06/15/2009 05:12 am ET Updated Dec 06, 2017

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: