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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.

In a 341-page opinion, In re Zantac (Ranitidine) Products Liability Litigation, 9:20-md-02924-RLR, slip op. (S.D. Fla. Dec. 6, 2022), the MDL court held that all of the Zantac plaintiffs’ general causation experts (concerning five cancer types) failed to meet the admissibility standards of Fed. R. Evid. 702. Consequently the court granted the defendants’ motions

Readers may recall our dissection of the ridiculous application of offensive, non-mutual collateral estoppel in Freeman v. Ethicon, Inc., 2022 WL 3147194 (C.D. Cal. 2022).  Ultimately, the thumb that Freeman put on the scale didn’t matter, because the defendant won at trial despite that handicap.

We described the prior adverse decision that formed the ground for the collateral estoppel claim as “factual findings entered by a state-court judge after a bench trial in earlier false-advertising and unfair-competition litigation.”  That description doesn’t really do the prior decision (in)justice.  That decision, People v. Johnson & Johnson, 2020 WL 603964 (Cal. Super. Jan. 30, 2020), decided an action filed by the California attorney general that had essentially converted the allegations that product liability plaintiffs had been making against the defendants’ pelvic mesh into the basis for a statewide civil action under certain California consumer protection statutes.  Here is the result of that decision, in a nutshell:

Continue Reading Interesting Pelvic Mesh Due Process Certiorari Petition

Three years ago we published a lengthy post, “Stupid Expert Tricks,” detailing several of the other side’s egregious attempts at passing off junk science “experts” as the real thing, along with our side’s trials and tribulations during the course of unmasking these phonies.  Our rogues’ gallery contained:  In In re Zofran (Ondansetron) Products Liability Litigation, 392 F. Supp.3d 179, 181-87 (D. Mass. 2019) (Zambelli-Weiner); In re 3M Bair Hugger Litigation, 924 N.W.2d 16, 19 (Minn. App. 2019) (Augustine); In re Mirena IUD Levonorgestrel-Related Products Liability Litigation (No. II), 341 F. Supp.3d 213, 222-23, 229-32 (S.D.N.Y. 2018) (Etminan); Gerke v. Travelers Casualty Insurance Co., 289 F.R.D. 316, 328-29 (D. Or. 2013) (Painter); McClellan v. I-Flow Corp., 710 F. Supp.2d 1092, 1119-25 (D. Or. 2010) (Matsen); Nelson v. Tennessee Gas Pipeline Co., 1998 WL 1297690, at *4, 7-8 (W.D. Tenn. Aug. 31, 1998), aff’d, 243 F.3d 244 (6th Cir. 2001) (Kilburn); and Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441, 1559-62 (D.V.I. 1994), aff’d mem., 46 F.3d 1120 (3d Cir. 1994) (Gilbert).

We’ve found another one – this time from talc litigation.

Continue Reading Stupid Expert Tricks Redux

The Supreme Court’s latest foray into the constitutional thicket of personal jurisdiction, Mallory v. Norfolk Southern Railway, No. 21-1168 – to decide whether states can force corporations to “consent” to general personal jurisdiction via foreign corporation registration statutes − was orally argued on November 8, 2022.  The transcript is available here.  Since Bexis has been involved (as amicus curiae) in Mallory since the trial court’s favorable decision (which he made sure was on Westlaw and Lexis) was first appealed in Pennsylvania, we thought we’d review the highlights of the oral argument.

Continue Reading Mallory Oral Argument – Litigation Tourists’ Last Stand?

We’ve written a number of posts on whether, in various jurisdictions across the United States, software and other forms of electronic/magnetic code can be considered to be “products” for purposes of product liability – usually strict liability.  As befits the decentralized product liability litigation landscape in the United States, there is considerable uncertainty, but most decisions, as well as both the Second and Third Restatements of Torts, have determined that incorporeal items composed of electronic bytes are not “products.”

Continue Reading Software as a Product – The European Union Goes There

The recent defense win in Dains v. Bayer HealthCare LLC, 2022 WL 16572021 (N.D.N.Y. Nov. 1, 2022), demonstrates why many plaintiff-side counsel are well-advised to steer away from cases involving PMA medical devices.  Between federal preemption and TwIqbal, not one of the plaintiff’s “seventeen separately enumerated causes of action” escaped the defendant’s motion to dismiss.  Id. at *3.

Continue Reading Preemption and Pleading Send Plaintiff Packing

One of the stock P-side responses, in the post-Bauman personal jurisdiction environment, to a jurisdictionally-based motion to dismiss is to seek “jurisdictional discovery” – the more onerous the better – in an attempt both to slow the often-inevitable dismissal and also to drive up the nuisance value of the case.  That’s the main reason that on our personal jurisdiction cheat sheet we note when jurisdictional discovery is denied.

Continue Reading Jurisdictional Discovery Is Not Bigger in Texas

Today’s guest post is by Jim Fraser of Greenberg Traurig.  Jim is a long-time product liability defense lawyer, but who also worked as a litigation attorney in FDA’s Office of the Chief Counsel (“OCC”).  Utilizing his FDA perspective, he offers some useful suggestions on the regulatory aspects of defending drug or medical device product liability cases.  As always, our guest-posters are 100% responsible for what they wrote, deserving all of the credit and (any) of the blame.

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Lawyers defending drug and medical device companies in product liability litigation routinely deal with FDA-related issues.  For example, they present expert witnesses to testify that their clients complied with the applicable regulatory requirements, they move to exclude purportedly “bad” FDA documents (e.g., FDA Form 483s and Warning Letters), and they file summary judgment motions arguing that the FDCA or FDA regulations preempt plaintiffs’ claims.

Continue Reading Guest Post – What a Product Liability Defense Lawyer Learned While Working for FDA.

We’ve written several posts about ridiculous absolute liability theories seeking to hold drug manufacturers liable simply for making an FDA approved prescription drug.  Wilkins v. Genzyme Corp., 2022 WL 4237528 (D. Mass. Sept. 14, 2022), is an even stranger claim, with the plaintiff seeking to hold the defendant liable for not manufacturing a prescription drug.  Fortunately, in Wilkins, those claims (several theories alleging essentially the same thing) did not state a claim.

Continue Reading No Liability for Not Manufacturing a Product