Parker Waichman LLP

DePuy Pinnacle Hip Implant Caused Elevated Blood Metal Ion Levels, Alleges Lawsuit

In a lawsuit filed on December 16, a Rhode Island couple alleges that the husband’s DePuy Pinnacle hip implant device caused complications including extreme pain and weakness, and elevated chromium and cobalt levels in his bloodstream. According to the complaint, the man received the Pinnacle hip implant, known as the Pinnacle Acetabular Cup System, on […]

de-puy-elevated-blood-metal-levelsIn a lawsuit filed on December 16, a Rhode Island couple alleges that the husband’s DePuy Pinnacle hip implant device caused complications including extreme pain and weakness, and elevated chromium and cobalt levels in his bloodstream.

According to the complaint, the man received the Pinnacle hip implant, known as the Pinnacle Acetabular Cup System, on his right side in February 2005. The suit alleges he suffered injuries and complications because of the device’s defective design.

The lawsuit also alleges that defendants, DePuy Orthopaedics and Johnson & Johnson, knew of the potential risks associated with the now-recalled Pinnacle device, but did not disclose this information to the couple, their physician, or the public. The couple claims that if the defendants had disclosed the risks, the man would not have agreed to the Pinnacle hip device in his hip replacement procedure. The complaint notes that over 1,300 adverse event reports have been filed with the U.S. Food and Drug Administration (FDA) over Pinnacle device failures or complications, including hip dislocation, bone fracture, joint infection, local nerve damage, metallosis, numbness/weakness, device loosening and breakage, difference in leg lengths, and bone loss. Some implant recipients have needed revision surgery to remove and replace a failed hip.

The complaint alleges that the Pinnacle device is flawed and, because of this, the metal components shed chromium and cobalt particles within the body when the metal parts of the hip device rub against each other, even during normal activities, such as walking. The couple alleges that the defendants are aware that Pinnacle devices may lead to metallosis and biologic toxicity, and that the devices are associated with premature and high failure rates.

The FDA issued a Safety Alert in January 2013 acknowledging these risks and also issued new guidelines for metal-on-metal hip recipients. The FDA advises symptomatic all-metal hip implant patients to undergo physical examinations, diagnostic imaging testing, and blood metal ion testing.

The FDA has also proposed that medical device manufacturers be subject to stricter guidelines for device approval. The proposal seeks to have device manufacturers prove a device’s safety and efficacy through so-called pre-market clearance, which involves clinical testing. The current 510(k) clearance route allows a device to be brought to market if the manufacturer shows the product is comparable to a previously approved device.

The lawsuit was filed by national law, firm Parker Waichman LLP, in the U.S. District Court for the Northern District of Texas (Case No. 3:13-cv-04891-K) as part of the DePuy Pinnacle multidistrict litigation (MDL No. 3:11-md-02244).

What Our Clients Say About Us
We have worked with thousands of clients and we appreciate them and their positive reviews. Here are just a few recent client reviews...
5 Star Reviews 150
Parker Waichman are the best. They are always there for you. Theh really care about you. Thank you Jorge peniche and Linda Ingber for helping me
Ramon Mella
4 years ago
5 Star Reviews 150
They worked great with my husband's case. Jillian G. was in constant communication with us. She was always available to answer any questions or concerns. Just the mention of their name to doctors and insurance companies received an urgency to provide service. I would totally recommend them to EVERYONE I know.
zulia polanco
6 years ago
5 Star Reviews 150
I worked with Parker waichman on a personal injury lawsuit. They made the process easy and got me a fair amount of money. Alex and Kathy were both super helpful and patient during the whole process. I'd definitely recommend them.
Kelly Curto
a year ago

Why Choose Us to Help You?

We Take Care of Everything
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
No Recovery = No Legal Fees
We work on a contingency-fee basis, meaning that we only get paid from a portion of your settlement or jury award. If you don't get compensation, you owe us nothing.
Decades of Experience
Your situation is stressful enough: Let us take on the deadlines, paperwork, investigation, and litigation. We'll handle every detail so you don't have to worry.
Respected by Our Peers
Judges, insurance adjusters, and fellow attorneys all speak highly of our skills, and we've earned numerous accolades, including a flawless rating from AVVO.
We Have Many Locations To Serve You
We have the experience and the skilled litigators to win your case. Contact us and speak with a real attorney who can help you.
Long Island – Nassau
Parker Waichman LLP
6 Harbor Park Drive
Port Washington, NY 11050
Long Island – Suffolk
Parker Waichman LLP
201 Old Country Road – Suite 145
Melville, NY 11747
New York
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038
Queens
Parker Waichman LLP
118-35 Queens Boulevard, Suite 400
Forest Hills, NY 11375
Brooklyn
Parker Waichman LLP
300 Cadman Plaza West
One Pierrepont Plaza, 12th Floor
Brooklyn, NY 11201
New Jersey
Parker Waichman LLP
80 Main Street, Suite 265
West Orange, NJ 07052
Florida
Parker Waichman LLP
27299 Riverview Center Boulevard
Suite 108
Bonita Springs, FL 34134
Nationwide Service
Parker Waichman LLP
59 Maiden Lane, 6th Floor
New York, NY 10038