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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.

Not too long ago we blogged about the value that the Product Liability Advisory Council (“PLAC”) brings to the table – particularly to drug and device manufacturers faced with relentless product liability claims.  For the third time, we urged our corporate readers to support PLAC’s pro-defense advocacy by joining and becoming members.

Still not

California’s Proposition 65, which has spawned litigation over scientifically questionable “known to the state [of California] to cause cancer” warnings on such everyday products as cola drinks, coffee, beer, and soy sauce, see Riva v. Pepsico, Inc., 82 F. Supp.3d 1045, 1062 (N.D. Cal. 2015), took one on the chin recently in the Ninth Circuit at the hands of free speech under the First Amendment.

We can’t say it was unexpected – indeed, Prop 65 was one of the targets of the First Amendment’s prohibition on governmentally compelled speech that we identified in our 2019 post on American Beverage Ass’n v. City & County of San Francisco, 916 F.3d 749 (9th Cir. 2019) (en banc) (“ABA”).  And lo it has come to pass.

Continue Reading Ninth Circuit – First Amendment Prevails Over Prop 65

We have posted twice before about decisions that reject duty-to-train claims under the rubric of “educational malpractice.”  Now Pennsylvania has joined the party.  Grady v. Aero-Tech Services, Inc., 2022 WL 683720 (Pa. Super. March 8, 2022), an unpublished, but citable, decision of Pennsylvania’s major intermediate appellate court, applied Pennsylvania’s prior precedents that reject educational

As regular readers know, we bloggers have been following the issue of whether software of various sorts – electronic bytes – is a “product” for product liability purposes.  It’s a longstanding issue, since the current Restatements of Torts specifically defines a “product” as something “tangible,” which arrays of electrons are not.  “A product is tangible

Federal Rule of Evidence 407, dealing with the inadmissibility of subsequent remedial measures, isn’t all that complicated – as Federal Rules go.  It’s only 73 words long:

When measures are taken that would have made an earlier injury or harm less likely to occur, evidence of the subsequent measures is not admissible to prove:

  • negligence;

Not too long ago we researched precedent that forbade persons claiming to be “FDA experts” from opining that products are “adulterated” or “misbranded.”  In that post, we mentioned that this research is a subset of a “general” precedent “precluding expert opinions on questions of law,” which we didn’t get into because Bexis’ book addressed it. 

A few years ago we did a couple of posts about the learned intermediary decision that arose from the Zimmer Nexgen Knee Implant MDL, and was subsequently affirmed by the Seventh Circuit Court of appeals.  We designated the opinion In re Zimmer Nexgen Knee Implant Products Liability Litigation, 218 F. Supp. 3d 700 (N.D.

One of the problems with so-called Lone Pine orders in MDLs is timing – they are usually entered way too late, more as vehicles to enforce settlements than as any genuine effort to weed out the large number of bogus cases that everyone, including plaintiffs, admits are present in MDLs.

We can’t say that the

We had occasion recently to reread Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), and here’s what the Court said about why the “reasonable assurance of safety and effectiveness” standard is preemptive of personal injury claims:

[The FDA] may thus approve devices that present great risks if they nonetheless offer great benefits in light