When it comes to massive product-liability litigation, drug and device makers generally make payouts after losing a trial and any appeals. After all, why incur expenses when the outcome of an unfolding number of lawsuits is far from clear? However, Johnson & Johnson's DePuy unit is taking what some lawyers say is a unique approach to defending the roughly 36,000 lawsuits filed over its hip replacement device, and upsetting some lawyers in the process.
The device, known as the ASR Hip System, was recalled last August after researchers found a second operation, or revision surgery, was needed after five years at rates higher than expected. That's because the so-called 'metal-on-metal' devices contained design defects that generated cobalt and chromium particles causing tissue death, fractures, and other injuries, according to lawsuits. The failure rate was estimated to be about 12 percent, by the way.
Last fall, however, J&J's DePuy unit hired Broadspire, a claims adjuster, and began encouraging ASR patients to submit paperwork that might allow them to receive reimbursement for lost wages, medical expenses and out-of-pocket costs associated with treatment. Forms were apparently sent with recall letters to patients. "DePuy intends to cover reasonable and customary costs of testing and treatment for patients who need services, including revision surgery, associated with the ASR recall," according to a statement on its web site.
The move has some plaintiff lawyers grumbling. At issue is the notion that J&J's DePuy and its legal team are using a stealthy tactic to gather comprehensive medical info about patients and insights into what their doctors might say in court. In other words, this is akin to sending a spy over enemy lines to report on strategy and details before the battle breaks out. "This is unique," one plaintiff's lawyer tells us. "You normally don't see this kind of situation in drug or device litigation. By doing this, they may be able to get insights into patients and their doctors they otherwise might not be able to obtain."
DePuy, however, is not requiring patients to sign releases that would restrict lawsuits from being filed, but some attorneys complain privately that the tactic may, nontheless, breach lawyer-client confidentiality, possibly setting up an ethics argument. And some lawyers, meanwhile, have posted warnings about the DePuy overtures on their web sites and specifically caution about voluntarily providing medical info to DePuy.
"Signing these medical authorization forms carries very real consequences for the patient," writes one attorney on the InjuryBoard blog network, a site promoted by plaintiff lawyers. "Specifically, by signing the form, a patient waives their right to medical privacy and any information that is released to DePuy can be used as evidence against them in any court proceedings related to their claims based on the hip replacement recall. There is a risk that such a broad release of information could be detrimental to the outcome of a patient’s hip recall claim and the amount of recovery obtained for DePuy’s medical errors. Patients are not alerted of this risk when they receive the recall letter and medical authorization form from DePuy."
In response to questions, a DePuy spokeswoman wrote us to say that "We understand that this recall is concerning for patients, their family members and surgeons, and since the recall decision was made...DePuy does not want cost to be a barrier to treatment. We are committed to addressing reasonable and customary costs of testing and treatment for reasons related to the recall, including revision surgery if necessary." She declined, however, to provide any details claims paid, such as the number of payouts or the average amount involved.