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Device Preemption Win In Connecticut

By James M. Beck and Mark Herrmann

A tip of the cybercap to Harley Ratliff of Shook Hardy for sending us word of a device preemption win on appeal in Connecticut. Mullin v. Guidant Corp., AC29829, slip op. (Conn. App. May 12, 2009). We'd blogged about the trial court decision in Mullins - back when it was the first post-Riegel state court preemption decision.

The original Mullin opinion was always a little unusual, since it held that preemption divested the court of subject matter jurisdiction. Trial Slip op. at 3. On appeal, the court fixed that, slip op. at part I, but held, properly, that the defendant - a manufacturer of a PMA-approved implantable defibrillator - was entitled to summary judgment.

Finally, as a policy matter we think that defibrillators are a product as to which preemption is peculiarly appropriate. They are implanted, as occurred in Mullin in seriously ill people who are at risk of sudden death through heart failure. Preemption is necessary to prevent the companies who make these lifesaving medical devices from being turned into insurers against heart attacks in a population already predisposed to heart attacks.

The Mullin complaint:

contained several allegations relating to the implant?s safety, design, manufacture and distribution, including breach of implied and expressed warranties, failure to evaluate the safety of the implant.

Mullin appellate slip op. (sorry, no page numbers). The appellate court held that all these claims were preempted. That product liability in Connecticut was a statutory rather than common-law cause of action was a "distinction without a difference." Slip op. at part II(B). All the claims - including manufacturing defect and express/implied warranty - would have imposed requirements that differed from the specifications approved by the FDA. Id. Nothing in Levine affected express preemption in the medical device area. Id. n.6. The plaitiffs raised "parallel" claims on appeal, but had not pleaded anything that could be interpreted as such. Id. Part II(C).

Finally, as a policy matter, we think that defibrillators are particularly deserving of preemption (and any other) defense. These devices are implanted in people who are already at serious risk of sudden death from heart attacks. Because these devices save so many lives, we're loathe to see their manufacturers turned into de facto insurers for every heart attack that a defibrillator patient might happen to suffer. That's what modern product liability law does.

Don't believe us? That's exactly what's been happening to the the makers of SSRI anti-depressants. Suicide is a risk of depression, but in case after case SSRI makers have been sued for suicides that all scientific evidence suggests would have happened anyway. It's no wonder that SSRIs have been at the core of preemption battles in the prescription drug area.

Full post as published by Drug and Device Law on May 07, 2009 (boomark / email).