Cases & Deals

Pharmaceutical manufacturer obtains dismissal with prejudice of pharmaceutical products and medical malpractice lawsuit

Clients Pharmaceutical manufacturer

A pharmaceutical manufacturer represented by Jones Day obtained an Illinois Appellate Court decision rejecting a plaintiff’s attempt to revive a product liability lawsuit that the trial court had previously dismissed with prejudice. The plaintiff alleged that she suffered a variety of adverse reactions following the injection of one of our client’s prescription drugs, which she had used to treat vaginal bleeding and a unicameral cyst, a non-indicated (off-label) use for the drug. Although she alleged multiple causes of action such as strict liability, breach of implied warranty, negligence and negligent misrepresentation, all of the plaintiff’s claims sounded in a failure to warn theory. Illinois is a fact-pleading state and applies the learned intermediary doctrine in pharmaceutical products cases. The pharmaceutical manufacturer used an expert affidavit to define terms on the product's package labeling and to compare those terms to the adverse reactions alleged in the complaint, and moved not just under 735 ILCS 5/2-615 for failure to state a claim for the non-indicated use, but also moved substantively under 735 ILCS 5/2-619 because the drug labeling warned for the reactions complained of and was therefore adequate as a matter of law. After giving the plaintiff many opportunities to re-plead her claim, the trial court dismissed her lawsuit with prejudice on the grounds that: (1) the label warned for the conditions alleged and was therefore adequate as a matter of law, and (2) except in very limited circumstances not alleged in the case, drug manufacturers are not liable for failing to warn of effects associated with off-label treatment.

After proceeding with the lawsuit against the remaining defendants, the plaintiff later attempted to revive the case by filing a motion to vacate the prior dismissal. The plaintiff argued that “newfound evidence” learned in the course of discovery supported the previously dismissed claims. The trial court denied the plaintiff’s petition. On appeal, the appellate court affirmed, holding that the trial court was well within its discretion in denying the motion, in part because the plaintiff’s petition to vacate addressed only one of the two grounds for dismissal.

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