April 9, 2008
Third Circuit Preemption Win for Manufacturers of Paxil & Zoloft
The Legal Intelligencer (via law.com) reports on a decision filed yesterday by the United States Court of Appeals for the Third Circuit holding that claims that the manufacturers of Paxil and Zoloft failed to warn of a risk of suicide were preempted. The court issued a narrow decision based on the fact that the FDA expressly had refused to order the very suicide warnings that plaintiffs argued were necessary:
"We do not decide whether the FDA's mere approval of drug labeling is sufficient to pre-empt state-law claims alleging that the labeling failed to warn of a given danger," Sloviter wrote. Likewise, Sloviter said, the court would not address "whether FDA approval of drug labeling constitutes minimum standards in the absence of the FDA's express rejection of a specific warning."
On the narrow question, Sloviter found that since both plaintiffs were suing over warnings that the FDA had explicitly refused to order, their failure-to-warn claims "conflict with, and are therefore pre-empted by, the FDA's regulatory actions."
Beck & Herrmann have a break-down of the decision's "high points." Judge Thomas L. Ambro dissented from the majority opinion.
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Tracked on Apr 9, 2008 4:40:42 AM
There is no increased risk of suicide from anti-depressants, only of suicidal ideas or gestures.
Left wing extremists bullied the FDA Psychopharmacology Committee. It issued a warning on suicidal ideas and gestures in 4% of people on antidepressants and 2.5% of people on placebo. If you slapped your forehead because you could have had a V8, it got recorded as a suicidal gesture.
The Committee also has not had 11th grade statistics. The number of patients across many studies was very large, making a clinically trivial difference statistically significant. In 11th grade, one learns about a correction for this effect. They did not apply it. Had they done so, the difference would lose its statistical significance (Same error of statistical ignorance was made in the case of Vioxx, by the Merck leadership. The FDA demanded Vioxx return to market, to their credit.)
A black box warning is intended (with scienter) to deter, and to make it less likely for patients to get a medication. It worked. As a result of this warning, in 2004, primary care physicians stopped prescribing anti-depressants to depressed young people. The steeply descending trend in suicide stopped. The rate of suicide in this age group has steadily increased, as the number of tracked prescriptions has decreased.
The entire Psychopharmacology Committee and the FDA Commissioner must resign. They are responsible for the foreseeable and preventable deaths by suicide of 100's of young people a year, since the 2004 warning. These cause unusual agony in the bereaved families. If a decision I made at work would kill 1000's of young people needlessly, I would resign.
Posted by: Supremacy Claus | Apr 9, 2008 2:55:02 AM
A left wing extremist denier left this misleading comment.
I provided this clarification and rebuttal of the misleading denier propaganda. It includes the central error made in the Vioxx litigation, a failure to do the same standard statistical correction, known to all 11th grade statistics students. I find it unfortunate that the three branches of government are controlled by lawyers. The lawyer's math ends at the fourth grade, the level needed to count money.
"An uninterrupted series of 80 hate filled, anti-medication extremists demanded the banning of anti-depressants entirely. They scapegoated medication for their failures as parents to control their criminal children. They scapegoated medications for intentional acts of illegal drug users, and mental patients.
The sole effective method to reduce the suicide rate is long term treatment of the underlying disorders. Counties with higher rates of anti-depressant use have lower suicide rates. The training of primary care doctors to diagnose and treat depression in a couple of European countries decreased the suicide rates in the surrounding areas. These were depression treatment, not suicide prevention initiatives. The US managed to achieve the reverse by deterring primary care doctors with this idiotic black box warning. Psychiatrist prescribing rates did not budge, because they knew how idiotic the warning was.
The members of the committee had a fiduciary duty and an oath to the public, to resist the haters and deniers threatening them. They failed to protect the public from these extremists. They must resign.
The medication responders are severely depressed. The lawyers and regulators have caused such patients to be excluded, to prevent litigation and ruinous interruption of trials by deaths. So only the mildest, non-suicidal patients get included. The left wing extremist lawyers attack the drug companies doing proper trials. Then they criticize the lack of additional response compared to placebo when they try to protect themselves from the lawyers. This shows the anti-corporation, America hater agenda is being furthered by the FDA. It must be eliminated entirely with new statutes.
Most cases of Vioxx litigation were won by the defense. The company settled out of a calculation of the legal costs of resistance.
The Vioxx statistics were similarly weak. The removal from the market disrupted the successful care of millions of people. As there were no suicides nor serious injuries in the anti-depressants trials, so there were no deaths in the Vioxx trials.
All medications that work are extremely dangerous, across doses, across individual responses, across time. However, the risks and benefits are to be calculated by the patient and the clinician as they apply to the individual case. They are not to be decided by lawyers, nor by hate filled scapegoaters.
As a patient, I would support the formation of patient direct action groups, to bring self-help to the enemies of clinical care. To deter the lawyers, extremists, and regulators."
Posted by: Supremacy Claus | Apr 9, 2008 4:08:50 PM