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.






7 Comments
That sounds like another huge mess!
I wonder if the action by J&J could potentially reduce a payout and lawyers' fees and that's a source of their objection.
Thank you for the information, Its good to see such quality post article. Keep them coming.
They shouldn't have released the product if its gonna cause problems with the users, even if the margin of failure is low, its still unacceptable in my opinion..
Well, the 12% failure rate is almost double then the "industry" accepted standard, so the recall was more then necessary and it was the morally right thing to do. Now there is another question of what comes next and how J&J will try to clean the mess left behind. The cost of a revision surgery is enormous, if I'm correct, here in the US is way over 30.000$. By a rough estimate this might cost J&J over a billion. When that amount of money is in line the game might get a little "dirty" and unethical.
That's what makes all this "scandal" everywhere you turn troubling on so many levels. Corrupting manufacturing to steal a buck for yourself from the cut to quality you made is what the FDA is empowered to shut down and prosecute. The SOP is a contract. Fair question to ask what the FDA is doing these days, especially based on the job descriptions they post on their official website for such things as employment opportunities. There is nothing remotely connected to a person having the job of shutting down places where manufacturing in not following their SOPs before the operation kills someone.
Nihilists.
The only ones with a 5 year plan....