Drug & Device News

Changes in Clinical Trial Reporting Standards Made Final

The U.S. Food and Drug Administration (FDA) recently issued a final rule clarifying the nature of the safety information that must be reported during clinical trials of investigational drugs and biologics. The new rule expands on the list of mandatory information, including the requirement that investigators report significant risks to study participants and divulge higher-than-expected adverse reaction rates. However, the rule also seeks to decrease over-reporting, by discouraging drug sponsors from informing the FDA of adverse events that are likely not caused by the product being tested. The new rule also revises definitions and reporting standards so that they are more consistent with those of two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization's Council for International Organizations of Medical Sciences. These last changes are expected to harmonize reporting of globally conducted clinical trials. For further information on the final rule, go to: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm.

Jury Returns $257 Million Verdict Against Johnson & Johnson

Johnson & Johnson has lost a key battle in its fight to minimize its liablity for promoting the use of its schizophrenia drug Risperdal while allegedly hiding its health and safety risks from the state programs that paid for it. The manufacturer had been fairly successful in previous state-initiated lawsuits, getting one suit dismissed in Pennsylvania and being ordered to pay only $3.95 million to West Virginia. In mid-October, however, a state court jury in Opelousas, LA, returned a verdict of $257 million against the company. The Louisiana jurors found that the manufacturer defrauded that state's Medicaid program by promoting off-label uses of Risperdal and by minimizing its links to the development of diabetes in users.

Lead Plaintiff Attorneys in Vioxx MDL to Share $315 Million

Although the mass tort cases against Merck relating to injuries caused by its drug Vioxx were largely decided in favor of the defendants (only five of 19 cases tried went to the plaintiffs), plaintiffs' lead attorneys were recently awarded a high payment for their services. Because of bad publicity and the potential for more legal problems, Merck settled the cases in 2007 for $4.85 billion. Now, in a 38-page ruling, the New Orleans federal district court judge who oversaw the Vioxx multi-district litigation, Judge Eldon Fallon, has awarded $315,250,000 to “all attorneys who performed common benefit work” in the MDL and associated state litigation. That equals 6.5% of the $4.85 billion settlement. Judge Fallon praised the plaintiffs' lawyers, noting that it took only 31 months for the parties to reach a settlement that benefited 32,886 claimants. “[That] efficiency is unprecedented in mass tort settlements of this size,” Fallon wrote. “Counsel met and exceeded this court's desire for expedited resolution of this matter.” Among the attorneys who will share in the fee award are Russ Herman of Herman, Herman, Katz & Cotlar; Andy Birchfield Jr. of Beasley, Allen, Crow, Methvin, Portis & Miles; Arnold Levin of Levin, Fishbein, Sedrad & Berma; Chris Seeger of Seeger Weiss; Thomas Kline of Kline & Specter; Richard Arsenault of Neblett, Beard & Arsenault; Shelly Stanford of Sanford Barlow; Elizabeth Cabraser of Lieff Cabraser Heimann & Bernstein; Gerald Meunier of Gainsburgh, Benjamin, David, Meunier & Warshauer; Troy Rafferty of Levin Papantonio Thomas Mitchell Rafferty; Mark Robinson Jr. of Robinson, Calcagnie & Robinson; Drew Ranier of Ranier, Gayle & Elliot; and Christopher Tisi of Ashcraft and Gerel.

Prostate Cancer Drugs to Display New Warnings

The FDA has asked manufacturers of the prostate cancer drugs gonadotropin-releasing hormone (GnRH) agonists to add new warnings to labeling of their products. GnRH agonists suppress the production of the hormone testosterone, which is involved in prostate cancer growth. The new warnings are to tell patients and health care providers that there is potential increased risk for heart disease and diabetes in men treated with these medications. For further information, go to: http://www.fda.gov/Drugs/DrugSafety/ucm229986.htm.

