CHARLESTON – A 76-year-old retired woman is unable to enjoy her post-work years due to a botched hip replacement surgery, according to recently filed court documents.
Maxine Akers filed a lawsuit Nov. 15 in U.S. District Court against Depuy Orthopaedics and Johnson and Johnson.
Since her hip replacement surgery on March 15, 2007, Akers claims she has suffered from multiple complications, including limited mobility, trouble walking, an inability to drive, difficulty concentrating and an inability to sleep and to perform housework. In fact, her pain is so great that Akers has not been able to sleep in her bed since the date of her surgery, according to the complaint.
Because of the defective hip replacement device, Akers was forced to undergo a revision surgery on Nov. 5, the suit states. Had she known of all the problems associated with the hip replacement device, manufactured by Depuy Orthopaedics and Johnson and Johnson, Akers alleges she never would have elected to have the device implanted.
The hip replacement device used in Akers, known as the ASR Hip Implant Devices, is composed of three components – a metal stem, which is inserted into the upper leg bone, a metal ball, which connects to the stem, and a metal socket, which replaces the natural hip socket. These devices, which are used to treat a variety of diseases, are supposed to last for at least 15 years, the complaint says.
Aggressively marketing the device, the defendants touted its reduced wear, its ability to match the hip's natural anatomy and its requirement of only a small incision to implant. Despite the device's tendency to fail early and to cause harm in a number of patients, the defendants continued their intense marketing campaign without warning the public of adverse effects, according to the complaint.
"Reports were received that the implant's 'ball' and 'socket' that make up the hip joint – which are both metal bearings – generate metal debris over time from wear which can spread throughout the surrounding bone and tissue and cause severe inflammation and damage," the suit states.
Since the start of 2008, the F.D.A. has received more than 400 complaints from customers who received the implants, but who were later forced to undergo revision surgery, the complaint says. Still, the defendants continued to promote their product until August.
Finally, nearly five months ago, Johnson and Johnson and Depuy Orthopaedics issued a voluntary recall of their hip replacement product after a British study was released to the public showing the dangers of the device, Akers claims.
The study showed that the implant devices "can generate large amounts of metallic debris as they wear over time," the suit states. "The metallic debris has been shown to cause severe inflammatory responses in some patients that cause pain in the groin, and death of tissue in the hip joint and loss of surrounding bone, requiring a revision surgery to replace the device soon after implant instead of the 15 or more years artificial hips are supposed to last."
Another, unpublished source from the National Joint Registry of England and Wales, revealed that the five-year revision rate for the defendants' hip replacement system is about 13 percent. Under traditional standards, no more than five percent of patients should have to undergo revision surgery, the complaint says.
Many physicians attribute the hip replacement system's failure to its shallow metal cup, which presents surgeons with the challenge of properly installing the device, Akers claims. Improper installation can lead to loosening of the device, misalignment of the device and fracture of the device from the bone, according to the complaint.
In addition to experiencing pain and inflammation, patients who experience problems with the hip replacement device may be exposed to increased levels of chromium and cobalt, which can be emitted from the device into the blood stream, the suit states.
"Tests have demonstrated that levels of chromium and cobalt can be 100 times higher than normal, and the patients have had soft tissue and muscle inflammation and benign tumors develop, called pseudo-tumors," the complaint says. "Chromium and Cobalt toxicity has been linked to cancer, and other severe medical conditions associated with heavy metal toxicity."
Akers claims that she now fears contracting a disease because of the device.
In her complaint, Akers alleges negligence, manufacturing defect, design defect, inadequate warning, failure to conform to representations, failure to adequately test, breach of express warranty, breach of implied warranty of merchantability, fraudulent concealment, intentional misrepresentation and negligent misrepresentation against the defendants.
She seeks economic damages, costs for medical monitoring, punitive and exemplary damages and disgorgement of all revenue the defendants obtained through their marketing of the device. In addition, she seeks attorneys' fees, costs, pre- and post-judgment interest and other relief the court deems just.
J. Farrest Taylor of The Cochran Firm in Dothan, Ala.; G. Patrick Jacobs of the Law Office of G. Patrick Jacobs in Charleston; Jane Lambertt Sams of Cochran, Cherry, Givens, Smith, Sistrunk and Sams in Atlanta; Douglas J. Fees of The Cochran Firm in Huntsville, Ala.; Bernard D. Nomberg of The Cochran Firm in Birmingham, Ala.; and David P. Nomberg of The Cochran Firm in Birmingham, Ala., will be representing her.
U.S. District Court case number: 2:10-cv-1303