Eleven people in seven states, including North Carolina, have sued Bayer Corp., saying they suffered strokes caused by a drug in an Alka-Seltzer product they used, joining nearly 700 people who are suing the Pittsburgh-based company in federal courts across the country.
The plaintiffs say Bayer should have known that a drug in its Alka-Seltzer Plus and Alka-Seltzer Cold medicines called phenylpropanolamine, or PPA, was dangerous.
In November 2000, the Food and Drug Administration warned that dozens of over-the-counter cold medicines and diet pills containing PPA could cause hemorrhagic strokes. Although the FDA has yet to formally ban the drug, most manufacturers, including Bayer, either pulled those products from the market or reformulated them without PPA.
But the plaintiffs in the Pittsburgh case, and hundreds of others filed in federal courts across the country, say the drug’s risks were well-known even before the FDA warning.
“I think we’ll be able to show the dangers of PPA were commonly known within the medical and drug manufacturing community and they withheld that information from the public,” said H. Blair Kahn, of Richardson Patrick Westbrook and Brickman, LLC, a Columbia, S.C. firm representing the Pittsburgh plaintiffs.
Kahn said his firm represents more than 100 people nationwide who have sued Bayer, or soon will, over PPA.
Bayer spokeswoman Anne Coiley said the company doesn’t comment on pending litigation.
The 11 plaintiffs in the lawsuits filed in U.S. District Court in Pittsburgh on Tuesday include six men and five women from Alabama, California, Florida, North Carolina, Ohio, South Carolina and Texas. Four were under 40 and all but one were younger than 60 when they suffered strokes between November 1995 and March 2001.
The youngest plaintiff, Vera Davenport, 33, of Berkeley County, S.C., suffered a stroke on Nov. 2, 2000 – four days before the FDA issued the drug warning.
FDA spokeswoman Laura Bradbard said PPA never received formal FDA approval as an over-the-counter drug. PPA was grandfathered in because it was in use before the federal Food, Drug and Cosmetics Act of 1938 was passed, creating federal drug oversight.
PPA relieves nasal congestion by causing blood vessels to become narrower. This can cause a rise in blood pressure that is harmless for most users but puts some people at risk of strokes. The drug was used in diet pills because it also suppresses the appetite, Bradbard said.
By the 1970s, questions about the drug’s safety were raised and the FDA asked the industry, now known as the Non-Prescription Drug Manufacturers Association, to study the drug’s safety. After getting no answers for about 20 years, the FDA and the drug manufacturers co-sponsored a Yale University study in 1994, Bradbard said.
Manufacturers were asked to pull the drug from shelves at the end of that six-year study, which examined FDA records showing 44 cases of hemorrhagic stroke among PPA users in the past 30 years. While the study showed women were more at risk, the FDA said not enough cases involving men were studied to conclude they weren’t at risk, too.
Bradbard said that although the risk of stroke is very low, the FDA was concerned because it couldn’t predict who might be at risk for the strokes and because the strokes could result in severe paralysis or death.
Although Bayer officials wouldn’t comment on the Pittsburgh lawsuits, the company’s attorneys have filed documents in other lawsuits saying Bayer had no evidence beyond “anecdotal reports” that the drug was dangerous, and that PPA has “been safely used for decades.”
The 11 Pittsburgh cases will be transferred to U.S. District Judge Barbara Jacobs Rothstein of the Western District of Washington, in Seattle, who is overseeing the other Bayer PPA lawsuits.
Complex federal cases that arise in several jurisdictions are often consolidated for discovery, the pretrial phase during which the sides exchange evidence and take depositions. Once that process is finished, the cases will go back to the district court where they were filed for trial, assuming that they are not settled first.
Bayer is already facing more than 300 lawsuits in Pennsylvania over the company’s anti-cholesterol drug, Baycol, which has been blamed for 100 deaths worldwide. The Baycol cases have attracted more than 100 law firms and estimated 40,000 to 50,000 plaintiffs.
Madison, N.J.-based American Home Products, makers of Dimetapp – another cold drug that contained PPA – have also been targeted by lawsuits, including one by the parent of a 10-year-old Oregon boy who died after a stroke.