Johnson & Johnson DePuy Unit Recalls Hip ImplantsAug 27, 2010 | Parker Waichman LLP
Beleaguered pharmaceutical giant, Johnson & Johnson (J&J), is issuing yet another recall this year; it’s tenth. This time, the recall is through J&J’s artificial joint business, DePuy Orthopaedics Inc., said the Associated Press (AP).
DePuy Orthopaedics confirmed it’s recalling its ASR Hip Resurfacing System and ASR XL Acetabular System, two of its hip replacement products, said the AP, which added that both devices indicated “higher-than-expected” incidences of repeat surgery, according to emerging data.
The recall comes as no surprise. In June we wrote that some orthopedic surgeons were souring on metal-on-metal hip implants. A survey at that time found that a significant number of surgeons 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. But, recently, metal-on-metal hip implants have received some bad press.
Hip implants should last about 15 years; however, a New York Times investigation published earlier this year found that, in many cases, metal-on-metal hip implants require replacement surgery within a year or two. According to the report, studies indicate that hip implants can quickly 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 Orthopedics warned that one of its hip implant devices appeared to have a high early failure rate. According to U.S. Food and Drug Administration (FDA) records, since early 2008, it received about 300 complaints on the ASR involving patients in the U.S. 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.
We recently wrote that J&J—also through its DePuy Orthopaedics division—received a warning letter from the FDA stating it is illegally marketed two products. In this case, the issue was with how the firm advertised its TruMatch Personalized Solutions System without marketing clearance or approval and in violation of the Federal Food, Drug, and Cosmetic Act. TruMatch is a CT scanner that provides three-dimensional images of a patient’s knee prior to implant surgery, said Daily Finance.
Meanwhile, J&J is facing significant legal and government fallout and over its recalls of children’s Tylenol and other over-the-counter medicines. In addition to a federal subpoena from the U.S. Attorney’s Office for the Eastern District of Pennsylvania, Congress is also investigating the recalls, which have spawned numerous lawsuits. The FDA’s Office of Criminal Investigations is looking at the McNeil recalls, with executives testifying for a Congressional committee, said Daily Finance. And, according to CNNMoney sources, the FDA might bring criminal charges against executives at those J&J companies that issued recalls over manufacturing violations, added Daily Finance.
In a filing with the Securities and Exchange Commission (SEC), J&J disclosed it received multiple subpoenas from federal prosecutors requesting documents “broadly relating to” both the recent recalls and inspections of two factories and said it received demands from multiple State Attorneys General Offices relating to the same issues.