With Dismissal Of Failure To Warn Lawsuit, District Court Sets Limits On Duty Owed

Contributed by Isabella C. Lacayo

When plaintiffs attempt to broaden the claims they can bring against manufacturers, it is a relief for defendants when courts refuse to play along.  A creative theory of recovery was rejected last week when a Pennsylvania federal district court dismissed a failure to warn lawsuit against Bristol-Myers Squibb relating to its drug, Abilify.  See Bergstresser v. Bristol-Myers Squibb Co., No. 12-1464 (M.D. Pa.).  In Bergstresser, the plaintiff attempted to hold the drug manufacturer responsible for failing to provide instructions to doctors on how to monitor patients for signs and symptoms of a potential side effect.

The plaintiff was prescribed Abilify by his psychiatrist for depression.  Abilify, or aripiprazole, is indicated as an add-on treatment for adults with depression when an antidepressant alone is not enough.  The plaintiff allegedly developed symptoms of dystonia, a neurological movement disorder characterized by involuntary muscle contractions that cause slow repetitive movements or abnormal postures, when his psychiatrist increased the dosage.  The plaintiff filed his original complaint in July 2012 and, after some claims were dismissed as a result of motion practice, filed an amended complaint in May of this year setting forth one claim – negligent failure to warn.  According to the plaintiff, Abilify’s label does not include a dystonia warning; it only includes a tardive dyskinesia warning.  Tardive dyskinesia, like dystonia, is a neurological movement disorder, but it is characterized by different types of involuntary movements that are primarily facial.

The plaintiff claimed that the label was deficient in that it failed to provide instructions to physicians on how to monitor for signs and symptoms of dystonia so as to prevent contraction of the condition.  In addition, the plaintiff claimed that the Abilify label should have provided directions to physicians on how to increase or decrease the dosage when prescribing it for depression in order to limit or prevent dystonia.

But the court disagreed and issued a memorandum accompanying an order dismissing the amended complaint.  To state a claim for negligent failure to warn under Pennsylvania law, a plaintiff must show: “that the manufacturer owed a duty to the plaintiff; that the manufacturer breached that duty; and such breach was the proximate cause of plaintiff’s injuries.”  Memorandum at 7 (citations omitted).  The court explained that Pennsylvania’s courts have adopted the learned intermediary doctrine, meaning that if a manufacturer provides proper warning to a consumer’s physician, it will have discharged its duty to the consumer.  See id. at 8-9.  And since under the learned intermediary doctrine, whether a warning provided to a prescribing physician is adequate is initially a question of law, the court considered Abilify’s labeling in deciding Bristol-Myers Squibb’s motion to dismiss.  See id. at 11-12.

Despite the plaintiff’s claim to the contrary, the court found that the Abilify label clearly “identifies the contraction of dystonia as a possible reaction to taking Abilify.”  Id. at 12.  The court’s review of the label also revealed that the package insert includes a section on dosage that includes recommendations for the initial, recommended, and maximum dose, for each indication for which Abilify could be prescribed, including for depression.  Id. at 13.  And while the plaintiff correctly noted that Abilify’s label does not contain specific monitoring instructions with respect to dystonia, such instructions were not required for dystonia, a side effect listed as a potential “adverse reaction.”  The Code of Federal Regulations only requires recommendations for patient monitoring to be included with respect to the most clinically significant information.  See id. at 16-17.

The court noted that, in any event, “judgments as to specific monitoring are better left to the physicians’ discretion” and that “[t]he law does not require that the drug manufacturer provide such detailed information or instructions so as to remove the medical judgment of the physicians, who are in the best position to monitor and treat their patients.”  Id. at 17-18. Ultimately, the court granted Bristol-Myers Squibb’s motion to dismiss because the plaintiff did not meet Twombly‘s pleading standard by failing to “provide sufficient factual allegations as to why the information provided to the intermediary was inadequate, what information should have been provided, and how that information would have caused the intermediary to act differently which would have prevented the plaintiff’s injury.”  Id. at 19.

While plaintiffs often push to broaden manufacturers’ duties, there must be reasonable limits.  Decisions – like Bergstresser – that require plaintiffs to meet the Twombly pleading standard and limit the scope of plausible theories of recovery — go a long way in setting boundaries for when a claim may be viable.