Products Liability Law Reporter

A federal district court held that a plaintiff failed to plausibly allege that her injuries were proximately caused by a drug manufacturer’s misconduct.

Bridgett Bolotin, 16, was prescribed guanfacine to treat attention deficit hyperactivity disorder. A CVS pharmacy in Vernon Hills, Ill., filled Bolotin’s prescription with 2-mg guanfacine extended release tablets, and she began taking them that day. Shortly after, she began to suffer poor and deteriorating health, including severe depression and suicidal ideations, which led to a hospitalization. While hospitalized, Bolotin received guanfacine provided by the hospital, and her symptoms improved. Once discharged and taking the CVS-filled guanfacine, her symptoms returned. This prompted another hospitalization, during which she improved while taking hospital-supplied guanfacine. Nevertheless, less than a week after her second discharge, she was admitted to a psychiatric unit after she expressed suicidal thoughts. Bolotin’s symptoms improved once again after taking guanfacine from the hospital’s supply.

The next month, Apotex Corp. issued a voluntary recall of three lots of 2-mg guanfacine extended release tablets after determining that a lot had been contaminated with trace amounts of quetiapine fumarate, a drug used to treat schizophrenia and bipolar disorder.

Bolotin sued Apotex Corp. and Apotex, Inc., alleging claims for strict liability and negligence. The plaintiff argued that she suffered severe injuries after taking the contaminated guanfacine. The defense removed the case to federal court and moved to dismiss for failure to state a claim. The plaintiff then filed an amended complaint, but the defense again sought dismissal on the basis that the plaintiff’s factual allegations did not raise her right to recovery above the speculative level.

Granting the defense motion, the district court concluded that the plaintiff had not asserted sufficient facts to raise a plausible inference that her symptoms were proximately caused by taking contaminated guanfacine. Citing case law, the court noted that under the plausibility standard, a plaintiff must show more than a mere possibility that a defendant acted unlawfully and must not rely on conclusory allegations or legal conclusions.

The court also found that proximate causation requires a showing of cause in fact and legal cause. The cause-in-fact element is satisfied when there is a reasonable certainty that a defendant’s acts caused the injury or damage, the court said. Here, the court concluded that the plaintiff’s complaint had failed to allege affirmatively that she actually took contaminated guanfacine tablets. The plaintiff asserted that her guanfacine was within the scope of the recall, but this raised only a one-in-three chance that her pills—from an undisclosed lot—were contaminated, the court found, concluding that the plaintiff had not alleged with reasonable certainty that the defendant’s conduct had caused her injuries.

The court also found that the plaintiff’s symptoms were not among those that the recall notice identified as possibly resulting from taking contaminated guanfacine. The court rejected the plaintiff’s attempt to bolster her allegations in light of the package insert for Seroquel, a brand of quetiapine fumarate, which warns of the risk of suicidal thoughts among young adults taking antidepressants. This warning offers no factual basis for the claim that taking trace amounts of quetiapine fumarate is associated with the plaintiff’s symptoms, the court said.

Consequently, the court dismissed the case, concluding that the plaintiff’s amended complaint had failed to plausibly allege that her injuries were proximately caused by the defendant’s alleged misconduct.

Citation: Bolotin v. Apotex Corp., 2024 WL 3637728 (N.D. Ill. Aug. 2, 2024).