The birth control pills Yaz and Yasmin, made by Bayer Pharmaceuticals, have caused some concern to FDA officials lately and this blog had a post on some aspects of that on September 23. Now there is some further trouble as one Candice Richardson and her deceased daughter have filed a wrongful death suit against Bayer alleging that Yaz (or Yasmin — it is not clear from news reports which of those drugs she used) had caused a blood clot which killed her baby.
The complaint, filed on September 18 in Texas, alleges that the Yaz or Yasmin possibly increased Richardson’s potassium levels, a condition called hyperkalemia. The hyperkalemia caused disturbances in her heartbeat, which in turn allowed the blood clot to form. To Richardson and her lawyers, this drug is more dangerous than the average consumer would expect.
The plaintiffs are alleging that the drugs have both manufacturing and design defects and inadequate warnings as to side effects. They charge Bayer with negligent misrepresentation or fraud and violation of the Deceptive Trade Practices Act. The lawsuit does not state when Richardson used Yaz or Yasmin, or for how long. News reports do not mention whether the baby’s father is involved.
Yaz and Yasmin
Yaz and Yasmin contain both estrogen and progestin components which work together to prevent ovulation so that no egg can be fertilized, and to prevent the uterus from building up tissue in preparation for implantation. However, they are made a little differently than all other birth control pills and offer the extra benefits of acne improvement and help with premenstrual syndrome.
The FDA had taken issue with Bayer’s marketing campaign and had eventually persuaded the company to change their advertisements in regard to the drugs’ effect on acne and premenstrual syndrome.
The wrongful death suit is seeking compensation for medical costs, pain and suffering, lawyer’s fees, and punitive damages against Bayer as a punishment. A jury trial is being requested and the case will be heard by a U.S. District Judge.
For more information about the FDA and drugs, please see our page on The Role of the FDA in Drug Recalls.