Officials of J&J's DePuy Orthopaedics unit knew for years many of the 93,000 patients with ASR hip implants required corrective surgeries due to the mechanisms' defects, lawyers for Maurice Brigham said in their lawsuit. Brigham, a heavy- equipment operator, received two implants in 2007, the suit said.
"For more than two years, defendants have known the ASR Hip Implant Devices were failing early and causing harm in a high number of patients," Brigham's attorneys said in the suit, filed earlier this week in federal court in San Francisco.
The recall last week came just two days after U.S. Food and Drug Administration officials warned DePuy about selling two other hip-replacement systems for unapproved uses. DePuy generated more than $5.4 billion in sales last year, according to court filings.
Bill Price, a Johnson & Johnson spokesman, didn't immediately return a call for comment on Brigham's suit.
Brigham's suit is one of the first of a likely surge of litigation over the hip products, which J&J pulled off the market Aug. 26, said Hunter Shkolnik, a New York-based lawyer who represents patients injured by faulty medical devices.
"93,000 is a monstrous recall and I think we'll see a sizeable pile of lawsuits filed to go along with it," Shkolnik said in an interview. Shkolnik said he's still investigating consumers' claims over the ASR devices and hasn't yet filed any cases.
Officials of New Brunswick, New Jersey-based J&J and Warsaw, Indiana-based DePuy said they recalled the devices, known as the ASR XL Acetabular and the ASR Hip Resurfacing systems, after researchers found many patients needed "revision surgery" after five years because of design defects.
The resurfacing system substitutes a metal device for the ball of a human hip while the Acetabular version helps address pelvic problems.
Researchers in the U.K. found recently that after five years, 13 percent of patients with complete hip replacements and 12 percent with resurfacing devices needed a second operation, known as a revision, J&J officials said in a statement announcing the recall.
Other medical-device makers have faced costly product- liability cases in the past over hip-replacement systems.
$1 Billion Settlement
Sulzer AG agreed in 2001 to a $1 billion settlement of suits alleging hip and knee implants made by its former Sulzer Medica unit were defective. Sulzer, the world's second-largest maker of pumps, is based in Winterthur, Switzerland.
The unit, based in Austin, Texas, began recalling hip implants in January 2001, saying they could loosen. Of the 31,000 patients who received the implants, more than 2,700 have had them replaced. More than 560 had knee implants replaced.
In Brigham's case against J&J and DePuy, the construction worker received two Acetabular hip replacements, according to the suit, filed by Dana Taschner, a Los Angeles-based lawyer who handles product-liability cases.
The 52-year-old Brigham, of San Bruno, California, suffered "pain, swelling inflammation, infection and damage to surrounding bone and tissue" due to defects with the hip- replacement mechanisms, the suit contends.
Brigham had one of the devices removed last month, but hasn't been able to get a replacement, the suit said. That's left him unable to walk, the suit added.
The case is Brigham v. DePuy Orthopaedics Inc. 10-CV-3886, U.S. District Court, Northern District of California (San Francisco).
Article by Jef Feeley, Bloomberg