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We have no personal knowledge of the litigation concerning GLP-1 receptor agonist medications and the Blog has not posted on it yet, but we do know something about litigation over widely used prescription medications.  Over the decades, there have been many drugs or classes of drugs that became “blockbusters” because they were widely prescribed to treatment of fairly common medical condition.  Often, even without reliable scientific research indicating a new or worse than previously suspected risk of a serious complication, litigation starts.  It is both a numbers game and a waiting game.  If there are enough cases and the cost of defense is high enough, then maybe the defendants will pay to end the litigation while the medications continue to be well-accepted.  If the litigation drags on long enough, then maybe there will actually be some science or liability evidence to support the plaintiffs’ claims after the fact.

Unless you have been living under the proverbial rock for several years, you have probably heard of the GLP-1 receptor agonist medications developed for diabetes and now widely prescribed for weight loss.  As veterans of prior litigation over multiple prescription diabetes and weight loss medications, we are aware of the significant individual and public health benefits from obese patients maintaining intentional weight loss and diabetics lowering their glycosylated hemoglobin levels.  When we look at the primary alleged injury in the MDL created for product liability claims over the GLP-1 receptor agonist medications, gastroparesis, we are underwhelmed.  (Apparently, the JPML may add venous thromboembolism claims to the mix.)  A perusal of the first few sentences from the pertinent Wikipedia entry—surely, the most superficial of inquiries—tells us that gastroparesis results “in food and liquid remaining in the stomach for a prolonged period of time,” which can cause symptoms such as “nausea, vomiting, abdominal pain, feeling full soon after beginning to eat (early satiety), abdominal bloating, and heartburn,” and that it is often idiopathic or due to damage to the vagus nerve from uncontrolled diabetes.  Early satiety is the point of the use of a GLP-1 for weight loss and, as expected, delayed gastric emptying and all of those resultant symptoms are labeled.  So, at first and second blush, the litigation does seem to fit the pattern described above.

The defendants were wise to propose and the MDL court was wise to accept bifurcated discovery so that threshold (or “cross cutting” as used in the decision we will be getting to) issues could be addressed first.  The three issues to be decided first, after appropriately tailored discovery, are “(1) gastroparesis diagnostic testing, (2) preemption and adequacy of warnings, and (3) general causation.”  In re Glucagon-Like Peptide-1 Receptor Agonists Prods. Liab. Litig., MDL No. 3094, 2024 U.S. Dist. LEXIS 188802, *3 (E.D. Pa. Oct. 17, 2024) (“GLP-1”).  Plaintiffs being plaintiffs, they urged that they should be allowed to pursue unfettered discovery into the marketing of the five different prescription medications currently at issue in the MDL before the court decides those threshold issues.  Even without going into the arguments offered by plaintiffs for why they should get such broad early discovery, we can offer that there are three real reasons:  1) marketing discovery will be costly and burdensome for defendants (see above); 2) marketing discovery will likely take time and bog down with motions practice, meaning it takes even longer (see above); and 3) marketing discovery may turn up something sufficiently salacious, but not substantive, to deter the court from issuing rulings on the threshold issues that are favorable to the defendants.  The decision in GLP-1 was actually on a motion to reconsider from plaintiffs after they lost the issue originally.  They started with the dubious position that the standard for deciding this motion to reconsider should not be derived from Fed. R. Civ. P. 59(e) as it usually is, because somehow the original decision was not on a full record.  They lost this argument and the motion, which was decided on the applicable “clear error of law” standard.

Given that plaintiffs had recycled their arguments that were rejected originally, the focus of the GLP-1 decision was to clarify the court’s prior analysis on why alleged overpromotion of the drugs is irrelevant to whether the warnings in their respective labels were adequate and whether any claim of inadequacy as to the label would be preempted because the allegedly required changes were not possible.  Id. at *17-18.  Plaintiffs argued, largely based on an early decision from the Avandia MDL, that marketing conduct must be examined to determine the adequacy of warnings.  (We note that later decisions from that MDL, including those affirmed by the Third Circuit, granted summary judgment on a number of warnings claims.)  From our perspective, even though it came to the right conclusion, the analysis in GLP-1 was a bit too generous to plaintiffs’ position in two respects. 

First, the GLP-1 court played along with some of the plaintiffs’ three-card monte with the words warnings, warn, label, and labeling.  The warnings in a label as to particular risks can be held to be adequate as a matter of law.  Claims based on the assertion that the label had to include specific additional information at a specific time to adequately warn of the true risks can be held to be preempted.  Either of those holdings usually will mean that the plaintiff loses her claim for failure to warn, but that is not always the case.  For instance, the warnings in the label could be adequate as to one but not both of the injuries the plaintiff alleges.  Or the asserted warnings claim could be preempted to the extent it is based on an alleged inadequacy during part of the time the plaintiff was prescribed the drug.  Or, in one of the few states that has law providing that “overpromotion” to the particular prescribing physician to undo the adequacy of the warning in the label, the plaintiff might have a chance to prove such an exception applies.  The court can decide the adequacy of the relevant warnings in the label and how impossibility preemption applies without looking at marketing broadly or individually.  Communications to physicians outside of the label (i.e., the package insert),

are not needed for the Court to determine whether a drug’s approved label already contains the warnings that Plaintiffs seek to add and if not, whether the FDA would have rejected additional warnings to the approved label, such that Plaintiffs’ state law failure to warn claims are preempted.

Id. at *28-29.

Second, in two footnotes, the GLP-1 court recapped that Avandia could identify Pennsylvania as the only state with an overpromotion exception and that its own research turned up a handful of other states that might also have some form of exception.  Id. at nn.7-8.  Generally, these cases involve, somewhat like Perez with direct-to-consumer advertising in New Jersey, the idea that the focus in an individual case should be on the warnings provided to the plaintiff instead of the warnings provided to the learned intermediary.  We will not belabor why those cases tend to be wrong, but we can say the substantive law of the forty-five or more states without such an exception would definitely not make marketing conduct relevant to determining label adequacy or the conflict with federal law.  Expanding the scope of discovery based on maybe 10% of the states instead of the other 90% or so would be strange. However, the court correctly concluded that the analysis of overpromotion where there is a recognized exception is a highly case-specific inquiry.  Id. at n.8.  The implication of that conclusion is that early generic discovery need not be expanded because of possible additional discovery in individual cases down the road.  Although the court did not have to go beyond relevance, a proportionality analysis under Fed. R. Civ. P. 26(b)(1) would have further supported the limit the court imposed.

At the end of the day, by keeping discovery focused on what the defendants knew, what the labels said, what FDA was told, and what FDA would have done with theoretical labeling changes, the court increased the chance of clean decisions on the adequacy of the warnings in the labels and the preemption of certain label-based warnings claims.  Along the same vein, we made sure to avoid any quips or wordplay about weight or weight loss so we could present what was really a fairly straightforward issue.