In February 2013, a jury panel consisting of 6 women and 3 men awarded $3.35 million in compensatory injuries and $7.76 in punitive damages to a woman who experienced severe injury from a Johnson & Johnson Gynecare Prolift product. The Plaintiff underwent 18 operations after the product was implanted to assist with weakened pelvic muscles.
Johnson & Johnson alleged that its Prolift product was safe and that adequate warning had been provided to Plaintiff and doctors regarding the risks associated with the device. However, Plaintiff’s attorneys demonstrated that Johnson & Johnson’s own emails, memorandums and marketing material stated that complications were rare and minor. Shockingly, the trial uncovered that Johnson & Johnson’s advertising and marketing expenses were $20.9 billion last year, approximately $57 million a day.
This verdict comes after years of concern regarding the use of this pelvic mesh in women for stress urinary incontinence and pelvic organ prolapse. The FDA issued two warnings, one in October 2008 and another in July 2011. Manufacturers rushed these products to the market without performing the proper clinical testing. As demonstrated by the $20.9 billion spent by Johnson & Johnson in marketing, more emphasis was put in advertising these products to gynecologists and urologists than ensuring that they were safe and effective.
As the Plaintiff, a South Dakota nurse, testified in this case, she underwent many painful and difficult surgeries to remove the mesh that had been implanted and it drastically changed her life. Had she or her doctor been warned about the risks associated with the product, she never would have consented to have it implanted. Women all over the country have voiced the same story.
These cases have demonstrated that device approval requirements need to be changed. In some of the most disturbing cases, manufacturers based their approval of the mesh and sling products on devices that had been recalled. For example, Johnson & Johnson’s Tension-free Vaginal Tape (TVT) approval was based on the design of a recalled Boston Scientific product, ProteGen. Protegen was approved in 1996 and was taken off the market in 1999 as a result of women experiencing horrific side effects including erosion and pelvic pain.
Currently, there are approximately 4,000 lawsuits pending over Johnson & Johnson’s mesh and sling products. However, more cases are expected to be filed given the widespread use of these products in women with pelvic organ prolapse and stress urinary incontinence.