Mother of Charles Bishop Files $70 Million Wrongful Death Suit Against Hoffmann-La Roche.

Business Editors & Legal Writers

TAMPA, Fla.--(BUSINESS WIRE)--April 16, 2002

Charges Accutane Caused Teen to Become Psychotic and

Crash Plane into Tampa Building and Commit Suicide

The estate of Charles John Bishop, the teenager who flew a Cessna aircraft into a downtown Tampa skyscraper, has filed a $70 million wrongful death and negligence suit against Roche Laboratories and Hoffmann-La Roche, Inc., the manufacturers of Accutane. The suit contends that Accutane, a medication prescribed for cystic acne, causes severe psychiatric side effects, including suicide, and caused 15-year-old Charles Bishop to take his own life.

According to documents filed today by Mrs. Bishop's legal team, a consortium of three nationally recognized law firms that specialize in pharmaceutical litigation, the suit asserts that, "Accutane is unreasonably dangerous and presents an unreasonable risk of harm. Charles Bishop was one of the unfortunate individuals for whom Accutane caused a severe psychotic break with reality which resulted in his death."

According to Peter McNulty, a Los Angeles, California, attorney who specializes in Accutane liability and a member of the legal team representing Charles's devastated mother Julia Bishop, "Charles was a healthy, loving son to his mother and a productive member of society, when he began taking Accutane in April 2001. He was an honor student who was selected to be an ambassador for the United States youth at an upcoming conference in Australia. Above all, he was a loyal and patriotic American citizen who, due to taking Accutane, became severely psychotic and lost touch with reality, consequently flying into the side of a building. His suicide is the ultimate avoidable side-effect of Accutane. As a result of the negligence of Roche/Hoffmann-La Roche and by virtue of the defective nature of their product, Julia Bishop has been deprived of her only son, Charles."

The wrongful death action contends that Roche/Hoffmann-La Roche manufactured an unsafe pharmaceutical product, used non-effective warnings and under reported the link between depression and suicide in its marketing, sale and distribution of Accutane. According to attorney Paul Smith of Austin, Texas, another member of Julia Bishop's legal team, "Roche/Hoffmann-La Roche is negligent for manufacturing a drug they knew or should have known could cause depression, psychosis and suicide and failing to adequately test the drug to determine whether it had dangerous side-effects." The suit also contends that Roche/Hoffmann-La Roche failed to act on and warn patients about established reports of depression and psychosis occurring in connection with the drug's clinical trials and adverse events that occurred after Accutane was approved.

The suit maintains that Roche/Hoffmann-La Roche, adding insult to injury, marketed Accutane to the public in a manner which created the impression that the drug relieved depression, when in fact Roche/Hoffmann-La Roche knew it might cause depression and suicidal ideation. According to Michael Ryan, a Fort Lauderdale, Florida attorney with Krupnick Campbell Malone Roselli Buser Slama Hancock McNelis Liberman & McKee, who is also part of Ms. Bishop's legal team, "In fact, there was a time when the FDA was requiring Roche/Hoffmann-La Roche to warn of the psychiatric risks associated with Accutane, but at the same time, Roche/Hoffmann-La Roche was advertising to the public that Accutane could improve psychiatric disorders by making teenagers with acne less concerned about their personal appearance."

Julia Bishop is not alone in her belief that Accutane caused her son to commit suicide. Michigan Rep. Bart Stupak, who believes it caused his 17-year-old son BJ to kill himself in 2000, states, "The side effects of Accutane are not worth it. This drug needs to be pulled from the market or put under the tightest kind of regulation.(1)"

More than 500 adverse reactions reports of suicide, suicide attempt and suicidal ideation have been recorded by national and international health agencies for Accutane. It has the fourth highest record of adverse drug reaction reports in the United States among the more than 500,000 prescription medications sold in this country. Julia Bishop's attorneys believe these figures are artificially low due to under reporting and probably amount to less than fifty percent of actual suicide attempts and ideation.

Accutane is a retinoid and before it was put on the market, literature reported that high doses of retinoids caused psychosis, depression, suicidality, aggressiveness, anger and impulsivity. It also is a known teratoger associated with birth defects and miscarriages. (2)

In 1993, Dr. P. Brevard and two other French dermatologists published a paper that found a high incidence of suicide among patients using Accutane as compared to other acne medication. The study was funded by Roche/Hoffmann-La Roche and the results were never published. However, the findings were a sufficient basis for the country of France to order Roche/Hoffmann-La Roche to strengthen its warnings to include suicide as a possible effect. Roche/Hoffmann-La Roche failed to inform physicians, consumers or potential consumers in the United States of the French health authorities' requirement that suicide attempt be added to Accutane's listed side effects until 1998.

In 1999, Dr. T. Middlecoop published a study which showed the number of people prescribed Accutane worldwide was 6 million while the number of people prescribed the other top five acne medications was approximately 300 million. According to the Middlecoop study, there were 170 cases of suicide, suicide attempt and suicide ideation recorded for Accutane among the 6 million population of users, but only eight reports of suicide attempts total, with no reports of suicide or suicide ideation, for the five other medications used by more than 300 million patients. The study concluded that Accutane is 900 times more likely to cause depression in its users than the five other acne medications reviewed.

Roche/Hoffmann-La Roche, who developed Accutane in 1971, initially chose not to pursue marketing and distribution of the drug because of the risk of serious, thalidomide-like birth defects. In June 1982, the Food and Drug Administration (FDA) approved Accutane for treatment of cystic acne and over the years the FDA has repeatedly required Roche/Hoffmann-La Roche to strengthen their warnings concerning the danger of birth defects associated with Accutane on 8 different occasions. In spite of these warnings, the number of Accutane related birth defects continues to increase.

Charles Bishop, a licensed student pilot, died on January 5, 2002 when he flew a Cessna aircraft from a flight school at the St. Petersburg-Clearwater International Airport and crashed it into the 28th floor of Bank of America Plaza in Tampa. He was killed, but no one else was hurt. Convinced her son's death is related to taking Accutane, Charles's mother, Julia, has retained the services of leading drug liability attorneys Peter McNulty of California, Paul Smith of Austin, Texas and Michael Ryan of Ft. Lauderdale, Florida.

Peter McNulty is an expert on drug liability. He has also founded the Accutane Victims Litigation Group (www.accutanelitigation.com) a nationwide group of attorneys experienced in products liability litigation regarding defective prescription drugs, especially Accutane. He is known in the legal community as a preeminent drug liability attorney and has commented on the subject for several national media outlets.

Paul Smith has a private practice in Austin, Texas, concentrating on Accutane and pharmaceutical litigation on a national basis. Paul specializes in products liability, medical malpractice, handles only pharmaceutical and medical device litigation. He was lead counsel in In Re Eli Lilly & Company Prozac Litigation, MDL Docket No. 907, a nationwide, multidistrict litigation concerning the anti-depressant drug Prozac which was alleged to cause suicidal and aggressive behavior in individuals taking this drug. Additionally, Paul was lead counsel and tried Fentress v. Eli Lilly & Company which was at the time the largest civil litigation case in Kentucky history.

Michael Ryan is an associate with Krupnick Campbell Malone Roselli, et al. (www.krupnicklaw.com) in Fort Lauderdale, Florida. Krupnick Campbell Malone Roselli specializes in national and international litigation against corporate giants. The firm has achieved settlements, after verdicts, involving defective products of over $200 million in the past 10 years alone. Personally, Mr. Ryan who specializes in medical device, medical malpractice, and pharmaceutical litigation, has assisted the firm in obtaining over $25 million in trial verdicts in two years.

(1) US News & World Report, April 1, 2002

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