Parents file lawsuit over ‘abortion pill’

SAN JOSE, Calif. – The parents of a Livermore, Calif., teen who died last year after an RU-486 abortion have sued the drug’s maker, health-care providers and others over their alleged role in her death.

Holly Patterson died in September 2003 of septic shock caused by inflammation of the membrane of the uterus several weeks after taking RU-486 to terminate her unwanted pregnancy. She was 18.

More than a year later, her death continues to spark controversy over the so-called “abortion pill,” sold under the brand name Mifeprex by Danco Laboratories.

In the lawsuit, filed Friday in Alameda County Superior Court, Monty and Deborah Patterson accuse Danco of failing to warn doctors about some of the potential dangers of Mifeprex, among other claims. The complaint, which claims wrongful death and product liability, does not specify an amount for damages.

“I haven’t filed this thing to get publicity,” said Mark Crawford, Monty Patterson’s attorney. “It’s filed because there’s been some wrongdoing on the part of the drug manufacturer and drug sponsor here in not getting the warning out.”

Mifeprex carries the U.S. Food and Drug Administration’s most serious “black box” warning. In November, however, the FDA expanded that warning to include information about potential complications after receiving reports of serious bacterial infections and bleeding in some women who used the drug.

The FDA approved Mifeprex in 2000 to end early pregnancies. The drug is used in conjunction with another medication known as misoprostol to terminate a pregnancy.

The lawsuit also names the New York City-based Population Council, which sponsored the development of Mifeprex; the emergency room doctor who treated Holly Patterson; Planned Parenthood Golden Gate, whose Hayward clinic provided Holly with Mifeprex; and ValleyCare Health System, which operates the Pleasanton, Calif., hospital where Holly died.

ValleyCare Health System spokeswoman Kathy Campbell said the company had not seen the lawsuit and could not comment. The Population Council declined to comment.

Planned Parenthood officials also declined to comment Monday, citing patient confidentiality.

In a response e-mailed to the San Jose Mercury News on Monday, Danco’s marketing and public affairs director, Cynthia Summers, said the company had not reviewed the allegations. However, she said, “no causal relationship between the use of the Mifeprex regimen and the unfortunate death of Ms. Patterson has been established.”