Last month, I wrote here as a dangerous drug lawyer about an Eighth U.S. Circuit Court of Appeals decision involving claims against generic and name-brand Reglan makers. In Bell v. Pfizer, the appeals court ultimately upheld dismissal of the defendants who made brand-name Reglan because plaintiff Shirley Bell never took any of their products before developing tardive dyskinesia. However, Bell won reversal of some of her claims against the generic manufacturers whose drugs she did take; the Eighth Circuit said some of her claims were not just restated failure to warn claims and thus not necessarily preempted under U.S. Supreme Court precedent. Hot on the heels of Bell, the Eighth decided a very similar case this month with Fullington v. Pfizer et al.. The outcome was also similar: Joyce Fullington may pursue certain claims if they are not restated failure to warn claims.
Fullington, of Arkansas, developed tardive dyskinesia after taking generic Reglan (metoclopramide) for a year. This disorder, caused largely or entirely by neurological and gastrointestinal drugs, is an incurable neurological problem causing repeated involuntary movements, especially of the face. In response, she sued two groups of defendants: makers of name-brand Reglan and makers of the generic version. Before the Supreme Court decided PLIVA v. Mensing, the district court dismissed the brand-name defendants because Fullington never took their products. After Mensing (pending which decision the case was stayed), the district court dismissed all claims against the generic defendants with prejudice, ruling that they were all versions of a claim for failure to warn and thus preempted under the logic in Mensing. Fullington received leave to amend based on the new disclosure that PLIVA failed to update its label according to FDA rules, and the district court again dismissed, citing a perceived internal inconsistency.
Relying on Bell, the Eighth Circuit ruled that the brand-name defendants must be dismissed because Arkansas law forbids plaintiffs from suing makers of products they did not use. On the generic defendants, however, the court revived some of the claims. While “the vast majority of the allegations” are premised on failure to warn and thus preempted, it found that the non-warning breach of implied warranty claims (substantially similar to Bell’s) are not preempted. It also reversed dismissal of her design defect claims, noting that Arkansas law doesn’t require her to allege that the generic manufacturers actually designed the drug. However, under the recent Bartlett v. Mutual Pharmaceutical Co., the Eighth felt that the district court should reexamine whether generic manufacturers have an opportunity under Arkansas law to alter their drugs. It remanded the case for consideration of the resurrected claims.
Interestingly, a concurrence by Judge Murphy notes that Fullington might have had a claim against name-brand manufacturers if she had alleged in district court that they are the “designers” of the generic drug. As a pharmaceutical liability attorney, I know that versions of this have been advanced all over the country, and found some favor in California and Alabama. The concurrence notes that prior cases have refused to hold brand manufacturers liable for generics’ labels because generics were assumed to do their own communications, but that Mensing undercuts this analysis. This “can no longer be credibly argued,” the judge concluded, particularly when pharmacists substitute the generic version of a drug for a name-brand prescription. As a defective drug lawyer. I couldn’t agree more.
If you’ve suffered a serious illness, injury or loss in the family because of a drug you thought would help, you may have a legal claim. Call Carey, Danis & Lowe today to discuss how we can help. You can reach us toll-free at 1-877-678-3400 or send us a message online.
Similar blog posts:
Appeals Court Permits Breach of Warranty and Defect Claims Against Drug Manufacturer – Bell v. Pfizer
Sixth Circuit Rules Generic Reglan Manufacturer Failed to Update Label – Fulgenzi v. PLIVA
Pfizer Asks Alabama Supreme Court to Reconsider its Ruling Over Innovator Liability
