A Reliable Regulatory Regime for Medical Devices: Saving Lives

The Senate HELP Committee yesterday held a committee hearing, “Protecting Patients from Defective Medical Devices,” with the central issue being federal preemption, that is, should FDA approval of medical devices preempt suits against those devices in state courts. In a 2007 decision in Riegel v. Medtronic, the U.S. Supreme Court ruled that Congress clearly intended such a consistent, federal regulatory regime. (Much more detail on the case at the ScotusWiki entry.)

Indeed, as the testimony of Peter Hutt of Covington & Burling, a former FDA chief counsel, explained yesterday, the specific and clear “Pre-Market Approval” (PMA) language was written into law in 1976.

The trial lawyer lobby has made elimination of preemption one of its top priorities. After defeat in Riegel v. Medtronic, they succeeded in the Supreme Court in the case of Wyeth v. Levine, dealing with prescription drugs.

For devices, Congress is now the focus. The goal is to replace the rigorous FDA approval process and recognized federal standards with the equivalent of a 50 state regulatory regimes, all determined by litigation and the courts. Once that happens, the trial lawyers will be able to identify particularly plaintiff-friendly and generous venues. There are bills to accomplish that goal now in the Senate and House, the Medical Device Safety Act (H.R. 1346 and S. 540).

Yesterday’s Senate hearing can be seen as part of that legislative push, but thankfully, testimony offered balance. One witness was Michael Roman, a race car driver from Missouri, who suffered debilitating chronic pain after his leg was amputated, pain only relieved after he started using a spinal cord stimulator manufactured by Boston Scientific, the Precision Plus ™ Spinal Cord Stimulator System, based on the same technology used in cochlear implants.

His testimony tells a wrenching story of what he suffered and what he regained thanks to the medical research that led to the device’s creation. The costs of increased litigation could have made it all impossible:

What if Congress had enacted the Medical Device Safety Act in 2001? For me, I’m sure it would have been game over.

It scares us to think I would lose the life I have today because a researcher decided to throw in the towel in 2002 – deciding that the status quo was good enough – and that the $60 million in development and testing costs of my device weren’t worth the risk of putting a cutting edge, FDA-approved product on the market, only to have that product’s value systematically reduced by lawsuits. There are millions of people out there who might one day benefit from the breakthrough therapies still in development. We need to think about those people when we think about the consequences of this bill.

Roman also issued a statement through the AdvaMed trade association, saying, “Decisions about the safety of medical devices should be left to the experts and scientists at the FDA who evaluate new products with the overall public good in mind. When juries are hearing about a patient who is harmed, it is easy to forget about the people like me who have had a great experience with a device.”

The question boils down to, which serves the public better — lawsuits or medical research?

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