DePuy’s Hip Repair Offer Comes With Conditions

It hasn’t been the best of summers for Johnson & Johnson.

Besides dealing with the fallout from its highly-publicized recall of 40 different infant and children’s medicines (which included a late May grilling by U.S. Food and Drug Administration [FDA] officials), the beleaguered healthcare giant pulled two hip replacement products from the global market in late August due to design defects. J&J issued the recall (its 10th of the year at that point) through its artificial joint division, DePuy Orthopaedics Inc. of Warsaw, Ind.

The recall of DePuy’s ASR XL Acetabular System, a hip socket used in traditional replacement surgery, and ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the femur in order to preserve more bone, came several days after the FDA ordered the company to stop selling two other hip replacement systems. The company said it recalled both ASR hip products due to the number of patients who needed a second hip replacement.

When it pulled the devices from the market, DePuy officials promised to pay for the cost of patients’ “doctor visits, tests and procedures associated with the recall.” The company, however, now has put several conditions on its all-inclusive offer.

According to Irish broadcasting firm RTÉ News (Raidió Teilifís Éireann), DePuy’s generosity in covering the cost of doctor’s visits, X-rays and replacement surgeries is conditional upon patients providing the company with all medical records, the defective hip and a signed consent form. Attorneys, though, are not convinced that patients should be so forthcoming.

An attorney quoted by RTÉ News claimed that surrendering the faulty hip device as well as medical records could hamper future product liability claims. Not surprisingly, those claims already have started to surface. Earlier this month, a California construction worker who received two Acetabular hip replacements filed suit against J&J, claiming defects with the hip replacement mechanisms caused him “pain, swelling, inflammation, infection and damage to surrounding bone and tissue,” according to the lawsuit filed in federal court in San Francisco. The worker, identified as Maurice Brigham, had one of the devices removed in August, but had not yet been able to get a replacement (at the time the suit was filed). The delay in getting a replacement device has left him unable to walk, the suit charges.

Similar suits have been filed in Los Angeles and Newark, N.J. Vicki Aiken of Roanoke, Va., sued DePuy on Sept. 3 in New Jersey, claiming the company had received more than 300 reports of ASR hip failures by the end of 2008 and was “fully aware” the devices were defective. Martin Aronson contended in his lawsuit (filed in Los Angeles) that a design flaw within the hip implant allowed metal components to grind together and damage surrounding tissue. “The toxic metal particles that were generated by the defective hip implant caused Mr. Aronson’s body to reject the hip implant and not allow it to grow properly into his bone,” said Brian Devine, a San Francisco-based attorney for the Van Nuys, Calif.-based Aronson. The lawsuit was filed Aug. 30.

The recall of DePuy’s hip implants is not a surprise to orthopedic industry experts. In June, media reports surfaced about orthopedic surgeons souring on metal-on-metal hip implants. Most surgeons surveyed at that time said they planned to reduce their use of the devices.

In the U.S., metal-on-metal hip implants are used in roughly 250,000 of all hip replacements annually and are also used in hip resurfacing procedures. The implants, whose ball-and-socket joints are made from metals like cobalt and chromium, were thought to be more durable than earlier devices.

Hip implants should last about 15 years; however, a New York Times investigation published earlier this year found that many metal-on-metal implants require replacement surgery within one or two years. Studies indicate that hip implants quickly can wear, generating high volumes of metallic debris that is absorbed into a patient’s body, leading to soft-tissue and bone destruction.

In March, DePuy warned that one of its hip implant devices appeared to have a high early failure rate. Since early 2008, DePuy received about 300 complaints on ASR devices from U.S. patients, according to FDA records. In April, European regulators announced they would be conducting a review of 40,000 metal-on-metal hip replacements over fears the devices could cause non-cancerous tumors and tissue damage.