Changes in Clinical Trial Reporting Standards Made Final

The U.S. Food and Drug Administration (FDA) recently issued a final rule clarifying the nature of the safety information that must be reported during clinical trials of investigational drugs and biologics. The new rule expands on the list of mandatory information, including the requirement that investigators report significant risks to study participants and divulge higher-than-expected adverse reaction rates. However, the rule also seeks to decrease over-reporting, by discouraging drug sponsors from informing the FDA of adverse events that are likely not caused by the product being tested. The new rule also revises definitions and reporting standards so that they are more consistent with those of two international organizations, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the World Health Organization's Council for International Organizations of Medical Sciences. These last changes are expected to harmonize reporting of globally conducted clinical trials. For further information on the final rule, go to: http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/InvestigationalNewDrugINDApplication/ucm226358.htm.

Jury Returns $257 Million Verdict Against Johnson & Johnson

Johnson & Johnson has lost a key battle in its fight to minimize its liablity for promoting the use of its schizophrenia drug Risperdal while allegedly hiding its health and safety risks from the state programs that paid for it. The manufacturer had been fairly successful in previous state-initiated lawsuits, getting one suit dismissed in Pennsylvania and being ordered to pay only $3.95 million to West Virginia. In mid-October, however, a state court jury in Opelousas, LA, returned a verdict of $257 million against the company. The Louisiana jurors found that the manufacturer defrauded that state's Medicaid program by promoting off-label uses of Risperdal and by minimizing its links to the development of diabetes in users.

Lead Plaintiff Attorneys in Vioxx MDL to Share $315 Million

Although the mass tort cases against Merck relating to injuries caused by its drug Vioxx were largely decided in favor of the defendants (only five of 19 cases tried went to the plaintiffs), plaintiffs' lead attorneys were recently awarded a high payment for their services. Because of bad publicity and the potential for more legal problems, Merck settled the cases in 2007 for $4.85 billion. Now, in a 38-page ruling, the New Orleans federal district court judge who oversaw the Vioxx multi-district litigation, Judge Eldon Fallon, has awarded $315,250,000 to “all attorneys who performed common benefit work” in the MDL and associated state litigation. That equals 6.5% of the $4.85 billion settlement. Judge Fallon praised the plaintiffs' lawyers, noting that it took only 31 months for the parties to reach a settlement that benefited 32,886 claimants. “[That] efficiency is unprecedented in mass tort settlements of this size,” Fallon wrote. “Counsel met and exceeded this court's desire for expedited resolution of this matter.” Among the attorneys who will share in the fee award are Russ Herman of Herman, Herman, Katz & Cotlar; Andy Birchfield Jr. of Beasley, Allen, Crow, Methvin, Portis & Miles; Arnold Levin of Levin, Fishbein, Sedrad & Berma; Chris Seeger of Seeger Weiss; Thomas Kline of Kline & Specter; Richard Arsenault of Neblett, Beard & Arsenault; Shelly Stanford of Sanford Barlow; Elizabeth Cabraser of Lieff Cabraser Heimann & Bernstein; Gerald Meunier of Gainsburgh, Benjamin, David, Meunier & Warshauer; Troy Rafferty of Levin Papantonio Thomas Mitchell Rafferty; Mark Robinson Jr. of Robinson, Calcagnie & Robinson; Drew Ranier of Ranier, Gayle & Elliot; and Christopher Tisi of Ashcraft and Gerel.

Prostate Cancer Drugs to Display New Warnings

The FDA has asked manufacturers of the prostate cancer drugs gonadotropin-releasing hormone (GnRH) agonists to add new warnings to labeling of their products. GnRH agonists suppress the production of the hormone testosterone, which is involved in prostate cancer growth. The new warnings are to tell patients and health care providers that there is potential increased risk for heart disease and diabetes in men treated with these medications. For further information, go to: http://www.fda.gov/Drugs/DrugSafety/ucm229986.htm.