A woman from Massachusetts claims faulty design in her double metal on metal hip replacement caused the devices to require surgical removal.

Plaintiff Sandra L. says she underwent hip replacement surgery in May 2004, receiving a Pinnacle metal on metal hip replacement with an Ultamet metal liner in her left hip. She received the same setup in her right hip in a second surgery in January 2005.

Following the two implantations, she alleges, she began to feel severe pain and discomfort in both hips and thighs. She had to undergo revision surgery in both hips in early 2015 to remove the Pinnacle implants from both hips.

She now believes the pain she experienced and the subsequent need for surgery were caused by “toxic amounts of cobalt-chromium metal debris” released by the Pinnacle implants into the surrounding tissue.

Sandra says the complications she suffered were caused by the “defective design, lack of adequate warnings, construction and unreasonably dangerous character” of the metal on metal hip replacement.

She also accuses manufacturer DePuy Orthopaedics and its parent company Johnson & Johnson for failing to warn her and her doctor about the risk of metal toxicity from hip replacement. She says that if she had known about those risks, she never would have agreed to have the Pinnacle implants used in her hip replacements.

The Pinnacle Metal on Metal Hip Replacement

According to Sandra’s hip replacement lawsuit, defendant DePuy Orthopaedics put the Pinnacle Acetabular Cup System on the market in 2001. When used with the metal Ultamet acetabular liner, the device functions as a metal on metal hip replacement, with both articulating surfaces composed of a cobalt-chromium combination.

Sandra says DePuy marketed the Pinnacle system to younger, more active patients under the guise that it was more suitable for patients with more athletic interests. About 150,000 Pinnacle devices have been sold, she says, and she quotes DePuy as saying that 99.9 percent of those are still in use today.

But Sandra claims that the Pinnacle system can cause metal toxicity from hip replacement.  She says the device sheds debris that causes “severe inflammation, severe pain, tissue and bone loss, and other related diseases.”

The hip replacement lawsuit accuses DePuy of exploiting a fast-lane FDA approval process to get the Pinnacle system approved without the usual clinical trials and testing that new medical devices are subject to. Under this process, the manufacturer can get expedited FDA approval for a new device if that device is “substantially similar” to an older device already on the market.

Sandra claims that approval under this process allowed DePuy to put the Pinnacle system on the market with “virtually no clinical or non-clinical trials or FDA review of the implant for safety and effectiveness.”

Sandra’s hip replacement lawsuit raises claims for negligence, failure to warn, manufacturing defect, design defect, negligent misrepresentation, and breach of warranty. She seeks an award of damages, including punitive damages to deter the defendants from similar conduct in the future, plus court costs and attorney’s fees.

The Metal on Metal Hip Replacement Lawsuit is Case No. 3:16-cv-1539 in the U.S. District Court for the Northern District of Texas, Dallas Division.