Products Liability Law Reporter

A federal district court held that dismissal of a plaintiff’s design defect and punitive damages claims arising out of his implantation with a Biomet M2a Magnum hip device was not warranted.

Mark Fitzsimmons underwent surgery to implant an M2a Magnum hip manufactured by Biomet Orthopedics, Inc. After the surgery, Fitzsimmons remained pain free. But eight years later, he began experiencing hip pain and hearing a clicking sound from his hip. He was diagnosed as having excessively high cobalt and chromium levels and metallosis, necessitating revision surgery.

Fitzsimmons filed suit against Biomet Orthopedics, Biomet, Inc., and Biomet Manufacturing Corp., alleging strict liability claims for manufacturing defects, design defects, and inadequate warnings; negligence; breach of implied warranties; breach of express warranties; and failure to warn. He sought both compensatory and punitive damages. The case was consolidated for pretrial proceedings into the M2a Magnum MDL in the Northern District of Indiana but was later transferred back to the Middle District of Florida. The defense moved for summary judgment on all of the plaintiff’s claims and argued that his request for punitive damages should be dismissed.

Granting in part and denying in part, the district court noted that the plaintiff did not oppose summary judgment on his manufacturing defect or breach of warranty claims. Turning to the plaintiff’s strict liability design defect claim, the court noted that to prevail on this claim, the plaintiff must establish the defendants’ relationship to the product, the product’s defect, and proximate cause.

Here, the court said, the plaintiff presented an engineering expert who concluded that all of Biomet’s metal-on-metal hip systems, including the M2a Magnum, are defective in design and that the plaintiff’s hip implant had several specific design defects. Additionally, the plaintiff’s medical expert stated that the M2a Magnum caused the plaintiff to sustain permanent and irreversible hip damage. Thus, the court concluded, the plaintiff had presented evidence of both defective design and medical causation, precluding summary judgment.

Regarding the plaintiff’s failure-to-warn claims, the court noted that in medical device cases, the determinative issue is whether a product’s warning adequately warned a patient’s treating physician that the device may cause the alleged injury. A plaintiff must also prove the manufacturer’s failure to warn the physician was the proximate cause of the plaintiff’s injuries, the court said. Here, the court found that the plaintiff had offered insufficient evidence to create a fact issue on causation. The plaintiff failed to show his treating physician had ever read Biomet’s instructions, the court reasoned, adding that the surgeon also testified that he had not selected the hip implant based on any marketing materials received from Biomet or from anything he had heard from the company’s sales representatives. Notwithstanding the defendants’ alleged inadequate warnings, the court found, the plaintiff has not proven the proximate cause element of his failure-to-warn claims.

However, the court rejected the defense argument that the plaintiff’s claim for punitive damages must fail. The plaintiff has offered evidence on the defendant’s knowledge of elevated levels of cobalt and chromium and the health damages resulting from metal-on-metal hip device debris, the court said, concluding that this creates a genuine issue of material fact as to whether the defendant had known about but ignored potential problems with its M2a Magnum hip device.

Citation: Fitzsimmons v. Biomet, Inc., 2021 WL 211267 (M.D. Fla. Jan. 21, 2021).

Plaintiff counsel: AAJ member Matthew S. Mokwa, Winter Park, Fla.; and AAJ member Brian J. Madden and Nathaniel M. Jones, both of Kansas City, Mo.