Can Roche Handle the Truth? "A Few Good Men" Case Could Expose Acne Drug Dangers
A lawsuit filed by one of the stars of "A Few Good Men" -- the movie in which Marine Corps commander Jack Nicholson bellows "You can't handle the truth!" at Tom Cruise's trembling Navy prosecutor -- could expose much of Roche (ROG.VX)'s dirty laundry on the acne drug Accutane. Roche has not done much to publicize the extent of its potential liabilities on Accutane. Although the company faces perhaps as many as 5,000 cases, it makes no mention of its liabilities in its annual or half-yearly reports. And legal documents in the case show Roche began to notice bowel problems in its patients as early as 1985.
The actor James Marshall (pictured at right) has lined up Martin Sheen and Brian Dennehy, along with "A Few Good Men" director Rob Reiner to testify for him:
... [They] will testify that Marshall, 43, was headed for stardom before bowel ailments allegedly caused by Accutane forced doctors to remove his colon, ...The Hollywood heat will not be good for Roche, which stopped marketing Accutane last year when legal costs outstripped the profits it was making on the drug. How bad things might get for the company is an open question, however, as Roche has not told its investors how big the scale of the Accutane problem is. Bloomberg says the company faces "thousands" of cases and has lost seven of them so far in which courts have ordered the company to pay a total of $45 million. This web site, run by plaintiffs' lawyers, says Roche faces 5,000 cases -- or about $32 billion in potential damages if that run-rate kept up.
Roche marketed the drug from 1982 until 2009, but internal Roche documents show that scientists at the company began documenting bowel problems as early as 1985, according to a ruling in one of the New Jersey cases. At the time, the warning on the drug was inadequate, judge Carol Higbee ruled:
The Court accepts plaintiffs' testimony that they did not read the warning on the blister pack as true. However, even if the plaintiffs did read the warning on the blister pack, the warning is not enough to connect their prior use of Accutane with their IBD. The warning advises the patient to stop taking Accutane if he or she develops certain gastrointestinal symptoms while taking the drug. The warning does not advise the patient that if he/she may develop IBD even a year or two after taking Accutane, or that if they develop IBD it will be too late as there is no cure for IBD. It is a permanent condition. In fact, the blister pack doesn't even mention IBD, which is a serious disease much different than about of diarrhea.Although Roche no longer sells Accutane, several much less reputable companies continue to churn it out, and it's also available online. Given that the drug is incredibly poisonous -- it can kill a baby in utero -- it's a wonder the FDA isn't looking at whether to restrict the drug's marketing further, especially as new research suggests it works at much lower than approved doses.
Related:
- Acne Drug Accutane's Side Effect Is Death. So Why Is It Still on the Market?
- Roche's Accutane: Suit Over Death of Congressman's Son Nixed