The Fifth Circuit affirmed Novartis’s summary judgment win in Johnson v. Novartis Pharm. Corp., No. 20-50462 (5th Cir. Feb. 5, 2021). The court, in an opinion issued without oral argument, affirmed the Western District of Texas’s dismissal of plaintiff’s innovator liability claims under FRCP 12(b)(6) based upon Fifth Circuit precedent.

Plaintiff/Appellant Ramon Johnson II alleged that his ingestion of generic carbamazepine—the generic version of the brand name drug Tegretol manufactured by Novartis—both caused and worsened his Peyronie’s Disease (“PD”), a condition caused by plaques and scar tissue in the penis. His doctors advised him that the carbamazepine did not cause PD.  Ultimately, plaintiff sued Novartis and the multiple generic manufacturers of carbamazepine and another drug.

The district court issued an order on Novartis’s Rule 12(b)(6) motion to dismiss all counts against it, including strict liability, negligent manufacturing, negligent failure to warn/fraudulent misrepresentation, breach of express and/or implied warranty, and loss of consortium—all based on the novel innovator liability theory—concluding that, “Texas law rejects this theory of liability”.  Johnson v. Novartis Pharm. Corp. The court cited to Fifth Circuit decisions Eckhardt v. Qualitest Pharm., Inc. and Lashley v. Pfizer, Inc. in holding that plaintiff’s admission that he did not ingest an Novartis product was fatal to his claim.

Plaintiff/Appellant appealed the dismissal of his claims, arguing that the district court erred by not considering Novartis a manufacturer under Texas products liability law.  The Court of Appeals disagreed, holding that “[b]ecause Mr. Johnson alleges that he only ingested the Generic Defendants’ drugs and not the Brand Defendants’ drugs, he has failed to state a products liability claim against the Brand Defendants.”  Further, the court cited prior precedent that Texas’s fraud-on-the-FDA rebuttal is preempted by the Food Drug and Cosmetics Act unless the FDA itself finds fraud”; thus the court affirmed judgment for Novartis.