The Bush Administration has switched the government’s position on an important product liability question in a case that could have profound effects for all Americans. At issue in Riegel v. Medtronic Inc., No. 06-179, is whether citizens are preempted or barred from suing a company for a product that was approved for sale by the Food and Drug Administration.
The case before the Supreme Court involves a balloon catheter that burst during an angioplasty being performed on Charles R. Riegel. The manufacturer, Medtronic had received FDA approval for the device and successfully argued that this approval preempted any tort lawsuits. Two lower courts agreed with the company.
The Court held in 1996 that such approvals did not preempt tort liability — a position supported by the federal government. However, things have changed. The Bush Administration has changed the government’s position to support the industry and the Court has changed — particularly with the addition of Sam Alito and John Roberts, who are both viewed as highly sympathetic to such industry arguments.
In tort law, there has long been a concept of negligence per se where the violation of a statutory or regulatory standard of conduct is treated as a clear act of unreasonableness (one still have to prove causation and other elements of the tort). However, there is not a concept of reasonableness per se where compliance with such a statute means that you must be created as clearly reasonable.
The common law had it right. The prior rule protected consumers by allowing juries to respond to a defective product despite the failure to act by the government. There are a variety of reasons why, after approval, an agency may not act to deal with a defect. First, the government simply moves slowly in such matters due to limited resources or information. Second, there is danger of agency capture — a close affinity that can develop between a regulator and regulated party. Third, an Administration like the Bush Administration can show routinely favor industry protection over consumer protection.
If successful, the Administration would prevent citizens from litigating risks that it has ignored in products. For an administration like this one, it reduces the likelihood that your protection of an industry will not be challenged in a substantive way in court.If one looks back historically, however, litigation has been one of the main driving forces of uncovering risks — long before the government has acted.
Ironically, this case was heard the day that consumer advocates found that 35% of toys on the shelves for the holidays contain lead. For the story, click here
This is a decision that would cost lives and, if the industry prevails, it is something that Congress should move to correct. It is a case that has not gotten much attention, but holds enormous implications for citizens and product safety.
For a copy of the excellent public citizen brief, click here
One last point. Ted Olson’s remarks concerning post-PMA coordination between the FDA and the manufacturers was predicated on the FDA being at the funding and staffing and leadership it enjoyed in previous political eras.
Consistent with the political philosophy in the Administration, the FDA doesn’t enjoy the resources it formerly had nor is its mission what it was.
I hope the Justices bear that in mind, although the ruling by no means will hinge on what was essentially a placative device by Olson.
Odd but were no questions were directed as to the legislative history? I thought the SG would have to deal with at least one such.
It would seem that there was no Congressional intent to pre-empt the common-law tort process. Indeed there seemed to be the over-arching goal of consumer, not industry, protection. This would cast 360k(a) in a different, narrower light
If the Court rules as I suspect it will, that goal is going to be turned on its head.
The common-law tradition of civil remedies is beginning to resemble Napoleon’s army in its winter retreat from Moscow. Once mighty, now in full retreat.
The question of whether it is, arguably, prudent to limit excessive jury awards in medical product liability cases and medical malpractice cases is different than what’s being decided here.
There is an obvious distinction raised between drugs and devices.
I question how much improvement constitutes a different device, entirely, and if instituted, whether by whom, when, and under what circumstances constitutes a different cause of action.
Actually, the composition of the Court hasn’t changed materially on the preemption issue. Roberts and Alito replaced justices who had supported preemption in the prior Lohr decision. I think your view of the import of the Riegel case is a bit overstated, since the issue is express preemption, which is limited to the one statute, and PMA approval (which is how this product was approved) applies to less than 1% of medical devices (although they are the most sophisticated).
We have a justice-by-justice analysis of the Riegel argument at our (admittedly pro-industry) site:
http://druganddevicelaw.blogspot.com/2007/12/riegel-our-intrepid-correspondent.html
If the government is so confident in the FDA, and completely backs any product it approves, can the government be held liable for those decisions? If not, there will be a sort of corporate holiday for pharmaceutical companies the day this law gets passed. Conversely, consumers will be completely screwed with noone to hold liable for faulty medications.
I’ve been wrong before! 🙂
I have a Supreme Court Magic Eight ball on my desk with a custom answer polygon. My custom Eight Ball this morning came up with:
Narrowly Crafted Ruling
I didn’t like that answer so I shook it and the window showed:
Kennedy assigned Opinion
Speaking of oral arguments, today Boumediene/Al Odah.
I am not so sure. With Alito, Scalia, Roberts, Thomas, and likely Kennedy, we could see a sweeping opinion. Hard to say from oral argument.
Agree this is an important case. While most of America will be following the infotainment news-de-jour, the supervising adults will be attending to this “little,” boring, item.
Anticipate a very narrowly written ruling.