The New Jersey Appellate Division affirmed in its opinion of a verdict of $11 million against Johnson & Johnson, makers of Prolift urogynecological mesh, to a woman who suffered from a “catastrophic reaction” to the mesh according to her doctor.
Evidence presented in the case indicates that back in 2005, the company was preparing to roll out its Prolift product when a French physician who worked for Johnson & Johnson sent an urgent email to the company’s product director in the U.S. According to the doctor, there was clinical evidence that Prolift mesh occasionally eroded through the walls of the vagina in women implanted with it. The email further stated that there was a tendency for the mesh to retract and could interfere with a patient’s ability to have sex. The French physician suggested that cautionary language should be included in the product information for potential complications that came with the implantation of the Prolift urogynecological mesh in women who had hysterectomies but were still sexually active.
The company decided not to include the warning in the accompanying product literature because the copy for the printouts had already been sent to the printer. The company, according to sworn testimony that was given by a witness for Johnson & Johnson, did not want to go to the added expense and the potential delay of having to revise and reprint the materials. The company may have intended to add the cautions later, but failed to do so until 2008.
This decision proved to be too late for South Dakota nurse, Linda Gross. Gross was diagnosed with pelvic organ prolapse in 2006 after a hysterectomy when she was 41 years old. Gross and her physician discussed her condition and both concluded that Prolift was the best option available.
Gross’ reaction to the mesh caused severe pain and debilitation and has made it so that she can no longer have sexual relations with her husband. In her case that was brought before a New Jersey Superior Court in 2013, Gross said that she would not have chosen Prolift if she had been aware of the risks. Gross’ physician who performed the surgery also indicated that he recommended Prolift based on the information Johnson & Johnson provided. He said that he would not have recommended it if he had known of the additional warning that was brought up by the French physician.
The panel of Judges which consisted of Judge Clarkson Fisher, Marianne Espinosa and Garry Rothstadtis rendered a 68-page decision that said the company made an ill-considered choice of disregarding the warnings from the French doctor concerning the adverse clinical results that were a clear cause for concern.
Johnson & Johnson ceased the sale of Prolift in 2012 and has introduced other products to market for the treatment of prolapsed and urinary incontinence. Johnson & Johnson, unlike other pelvic mesh manufacturers Boston Scientific and C.R. Bard, has not reached a settlement with mesh plaintiffs which number in the thousands. However, the company did indicate in January a $120 million deal to resolve any claims on behalf of as many as 3,000 women.
That may not be the end of it, however. Johnson & Johnson and its products may have potentially harmed tens of thousands of women. It may mean that the damage caused by mesh implants they produced may total to hundreds of millions of dollars through class action and personal injury lawsuit claims that are likely to still be filed.
If you or someone you know has been injured as a result of the implantation of urogynecological or transvaginal mesh, then contact the law offices of John Foy & Associates. At the “Strong Arm” attorneys, we will evaluate your case and help you get the compensation that you deserve.