From the outset of the fen-phen litigation in 1996, knew it would push the limits of science, medicine, and law. The case quickly grew into one of the largest mass tort actions in American legal history, with 45,000 women claiming to have developed serious heart and lung conditions from taking the popular diet drugs.
It would take four years, but Resnik would win a giant legal victory for his client, Fisons, the company that sold phentermine, half of the popular diet drug combination.
PHOTO: NY TIMES
Science emerged in Fisons' favor. Studies linked fenfluramine, not phentermine, to the deadly side effects, and Fisons was dismissed from the case.
The litigation continues against the maker of fenfluramine, American Home Products (now Wyeth), and to cover its anticipated costs, the company has set aside about US$14 billion.
The victory barely behind him, the Boston attorney embarked on yet another high-profile case -- this time, defending Garst Seed Co, the seller of the genetically modified Starlink corn that sneaked, unapproved, into the nation's food supply two years ago. Like the fen-phen litigation, the Starlink cases promise to play out in courts across the nation, once again bumping into the boundaries of science, law, and regulation.
"Fen-phen and Starlink are cases where the hysteria and fear got ahead of the science," said Heidi Chesley, a partner at McDermott, Will & Emery who works with Resnik on both cases. "The litigation is unfolding as the science unfolds. Complaints are filed before anyone really knows what is going on. And on the defense side, you don't know what is going to unfold either."
Starlink, a variety of corn genetically altered to poison small inchworm-like pests known as corn borers, had only been on the market three years. In an unprecedented move, regulators had approved it for animal and industrial uses, but not for human consumption. In September 2000, however, the corn began showing up in places and products where it didn't belong, including taco shells, corn chips, breweries, and muffin mix. The discovery grabbed headlines, fanned fears of allergic reactions to corn products, created hassles for corn growers, grain-elevator operators, and food processors, and gave rise to more than 300 product recalls.
Although there is no evidence of serious physical harm from eating Starlink, numerous lawsuits have been filed against Garst and Aventis CropScience, the company that invented and licensed Starlink to Garst.
Hundreds of millions of dollars are hanging in the balance. Aventis has already taken a US$100 million charge against last year's earnings to account for costs related to the Starlink contamination, including a program intended to reimburse farmers for added costs associated with the contamination.
A class-action suit brought by consumers who purchased the recalled food products cost US$9 million to settle. And nearly 30 other cases are pending in multidistrict litigation that has been consolidated in a federal court in Chicago.
Although the public controversy over Starlink has largely quieted, issues regarding the regulation of genetically modified corn and other crops continue to emerge. Against that backdrop, Resnik and other attorneys involved in the case are busily filing legal briefs and deposing witnesses as the cases slowly march toward trials, which could begin as early as spring 2003 or as late as 2004.
David AP Brower, a partner with Wolf Haldenstein Adler Freeman & Herz in New York who represents corn growers, doesn't believe Garst has a viable defense to claims that farmers suffered economic losses because of Starlink contamination. But he acknowledges that Resnik is a formidable opponent.
"His client has no defense," Brower said. "The only thing going for his client is Peter Resnik."
As head of the trial department in McDermott, Will & Emery's Boston office, Resnik is spearheading the firm's nationwide defense of Garst in the Starlink corn case, managing a team of more than a dozen lawyers within the firm as well as dozens more outside the firm. Over nearly two decades, Resnik has built a nationally recognized practice of defending pharmaceutical and biotech firms in product liability cases.
The work is demanding -- and becoming more so, as suits like fen-phen and Starlink rapidly grow into large mass tort litigation. Because the cases are filed in numerous jurisdictions, the logistics alone become daunting. The hours are long, and the travel frequent. And his clients are often portrayed as corporate villains who care more about profits than the well-being of people.
Points of view
Not surprisingly, Resnik sees things from a different vantage point. Scientific and medical advances have always relied on a balancing of risk and benefit. No drug -- no scientific advance -- is free of risk. Even the most benign of drugs, such as aspirin, carry potentially serious side effects. Villainizing drugs or biotech products such as Starlink, Resnik argues, can rob the public of their potential for good.
"A distorted picture of the value of pharmaceuticals, of the good that pharmaceutical companies do, isn't in the public's interest," Resnik said. "If you look only at the plaintiff's side, you get a distorted picture. It's important that these issues be placed in context so good products are not taken away from the public based on unfounded or distorted fears."
