The Next Medical Device Flap: Vaginal Mesh

As problems surface with the implants, lawsuits are mounting

"The FDA notification brought it to the attention of a lot of lawyers" Marci Sutin Levin says U.S. regula- tors failed her by not requiring exten- sive testing before allowing Johnson & Johnson to sell the type of surgical mesh implanted in her in 2007 to hold her pelvic organs in place. Now the 65-year-old New York marketing exec- tive says she can't work, sleep through the night, or have sex with her husband due to endless pain worse than that of natural childbirth. "The pain of child- birth was finite, and you're delivering a child," Levin says. "This was very, very different. It's relentless, and it's unten- able. And it doesn't lead to anything." Levin has filed one of about 270 law-suits pending against J&J. In all, about 600 suits have been filed against it and other mesh makers, including C.R. Bard, Boston Scientific, and American Medical Systems, acquired in June by Endo Pharmaceuticals Holdings. The U.S. Food and Drug Administration warned on July 13 of a fivefold increase in women suffering pain and injuries after surgeons inserted mesh through vaginal incisions Last week an advisory panel agreed with FDA staff that the agency should reclassify mesh from moderate risk to high risk of harming patients if it fails, and require more studies to determine if it's safe and effective. Personal injury lawyers say they expect a surge in lawsuits by women responding to ads about the dangers of transvaginal mesh for "pelvic organ prolapse." This refers to a condition in which organs like the bladder bulge, or prolapse, into the vagina. "We're getting an amazing number of calls," says attorney Bryan F. Aylstock of Aylstock, Witkin, Kreis & Overholtz in Pensaco-la, Fla. "The FDA notification brought it to the attention of a lot of lawyers who were doing other things and to women who had been suffering in silence." So far, none of the cases have gone to trial, and women must prove their claims that mesh makers knew of safety S risks and failed to disclose them and that the products were defective. An industry group whose members include J&J, Boston Scientific, Bard, and American Medical Systems told the FDA advisory panel last week that using mesh in trans-vaginal procedures is safe and effective and serious injuries are rare. J&J spokesman Matthew Johnson says it's too early to comment on the potential impact of mesh lawsuits, but that the company is willing to conduct studies of the devices to ensure doctors and patients have "in-formed access to treatment options."Boston Scientific and Bard in statements defended mesh as a valuable option for women. American Medical Systems didn't return a call for comment. About 300,000 women in the U.S. had pelvic organ prolapse surgeries last year, including more than 70,000 who received vaginal meshes. Between 2008 and 2010, the FDA received 1,503 reports of injuries or malfunction, a fivefold increase from 2005 to 2007. Concern over mesh safety is slowing; the pace of implants, says Mike Matson, an analyst at Mizuho Securities USA. Bard, which estimated the global prolapse mesh market at $175 million, saw its own pelvic prolapse business fall about 30 percent in 2010 due to what it called "regulatory delays" on product approv-als. Matson says J&J is the global leader in prolapse mesh, followed by American Medical Systems, Boston Scientific, and Bard. He figures mesh products represent no more than 2 percent of any of the makers' sales, limiting financial risk. Still, the suits are another high-profile controversy pushing the FDA toward toughening its approval process for devices, Matson says. As moderate risk devices, vaginal meshes currently need only show that they are "substantially equivalent" to existing products. A change to a high-risk status would require tests to show efficacy and safety. David Voreacos and Alex Nussbaum The bottom line Medical device makers face litigation for failure of vaginal meshes used to support pelvic organs. More than 600 suits have been filed.

1. There are two category of torts, intentional or unintentional. Explain the difference between the two:

2. List and explain the 3 categories of unintentional torts that a business could face.

3. Explain how a business can do to avoid each type of unintentional tort.

4. List & Explain the 2 types of intentional torts that a business could face.

5. Which type of tort action one do you think will be brought against Johnson & Johnson in this case of surgical mess? Explain your answer

6. What is negligence? Not all parties in a case will be found equally negligent, with that in mind list all the parties that could be seen as negligent in this case?

7. What are the 3 elements that must be addressed in any tort action?

8. In this case, the "surgical mesh" that is being used to hold internal organs in place is resulting possible quantifiable harm. List the events that a lawyer preparing this case, could be indentify as quantifiable harm?

9. List the 4 common ways a company could defend a tort action that is brought against it.

10. Explain how Johnson & Johnson could apply each of the methods of defense outlined in the previous question to defend a potential tort action brought against them.

11. Which method of defense would you recommend to Johnson & Johnson, in order to give them the greatest chance of success or to minimize their exposure? Give reasons for your answers.

12. Explain the difference between pecuniary damages and non-pecuniary damages.

13. List and explain using Marci Levin's case as an example the types of pecuniary damages that could be awarded.

14. List and explain using Marci Levin's case as an example the types of non-pecuniary damages that could be awarded.