A growing number of flawed device cases are going to court, according to the lawyer representing a New Mexico man who was just awarded more than $2 million in a product liability case against Zimmer Biomet for a faulty hip implant.

Amanda Pedersen

Following a two-week bench trial, Zimmer Biomet Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective hip implant. New Mexico Judge Nan G. Nash ruled that the defective design and insufficient testing caused likely permanent harm to the plaintiff, resulting in a buildup of cobalt debris harming the hip joint and contaminating blood.

The case involved Zimmer's dual modular hip implant, the M/L taper hip prosthesis with Kinectiv Technology, and a cobalt-chromium head. The company had to deal with a major recall of the same device in 2015, due to manufacturing residues.

"It is never appropriate to design a hip implant system that would create an unreasonable risk of injury to the health or safety of a patient," Nash wrote in her 27-page decision, ruling for the patient on grounds of strict products liability.

Joseph Osborne Jr., of Boca Raton, FL-based Osborne & Associates, tried the case with Randi McGinn and Allegra Carpenter of Albuquerque, NM-based McGinn, Carpenter, Montoya & Love.

The orthopedic device industry is all too familiar with cases involving defective metal-on-metal hip implants, but this case represents a new trend in that it was not settled out of court.

"This is the first case we know of that has gone to trial in the country, and a growing number of these cases are going to court," Osborne said.

The plaintiff, Michael Brian McDonald, received the hip implant in June 2010. He seemed to recover well, at first. Then, in May 2011, McDonald suffered from hip and groin pain, and loss of flexibility, and had to have two corrective surgeries that fall. During the revision procedures, the doctor implanted two new prostheses, and replaced the cobalt-chromium head with a ceramic head.

McDonald sued Zimmer, and the case went to bench trial last December. Nash issued her ruling March 31, and noted that McDonald has to take antibiotics permanently, runs a risk of a recurrent infection, and had to give up playing golf and tennis. He may also need a third, more complicated revision surgery down the road, according to the judge. That surgery will cost about $250,000, she said, and will involve removal of all of the implant components for up to three months to try and kill the infection, during which he will need to use a wheelchair.

According to the decision, Nash traced the product defect to Zimmer's testing its components in isolation, but not their interactions together, which would have determined the potential harm.

Nash said that Zimmer knew when it designed the device that the use of dissimilar metals can result in a higher potential for corrosion, and that wear debris from a junction of two dissimilar metals had been documented to be toxic and harmful to the body. She ordered Zimmer to pay $1 million for past and future pain and suffering, $480,000 for lost enjoyment of life, and the rest of the $2.027 million award is expected to cover past and future medical expenses, lost household services, and out-of-pocket expenses.

A slew of orthopedic device makers have coughed up millions of dollars over the past few years to settle lawsuits stemming from defective metal-on-metal hip implants. Wright Medical agreed to a $240 million settlement last November, covering 1,292 lawsuit claims. Stryker, Johnson & Johnson, and Biomet (before the company merged with Zimmer) have all spent a healthy chunk of change on these lawsuits.

The issue prompted FDA to toughen up on regulatory requirements of these devices. Last year the agency decided to make manufacturers file for premarket approvals for all existing or new metal-on-metal hip replacement devices.

Amanda Pedersen is Qmed's news editor. Contact her at [email protected].

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