Bayer Sued Over Medical Device Defects

On Monday, a complaint was filed by LHC Group, Inc. against Bayer Corp. et al. The case, filed in the Alameda County, California Superior Court, regarding an allegedly defective product commercially called Essure, was immediately transferred to the California Northern District.  

Essure was designed and marketed as a permanent birth control device.  The product was reportedly “manufactured, designed, formulated, tested, packaged, labeled, produced, created, made, constructed, assembled, marketed, advertised, promoted, distributed, and sold by Defendants.” 

According to the filing, the device consists of two coils made of nickel and titanium which are inserted into the fallopian tubes, and received approval by the FDA after initial clinical studies. However, there are post approval studies and reviews of adverse events to continue the approval process. During these after-approval studies, the complaint said that negative conditions such as perforation of the uterus or fallopian tubes, device migration or fracture, chronic pain, prolonged bleeding, and unintended pregnancies were reported. Also, contrary to design intent and marketing, it was discovered that removal of the device frequently required major surgery with the attendant risks. As a result of this information, the device was moved to a restricted category, and the FDA required additional warnings including a black box warning and official patient decision checklist regarding these severe medical complications.

The plaintiffs accused Bayer and its subsidiaries of negligence in the monitoring and reporting of complications regarding the insertion and retention of the device. As noted in the complaint, while tracking all reports of loose coils or coils that migrated and injured the patients, the plaintiff alleged that Bayer only reported cases that met specific conditions, and did not report the total numbers of complications. This failure to report, coupled with continued advertising and marketing which presented the product as safe and effective, caused the plaintiff further harm as members of the plaintiff insurance company received the device without knowledge of the possible complications.

The plaintiff’s causes of action include negligence, strict product liability, fraudulent concealment, negligent misrepresentation, intentional misrepresentation, breach of express warranty, and unjust enrichment. They are represented by Jessica A. Schaps and Martin Bienstock. Bayer is represented by DLA Piper