SCOTUS forcibly rogers the injured yet again

Here this blog previewed Riegel v. Medtronic, Inc., a case in which the U.S. Supreme Court was called upon to address the preemptive effect of the 1976 Medical Devices Amendments (“MDA”) to the federal Food, Drug, and Cosmetic Act. The question was whether a person injured by an allegedly defective medical device can recover damages from the manufacturer under state tort law where the device went through and passed MDA’s premarket approval process.

I predicted a win for preemption advocates, and the Court toed the line nicely. In an 8-1 decision, the Court held yesterday that MDA’s preemption clause — codified at 21 U.S.C. § 360k — bars state common law tort claims challenging the safety or effectiveness of a medical device that received premarket approval from the federal Food and Drug Administration. Riegel v. Medtronic, Inc. (pdf, 37 pages).

MDA’s preemption clause disallows states from establishing a “requirement” that is “different from” or “in addition to” a “requirement applicable under [MDA] to the device,” or “which relates to safety or effectiveness of the device . . . included in a requirement applicable to the device under [MDA].” The FDA’s premarket approval process imposed “requirements” on the Medtronic catheter at issue in this case since FDA regulations prohibit marketing a medical device in a way that deviates significantly from the specifications set forth in the manufacturer’s premarket approval application. The FDA’s approval, the Court said, is based on the agency’s determination that specifications provide reasonable assurances of safety. State common law negligence and strict liability in tort causes of action would impose “requirement[s]” as to the safety of the catheter over and above those imposed by federal law, a result that MDA’s preemption clause doesn’t allow.

The majority opinion, penned by Justice Scalia, oozes disingenuousness from every pore. My personal favorite example appears on Pages 11-12 of the opinion where Scalia contrasts the supposedly painstaking balance of a particular design’s risks and benefits conducted by administrative agencies with the supposedly breezy, devil-may-care approach of a jury, which Scalia tells us “sees only the cost of a more dangerous design, and is not concerned with its benefits; the patients who reaped those benefits are not represented in court.”

Scalia knows full well that the risk-utility test for strict liability based on an allegedly defective design requires the trier of fact to balance the risks and benefits of that design. He also knows that all relevant bearing on risks and benefits comes in at trial. Since Scalia’s statement can’t be explained away by garden variety shit-all ignorance, I submit that something more sinister is afoot.

As is all too often the case, Justice Ginsburg is the lone voice of reason in these cases. She noted that there was no such thing as premarket approval of medical devices before the Dalkon Shield disaster. In the wake of that mess, states began imposing premarket approval requirements on medical device manufacturers. MDA was a response to those state efforts. Congress didn’t want companies subjected to fifty different sets of requirements, so it created a uniform nationwide premarket approval system. MDA’s preemption clause was aimed at premarket approval systems developed by state legislatures and state administrative agencies, nothing more.

The one glimmer of hope the majority allows comes in its statement that “§360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements.” Thus, a person injured by a defective medical device could conceivably recover tort damages if the device violated FDA regs or failed to comport with the FDA-approved premarket approval plan.

The issue there is whether the state in which the cause of action arose would recognize such a claim. In my experience, courts tend to frown on what they derisively call “private causes of action” for violation of administrative regulations, at least where a statute vests enforcement authority in the agency itself.

“What’s the big deal,” you might ask. “Nothing’s entirely safe. The best we can legitimately expect is reasonable safety. Doesn’t the FDA’s premarket approval process provide that?”

Tell that to the users of Pfizer’s drug Chantix who wanted to quit smoking and got an extra added bonus in the form of psychotic breaks. You could also tell it to the 22,000  people who died unnecessarily because of delays in recalling Bayer’s drug Trasylol, but it wouldn’t do much good seeing as how they’re dead and all.

The simple truth of the matter is that the FDA approval process for drugs and medical devices is heavily dependent on manufacturers volunteering accurate information. If manufacturers hide data and/or outright lie about the results of their clinical trials — as they do with appalling regularity — FDA approval isn’t worth the paper it’s printed on.

Riegel may be just the beginning, sad to say. There are two defective drug cases still before the Court in which manufacturers are claiming FDA preemption of state tort law.

More: Eric Turkewitz of the New York Personal Injury Law blog brought a smile to my ugly, beaten-down old face with an entry titled Lawyers Celebrate Losing Business (a/k/a Riegel Decision Heralds Era of Bigger Government.

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