Pensacola, FLPeter Kaufman, a shareholder partner in Levin, Papantonio, Thomas, Mitchell, Echsner and Proctor, P.A., describes his practice as "almost exclusively pharmaceutical litigation on behalf of plaintiffs." He's been involved in litigation around Baycol, phenylpropanolamine (PPA), and Vioxx, as well as in three successful personal injury suits against Roche Pharmaceuticals for their "last resort" acne drug Accutane.
In the most recent case, a state court jury in Atlantic City, New Jersey, ordered Roche to pay plaintiff Kamie Kendall more than $10.5 million in compensatory damages—the largest Accutane award to date. Kendall suffered ulcerative colitis as a result of using Accutane between 1997 and 1999.
Kaufman says, "The case was tried by a four-lawyer team; Mike Hook of Hook Bolton and I handled the witnesses. There's no question that Mike was the lead lawyer; he opened and closed the case. In cases like this, you almost need that sort of collaboration.
"Roche only called two witnesses but had seven listed. They tried to make the case as complicated as possible, so they identified an FDA expert, a retinoid biologist, a gastroenterologist, and a dermatologist, and at various times told us they would call two to four company witnesses. Just to cross-examine requires a couple of lawyers. When you compare it to the defense team, the plaintiffs are nearly always outnumbered at these trials. They had a lot of lawyers—they always do."
At trial, however, Roche only called two witnesses. "Maybe they thought they were ahead, but if that was their impression they were drastically mistaken," Kaufman observes .
Kamie Kendall first took Accutane in January through April 1997, then again in July 1997 and in 1998. "Her dermatologist said it was off label, but it was barely off label in this case," Kaufman says. "Accutane is indicated for severe recalcitrant nodular acne; she had cystic scarring acne, which is pretty close to that, so the off label issue wasn't a feature of the case."
In 1999, Kendall was diagnosed with ulcerative colitis. According to Kaufman, "Her entire large intestine, her entire colon, was removed. That was the only way to contain the disease, but she'll have this condition the rest of her life; it's a profoundly serious injury. There's no question that this was a known potential side effect of using Accutane, but Roche downplayed the risk for so long. That's what we argued and that's what the jury agreed. Her dermatologist was quite a good doctor and was aware of the indications; he just wasn't aware of the true risk of inflammatory bowel disease." Ulcerative colitis, along with Crohn's Disease, is one of the major forms of IBD.
According to Kaufman, in 1994, Roche undertook causality assessments to determine the risk of IBD from Accutane. He says, "They determined that in 33 cases Accutane was possibly or probably causally related. Now that was an enormous signal, and they should have reported it to the FDA, but they didn't. They didn't change the drug's labelling, either. Their labelling said that Accutane had been temporally associated with IBD, which meant that you might have symptoms while taking it, but not that you could get a life-changing permanent disease, and that was really the problem."
The trial started March 31, 2008 and lasted three and a half weeks; the heart of the case, Kaufman says, was Roche's failure to warn doctors and patients adequately of the IBD risk. On that basis, the jury awarded $10.5 million for pain and suffering and $78,500 for medical expenses.
In the aftermath, Kaufman says of Accutane, "It's a very dangerous drug—it causes birth defects, it causes psychosis, it causes IBD. When you've got a drug like this you shouldn't mince words at all, which is at the heart of the case. No question that's been our point, and in three cases, we've won $2.5 million, then just over $7 million, then now almost $11 million. That's closing in on $20 million in three verdicts."
With more than 400 similar cases pending, will Roche move to settle rather than go to trial? Kaufman says, "In these cases, as opposed to something like a Vioxx heart attack case where a jury may see someone who's fully recovered, they see people with severe permanent damages. Many of the plaintiffs present very well, the jury hears what the company did and didn't do, and they say, 'That's not right.' If Roche persists in trying these cases, we'll show up, we'll work as hard as we did on the first three, and we'll see how it shakes out."
Peter Kaufman is a member of Levin Papantonio's Mass Tort department. A 1996 graduate of the University of Wisconsin, he received a JD from the University of Florida's Fredric G. Levin College of Law in 2001. A US Army veteran and graduate of the Defense Language Institute, Kaufman served with the 3d Armored Division, 533d Military Intelligence Battalion in Operations Desert Shield and Desert Storm in 1991.