ClassAction.org has reported multiple times on the problems with Stryker hip components, including Rejuvenate and ABG II hip stems. Patients and doctors have alleged that the devices can corrode, which may lead to tissue damage and painful complications. In July 2012, Stryker Corp. announced a voluntary recall would begin, “due to the potential for fretting and corrosion at the modular-neck junction which may result in ALTR (adverse local tissue reactions), as well as possible pain and/or swelling at or around the hip.”
What costs will Stryker be covering regarding this voluntary recall?
Other companies have also been accused of manufacturing hip implants that can lead to metal poisoning, hip implant failure and other problems. Wright, Biomet, Johnson & Johnson and Zimmer have all faced lawsuits.
Stryker’s Rejuvenate and ABG II modular-neck hip stem recall is voluntary, and the company has decided to settle some of the terms on their own. Rather than filing a lawsuit, patients can choose to submit a claim to Stryker and, if covered by the reimbursement plan, the company will pay for treatment, including removal or replacement of devices. There’s one issue, however – seemingly small, but with big consequences – that’s drawn attention: the wording of the Claims & Reimbursement FAQs. In answering the question ‘What costs will Stryker be covering regarding this voluntary recall?’, the company informs patients that ‘testing, treatment, and revision surgery’ will be covered – before adding ‘if necessary’.
Those two words could cause a lot of trouble.
When Johnson & Johnson DePuy ASR hip implant recipients faced a similar situation, the company used a third party claims administrator to help settle multiple claims that the recalled device was faulty and had led to serious injuries. Crucially, though, the use of the third party administrator mean that in settling claims, the administrator’s physicians, and not patients’, decided whether implants qualified for replacement as part of the company’s reimbursement plan. Patients’ doctors were removed from the process and, should the administrator decide an individual doesn’t qualify, the company will not cover the patient’s costs.
Suddenly Stryker’s ‘if necessary’ is looking a bit more suspect. The question is a simple one: who decides what’s necessary? The patient? Their doctor? Or Stryker and their partners? It’s not a conflict of interest, but it’s not exactly ideal.
One thing’s clear – patients must ensure they fully understand anything they agree to or sign, as well as the legal, financial and medical implications. Stryker may well be acting in good faith or simply ensuring they cover their backs, but until absolute clarity is achieved, individuals may want to act cautiously in seeking reimbursement for alleged device defects.