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We consistently defend the ability of physicians to engage in off-label use. Bexis helped lay the scholarly foundation for courts to utilize the term “off label use,” and two of his law review articles remain go-to reads on the subject.  Not surprisingly, we follow medical malpractice decisions that address off label use.  Back in 2009, Mark Herrmann (the Blog’s co-founder with Bexis), published a law review article articulating the reasons why package inserts should not be admitted as standard of care evidence in medical malpractice actions. More recently, we wrote a comprehensive post collecting case law rejecting the admission of package insert evidence to establish a violation of the standard of care by physicians who used drugs or devices off label. Today’s case is a detailed opinion from the Iowa Supreme Court joining what is now the majority view—that package inserts should not be admitted as substantive evidence of the standard of care.Continue Reading Package Inserts Are Not Admissible to Establish Standard of Care

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For a decision that affirmed not just a verdict, but an award of punitive damages, against a device manufacturer, Nicholson v. Biomet, Inc., 46 F.4th 757 (8th Cir. 2022), is not as bad as it could have been.  That’s because most of the decision was about evidentiary rulings that the court found to be “harmless” error, and one might even have some benefit for our clients in the long run.

Still, Nicholson was pretty darn depressing.Continue Reading Nicholson – Not So Harmless

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A couple of times in recent weeks we have discussed pelvic mesh cases where a central issue was whether the cases were time-barred by a statute of limitations or repose. (See here and here.) There is a reason why this issue crops up persistently. The pelvic mesh litigation started off as a mass tort…

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Kelly v. Ethicon, Inc., 2020 U.S. Dist. LEXIS 191665 (N.D. Iowa Oct. 16, 2020), is a remanded pelvic mesh case. The complaint included the usual panoply of causes of action for negligence, strict liability, fraud, and breach of warranty. Failure to warn, as usual, was central to the plaintiff’s case.

During the years while…

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We (in the peculiarly singular sense) last posted on the day after Thanksgiving, a day sometimes referred to as Black Friday because of the number of retailers that offer purportedly discounted prices to lure eager holiday shoppers.  We have discussed before how the moniker seems more appropriate for other historic events.  It was probably apparent from that post that shopping, particularly at brick-and-mortar stores, is not our favorite thing to do.  We do know, however, that others can be drawn to certain, packed locations by the lure of a good deal.  So too—seamless transition, huh?—can plaintiffs flock to jurisdictions where their lawyers expect a good deal from judges and juries.  Assuming subject matter and personal jurisdiction exists, an assumption we think may be less likely to be foregone in the future, the plaintiff generally gets to pick where the defendant will have to show up to see what kind of deal it can get.

Once jurisdiction exists, there are two vehicles for a defendant to move a case.  The first often has less utility—a motion to transfer to another court within the same state (or to a different federal court when the case is in federal court, which plaintiffs generally try to avoid in the first place).  Consolidation of cases involving the same product through the application of aggregation procedures limits the availability of motions to transfer, but transferring from one court in a state in which the big drug or device manufacturer does not want to be to another court in the same state may not improve the deal much.

The second vehicle is to claim that the forum, typically meaning anywhere in the state where sued, is an inconvenient one for the defendant and the case.  There is some basic appeal for the plaintiff’s response to a forum non conveniens motion lodged by a defendant sued in its own state—how can it be inconvenient for you to be sued in your own state?  Because many drug and device manufacturers are based in, or have subsidiaries that are based in, New Jersey, and because one of the mass tort judges in New Jersey was generally thought to be somewhat inclined to one side of the v., Atlantic County, New Jersey, became a favorite destination for litigation tourists.Continue Reading Inconvenient (Forum) Shopping in New Jersey

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August signals different things to different people.  When it comes to football, two August events come to mind:  1) NFL preseason games and 2) high school “two-a-day” practices.  The former are not like real NFL games, but they are better than nothing, particularly if you like to see how rookies are doing, guess at final rosters, or look for insight into compiling fantasy teams.  The latter have lost some of their mysticism due to school restrictions driven by safety concerns.  Long gone are the days of no water during practices (see Bear Bryant at Texas A&M in 1954) and the tradition of two practices per day in full pads seems to be disappearing.  There are still vomit-inducing gassers and thigh-burning hills.  There are also still numerous drills focused on the most basic of football plays, the run up the middle.  Good offenses need to be able to get the crucial yard with a dive on third and 1 and good defenses need to be able to stop the offense cold in such situations.  This has not changed.  There was a time, however, when an end run, a run to the outside, was considered a bit sneaky, particularly if there was an accompanying fake dive.  The “end run” has lived on in our vernacular as a less than straightforward way to accomplish a goal.

When it comes to prescription drug product liability cases, the most direct—and we would maintain, appropriate—way to establish liability cases is with a failure to warn claim.  The vast majority of jurisdictions recognize that the duty to warn in such cases runs to the prescribing physician (or other health care provider).  We have gone on many times about what the learned intermediary doctrine really means.  One thing most courts to come down clearly on the issue of proximate cause in prescription drug failure to warn claims have recognized is that a plaintiff bears the burden of establishing that a different warning (at the time, as to the condition plaintiff claims to have developed) would have changed the prescriber’s behavior such that the injury would not have happened.  Overwhelmingly, proximate cause in such cases turns on the testimony of the prescribing physician that she likely would or would not have still prescribed the same drug to the plaintiff even if the drug’s label (and other labeling like Dear Doctor Letters) had been changed to what plaintiff contends it should have.  We think this is appropriate.Continue Reading Allowing An End Run on Proximate Cause for Failure to Warn

This post is from the Reed Smith side of the blog only – the Dechert lawyers were not involved.

The Iowa Court of Appeals has affirmed summary judgment entered in favor of both branded and generic manufacturers of metoclopramide, looking at Mensing’s effect on both in the process.  In Huck v. Trimark Physicians Group,…

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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.
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