Drug & Device News

Three Judges Say Vaccines Did Not Cause Autism

The three claimants who a year ago were denied compensation from the National Vaccine Injury Compensation Program (VICP)(See 42 U.S.C. ' 300aa-10, et. seq.) because they could not prove a cause-and-effect connection between childhood vaccinations and their development of autism have lost their bids to have those decisions overturned. In order to collect from the Vaccine Injury Compensation Program, the claimants had to show that: 1) their child received a vaccine covered by VICP; 2) the vaccine was given in the United States; 3) the child suffered a serious and long-term injury because of the vaccination; and 4) there has been no previous award or settlement concerning that injury. In the rulings in the three cases, issued on the same day in March by three different judges, claimants learned the judges had rejected their proffered evidence, finding it inadequate for a showing that the mercury-containing preservative thimerosal used in vaccines harmed their children.

California County Sues Diabetes Drug Manufacturer

The County of Santa Clara, CA, is suing GlaxoSmithKline, the maker of diabetes drug Avandia, seeking repayment of the $2 million it spent to buy the drug for county health care recipients. The County also wants to recover the costs of treating county residents who developed heart problems after taking Avandia. Some say Avandia use increases a consumer's chances of suffering a heart attack, but the connection has not been proven.

Seventh Circuit Reverses Pre-Emption Holding

In a unanimous decision, the U.S. Court of Appeals for the Seventh Circuit has reversed the dismissal of a case in which a drug manufacturer had successfully argued that its failure to change its warning label for Paxil was justified by the fact that the Food and Drug Administration (FDA) would not have allowed it to include the stronger warning with its packaging. The ruling in Mason v. SmithKline Beecham, Case No. 08-2265 (7th Cir. 2010), reinstates a case brought by the family of a 23-year-old woman who committed suicide two days after she began taking the anti-depressant/anti-anxiety drug Paxil. The Seventh Circuit found that the drug's manufacturer, GlaxoSmithKline, did not meet its burden of showing by “clear evidence” that, had it attempted to change the labeling to include a stronger warning about suicide risk with the use of Paxil, the FDA would have rejected the change. If the manufacturer had been able to make such a showing, it would be entitled to avoid liability in a state court action, on the basis of federal pre-emption. The “clear evidence” rule was established by the U.S. Supreme Court in 2009, in the case of Wyeth v. Levine.

Prozac Manufacturers Could Have Warned of Suicide Risk

A generic manufacturer of the antidepressant Prozac could have warned about an increased risk of suicide associated with its prescription medication by changing its labels without approval from the U.S. Food and Drug Administration (FDA), according to a federal judge in the Central District of California. The decision, issued March 26, aligned with at least three other circuit court decisions, as well as the U.S. Supreme Court's 2009 decision in Wyeth v. Levine, which prevents drug companies in most cases from arguing that state tort claims are pre-empted by federal law because the FDA regulates their products. The suit was filed on behalf of Rosemary Dorsett, the mother of a 26-year-old man who committed suicide in 2004 after taking fluoxetine, a generic version of Prozac, for 36 days. It alleges that name brand maker Eli Lilly & Co. failed to adequately warn about the risks of suicide associated with the antidepressant.

Three Judges Say Vaccines Did Not Cause Autism

The three claimants who a year ago were denied compensation from the National Vaccine Injury Compensation Program (VICP)(See 42 U.S.C. ' 300aa-10, et. seq.) because they could not prove a cause-and-effect connection between childhood vaccinations and their development of autism have lost their bids to have those decisions overturned. In order to collect from the Vaccine Injury Compensation Program, the claimants had to show that: 1) their child received a vaccine covered by VICP; 2) the vaccine was given in the United States; 3) the child suffered a serious and long-term injury because of the vaccination; and 4) there has been no previous award or settlement concerning that injury. In the rulings in the three cases, issued on the same day in March by three different judges, claimants learned the judges had rejected their proffered evidence, finding it inadequate for a showing that the mercury-containing preservative thimerosal used in vaccines harmed their children.

California County Sues Diabetes Drug Manufacturer

The County of Santa Clara, CA, is suing GlaxoSmithKline, the maker of diabetes drug Avandia, seeking repayment of the $2 million it spent to buy the drug for county health care recipients. The County also wants to recover the costs of treating county residents who developed heart problems after taking Avandia. Some say Avandia use increases a consumer's chances of suffering a heart attack, but the connection has not been proven.

Seventh Circuit Reverses Pre-Emption Holding

In a unanimous decision, the U.S. Court of Appeals for the Seventh Circuit has reversed the dismissal of a case in which a drug manufacturer had successfully argued that its failure to change its warning label for Paxil was justified by the fact that the Food and Drug Administration (FDA) would not have allowed it to include the stronger warning with its packaging. The ruling in Mason v. SmithKline Beecham, Case No. 08-2265 (7th Cir. 2010), reinstates a case brought by the family of a 23-year-old woman who committed suicide two days after she began taking the anti-depressant/anti-anxiety drug Paxil. The Seventh Circuit found that the drug's manufacturer, GlaxoSmithKline, did not meet its burden of showing by “clear evidence” that, had it attempted to change the labeling to include a stronger warning about suicide risk with the use of Paxil, the FDA would have rejected the change. If the manufacturer had been able to make such a showing, it would be entitled to avoid liability in a state court action, on the basis of federal pre-emption. The “clear evidence” rule was established by the U.S. Supreme Court in 2009, in the case of Wyeth v. Levine.

Prozac Manufacturers Could Have Warned of Suicide Risk

A generic manufacturer of the antidepressant Prozac could have warned about an increased risk of suicide associated with its prescription medication by changing its labels without approval from the U.S. Food and Drug Administration (FDA), according to a federal judge in the Central District of California. The decision, issued March 26, aligned with at least three other circuit court decisions, as well as the U.S. Supreme Court's 2009 decision in Wyeth v. Levine, which prevents drug companies in most cases from arguing that state tort claims are pre-empted by federal law because the FDA regulates their products. The suit was filed on behalf of Rosemary Dorsett, the mother of a 26-year-old man who committed suicide in 2004 after taking fluoxetine, a generic version of Prozac, for 36 days. It alleges that name brand maker Eli Lilly & Co. failed to adequately warn about the risks of suicide associated with the antidepressant.