The makers of Roundup just lost another big case, this time involving a couple who used the weedkiller and were later diagnosed with non-Hodgkin lymphoma. This month, a jury in California awarded Alva and Alberta Pilliod more than two billion dollars. The jury found that Monsanto and Bayer acted negligently and failed to warn the plaintiffs of the dangers of using Roundup. The key active ingredient in Roundup, glyphosate, has been shown in studies to increase the risk of developing non-Hodgkin lymphoma (NHL). The jury then awarded Mr. Pilliod $18 million in “compensatory damages,” which is a money award for actual injuries suffered. The jury awarded Ms. Pilliod $37 million in compensatory damages, for a total of $55 million in compensatory damages. Finally, the jury awarded the Pilliods $1 billion each in punitive damages. The final jury award was $2,055,000,000. A truly astonishing number, and a major rebuke to the makers of Roundup.

The Pilliods testified that they used Roundup on their property for more than thirty years, from 1975 and 2011. They were diagnosed with NHL in 2011 and 2015.

Punitive damages play an important role in consumer protection. Punitives are awarded by a jury to punish or deter a bad-acting company, and similarly situated companies, from engaging in similarly awful conduct. Punitive damages are not common, and are usually awarded when a jury decides that the defendants had prior knowledge of a serious issue or problem and ignored this knowledge to the serious injury or detriment of other people.

The idea behind the deterrent effect of punitive damages goes something like this:

CEO of Company A: “Hey look, Company B is making billions of dollars selling that glyphosate-based weedkiller. We have to get in on that dangerous-chemical weed-killing market . . .” COO of Company A: “But wait a minute. Company B is being sued by thousands of people who say glyphosate caused their non-Hodgkin lymphoma. And just last week a jury awarded $2 billion in punitive damages to a couple who used Roundup and were later diagnosed with cancer.” CEO: “That’s not good. So selling this product could harm people’s lives, plus it could end up costing our company a huge amount of money, and we would look horrible in the media? Maybe we shouldn’t sell harmful chemicals to millions of people and tell them it’s a safe product, the way Company B did.”

Anyway, that is how it is supposed to work. Unfortunately, the allure of massive profits often overcomes the fear of punishment or even the motive to do the right thing.

Even worse, in many states, including my state of North Carolina, business-friendly legislatures have placed limits on the amount of punitive damages that must be paid. In North Carolina for example, no matter what amount a jury awards in punitive damages, the trial judge is required to reduce the punitives award to three times the amount of compensatory damages awarded (or a flat $250,000, whichever is greater).

If the Pilliod case had been tried in North Carolina, Mr. Pilliod’s punitive damages award would have been reduced by $946,000,000, and $889,000,000 would be stripped from Mrs. Pilliod’s award. The jury in California decided to send a loud message to Monsanto and Bayer that their corporate behavior was reprehensible, and to punish them by awarding two billion to two cancer-stricken plaintiffs; yet in “tort reform” states the legislatures insert their own, “better” judgment and announce, “we politicians, who did not sit through this trial and know nothing about the facts of this case, will decide how much punitive damages to award these people. In this case, we’ve decided to strip $1.835 billion from the award made by this jury to this cancer-stricken couple.”

Fortunately, the Pilliods live in California, without draconian tort reform laws. Still, Monsanto and Bayer have announced they will appeal the verdict, and the money award will likely be reduced eventually. Still, it was a big win for the Pilliods and for other victims of Roundup.

Currently there are more than 13,000 lawsuits pending against Monsanto and Bayer. Just yesterday, the federal judge handling the Roundup multidistrict litigation in California appointed Kenneth Feinberg to serve as Special Master to develop a plan to resolve the thousands of Roundup lawsuits against Monsanto and Bayer. You may remember that Feinberg oversaw the compensation fund for victims of the September 11th attack. The parties will meet shortly to discuss a potential framework for resolution of the Roundup cases.

Plaintiffs in these cases allege that the defendants not only sold a dangerous and unsafe product, but also manipulated research to suggest that glyphosate was safe for human use when the actual studies showed that it could cause cancer.

