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CLASS ACTION PETITION HEARING SET FOR SEPT. 16 IN DETROIT: TARGETS GENERIC PHARMACEUTICAL MAKER FOR PRODUCING FRAUDULENT, UNSAFE DRUGS

 CLASS ACTION PETITION HEARING SET FOR SEPT. 16 IN DETROIT: TARGETS
 GENERIC PHARMACEUTICAL MAKER FOR PRODUCING FRAUDULENT, UNSAFE DRUGS
 DETROIT, Sept. 15 /PRNewswire/ -- A hearing is scheduled in U.S. District Court in Detroit on Wednesday, Sept. 16, regarding a petition for a class action suit against a New York-based manufacturer of generic drugs which allegedly deliberately produced and sold fraudulent and contaminated generic versions of eight different prescription medications between 1984 and 1991. The class action petition alleges that Bolar Pharmaceuticals Company of Copiague, N.Y., earned more than $186 million in revenues from the sale of the eight bogus medications between 1984 and 1990, according to Prather & Foley, P.C., the Detroit- area law firm representing plaintiffs in the case.
 The eight generic drugs manufactured by Bolar Pharmaceutical Company range from high blood pressure treatments to tranquilizers, and were each approved for use by the U.S. Food and Drug Administration (FDA) based on fraudulent information supplied by Bolar, according to the petition.
 The motion to allow a class action suit against Bolar Pharmaceuticals on behalf of the former users of the eight generic drugs was filed by Prather & Foley for a Detroit-area man who filed suit in December 1991, claiming severe and permanent medical complications resulting from his prescribed use of one of the generic drugs manufactured by Bolar.
 The drug, sulfasalazine, is often substituted by doctors and pharmacists for the brand-name medication Azulfidine(R), produced by New Jersey-based Lederle Pharmaceuticals. It is prescribed for treatment of the chronic inflammatory intestinal condition known as ulcerative colitis.
 In addition to sulfasalazine, the seven other generics named in the class action petition are an anti-inflammatory drug known as meclofenamate (often substituted for Parke-Davis' Meclomen(R)); an antibiotic, nitrofurantoin (often substituted for Norwich Eaton Pharmaceuticals' Macrodantin(R)); a blood pressure medication, triamterene HCT (often substituted for SmithKline Beecham's Dyazide(R)); a heart medication, procainamide HCL (often substituted for Parke-Davis' Procan(R)); a blood pressure medication, methyldopa HCT (often substituted for Merck Sharp & Dohme's Aldoclor(R)); an anti-epileptic medication, phenytoin sodium (often substituted for Parke-Davis' Dilantin(R)); and ergoloid mesylate (often substituted for Sandoz Pharmaceuticals' Hydergine(R)), prescribed for age-related memory and cognitive decline.
 According to attorney James Stearns of Prather & Foley, Bolar is responsible for endangering the health of millions of individuals across the country. "At its peak, Bolar Pharmaceuticals sold contaminated products for some of the most common ailments in our society," Stearns said. "Right now there is no telling how many consumers have been seriously hurt by taking Bolar's bogus generic drugs."
 The suit alleges that Bolar obtained FDA approval for generic sulfasalazine and seven other generic drugs produced by the company during the late 1980s by substituting proper laboratory protocols and clean drug samples from brand-name manufacturers in their review samples to FDA-licensed testing laboratories. After clearing FDA review, Bolar then produced adulterated versions of the drugs using unapproved procedures, the suit alleges.
 In early 1990, the FDA ordered Bolar Pharmaceuticals to stop production of each of the eight drugs after federal inspectors uncovered evidence the company had deliberately falsified records relating to the generic drugs' chemical equivalence to similar brand-name medications. In 1991, the company plead guilty and was fined $10 million by the federal government for knowingly marketing generic products that were either contaminated or of uncertain chemical makeup.
 According to court records from the 1991 suit brought by the U.S. government and the class action petition filed by Prather & Foley, Bolar took advantage of relaxed testing standards for generic drugs passed in 1984 to receive quick FDA approval for its line of generic products. Company representatives have admitted in court that Bolar falsified production records and substituted clean, brand-name versions of medications in batches that were to be sent for testing to independent laboratories.
 After receiving FDA approval for its generic drugs, Bolar managers and executives then instructed employees to produce drugs according to different chemical formulas, procedures and specifications, using cover sheets with falsified production specifications in an attempt to fool FDA investigators.
 Prather & Foley, P.C., based in Detroit, represents plaintiffs in litigation ranging from personal injury and labor law to marriage dissolution. Partner Kenneth Prather is listed in the "Best Lawyers of America." He is a graduate of the University of Detroit School of Law, where he now teaches law in addition to his practice. John Foley is a graduate of the Detroit College of Law and has been in practice with Ken Prather since 1981. He specializes in personal injury and labor law. James Stearns, who is working with John Foley on the Bolar Pharmaceuticals case, has been with Prather & Foley since 1984. He is a cum laude graduate of the Detroit College of Law and received his bachelor of general studies from the University of Michigan in 1978.
 -0- 9/15/92
 /CONTACT: Freda Counceller or Gregory Sendi of daVinci Public Relations, 812-376-0660, for Prather & Foley, P.C./ CO: Bolar Pharmaceuticals Company; Prather & Foley, P.C. ST: New York, Michigan
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Date:Sep 15, 1992
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