Raptiva readying for first court trial.

[Hanna]

Genentech Inc. is facing the first trial of patients’ claims that its withdrawn Raptiva psoriasis drug spawned fatal infections in some users.

Officials of Genentech, a unit of Basel, Switzerland-based drugmaker Roche, are readying for a Jan. 30 jury trial in state court in California over allegations that Raptiva caused Stephen Johnson’s death. The 46-year-old Louisiana businessman took the drug to treat a skin condition. Genentech withdrew the medication from the market almost three years ago after it was linked to fatal brain infections.

“Psoriasis isn’t life-threatening and his wasn’t even that horrible,” Mark Lanier, a lawyer for Johnson’s family, said in an interview. “This drug was never about the patients. This drug was about the money.”

Genentech, based in South San Francisco, California, began withdrawing Raptiva from U.S. and European markets in April 2009 after three psoriasis patients were diagnosed with progressive multifocal leukoencephalopathy, or PML, a rare, incurable brain infection. The month before the withdrawal, Roche completed a $46.8 billion buyout of the biotech company.

Nadine O’Campo, a Genentech spokeswoman, declined to comment on the upcoming Raptiva trial. “Given this litigation is ongoing, we are not commenting,” she said in an e-mailed statement.

Psoriasis is a disease that leaves sufferers dealing with red, itchy skin lesions, lawyers for Johnson’s family said in court filings. Johnson had taken the drug for almost five years before his death in January 2009, the filings show.

Damages Sought
Genentech officials estimated in 2009 about 2,000 U.S. patients were taking the drug when the company began pulling it from shelves. The medication, which generated $108 million in sales in 2008, had been used by an estimated 46,000 patients worldwide. The psoriasis treatment was approved for sale by the U.S. Food and Drug Administration in 2003.

Johnson’s case is the first of about 100 Raptiva suits that have been consolidated before Judge Steven Brick in state court in Oakland, California. Lanier said there are other cases in federal and state courts in Texas and Massachusetts.

The family is seeking $15 million in compensatory damages over Johnson’s death along with “several hundred million dollars” in punitive damages, Lanier said.

Weakened Immune System
Johnson’s wife contends the businessman, who owned a medical-supply store in a suburb of New Orleans, was healthy when he started taking Raptiva to treat his psoriasis and the drug weakened his immune system to the point that he developed a fatal infection.

Doctors at an emergency room in Kenner, Louisiana, noted that Johnson’s death was likely caused by “overwhelming sepsis complicated by the fact that patient was relatively immunosuppressed from his Raptiva,” according to a Jan. 5 court filing.

Lanier and other lawyers for former Raptiva patients contend in the cases that Genentech officials downplayed the medication’s health risks and failed to alert regulators about a patient’s death in 2004 from the same kind of infection that claimed Johnson’s life five years later.

To boost the drug’s prospects, Genentech officials hired an FDA regulator who was responsible for with monitoring Raptiva’s development and discussed “paying the official up to $30,000 to buyout out his contract,” Susanne Scovern, another lawyer representing Johnson’s family, said in a court filing.

The former FDA official, Dr. William Schwieterman (CHTP), later left Genentech and now serves as a consultant to biotech and pharmaceutical makers, Scovern said in an interview.

The biotech company also failed to disclose an internal 2007 analysis that found Raptiva users were five times as likely to get types of pneumonia infections as the general population, Scovern said in the filing.

The case is Johnson v. Genentech Inc., RG 10-494957, California Superior Court, Alameda County (Oakland).

Source: bloomberg.com

I wondered why I hadn't heard much about that drug lately.........scary stuff