Mifeprex News:
Mifeprex is one of two drugs administered for a medical abortion up to 7 weeks after conception, and is an alternative to surgical abortion. Mifeprex also is known as the early option pill or RU-486, and its generic name is mifepristone. Mifeprex and medical abortion are not to be confused with the emergency contraception (EC) pill, or Plan B, which may be taken within 72 hours of unprotected sex or contraceptive failure to prevent conception.
Under the FDA-approved medical abortion regimen, a patient takes orally three 200 mg Mifeprex pills at the medical provider's office. The patient returns to the provider's office in two days, and takes orally two 200 mcg Cytotec (misoprostol) pills if the abortion is not complete. The patient then follows up with a visit to the provider 13 to 16 days after taking the initial dose of Mifeprex. Many clinics now vary the FDA-approved regimen by administering a lower dose of Mifeprex and a higher dose of Cytotec, and having the patient self-administer the Cytotec vaginally at home rather than at the provider's office.
The FDA approved Mifeprex and the medical abortion procedure in September 2000. The drug was sponsored by The Population Council, Inc., which acquired the rights to develop and market the drug in the United States. The Population Council has licensed some or all of those rights to Danco Laboratories, LLC.
In November 2004, Danco Laboratories placed a black box warning in the Mifeprex package insert (or product label) warning medical providers and patients of serious and sometimes fatal bacterial infections and sepsis associated with the medical abortion procedure. The black box warning followed the deaths of several California women who died within 1 to 2 weeks after taking Mifeprex, including the death of 22 year old Holly Patterson in September 2003. The Centers for Disease Control has confirmed that several of the women were infected with Clostridium sordellii, which is a rare but extremely deadly bacterial infection.
Lopez, Hodes currently represents Ms. Patterson's father in litigation against Danco Laboratories and The Population Council, as well as the families of other women who died in California after undergoing the Mifeprex medical abortion procedure. The complaints filed in those lawsuits allege that Danco and The Population Council were aware years before their black box warning of the risk of infection, sepsis and death from Mifeprex, yet failed to provide an adequate warning to medical providers and patients about those risks.
If you or a family member have suffered serious injury from an infection following medical abortion with Mifeprex, or if a family member has died following such a procedure, please contact one of our attorneys today.
