Not since the days of Monica Lewinsky has parsing the meaning of a word—or two in this case—been worthy of such scrutiny. The words, “if necessary” in this “Claims & Reimbursement FAQs” link on the Stryker website should perhaps make any hip replacement patient who’s been affected by the Stryker Rejuvenate and ABG II modular-neck hip stems recall suspect.
Why?
Well, a little walk down memory lane on LawyersandSettlements.com brings up a story we had published back when Broadspire was the third-party claims administrator brought in by J&J to handle DePuy hip replacement claims.
At the time, a Reuters article noted that the move means that Broadspire’s physicians—not the patient’s physician—will determine whether a hip should be replaced. This means that even if the patient’s physician recommends replacing the hip, if a Broadspire physician disagrees with the decision, Johnson & Johnson may not pay to cover the costs of that surgery.
So is history repeating itself?
Clearly by inserting the words “if necessary” in discussing defective hip replacement revision surgery reimbursements Broadspire retains the right to deem whether a revision surgery was necessary, or not; the “not” undoubtedly necessitating a denial—or reduction—of reimbursement.
What we’re hearing from attorneys like Ben Stewart of Stewart Law Group PLLC., who’s familiar with defective hip lawsuits, is that before a patient submits any paperwork with Broadspire—or signs anything—for a Stryker hip reimbursement claim, he or she should first talk to a lawyer.
The requirement by the FDA for post-market testing on metal-on-metal hips is a sign that the federal regulator may be finally coming to its senses over the longstanding invitation to manufacturers to escape the road of rigorous testing for some medical devices.
It’s about bloody time.
The FDA is both a regulatory body and a political body, with the majority of its power reserved for manufacturers of new drugs and new medical devices. To that end the FDA can play hardball and make a manufacturer jump through hoops until the agency is satisfied that a device or drug delivers more benefit than it does risk.
Once a device is on the market however, the FDA has pretty weak powers. A letter, such as the one sent to about 20 manufacturers of metal-on-metal hips on Friday, is about the extent of the FDA’s post-market authority.
Basically, the FDA has ordered all artificial hip manufacturers to conduct post-market testing of their devices, in light of the failure rate of various artificial hips.
However, had this testing been conducted in the first place, hundreds if not thousands of patients with problematic hips would have been spared the pain and frustration that comes with having an allegedly defective hip placed inside your body—at great expense—only to have it fail within five years of an expected 15 to 20-year lifespan.
A failed artificial hip needs, in most cases, to be replaced—along with more pain, more downtime, and more money.
At least it can be replaced…
Witness the situation over heart leads a few years ago. One brand of defibrillator lead, a wire Read the rest of this entry »