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After initially requesting appointment of a special master to review documents in a product liability lawsuit, pharmaceutical giant Novartis is asking a Broward, Fla., Circuit Court judge to remove a Nova Southeastern University law professor from serving in that role — 1 million documents and $900,000 later. New Jersey-based Novartis Pharmaceuticals claims that professor Marilyn Cane, who has catalogued nearly 1 million documents in the suit, has spent far too much time and money on the project, for which the drug maker is paying. The lawsuit was filed by a Sunrise, Fla., couple, Connie and Rene Carnoto, who allege that Mrs. Carnoto was severely injured by Novartis’ anti-lactation drug Parlodel. But Judge Robert Lance Andrews, who is presiding over the case, has denied the motion. He told the Daily Business Review that Novartis has only itself to blame, because it is trying to “bury the plaintiffs in documents.” He says the defense’s strategy backfired. Novartis officials and the company’s local counsel, R. Layton Mank, of counsel at Wilson, Elser, Moskowitz, Edelman & Dicker in Miami, and its national counsel, Joe Hollingsworth, Katharine Latimer and Cynthia Kendrick, all partners at Spriggs & Hollingsworth in Washington, D.C., did not return calls for comment. According to a recent order by Judge Andrews, Novartis moved for appointment of a special master in 2000 to conduct an in camera review of all documents related to the case and determine which documents were privileged in terms of attorney-client privilege and trade secrets. Andrews agreed. In April 2000, he appointed Cane, who chairs the corporate securities committee of the Florida Bar’s business law section. Novartis was ordered to pay all costs, with Andrews “retaining jurisdiction to later apportion costs between the parties.” Over the past two years, Novartis has produced 247 boxes containing more than 1 million documents, not all of them catalogued yet. A total of 50 law students have worked on the project, which Andrews jokingly calls the “Nova Law School Relief Program.” But this month, Novartis filed a motion to remove the special master, obtain a full cost accounting, receive refunds and revise the billing structure. The company claimed it had no input into the selection of the special master, that the bills have been “grossly excessive” and unjustified, and that “the review has taken on proportions beyond the realm of reason.” On Sept. 20, Andrews denied the defendant’s motion. “Because the facts as shown fail to support any of [Novartis'] allegations, a less competent court might easily perceive the motion as nothing more than a baseless attack on the integrity of the court, via the special master,” he wrote. “The special master and her assistants have, from the outset, conducted themselves in an entirely professional manner.” The Carnotos’ lawyer, George Truitt, a partner at Wilton L. Strickland in Fort Lauderdale, Fla., also ridiculed Novartis’ motion. “Through its own attempts to obfuscate discovery, [Novartis] has created a nearly complete, inexpensive, searchable database of documents stored on compact disc which may well become available to plaintiffs and their attorneys around the world,” he wrote. “Novartis blames the court, the special master, opposing counsel — everyone but itself, for the fiasco.” The corporation’s defense lawyers have clashed with Andrews from the start, asking Florida’s 4th District Court of Appeal four times to disqualify him from the case. All four requests were denied. Plaintiffs’ attorneys say large, corporate defendants often attempt to bury them in paperwork as a ploy to frustrate discovery efforts. But defense attorneys counter that the plaintiff side frequently asks for too much information and violates confidentiality rules by sharing discovery gems with colleagues all over the country. In October 1990, Connie Carnoto of Sunrise gave birth to a healthy son, Michael. She chose not to breastfeed, and her doctor gave her a prescription for Parlodel — common practice at the time — to prevent lactation. Less than a month later, Carnoto suffered a debilitating stroke that left the former BellSouth administrative assistant with permanent numbness and loss of muscle control. The Carnotos said at the time that their lives were ruined. In 1996, the Carnotos sued Sandoz Pharmaceuticals, which later became part of Swiss-based Novartis AG. The suit also named Dr. Celina Poy-Wing, Dr. Alison Clarke-Desouza and All Women’s OB/GYN Group of Plantation, Fla. The Sunrise couple are among hundreds of plaintiffs nationwide who have sued Novartis over Parlodel, which was used to suppress lactation in new mothers until the Food and Drug Administration linked it to strokes and it was taken off the market for this purpose in 1994. The drug is still prescribed for Parkinson’s patients. The drug maker lost its first big trial over the drug. And it generally settled these cases. But when Sandoz and Ciba-Geigy merged to form Novartis in 1998, the new $23 billion company changed its strategy and began fighting the suits aggressively, as it has in the Carnoto case. The special master was appointed in the Carnoto case because, according to Judge Andrews’ order Friday, Novartis refused to answer plaintiffs’ interrogatories from the start, insisting that it was entitled to simply produce documents in response. Novartis moved for appointment of a special master to conduct an in camera review. Cane and her students have scanned and catalogued the huge volume of documents. “I use Nova a lot,” Andrews told the Daily Business Review, noting that he appointed an expert from the law school in the recent state legislative redistricting challenge that came before him. “I find them highly reliable.” Andrews’ order called for Cane to receive $325 an hour for 25 hours of work a week, with five law student assistants receiving $100 an hour for 40 hours a week of work. He later amended his motion to allow for 10 assistants to work on the project. In addition, all documents would be scanned at a cost of 22 cents per document, for the establishment of a database. Nova has assigned a locked room at the law school for storing the documents to ensure confidentiality, and the students who participate must sign a confidentiality agreement. After Cane reviews the documents, they are scanned onto CD-ROMs by the students using Nova’s high-speed scanners. The entire database will provide a national plaintiffs’ blueprint for filing suit against Novartis over Parlodel, Judge Andrews says. Cane keeps her share of the fee, while part of the students’ pay goes to a scholarship fund at the law school. That fund has received $9,000 so far, Cane says. Andrews consistently has ruled in favor of the plaintiffs. In 1999, he moved that the Carnotos could add hefty punitive damages to their lawsuit. He pointed out in his ruling that, nationwide, 10 deaths have been linked to the drug, and cited FDA documents claiming the drug company lied about the number of deaths in order to keep doctors prescribing the drug. Nationally, plaintiffs have had mixed success suing over Parlodel. In October 2001, a federal magistrate in Alabama denied Novartis’ motion for summary judgment, finding that the plaintiffs’ expert opinions were “scientifically reliable and admissible.” That ruling came nine days after a federal judge in Illinois reached the opposite conclusion in another Parlodel case, and excluded the plaintiffs’ expert testimony as “scientifically unreliable.” And two months ago, the 11th U.S. Circuit Court of Appeals affirmed a Georgia federal district court ruling that held that expert testimony asserting that the drug caused strokes was not sufficiently reliable under the U.S. Supreme Court’s standard in Daubert v. Merrill Dow Pharmaceuticals. Meanwhile, the Carnotos’ case is still working its way through Broward Circuit Court, 12 years after Mrs. Carnoto allegedly was injured by the drug. Professor Cane says she had no idea when she took the assignment that she would spend two years of her life on the project. “The reality of it doesn’t sink in until you’re staring at 247 boxes,” she says. “I’ve worked as a special master before, but this scope is unprecedented.”

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