Photo of Bexis

Bexis

Subscribe to Bexis's Posts

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.

Follow:Read more about BexisJames's Linkedin Profile

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.

********

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

As we head past Halloween, your Reed Smith bloggers wanted to offer our loyal readers a treat: Reed Smith is once again offering its virtual “Life Sciences CLE Week” starting Monday, November 7. (See the end of this post for information on jurisdictions in which credit is offered. You can register for the webinars here.)

And we will now mix our holiday references to note that yes, Virginia, there is an Ethics Credit session.

Bexis will be kicking things off on Monday, November 7, at 2 p.m. ET with a presentation on “The Ebb and Flow of the Law – A Year of Drug, Medical Device, and Vaccine-Related Preemption Developments,” which will discuss significant preemption-related developments over the last twelve months, both favorable and unfavorable, in product liability litigation involving prescription drugs (including generics), medical devices, vaccines, and OTC drugs.

Next up, on Tuesday, November 8 at 12 p.m. ET, our colleagues Dave Cohen and Selina Coleman will discuss “Ethics and E-Discovery: Lessons Learned from the Alex Jones Cases and Others.” Dave and Selina will use the Alex Jones cases as a starting point for discussing Model Rules 1.1, 1.6, 3.1, 3.3, and 3.4 and other recent matters where sanctions or major fines were issued relating to discovery or information governance.

Continue Reading Shameless Plug: Reed Smith’s Virtual Life Sciences CLE Week

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.
Learn more about this book