A 39-year-old Newark woman has filed a lawsuit this week against Bayer Corp., blaming its popular birth control product Yaz for causing her stroke and other related health issues.
Susan Galinis, the mother of 3-year-old twin girls, took the prescription-only product for four weeks in the summer of 2008, and wound up suffering a stroke that caused her to be hospitalized for six months, said her attorney, Michael Danko.
The lawsuit was filed Monday in U.S. District Court in San Francisco.
Galinis had been taking the pills to help reduce premenstrual pains — which was one of the advertised uses, Danko said.
While hospitalized, Galinis had part of her skull temporarily removed because of excessive swelling in her brain. That portion of skull later was replaced, he said.
As a result of the stroke and related illness, Danko said, Galinis also suffered a diminished IQ — Danko said his client is now borderline mentally handicapped — and has experienced a change in her mood and speech.
"Her kids feel as though they have lost their mother," he said.
Galinis' suit attributed her health problems to Yaz.
The No. 1 selling birth control in the world, Yaz has been at the center of much criticism in recent years.
Galinis and more than 100 others have filed suit against the product's maker, claiming the drug presents additional health risks not associated with other birth-control pills, the suit said.
The Food and Drug Administration has admonished the makers of Yaz three times in recent years regarding the company's advertising campaign, the suit said.
In a letter issued to Bayer in October 2008, the FDA stated:
"The TV ads are misleading because they broaden the drug's indication, overstate the efficacy of Yaz, and minimize serious risks associated with the use of the drug."
The company has agreed to spend at least $20 million in recent years for corrective television advertisements to make women better aware of the products' side effects, according to published reports.
The ultimate goal of Galinis' lawsuits and others like it is to get the product off the market, the attorney said.
The San Mateo-based attorney said he also has filed a lawsuit on behalf of a Tracy woman who suffered health issues after taking the product.
In the days after the lawsuit was filed, Bayer released the following prepared statement:
"Bayer has received lawsuits relating to its drospirenone-containing oral contraceptives. The company is in the process of gathering information on these cases, but the complaints we have reviewed so far pertain to side effects that are warned about in our approved product labeling. Bayer will defend itself vigorously against these lawsuits.
"We will not comment on ongoing litigation or individual lawsuits."
Reach Ben Aguirre Jr. at 510-353-7011. Follow him on Twitter at www.twitter.com/benaguirrejr.