And it’s the start of another season of too much eating, drinking, shopping, and socializing. Sometimes it feels like a year’s worth cramped into a little over a month. And, for some of us (OK, me), we’re entering this week still a little groggy and foggy. So, we’ll admit to looking for something fairly straightforward and on the shorter side to post about as we clear our heads and shake off the haze. That’s not to say Mitchell v. Boehringer Ingelheim Pharma, Inc., 2017 U.S. Dist. LEXIS 192498 (W.D. Tenn. Nov. 21, 2017) isn’t noteworthy, it’s just not overly complicated. Sometimes that’s what you need to get the ball rolling again.

Plaintiff in Mitchell alleged that she suffered diabetic ketoacidosis (“DKA”) as a result of using the prescription drug Jardiance to treat her type-2 diabetes. Id. at *3. The drug, one of a class of drugs known as SGLT-2 inhibitors, was approved by the FDA in August 2014 and plaintiff began using it in February 2015. In May 2015, the FDA issued a safety alert warning about the risk of DKA with this class of drugs. The alert was based on a review of adverse event reports collected from March 2013 to June 2014 – before Jardiance was approved. Id. at *3-4.

Products liability claims in Tennessee are governed by the Tennessee Products Liability Act. Under the TPLA, drug manufacturers have a duty to minimize the risk or dangers from their products and they can discharge that duty by providing adequate warnings and instructions. Id. at *7. Plaintiff in Mitchell alleged defendant failed to satisfy that duty because it did not warn about DKA at the time the drug was approved and did not amend the warning via the FDA’s Changes Being Effected (“CBE”) process at any time before plaintiff was injured. Id. at *4.

We see CBE and we immediately start looking for a preemption discussion. Sure enough, there is one. As discussed here many times before, the CBE process allows a manufacturer to add or strengthen a warning based on “newly acquired information” without first obtaining FDA approval. Id. at *9-10. Where a CBE label change is an option for a manufacturer, the Supreme Court has held that failure to warn claims are not preempted. See Wyeth v. Levine, 555 U.S. 555 (2009).

But what about when a CBE is not an option? In Mitchell, the court broke the plaintiff’s failure to warn claim into two pieces – a challenge to the original labeling and a challenge to warning as it was at the time plaintiff used the drug. The court found the former preempted because defendant could not have changed the original FDA approved labeling. The data plaintiff relied on to support her allegation on this claim was pre-launch data. In other words, data that was known to the FDA at the time they approved the drug’s warnings – not newly acquired. “[T]he FDA is the exclusive judge of safety and efficacy based on information available at the commencement of marketing.” Id. at *11 (citing  In re Celexa & Lexapro Mktg. & Sales Practices Litig., 779 F.3d 34, 41 (1st Cir. 2015).

Similarly, plaintiff cannot base her failure to warn claim challenging defendant’s failure to amend the warning after the drug was introduced on the market on information that existed pre-FDA approval. Id. at *13. So plaintiff cannot rely on the adverse events collected before June 2014. Plaintiff’s allegations must be based on information that was not known by the FDA at the time of approval. In her complaint, plaintiff alleged that additional DKA adverse events were reported in 2015. Defendant, citing federal regulations, argued that while later in time, the additional reports did not provide any “new” information that would support a CBE. The court determined that was an issue better suited to a motion for summary judgment and that plaintiff had done enough to withstand a motion to dismiss. Id. at *15. Not a win yet, but the door is certainly still open.

The court made a few other rulings as well. Based on the learned intermediary doctrine, plaintiff cannot bring a failure to warn claim premised on failing to warn plaintiff directly. She is limited to a claim for failure to warn her prescriber. Id. at *17-18. And plaintiff must plead warning inadequacies with specificity. The court determined her allegations as to DKA were sufficient. But, plaintiff failed to state a claim to the extent she was looking to recover for “other related health complications.” Id. at *22. Plaintiff’s complaint neither specified the alleged complications nor how the drug’s warnings were inadequate as to those complications. So, as to unspecified complications, the failure to warn claim was dismissed.

In the end, plaintiff is left with a narrow failure to warn claim and the hurdle of proving proximate cause.