Resnik's interest in pharmaceutical and biotech product liability cases was born in the mid-1980s, nearly two decades after he began working as a commercial litigator. At the time, the asthma drug theophylline was the target of a lawsuit. The drug was widely used in children with cases of severe asthma. In high doses, however, it could cause brain damage, and even death.
Resnik had seen the drug's benefits firsthand in one of his own children, however, and he believed that theophylline, when used correctly, saved lives and eased the symptoms of severe respiratory disease. He took on the drug's maker as a client, put together a team of attorneys, and enlisted a group of top physicians and scientists to testify about the drug. Dozens of cases had been filed. Many were dismissed on pretrial motions. In other cases, Resnik's team showed that other factors, aside from the asthma drug, had caused the medical complications. And the remaining cases were settled.
The case laid the foundation for what would become Resnik's approach to litigating such cases -- one focused on teamwork, depending on solid science, and informed by a keen instinct for legal strategy.
By the time the fen-phen litigation came around, Resnik was ready. As he had many times before, he formed a team of attorneys he trusted, including Chesley and Don Frederico, to hash out the legal and scientific challenges.
He recruited nearly 140 specialists -- obesity doctors, pharmacologists, neurologists, cardiologists, pulmonologists, anyone who could help decipher and explain the science behind fen-phen.
Chesley managed the extensive network of expert witnesses and local attorneys working on the case; Frederico was assigned to weed out the good science from the bad and keep the bad science from being presented to a jury. By the time Fisons was dismissed as a defendant in the fen-phen litigation, opposing lawyers led by another Boston attorney, Alex H. MacDonald, chairman of the mass tort group at Robinson & Cole, were relieved. MacDonald said Resnik's group had the toughest attorneys and the best experts on their side.
Resnik's strength as an adversary, MacDonald said, is his ability to harness the talents of a first-rate team of attorneys. He is always prepared, he understands the "real world" of the court room, and never gets lost in legal theory, MacDonald said. And as vehemently as MacDonald disagreed with Resnik's legal position, he said Resnik is a hard man to dislike.
"He is a very, very able guy," MacDonald said. "This is his niche. He's been working at least 20 years on pharmaceutical litigation. He's been present as the phenomena of mass tort pharmaceutical litigation has evolved to its present level of organization, and that gives him among the longer track records in Boston, if not the country, in this sub-specialty."
Starlink has been blamed for outbreaks of hives, depressed crop prices, and with stigmatizing more than 100 Taco Bell outlets after Starlink corn was found in Taco Bell brand taco shells sold in grocery stores.
Wierd science
One by one, Resnik carefully unravels the claims. The science, he said, is again emerging in his client's favor. A study by the Centers for Disease Control uncovered no evidence of allergic reactions to Starlink in people who suspected they had eaten the corn. Starlink and non-Starlink farmers whose crops were contaminated were compensated by Aventis for the costs of diverting those crops for use as animal feed. So how, Resnik asks, can they claim additional damages?
He argues that the law of supply and demand runs counter to the allegations made by farmers whose crops were not contaminated that they suffered economic losses from an overall drop in corn prices. Starlink-free corn should have reaped a premium at a time when other corn supplies were contaminated.
And he describes Taco Bell's claim as "novel legal theory," saying it is unrealistic to hold Aventis or Garst responsible for stigmatizing Taco Bell when Starlink was never found in its restaurants.
With a spring trial date possible in some of the cases, many of these issues are likely to be hashed out over the coming months. And Resnik will have to counter arguments from his adversaries that Garst was negligent in informing corn growers about the restrictions placed on Starlink corn and that by failing to keep the corn out of the food supply, the company created a fiasco that depressed corn prices, gave rise to bans by two of the largest importers of American corn, and placed undue burdens on America's corn growers.
"Defendants always want to say the plaintiff has novel claims, but in essence, these are garden variety public nuisance claims," said Brower, who represents a class of about 425,000 corn growers. "Peter has a narrow view of the world. I'm not sure his arguments will fall on very receptive ears in Iowa, southern Illinois, Indiana, Kansas, and the like, where these cases will be tried." Naomi Aoki can be reached at naoki@globe.com.
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