Tuesday, March 12, 2013

Johnson & Johnson Falls under Federal Scrutiny for Marketing Practices Related to Metal-on-Metal Hip Implants

Almost everyone is familiar with Johnson & Johnson—after all their reach extends to virtually every industry in the medical sector. Unfortunately, the warm and fuzzy feelings many of us have regarding J & J as a result of their marketing of baby products is fading fast amidst the recent rash of recalls and lawsuits.

Overseas Recall of the Adept Hip Implant

Recently J & J issued a recall on yet another hip implant, the Adept all-metal hip implant. The Adept was recalled overseas because of a much higher-than-expected rate of failure of a specific part which then required replacement. On February 22nd 2013, Johnson & Johnson suffered yet another blow after finding out that both the U.S. Justice Dept. and the U.S. Attorney’s Office were looking into dubious practices related to marketing of hip implants by their subsidiary, DePuy.

DePuy’s ASR Recall

DePuy is the manufacturer of the recalled ASR metal-on-metal hip implant and is currently attempting to defend themselves from well over 8,000 lawsuits across the nation. Many of these lawsuits have been consolidated into a multi-district litigation in order to allow plaintiffs to have a quicker resolution. The first DePuy trial is currently underway in Los Angeles Superior Court. This case involves Loren Kransky, a 65-year-old retiree who alleges he suffered extreme health complications and side effects after receiving an ASR hip implant. Evidence in the case suggests DePuy placed the ASR on the market even though they were aware of specific safety hazards involved with the implant. 

Recalls of Over Thirty Products

In the past 3-4 years, Johnson & Johnson has recalled more than thirty of its products, with the ASR being recalled in August of 2010 after extremely high numbers of failure rates. DePuy claimed at the time of the recall the failure rate of the ASR was 12%, however Bloomberg reports that number to be closer to 40%. It is estimated that more than 90,000 ASR implants were recalled in the U.S and overseas. DePuy and J & J are also under fire for the DePuy Pinnacle metal-on-metal hip implant which, though still on the market is also the target of lawsuits from recipients claiming harm from the implant. While the all-metal implants were expected to last from 10 to 20 years, where the ASR implants are concerned, one in eight patients require revision surgery within five years of their original implant.  

The Legal Impact

Legally speaking, since the Adept’s recall does not affect products sold in the U.S., Johnson & Johnson will likely not have to repeat the over $900 million already spent fighting and settling ASR lawsuits. The number of Adepts implanted is also much smaller—approximately a tenth as many as the ASR. Considering that orthopedics sales make up more than a quarter of J & J’s medical device revenues and approximately 11.6% of their total company revenues. Despite J & J’s tougher stance in dealing with Pinnacle claims as compared to the ASR settlements, doctors and surgeons continue to back away from recommending a Pinnacle implant—or any metal-on-metal hip implant—to their patients.

Further Problems for J & J

Although Johnson & Johnson is hardly the only company suffering recall problems from their line of metal-on-metal hips, they have likely taken the biggest hit to their former sterling reputation. Despite the troubles suffered by Johnson & Johnson, they remain the largest player in the health care industry. Back in 2007, Johnson & Johnson agreed to pay over $80 million dollars in fines following an investigation alleging kickbacks. Johnson & Johnson, along with four other corporations involved in the manufacturing of artificial hips and knees, were charged with offering payoffs to surgeons in order to ensure the surgeons used their artificial implants rather than others.     

It is likely we will be hearing more about the troubles suffered by Johnson & Johnson as time passes. Closing arguments on the Kransky case were given on March 1st, and the outcome of that first ASR trial will likely be critical to how the remainder of the cases will go. The consolidated MDL trials for the ASR are scheduled to begin on May 6, 2013. Thousands of other plaintiffs have chosen to go before a state court, so Johnson & Johnson may have to continue its legal maneuvering for quite some time to come.

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