Drug & Device News

Judge's Personal Qualms No Reason to Deny Attorney Fees

A New Jersey judge's denial of a pharmaceuticals company's request for attorney fees was recently reversed by the state's appellate division due to the judge's failure to state a valid reason for denial. Novartis Pharmaceuticals Corp. had asked for attorney fees of $500,000 from the defeated whistleblower claimant. Normally, attorney fees might be warranted if a plaintiff acted in bad faith. Stating that he was “not a fan of fee shifting,” Morris County Superior Court Judge W. Hunt Dumont denied the request. On appeal, the panel in DiMaggio v. Novartis Pharmaceuticals Corp., A-4810-07, found that this explanation was not reason enough to support the denial. In reversing, the appellate panel stated, “We are constrained to reverse and remand because the trial court either failed to consider or simply failed to state its findings with regard to defendant's claim that plaintiff's lawsuit was commenced and continued in bad faith.”

Lawyer Indicted for Making False Statements to Shield Drug Company

According to a Nov. 9, 2010, U.S. Justice Department (DOJ) release, an attorney for a large but unnamed pharmaceuticals company has been charged with obstruction and making false statements in connection with an FDA investigation into the company's promotion of off-label uses of one of its products. Lauren Stevens, of Durham, NC, is accused of sending a series of denials of the company's wrongdoing to the FDA after that agency asked the manufacturer for information about the promotion of one of its prescription drugs. The indictment alleges Stevens knew at the time of her letter-writing campaign that the company had paid one physician to promote off-label uses in speeches given at 511 promotional events, and had paid another physician to make similar speeches at 488 such events. The indictment also claims Stevens said she would provide the FDA with slide sets used by the physicians at these events but then willfully failed to do so, falsely representing to the agency that the materials the company did turn over to it were “final” and “complete.” The government's evidence in this regard includes a legal memorandum prepared for Stevens listing the “pros” and “cons” of surrendering the slides to the FDA, with one of the “cons” being that the slides would serve as “incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation.” Noting that individuals, not just corporations, are responsible for complying with the law during government investigations, Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, said, “Criminal charges are appropriate when false statements such as those alleged here are made to the FDA.” Stevens's employer is not charged with any wrongdoing concerning her alleged false statements.

Darvon and Darvocet Are Pulled from U.S. Market

Xanodyne Pharmaceuticals Inc. has voluntarily withdrawn Darvon and Darvocet, its brand-named versions of the prescription pain medication propoxyphene, from the U.S. market, at the “request” of the U.S. Food and Drug Administration. The agency has also asked a generic distributor of proposyphene to follow suit. The FDA asked the drug manufacturers to pull out of the U.S. market because of new concerns that propoxyphene-containing products can cause heart rhythm abnormalities that can be fatal or otherwise harmful. In a release announcing Xanodyne's withdrawal from the market of Darvon and Darvocet, John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER), stated that the new data the FDA recently obtained on the drug “significantly alter[s] propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks.”

Judge's Personal Qualms No Reason to Deny Attorney Fees

A New Jersey judge's denial of a pharmaceuticals company's request for attorney fees was recently reversed by the state's appellate division due to the judge's failure to state a valid reason for denial. Novartis Pharmaceuticals Corp. had asked for attorney fees of $500,000 from the defeated whistleblower claimant. Normally, attorney fees might be warranted if a plaintiff acted in bad faith. Stating that he was “not a fan of fee shifting,” Morris County Superior Court Judge W. Hunt Dumont denied the request. On appeal, the panel in DiMaggio v. Novartis Pharmaceuticals Corp., A-4810-07, found that this explanation was not reason enough to support the denial. In reversing, the appellate panel stated, “We are constrained to reverse and remand because the trial court either failed to consider or simply failed to state its findings with regard to defendant's claim that plaintiff's lawsuit was commenced and continued in bad faith.”

Lawyer Indicted for Making False Statements to Shield Drug Company

According to a Nov. 9, 2010, U.S. Justice Department (DOJ) release, an attorney for a large but unnamed pharmaceuticals company has been charged with obstruction and making false statements in connection with an FDA investigation into the company's promotion of off-label uses of one of its products. Lauren Stevens, of Durham, NC, is accused of sending a series of denials of the company's wrongdoing to the FDA after that agency asked the manufacturer for information about the promotion of one of its prescription drugs. The indictment alleges Stevens knew at the time of her letter-writing campaign that the company had paid one physician to promote off-label uses in speeches given at 511 promotional events, and had paid another physician to make similar speeches at 488 such events. The indictment also claims Stevens said she would provide the FDA with slide sets used by the physicians at these events but then willfully failed to do so, falsely representing to the agency that the materials the company did turn over to it were “final” and “complete.” The government's evidence in this regard includes a legal memorandum prepared for Stevens listing the “pros” and “cons” of surrendering the slides to the FDA, with one of the “cons” being that the slides would serve as “incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation.” Noting that individuals, not just corporations, are responsible for complying with the law during government investigations, Tony West, Assistant Attorney General for the Civil Division of the Department of Justice, said, “Criminal charges are appropriate when false statements such as those alleged here are made to the FDA.” Stevens's employer is not charged with any wrongdoing concerning her alleged false statements.

Darvon and Darvocet Are Pulled from U.S. Market

Xanodyne Pharmaceuticals Inc. has voluntarily withdrawn Darvon and Darvocet, its brand-named versions of the prescription pain medication propoxyphene, from the U.S. market, at the “request” of the U.S. Food and Drug Administration. The agency has also asked a generic distributor of proposyphene to follow suit. The FDA asked the drug manufacturers to pull out of the U.S. market because of new concerns that propoxyphene-containing products can cause heart rhythm abnormalities that can be fatal or otherwise harmful. In a release announcing Xanodyne's withdrawal from the market of Darvon and Darvocet, John Jenkins, M.D., director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research (CDER), stated that the new data the FDA recently obtained on the drug “significantly alter[s] propoxyphene's risk-benefit profile. The drug's effectiveness in reducing pain is no longer enough to outweigh the drug's serious potential heart risks.”