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Wednesday, March 11, 2009
Two Drug Manufacturers Sued by US for Promoting Drug for Unapproved Use
The Food and Drug Administration (FDA), responsible for approving drugs for prescription use, does so, allowing specific uses. Among the provisions for approving any drug is a list of specifically permitted uses. These are uses for which the drugs passed a series of clinical trials, and documented results are evidence of their safety and efficacy under the tested conditions. When a company applies for FDA approval it must state the intended uses for that drug in its application. The manufacturer must not market or encourage any other uses of the drug.
After an investigation by the Civil Division of the U.S. Department of Justice, the U.S. Attorney’s Office for the Northern District of California, the Federal Bureau of Investigation, and the Offices of Inspector General of the Department of Health and Human Services, the FDA, the Department of Veterans Affairs, the Office of Personnel Management, and the Department of Defense, Johnson & Johnson, Inc. and its subsidiary, Scios, Inc. were sued by the United States Government for off-label use of the drug Natrecor.
The stated use for Natrecor is “the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea [shortness of breath] at rest or with minimal activity.” Natrecor’s 2001 FDA approval was based upon studies in which the drug was administered by intravenous infusion over a 36-hour period to a specified populations having severe heart failure with specific complications.
Scios, however, began aggressively marketing Natrecor for scheduled, serial outpatient infusions, and for patients whose heart failure was less severe than the population indicated in the drugs’ FDA application. This use is not included in the FDA-approved label, thus is considered an off-label use.
Medicare doesn’t cover off-label use of drugs, with the single exception being when such use is medically necessary. Because leading cardiologists told Scios that it should not promote the off-label use, along with a 2007 study that showing that there was no significant benefit to the serial outpatient infusions, Scios notified healthcare providers of its findings.
Two former sales employees notified the FDA of the off-label marketing in a whistle-blower report, bringing it to the attention of the federal government. Patients are assured of safe medical care and the right to medications prescribed based upon proven and safe outcomes by the Federal Food, Drug, and Cosmetic Act.
While this is a case that is not known to have caused physical or mental personal injury or death to any patient, it is a matter of fraud, Medicare fraud, and deceptive practices. Where this practice involves other drugs and medical devices, food labeling and safe manufacturing practices, there is great potential for claims for personal injury, illness and death, as well as product liability.
The Cochran Firm, with offices throughout the United States, has personal injury attorneys who are experienced in investigating and settling cases involving personal injury and product liability claims. If you suffered any loss due to off-label use of medications, please contact the personal injury attorneys at The Cochran Firm in Houston, Texas for a consultation and case review.
After an investigation by the Civil Division of the U.S. Department of Justice, the U.S. Attorney’s Office for the Northern District of California, the Federal Bureau of Investigation, and the Offices of Inspector General of the Department of Health and Human Services, the FDA, the Department of Veterans Affairs, the Office of Personnel Management, and the Department of Defense, Johnson & Johnson, Inc. and its subsidiary, Scios, Inc. were sued by the United States Government for off-label use of the drug Natrecor.
The stated use for Natrecor is “the intravenous treatment of patients with acutely decompensated congestive heart failure who have dyspnea [shortness of breath] at rest or with minimal activity.” Natrecor’s 2001 FDA approval was based upon studies in which the drug was administered by intravenous infusion over a 36-hour period to a specified populations having severe heart failure with specific complications.
Scios, however, began aggressively marketing Natrecor for scheduled, serial outpatient infusions, and for patients whose heart failure was less severe than the population indicated in the drugs’ FDA application. This use is not included in the FDA-approved label, thus is considered an off-label use.
Medicare doesn’t cover off-label use of drugs, with the single exception being when such use is medically necessary. Because leading cardiologists told Scios that it should not promote the off-label use, along with a 2007 study that showing that there was no significant benefit to the serial outpatient infusions, Scios notified healthcare providers of its findings.
Two former sales employees notified the FDA of the off-label marketing in a whistle-blower report, bringing it to the attention of the federal government. Patients are assured of safe medical care and the right to medications prescribed based upon proven and safe outcomes by the Federal Food, Drug, and Cosmetic Act.
While this is a case that is not known to have caused physical or mental personal injury or death to any patient, it is a matter of fraud, Medicare fraud, and deceptive practices. Where this practice involves other drugs and medical devices, food labeling and safe manufacturing practices, there is great potential for claims for personal injury, illness and death, as well as product liability.
The Cochran Firm, with offices throughout the United States, has personal injury attorneys who are experienced in investigating and settling cases involving personal injury and product liability claims. If you suffered any loss due to off-label use of medications, please contact the personal injury attorneys at The Cochran Firm in Houston, Texas for a consultation and case review.
Labels: Houston
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