Lawsuits over anti-seizure drug Dilantin turn into a mini mass tort About 100 cases have been filed nationwide

By Sylvia Hsieh The Daily Record Newswire BOSTON, MA -- Litigation over the anti-seizure drug Dilantin has developed into a smaller-scale mass tort, with dozens of suits claiming that it causes horrendous and life-threatening skin burns. The suits allege that the drug, used to treat epilepsy and in hospitals and emergency rooms to prevent seizures following head injuries, causes Stevens Johnson Syndrome (SJS) and its more severe counterpart, Toxic Epidermal Necrolysis (TEN), where a patient's skin literally burns off. These conditions also lead to blindness, internal organ damage and sometimes death. Plaintiffs are proceeding individually and there are no plans to consolidate the litigation or petition for multidistrict litigation. Brandon Smith, a plaintiffs' attorney at Childers, Schlueter & Smith in Atlanta whose firm has filed 15 cases and is reviewing dozens more, estimated that about 100 cases have been filed nationwide and the total will be around 300. While the number of cases may be small, the damages involving the rare but severe condition could be big if past cases are representative. In October, a lawsuit filed by the family of a 9 year-old girl, Jesse Nichols Jacobson, who died after taking Dilantin for less than a month, settled against Pfizer for $3.78 million. "It's a nasty disease so there will be very sympathetic plaintiffs. Plaintiffs' lawyers are going to be interested in death cases, especially young kids with high pain and suffering [damages]," said James Beck, a products liability defense attorney at Dechert LLP in Philadelphia who co-authors a drug and device law blog. The lawsuits name Pfizer, the maker of Dilantin, as a defendant, in addition to eight manufacturers of the generic version phenytoin, including Mylan Pharmaceuticals and Baxter Healthcare. No cases have made it to trial yet. Plaintiffs' attorneys say Pfizer has resolved several cases for confidential amounts. 'It cooks you from the inside out' Dilantin had been on the market since the 1930s, prescribed as an anti-seizure drug for epileptics. The drug is also used as a precautionary measure against seizures for people who suffer head injuries. In some cases, it has been prescribed as a pain reliever for severe headaches when other drugs don't work, according to Keith Jensen, an attorney at Jensen, Belew & Gonzalez in Fort Worth, Texas, who represented Jacobson. An FDA safety notice issued on Nov. 24, 2008 first alerted lawyers to the problems with the drug, said Kenneth "Tommy" Fibich, whose firm Fibich, Hampton & Leebron in Houston, has filed several cases. Fibich said he has also reviewed cases involving patients who developed SJS or TEN after they were prescribed Dilantin for off-label uses, such as anxiety, panic attacks, mood stabilization and depression. Steven Johnson Syndrome typically starts with flu-like symptoms and then develops into a rash and burning of the skin, internal organs and mucosal areas, such as the eyes and throat, often causing blindness and liver failure. "It cooks you from the inside out," said Smith, who noted that SJS patients are often treated at burn units. "It's beyond third degree burns. It literally looks like they were thrown in a fire." A patient develops the more severe Toxic Epidermal Necrolysis when 30 percent or more of his or her skin burns off. In one case, Fibich alleges that phenytoin caused three-year-old Brendon Brown to develop TEN and lose his eyesight. The rare disease is estimated to affect 1,400 out of 1 million children and 900 out of 1 million adults, according to one study, Jensen said. African Americans and Asian Americans are particularly susceptible to the disease. This is thought to be because of a gene in certain people that kicks their immune system into overdrive when metabolizing the drug, killing off healthy skin cells at a fast rate. "There is a recognized genetic propensity for Asian and African Americans that put them at a higher risk than people of other ethnic backgrounds," said Fibich. With only a handful of drugs that cause the condition, plaintiffs' attorney believe they will have an easier time proving causation than in mass torts involving illnesses with a significant number of potential causes, such as cancer and heart disease. "SJS and TEN are always caused by drugs. If a patient only has Dilantin in their system, it's a pretty strong case of specific causation," said Jensen. As far as general causation, he claims that Pfizer's own expert medical director and the former director of the American Dermatological Association have admitted that Dilantin causes SJS and TEN. On the other hand, patients who have taken any of the other types of drugs that also are known to cause SJS and TEN, including some antibiotics, anti-gout medication and children's pain medication like Motrin, will have a more difficult route to causation. Chuck Socha, an attorney at Tucker Ellis & West in Denver who represents Pfizer, and Clem Trischler, an attorney at Pietragallo Gordon Alfano Bosick & Raspanti in Pittsburgh who represents Mylan, did not return calls seeking comment. Labels - foreign and local As part of their claims for failure to warn, plaintiffs' lawyers say they have evidence that Pfizer knew about the increased risks of SJS and TEN. Foreign labels on the drugs sold in countries such as Canada, the Czech Republic and the Netherlands contain stronger warnings, plaintiffs' lawyers claim. According to Jensen, those labels warned doctors and patients directly, through a patient insertion leaflet that the drug carries a higher risk of SJS and TEN for black people. Plaintiffs' lawyers question why the company would use a stronger warning in other countries, but fail to provide similar warnings in the United States, where the minority population is much larger. "I did my best to determine how many blacks are in the Czech Republic and the Netherlands, but the best I could tell is their census bureaus don't attempt to track them because they are so numerically miniscule," Jensen said. He added that as of last week Pfizer changed its label on its oral Dilantin medication to include warnings to doctors about higher risks to black patients, but it does not warn patients directly. The change has not been made on the tablet or IV forms of the drug, Jensen said. Plaintiffs' lawyers also contend that alternative anti-seizure drugs in the U.S. contain stronger warning labels than Dilantin. "A number of anti-epileptics have a full black box warning against this exact thing," said Jensen. For example, he noted that the anti-seizure drug Lamictal contains a black box warning that specifically warns against use in children unless a doctor thinks it is necessary. It also warns about the higher risk in certain ethnic subpopulations, recommending a blood test for those groups before taking the drug. "Dilantin should clearly have the same warnings," Jensen said. Published: Wed, Feb 9, 2011