Bayer Dealt Setback in Alka-Seltzer PPA Case

A jury award in favor of a plaintiff who used phenylpropanolamine-containing Alka-Seltzer may not bode well for Bayer in its ongoing PPA litigation.

An El Paso, Tex. state court ruled in favor of the claimant Oct. 13, awarding him $400,000 in damages; no punitive damages were awarded.

The plaintiff contended he suffered a stroke caused by Bayer's cough/cold Alka-Seltzer product.

FDA requested manufacturers, distributors and retailers pull PPA-containing products from the market in 2000 due to an apparent link between the ingredient and hemorrhagic stroke (¹ (Also see "Retailer In-Store Signs Explain PPA Product Removal To Customers" - Pink Sheet, 13 Nov, 2000.), p. 3). A formal notice was published in the Federal Register in August 2001 (² (Also see "PPA-Containing NDA Drugs, Weight-Control Aids Subject Of FDA Formal Notice" - Pink Sheet, 20 Aug, 2001.), p. 14).

Bayer is named as a defendant in roughly 1,150 cases alleging harm as a result of using Alka-Seltzer.

If the $400,0000 award sets a precedent for future cases, Bayer's liability could approach the $50 mil. mark.

The Alka-Seltzer marketer is named as the sole defendant in 700 of the 1,150 cases, and as one of multiple defendants in the remaining 450.

Bayer also was named in 14 class action suits, although 12 of those cases have been denied. The final two cases have seen very little activity since they were filed in 2001, the firm said.

In an Oct. 13 statement, Bayer said it is "disappointed with the jury verdict."

"Bayer believes that the verdict stands in marked contrast to the evidence which showed that the PPA, which had been in Bayer's effervescent cough and cold medicines, was safe and effective and did not cause [the claimant's] injuries."

The firm noted it is "evaluating its legal options."

Following the news, Bayer's stock price closed the day down 1.1% to $27.32.