risk of an inflammatory mass has been part of the product labeling since 2001.

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The Food and Drug Administration reported recently new data on Medtronic’s AneuRx stent. The new data showed patients treated with the Medtronic stent to prevent aneurysms appear more likely to die than those who undergo surgery. It further describes that those who had the device implanted for five years are at an increased risk of death by aneurysms. The FDA have reported similar risks in the past, but the new data show the risks continue to climb each year after the stent is implanted. Medtronic said about 75,000 patients in the U.S. have its AneuRx stent as an alternative to surgery. The FDA estimates that 1.5 percent of patients who've had AneuRx five years will die from an aneurysm, well above the 0.18 percent death rate in patients who had surgery. FDA recommended that doctors use AneuRx only for what its label prescribes. Doctors sometimes use stents outside of FDA approved uses.

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Paramjit Singh, 54, of Mount Vernon Washington checked into Providence Everett Medical Center for cardiac bypass surgery. What he received was a heart transplant. During the operation a monitor manufactured by Edwards Lifesciences Corp malfunctioned, causing a catheter to overheat and burn his heart, irretrievably damaging it. He now suffers other problems as a result of the malfunction and must take anti-rejection drugs the rest of his life. A Superior Court jury awarded Singh $40.1 million. The award included $8.35 million in punitive damages. Edwards Lifesciences Corp blames Providence Everett Medical Center for using a damaged cable and the hospital blames Edwards for failing to disclose a problem with the monitor. The jury ordered Edwards to pay 99.99 percent of the damages, leaving Providence responsible for .01 percent. Edwards was also ordered to pay Providence $310,000 in damages.

Posted by Scott J. Eldredge at 08:19 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)

A Supreme Court decision in a case involving Medtronic and its defective defibrillator leads has severely limited recourse for victims injured by medical devices. The U.S. Supreme Court sided with Medtronic in the ruling that, if federal regulators have approved a medical device a lawsuit cannot be filed under Minnesota state laws. It is a big business friendly ruling that is disturbing and could be contagious nationwide. Lawyers defending patients who are the survivors or family of the victims of defective medical devices said that the threat of litigation has long been an incentive for medical device makers to produce the safest product possible before releasing it for consumer use. If a patient is harmed or killed by a defective device, they should have the right to sue the company that made it. The court's ruling virtually thwarts that possibility. What is particularly upsetting are recent reports that the FDA is not doing its job of protecting the public from dangerous drugs and medical devices and people have been injured or killed as a result. The ruling has essentially left the protection from defective devices or drugs in the hands of the FDA and protected big business from responsibility.

Posted by David P. Hersh at 08:51 AM | Permalink | Comments (0) | TrackBacks (0)

Colorado Senate Bill 164 has cleared its first hurdle. The Senate State, Veterans and Military Affairs Committee has approved the bill which will now head to the Senate floor for debate. SB164 calls for an increase from $300,000 in non-economic damages to $450,000 to account for inflation in victims of medical malpractice. Additionally, impairment and disfigurement would not be subject to the cap as it had been previously. Senate President Peter Groff, D-Denver, sponsored the bill, which he called moderate and reasonable. The changes are in line with the 1988 Health Care Availability Act, which limited the amount doctors pay if found guilty of malpractice. Under that law, impairment and disfigurement weren’t considered non-economic damages, but a law passed in 2003 changed that. Doctors and lawyers who testified predictably disagreed on the outcome. Groff said he expects doctors and their lobbyists will continue to fight the bill once the full Senate takes up the debate. They are already using “fear, threats and distortion” to fight something that would affect “about a handful of . . . cases every year that dramatically alters (someone’s) quality of life,” he said. In 2006, 13 malpractice cases went to trial in Colorado. Of the six cases won by the plaintiffs, five exceeded the $1 million cap.

Posted by Scott J. Eldredge at 12:41 PM | Permalink | Comments (0) | TrackBacks (0)

Medtronic Inc. won approval to end the consolidation of more than 2,600 lawsuits over defective defibrillators after reaching a $114 million settlement. U.S. District Judge James Rosenbaum in Minneapolis said he would disband the consolidation of lawsuits over Medtronic's Marquis line of defibrillators now that almost all the patients who asserted the devices malfunctioned have resolved their claims. The decision ends the majority of litigation over the defibrillators, which patients contend failed to help during heart attacks because of battery defects. The settlement resolves 2,682 claims filed since 2005 over the implantable defibrillators. There are still 19 defibrillator patients who have refused to settle their cases and will have a chance to press their claims at trial. Medtronic still has pending litigation in its defective Spring Fidelis leads in another version of their defibrillators.

Posted by David P. Hersh at 04:00 PM | Permalink | Comments (0) | TrackBacks (0)

After the recall of its Sprint Fidelis leads, Medtronic has reported that their second-quarter revenue was reduced by $150 million to $250 million. Following the recall in October, Medtronic was targeted by a patient suit alleging emotional distress and negligence. The plaintiffs are seeking restitution, disgorgement of profits and punitive damages. An analyst said to clients that while the Fidelis lead recall would hurt earnings, cost control efforts and a low tax rate could help. Further that, “Physician conversations suggest doctors think the recall is more of a near-term 'hiccup' than a permanent stain for Medtronic -- potentially positive for longer-term share retention.” Shares of Medtronic fell about 10.9 percent during the second quarter and roughly 10.8 percent since the start of fiscal 2008.

