Stryker, one of the medical device “giants,” announced in November of 2012 they would be bringing former DePuy CEO David Floyd on as the new president of the orthopedics division. This decision came on the heels of a Stryker hip implant recall— both the Rejuvenate and ABGII—in July of 2012. Floyd left DePuy—a subsidiary of Johnson & Johnson—amid a considerable level of controversy following the recall of the ASR metal-on-metal hip implants. Johnson & Johnson is currently facing over 8,000 legal claims over the ASR hip implant and 2,900 due to the Pinnacle hip implant.
As for Stryker, it is estimated that over 20,000 of the recalled hip devices were implanted and it is believed Stryker will be facing lawsuits from those suffering metal toxicity or poisoning as a direct result of the defective implants. After the Johnson & Johnson subsidiary issued its 2010 recall notice, a letter—known as the “Broadspire letter”—was sent to surgeons who had implanted the ASR hip system in their patients. This letter offered to pay for the costs of revision surgery for any patients who had suffered serious, adverse health issues from the implants. The company wanted something in return, however: the removed hip implant and all medical records associated with the implant.
The Broadspire letter was later sent to recipients of the recalled hip implants as well. This letter alarmed many attorneys on behalf of the patients who had been harmed by a recalled ASR or Pinnacle hip implant. Just because a company manufactures a hip implant, they do not have the right to have the explant returned to them following revision surgery. You—the patient—bought the hip implant and it belongs only to you. Turning over the explant to a company you will likely end up having to sue is essentially handing them your case.
Broadspire is a subsidiary of Crawford & Company—the largest insurance and claims adjuster in the world. The motivation in retaining Broadspire for the Stryker cases is likely the same as for the previous Johnson & Johnson cases—to protect the company’s interests rather than those of the consumers affected by the hip implant recalls. Many attorneys believe the goal of the original Broadspire letter was to gain unrestricted access to patients’ medical records thereby reducing the potential liability of the company (and reducing the amount claimants will be able to recover).
As of January, 2013, many recipients of the Stryker Rejuvenate or ABGII hip implant had received a Product Experience Report or PER. These letters appeared—at least on the surface—to be relatively harmless, simply thanking the patient or surgeon for submitting any issues related to their hip implants. Just as with the J&J Broadspire letter, the PER letter asked patients to grant permission to obtain personal medical records in order to “conduct an investigation of the issue.” The PER letter did not offer to pay for revision surgery or that explants be turned over to them, however allowing Stryker access to highly personal medical records can only be a mistake in the long run.
Because no third party oversight is involved in the PER letter, Stryker is free to reply with a vague “best assessment” of the performance of the Rejuvenate or ABGII while gaining access to sensitive patient medical records. Just as with a Broadspire letter, it is extremely important that recipients of a PER letter consult with an attorney and consider all aspects of a future lawsuit carefully before signing an authorization to release your medical records.