Wonder Drug or Killer?

Wonder Drug or Killer?

By Janet Leiser

Senior Editor

As the American psyche still reeled from the devastation of 9/11, a teenager, suicide note in pocket, flew an airplane into the 28th floor of a downtown Tampa office building.

It was Jan. 5, 2002.

Charles Bishop, a 15-year-old student pilot from Palm Harbor had taken his own life in support of Osama bin Laden. At least that's what he wrote in his suicide letter.

His mother, Julia Bishop, and grandmother, Karen Johnson, and their attorneys, blame his bizarre behavior on an acne drug.

They contend Accutane can cause psychosis weeks or months after a person stops taking it, and they want Roche Laboratories and Hoffman-LaRoche, subsidiaries of Switzerland-based Roche Group, to pay $70 million in damages.

The wrongful death lawsuit, filed in 2002, claims the company manufactured an unsafe drug, used ineffective warnings and under-reported the link between the drug and suicide.

Bishop and Johnson are the lead plaintiffs in more than 20 lawsuits from across the country consolidated through multi-district litigation (MDL) in Tampa federal court. U.S. District Judge James Moody and Magistrate Thomas McCoun are deciding all pretrial issues in the cases.

Plaintiff's lawyers requested the Tampa MDL, and a panel of judges approved it, even though defense lawyers objected to it being based in Tampa, says plaintiff lawyer Michael Lynch of Orlando's James Hooper PA.

"They did not want it here," Lynch says. "They wanted it almost anywhere else."

The MDL helps the lawyers, defense and plaintiff, work more efficiently with less duplication, says Michael J. Ryan, one of the attorneys who represents Bishop and as many as 100 Accutane plaintiffs.

"It also coordinates the discovery that's being provided so that all plaintiffs get the same discovery materials," Ryan says. "Everyone is on the same playing field."

The Bishop case, set for trial next July likely will be the first federal Accutane lawsuit. Ryan says about 150 Accutane lawsuits are pending in New Jersey state court, where Roche is based. He's also co-counsel in many of those lawsuits.

Roche, whose lead attorneys in the federal litigation are Edward A. Moss of Miami's Shook, Hardy & Bacon LLP and Bonnie L. Gallivan, has said repeatedly there's no scientific evidence to tie Accutane to depression or suicide. In fact, the company says statistics show suicides are fewer among Accutane users than the general population.

Earlier this year, Roche won a victory when the judge agreed with its request that documents released through discovery remain confidential unless made part of the court record.

Those documents, expected to exceed one million, are being kept at Ryan's firm Krupnick, Campbell, Malone, Buser, Slama, Hancock, Liberman & McKee PA. The Fort Lauderdale-based firm, the official repository for the MDL, sorts and organizes the documents and makes them available to plaintiff lawyers.

Ryan accuses Roche of trying to keep information about what it knew and when it knew it from the public. "Roche stamped every document confidential, even if it was a newspaper article," he says.

Plaintiffs' lawyers, including J. Michael Papantonio, Michael D. Hook and Terrie L. Didier, all of Pensacola, Michael Lynch of Orlando and Paul L. Smith of Austin, Texas, objected to the documents being kept private.

"We actually said we think parents, physicians and neighbors should know what we know - what evidence there is that this drug causes side effects," Ryan says.

"We feel very strongly that Accutane caused Charles' death," Ryan adds. "It does terrible things to good kids. It's difficult to see something like this happen when you kiss your son or daughter goodbye in the morning and without any warning they commit a horrendous act of violence or suicide that afternoon."

Heated debate

It sounds so simple: a medication based on a derivative of vitamin A that cures severe acne for life after only four months of use. But Accutane, known generically as isotretinoin, has been associated with birth defects since it was introduced in the United States in 1982 to treat recalcitrant cystic acne, which can leave long-lasting emotional scars as well as pockmarks.

In 2000, Accutane sales totaled $759.4 million or 8% of Roche's prescription sales, according to reports. But Roche sales of the acne drug have declined since competitors introduced generic versions in the past couple of years. This year, analyst Bank Leu expects Accutane sales to reach $243 million or 1% of Roche's pharmaceutical sales.

"They now sell more of this drug overseas than they do in the U.S.," Ryan says.

Earlier this month, the FDA announced it was starting a national registry to limit access to isotretinoin by women who might be pregnant or become pregnant. If a woman becomes pregnant while taking the drug or soon after stopping it, her baby can suffer brain and heart defects, mental retardation and other abnormalities.

Under the new rules, there are requirements for a physician to prescribe the drug, a pharmacist to fill it or a patient to use it. Women must undergo pregnancy tests prior to taking isotretinoin and agree to use two forms of birth control while on it or abstain from sex.

Ryan contends physical ailments linked to use of the drug run the gamut - from psychosis to gastric problems. "This is a company that in the early '80s, they were recommending abortions to physicians whose clients became pregnant while taking Accutane," Ryan says. "This was all about money. This drug has been wildly over-prescribed. It has been the top-selling drug for Roche worldwide for years. And in the meantime, children with horrible defects are being born. Women are having abortions. Families are being wrecked - all in the name of profit."

Physicians, especially dermatologists, have not fully realized the danger of the drug, Ryan says. "It is prescribed by dermatologists who run into side effects that all of a sudden require these dermatologists to be experts in childhood psychology, gastrointestinal and kidney disease, bone defects, cardiac side effects and on and on, all for a five-minute visit regarding acne," Ryan says.

The plaintiffs' firms are investing thousands of hours to take on Roche, all with no guarantee of a win.

"It is a risk," Lynch says. "If pharmaceutical companies are going to be kept in check, you need lawyers who are willing to do this."

But the firms also might strike it big.

Look at the recent $253 million jury verdict against Merck & Co. over Vioxx, a painkiller.

The jury in Angleton, Texas, ordered Merck to pay damages to the family of Robert Ernst, a 59-year-old Wal-Mart Stores Inc. manager who died in 2001 after taking Vioxx for eight months.

Based on the typical flat fee of 33%, that's about $83.5 million for the lawyers, if the verdict isn't overturned or cut.