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Today, the summer solstice, is one of our favorite days of the year.  It’s the first official day of summer, and readers in the U.S. will have anywhere from 14-16 hours of daylight (the farther north, the more daylight). We hope you get to enjoy some of the summer sunshine today—or at least this weekend.  As the late, great, Brian Wilson put it, “Sunshine, can’t get enough sunshine, I’m following the sunshine, everywhere I go.”Continue Reading Eighth Circuit Affirms Rule 702 Exclusion of Plaintiff Design Defect Expert

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There are some basic rules for medical product liability litigation, at least as we—and the vast majority of courts—see it.  One is that the manufacturer of the medical product that the plaintiff used and allegedly injured her is typically the right defendant.  Part of what a potential plaintiff is supposed to do during the statute…

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It’s crunch time people.  No more browsing.  No more pondering.  No more scrolling.  Pick something and buy it.  More importantly, you need to ship it.  You may not be able to see all of your family this year, but you still want to make sure your gift makes it under their tree.  If so, today…

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If preemption had a family tree, the drug and device branch would be heavy.  And, as our scorecards and cheat sheets demonstrate, there are obvious sub-branches that sprouted out of major Supreme Court decisions.  We have the Wyeth v. Levine, 555 U.S. 555 (2009) pharmaceutical branch; the Medtronic, Inc. v. Lohr, 518 U.S.…

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This post is from the non-Reed Smith side of the blog.

It’s been awhile since we’ve posted about PMA preemption in an Infusion case – but that litigation continues to make good law.  This time in Minnesota state court which fortunately took a lot of its cues from strong federal law.  In Stiltner v. Medtronic Inc., 2016 WL 4005471 (Minn.Dist.Ct. Jul. 25, 2016) the court dismissed all of plaintiffs’ claims as preempted and while the dismissal is without prejudice, the court laid down tough pleading standards for plaintiff to meet if he wants to try a comeback.

Plaintiff had an Infusion pain pump installed and that particular pump model was recalled about one year later.  Three years after the recall, plaintiff began experiencing complications which necessitated revision and re-implantation surgeries.  Id. at *1.   Plaintiff brought claims for manufacturing defects, failure to warn, negligence, breach of express and implied warranties, and violations of the Minnesota Consumer Fraud Act.  Id.  Because the Infusion pain pump was Pre-Marketed Approved (“PMA”) by the FDA, it is subject to both Riegel express preemption and Buckman implied preemption.  Therefore, in response to defendants’ motion to dismiss, plaintiff had to demonstrate that his claims fit within the “narrow gap” left open between Riegel and Buckman – emphasis on the “narrow” part.  To pass through, plaintiff needs to be suing for conduct that violates the FDCA (the state law claim must parallel device-specific regulations to survive express preemption) but not suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted).  Id. at *4.

Plaintiff attempted to overcome preemption by relying on the recall and by citing to certain FDA actions such as warning letters issued to defendants to establish that defendants violated Current Good Manufacturing Practices (“CGMP”) regulations.  Id. at *1.  But in assessing the sufficiency of plaintiff’s pleadings, the court concluded that plaintiff simply surmised that “because of the [FDA warnings] and Defendants’ . . . recall of the Device, Defendants must have violated federal regulations which must have resulted in injury to Plaintiff.”  Id. at *6.  “Must have” is about on par with “would of, should of, could of.”  Not nearly enough.Continue Reading In Minnesota PMA Preemption Requires Plaintiffs to be Specific, Very Specific

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This post comes from the non-Reed Smith side of the blog.

Last week we reveled in the Tenth Circuit affirming the Caplinger decision – a complete rejection of plaintiffs’ attempt to utilize allegations of off-label promotion to slip through the exceedingly narrow gap that remains in Pre-Market Approval device cases.  Think of it like taking a shot on goal.  The shot deflects off the goalie’s stick and goes wide – that’s express preemption.  The shot hits the goalpost and sails over the net – that’s implied preemption. Between the puck and the net are the sticks of the opposing team – they’re pleading requirements.  You don’t give the who, what, where and when – the puck’s going to be stolen. Plaintiffs have been trying to push the puck into the net with diversion.  Get the courts thinking off-label use changes the rules; that it should force a penalty on the manufacturers that opens up the lane for a clean shot.  Wrong. No free shot.  No empty net.  All the obstacles remain in place.  Only, in PMA cases plaintiffs are less likely to score than Sidney Crosby facing Henrik Lundqvist (sorry Pittsburgh, and to be clear this blogger is not supporting Lundqvist in the next series.  Go Capitals!).Continue Reading InFuse State Court Appellate Win

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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