Monsanto and Bayer have now lost three straight jury trials over Roundup weedkiller. The next Roundup trial is scheduled to start in August in St. Louis County, Missouri.

If you used Roundup for an extended period and were later diagnosed with non-Hodgkin lymphoma, give me a call to discuss further: (919) 830-5602.

Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer needed to do more to warn patients about the risks of the birth control device.

Now that women are making informed decisions, use of the birth control device has dropped off so precipitously that Bayer is ending its production. Let’s look at what Essure is and why it’s so dangerous.

The Essure Birth Control Implant

The Essure birth control implant is actually two implants, each a narrow coil of metal and fiber that must be inserted in the fallopian tubes. For three months or so after the implants are inserted, scar tissue grows around the devices, permanently closing the fallopian tubes and—at least in theory—preventing sperm from reaching the eggs.

Essure is a permanent form of birth control that cannot be removed. The coils essentially become part of the patient’s body, encased in her own scar tissue. As Bayer describes it, Essure results in irreversible female sterilization.

The FDA approved the device in 2002. At first, all seemed to be well. Essure doesn’t involve any drugs or artificial hormones. The procedure requires no incision or, usually, anesthesia. It’s a walk-in, walk-out appointment that takes about 30 minutes. Sounds great, right?

Wrong.

Problems With the Birth Control Implant

In the last few years, the FDA finally noticed “the growing number of adverse event reports” from women with Essure implants. Those reports included serious, life-threatening symptoms:

• persistent and significant pain;
• punctures to the uterus and fallopian tubes;
• movement of the implant into other areas of the body, including the abdomen and pelvis;
• bleeding;
• allergic reactions; and
• deaths.

Women seeking removal of their Essure devices have needed painful surgery—whether the devices were still where they were placed or had migrated elsewhere.

In addition, a few women with the implants nonetheless became pregnant, sometimes with catastrophic results. The FDA states that it received 26,773 medical device reports related to Essure between its approval in November 2002 and the end of 2017. In that time, there were 40 reported deaths. While eight of those deaths were of adults, the majority were infants who died during pregnancy.

The FDA assembled an expert panel to evaluate these safety concerns and the extent of the warnings that doctors were giving to potential patients. In October 2016, it required a new warning on the device label and created a “Patient Decision Checklist” to help women considering Essure implants make informed decisions about the risks.

These efforts to counsel patients about the risks had a huge impact: since the increased warnings, Bayer has seen a 70 percent decline in Essure sales in the U.S.

But in April 2018, the FDA realized that “some women were not being adequately informed of Essure’s risks … despite previous significant efforts.” Clearly, while more women were rejecting the devices, women were still getting this permanent implant without ever hearing about its risks. Therefore, the FDA imposed a restriction limiting Essure sales to facilities that agreed to counsel patients and use a signed acknowledgment form.

Shortly after that, things got even worse for Bayer’s attempts to promote this dangerous device.

The Public Campaign About Essure’s Dangers

Essure isn’t, of course, the only dangerous implant; medical devices of all types are often under-regulated and risky. Fortunately, the word is getting out about those dangers. In July 2018, Netflix released a documentary called The Bleeding Edge that discussed five medical devices, including Essure, and the often unmentioned risks associated with them.

Just before the release date for The Bleeding Edge, Bayer announced that it was taking Essure off the market at the end of 2018—but not because it was causing harm to patients. Rather, Bayer pulled the device as a “business decision” because it is no longer generating enough profit. In its announcement, Bayer blamed, in part, “inaccurate and misleading publicity about the device” for those declining sales. Bayer firmly stated that it “continue[s] to stand behind” the safety of the birth control device.

But with a device that literally becomes part of the patient’s body, ending sales doesn’t do anything to help women who already have the permanent implants. The FDA was careful to announce that “postmarket safety … will continue to be a top priority.”

As of now, around 16,800 lawsuits have been filed against Bayer for problems related to Essure implants. Bayer reports that “additional lawsuits are anticipated.”

Have you had problems with an Essure implant or another medical device? Let’s discuss your options. Call me at (919) 830-5602.