Posted by Kerry N. Jardine at 10:29 AM | Permalink | Comments (0) | TrackBacks (0)

A medical device similar to the Medtronic implantable defibrillators has reportedly been implicated in a number of cases of perforated hearts. The medical journal PACE reported that wires from the St. Jude Medical Inc. implantable defibrillators are known to have perforated four patient’s hearts. According to the journal, one patient had a wire move from inside the heart out to a quarter inch from the patient’s skin. Regardless of the difficulties experienced by these heart patients, the company has issued no recall. Last month, Medtronic Inc. acknowledged five patient deaths linked to breaks in its Sprint Fidelis wires, which have since been recalled. All four of the patients with the St. Jude wires had them removed. Dr. Stephen C. Vlay wrote in a PACE editorial that the wire problems are especially troubling because the perforation often isn't discovered until it is well through the heart wall. One woman had no sign of problems. Doctors discovered her perforation in a routine follow-up visit after her defibrillator had been implanted. The defibrillator had not been delivering a sufficient jolt. Doctor's found the perforation in another woman after her defibrillator shocked her five times within one 24-hour period. Vlay believes that doctors may not have been reporting the wire problems because they thought they were isolated events. “It was only when multiple case reports emerged from different geographic areas and were submitted for publication that editors recognized a problem that seemed to be neither isolated nor rare,” he wrote.

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

Since the Food and Drug Administration recalled the Sprint Fidelis leads wires used in Medtronic’s cardioverter defibrillators (ICDs), the company’s shares have dropped 18 percent, from $56.33 to $45.99. The FDA noted that broken leads are causing “inappropriate shocks” in patients who have the medical devices implanted. On October 15th, the company said it would stop selling the Fidelis leads and that they may have contributed to the deaths of five patients. Medtronic had received 679 reports of injuries caused by fractures in the leads. Last February, the Minneapolis Heart Institute told Medtronic that it would no longer use the leads.

Posted by Kerry N. Jardine at 06:32 AM | 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.

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

On September 29, 2006, The Heart Rhythm Society (HRS) finalized recommendations for revising the system used by industry, regulators and clinicians to monitor and publicize implantable-device performance problems. Key goals of the recommendations include:
• improved recognition of potential device malfunctions
• postmarket surveillance and reporting of any problems
• communication among industry, federal agencies, clinicians and patients
This document is one of several fixes to the system used by device companies and the US Food and Drug Administration to track and respond to malfunctions in pacemakers and implantable cardioverter defibrillators (ICDs). The shortcomings of the present system were widely criticized in 2005 after a highly publicized recall of Guidant ICDs with potentially fatal design flaws; Guidant was criticized, too, for how they responded to the recall. Even though the company reported the problems to the FDA, they did not promptly inform clinicians and the public.

Continue reading "Defibrillators and Pacemakers " »

Posted by David P. Hersh at 06:38 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA issued a warning to Medtronic, Inc. on Friday, September 29, 2006 regarding the delayed filing of a post market surveillance interim report on the AneuRx Stent Graft System. According to Medtronic, Inc. the letter is not related to the quality, design or manufacture of the product. However, the purpose of the Postmarket study is to make sure the device is appropriately labeled for use in designated patient populations and to confirm the necessary training and experience for users of the device which is used to treat patients suffering from life-threatening Abdominal Aortic Aneurysms. The System was commercially approved in 1999 and the interim postmarket surveillance report, initially issued in 2002, has been filed on an annual basis until now.

The FDA has issued alerts and recalls affecting more than 337,000 defibrillators since 1990. There has been a reduced market for defibrillators since that time and a reported 8% decrease in the last 12 months.

Posted by David P. Hersh at 05:51 PM | Permalink | Comments (0) | TrackBacks (0)

Just eight months after losing the bid for medical-device maker Guidant, Johnson & Johnson is suing Boston Scientific and Abbott Laboratories saying that the two companies intentionally interfered and induced Guidant to breach the deal by leaking confidential information to Abbott to arrange a prepackaged divestiture of Guidant businesses to Abbott.

J&J wanted to purchase Guidant which was one of three companies preparing to put drug-coated stents on the market to give the company entry into the lucrative market for implantable pacemakers and defibrillators.

Posted by David P. Hersh at 05:49 PM | Permalink | Comments (0) | TrackBacks (0)

About 85,000 Taxus stents are being recalled voluntarily by Boston Scientific because of possible defects. Of the 42 complaints received, 30 systems showed actual performance flaws generally thought to be the result of excess heat being applied during the laser welding stage during the manufacture of the product. 200 Taxus stents were recalled earlier this month.

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Posted by Seth A. Katz at 09:58 PM | Permalink | Comments (0) | TrackBacks (0)