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Eric T. Chaffin
Eric T. Chaffin
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Will a J&J Drug-Marketing Settlement Become the Second Largest to Date?

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According to a recent article in The Wall Street Journal (June 20, 2012), Johnson & Johnson (J&J) and the U.S. Justice Department are close to settling a government investigation into the company's marketing practices related to the antipsychotic drug, Risperdal. The Justice Department has been looking into J&J's promotional activities of Risperdal since 2004, a part of the government's aggressive stance on marketing violations.

Should the settlement go through, it is estimated to become one of the highest sums to date in a drug-marketing case, second only to Pfizer's $2.3 billion off-label marketing deal from 2009.

J&J Planning to Pay

In addition to claims concerning off-label promotion of Risperdal, the deal would also conclude probes into the illegal marketing of Natrecor, a treatment for congestive heart failure, and Invega, another antipsychotic drug. In addition, it would include a wrap-up of whistleblower lawsuits alleging J&J paid kickbacks to nursing home pharmacy provider Omnicare to boost sales of Risperdal, Levaquin (an antibiotic), and Procrit (used to treat anemia).

The deal would also resolve civil claims, and would include claims from some states, which allege that J&J improperly marked Risperdal for non-FDA-approved patients and conditions. According to The Wall Street Journal article, experts are estimating the potential settlement to total at least $1.5 billion, while Bloomberg reports it could reach as high as $2.2 billion. The settlement may include a criminal fine up to $600 million.

Other Settlements Paid by J&J

A settlement in this investigation could put to rest many of the legal battles J&J is involved in right now, but there will still be many more to come. The company is facing thousands of lawsuits alleging injuries from its DePuy ASR hip system and DePuy Pinnacle hip system, both of which have been linked to injuries like premature loosening, hip implant failure, and metal poisoning. Consolidated litigation for the ASR is currently proceeding in the Northern District of Ohio, while the Pinnacle MDL is ongoing in the Northern District of Texas.

The company has also paid out millions in settlements to thousands of women allegedly injured by the Ortho Evra birth-control patch. Plaintiffs allege suffering from deep vein thrombosis, pulmonary embolism, heart attacks and strokes. Meanwhile, the U.S. District Court, Southern District of West Virginia, is gearing up to hear Gynecare vaginal mesh lawsuits, made by another J&J subsidiary – Ethicon.

Women who were implanted with the mesh for the treatment of pelvic organ prolapse and/or stress urinary incontinence have complained of serious injuries including pelvic pain, infections, bleeding, and mesh erosion and protrusion, which can require additional corrective surgeries. On June 4, 2012, J&J announced that it was discontinuing sales of four Gynecare transvaginal mesh devices, including the Gynecare Prolift and Gynecare TVT Secur.

In 2009, Pfizer, Inc. agreed to pay $2.3 billion to settle the investigation into their illegal promotion of the pain drug Bextra and other medications. This, so far, has been the largest penalty paid to date by a drug maker for illegal marketing.