Product/Medical Device – Liability/Injury or Death

Several thousand lawsuits have been filed by people who have either had a hip implant replaced or will need to have one replaced in the future. Most claims involve the DePuy Orthopaedics metal‐on-­metal (MoM) ASR and the DePuy Pinnacle, but there are similar suits filed against other MoM manufactures. DePuy is a subsidiary of Johnson & Johnson. Hundreds of people in Tidewater have had those hips implanted in their body. The physicians who performed the surgeries are not defendants. Some believe that the surgeons have been left to deal with the effects of a recalled product that was marketed and promoted as state­‐of‐the art. One group of local orthopaedic surgeons has sued DePuy and Johnson & Johnson alleging essentially that the ASR MoM hip implant is defective and that DePuy provided misleading promotional literature to the patients andto the physicians.

The newer metal-­on-­metal products came on the market in the early 2000’s. Until that time ceramic-­on-­ceramic and metal­‐on‐polyethylene implants were the products of choice. However, the MoM hip implant was touted to surgeons as being more durable and better for an active, longer-­living population.

Because the MoM implant was supposedly an updated version of a previously­‐approved implant it was represented to the FDA as a “substantially equivalent” product. This allowed the product to be put on the market without going through the normal clinical testing and investigative process.Some of these products do not perform as represented and, in fact, present certain dangers to the men and especially to the women who have the allegedly defective hip implanted in their bodies.These dangers include a higher rate of implant failure involving loosening, dislocations and fractures of the bone around the implant. Friction of the metal‐on‐metal parts causes toxic metal shavings to be released into the tissue surrounding the implant site. This metal debris contains cobalt and chromium which can cause metallosis.

Symptoms of metallosis include groin or thigh pain, spontaneous dislocation of the implant, stained and necrotic (dead) muscle and tissue, the formation of painful masses (pseudotumors) and bone loss. These conditions make revision surgery more difficult and recovery more problematic. Importantly, some patients have no pain even though they suffer higher than normal cobalt and chromium levels.The FDA began receiving complaints about certain MoM hip implants soon after they went on the market. In fact, some patients were having revisions surgery within one year of the implant. Surgeons were finding extensive necrotic tissue and fluid build up.

An early report noted that debridement of dead tissue from the patient required more than an hour and multiple biopsies. These early findings are consistent with the operative reports we are reviewing for our clients. Most failures are occurring from three to five years from the implant date.In August 2010 DePuy “voluntarily” recalled one of their best selling models in the United States. DePuy had already withdrawn it from the market in Australia and Great Britain. In the United States, Depuy’s letter to physicians accompanying the Recall Notice recommends yearly follow-­up appointments whether the patient is experiencing symptoms or not. It notes that blood test and imaging tests may be appropriate.

Although DePuy still maintains that it is only “phasing out” this hip implant, it has offered to reimburse revision patients for certain expenses after payment by health insurance or Medicare. These expenses are just the tip of the iceberg. We have clients who have endured multiple hip implant revisions and still suffer significant pain and loss of mobility.Persons with MoM hip implant should see their orthopaedic surgeon and ask about blood testing for cobalt and chromium and about revision surgery. They should seek a second opinion if they continue to have problems or are uncomfortable with the advice.It is critical that patients understand that there is a very limited time in which to take legal action against the manufacture of a defective hip implant because of the peculiar Virginia statute of limitations. Thus statue may be running out even though the patient is not yet feeling any symptoms of hip replacement failures.

Thomas Joyce, a biomedical professor in Great Britain, termed this recall, “[T]he biggest disaster in the history of orthopaedics.” Indeed, some believe that the current litigation is only the beginning as more and more MoM hip implants fail and the long‐term effect of elevated blood levels of chromium and cobalt becomes better understood.

Duncan Garnett is former President of the Virginia Trial Lawyers Association and a Partner at Patten, Wornom, Hatten & Diamonstein, L.C. He is currently involved in the national hip litigation.

First published in The Oyster Pointer.