After maintaining a position for a number of years that gallbladder injuries associated with Bayer’s family of oral contraceptives - Yasmin, Yaz, Ocella and Beyaz - would be a no-pay situation, Bayer, on March 15, 2013, did an about-turn and agreed to set aside $24 million to settle lawsuits claiming that its birth control pills caused gallbladder disease, according to court documents. What made Bayer reach this decision?
“I can only speculate that Bayer saw these thousands of filed cases as a potential financial liability down the road,” says Dr. Malik. “They know that eventually medical science will catch up and prove causation - that their products led to increased risk of gallstones and gallbladder problems.”
Malik says that gallbladder claims are a “ticking time bomb.” The number of gallbladder cases are unknown but one report (Reuters, March 20, 2013) estimates 8,000 claims. “Sooner or later Bayer had to address all of these people. Their gallbladder problems are well known and it is documented that Yasmin or Yaz is a contributing factor, but specific causation was lacking.”
In order to prove your case, you must demonstrate general and specific causation. Regarding general causation, there are several risk factors for having gallstones. Being Caucasian and female, over 40 years of age and obesity are the main contributing factors. As well, alcohol abuse, inflammation of the pancreas, pancreatitis and several genetic disorders that affect your ability to digest fat can all lead to gallbladder disease.
“Once general causation is determined, you come to specific causation,” says Dr. Malik. “You have to prove that Yasmin or Yaz was the culprit to cause the disease. You must be sure, to a reasonable degree of medical certainty, that a particular woman’s gallbladder disease was caused by Yasmin or Yaz, instead of just the general risk factors. Then you can prove statistically that Yasmin was involved in this case. You must show in this instance that Yaz was a causative agent in getting gallstones.”
What would happen if Bayer chose not to settle gallbladder cases?
“If Bayer didn’t settle now, they would be looking at paying out a lot more down the road,” explains Dr. Malik. “Bayer did a sneaky move because the cost of defending, say 10,000 cases, would cost several thousand dollars to defend each case. Now, with only a 10-day filing window, Bayer can settle your case for chump change.”
The first issue is that Bayer doesn’t want plaintiff attorneys or injured plaintiffs to file more complaints. The deal Bayer made was that attorneys would have to sign and retain their client by March 15, and then you have to file the case by March 25. And if you didn’t do that, your agreed settlement time has basically gone.
The second issue is that the amount of money Bayer will give you is $3,000 maximum, with a total cap of $24 million. “This means that, if there are more than 8,000 gallbladder removal cases, the amount will be reduced pro-rata,” adds Dr. Malik. “This means that if 10,000 people file gallbladder cases, the average pay-out will be reduced to $2,400. And the window is closed. If you haven’t filed, however, you can still bring your claim but your case must be tried.”
You don’t have to accept the offer from Bayer. Instead, you can continue to file and try your case. But all gallbladder plaintiffs are automatically enrolled in the settlement. Those wishing to opt out must do so by April 29. As well, Bayer may walk away from the settlement if less than 90 percent of gallbladder plaintiffs participate. Bayer denies any liability or wrongdoing.
Dr. Malik is advising his clients to accept Bayer’s $3,000 settlement because the cost of litigation will be prohibitive for such a small amount in the way of damages. “And chances are you won’t be successful at trial or get enough recovery to justify the cost of pursuing litigation. It is not economically viable for a law firm to take your case to trial - I don’t think an attorney would accept a case for trial purposes. The science is not there yet on specific causation.”
Dr. Malik adds that Bayer could have taken the position not to settle but their cost of defense would be much more than $3,000 on each individual case. This settlement is a business decision that is ultimately saving Bayer a huge amount of money. The cost in trial courts across the country would cost much more than $24 million to defend. And Bayer doesn’t want attorneys to take any more cases. “This settlement is basically ‘take it or leave it,’” concludes Dr. Malik.
READ MORE YASMIN BIRTH CONTROL LEGAL NEWS
(According to the Gallbladder Resolution Program, which will be capped at $24 million, Tier 1 patients who underwent cholecystectomies [gallbladder removal surgery] will receive $3,000, and Tier 2 patients who developed gallbladder symptoms but didn’t require surgery will receive $2,000.)