Growing up down in Georgia, Bexis used the phrase “a whole lotta nuthin’” frequently when encountering things (like the 1970s Underground Atlanta tourist trap) or people (like Lester Maddox, who governed the same way he rode bicycles) that didn’t impress him much. That’s the phrase that came to mind when we read In re E. I. du Pont de Nemours & Co. C-8 Personal Injury Litigation, ___ F.4th ___, 2023 WL 8183812 (6th Cir. Nov. 27, 2023). Indeed, the opening sentence of the du Pont opinion was: “Seldom is so ambitious a case filed on so slight a basis.” Id. at 81. And yes, du Pont was an appeal from yet another bizarrely pro-plaintiff MDL decision.Continue Reading A Whole Lotta Nuthin’

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.
Medical Cannabis in Pennsylvania – Since It’s Legal, It’s Reimbursable, FDA Regulatory Status Notwithstanding
We generally keep our distance from medical cannabis/marijuana. We’re not one of those blogs. But if legal holdings of interest to us happens to involve cannabis, we will comment. Thus, we bring you Schmidt v. Schmidt, Kirifides & Rassias, PC, ___ A.3d ___, 2023 WL 7502499 (Pa. Commw. Nov. 14, 2023), holding that…
Wrecked on a Li Shore – The Saga of a Turncoat Expert
In prescription medical product liability litigation, both sides invest a lot in their expert witnesses. In addition to spending time, money, and effort, we work out our legal theories with our experts, and share with them our views of the facts, both good facts and bad facts. Thus, when the other side inveigles one of ours to switch sides – usually with the promise of a lot more money for a lot more testimony – the result can be a lot of collateral litigation.
We’ve blogged a couple of times before about turncoat experts, so the recent decision in Hawkins v. DePuy Orthopaedics, Inc., 2023 WL 7292164 (D.D.C. Nov. 6, 2023), attracted our interest. Then we discovered that Hawkins was only the most recent of several decisions barring testimony by the same turncoat expert – one Stephen Li – due to his prior employment with the same defendant concerning product liability litigation involving the same product (and other similar products, as well). See also King v. DePuy Orthopaedics, Inc., 2023 WL 5624710 (D. Ariz. Aug. 31, 2023); Cannon v. DePuy Orthopaedics, Inc., 2023 WL 7477903 (N.D. Ga. Aug. 16, 2023); McCoy v. DePuy Orthopaedics, Inc., 2023 WL 4551081 (S.D. Cal. July 14, 2023); but see Winkelmeyer v. DePuy Orthopaedics, Inc., 2023 WL 2974480 (W.D. Mo. Apr. 17, 2023). We note that a couple of other decisions (both precluding Dr. Li from testifying) apparently exist, but because they are either oral or under seal, we have not seen and do not discuss them. The plaintiffs in those cases were named Sheehy and England.Continue Reading Wrecked on a Li Shore – The Saga of a Turncoat Expert
Second Shameless Plug: Discount Code for Our Readers to 2023 ACI Drug & Device Conference
We hope our loyal readers had a wonderful Thanksgiving. As you reflect on what you’re thankful for this year, we would like to suggest one more item for your list: Discounted registration to ACI’s Drug and Medical Device Litigation Conference, coming up on December 5-6. As we mentioned, the good people at ACI asked…
Post-Out Sticky Notes
In stark contrast to the “MDL treatment” that the Valsartan plaintiffs received earlier this year, the decision in Post v. Amerisourcebergen Corp., 2023 WL 5602084 (N.D.W. Va. Aug. 29, 2023), was more mainstream. Class certification was denied for a variety of good reasons.
Unlike the result, the Post class action allegations, were relatively unusual. The members of the class were all patients of the same physician. Plaintiffs alleged that “defendants” “unlawfully made payments to [the physician] to induce him to misdiagnose” them so that they were eligible for the product at issue. Id. at *1 We’re not 100% sure, but only one of these “defendants” apparently was the product’s manufacturer. Plaintiffs sought “the return of every payment made from every source” for this treatment – essentially, they wanted after-the-fact (Post-hoc?) free medical care. Id. In addition, they demanded various damages for “invasion of privacy” and “negligence,” as well as punitive damages. Id.
And they wanted this all as a class action.
