Monday, February 12, 2007

In lawsuits, secrecy can have dangerous side effects

Citation at end of article.

In lawsuits, secrecy can have dangerous side effects
BY RICHARD ZITRIN

Drug giant Eli Lilly & Co. recently settled 18,000 lawsuits brought by people claiming they were injured by the side effects of its biggest-selling drug, Zyprexa, which is used to treat schizophrenia and bipolar disorder. But the $500 million in settlements says less about the dangers of the drug than the dangers of secrecy.

About 18 months earlier, Lilly had settled 8,000 other Zyprexa cases for $700 million. But those settlements required the plaintiffs to return all sensitive documents obtained through the legal discovery process to Lilly — a requirement that kept the strongest smoking-gun evidence out of public view. The plaintiffs also had to agree "not to communicate, publish or cause to be published, in any public or business forum or context, any statement, whether written or oral, concerning the specific events, facts or circumstances giving rise to (their) claims."

Lilly had strong motivation to settle. The documents contained evidence that Zyprexa caused large, often enormous, weight gain in many patients, significantly increasing the risk of dangerously high blood-sugar levels and diabetes. They also showed that Lilly knew about the problems in 1999, largely through its own research. Other documents outlined a marketing scheme to encourage physicians to prescribe Zyprexa for elderly patients with early signs of dementia. This strategy not only had no clinical evidence to support it, it promoted an "off-label" use not approved by the Food and Drug Administration, a violation of federal law.

Lilly gave the original 8,000 plaintiffs ample incentive to settle. Those plaintiffs received substantial compensation, and by agreeing to secrecy, they surely avoided years of scorched-earth litigation, extremely costly in terms of time, money and emotion.

When secrecy is the price of a legal settlement, wrongdoers hide their mistakes as if they never happened and continue with business as usual. That's what happened in the Lilly case. The thousands of plaintiffs and dozens of lawyers involved in the 2005 settlements kept their part of the bargain, while Lilly continued to sell Zyprexa in huge quantities — a reported $4.2 billion in sales in 2005 — without warning either patients or doctors about the drug's dangers.

Part of the problem was that those plaintiffs had little control over their cases. They were consolidated — as these matters often are — in one huge federal case in which a committee of plaintiffs' lawyers has much more say over a settlement than in typical civil suits. In exchange for access to key Zyprexa data in the Lilly case, the committee agreed to a "protective order" that kept the information secret. That may have expedited things for their clients, but it was a public disservice.

Courts have the power to grant protective orders only to limit the disclosure of highly personal information and legitimate trade secrets. But when all the lawyers in a case agree, judges often grant protection even if the trade secrets in question show how the product does not work, not how it does. Neither lawyers nor judges should ever be party to such agreements. It is simply unacceptable as a matter of public policy to permit secret deals that conceal evidence of dangers to the public.

In the Zyprexa cases, the documents eventually were exposed when Alaska attorney James B. Gottstein, working on an entirely unrelated case, subpoenaed the records of one of the plaintiffs' expert witnesses. Gottstein not only used the documents in his lawsuit but, to his great credit, disclosed them to the New York Times and several health care groups.

Gottstein was almost immediately ordered to return all the documents he had, but the train had left the station: The New York Times published articles about the dangers of Zyprexa, and excerpts from the documents began appearing on the Internet. Within two weeks, with much of the Zyprexa evidence now out in the open, Lilly settled the additional 18,000 cases. Negotiated secrecy, Lilly's primary goal, had become moot.

Some intrepid plaintiffs and their lawyers refuse to play the secrecy game. In Northern California, plaintiffs in dozens of Catholic Church sexual abuse cases have banded together and refused to keep the names and whereabouts of molesters secret. And recently, Eva Rowe, who lost her parents as the result of an explosion at a Texas oil refinery in 2005, refused to settle with BP unless the oil company agreed to release the millions of documents obtained as evidence. Rowe and her lawyer hope the documents, which they say show how BP's underfunding and lackadaisical attitude created significant safety problems, will serve as an industry blueprint on how refinery safety should, and shouldn't, be handled.

Unfortunately, disclosure is still the exception. But we should have learned our lesson by now. From Zomax and Halcion in the 1980s to shredding Firestone tires and GM gas-tank fires in the 1990s, to Vioxx and Zyprexa today, when lawyers cut secret deals behind the public's back, what we don't know can and does hurt us. The civil justice system belongs to all of us, and no one should be allowed to use it to keep the public in the dark.

