Brief history of Drospirenone
The FDA approved Yasmin, then produced by Berlex, in May, 2001. Bayer Healthcare acquired Berlex in 2006, and shortly thereafter introduced its own update to Yasmin: Yaz. The FDA approved this slightly reformulated version of Yasmin in March, 2006. Following several prominent national marketing campaigns which the FDA rejected in 2008 for encouraging off-label use, Yaz quickly became the most popular form of oral contraception on the market. Yaz and Yasmin both enjoyed enduring popularity: Yaz commanded a U.S. market share of 18% at its peak in 2009, earning upwards of $600 million for Bayer in that year alone. Yasmin, despite its diminished popularity after Yaz’s release, was still the fourth-most popular oral contraceptive of 2011.
Yaz and Yasmin are members of a class of birth control pills known as combined hormonal oral contraceptives (“COCs”). These oral contraceptives work by delivering synthetic forms of the natural female hormones estrogen and progesterone (progestin). The synthetic version of estrogen provided by drugs in the Yasmin family (Yaz, Yasmin, Ocella, and several other generics) is ethinyl estradiol, which is present in many varieties of hormonal birth control—nearly 200 according to the FDA’s drug database. Ethinyl estradiol presents risks typical of any hormonal contraceptive: most notably, very slightly increased chances of blood clots (.03- .09%, compared to the .01- .05% risk shared by the overall population). The increase in risk for clotting events, while highly dose-dependent, therefore, is relatively minimal. The far more contentious ingredient in the Yasmin family is its synthetic form of progestin: drospirenone.
There are several potential injuries plaintiffs have contested are related to the use of drospirenone: gallbladder disease, thromboembolism, and pulmonary embolism, as well as other clot-related injuries such as aneurysm and heart attack. The former is related to the drug’s tendency to elevate potassium levels; the later two injuries are dangers inherent with any synthetic progestin. The FDA noted from the outset in its approval of the drug in 2001 the potential for elevated potassium levels, or hyperkalemia. Public consumer watchdog group Citizen.org cautioned birth control users as early as April, 2002 of the dangers of Yasmine. The Citizen.org report cited potassium retention and the potential for blood clots, and ultimately recommended that consumers avoid Yasmin. It is believed that these elevated potassium risks resulted in the numerous gallbladder injuries by users of the drugs in the Yasmin family, although such claims suffer from specific causation problems.
Clotting injuries, alternatively, emerged as a dangerous side effect of drospirenone only over time: for one, clotting is a known danger of any hormonal contraceptive, and has been justified by medical professionals since the Pill’s inception decades ago as a risk factor insignificant when compared to the clotting risk posed by pregnancy. Thromboembolic events are also notoriously difficult to track: a heart attack, for instance, may or may be caused by a clotting event, and therefore might be overlooked as a thromboembolic event, and not reported as such for the purposes of cohort studies. Even the drospirenone studies tracked by the FDA failed to provide consistent estimates of the comparative risk of clotting injuries between types of birth control. Despite some uncertainty across studies, however, the FDA was confident enough to amend the warning labels for drospirenone-containing oral contraceptives in 2011 and again in 2012. The revised labels now must indicate that studies demonstrate up to a three-fold increase over the clotting risk posed by other popular oral contraceptives.
The clotting risks posed by a drug like Yaz or Yasmin are still low in absolute terms: around nine out of 10,000 women. This low absolute risk is, in part, why the FDA continues to allow the marketing and distribution of drospirenone-containing drugs. The problem, however, is that Yaz and Yasmin together commanded a huge portion of the market share: many millions of women, many with clotting or gallbladder risk factors, took Yaz, Yasmin, or a similar generic drug.
As suits contending Yaz/Yasmin injuries flooded federal courts (many more remain in state courts; presumably Bayer could not remove to federal court given the low amount in controversy in those cases), the judicial panel on multi-district litigation decided to aggregate all Yaz/Yasmin claims against Bayer under US Chief District Judge David Herndon in the Southern District of Illinois. Lead counsels for the plaintiffs are: Michael S. Burg, Michael London, and Mark N. Niemeyer of, respectively, Burg Simpson Eldredge Hersh & Jardine, P.C.; Douglas & London, P.C.; Onder, and Shelton, O’Leary & Peterson, LLC.
