[Drug and Device Law] Plaintiff Seeking to Remake Sprint Fidelis Gets Shut Down
This post is from the non-Reed Smith side of the blog.
The remake is a Hollywood staple. From Annie to Planet of the Apes. From The Thomas Crown Affair to Willard (couldn’t come up with a “Z” remake) – everything old is new again. Sometimes a remake turns out better than the original – True Grit, The Fly, You’ve Got Mail, and maybe Ocean’s 11 (feel free to disagree). More often than not, remakes do not live up to our expectations. Why, oh why, did Steve Martin even attempt to remake The Pink Panther? Sorry Billy Bob, but your Bad News Bears is not even in the same league as Walter Matthau’s. Russell Brand and Jennifer Garner don’t even come close to Dudley Moore and Liza Minnelli’s magic in Arthur. And while Patrick Swayze’s Point Break and Road House may not be of the same caliber as the aforementioned originals – do they both need to be remade? (With all due respect to Rhonda Rousey who we are quite certain would make an extremely effective bouncer in real life).
Remakes are apparently inevitable and not limited to the movies. Lawyers on both sides of the v. are often looking to “remake” the law. But when it comes to PMA preemption, we defense counsel say leave it alone. That’s just what the court did in today’s case – Pearsall v. Medtronics, Inc., 2015 U.S. Dist. LEXIS 164199 (E.D.N.Y. Dec. 7, 2015). At issue was the same cardiac defibrillator and lead that was the subject of the In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation (D. Minn.) in which the Eighth Circuit affirmed dismissal of plaintiffs’ claims as preempted. The blog is peppered with mentions of Sprint Fidelis as it was probably the first major post-Riegel PMA preemption battle and victory. So plaintiff had a bit of an uphill fight on his hands. His approach: draw attention away from Sprint Fidelis by focusing on Hughes and Stengel. The blog also is loaded with references to these cases, only they aren’t as flattering. The court didn’t fall for the old switcheroo.
Rather the court applied the Riegel two-prong test just as it should. After finding that pre-market approval satisfies the first prong, the court turned to whether any “claims in this case are based on state requirements that are different from or in addition to the federal requirements imposed by the PMA process.” Id. at *16.
Plaintiff made three arguments on manufacturing defect. First, plaintiff argued that defendant violated the Current Good Manufacturing Practices (“CGMPs”) by failing to adequately test the device. Id. at *17-18. But the CGMPs are general guidelines for all device manufacturers; they are not device-specific and therefore “a claim based on alleged failure to comply with the guidelines fails to plead a violation of a federal requirement.” Id. at *19. The CGMP’s are too vague to be considered requirements and to mandate compliance would impose and additional or different standard on manufacturers. Therefore, a manufacturing claim on this ground is preempted. Just like in the original.
Next plaintiff tried to argue that his manufacturing defect was premised on defendant’s failure to submit a PMA supplement to the FDA for certain changes to the device. Id. at *20. Regardless of what the federal requirement is, there is no state law duty to submit supplements or a state law remedy for failure to do so. Id. at *22. In other words, it is not enough to point to a federal requirement. There must be an “actual” state law requirement. Otherwise, plaintiff’s claim is really seeking private enforcement of the FDCA – not allowed. See 21 U.S.C. §337(a) and Buckman.
Finally, plaintiff pointed to the welding technique used in the manufacturing process and argued that use of that technique caused the device to be defective. Taking a page from the Sprint Fidelis state court litigation, the court found that because the FDA had specifically approved the design and manufacturing processes at issue, permitting such a claim “is akin to asking a jury to sit in judgment of the FDA’s approval and review process.” Id. at *24. Another no-no.
The court then moved on to plaintiff’s failure to warn claim. Here plaintiffs wanted the court to recognize a Stengel failure to report adverse events to the FDA claim. Plaintiff pointed to a decision by the Northern District of New York holding that a manufacturer’s duty to warn extends not to the plaintiff but to the plaintiff’s physician and that that duty is parallel to the federal duty to report adverse events. Id. at *27. Fortunately, the Eastern District’s sense of parallelism is more in line with ours:
While New York law may require manufacturers to warn the medical profession, that is not the same as a duty to report to the FDA. Thus, since the state law duty imposes obligations that are "different from, or in addition to" the federal requirements, the Court finds that Plaintiff's failure to warn claim is preempted.
Id. at *28-29. Further, since the duty to report to the FDA is based only on a federal requirement, “authority to enforce the claim rests [solely] with the FDA.” Id. at *29.
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Posted By Michelle Yeary to Drug and Device Law at 12/15/2015 03:25:00 PM --
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