J&J Coughs Up $3.4 Million for Bad Vaginal Mesh

J&J Coughs Up $3.4 Million for Bad Vaginal Mesh

February 25th, 2013 // 6:53 pm @

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In the latest sign of difficulty for Johnson & Johnson, a New Jersey state court jury ruled today that the health care giant must pay $3.35 million to a woman because its Ethicon unit failed to properly warn of the risks of a vaginal mesh implant and made fraudulent misrepresentations. However, the jury ruled that J&J did not defectively design the mesh implant or make fraudulent misrepresentations to the woman’s physician, Bloomberg Newsreports.

Nonetheless, the verdict was the first of more than 2,100 lawsuits to go to trial over claims that the Gynecare Prolift injured women and extends a series of setbacks – from court rulings and government probes to numerous product recalls and manufacturing problems – that have plagued J&J (JNJ) over the past three years and contributed to a stain on its corporate reputation.

Although defective hip implants and a failure to publicly disclose damaging failure rates have generated the most notice in recent months, J&J last summer halted marketing of four vaginal mesh implants, which are used to treat incontinence and pelvic organ prolapse in which internal organs slump into the vagina. An estimated 300,000 women have reportedly had the devices implanted and a steady stream of FDA alerts were issued.

As we reported previously, two years ago, the FDA issued a statement saying it is unclear whether prolapse implants provide any benefit over traditional surgery and noted a large increase in deaths and injuries. The MedWatch alert was made three years after the agency acknowledged a problem in a 2008 report that found complications were serious. Meanwhile, an FDA panel recommended the devices should be classified as high risk (back story).

In the New Jersey trial, Gross claimed that J&J failed to warn her and her doctor of the risks and made fraudulent misrepresentations, Bloomberg writes. Her lawyers said internal documents and e-mails showed Ethicon knew the mesh would cause pain and harm women, the news service continues, and that Gross “blamed the mesh for constant pain that makes it hard to sit and for subsequent operations to remove mesh that hardened.”

The payout is relatively modest, underscoring the likelihood that J&J will continue to fight the additional cases, although 2,000 cases at that price can add up. In any event, the health care giant is also likely to remain under a harsh glare as headline after headline appears as a reminder that J&J has turned out a wide variety of products that have either allegedly caused patient harm or simply were not up to standards and had to be recalled. The varied list also includes Tylenol and Motrin.

As an aside, the decision last year to halt marketing of the vaginal mesh implants also renewed attention on the FDA 501k approval process for devices, which is used to determine if a device is substantially equivalent to another marketed device and, therefore, requires little testing in patients. The US Government Accountability Office had recently criticized the FDA for failing to strengthen its approval and recall procedures.


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