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Bolar Pharmaceuticals Settles For $3.8 Million In Class Action Suit

November 12, 1991

PHILADELPHIA (AP) _ Bolar Pharmaceutical Co. has agreed to pay $3.8 million to settle several lawsuits that accused Bolar of lying to get government approval for generic versions of two big-selling drugs, an attorney in the case said Monday.

U.S. District Judge Edward N. Cahn approved the settlement agreement last week between the generic drug manufacturer and consumers who had bought Bolar’s version of Dyazide, a high blood pressure medication, and Macrodantin, which treats urinary tract infections.

The case combined several class-action lawsuits filed against Bolar since 1990, said Bill Hoese, a Philadelphia lawyer representing consumers who participated in the suits.

A spokeswoman for Bolar, of Copiague, N.Y., declined to comment on the settlement.

Bolar removed its generic version of Dyazide in January after acknowledging the company had faked lab results. The lawsuits alleged that Bolar obtained Food and Drug Administration approval of generic forms of Dyazide and Macrodantin in 1984 and 1985 by submitting samples of the actual drug rather than its generic copy.

Generics are imitations of more expensive brandname drugs made after patent protection expires.

Bolar employees then tried to cover up the falsified test results by destroying documents, the lawsuits said.

Dyazide is made by SmithKline Beecham, a pharmaceutical firm with headquarters in England and Philadelphia. Bolar in August settled a lawsuit filed by SmithKline for $40 million.

Dyazide is among the nation’s top-selling drugs, contributing about $237 million to SmithKline’s 1990 revenues of $9.2 billion. SmithKline reported that Dyazide’s U.S. sales peaked at $320 million in 1987 and fell to $153 million in 1988 - a 52 percent decline in one year - after the generic substitutes entered the market.

The $3.8 million will go into a fund to be divided by the number of consumers who make a claim, Hoese said. Consumers must have purchased the drugs between Aug. 21, 1987, and Dec. 12, 1990, in the United States and file claims before February 1992, Hoese said.

Under the settlement, Bolar admitted no wrongdoing but agreed to establish the fund, he said.

No consumers have come forward and said they became sick from taking the drugs, Hoese said. But the settlement does not prohibit consumers from filing personal injury lawsuits against Bolar, he said.

So far, 16 people, including three Bolar executives, five former FDA officials and representatives of three generic-drug companies, have pleaded guilty in the investigation in the alleged faking of test results.

In February, the U.S. Attorney in Baltimore charged Bolar with 20 criminal counts of misrepresenting its products and lying to investigators. If convicted, the company faces a $10 million fine.

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