Senate Hearing Held on Restoring Rights to Sue Medical Device Makers

A panel of U.S. Senators heard testimony on Tuesday from patients and medical experts about the potential dangers of defective medical devices and the impact of a recent Supreme Court ruling that insulates manufacturers from product liability lawsuits for injuries caused by certain defective products that were approved by the FDA.

The hearing before the U.S. Senate Committee on Health, Education, Labor and Pensions was the second in recent months over the Medical Device Safety Act of 2009, which seeks to clarify that FDA approval does not preempt lawsuits against medical device manufacturers, overturning the 2008 Supreme Court decision in Riegel vs. Medtronic.

As a consequence of that decision, thousands of pending medical device lawsuits have been dismissed, including cases filed on behalf of patients injured by the defective Medtronic Sprint Fidelis defibrillator lead that was recalled in October 2007. Although the design of the Medtronic lead makes it prone to fracture or break, a federal judge ruled earlier this year that patient claims for medical expenses and other compensation are now barred because the FDA approved the device.

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“This has had catastrophic consequences for ordinary Americans. While the FDA approval of medical devices is important, it cannot be the sole protection for consumers,” said Senator Tom Harkin of Iowa. “I say that because FDA approval…is simply inadequate to replace the longstanding safety incentives and consumer protections provided by long-standing state tort law.”

Opponents of the legislation say that enacting the Medical Device Safety Act of 2009 would stifle innovation and cannot be a substitute for strengthening the FDA.

Consumer advocates who support the bill point to a recent Government Accountability Office (GAO) report that highlights how FDA oversight of medical devices is inadequate, arguing that they are not an effective guardian of patient safety. Removing potential exposure to liability for injuries caused by dangerous and defective products may further reduce the incentive for manufacturers to ensure the safety of their device and result in more cases where profits are placed ahead of patient safety.

At the Senate hearings this week, one patient, Michael Mulvihill of Iowa, testified that a Medtronic defibrillator implanted in his chest malfunctioned and applied more than 20 electrical shocks to his heart in the span of about one hour while he was driving. His injuries forced him into early retirement. Another family told of how their young daughter also received shocks from a defective defibrillator and had to have the device replaced. Medtronic, the manufacturer, has refused to pay their medical fees.

6 Comments

  • LoraSeptember 17, 2009 at 2:08 pm

    My husband was another patient that had the lead "fracture"!! Yes, the wire "broke" and delivered over 30 shocks -- and he felt each one!! He lived - a new device and the broken lead were replaced but it made a frightened old man of him. He is on medication for his anxity, has trouble sleeping (his incident happened at 2 a.m. - thus the fear of going to sleep). He was very active and now has tr[Show More]My husband was another patient that had the lead "fracture"!! Yes, the wire "broke" and delivered over 30 shocks -- and he felt each one!! He lived - a new device and the broken lead were replaced but it made a frightened old man of him. He is on medication for his anxity, has trouble sleeping (his incident happened at 2 a.m. - thus the fear of going to sleep). He was very active and now has trouble doing much of anything. We wait patiently praying that the MDSA passes and the court cases can move forward. The offer from Medtronic to pay $800 was an insult!!!!

  • judAugust 20, 2009 at 10:01 pm

    I am one of the victims of the Charite artificial disk. I had it implanted in May of 05. Directly after the surgery I had problems. I started having bouts of paralysis and extreme pain. It broke my facet joints in my back and caused me to have have to get rods to hold my back together. I than got a severe infection which required my back to have to be reopened, drained, and than sewn shut. I had t[Show More]I am one of the victims of the Charite artificial disk. I had it implanted in May of 05. Directly after the surgery I had problems. I started having bouts of paralysis and extreme pain. It broke my facet joints in my back and caused me to have have to get rods to hold my back together. I than got a severe infection which required my back to have to be reopened, drained, and than sewn shut. I had to be on IV antibiotics for nearly six months. The company knew that it was defective before it was put on the market and suppressed any beliefs or data that the device was unsafe. This device has totally destroyed my life. I not been able to work since I have had it. I now have to be on countless medications everyday for pain, insomnia, depression, and anxiety. I have two young children who think that daddy doesn't want to hold them. Now if this bill does not pass these companys have no way to be held responsible for the severe physical, emotional, and financial damage that they cause. I just wish that the opponents of this bill would come see the real life consequences of this choice and explain to my family why daddy can't afford to feed them or send them to college. Anyone reading this PLEASE encourage your Senators and Congressmen or women to vote yes and allow all these families devastated by a defective medical product a glimse of hope!!!

