FDA Approval Of Medical Devices Not Enough

This week in Congress Michael Kinsley and Bridget Robb both testified before the US House Energy and Commerce's Subcommittee on Health about their medical devices.

Kinsley, a popular columnist and former talk show host of Crossfire, discussed his medical implant that helps control the effects of his Parkinson's disease. He described how his brain stimulator helps him function and restore normalcy to his life each day.

Robb, a single mother described her heart condition and the defibrillator she had implanted to prevent a fatal arrhythmia. Robb described how one evening the lead to her defibrillator malfunctioned, sending 31 dangerous shocks to her heart and throughout her body as her daughter watched, thinking her mother was dying. The episode has resulted in ongoing trouble, including multiple extended hospital stays since the incident.

Both Kinsley and Robb were testifying about the Medical Device Safety Act (MDSA), legislation that would restore the rights of victims injured by medical devices to seek justice in state courts. But the two are on opposite sides of the issue; Kinsley was arguing against the legislation, saying patients will be denied life saving devices, while Robb argued that manufacturers should be held accountable for the devices they produce, instead of putting the cost on others when the devices fail.

Neither Kinsley nor Robb would argue against the life-changing benefits medical devices provide. The question is -- who pays the price when medical devices fail? Kinsley would argue, the patient, insurance companies, and even the federal government though Medicaid and Medicare. Robb believes the medical device company bears part of the responsibility.

Last year, the Supreme Court ruled in Riegel v. Medtronic that Congress had intended that medical devices approved through the Food and Drug Administration's pre-market approval process are immune from state tort suits. In other words, injured patients do not have any recourse to hold the manufacturers of faulty medical devices accountable.

In 2008, the Supreme Court ruled in Wyeth v. Levine that pharmaceutical companies bear the responsibility for prescription drug labels. The MDSA would restore the right recognized in Wyeth to medical device patients.

Kinsley and the device industry argue medical devices need to keep their complete immunity status, or patients will be denied lifesaving devices.

Immunity is about accountability, not denying patients safe effective products.

Medtronic knew there were problems with the defibrillator lead implanted in Robb; in fact, it had been recalled two months before Robb's malfunctioned. Medtronic recalled the lead in 2007 only after 665 failures and five reported deaths, according to Heart Rhythm, the Official Journal of the Heart Rhythm Society.

The Journal points out that in a study of 3,037 cardioverter-defibrillator leads, 72 (8.5%) of 848 Sprint Fidelis leads failed, while only 94 of all 3,037 defibrillator leads studied failed. According to the Journal article, "the cumulative hazard of Sprint Fidelis failure was significantly greater compared to 2,189 other defibrillator leads."

The point is Ms. Robb had options. While her defibrillator did offer her a medical benefit that she will not deny, there were other products, safer products on the market.

The only way to hold Medtronic accountable and encourage them to make safer products is to allow the civil justice system to provide the added consumer protection the system was intended to provide.

The Medical Device Safety Act would restore patients' right to hold the manufacturer responsible when their products are defective. Kinsley, Robb and all patients with medical devices will benefit from safer products.

Hear more stories from victims of faulty medical devices:

Visit www.stopcorporateimmunty.org.

Comments

[TCB1965]

It seems understated that millions of people benifit from these medical devices every minute in this country. It also seems understated that all procedures and devices have risks, and these risk should be and I belive are disclosed prior to their use. If a patient understands the risks and then something happens, that is the best we can do in a world that is not perfect and predictable in every way. In addition, it should be recognized in this down economy that millions of jobs and tax revenue derive from the medical device industry, not just at Medtronic and Stryker, but at the thousands of start up companies where company founders and the teams thye build develop new technologies to address illnesses like heart disease, cancer, epilepsy, trauma patients, etc. While I understand the need to be protected from gross negligence by big companies, cant we find a way to strike a balance that preserves the capacity for Innovation in healthcare and medical devices? This legislation has the potential to crush innovation and hand a windfall to the product liabiltiy lawyers, and insurance companies who will simply raise thier rates at the very least. These costs will be passed on to the consumer in higher prices for new medical devices. We all need new and innovative devices at a less expensive prices. Creating a windfall profit for the product liability lawyers and insurance companies is not going to accomplish this goal.

[donf3]

Mr. Kinsley is the best argument against his position. His device had to have been developed before the Riegel v Medtronic decision immunized the device makers, yet it WAS developed. The MDSA does nothing more than restore the balance that was in place from 1976 when the Medical Device Amendments became law through January 2008 when the Supreme Court ignored Congressional intent.
I was, like Ms. Robb, a victim of the Sprint Fidelis leads. I believe that Medtronic knew before my lead was implanted that it had an unacceptably high failure rate. I can only confirm this through discovery related to a lawsuit, but of course that can't happen without the MDSA, and the truth would never come out.
When Medtronic took the leads off the market, the FDA issued a Class I recall. An addendum to the recall notice concurred with Medtronic's position that the leads should not be removed without specific cause.
The FDA did, however, present 2 alternatives. One alternative was to replace the lead without removing it. The other was to "closely monitor" the leads.
Had Medtronic monitored my lead, the failure would have been detected 2 weeks before the complete failure that caused my shocks. They did nothing, and I believe that the lack of action represents the grossest negligence possible.
I want to sue Medtronic for both of these issues, but I cannot until the MDSA becomes law. Does this make sense to anybody?