In October, federal district court judge Marilyn L. Huff denied in part a motion for summary judgment in an indemnity lawsuit where a surgeon alleged medical device manufacturer Smith & Nephew failed to provide proper training, surgical materials, and warnings for performing a hip resurfacing procedure.
Smith & Nephew’s metal-on-metal hip implants have come under scrutiny within the last two years.
The surgeon seeks compensation from the medical device company in connection with a $2.2 arbitration award where the arbitrator ruled that he was professionally negligent in lacerating an obese patient’s femoral artery during hip resurfacing surgery using Smith & Nephew’s tools and instructions. In January 2013, the surgeon filed a complaint seeking indemnification against Smith & Nephew, alleging that the patient’s injuries were a result of the manufacturer’s negligence.
Prior to the surgery, Smith & Nephew provided the doctor with a special pair of surgical scissors and directions for the hip resurfacing procedure. The company allegedly instructed the doctor to push the tines of the scissors in a position where he could not see the top of them, causing the doctor to accidentally cut the patient’s femoral artery. The doctor claimed that the patient’s injuries resulted from following the provided instructions.
Smith & Nephew filed a motion for summary judgment on three grounds. First, the company argued that the surgical scissors provided were “reasonably safe” as they were approved by the U.S. Food and Drug Administration. Smith & Nephew cited a 1976 amendment to the Food, Drug, and Cosmetics Act, that preempts any state law claims that would impose different or additional requirements on medical devices that have received pre-market approval from the FDA. Second, Smith & Nephew argued that the instructions in their training videos complied with FDA training standards, and submitted several exhibits to show that there were no meaningful differences between the videos and surgical technique brochure. Finally, the manufacturer argued that the company provided an adequate warning against performing the surgery on obese patients. Both parties agreed that the training materials warned against hip resurfacing on obese patients, and the surgeon even got express permission from his patient before the surgery because he was worried about potential complications.
Judge Huff granted Smith & Nephew’s motion for summary judgment with regard to the allegations about the surgical scissors and the failure to warn against performing the surgery on obese patients. The judge, however, refused to grant summary judgment with regard to the allegations that Smith & Nephew failed to comply with FDA training materials in their own video instructions still stand.
Judge Huff ruled that the present record did not warrant summary judgment on whether the instructional videos conformed to the FDA approved instructions. The judge concluded that if Smith & Nephew failed to provide the surgeon with training required by the FDA’s pre-market approval, then the doctor’s lawsuit would not be barred.
Smith & Nephew’s metal-on-metal hip implants have come under scrutiny within the last two years due to a voluntary recall on the metal liners used with their R3 Acetabular System, which required higher rates of revision surgeries. Smith & Nephew currently faces numerous lawsuits filed by patients alleging to have suffered serious complications after undergoing hip replacement surgery and being implanted with the company’s allegedly defective R3 device.