Will The Medical Device Safety Act of 2009 Ultimately Benefit Patients?

The Senate Health, Education, Labor and Pensions (HELP) Committee started hearings on medical device safety yesterday, in an effort to pave the way for the Medical Device Safety Act of 2009. Proponents argue that manufacturers should not be shielded from liability and that patients should have the legal right to sue manufacturers if they are harmed by a medical device. Opponents argue that the Medical Device Safety Act will make devices more costly and, ultimately, less accessible.

A 2008 Supreme Court decision in Riegel v. Medtronic found that manufacturers of medical devices with Food and Drug Administration approval cannot be sued under state law by patients alleging harm from the device. As a result, many lawsuits against manufacturers, such as Medtronic, have been thrown out of court. In response, the Medical Device Safety Act of 2009 addresses the ability for patients to sue medical device manufacturers by adding language to the Medical Device Amendments of 1976 to the Food, Drug, and Cosmetic Act.

 

In the editorial  "The Medical Device Safety Act of 2009", NEJM, Volume 360:1550-1551 April 9, 2009   Number 15, the authors argue that this is a statutory decision which is not in the best interest of patients and appears to be in conflict with other Supreme Court decisions related to drugs.

 

But the Medical Device Manufacturers Association has concerns that the Medical Device Safety Act of 2009  "would significantly stifle innovation in the industry and limit patient access to medical technologies", citing patient concerns (see also a May 12, 2009 Wall Street Journal article entitled "Hearing Shows Debate Over Rights To Sue Medical-Device Cos.").

 

In the end, what will be the impact for patients? Medical device regulations in the U.S. are already some of the most stringent in the world. As a result, advanced devices developed by U.S. based companies are often available outside the U.S. well before they can be accessed by patients inside the U.S. Excessive legal costs in defending lawsuits surely exacerbate this problem.

 

Clearly, device manufacturers must continue to do everything in their power to ensure medical device safety. But will more lawsuits against manufacturers achieve this goal, or will it simply increase device cost, decrease access, and reduce innovation in an industry where fewer technological advances will surely mean more loss of life?

 

 

 

 

This author consults with leading institutions through GLG