So maybe you’ve heard the news that Washington and California recently sued Johnson & Johnson for misrepresenting the safety of its transvaginal mesh (or “pelvic mesh”) products. I pulled the Washington lawsuit and read it. It is alarming. If Washington can prove the allegations in the complaint, it will be a damning indictment of Johnson & Johnson and the pelvic mesh industry generally.
The Washington Lawsuit
States can sue companies on behalf of their injured citizens. If the state’s attorney general decides that a “bad act” is harmful to enough citizens, her office can file a lawsuit on behalf of the state and the group of people who were injured. It is an important consumer protection function provided by the states. This is what happened in Washington and California a few days ago. The Washington Attorney General reported that 11,728 transvaginal mesh products were sold (and implanted) in women in the state. The attorneys general in those states filed suit against Johnson & Johnson and made a series of chilling allegations against the company for its marketing of transvaginal mesh.
Let’s look at some of the key allegations in the Washington State lawsuit. When I refer to “Defendants,” I mean Johnson & Johnson, Ethicon, Inc., and their related companies, who made and marketed several types of transvaginal mesh.
- Defendants misled consumers through informational and marketing materials that misrepresented the safety and effectiveness of transvaginal mesh. (Complaint, p. 7)
- Defendants did not conduct human trials prior to the initial sale of transvaginal mesh. (p. 10)
- Defendants destroyed the underlying data they claimed supported the safety and effectiveness of their original mesh products. (p. 11)
- Defendants misrepresented the safety history of the transvaginal mesh to doctors. (p. 11)
- Defendants made misrepresentations about the mesh directly to consumers through advertisements, brochures, and other marketing materials. (p. 11)
- Defendants’ marketing materials failed to disclose the possible health complications from implantation of transvaginal mesh. These health problems include incontinence, defecatory dysfunction, dyspareunia (pain during sex), dysuria (pain while urinating), fistula, hematoma, hemorrhage, pain to partner during intercourse, permanent urinary dysfunction, recurrence, pain, UTI, urinary tract obstruction, vaginal scarring, and worsening incontinence. (p. 12)
- Defendants knew about these mesh health problems but did not report this information. (p. 12-13)
- Defendants’ Polypropylene Mesh Products present risk of chronic bacterial infection. These infections can occur years after the mesh was removed surgically. (p. 14)
- Polypropylene mesh degrades and oxidizes in the body over time. This can cause a reaction in the body which can cause chronic inflammation. (p. 14)
- The transvaginal mesh cannot be removed effectively when the medical device fails. (p. 15)
- Transvaginal mesh implantation may also cause cancer in women. (p. 15)
- Defendants knew about problems with sexual function and shrinkage at least as early September 2006, based on the discovery of a Johnson & Johnson internal document. (p. 15-16) Despite this knowledge, J&J sold thousands of mesh products after 2006.
- Defendants falsely claimed that their transvaginal mesh products were “FDA Approved.” (p. 16) Rather, the mesh products were cleared under the 510(k) equivalency process. (p. 17) I have written about the 510(k) process several times in this blog.
- Defendants failed to update informational and marketing materials. (p. 18)
Washington State’s Individual Claims Against J&J:
Washington State brought the following individual claims against Defendants:
- Misrepresentation and Omissions Regarding Safety
- Misrepresentations or Omissions Regarding Efficacy (the ability to produce a result)
- Failure to Update Information Provided to Consumers
The State of Washington asked the court to “decree” (to determine, conclude) that Johnson & Johnson engaged in all the bad acts listed in the complaint. It also asked that the court find that J&J engaged in “unfair and/or deceptive acts” in violation of that state’s consumer protection laws. Washington then asked for a permanent injunction which would prohibit Johnson & Johnson from selling transvaginal mesh products in Washington. It also asked for civil penalties for every violation of state law. And finally, Washington asked for “restitution to consumers.”
The Complaint is captioned: State of Washington v. Johnson & Johnson, et al. (Wash. Super. Ct., King Cty.), and is worth reading if you have the time.
Meanwhile, in California
Kamala Harris, Attorney General for California, also filed suit on behalf of California on May 25, 2016. Attorney General Harris stated that Johnson & Johnson sold almost 800,000 pelvic mesh devices nationwide between 2008 and 2014. According to AG Harris, 42,000 mesh products were implanted in California women during this period. On behalf of the citizens of California, Harris sued Johnson & Johnson, alleging false advertising and deceptive marketing of its transvaginal mesh. The lawsuit alleges that J&J failed to inform patients and doctors of possible severe complications and misrepresented the frequency of these risks.
Johnson & Johnson’s Blanket Denial of Wrongdoing
Remarkably, despite more than a hundred thousand serious injuries, thousands of lawsuits, millions paid in jury verdicts and settlements, Johnson & Johnson still contends the mesh product is safe and is the preferred treatment for certain female health issues. According to the Wall Street Journal, Johnson & Johnson responded to the states’ lawsuit by stating, “the use of implantable mesh is often the preferred option to treat certain female pelvic conditions . . . .” As I’ve said before on this site, this blanket denial is a dangerous game for Johnson & Johnson to play, particularly when intentional misrepresentations are alleged.
An injured person often feels powerless when facing a huge corporation like Johnson & Johnson. And rightly so. No individual, standing alone, can absorb a long legal fight in the same way that a multi-billion dollar corporation can. But when a state gets involved, the fight gets fair. California and Washington can bring the full power of the state to the legal fight against J&J. These lawsuits are therefore a huge step forward in protecting women against future pain and injury from transvaginal mesh. I will keep you posted on key developments in both cases.
Note: Again, I am no doctor. Please call your doctor if you have transvaginal mesh implanted in your body and you have concerns about your health. The information in this post comes mostly from the State of Washington’s lawsuit, which is a public document. I encourage you to review it carefully for further information.