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Name and title: Lawrence V. Stein, senior vice president and general counsel Age: 55 The company: Wyeth, a research-based pharmaceutical and biotechnology company, serves the health needs of people in 145 countries from its headquarters in Madison, N.J. It has four primary segments: pharmaceuticals being the largest; consumer health care, featuring household products including Advil, Centrum and Chap Stick; Fort Dodge, specializing in animal health products; and Wyeth Research, which focuses on developing vaccines, therapies and products in areas such as infectious diseases, internal medicine, immunology and oncology. The company’s reported 2004 net income of $1.234 billion placed it No. 125 on the Fortune 500. Wyeth has 51,401 employees worldwide. Legal team and outside counsel: Stein’s law department numbers approximately 110 attorneys, augmented by another 20 who practice with overseas affiliates. There are also separate sections of tax and employment lawyers. Among his team are a group that represents the research apparatus, and three Food and Drug Administration (FDA) specialists. The head of litigation also provides legal support for the company’s outside insurers. General Counsel Stein reports to Robert A. Esser, Wyeth’s chairman, president and chief executive officer. Stein estimated that 95% of the legal group’s expenses are concentrated outside, noting that “We send a huge amount of legal work out because we are involved in massive litigation.” He chooses external counsel from a diversity of firms: Arnold & Porter, Williams & Connolly, and Finnegan, Henderson, Farabow, Garrett & Dunner, all of Washington; Reed Smith; Wilmer Cutler Pickering Hale and Dorr; Nelson Mullins Riley & Scarborough of Columbia, S.C.; New York’s Simpson Thacher & Bartlett; Jones Day; and Gordon & Rees of San Francisco. Daily duties: Stein calls himself “a generalist who gets involved in the full range of stuff we do.” By far the biggest amount of his time is spent on the “very demanding and time-consuming” litigation faced by Wyeth. Some hours are devoted to compliance matters related to the Sarbanes-Oxley Act of 2002, although many of those responsibilities have been “dispersed.” He works on issues involving FDA regulation and he has “a whole dedicated team” that provides advice on laboratory protocol, including relevant government and industry standards, informed consent, clinical contracting and relationships with clinical sites. Stein retains an interest in mergers and acquisitions, and tries to keep his hand in such matters. If a particularly thorny issue arises, he will get involved in Wyeth’s “very formal” copy-clearance program for its pharmaceutical advertising. He participates on a “macro level” in terms of policies and trends on the employment side, and also keeps abreast of individual cases. He signs off on all settlements and litigation as well. Stein draws on outside counsel for their expertise in foreign laws and uses resident counsel stationed in Wyeth’s affiliates for the same purpose. Diet-drug debacle: Litigation spawned by products liability is Stein’s major area of concern. Wyeth faces a number of mass torts involving pharmaceuticals used in hormone replacement therapy, its vaccine-preservative thimerosal and a decongestant called TPA. But “of a magnitude and in a class by itself” is the nationwide “diet drug” or “fen-phen” litigation generated by the company’s sale and marketing of obesity treatments Redux (dexfenfluramine) and Pondimin (fenfluramine), which the company has voluntarily withdrawn at the behest of the FDA. When used in combination, the medications are alleged to have led to pulmonary hypertension and heart valve thickening. To this point, Wyeth has reserved more than $21 billion to satisfy potential liability. A multibillion-dollar nationwide class action settlement with Wyeth received final judicial approval on Jan. 3, 2002, in the U.S. District Court for the Eastern District of Pennsylvania ( Sheila Brown v. American Home Products). Ten class actions have been filed in jurisdictions including New York, New Jersey, Vermont, Pennsylvania, Florida, Kentucky, Indiana, Arizona, Oregon and Arkansas. There are still 60,000 individual fen-phen cases pending. Thimerosal is a mercury-containing preservative used in vaccines since the 1930s. A known neurotoxin, thimerosal has now been allegedly linked to the growing rate of autism and learning disabilities in children. In 1999, the FDA requested that manufacturers remove the compound from pediatric vaccines, but it remains in use, and its potential for harm, debated. ‘A great job’: Having experienced the job from both sides of the coin-as general counsel of a small, entrepreneurial company and as the chief legal officer of a huge, multinational firm-Stein considers being a GC to be “a great job.” He is proud that in both sets of circumstances, he was able to construct law departments that “rival the best law firms” in terms of their quality and dedication. He also praised Wyeth’s efforts to resolve the “fen-phen” matter. Stein touts the importance of pharmaceutical companies, but admitted it is a “difficult time for the industry.” He acknowledged “public perception problems,” and he feels that companies such as Wyeth are unfairly demonized. Route to the top: Stein holds three college degrees: a bachelor’s from Columbia University (1971), a master’s from Cornell University (1974) and a juris doctor degree from the University of Pennsylvania Law School (1976). Upon leaving academia, he joined Arnold & Porter in Washington, where he practiced from 1976 until 1992. Principally a litigator, late in his tenure he specialized in regulatory work for pharmaceutical companies. His next stop was Cambridge, Mass.-based biotech company Genetics Institute, for which he served as senior vice president and general counsel. In 1996, Genetics was acquired by then-American Home Products, now Wyeth. Stein, who performed as chief counsel for the combined pharmaceutical businesses of Wyeth and Genetics Institute, became Wyeth’s deputy general counsel in 2001 and ascended to GC status in 2003. Personal: The Newark, N.J.-born attorney is married to Donna Baier Stein, and is the father of Jonathan, 19, and Sarah, 14. He plays golf in his spare time. Last book and movie: The Piano Teacher, by Elfriede Jelinek; and Sideways.

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