Richard Zitrin practices law in San Francisco and teaches at the University of California, Hastings, College of the Law. He is also the founder of the Center for Applied Legal Ethics at the University of San Francisco. He wrote this piece for the Los Angeles Times.

Merck Pharmaceutical Drug War Comes to Heartland -- First Vioxx Trial in Midwest Announced

The upcoming wrongful death lawsuit, Schwaller vs. Merck & Co, will be the first Vioxx case to be tried in the Illinois Circuit Court in Madison County and the first anywhere in the Midwest. It is possible that this case will set the tone for how Merck will handle cases in the future.

St. Louis, MO (PRWeb) February 12, 2007 -- The legal war between drug manufacturers and people who use the drugs has now moved into the heartland of America. The law firm of Brown & Crouppen www.BrownandCrouppen.com along with lawyers from the Watts Law Firm www.Wattslawfirm.com and Beasley Allen www.BeasleyAllen.com will begin the first Vioxx case to be tried in the Midwest beginning Tuesday, February 20th. . Until now most Vioxx cases filed against the giant drug maker Merck & Co. have been tried on the east and west coasts and New Orleans.

The Role of Litigation in Defining Drug Risks
"This is the first time that this war has been fought in the heart of America and it's possible that this case will set the tone for how Merck will handle cases in the future," said Andy Crouppen, attorney for Brown & Crouppen, the law firm representing the case of Schwaller vs. Merck & Co.

The upcoming wrongful death lawsuit, Schwaller vs. Merck & Co, Madison County ILL Case No. 05-L-687,will be the first Vioxx case to be tried in the Illinois Circuit Court in Madison County and the first anywhere in the Midwest. Brown & Crouppen has a long history in standing up for the consumer in drug litigation.

The case of Patricia Schwaller, a 52-year-old mother of two adult children, who died suddenly of a heart attack on August 8, 2003, will be tried by a trial team assembled by Brown and Crouppen consisting of Mikal Watts of The Watts Law Firm, Andy Birchfield of Beasley Allen and John Driscoll of Brown & Crouppen. She had been taking the drug Vioxx for just over 20 months. Schwaller was a long-time resident of Granite City, Ill in Madison County. Frank Schwaller, her spouse, is the plaintiff.

Merck, the number four (4) U.S. drug maker, withdrew Vioxx in 2004 when a study showed it raised the risk of heart attacks and strokes. Merck faces a reported 27,000 Vioxx lawsuits. So far Merck & Co. has gone to court with 13 plaintiffs.

"One must understand the importance of this type of litigation," said Crouppen, attorney for Brown & Crouppen. "The money awarded to the plaintiff might be a better 'headline,' but it is secondary to the thousands of lives it saves a year by ensuring that dangerous drugs are detected and either labeled or pulled."

A report by the Journal of American Medical Association (JAMA) January 17, 2007 titled "The Role of Litigation in Defining Drug Risks" seems to support this statement. A summary statement says "…limiting legal involvement in the prescription drug arena is likely to increase the nation's problem of poorly defined or inadequately presented drug risk information. These case studies indicate that clinical trials and routine regulatory oversight as currently practiced often fail to uncover important adverse effects for widely marketed products. In each instance, the litigation process revealed new data on the incidence of adverse events, enabled reassessments of drug risks through better evaluation of data, and influenced corporate and regulatory behavior. In performing these tasks, lawyers and their clients often find themselves serving as the drug safety researchers of last resort."

A love story-that has died- Patricia Schwaller graduated from Granite City High School in June 1969 and married Frank, her high school sweetheart, that same year. After discharge from the service, Frank often worked the night shift. Patricia would stay up to wake Frank in time for work and make his lunch - Patricia lovingly put mustard "hearts" on his sandwiches. During the last year or so of Patricia's life, her interests included her family, going to the theater with friends, relaxing in the pool, and enjoying a comfortable life-style with Frank. They had two children, Melissa and Jonathon, now grown. Frank has never recovered from Patricia's sudden death and the loss of the times they shared. He does not know what to do with his life. Patricia will be missed by many.

Other Vioxx lawsuits have alleged that Merck & Co. failed to heed warning signs about the cardiovascular risks of its painkiller before rushing it to market, alleging the drug maker failed to warn doctors and patients of the medicines harmful effects. Also, alleging that the popular pain-relieving drug Vioxx caused heart attacks.

Brown and Crouppen has a successful track record in Madison County, with a 19 million dollar verdict in a trial just two years ago. For more information about the firm and for daily updates on the progress of Schwaller vs. Merck & Co, please visit www.brownandcrouppen.com.