Stryker (NYSE:SYK) should pay for medical monitoring of all Florida patients implanted with its recalled Rejuvenate hip replacement, according to a federal lawsuit.
Bernard Owen, a Florida man who received the device in July 2011, wants the court to recognize a class of plaintiffs and force Kalamazoo, Mich.-based Stryker to cover the cost of monitoring them for problems with the Rejuvenate implants – but doesn’t want any damages related to the case, according to court documents.
Stryker recalled the Rejuvenate implants in July 2012, a year after Owens received his device, and early this year advised Rejuvenate patients to have their surgeon check the implant for problems, according to the documents, which cite "risk of fretting and corrosion at the modular neck junction."
"This action for medical monitoring seeks to recover the quantifiable costs of periodic medical examinations necessary to detect the onset of physical harm, but does not seek a damage award attributable to the increased risk of injury caused by the implantation of the defective Rejuvenate system," according to the lawsuit. "Plaintiff requests that the court exercise its equitable powers to create and supervise a fund for the purpose of monitoring the condition of plaintiff and class members because such monitoring is reasonably necessary."
Although Stryker allegedly claims that the Rejuvenate device is not a metal-on-metal implant, the lawsuit argues that the point where the implant’s stem enters the femur is made of two different metals, titanium and cobalt-chromium.
"This junction is known as the ‘taper neck junction.’ The metal-on-metal contact at the taper neck junction is leading to fretting, corrosion and the creation of metal debris," according to the suit.
Owens wants the court to grant class status and mandate that Stryker cover the cost of monitoring the patients every 6 months, including blood tests to determine serum chromium and cobalt concentration; aspiration of joint fluid; imaging studies; and regular physician examinations. The lawsuit also seeks legal costs.
