In 2009 Mary McGinnis was implanted with the Avaulta Solo Support System and Align Trans-Obturator Yrethral Support System, two pelvic mesh products manufactured and sold by C.R. Bard, Inc. and other defendants. Ms. McGinnis was implanted with these mesh products in an attempt to treat Ms. McGinnis’ stress urinary incontinence and to provide bladder support. Shortly after implantation of the mesh, Ms. McGinnis began having severe pains from nerve damage and pain during sex. She had to undergo several surgeries to attempt to correct the problems.

Ms. McGinnis and her husband filed suit in 2011, alleging that C.R. Bard knew the pelvic mesh was unsafe at the time the products were implanted in Ms. McGinnis, and that Bard failed to warn doctors about the dangers of the Avaulta and Align pelvic mesh. At trial lawyers for Bard argued that the Defendants met all industry standards and requirements for placing the Avaulta and Align mesh products on the markets.

Compensatory Damages

On April 12, 2018, after a four-week trial, the McGinnis family finally got some justice. The jury in New Jersey state court awarded $33 million in compensatory damages. These damages were broken down this way: Ms. McGinnis received $23 million for her specific injuries, medical costs, and pain and suffering, and her husband received $10 million for his derivative “loss of consortium” claim. (Let me add here that loss of consortium claims can be substantial in these kinds of cases, as one of the key mesh injuries is pain during sex, often leading to couples abandoning marital relations altogether. That kind of injury has real value for most couples.)

Punitive Damages

On April 13, 2018, the jury returned to court to consider whether to impose punitive damages on C.R. Bard. Plaintiffs’ lawyers argued that Bard acted “maliciously” and in “wanton and willful disregard” for the rights of Ms. McGinnis and her husband when Bard placed these flawed products in the market. Ms. McGinnis’ lawyers argued that corporate profits should never take precedence over the health of patients. Again, Bard lawyers countered that Bard complied with industry standards, that $33 million (in compensatory damages) was compensation enough, and that anyway the vast majority of of medical devices reach the market without clinical trials. Therefore, said Bard, the jury should not impose punitive damages.

The jury then awarded the Mary and Thomas McGinnis $35 million in punitive damages. The two-day verdict reached $68 million. Of course it can never repair Ms. McGinnis’ internal injuries, the pain she suffers during intercourse, or her incontinence, but the money may at least provide the best medical care going forward and some comfort as she grows older.

“Most Medical Devices Do Not Undergo Clinical Trials”

As noted above, this was one of the main arguments offered by attorneys for C.R. Bard and the other defendants. Because so many similar mesh products were already on the market, Defendants argued, clinical studies on these new products were not necessary.

This is crazy talk. Clinical testing is critically important for new medical devices. And this is a major problem in our medical device device industry. It goes like this: ‘because this new product, let’s say a metal-on-metal (MoM) artificial hip looks very similar to an older, metal on ceramic hip, we don’t need to test our MoM hip. Let’s just put it on the market now, without testing.’ (Over a decade later, ask the many thousands of people injured by MoM artificial hips whether clinical testing was unnecessary.) The same holds for pelvic mesh, IVC filters, artificial knees, and virtually all other medical devices.

This subject is too important to ignore. If a company wants to sell a product that is to be implanted in a human body, the company should do all that it can to ensure that the product is safe.

Fortunately, the Avaulta and Align mesh products implanted in Mary McGinnis have been taken off the market. But not before thousands of women were severely injured by these flawed pelvic mesh products. Thousands of cases have been filed and more trials are scheduled for 2018 and beyond. I’ll keep you posted.

Note: This post was drafted from review of several news reports on the McGinnis trial.

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.

more Key Allegations:

1. Defendants misled consumers through informational and marketing materials that misrepresented the safety and effectiveness of transvaginal mesh. (Complaint, p. 7)
2. Defendants did not conduct human trials prior to the initial sale of transvaginal mesh. (p. 10)
3. Defendants destroyed the underlying data they claimed supported the safety and effectiveness of their original mesh products. (p. 11)
4. Defendants misrepresented the safety history of the transvaginal mesh to doctors. (p. 11)
5. Defendants made misrepresentations about the mesh directly to consumers through advertisements, brochures, and other marketing materials. (p. 11)
6. 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)
7. Defendants knew about these mesh health problems but did not report this information. (p. 12-13)
8. Defendants’ Polypropylene Mesh Products present risk of chronic bacterial infection. These infections can occur years after the mesh was removed surgically. (p. 14)
9. 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)
10. The transvaginal mesh cannot be removed effectively when the medical device fails. (p. 15)
11. Transvaginal mesh implantation may also cause cancer in women. (p. 15)
12. 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.
13. 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.
14. 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:

1. Misrepresentation and Omissions Regarding Safety
2. Misrepresentations or Omissions Regarding Efficacy (the ability to produce a result)
3. 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.

The Takeaway

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.