The company BioEnterics first obtained approval from the Food and Drug Administration (“FDA”) in 2001 for Lap-Band which was designed to induce weight loss in obese patients by limiting food consumption. The device is surgically placed around the stomach in such a way that it reduces the room for food so that patients feel full after eating smaller portions than they are used to.
When Lap-Band was first approved, the FDA indicated that its labeling must “specify the requirements that apply to the training of practitioners who may use the device” and required annual progress reports on a pos-tapproval study.
Lap-Band's brochure states the following requirements:
- Surgeons planning laparoscopic placement must have specific experience
- Surgeons must participate in a training program authorized by the manufacturer
- Surgeons must be observed by qualified personnel during their first Lap-Band placements
- Surgeons must have the equipment and experience necessary to complete the procedure by way of laparotomy if required, and
- Surgeons must report on their personal experiences using the device.
All of the above is relevant because a plaintiff underwent a surgical procedure to implant a Lap-Band, which eventually eroded into her stomach and her liver. The device became entangled with her small intestine and required surgery to remove the device. However, during surgery to remove the Lap-Band the plaintiff suffered a massive hemorrhaging from her liver which caused brain damage.
Usually in such a situation, a plaintiff would file a medical malpractice lawsuit within a short amount of time. However, this patient did not begin the proceedings for nine years.
More than nine years later, plaintiff filed suit. The trial court dismissed the plaintiff's claim that the manufacturer failed to adequately train physicians that were to surgically implant the Lap-Band.
The plaintiff then appealed. The appeals court looked at the fact that the plaintiff failed to call out the Lap-Band brochure and/or training methods. Instead, the plaintiff referenced physician error as evidence that improper training occurred. The court ruled that physician error is not enough to support a claim against a manufacturer for improper training.
The court also found it difficult to agree with the plaintiff's claim that federal provisions contained in the FDA's Quality System Regulation were violated. Of the regulations the plaintiff believed to have been violated, none of them tied together a requirement to train physicians in the use of the approved medical device.
The court of appeal affirmed dismissal of the plaintiff's claim that the company failed to adequately train physicians in the use of the Lap-Band, as preempted by federal law. The decision is especially important because it largely takes the “failure to train” tool away from plaintiffs looking to sue medical device manufacturers. Now the field of available product liability claims against manufacturers has narrowed considerably.
Medical malpractice can have devastating effects that last a lifetime. If you have been injured by a physician's neglect, attorneys Charles Gilman and Briggs Bedigian will work to get you the full compensation to which you are entitled. Call 800-529-6162 today or contact them online for a free case evaluation. They handle cases in Maryland, Pennsylvania, and Washington, D.C.