The Executive Editor of the New England Journal of Medicine recently called the DePuy ASR hip replacement recall a “public health nightmare” and a prime example for why the FDA needs to fix the “510(k) clearance” loophole that allows the sale of certain medical devices — even implants — to be sold without any clinical data or testing. The Institute of Medicine, too, has recently recommended that 510(k) clearance be eliminated.
In the meantime, 93,000 patients are stuck with defective ASR hip replacement implants with a shocking replacement rate: 21% revision rate at 4 years (up to 35% if all currently known painful implants progress to revision) to 49% at 6 years. Other hip replacement devices have a revision rate of 12% to 15% at 5 years. DePuy Orthopedics is negligent and they know it; they spend about a quarter billion dollars every four months dealing with the product recall and the litigation associated with it.
In a highly unusual move, DePuy has hired a third party — Broadspire Services Inc, which manages workers compensation and other medical claims on behalf of insurance companies and employers — to administer patient claims for out-of-pocket medical costs associated with the recall.
The move has prompted debate among industry and legal experts. Some see it as an efficient way to outsource a process that is unrelated to making artificial hips. Others see it as a way for J&J to limit payments while gaining control of medical records and other material that could be used against patients in court. …
To critics, DePuy’s handling of its hip implant recall is designed to save money by potentially settling claims with patients before they fully understand their legal rights, or the likely cost of their hip-related medical costs in the future.
Indeed, that’s exactly what Johnson & Johnson (which owns DePuy Orthopedics) and DePuy are trying to do: manipulate patients and their treating physicians outside of the appropriate court processes. You can read medical device manufacturers’ defense lawyers talking about how much they would like to overcome patient—physician privilege on their blogs.
This sort of pre-litigation intrusion isn’t harmless. It isn’t just the company obtaining a handful of medical records they would get anyway if the patient filed a lawsuit. DePuy offers to pay patients’ doctors for obtaining privacy releases from their patients, then sends the patients into a paid-by-DePuy bureaucracy with all of the drawbacks of an insurance company — like endless dealings with a review panels, claims adjusters, etc. — but without the one benefit of an insurance company, which is their legal obligation to pay all valid claims. DePuy has no obligation to pay anything, not until a lawsuit and judgment establishes that responsibility.
If you finally convince that bureaucracy to help you out, we can only guess what the pages and pages of dense documents drafted by Johnson & Johnson’s lawyers will do; one presumes they’ll ask patients with the densest legalese to waive their legal rights to compensation down the line.
Much of it for no benefit at all. Consider this anecdote from the Reuters story:
Aubie Brennan, a 56-year-old teacher on the Hawaiian island of Oahu, had replacement surgery for each hip in 2007 and 2008 due to bone deterioration.
In 2009, he began to be plagued by flu-like symptoms, rashes, swollen lips and debilitating fatigue. Doctors were unable to locate the cause. They thought he might have allergies, or be depressed, or poisoned by a substance in the ocean surrounding his home.
But last August, Brennan said he received a letter from his health insurance company, Kaiser Permanente, alerting him to the recall and urging him to come in for tests. These showed that his left hip was crooked and that his blood contained significantly elevated levels of chromium and cobalt ions. …
“[The surgeon] looked at my results and said, ‘I think you need surgery, on both hips, and you need it now,'” Brennan said. … The Honolulu surgeon was not part of Kaiser’s network, so Kaiser declined to pay, Brennan said. He turned to Broadspire for reimbursement.
Broadspire told Brennan it would not agree in advance to pay. His only option would be to pay for the surgery himself. Then he would have to submit the doctor’s report to Broadspire, whose physicians would review the case and make a decision on whether the procedure had been necessary.
Not having $43,467 to pay upfront for the hip replacement surgery, he cancelled. Only when Kaiser reversed itself and agreed to pay for the surgery, did he get it.
A hip implant patient doesn’t get swelling, rashes, and “significantly elevated levels of chromium and cobalt ions” by accident. There’s only really one plausible cause: deterioration of the metal-on-metal hip implant.
Which makes Broadspire’s decision not to pay Brennan’s obvious claim all the more revealing. DePuy never wanted to pay the claim in the first place. Why not? My hunch is that they wanted to stall him until he was outside the statute of limitations. A simple bait-and-switch. Patients spend all their time fighting with Broadspire — as if fighting with their own insurance companies wasn’t enough — until they don’t have any more legal rights against the company.
It is, to put it mildly, a disgrace. At least when the BP oil spill contaminated the entire gulf, BP set up a claims facility with a bona fide honest mediator, one with the authority and inclination to pay reasonable claims, instead of drawing them out and cutting them off.
And so it’s come to that: one of the biggest names in healthcare, Johnson & Johnson, and one of the biggest in orthopedics, DePuy, have ethics and morals lower than those of an oil company.