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Shezad Malik MD JD
Shezad Malik MD JD
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J&J Ethicon Under Fire by States over its Mesh Device Injuries

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There are over 100,000 vaginal mesh injury lawsuits pending nationwide, involving claims that women suffered painful and serious side effects/complications after receiving pelvic mesh products sold by Johnson & Johnson (J&J), American Medical Systems (AMS), Bard, and Boston Scientific among others.

Vaginal Mesh Lawsuits

Vaginal mesh and bladder slings for uterine prolapse and urinary incontinence lead to pain, further surgery, recurrence of symptoms and erosion of the devices through soft tissue.

Now J&J, the largest mesh manufacturer and its subsidiary Ethicon are exposed to consumer fraud claims filed by the state Attorneys General in Washington and California.

Both states’ Attorneys General allege that J&J and Ethicon broke consumer protection laws by failing to warn about the risk of complications from transvaginal mesh and bladder sling products. Furthermore the states allege that the company participated in deceptive and misleading advertising for the surgical products used to treat pelvic organ prolapse and stress urinary incontinence.

Washington Attorney General Hammers Johnson and Johnson

According to Washington Attorney General Bob Ferguson, “It’s difficult to put into words the horrific injuries and pain many women are still suffering as a result of Johnson & Johnson’s deception, they believed they were making informed medical decisions, but that was impossible when Johnson & Johnson was spreading inaccurate information about its products’ risks, essentially duping doctors into using their own patients as clinical trials. this is an unacceptable way of doing business, and I will hold the company accountable.”

The Washington state complaint alleges that about 12,000 mesh devices were sold in that state. About 42,000 were sold in California, which led a multistate investigation into Johnson & Johnson’s surgical mesh activities.

California Attorney General Hammers Johnson and Johnson

According to California Attorney General Kamala Harris, “Johnson & Johnson put millions of women at risk of severe health problems by failing to provide critical information to doctors and patients about its surgical mesh products, Johnson & Johnson’s deception denied women the ability to make informed decisions about their health and well-being.”

Failure to Warn about serious side effects

The lawsuits allege that the mesh maker failed to provide adequate warning of complication risks and used shoddy plastic materials that could house bacteria indefinitely, cause inflammation, and erode through vaginal walls and other soft tissue.

Severally Injured Plaintiffs

A doctor sent an email in 2009 to Johnson & Johnson that said, “I am currently getting a patient to the OR who had an anterior and posterior prolift implanted by another physician. She will likely lose any coital function as her vaginal length is now 3cm, and there is mesh extruding literally everywhere… This patient will have a permanently destroyed vagina.”

Over 100,000 Permanently Injured Women

Similar allegations are presented in more than 35,000 Ethicon vaginal mesh lawsuits filed on behalf of women who suffered severe injuries and against other mesh manufacturers.

FDA Mesh Warnings

The number of injury and product liability cases began to rapidly increase after July 2011, when the FDA warned that it had received thousands of adverse event reports involving problems with vaginal mesh products between January 2008 and December 2010.

The FDA announced that there was no evidence that transvaginal mesh provides any benefits when compared to more traditional surgery for treatment of pelvic organ prolapse.

In 2012, the FDA notified mesh manufacturers that they had to conduct studies to evaluate the safety of transvaginal mesh products, and demonstrate whether they pose an unreasonable risk of injury.

The mesh manufacturers responded by discontinuing the mesh devices and avoid studying the safety of products they have sold with impunity for years without any safety testing.

Vaginal Mesh Litigation Update

After several bellwether trials, some of which resulted in significant multi-million dollar damage awards, most of the manufacturers have begun to settle vaginal mesh lawsuits involving their products. J&J has been one of the remaining hold-outs, and continues to push hundreds of cases toward trial.

J&J is facing several large “waves” of Ethicon mesh cases that are being prepared for trial dates over 2017.