A Double Dose of Preemption

by Dechert LLP

In medical device cases, preemption will hunt you down. 
In Hinkel v. St. Jude Medical, S.C. Inc., 2012 U.S. Dist. LEXIS 56322 (E.D. La. April 23, 2012), the plaintiff survived removal and discovery only to be caught by preemption at the summary judgment stage. 
In Cooley v. Medtronic, Inc., 2012 U.S. Dist. LEXIS 55878 (E.D. Ky. April 20, 2012), the plaintiff took an unusual and lengthier path but met the same end.  Her case was removed and consolidated in an MDL only to be met with a dismissal order by the MDL court.  On appeal, the 8th Circuit affirmed.  Thereafter 219 of the 225 cases settled.  Plaintiff’s wasn’t one of them.  Her case remained active but facing the MDL court’s now-affirmed dismissal order.  Surprisingly, though, the MDL court didn’t enter judgment against plaintiff.  Instead, it remanded the case to the original transferor court for further proceedings.  A new life for plaintiff?  Not a chance.  That’s where preemption caught her.  The transferor court granted defendant’s motion to dismiss based on preemption.  
Other than illustrating preemption’s unrelenting pursuit of the plaintiffs’ claims, there’s little new or interesting about these two cases.  The opinions do provide, however, good reasoning on why a myriad of claims that plaintiffs ordinarily bring in these cases are preempted.  We thought it would be useful to share some of it with you:
Express Warranty Claims:
A jury hearing a breach of express warranty claim would . . . be required to determine whether [the defendant’s] representations regarding the [medical device] - including the FDA-approved label, warnings, and instructions for use - were false.  Such a determination would clearly undermine the federal regulatory scheme.  Hinkel, 2012 U.S. Dist. LEXIS, at *21; see also Cooley, 2012 U.S. Dist. LEXIS 55878, at *12 (“The MDA preempts these [warranty] causes of action because a jury would have to find that the devices were ‘not safe and effective,’ a finding that would be contrary to the FDA’s approval.”)
Failure to Warn Claims:
The same is true should Plaintiffs wish to proceed on a failure to warn theory.  The FDA approved the product’s warnings based on its evaluation of the results of the extensive clinical trials and safety studies required during the PMA process.  To permit a jury to decide that these warnings are inadequate under [state] law would effectively displace the FDA’s exclusive role and expertise in this area and risk imposing inconsistent obligations on manufacturers of PMA-approved devices.  Hinkel, 2012 U.S. Dist. LEXIS, at *21-22; Cooley, 2012 U.S. Dist. LEXIS 55878, at *10 (“The MDA preempts this [failure to warn] claim because success on the claim would require Medtronic to have provided different or additional warnings from those approved by the FDA.”).
Design Defect Claims:
[W]ere Plaintiffs to maintain a claim that the [medical device] was “unreasonably dangerous” because of a defective design, they would have to prove that an alternative design existed and that [the defendant’s] choice not to adopt this alternative design was unreasonable under the circumstances. . . .  Rather than mirroring federal requirements, this would allow the state to directly contradict the FDA’s determination that the approved design of the [medical device] was both “safe and effective.”  Hinkel, 2012 U.S. Dist. LEXIS, at *22.
Manufacturing Defect Claims:
[T]he manufacturing defect claim simply alleges that [defendant’s] manufacturing process or the ICD specifications themselves are deficient.  The MDA preempts this cause of action because [plaintiff] would have to prove that the devices should have been manufactured differently from the manner approved by the FDA.  Cooley, 2012 U.S. Dist. LEXIS 55878, at *11-12; Hinkel, 2012 U.S. Dist. LEXIS, at *20 (“[W]ere Plaintiffs to prove that the [medical device] was defective due to the construction or composition of the system, they would essentially be challenging the construction, composition, and manufacturing process that the FDA approved for the device.”).
Derivative Claims Like Negligent or Intentional Infliction of Emotional Distress, Unjust Enrichment, State Consumer Protection Statute Violations, and Loss of Consortium:
All of [plaintiff’s] remaining claims are derivative of the above tort claims.  Since the MDA preempts all of the tort claims, the MDA preempts all of the derivative claims as well.  Cooley, 2012 U.S. Dist. LEXIS 55878, at *13-14.
Finally, the Hinkel court addressed plaintiff’s unusual (maybe desperate) argument to avoid preemption.  Plaintiff argued – with no support – that any violation of the state product liability act constituted the equivalent of a violation of FDA regulations.  So any claim under the state act was a permissible parallel violation claim.  This argument would swallow whole the Supreme Court’s preemption decision in Riegel.  The court didn’t buy it:
Plaintiffs have cited no authority for this bold contention . . . and as noted above, the cases that have addressed the issue have quite clearly found the opposite to be true. It is clear that any [state law] claim based on the [the medical device’s] construction or composition, design, warnings, or express warranties would each specifically impose requirements different from or in addition to the FDA-approved requirements for the device. Hinkel, 2012 U.S. Dist. LEXIS, at *19-20. 

As you can see, there’s lots of good stuff, and good quotes, in these two opinions.  We hope you find them useful.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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