Baycol legal battles begin

August 14, 2001 Posted: 1958 GMT

NEW YORK (CNNfn) -- Lawyers on behalf of a Florida woman, an Oklahoma family, and everyone ever prescribed the cholesterol-lowering treatment Baycol took aim at Bayer AG Tuesday.

A Chicago-based law firm is set to file the first class-action lawsuits against Bayer on behalf of all patients prescribed Baycol, now linked to 52 deaths, while the family of an Oklahoma man who died of kidney failure after taking the drug is also suing.

A Florida woman also sued the company, claiming the drug caused her muscle degeneration and chronic fatigue.

The law firm of Kenneth B. Moll & Associates Ltd. said it plans to file the Baycol class-action suit at Cook County, Ill., Circuit Court Wednesday morning.

Lead attorney Kenneth Moll told CNNfn.com the lawsuit could cost the company at least $3 billion.

Bayer could not immediately be reached for comment.

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The suit calls for a fund to be established to help people who have taken Baycol to monitor the existence of dangerous side effects. Moll estimated the fund would cost $500 for each of the 6 million people who were prescribed Baycol.

In addition to that $3 billion, Moll said the company would be liable for personal injury claims for the 52 people who have died and 480 injured by use of Baycol which could be $1 million each.

He added there were sufficient reports for the company to have pulled the drug off pharmacy shelves earlier.

On Monday, Bayer said 52 people are thought to have died after taking what was its fastest-growing drug. The company recalled the drug from all markets except Japan on Aug. 8 after the company received reports that the drug caused deterioration in muscle tissue, a condition called rhabdomyolysis, which is known to cause severe pain and potential kidney failure.

"Each of these types of drugs has a risk of this condition and in this case it just occurred way too often," Moll said.

Two lawsuits filed Tuesday

Don Strong, attorney for the Oklahoma family, said he expects damages sought in his suit could reach the "multimillion-dollar level" if it is granted class action status.

The suit alleges that Baycol "was defective at the time of its manufacture, distribution and sale, and said medication was unreasonable dangerous to a person taking the medication."

It also claims that Bayer "failed to adequately warn physicians, other health care professionals and consumers of the dangers" of taking Baycol and failed to inform the public of injuries or death related to the drug.

The suit was filed in the U.S District Court for the Western District of Oklahoma on Friday on behalf of Steven Sparks, a survivor of Lilbert Sparks Jr., who died of kidney failure brought on by severe muscle degeneration, Strong told Reuters.

The civil lawsuit was filed in Leon County Court on Monday on behalf of Melissa Elaine Smith, whose doctor prescribed the drug for her last year to help lower her cholesterol.

Her doctor took her off the medication shortly after she experienced the side effects, but her symptoms have continued, attorney Tom Equels said.

The lawsuit sought at least $15,000 in damages, the legal minimum for the court to have jurisdiction in the personal injury case. Equels said he would ultimately seek "very substantial" damages but would wait to see how severely Smith's impairment was before naming a figure.

Bayer hit with manufacturing concerns

Bayer's pharmaceuticals unit has also received a warning from federal regulators over violations of manufacturing standards at two U.S. plants.

The Food and Drug Administration detailed several alleged problems uncovered late last year and early this year in a warning letter made public Tuesday.

Among them, the agency said Bayer Corp. did not maintain or follow written procedures "to assure that the drug products have the identity, strength, quality and purity" they claimed to have.

Also, the German-based firm failed to investigate unexplained discrepancies in some batches of Prolastin, an emphysema treatment, the FDA said. In addition, inspectors said Bayer did not report errors and accidents within the required 45 days.

The violations occurred at Bayer manufacturing facilities in Clayton, North Carolina, and Berkeley, California, the FDA said. The warning letter was sent on July 24.

Bayer, whose other businesses include chemicals, synthetic rubber, plastics and man-made fibers, said in a statement that the FDA "in no way questioned the safety or efficacy of Bayer's biological products."

The firm has implemented a review of manufacturing processes "to identify weaknesses in those processes and to formulate effective solutions. Bayer remains committed to promptly implementing those solutions," the statement said.

-- from staff and wire reports

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