Sunday, March 16, 2014

A hell of a mesh

J&J Lawsuit Sheds Light on Link Between Doctors and Device Makers

Johnson & Johnson

One lawsuit taking legal precedence on Johnson & Johnson’s (NYSE:JNJ) docket dates back to March 2005, when the pharmaceutical giant’s Ethicon unit introduced the Gynecare Prolift transvaginal mesh device. Several years later, the company’s 2007 annual report touted the device as an “innovative and effective surgical option” for weakened pelvic muscles.

The problem was the U.S. Food and Drug Administration did not approve the device for another three years after its initial release. At the time, the company said it could market the Prolift without approval because it was so similar to an approved device called the Gynecare Gynemesh, FDA spokeswoman Morgan Liscinsky told Bloomberg in a March 2012 email. In 2007, the federal agency became aware of the Prolift when Johnson & Johnson sought regulatory approval for a related device. By May 2008, both devices had been cleared.

But while Gynecare Prolift was eventually approved by the FDA, lawsuits streamed in nonetheless. However, the implications of Johnson & Johnson marketing the device without government approval are not just limited to the lawsuits — although this is not to say that devices or drugs that have been approved by the FDA never cause widespread problems.

Ethicon’s conduct raised questions about the FDA’s approval process and contributed to the storm of criticism raining down on the federal agency for recent high-profile recalls of devices like Johnson & Johnson’s hip prosthetics, also prompting Congress to consider changes to the system. But more important is what the unapproved release of the device says about the importance of relationships between pharmaceutical companies and doctors in marketing products: Doctors can be vital in providing or influencing the information consumers hear about medical products.

As of early 2014, at least 5,000 product-liability lawsuits have been filed againstJohnson & Johnson in New Jersey, and 15,000 have been filed in federal court. Plaintiffs and associated interest groups have argued that the transvaginal mesh devices, which are used to treat stress urinary incontinence and pelvic organ prolapse, have caused thousands of women to suffer, and in a few cases, die.

“They were initially able to put the Prolift on the market without even telling the FDA,” attorney Adam Slater, who is suing Johnson & Johnson on behalf of more than 100 women, told Bloomberg last year. “Even though Johnson & Johnson supposedly lives by a credo to put the patient first, this is an example of fast-tracking a product to market quickly rather than going to the FDA first.” Upon hitting the market, the transvaginal mesh became a popular alternative to a more invasive surgery procedure that props up organs that can protrude into the vagina, causing pain.

According to the FDA, approximately 75,000 women underwent the transvaginal mesh procedure. But then reports surfaced claiming that the mesh can shrink or erode from original placement, and numerous lawsuits began piling up. Johnson & Johnson pulled the mesh kits off the market in 2012.

Before the troubles began piling up, though, in 2007, Johnson & Johnson was working to grow demand for the devices. That was where the help and influence of medical professionals became necessary.

In the case of the Gynecare Prolift, the Wall Street Journal obtained emails and other documents related to the Ethicon lawsuits that Johnson & Johnson provided during the discovery process, which indicated that a physician paid by the pharmaceutical company as a consultant attempted to influence the language of treatment guidelines for pelvic organ prolapse published by a medical society in 2007.

The documents also show that Johnson & Johnson sought to change the language of a research paper on the mesh procedure that was published in the New England Journal of Medicine in 2011. At issue was the use of the world “experimental.” Emails revealed that Vincent Lucente — a well-known urogynecologist who was an advocate of the procedure and was paid $800,000 by Ethicon for consultancy work — was primarily responsible for wording changes in a piece published by The American College of Obstetricians and Gynecologists.

According to the Wall Street Journal, he told company executives that “no further use of the word experimental” should be made when explaining the procedure because the devices had been cleared by the FDA, according to the emails. He explained that the characterization of the product as experimental would scare off patients. ACOG’s initial bulletin, published in February 2007, said, “Given the limited data and frequent changes in the marketed products … the procedures should be considered experimental and patients should consent to surgery with that understanding.”

But then the publication began receiving emails, letters, and phone calls from members of the American College of Obstetricians and Gynecologists who took issue with the use of the word “experimental,” as the ACOG told the Journal. Johnson & Johnson denied any involvement in those objections to the publication.

The new guidelines were officially published several months later without the word “experimental.”

L. Lewis Wall, a urogynecologist and professor at Washington University, told theWall Street Journal that the speed of the turnaround was “unprecedented” and that it was likely related to the fact that insurers would not reimburse doctors for the mesh devices or the procedures if they were experimental.

It should be noted that financial relationships between the medical community and device manufacturers are both legal and commonplace. Johnson & Johson also told the Journal that the company is “confident the evidence shows that Ethicon acted appropriately and responsibly in the research, development and marketing of our pelvic mesh products, and will continue to vigorously defend all product-liability lawsuits concerning their use.”

Since 2009, Johnson & Johnson has faced a series of quality issues that have resulted in numerous recalls, withdrawing products ranging from certain hip-replacement parts to contact lenses to glucose meters to birth control pills. A recall is never a decision that a healthcare company wants to make, especially as lawsuits can stream in afterwards and sales are likely to collapse. To give perspective on how destructive recalls can be, manufacturing problems have cost the company hundreds of millions of dollars in lost sales while also damaging its reputation with consumers and leading the FDA to monitor some of its manufacturing plants.

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