PENNSYLVANIA RECORD

A Montgomery County man is suing DePuy Orthopaedics and Johnson & Johnson over

allegations that he sustained injuries as a result of having had a defective hip replacement system implanted in his body.
Mark Hart, who resides in Telford Borough, filed suit March 4 in federal court in Philadelphia against the two medical device manufacturers claiming that the Pinnacle Acetabular System Device caused him to suffer significant physical pain and a debilitating lack of mobility.
Hart was also required to undergo a complicated and painful revision surgery to replace the device last year, but because of the lack of remaining bone structure in his body, he will be unable to undergo another surgery for suggested implantation of a third replacement device, the complaint states.
The plaintiff is being represented by attorneys Diana Nickerson Jacobs and Howard M. Louik of the Pittsburgh firm Goldberg, Persky & White.
The complaint says that the Pinnacle device, which is a “metal to metal” hip prosthesis, and was designed for human hip joints damaged or diseased due to fracture, osteoarthritis, rheumatoid arthritis and avascular necrosis, has been the subject of more than 1,300 reports of failures or complications.
The defendants, the suit alleges, were aware prior to August 2010 that the use of the device in patients can result in metallosis, biologic toxicity, and an “unacceptably high” failure rate requiring replacement revision surgery.
The general allegation is that the Pinnacle device results in an unsafe release of toxic metal ions into recipients’ tissue and bloodstream, and that the metal particles can result in tissue death, bone erosion, swelling, nerve and muscle damage, and even the development of tumors.
The suit states that for more than two years prior to the summer of 2010, the defendants knew that their hip replacement devices, which also included the ASR XL Total Hip System and ASR Hip Resurfacing System, were prone to fail within about two years of implantation despite the fact that such devices are supposed to last more than 15 years.
In the present case, Hart’s suffering could “easily have been prevented,” the lawsuit states, if only the defendants had properly warned of the problems patients were experiencing due to implantation of the medical device.
The complaint also alleges that Hart’s injuries will likely mean he’ll eventually be confined to a wheelchair.
“None of this would have occurred had either Defendants either warned the public of the dangers of the Pinnacle Device or ASR Device in 2007 when dozens of complaints began being made to the FDA regarding the device’s failures, or, even better, taken the affirmative step of recalling the Pinnacle Device and/or ASR Device at that time,” the lawsuit reads.
The complaint further states that the companies’ recent recall of only the ASR device has come too late for many patients who will now live with the “permanent and irreparable consequences of the faulty Pinnacle Device for years, if not the rest of their lives.”
The complaint contains counts of negligence, strict products liability, breach of warranty, common law fraud, intentional misrepresentation, negligent misrepresentation, and violations of Pennsylvania’s Unfair Trade Practices and Consumer Protection Law.
Hart seeks reimbursement for medical and hospital bills, damages for physical injuries, and damages for fear, humiliation, embarrassment, emotional distress and mental pain, disfigurement and disability.

The federal case number is 2:13-cv-01133-JP.