The approximately 10,000 injury claims aggregated under the Yaz MDL involve only clotting and the gallbladder disease. There are, however, several complex legal issues posed by both gallbladder and clotting injuries. Whether the suit alleges strict products liability or negligence, the most difficult issue is causation: epidemiologically speaking, a certain percentage of at least the clotting plaintiffs must have been injured by exposure to the drug if the studies establishing. Similarly, certain percentage of the population is likely to suffer gallbladder disease—and it is unclear whether any of that percentage is attributable to Yaz given the tenuousness of the medical research on the subject. While background risk is a problem universal to plaintiffs, however, there is another causality issue for the individual plaintiff: plaintiffs with any background of smoking, or a family medical history of clotting events, would have a particularly hard time demonstrating legal causation. These epidemioloical issues together, unfortunately, undermine causality for the entire group: it is difficult for any given specific plaintiff to prove that her injuries were directly caused by Bayer’s products with a degree of certainty necessary as a matter of law.
The MDL also faces a choice of law hurdle: in some jurisdictions, strict products liability is not available in claims against contraceptives. In those cases, plaintiffs must establish negligence under traditional products liability: design defect, or failure to warn. In order to substantiate their claims, those plaintiffs would need to demonstrate that Bayer knew of clotting risks particular to drospirenone, and that they exceeded those risks posed by standard hormonal contraceptives.
Individual plaintiffs would also have a difficult time recovering damages in negligence actions against the manufacturer of combined oral contraceptives where she failed to advise her physician of premonitory symptoms.
Ultimately, likely due to the pervasiveness of the causation issues, choice of law issues, and the divisiveness of pending litigation, Illinois Federal Judge David Herndon ordered a stay on the first scheduled bellwether trial in January, 2012. Judge Herndon’s order strongly urged settlement of pending MDL cases, and appointed Stephen Saltzburg, a George Washington School of Law Professor, special master for the mediation. There have since been no further bellwether trials
A settlement class of the vast number of thromboembolism Yaz/Yasmin plaintiffs, even a class bifurcated into FRCP 23(c)(5) is, unfortunately, extremely unlikely to result from the litigation: class settlements rarely arise from MDL proceedings (see, eg, Vioxx) and courts have been extremely reticent to find that common issues predominate where the injury is one best demonstrated in the aggregate by statistical epidemiology (See WalMart v Dukes; Amchem Products v Windsor, In Re Rhone Poulenc Rorer.) This is potentially good news for individual plaintiffs (and plaintiffs’ lawyers hoping for contingency fees), who are likely to recover higher awards more quickly when recovering individually under the multi-district litigation—though plaintiffs lose out on the peace premium enjoyed by class settlements. Thus far, many of the cases have, under pressure from the MDL transferee judge and in coordination with the special master for mediation: over 5,000 cases at a cost so far of nearly $1 billion, according to Bayer’s financial reports.
Unfortunately, it is difficult to appraise the value of any particular claim, as bellwether trials meant to establish settlement ranges were abandoned and other settlements within the MDL are subject to non-disclosure clauses. It is entirely likely, however, that the causation issues illustrated above undermine the settlement value of a thromboembolism Yaz claim. Given the impossibility of a class settlement, as explained above, epidemiological causation issues are likely to weaken individual and aggregate settlement recoveries.
Though there may be thousands more clotting cases left to be settled (presumably) individually, the MDL transferee Judge David Herndon, in conjunction with state court Judges in Pennsylvania, New Jersey, and California, already approved a settlement agreement of the cases alleging gallbladder injuries. This outcome seems at first counterintuitive: there is, as of this writing no study reliably linking Yaz/Yasmin to gallbladder disease, and the legal argument for causation would be nearly impossible. By settling the weakest claims in aggregate, however, Bayer was able to settle the cases at a relatively low cost, while guaranteeing minimal reputational harm caused by contentious ongoing litigation. Bayer was also able to achieve a relatively universal outcome by leveraging the unlikeliness of recovery for any given claim against the certainty of recovery under the settlement.
The Gallbladder Resolution Program provides a fund capped at $24 million, with individual recoveries settled at $2,000 per plaintiff with gallbladder symptoms, and $3,000 per plaintiff who underwent surgical gallbladder removal. The opt-out (or, opt-in, for those plaintiffs with both gallbladder and thromboembolism claims, or those plaintiffs with claims outside the MDL settlement agreement) was March 25, 2013. Total payout, however, is capped at $24 million: individual recoveries will be reduced if the cap is exceeded.