The Post reaction? No way.Continue Reading Post-Out Sticky Notes
Shameless Plug: ACI Drug & Device Conference (December 5 – 6)
Several of your Reed Smith bloggers are making plans to be in New York on December 5 – 6 to attend ACI’s annual Drug and Medical Device Litigation conference. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.…
Another Opioid Addict Overdose Case Dismissed, Several Times Over
We don’t have much patience for litigation attempting to seek damages for drug addicts who injured or killed themselves through their illegal use of drugs. We’ve discussed several times how such plaintiffs (or their estates) should lose under the in pari delicto doctrine that prevents criminals from recovering damages for the consequences of their own criminal acts. Lots of cases so hold. See, e.g., Albert v. Sheeley’s Drug Store, Inc., 265 A.3d 442, 448 (Pa. 2021); Price v. Perdue Pharma Co., 920 So.2d 479, 486 (Miss. 2006); Orzel v. Scott Drug Co., 537 N.W.2d 208, 213 (Mich. 1995); Patten v. Raddatz, 895 P.2d 633, 637-38 (Mont. 1995); Lastrina v. Bettauer, 289 A.3d 1222, 1234 (Conn. App. 2023); Gentile v. Malenick, 112 N.Y.S.3d 364, 365 (N.Y.A.D. 2019); Kaminer v. Eckerd Corp., 966 So.2d 452, 454 (Fla. App. 2007); Pappas v. Clark, 494 N.W.2d 245, 247 (Iowa App. 1992); Inge v. McClelland, 725 F. Appx. 634, 638 (10th Cir. 2018) (applying New Mexico law); Romero v. United States, 658 F. Appx. 376, 380 (10th Cir. 2016) (applying New Mexico law); Messerli v. AW Distributing, Inc., 2023 WL 4295365, at *5 (D. Kan. June 30, 2023), certif. denied, 2023 WL 6961977 (D. Kan. Oct. 20, 2023); Alston v. Caraco Pharmaceutical, Inc., 670 F. Supp.2d 279, 287 (S.D.N.Y. 2009); Sorrentino v. Barr Laboratories, Inc., 397 F. Supp.2d 418, 422-23 (W.D.N.Y. 2005), aff’d, 218 Fed. Appx. 7 (2d Cir. 2007); Foister v. Purdue Pharma, L.P., 295 F. Supp.2d 693, 705 (E.D. Ky. 2003).Continue Reading Another Opioid Addict Overdose Case Dismissed, Several Times Over
An Abuse of Discretion So Vast…. Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications
In 1919, J. Edgar Hoover described Communism as a “conspiracy so vast” that it was impossible for the populace to comprehend it. The Palmer Raids and the first Red Scare soon followed.
That phrase echoed in our minds when we first read In re Valsartan, Losartan, & Irbesartan Products Liability Litigation, 2023 WL 1818922 (D.N.J. Feb. 8, 2023). The Valsartan opinion was similarly mind-boggling in its scope. It certified not one, not two − but four class actions: one for economic loss, one for third-party payors (“TPPs”), and two for medical monitoring (“remedy” and “independent claim”). Id. at *3. Compare that to the state of class action precedent in product liability litigation not too long ago when we made this statement in 2007:
As far as we know, there has not been a single contested class action in product liability, personal injury litigation that’s been affirmed anywhere in the federal system in the decade since the Supreme Court put the kibosh on such things with its Ortiz and AmChem decisions. That’s not limited to just pharmaceuticals, that’s every kind of product that’s made.
Four in a single MDL order? These class certifications glommed together no less than 111 consumer and TPP subclasses. Valsartan, 2023 WL 1818922, at *24. These class certifications combined 428 different pharmaceutical products, produced and marketed by 28 separate defendants, with claims governed by the laws of 52 separate jurisdictions. There’s no way on earth that common issues could predominate over individual ones, or that this morass could possibly be tried to a jury.Continue Reading An Abuse of Discretion So Vast…. Our Long-Delayed Critique of the Valsartan MDL Class Action Certifications
FDA and Off-Label Communication – Getting Closer to Truth
In addition to its recent revamp of its “§510(k)” substantial equivalence clearance process for medical devices, (see our post here), the FDA has also been active with respect to off-label communications – another regulatory area of continuing interest to this Blog. Our position has been clear, and the same from the Blog’s beginning…
Tort-Related Implications of Recent FDA Device Draft Guidances
The FDA has taken recent steps that may, or may not, affect product liability litigation. We’re discussing the “may” aspect. For purely regulatory analysis, plenty of other commentary is available.
These actions occurred on September 7, 2023, and involve three “draft guidances” bearing on the “§510(k)” substantial equivalence clearance process for medical devices. Any litigator with even passing knowledge of medical device preemption knows that this − more properly, a prior (1982) version − is the process that the Supreme Court stated, was “focused on equivalence, not safety” in Medtronic, Inc. v. Lohr, 518 U.S. 470, 493 (1996) (emphasis original).Continue Reading Tort-Related Implications of Recent FDA Device Draft Guidances