Joint replacements are the #1 expenditure of Medicare. The process of approving these medical devices is flawed according to the Institute of Medicine. It is time for patients' voices to be heard as stakeholders and for public support for increased medical device industry accountability and heightened protections for patients. Post-market registry. Product warranty. Patient/consumer stakeholder equity. Rescind industry pre-emptions/entitlements. All clinical trials must report all data.
Please share what you have learned!
Twitter: @JjrkCh

Wednesday, April 5, 2017

Zimmer MLTK Hip Replacement: Unreasonably Dangerous Design

Judge rules Zimmer liable for $2 million in hip implant case FiDA highlight

New Mexico court cites 'unreasonably dangerous design'; plaintiff represented by Joseph Osborne of Boca Raton Fl., and Randi McGuinn of Albuquerque
BOCA RATON, FLORIDA, UNITED STATES, April 4, 2017 / -- Medical device manufacturer Zimmer Inc. has been ordered to pay more than $2 million to a New Mexico man for a defective hip implant with an “unreasonably dangerous design,” following a two-week bench trial.

“This is the first case we know of that has gone to trial in the country, and a growing number of these are going to court,” said Joseph Osborne, Jr., of Osborne & Associates in Boca Raton, Fla., who represents medical device plaintiffs around the country. Osborne tried the case with Randi McGinn and Allegra Carpenter of McGinn, Carpenter, Montoya & Love, P.A., of Albuquerque, N.M.

The product in question is Zimmer’s dual modular hip implant, the M/L Taper Hip Prosthesis with Kinectiv Technology (“MLTK”) and a cobalt-chromium head.

In a 27-page decision, New Mexico Judge Nan G. Nash ruled that the defective design and insufficient testing caused likely permanent harm to the plaintiff, resulting in “metallosis,” or a buildup of cobalt debris harming the hip joint and contaminating blood.

“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, ruling for the patient on grounds of strict products liability.

In February 2010, Michael Brian McDonald, an Albuquerque economist then in his sixties, was suffering right hip pain that was preventing him from his usual tennis and golf. That June, McDonald received the MTLK implant. 

Initial recovery went well, but by May 2011, McDonald suffered from hip and groin pain and loss of flexibility, resulting in two corrective surgeries that October and November, during which the doctor implanted two new prostheses and replaced the cobalt-chromium head with a ceramic head

After a lengthy recovery, McDonald sued and the case went to bench trial before Judge Nash December 12-23, 2016, in the Second Judicial District Court in Albuquerque. 

In her March 31 ruling, Judge Nash wrote that the ordeal has forced McDonald to a permanent course of antibiotics, an end to golf and tennis, and the likelihood of a recurrent infection.

“It is more probable than not that Plaintiff will need a third, more complicated revision surgery in the future,” Nash wrote. “This surgery will cost approximately $250,000 and will involve removal of all of the implant components for a period of 2-3 months to try and kill the infection, during which Plaintiff will be wheelchair bound. If the infection can be successfully eradicated, another hip prosthesis will be implanted, necessitating the same type of physical therapy and recovery period as the first two revision surgeries.”

The judge traced the product defect to Zimmer’s testing its components in isolation, but not their interactions together, which would have determined their potential harm.

“In designing the MLTK, Defendants knew 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 human body,” she wrote. 

In determining the damages of $2.027 million, Judge Nan apportioned it into $1 million for past and future pain and suffering, $480,000 for lost enjoyment of life, and the rest for past and future medical expenses, lost household services, and out-of-pocket expenses.

SECOND JUDICIAL DISTRICT, New Mexico County for Bernalillo, McDonald v. Zimmer Inc. and Zimmer Holdings, Case No. D-202-CV-2013-0406

Osborne & Associates:

McGinn, Carpenter, Montoya & Love, P.A.,
Mark Sell
Mark Sell Media


No comments:

Post a Comment