As I’ve written here many times, the appeals courts have not yet settled whether and how injured people may pursue payment for injuries caused by defective generic prescription drugs. After the Supreme Court’s decision in Pliva v. Mensing, it is settled that generic drug manufacturers cannot be sued for failure to warn about a drug’s safety risks—regardless of how blatantly they failed to make that warning. But since then, pharmaceutical liability lawyers like me have attempted to hold generic manufacturers liable for other torts, such as defective design, which are legally distinct from failure to warn. And a few courts, including the Alabama Supreme Court, have permitted injured people to sue the manufacturer of the name-brand drug given the legal responsibility for the warning. A new case along those lines recently arrived from the Eighth U.S. Circuit Court of Appeals.
In Bell v. Pfizer et al., Shirley Bell alleged she developed tardive dyskinesia from taking metoclopramide, the generic form of Reglan, over several years. The manufacturer of the drug was Pliva USA, but she also named various makers of name-brand Reglan. Her lawsuit alleged negligence, breach of warranty, strict liability, fraud and more. The brand-name defendants were granted summary judgment on the grounds that Bell didn’t use their products, to which she stipulated. After the Supreme Court decided Mensing, the trial court permitted Bell to amend her complaint to address it. After the amendment, however, the court agreed with Pliva that the new allegations were essentially failure to warn claims and dismissed them. Bell appealed to the Eighth Circuit.
That court upheld in part and reversed in part. It first upheld the summary judgment ruling for the name-brand manufacturers, rejecting Bell’s argument that they should be liable because they controlled the language of the warning that generic manufacturers were legally required to publish word for word. Despite that requirement, the court reasoned that name-brand manufacturers don’t control the manufacturing of generics, or owe any duty of care to generic-taking patients. But on the counts against Pliva, Bell had more luck. Of the design defect, negligence, breach of warranty and fraud claims, the Eighth found that some were not just restatements of a failure to warn claim. The breach of implied warranty and design defect claims don’t allege problems with the label, the Eighth said, yet the district court failed to analyze whether they stated a claim under Arkansas law. Thus, it sent the case back for further consideration of those claims.
As a defective drug attorney, I’m disappointed by the court’s insistence that name-brand manufacturers aren’t responsible for warnings on generic drugs. The U.S. Supreme Court ruled in Mensing that generics can’t be held liable precisely because name-brand drug makers do control labels. This inconsistency creates a Catch-22 for injured people like Bell, and a situation in which drug makers face no accountability for their actions. Tardive dyskinesia is a serious and permanent neurological disability that makes patients unable to stop themselves from making repeated small motions. It is life-changing and has no known cure. As a dangerous drug lawyer, I believe that if Pfizer or Pliva knew about this risk, they should be held legally responsible for failing to warn patients.
If you suffered a serious injury after taking a medication you thought was safe, don’t hesitate to call Carey, Danis & Lowe for help. Based in St. Louis, we represent clients across the United States. Call us today at 1-877-678-3400 or send us an email.
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