Public Citizen

Maybe, the founding fathers actually knew what they were doing when they set up a system of checks and balances that ensure that no one branch of our government can become too powerful. We see examples all the time where the President and Congress clash over issues or where the U.S. Supreme Court weighs in on a law that Congress passed or some power that the President claims is his executive right. Now, comes an example where Congress has the potential to turn back a recent Supreme Court decision that took away the rights of patients to sue the makers of defective medical devices.

A bill introduced in the U.S. House of Representatives by Reps. Henry Waxman (D-Calif.) and Frank Pallone (D-N.J.) would overrule the high court’s decision in Riegel v. Medtronic. In that case, the court found that Medtronic could not be held liable for one of its balloon catheters that burst during an operation because the catheter had been approved by the Food and Drug Administration.

The federal law that gave the FDA the authority to regulate medical devices in effect preempted the state laws that would have allowed Charles Riegel, the plaintiff in that case, to sue Medtronic, the court ruled.

Public Citizen says it is critical for Congress to pass this legislation, dubbed the Medical Device Safety Act of 2008 (H.R. 6381). A similar bill is expected to be filed shortly in the Senate.

Here’s what Allison Zieve, the Public Citizen attorney who argued on behalf of the Riegels, had to say:

The possibility of being held liable for injuries their products cause creates an invaluable incentive for manufacturers to make their products as safe as they can, to revise labels as soon as they become aware that they are inadequate and to remove unsafe products from the market.

But as Sam Loewenberg in Politico points out in his article “Lawmakers try to remove tort shield,” the medical device industry is going to throw everything it has at killing this bill. But even some people in the medical device industry, concede that the threat of lawsuits can indeed help produce safer devices.

In hearings last month before the House Oversight and Government Reform Committee, a device maker testified that the prospect of legal liability is, indeed, an important motivator.

Christine Ruther, the president of C&R Engineering, a medical device firm in Mission Viejo, Calif., told the committee that when her company is designing a product, “the words that draw our attention are not ‘What would the FDA think?’ but ‘Ladies and gentlemen of the jury.’”