J & J Execs to be Deposed About Vaginal Mesh - What Did They Know - When Did They Know It

Alex Gorsky, CEO J & J

July 29, 2012 ~ Johnson & Johnson’s new CEO is on the hot seat. Alex Gorsky must show up to provide a videotaped deposition concerning the upcoming Ethicon transvaginal mesh lawsuits pending before a New Jersey Superior Court.

Ethicon is a wholly owned subsidiary of Johnson & Johnson.

The decision to require Gorsky and two other executives to testify was made by the Honorable Carol Higbee, an Atlantic County Superior Court judge who is overseeing more than 1,000 mesh cases reports Digital Journal (here).

The ruling was issued July 19, 2012, one day before a landmark ruling in another mesh case in California against C.R. Bard that resulted in a $5.5 million favorable verdict for a Bakersfield woman injured by a transvaginal sling.

Former J & J Vice Chairman and current Avon CEO Sheri McCoy, and Ethicon Franchise head, Gary Pruden must also be produced for videotaped depositions in connection with vaginal mesh litigation. McCoy has a chemical engineering and M.B.A.background who was vying for the J & J CEO job which went to Gorsky last April.

The complaint filed by Plaintiffs' attorneys (here) lays out the case against Ethicon.

Sheri McCoy, CEO Avon

Judge Higbee has also ordered executives’ computers be searched and any relevant information be turned over to lawyers for plaintiffs before the deposition are scheduled. Former J&J CEO Bill Weldon will be deposed if there is any information uncovered in an electronic search of his computer that is relevant to the question of what executives knew about the complications concerning vaginal mesh and when they knew it.

What Did They Know - When Did They Know It

While J & J lawyers argued that executives have little knowledge of the dangers of transvaginal mesh, the depositions may reveal just how high up in the corporation the marketing of transvaginal mesh continued despite the numerous defective product calls that have been reported to J & J as well as the FDA.

Ethicon's Women’s Health and Urology makes Gynemesh products for the treatment of pelvic organ prolapse (POP) and stress urinary incontinence (SUI) which uses Prolene Mesh, the proprietary name for polypropylene, a petroleum product used to make hernia and gynecological mesh.

The Litigation

In September, 2005, the company began to market and sell a mesh known as Prolift, used for anterior, posterior or total repair. By 2008, Ethicon began marketing a mesh known as Prolift +M, a total repair system. Ethicon also markets TVT for stress incontinence as well as TVT-O, and TVT-S.

Ethicon continues to market surgical vaginal mesh products to the medical community as safe, effective and reliable however the complaint (here) says that contrary to the representations, Ethicon’s pelvic mesh products have a high failure, injury and complication rate, resulting in irreversible injuries, re-operations and the company has failed to design and establish a safe, effective procedure for the removal of mesh.

“The Defendants intentionally, recklessly, and maliciously misrepresented the safety, risks, and benefits of the Defendants’ Pelvic Mesh Products, understating the risks and exaggerating the benefits in order to advance their own financial interests, with wanton and willful disregard for the rights and health of the Plaintiffs.”

The plaintiffs' lawyers say Ethicon violated state consumer laws that protect the public from

“unfair, deceptive, fraudulent, and unconscionable trade and business practices and false advertising, by knowingly and falsely representing that the Defendants’ Pelvic Mesh Products were fit to be used for the purpose for which they were intended, when in fact they were defective and dangerous, and by other acts alleged herein. These representations were made in marketing and promotional materials.”

“Defendants had actual knowledge of the defective and dangerous condition of the Defendants’ Pelvic Mesh Products and failed to take any action to cure such defective and dangerous conditions.”

Gorsky Compelled to be Deposed in Risperdal Case

Lawyers for J & J said insisted Gorsky has no knowledge but lawyers for the Plaintiff say, a court should prevent the deposition of a high-ranking corporate official only “when it is clear that the information which plaintiff wants is available through other employees. J & J cannot meet this high standard.”

In January 2009, Mr. Gorsky testified in a Texas state court case in which it was alleged that J &J marketed the antipsychotic drug, Risperdal, for off-label uses.

In April of this year, the U.S. Department of Justice filed a motion to compel the deposition of Mr. Gorsky in litigation involving Risperdal, illegally marketed to nursing homes for dementia patients and marketed for off-label use. Mr. Gorsky was the VP of Marketing for Janssen, the pharmaceutical division that oversaw Risperdal which was distributed off-label through Omnicare, a healthcare provider that allegedly received illegal payments from J & J to use and recommend Risperdal.

The company was fined $1.1 billion after the Department of Justice found it was hiding dangers of the drug and illegally marketing it for off-label uses.

BusinessWeek (here) has more on the DOJ deposition.

More background on Bill Weldon in this NYT piece, February 24, 2002 (here).

MDND background story on Alex Gorsky (here).

ATRA Calls Atlantic County Superior Court a Judicial Hellhole

The American Tort Reform Association, an anti-lawyer, pro-business interest lobbying group in 2009 ranked the Atlantic County Superior Court, where Judge Carol Higbee presides, the fourth worst Judicial Hellhole in the country (here). In 2011 its ranking lowered to the Watch List. Since drug companies make up the backbone of the New Jersey economy, they are particularly sensitive to losses in state courts. ATRA calls this “unfair treatment” which earns the state court ranking.

ATRA is about (here) supporting business and the lobbying group says lawsuits are bad for business, especially when the injured party, the plaintiff, wins. #