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NAME AND TITLE: Catherine L. Ruster, general counsel AGE: 36 ANTHRAX ALERT: On Oct. 5, 2001, Robert Stevens, a mailroom employee of tabloid publisher American Media Inc. of Boca Raton, Fla., died of inhalation anthrax. More than 1,000 miles north in Lansing, Mich., the first reports of Stevens’ illness sent shock waves through BioPort Corp., recalled General Counsel Catherine Ruster. The 220 employees of BioPort, the nation’s only producer of anthrax vaccine, did not need CNN to tell them about anthrax and its deadly effects. The anthrax virus occurs naturally in cattle and sheep, and the company had previously shipped its vaccine to contain livestock-based outbreaks. “But this was completely different,” said Ruster. “We didn’t know whether this was going to be a doomsday scenario. Was it going to be spraying [anthrax] in the subway?” In the next days, anthrax-laden letters in Washington, D.C., and New York claimed four more lives, shut down Capitol Hill and caused a nationwide panic. The mood at BioPort, though, turned from fear to pride and resolve, said Ruster. “It brought home why we do this — why we keep coming back every day, even though there are people publicly telling us that we’re incompetent or that we make a dangerous product,” Ruster said. As a national spotlight shone on BioPort, however, it proved troubling for the company and controversial for the federal government. At the time of the attacks, BioPort’s vaccine production was in suspension. BUYING A PROBLEM: When the state of Michigan sold its vaccine-production facility to BioPort in September 1998, the small company bought itself some big headaches. In March 1997, the U.S. Food and Drug Administration (FDA) had threatened to revoke Michigan’s vaccine-production license over compliance lapses. The state had shut down production for facility upgrades to meet FDA standards. It wasn’t until January 2002, months after the anthrax attacks, that BioPort received final FDA approval to resume vaccine production at the renovated facility. “[W]hile everyone was gratified — that there is an anthrax vaccine,” Ruster said, the focus in the autumn of 2001 had been on FDA regulatory problems and old lawsuits over the vaccine. “The fact that BioPort inherited these issues, and is the one that is resolving them, really got lost,” she said. BACKGROUND: BioPort is a privately held company, formed to buy and operate the state of Michigan’s privatized vaccine-production facility in Lansing. The company does not disclose its annual revenues. Shortly after the Sept. 11, 2001, attacks, the Michigan National Guard was temporarily dispatched to guard BioPort’s 12-acre campus in north Lansing, which is now ringed with concrete barriers and concertina wire. RUSTER’S ROLE: With the help of associate corporate counsel Juan Balboa, Ruster handles litigation management, contract review, business development and corporate-governance matters. Ruster also helps her colleagues work with the FDA on regulatory-compliance issues, and cooperates with the FBI and other federal authorities on security and law-enforcement matters. SAFETY CONCERNS: The FDA approved the anthrax vaccine for human use in 1970, but it was not widely used outside the agricultural setting until the 1991 Persian Gulf War, when the U.S. military began inoculating soldiers as a precaution against Iraq’s biological weapons. In 1997, the Defense Department announced plans to immunize all active-duty service members. This mandatory program has sparked controversy about the vaccine’s safety, with some veterans charging that the product has caused an array of serious medical problems. According to Ruster, scientific studies have consistently shown that the anthrax vaccine is safe and effective. There have been 1,850 “adverse event” reports from the 2 million doses of anthrax vaccine administered between 1990 and October 2001, including reports of six deaths. None of the fatalities has been causally linked to the vaccine, said Ruster, and the overwhelming majority of other reports involve temporary side-effects — such as muscle aches and skin inflammation — that are common for any subcutaneous injection. “If you take any group of people — and 500,000 servicepeople have been immunized — you are going to have some people who develop … leukemia and all sorts of horrible things, just like the ones who did not receive the vaccine,” she said. LITIGATION: In its contract with the Defense Department, BioPort secured the government’s pledge to pay its defense costs and liability related to the anthrax vaccine. That indemnification clause has proven to be a critical contract provision. Some 40 plaintiffs, including active-duty and former servicemembers, have filed wrongful-death and personal-injury suits against BioPort and the state of Michigan in U.S. District Court in Washington, D.C. The first suit, filed in October 2001, alleges that the anthrax vaccine killed Army Sergeant Sandra Larson and permanently disabled Army pilot Ronda Wilson. Citing BioPort’s lack of minimum contacts with the District of Columbia, the court recently dismissed this suit on jurisdictional grounds. Ruster predicts the other suits will be dismissed on the same grounds and that, if refiled in Michigan, BioPort will also prevail. In 1998, pilots Russell Dingle and Thomas Rempfer quit the Connecticut Air National Guard rather than take the vaccine. The pair then petitioned the FDA to revoke BioPort’s license to produce the anthrax vaccine, and filed a federal False Claims Act suit in Michigan. The plaintiffs claim that the FDA did not approve important equipment changes in the vaccine-production lab, thereby rendering the vaccine an adulterated product under the Food and Drug Act. The FDA has rejected the petition, and the company has moved to dismiss the federal lawsuit. According to Ruster, the FDA’s opinion contradicts the plaintiffs’ claims on the merits, and BioPort cannot be held liable for vaccines produced by the state of Michigan. Two former Air Force officers launched another legal attack against the anthrax vaccine. Retired Major Sonnie Bates and Capt. John Buck filed a declaratory judgment action in federal court in D.C. against the federal government and BioPort, seeking a ruling that the anthrax vaccine was an investigational new drug which could not be administered to servicemembers without their informed consent. The court dismissed the lawsuit on standing grounds in May 2002. Bates and Buck later dropped their appeal. PRINCIPAL OUTSIDE COUNSEL: The Washington office of Thelen Reid & Priest is BioPort’s main outside counsel, handling contract, government relations and litigation. Arent Fox Kintner Plotkin & Kahn of Washington worked on BioPort’s initial purchase of the Lansing lab, and the firm continues to handle some regulatory and litigation work. UK TO GC: Ruster’s Midwestern twang betrays no sign of her roots in the United Kingdom. When she was 8, her family moved from Cardiff, Wales, to Midland, Mich., where her father worked as a scientist for Dow Corning. Ruster graduated from Michigan State University in 1989 with a degree in international relations. She received her law degree in 1993 from the University of North Carolina in Chapel Hill, where her husband Brian attended dental school. In 1993, the couple moved to Rochester, N.Y., where Ruster spent time working for small law firms before going in-house at Bausch & Lomb Inc. Ruster was hired as associate general counsel at BioPort in January 2001, becoming general counsel in May 2001. PERSONAL: Catherine and Brian Ruster have a son, Owen, 5. LAST BOOK READ: “Off the Planet: Surviving Five Perilous Months Aboard the Space Station Mir,” by Jerry Linenger.

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