Pharmacy Removes Black Box Warning Case to Federal Court

Via a notice of removal filed earlier this week, pharmacy CVS relocated a case alleging negligent labeling and distribution of a Bell’s palsy treatment to the Central District of California. The underlying opinion alleged that the pharmacy failed to screen the plaintiff for a certain genetic marker as directed on the drug’s “black box” warning, resulting in a severe skin disease.

The complaint explained that the black box warning, approved by the Food and Drug Administration (FDA), requires that patients be screened for the HLA-B*1502 allele if they are of Asian ancestry, like the plaintiff. The presence of the allele brings a serious risk of Stevens Johnson Syndrome if a patient ingests Tegretol, which the plaintiff was prescribed.

The plaintiff further alleged that while the FDA approved labeling calls out the necessity for this screening, the defendants’ drug monograph did not mention the concern. As a result, the plaintiff said, they contracted the skin disease, causing pain, burns, scarring, and loss of consortium.

The specific counts include negligence and strict liability, arguing that the defendants failed to warn the plaintiff. The plaintiff is represented by The Miller Firm, while CVS is represented by LaFollette Johnson Fesler DeHaas and Ames.