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JAMES M. BECK is Reed Smith's only Senior Life Sciences Policy Analyst, resident in the firm's Philadelphia office. He is the author of, among other things, Drug and Medical Device Product Liability Handbook (2004) (with Anthony Vale). He wrote the seminal law review article on off-label use cited by the Supreme Court in Buckman v. Plaintiffs Legal Committee. He has written more amicus briefs for the Product Liability Advisory Council than anyone else in the history of the organization, and in 2011 won PLAC's highest honor, the John P. Raleigh award. He has been a member of the American Law Institute (ALI) since 2005. He is the long-time editor of the newsletter of the ABA's Mass Torts Committee.  He is vice chair of the Class Actions and Multi-Plaintiff Litigation SLG of DRI's Drug and Device Committee.  He can be reached at jmbeck@reedsmith.com.  His LinkedIn page is here.

An interesting issue recently arose (but was not resolved) in In re: Proton-Pump Inhibitor Products Liability Litigation, 2022 WL 2188038 (D.N.J. June 17, 2022) (“PPI”).  The ability of an FDA expert witness to testify was challenged under 18 U.S.C. §207, a federal conflict of interest statute.  We have never seen that statute invoked in connection with an ex-FDA witness before, and apparently neither has anyone else, since the opinion observes that “the fact pattern presented here is something of an unprecedented issue.”  Id. at *4 (citation and quotation marks omitted).  So we thought we’d alert our readers.

Continue Reading Regulatory Witnesses – Something Else To Watch

In our civil society, many non-governmental entities certify various things.  We’ve all heard of the Good Housekeeping Seal of Approval, which has been around for over a century.  Then there is Consumers Union/Consumer Reports – a magazine that does nothing but rate products, and recommends those it rates particularly highly rated or as providing a particularly good value.  There are a host of private standards testing organizations like the ASTM International, the American National Standards Institute, and the International Standards Organization, which in their respective fields create and maintain voluntary industrial standards for any number of commercially related operations.  These entities determine things such as what the “N95” in an N95 facemask means.  A myriad of other industry, medical, and online organizations certify and rate an almost endless variety of goods and services.  Heck, even lawyers get rated.

Continue Reading Suing the Certifiers – A Dangerous Undertaking

Last term the newly empowered conservative majority on the Supreme Court demonstrated to all that precedent is not so precedential, even when it had stood for nearly fifty years.  They very nearly did it again, but just missed, targeting precedent on religious exemptions and vaccine mandates that has been around for more than twice as long.

Continue Reading Vaccine Mandates and Religion at the Supreme Court

Whaley v. Merck & Co., 2022 WL 1153151 (S.D. Cal. April 12, 2022), is an ugly example of overly grasping personal jurisdiction permitted in the service of facilitating an even worse overreach by a state’s substantive law.  We’ve repeatedly criticized the substantive theory – innovator liability – because (among other things) it exposes manufacturers to liability for claimed defects in competing generic drugs from which the defendants received no benefit (quite the opposite), and did not control what their competitors did.  Indeed, innovator liability strays so far from traditional product liability that it creates personal jurisdictional problems – since the target defendant often has no jurisdictional contacts whatever with the forum state, since it didn’t even sell the product that allegedly caused (very attenuated) harm.

Continue Reading California Court Overreaches on Personal Jurisdiction

Three times previously we have “reported from the front” on the federal government’s efforts to dismiss False Claims Act litigation – ostensibly (and often ostentatiously) filed in the government’s name – after the government has concluded that the particular case is more bother than it is worth.  The most recent of those posts was late last year, and reported on Polansky v. Executive Health Resources, Inc., 17 F.4th 376 (3d Cir. 2021).

Continue Reading The FCA Front Moves To The Supreme Court

At the end of the term, the Supreme Court, in Ruan v. United States, 2022 WL 2295024,142 S. Ct. 2370 (2022), vacated the convictions of a couple of alleged “pill mill” doctors under the Controlled Substances Act upon finding that the government’s proof in their criminal trial did not meet the standard required

Although it is not a drug/device case (if it were, we would have discussed it before now), the recent Supreme Court decision in Gallardo v. Marstiller142 S. Ct. 1751 (2022), raises some interesting issues that attorneys defending personal injury action of any sort should consider.  Settlement of any personal injury case involving a

Particularly in economic loss class actions, we occasionally have to deal with claims involving the Magnuson Moss Warranty Act (“MMWA”).  Thus, we have covered MMWA issues before.  Here’s another one.  In In Re Hill’s Pet Nutrition, Inc., Dog Food Products Liability Litigation, 2022 WL 1641291 (D. Kan. May 24, 2022), the court held

Summary judgment was affirmed in Vesoulis v. ReShape LifeSciences, Inc., 2022 WL 989465 (5th Cir. April 1, 2022), although the recent troubling trend towards non-precedential defense wins but precedential defense losses continues.  Vesoulis was a one-off suit under Louisiana law against the manufacturer of a pre-market (“PMA”)-approved medical device and the implanting – or, more properly, explanting – surgeon.  Plaintiff allegedly suffered an injury that, according to the informed consent form he signed, was a one in 10,000 possibility.  Id. at *1.

The device being PMA approved, one might think that the chief defense was express preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  It wasn’t.  Rather, plaintiff’s central warning claim fell under the Louisiana product liability statute (“LPLA”) because the surgeon was “experienced.”  Id. at *2.  Instead the case turned on implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). 

Continue Reading FDCA-Based Negligence Per Se & Informed Consent Don’t Mix