On Thursday, we noted that the Ohio Supreme Court had upheld two tort reform provisions in Arbino v. Johnson & Johnson, 2007-Ohio-6948. We also said that we’d be back after we had a chance to read the decision.
We’re back.
You know what’s odd? Arbino is plainly an important case: It’s the most recent

Our recent fraudulent joinder post ended with the observation, “[h]aving found fraudulent or procedural misjoinder, the court ‘sever[ed] the action’ against the healthcare provider ‘so as to preserve [the manufacturer’s] right to removal in the remaining action.’” (quoting In re Stryker Rejuvenate & ABG II Hip Implant Products Liability Litigation, 2023 WL 6514996, at *3 (D. Minn. 2023)).

That started us thinking about other uses of severance of non-indispensable parties to preserve diversity – particularly, as in the Rejuvenate case, medical malpractice defendants in product liability litigation – to preserve federal diversity jurisdiction.  We have discussed several individual decisions that successfully employed Rule 21 in this fashion:  here (discussing Mayfield v. London Women’s Care, PLLC, 2015 WL 3440492 (E.D. Ky. May 28, 2015)); here (discussing In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2011 WL 2746086 (S.D. Ill. July 11, 2011)); here (discussing Stone v. Zimmer, Inc., 2009 WL 1809990 (S.D. Fla. 2009)); here (discussing DeGidio v. Centocor, Inc., 2009 WL 1867676 (N.D. Ohio June 29, 2009)); and here (discussing Joseph v. Baxter International, Inc., 614 F. Supp.2d 868, 872 (N.D. Ohio 2009)).Continue Reading Removal, Severance & Rule 21

We refuse to end the year on a bad note, so we’ll talk about a case that’s good – not good enough to make tomorrow’s top-ten list, but good enough to slam the door shut on 2020 with a reasonable amount of cheer.

Vicente v. Johnson & Johnson, 2020 WL 7586907 (D.N.J. Dec. 21,

Someone asked us the other day whether spoliation sanctions could lie against a non-party for alleged loss/destruction of electronically stored information sought through a third-party subpoena.  On the one hand, assuming there is personal jurisdiction, the substantive discovery rules do not vary between parties and non-litigants subjected to valid subpoenas.  On the other hand,

We confess, we can’t think of any good reason for admitting evidence concerning product risks that the plaintiff in a particular case never actually encountered – yet plaintiffs try it with a straight face all the time.  It’s another example of plaintiffs throwing mud against the wall to see if it will stick; anything to

We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.Continue Reading What If We Win? Off-Label Promotion & Product Liability