Joseph Osborne of Osborne & Associates in Boca Raton. (J. Albert Diaz)
A Boca Raton attorney won a $2 million award for a man who suffered metal poisoning after hip implant surgery.
The implant manufacturer, Zimmer Inc., never ran corrosion testing on the full device, which included head, neck and stem components, a New Mexico judge found March 31. Instead, the company tested the head-neck junction and the neck-stem junction separately.
Because of an adverse reaction between the cobalt-chromium head and titanium alloy neck on the device implanted during economist Michael Brian McDonald’s surgery, he found himself in immense pain and required two follow-up surgeries, with a third still to come, according to his attorney, Joseph Osborne of Osborne & Associates in Boca Raton.
“He can no longer play tennis and he cannot golf and fish the way he used to do,” Albuquerque District Judge Nan Nash found after a bench trial. “He must take daily antibiotics and await a future surgery.”
At the two-week trial in December, Zimmer’s attorneys argued the complication McDonald experienced was an unfortunate but rare occurrence with the M/L Taper Hip Prosthesis with Kinectiv Technology, or MLKT. The Warsaw, Indiana-based company has sold more than 148,000 MLKTs worldwide since the implant debuted in 2007.
A warning about the possbility of corrosion was included in the product insert for the implant, which McDonald’s initial surgeon testified he did not read because product inserts are “essentially useless in the daily use and understanding of implants.” The surgeon, who was not a defendant, said he was aware of a prior metallosis problem with the device but because that issue had been fixed, he didn’t believe McDonald would be at risk.
But Osborne and his co-counsel argued the Zimmer implant created an unreasonable risk of harm to McDonald. He called an expert witness, a biomechanical engineer with a history of designing and developing hip implants, who testified Zimmer’s testing was deficient. The full modular device should have been tested to see how the liberation of cobalt debris would affect both junctions, argued Osborne and Albuquerque, New Mexico, attorneys Randi McGinn and Allegra Carpenter of McGinn, Carpenter, Montoya & Love.
The plaintiffs attorneys also mined registry data from the U.K. and Australia, which track how medical devices perform after they’re implanted. There was some data that showed metal-related failures were “much higher than expected” for the MLKT, Osborne said.
Although the judge found Zimmer “exercised ordinary care in the designing and testing of the MLKT” and did not fail to issue a warning about the risk of corrosion, she found Zimmer strictly liable for an unreasonably dangerous design. (Even if a manufacturer has not acted negligently, strict liability leaves them on the hook for a defective product, defined by the unreasonable risk of injury associated with using it.)
“If a device is throwing off or creating so much metal debris and corrosion that it causes metallosis, that is not an acceptable risk of harm,” Nash wrote.
Nash awarded about $2.02 million, with $1 million for pain and suffering, $480,000 for lost enjoyment of life, about $287,000 for the upcoming surgery McDonald will need and his home health care afterward and $175,000 for his past medical expenses. The award also included approximately $63,000 for lost earnings, $17,000 for lost household services and $6,000 for out-of-pocket expenses.
Defense attorney Michael Kanute of Faegre Baker Daniels in Chicago did not respond to a request for comment. His Albuquerque, New Mexico, co-counsel was Charles Vigil and Nelson Franse of Rodey, Dickason, Sloan, Akin & Robb.
Osborne said the case is a sign of a larger problem that will continue to play out in courts across the country. He is pursuing similar cases against other medical device manufacturers, including Stryker Corp. and DePuy.
“Overall, this is an example of the fact that hip manufacturers, not just Zimmer, have been dealing with metal-related failures for a number of different reasons over the past five to 10 years,” Osborne said. “Unfortunately, I think because there are different ways that these implants can fail that people are going to continue to need help medically and legally because of how poorly some of these implants were designed. Doctors and patients just need to be aware of it.”
Case: Michael Brian McDonald v. Zimmer Inc. et al
Case No.: D-202-CV-2013-0406
Description: Medical device defect
Filing date: May 9, 2013
Findings and conclusions date: March 31, 2017
Judge: Albuquerque District Judge Nan Nash
Plaintiffs attorneys: Joseph Osborne, Osborne & Associates, Boca Raton; Randi McGinn and Allegra Carpenter, McGinn, Carpenter, Montoya & Love, Albuquerque, New Mexico
Defense attorneys: Michael Kanute, Faegre Baker Daniels, Chicago; Charles Vigil and Nelson Franse, Rodey, Dickason, Sloan, Akin & Robb, Albuquerque, New Mexico
Judgment amount: $2 million