  • DONAugust 14, 2009 at 1:51 pm

    When a car is recalled, the manufacturer pays for the parts and labor. When Medtronic recalled the Sprint Fidelis, they graciously offered to reimburse up to $800 of costs NOT covered by insurance. There is also evidence that they knew the leads were defective (design or manufacturing? it doesn't really matter) at least 7 months before they took them off the market. Depending on who you believe,[Show More]When a car is recalled, the manufacturer pays for the parts and labor. When Medtronic recalled the Sprint Fidelis, they graciously offered to reimburse up to $800 of costs NOT covered by insurance. There is also evidence that they knew the leads were defective (design or manufacturing? it doesn't really matter) at least 7 months before they took them off the market. Depending on who you believe, there are between 150,000 and 250,000 people with these leads in their chests, and Medtronic has done NOTHING to protect them. There may well be criminal issues on this matter. Nobody will know unless the MDSA is passed so that discovery can take place. The only innovation that will be stifled by MDSA will be the innovation that medical device manufacturers have come up with to pad their bottom lines at the expense of their victims. Oh excuse me, I meant customers, not victims!

  • DarleneAugust 13, 2009 at 7:36 pm

    Peter - failure rates aside, if you saw the hearing then you learned that these companies are not submitting failure reports and allowing the FDA to track them and force a recall. As in the case with the Medtronic Sprint Fidelis lead, they would rather sell off their inventory of the faulty protect first - putting thousands more patients at risk. Why wouldn't they? They can't get sued for it. [Show More]Peter - failure rates aside, if you saw the hearing then you learned that these companies are not submitting failure reports and allowing the FDA to track them and force a recall. As in the case with the Medtronic Sprint Fidelis lead, they would rather sell off their inventory of the faulty protect first - putting thousands more patients at risk. Why wouldn't they? They can't get sued for it. No one sets out to make a bad device, but if it is defective, companies should put their best foot forward and warn the public in a timely manner to prevent further injuries. They obviously will not if there's no threat of litigation. Now people like Beverly's husband suffer needlessly.

  • BeverlyAugust 7, 2009 at 10:04 pm

    Patients rights NEED to be restored. My husband was shocked multiple times and had to have that lead replaced. Our lives changed the day he had heart failure and we have had hundreds of thousands of dollars in medical bills that no one wants to take responsiblity for. This is disgraceful and appalling! Wake up people - take care of Americans suffering from these faulty devices of which we have[Show More]Patients rights NEED to be restored. My husband was shocked multiple times and had to have that lead replaced. Our lives changed the day he had heart failure and we have had hundreds of thousands of dollars in medical bills that no one wants to take responsiblity for. This is disgraceful and appalling! Wake up people - take care of Americans suffering from these faulty devices of which we have no choice about when implanted in an operating room. Walk a mile in our shoes, the replacement lead was then exchanged for a contaminated lead. This poor man had to have 2 additional surgeries - all a result of Medtronics defective lead to start with. And now he has to take pills for anxiety and sleep, he is terrified of being shocked again. WAKE UP out there and help us all.

  • PeterAugust 5, 2009 at 8:07 pm

    IIt was my understanding that FDA regulations allowed a 1.5% failure rate per "model" manufactured. No one at MDT, St.Jude or Boston Scientific intends to design or manufacture unsafe life support devices. Huge investmennts in highly educated specialists, R&D, materials and Consultants are required beyound that necessary for diagnostic/therepudic systems. "Life Support" products. FDA approved ,un[Show More]IIt was my understanding that FDA regulations allowed a 1.5% failure rate per "model" manufactured. No one at MDT, St.Jude or Boston Scientific intends to design or manufacture unsafe life support devices. Huge investmennts in highly educated specialists, R&D, materials and Consultants are required beyound that necessary for diagnostic/therepudic systems. "Life Support" products. FDA approved ,under 1.5% "man made" exception, should remain protected.

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