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Long before James F. Early filed suit April 23 against drug companies that sold phenylpropanolamine, or PPA, he first put the case on trial inside his 10-lawyer New Haven, Conn., office. He has specific criteria he applies before embracing a potential case. A veteran plaintiff’s lawyer, Early began battling asbestos companies 22 years ago. Since then he’s also pursued lead paint claims, fen-phen and now PPA litigation. The cases he’s looked at and rejected are as revealing as those that make the grade. “First of all, if the injuries are not of a permanent nature, or if death isn’t involved, we probably would not get involved in it,” he says. Second, Early checks to be sure the defendants have deep pockets — otherwise it’s not fair to the plaintiffs, he says. INJURY AND MONEY William A. Ruskin, a pharmaceutical defense lawyer in Stamford, Conn., says deep pockets are at the top of the list. “Rather cynically, the first piece of the analysis is looking at who makes it, and if they’re well-insured and well-heeled, that makes them a good target. If they’re not, no matter how serious the side-effects might be, the plaintiff’s bar is not into crusading to keep those drugs off the market.” Ruskin says herbal and home remedies made by tiny companies may pose serious health risks, but are rarely targeted by plaintiffs’ lawyers. “You have lead, you have phenols in a lot of home medications,” he noted, but said they’re seldom the target of litigation. Early’s criteria avoids little-used medicines: “If there’s a drug [that] has affected a small number of people, then it’s something we might not be particularly interested in.” A large group of potential plaintiffs doesn’t by itself make a drug case attractive, Early says. For example, he says, “There’s a body of thought that the shots children get when they’re young cause autism — a very, very serious injury. It comes from the mercury used in some of those injections. Yes, the injuries are severe. Yes, the population it reached is very significant. But when we looked into the medicine, it just didn’t warrant our going ahead at this point.” Similarly, he also avoided cases involving electromagnetic fields. But in the case of PPA, a significant drug industry-financed study by Yale scientists was published in the New England Journal of Medicine last fall. It indicated that people who use cold remedies and diet drugs containing PPA, such as Robitussin, Tavist-D and Dexatrim, could be at risk of hemorrhagic stroke. Early’s client, David Edwards, suffered a hemorrhagic stroke in November 1996, after using those cold remedies and diet pills. Edwards, of Windsor, Conn., is suing the manufacturers of the three drugs, along with Stop & Shop markets and Arthur Drug. The Yale scientists’ article resulted in the drug companies voluntarily removing PPA from the products. “I think it’s a great study for plaintiffs,” says Early. CAUSATION, CAUSATION, CAUSATION Evidence of injury on a broad statistical basis isn’t proof that the drug in question caused the plaintiff’s injury, notes Ruskin. “There are a lot of factors that cause stroke,” Ruskin noted. But, he asks, is there a causal link clear, or is it just coincidence? “There are also a lot of stroke victims among the people who drink Coca-Cola.” Ruskin cited the silicone breast implant cases as an example of weak proof of causation. Two prominent federal judges appointed scientists to weigh the studies, and they concluded the science did not link the implants to the injuries claimed. A final factor in Early’s analysis is the relative usefulness of the drug, compared to its risk. In Early’s evaluation, PPA had a relatively minor usefulness as an ingredient, and wasn’t unique. It was quickly replaced with pseudoepehdrine in many formulations, he said. Under year 2000 amendments to new Federal Rules of Evidence 701 and 703, courts can make a preliminary evaluation of the underlying medical science, Ruskin said. He added that “cases that would have been taken 10 years ago are being rejected out of hand now, because plaintiffs are making the same analysis that the courts are going to make. They don’t want to spend hundreds of thousands of dollars on a case, only to have some judge find it’s junk science. They’re much more careful.” Ethan A. Early, James’ son and an associate in the New Haven office, said a firm can waste irreplaceable lawyer time if its case can’t withstand threshold scientific scrutiny, he said. But in light of established medical findings and evidentiary rulings in the case of PPA, he says, “that challenge has been met.”

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