The newest form of combined oral contraceptives has given birthto a mass tort.
Several lawsuits have been filed in federal court against BayerCorp. over Yaz/Yasmin birth control pills, alleging that a newingredient in this 'fourth generation' contraceptive presentsdangerous risks that the company failed to warn about.
The plaintiffs claim injuries that include deep vein thrombosis,gallbladder damage, kidney stones, heart attacks, pulmonaryembolisms and strokes.
The lawsuits also allege fraudulent concealment of safetyinformation.
Hundreds more suits are expected to be filed in the near future,with lawyers around the country looking into these cases.
'We've filed four cases this week, and we will file more thisweek and every week as we go forward. There are a substantial numberof cases,' said Janet Abaray, a managing shareholder of Burg SimpsonEldredge Hersh in Cincinnati, Ohio and co-lead counsel for the Ortho-Evra (contraceptive patch) litigation.
Daniel Gallucci, an attorney with RodaNast, P.C. in Lancaster,Pa., who filed one of the first lawsuits, said that he isinvestigating hundreds of cases.
Joseph Weinstein, an attorney with Squire, Sanders & Dempsey inCleveland who represents Bayer Corp., declined comment for thisarticle. Bayer Corp. did not return a call seeking comment.
'Fourth generation'
Yaz, which was approved by the FDA in 2006, and Yasmin, which wasapproved in 2001, are fourth generation combination oralcontraceptives that combine estrogen and progestin to preventpregnancy.
What makes both drugs 'fourth generation' and different from anyother birth control pills is the progestin component, calleddrospirenone.
Plaintiffs' attorneys allege that drospirenone, a diuretic,causes an increase in potassium which can lead to 'hyperkalemia' orunsafe levels of potassium that disrupt heart rhythms and slow theflow of blood. This can lead to blood clotting.
'No other birth control uses a diuretic as an active ingredient,'said Gallucci, who noted that the number of adverse events reportedto the FDA appears disproportionately higher for Yaz and Yasmin thanfor other birth control pills.
Between 2004 and 2008, over 50 deaths of Yaz and Yasmin userswere reported to the FDA, according to the suit filed by Ohioplaintiff Anne Marie Eakins, who used Yaz for four months in 2007and suffered multiple bilateral pulmonary emboli.
Another common injury in these cases is gallbladder damage, saidDavid Zoll of Zoll, Kranz & Borgess in Toledo, Ohio, who authors theYaz, Yasmin and You blog.
'The diuretic causes you to lose water and so you develop sludgeor bile that wipes out the gallbladder,' he said.
Gallucci said some of his clients are women who were not of child-bearing age and suffered gallbladder removal or sudden death aftertaking the pills for acne.
According to the British Medical Journal, the Dutch College ofGeneral Practitioners recommends that its members prescribe older,second generation birth control pills instead of Yaz/Yasmin becauseof 40 cases of venous thrombosis, including the death of a 17 year-old.
Abaray contends that after first generation birth control pillswere found to cause health risks because of the levels of theestrogen component ethinyl estradiol, the second generation pillsdropped the level of hormones and the risks went way down.
'We're sort of going in a circle,' she said. 'Now that thepatents ran out, they have started patenting 'new and improved'progestins by monkeying with the levels again, and we're seeingincreased risks of blood clots.'
FDA warnings
The makers of Yaz and Yasmin have been warned about theirmarketing.
In 2003, the FDA warned Berlex Laboratories, which has since beenpurchased by Bayer, about TV ads which used the tagline: 'Ask aboutYasmin and the difference a little chemistry can make.'
The FDA said that the ads overstated the safety of the drug andfailed to communicate that increased potassium is a risk, incontrast to the bolded warnings in the package insert.
In 2008, the FDA warned Bayer about TV ads that claimed Yaz waseffective for treating acne and premenstrual syndrome (PMS), asopposed to the more severe disorder premenstrual dysphoric disorder(PMDD), for which Yaz is approved.
In those ads, women sing 'We're not gonna take it' while kickingand pushing away words such as 'IRRITABILITY,' 'MOODINESS,''BLOATING' and 'FEELING ANXIOUS.'
The company has released new ads designed to clear up the FDA'sconcerns.
But Zoll said that the cases are not limited to those occurringbefore the new round of ads.
'Even with the new ads, the warnings are still grosslyinadequate,' he claimed.
'The warning currently says if you are taking medication that isalso increasing potassium you should have your potassium levelschecked, but there is no warning of increased risk of blood clotscompared to other birth control pills,' said Abaray.
