Bill Would Eliminate Preemption In Device Suits
8 CommentsBy Ed Silverman // June 4th, 2008 // 7:25 pm
Democrats hope to bypass a recent Supreme Court decision shielding device makers from state liability lawsuits by unveiling legislation to reverse the ruling, Congress Daily reports.
Frank Pallone, who chairs the House Energy and Commerce Health Subcommittee, and Henry Waxman, who chairs the House Oversight and Government Reform Committee, plan to introduce legislation before the July 4 recess that would explicitly state that FDA regulation does not trump the ability of patients to seek damages under state law, a Pallone spokesman tells Congress Daily.
You may recall that, last February, the US Supreme Court ruled that patients injured by defective medical devices can’t sue for damages in state courts if the FDA approved the marketing of the product. The court decided that the 1976 Medical Devices Amendment preempted the right of patients to sue for damages in state courts over devices that receive premarket FDA approval.
Unlike medical devices, however, there is no statute providing for preemption for drugs. The Supreme Court will take up a pharmaceutical case this fall. The issue, meanwhile, has intensified the rivalry between trial lawyers and big-business lobbying groups, in thise case, over the issue of how far can federal regulatory agencies go in preempting states on consumer and product liability laws, Congress Daily writes. Here’s the rest of the story…
Jaynesday
This should be interesting. Maybe we will see a 4th of July fireworks display.
Congress v Supreme Court
Demacrats v Republicans,
Individuals v Corporations
Due Process v Torte Reform
Justice in Michigan
At the risk of overly parsing, I would suggest that the bill does not intend to “bypass” the Sup. Ct. ruling, but to reinstate Congressional intent in MDA (Medical Device Act(as originally passed). As most of its sponsors agree, that intent was to prevent states from setting up genuinely competing regulatory schemes, putting manufacturers in the position of having to meet competing regulatory requirements.
There was never the thought, at that time (including at the FDA), that state tort liability could be considered a competing regulatory scheme. Indeed, in virtually every case, the two systems complemented and strengthened each other.
The alternative view is pretty much the handiwork of the trial lawyers who work for the device industry. I understand eight Supreme Court justices agreed, in one form or other, in Riegel. History is like that, including the history of the Court.
In any case, this is not a constitutional issue but one of clarifying legislation. So it is entirely within Congressional purview to clarify the laws it passes when that becomes necessary. No bypassing involved (except perhaps the Court’s end-run around Congress).
AV Block
this will never get passed. it smells like another profitable opportunity for greedy lawyers.
Jaynesday
Or is it a correction of a profitable and insanely dangerous opportunity for greedy corporate lawyers?
laura
AV Block,
I’m just wondering, how much do you really know about medical device preemption? From your post, I get the feeling that you’re comment is the same reaction that I would have had two and a half years ago, before my mother was killed by a medical device that she didn’t ask for and didn’t need. I felt like you do…all lawsuits are frivolous, litigants are just looking for a way to make a quick buck, all plaintiff’s lawyers are “ambulance chasers”. This feeling is fed by the McDonald’s spilled coffee lawsuit, the midday television ads begging for people to call if they have a hangnail, your next door neighbor telling you that they’re going to sue because your tree hangs over the property line and it’s spilling apples into their yard. You are absolutely right in your assumption that there are way too many lawsuits out there that shouldn’t be…in your endorsement of preemption, however, you are not considering the many lawsuits that serve a very real purpose. These lawsuits bring to light major oversights and, many times, major cover-ups that occur in the medical device industry. Preemption preempts the frivolous lawsuits, of which, I agree, there are many, but it also preempts the very important lawsuits that hold medical device companies accountable for the products that they are placing on the market. Essentially preemption is throwing the baby out with the bathwater. I’m sure that there are ways that the government can address frivolous lawsuits. To prevent all lawsuits just because frivolous lawsuits exist, however, is immoral. I would also like to remind you that medical device companies also employ lawyers and their lawyers are probably just as “greedy” as the plaintiff’s lawyers.
HorusCat
laura,
Your points are well made. Unfortunately, there is no mechanism for weeding out the frivolous from the well-founded lawsuits. That doesn’t mean worthy suits shouldn’t be brought, it just means we have to come up with a process that saves the time, money and energy of dealing with the frivolous actions while preserving the juridical platform for the meritorious suits. Maybe a review committee of the kind that some states have for medical malpractice–made up of all the affected constituents (lawyers, consumers, doctors, device-makers).
laura
HorusCat,
You’re right. We need to find a mechanism to weed out the frivolous lawsuits. Preemption, however, is not the mechanism. In allowing preemption, we are disallowing accountability. I’m not sure what the answer is, but I’m certain that it is not preemption.
Justice in Michigan
Good to see a reasonable response. The realities are that the best, most deserving cases tend not to be brought. I am for reform as some have suggested above.
But the nuclear option of preemption will hurt everyone - including the industry - very badly indeed.