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Starting with our comprehensive post lambasting Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448 (W.D. Pa. 2019), for ignoring 75 years of hitherto unbroken Pennsylvania precedent and allowing a “strict liability” design defect claim against an FDA-regulated prescription medical product, we have both chronicled and opposed the other side’s attempt to infiltrate strict liability into Pennsylvania litigation involving such products (primarily medical devices). That attempt disregards seven Pennsylvania Supreme Court decisions between 1948 (Henderson) and 2014 (Lance), as well as the Pennsylvania Superior Court (an intermediate appellate court in Pennsylvania) (Creazzo), all rejecting application of strict liability principles to prescription medical products.  For the gory details, see the prior post.Continue Reading Pennsylvania Law, Federal Rules, and FDA Standards

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

We don’t usually report on securities-law cases, but today we do. That is because the well-reasoned decision in question, In re Allergan PLC Securities Litigation, 2022 WL 17584155 (S.D.N.Y. 2022), has major implications for the parallel Textured Breast Implant MDL now pending in…

We wrote recently that California’s courts have never met a case they did not like.  We were speaking somewhat tongue in cheek of course, but still California remains a destination for litigation tourists trying to take advantage of laws and procedures that many view as plaintiff friendly.  One bulwark against blatant forum shopping is personal jurisdiction under the U.S. Supreme Court’s Bauman and Bristol-Myers Squibb cases, the latter reversing the California Supreme Court, which restored some measure of discipline to jurisdiction over out-of-state defendants.

Another potential bulwark is choice of law.  That is to say, even when a plaintiff sues in California, the applicable choice-of-law rules might compel the application of another state’s law, which could doom the plaintiff’s claims.

That is what happened this week in Nelson v. F. Hoffmann-La Roche, Inc., No. 21-cv-10074, 2022 WL 17259056 (N.D. Cal. Nov. 28, 2022) (to be published in F. Supp. 3d), where a Florida resident and Army veteran used a generic prescription drug while stationed in Kentucky and overseas and allegedly suffered complications.  But he chose to sue in California.  Why?  Because the manufacturer of the branded version of the drug (not the generic version that the plaintiff actually used) was based in California at the time he filed (having relocated from New Jersey), and California is one of a very few states that allows innovator liability—i.e., holding an innovator/branded manufacturer potentially liable for a generic product that it did not make, did not sell, and from which it did not make any profit. Continue Reading Federal Judge In California Cabins Innovator Liability

Drug manufacturers are not insurers against injury from or while taking medications.  Neither are distributors or pharmacies.  Just because a patient experiences a complication while taking a medication, including the very condition the medication is supposed to help prevent, does not mean that some person or entity should be liable to the patient for her injuries.  Sometimes, there is no fault or liability to be found.  We do not think these are controversial principles, but we find that they apply to more than a few of the cases giving rise to the decisions about which we expound.

We also find that missing facts from complaints can speak volumes.  Similarly, when a plaintiff waits until the third complaint to add case-specific factual allegations that should have been there from the start or when factual allegations pop in and out of serial amendments you have to question the basis for those allegations.  At least we do.  As inveterate curmudgeons, we tend to think bare-bones, boilerplate allegations are unlikely to be supported if the case gets to the merits.  Of course, part of the game for some plaintiffs is to get past pleadings and hope the defendants opt for settlement instead of paying the costs of defense.  The Twombly and Iqbal decisions tightened pleading standards, and thus improved the chance of success on motions to dismiss in federal court and some states have followed along.  The hole, and source of our periodic grumbling, is how often dismissals are without prejudice and accompanied by leave to amend.  Too often, it seems that the provision in Fed. R. Civ. P. 15 that courts “should freely give leave when justice so requires” leads to leave even when it should be obvious that amendment will be futile, not to mention a waste of judicial resources.Continue Reading Five Strikes Needed To Dismiss A Questionable Case

We scratched our heads last year when the Third Circuit misconstrued the federal PREP Act to allow a state-law negligence claim arising from an alleged COVID-related death, in direct contravention of the Act’s express preemption.  See Maglioli v. Alliance HC Holdings LLC, 16 F. 4th 393 (3d Cir. 2021).  The other shoe dropped the…

If drugs and medical devices undergo a product life cycle, so do drug and medical device litigations. We are currently laboring in the relatively early stage of a Multidistrict Litigation, where the court seems terrified of making any substantive decisions. We get no rulings. Rather, the parties are forced to listen to lectures about the…

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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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