New Jersey Trans Vaginal Mesh (Prolift) Trial Begins



By Jill Smith Esq.

On Thursday, January 10, 2013, the trial of Linda Gross v. Johnson & Johnson, et al., opened in Atlantic City, New Jersey, before a jury of six women and four men. The trial will be closely watched as the first bellwether to proceed among the centralized cases pending in the Superior Court of New Jersey and as the first trial to proceed nationwide against Johnson & Johnson regarding its Prolift mesh product.

Plaintiffs’ opening statements were given by her counsel, Adam Slater of Mazie, Slater, Katz & Freeman. The plaintiff, Linda Gross, had Johnson & Johnson’s Prolift product implanted to correct a rectocele in 2006. Mr. Slater highlighted Linda’s generally healthy condition at the time of the implant surgery – she was coping with an inconvenient functional disorder, and certainly not a life threatening situation. After the implant surgery, however, the plaintiff has suffered through a staggering 18 corrective surgeries and, for the rest of her life, will be forced to catheterize herself to void urine. The plaintiff, presently in her fifties, cannot escape the constant pain as a result of nerve damage which prevents her from even sitting comfortably for more than brief periods of time.

Mr. Slater explained to the jury the regulatory path of the Prolift and the evolution of polypropylene mesh products in surgical procedures. In detail, and using the words of the companies’ own employees, Mr. Slater indicated that the defendants understood the nature and likelihood of the exact type of risks that Linda would suffer – namely, mesh shrinkage and mesh erosion. Moreover, according to Slater the defendants understood that these risks existed in the months and years before the product was released on the market and before the product was implanted in the plaintiff. Despite this, plaintiff alleged that the defendants failed to adequately test and study the product or to even communicate what it knew about these risks to the medical community and to the ultimate users, women suffering from pelvic organ prolapse. Moreover, Slater argued that the defendants grossly understated the risks of these products, including mesh shrinkage and mesh erosion.

Mr. Slater also highlighted the plaintiff's position concerning the defective design of the Prolift, explaining to the jury how it was understood by the defendants that the mesh did not meet the design criteria required for its safe and effective use. For example, although the pore size of the mesh was understood to be critical to ensuring its biocompatibility, the defendants knew that it could not guarantee pore size of the mesh would not be changed after its implant. Moreover, according to plaintiff, the mesh was designed specifically to be integrated into the surrounding tissue, which meant that when and if complications arose from the mesh, it would require invasive and dangerous surgical procedures to remove it. Although the defendants understood these critical failures, the defendants still pushed to release the defective product to the market again without testing the product, considering an alternative design of the product, or communicating these risks and dangers to the medical community and to women.

Christy Jones of Butler, Snow, O’Mara, Stevens and Cannada, PLLC, opened for the defense. Ms. Jones asked the jury to focus on two things. First, why was the Prolift surgery chosen for Ms. Gross? Second, was the outcome worse because the surgery involved mesh?

Ms. Jones focused on the plaintiff’s condition at the time of her implant surgery and claimed, in contrast to Mr. Slater’s representations, that the plaintiff suffered from a serious rectocele for which a Prolift surgery was the best option. Ms. Jones also claimed that the plaintiff’s initial surgery was a success because it corrected the plaintiff’s serious rectocele.

Notably, Ms. Jones did not explain the many corrective surgeries that the plaintiff was forced to undergo or the mesh fragments that had been repeatedly removed from her body (some of which had been photographed and which Mr. Slater showed the jury during his opening statement). Ms. Jones did, however, point out that the plaintiff had undergone some surgeries in which nothing was found to be wrong with the mesh at all.

Ms. Jones stated that mesh surgeries have shorter recovery periods and lower recurrence rates. Ms. Jones represented to the jury that as high as a 95% success rate has been demonstrated for mesh procedures, and that the defendants offered a number of training options for doctors, including lectures and cadaver labs.

According to Ms. Jones, polypropylene mesh products have been used in the body for over 50 years and have been demonstrated to be safe. Ms. Jones explained the relationship between hernia surgeries and the understanding in the surgical community that pelvic organ prolapse is similar in nature to a hernia, making hernia mesh a natural choice for this procedure. Ms. Jones claimed that, in contrast to Mr. Slater’s representations, the Prolift had been extensively studied before its release unto the market.

Finally, Ms. Jones focused on the warnings contained in the physicians’ Instructions for Use (IFU) and the patient education brochure for the Prolift, which she claimed to contain adequate warnings because both referenced a risk of erosion, dyspareunia (painful sex), and mesh contraction (shrinkage) among other things. She stated that Ms. Gross’s implanting doctor, and Ms. Gross herself, were aware of these risks because they were communicated in the IFU and in the patient brochure which Ms. Gross read.

Jillian A.S. Roman, Esq.

C / P / R

Cohen, Placitella & Roth, P.C.

Two Commerce Square

2001 Market Street, Suite 2900 / Philadelphia, PA 19103

215.567.3500 / 215.567.6019 (fax)