Congressional Hearing Highlights Need to Restore Medical Device Lawsuit Rights

A congressional hearing last week illuminated serious deficiencies in the FDA’s process of reviewing and approving medical devices. The hearing, which included a damning report by the Government Accountability Office, made it clear that consumers need Congress to restore their right to hold medical device manufacturers accountable for defective products, by passing the Medical Device Safety Act of 2009.

>>PRIOR POST (3/9/2009): Restore Medical Device Product Liability Lawsuits
Contact Your Legislators

The GAO report was unveiled at a hearing Thursday before the House Energy and Commerce Committee’s health subcommittee, and along with testimony from a panel of experts, made a strong case as to why the health and safety of consumers who make use of medical devices should not rest solely in the hands of the FDA.

The hearings came as lawmakers are considering the Medical Device Safety Act of 2009, which seeks to overturn a 2008 Supreme Court decision (Riegel vs. Medtronic) that protected manufacturers of some medical devices from liability lawsuits as long as their product was approved by the FDA.

The GAO report found problems with the FDA reviewing process, its postmarket surveillance and its ability to inspect medical device manufacturing facilities. In combination with other testimony heard that day, it is clear that the FDA is not currently capable of ensuring that consumers are fully protected from defective devices.

The Medical Device Safety Act faces opposition from Republicans and concerned consumers should contact their representatives to voice their support for the legislation. At the hearings, Republicans brought in former FDA official Philip Phillips to testify that the FDA approval process works. However, Phillips is more of a symbol of the problems than an advocate for the opposition. Phillips consults for ReGen Biologics, Inc., a medical device company whose lobbying tactics for a knee surgery device have led to a congressional investigation of the industry’s influence over the FDA approval process.

ACT NOW TO SUPPORT THE MEDICAL DEVICE SAFETY ACT

To preserve your rights and the right of your friends and family members to pursue a product liability lawsuit for injuries caused by dangerous and defective medical devices, it is important that you contact your Senators and Representative to make sure they understand the importance of supporting the Medical Device Safety Act of 2009.

The civil justice system is an important safeguard to hold companies accountable for decisions that place profits ahead of consumer safety, which we unfortunately see time and time again. Let your voice be heard.