Tuesday, April 08, 2008

Preemption Affirmed in Colacicco

The Third Circuit has affirmed the finding of extensive preemption in the Colacicco/McNellis suicidality litigation. Here's a copy of the opinion. Judge Sloviter wrote the opinion. There is a dissent, by Judge Ambro. This is the first federal court of appeals decision to address preemption following the FDA's 2006 Preemption Preamble.

The high points:

1. The "direct and positive conflict" language in the 1962 FDCA amendments "merely states that conflict preemption applies." Slip op. at 17 n.8.

2. In a case "of conflict preemption, the lack of a Congressional directive expressly approving or rejecting preemption in the context of drug labeling regulations is not determinative. Rather, the conflict preemption analysis is designed to determine the propriety of preemption where Congress has not explicitly stated its intent." Slip op. at 22.

3. While the court allows a presumption against preemption in conflict preemption cases, it finds that presumption in "tension" between the presumption, which is based on congressional "intent," and the nature of conflict preemption, "which analyzes preemption in the absence of any explicit intent." Slip op. at 22.

4. "[B]efore we can hold that a federal regulation or...the failure to regulate as extensively as plaintiffs sought, has preemptive force, we must review the record of the FDA’s treatment of the desired warning at issue." Slip op. at 26.

5. "The FDA has actively monitored the possible association between SSRIs and suicide for nearly twenty years and has concluded that the suicide warnings desired by plaintiffs are without scientific basis and would therefore be false and misleading." Slip op. at 28-29.

6. Deference to the FDA is different depending on whether the Agency is discussing facts or law. "The FDA’s summary of its scientific determinations must be distinguished from the agency’s construction of a statute, as the review of scientific information is strictly within its expertise. The FDA asserted facts in support of its legal position, and we take notice of its statement of those facts, rather than its legal position." Slip op. at 30 n.15.

7. Suicidality claims are preempted. "Because the standard for adding a warning to drug labeling is the existence of “reasonable evidence of an association of a serious hazard with a
drug,” 21 C.F.R. § 201.57(e), and the FDCA authorizes the FDA to prohibit false or misleading labeling, a state-law obligation to include a warning asserting the existence of an association
between SSRIs and suicidality directly conflicts with the FDA’s oft-repeated conclusion that the evidence did not support such an association." Slip op. at 32.

8. The decision is relatively limited. The court "need not decide whether preemption would be appropriate under different facts--such as where the FDA had not rejected the substance of the warning sought or where the FDA only stated its position after a lawsuit had been initiated--or under the broader theories of preemption argued by the parties." Slip op. at 33.

8. There is no prerequisite of an FDA "formal rejection of a CBE supplement" prior to a finding of preemption. Slip op. at 34. The court does not "favor encouraging regulated parties to submit CBE supplements for the sole purpose of insulating themselves from potential liability." Id.

9. Any claim that the a defendant "manipulated or withheld information from the FDA...should be brought before the FDA." Slip op. at 35.

10. "In light of the FDA’s continued review of existing scientific studies, we reject plaintiffs’ arguments that the FDA lacked information that would have dissuaded it from rejecting an adult
suicidality warning." Slip op. at 37.

11. The FDA's preemption positions are entitled to Skidmore deference. "[W]e conclude (1) that an agency’s position concerning preemption need not be contained in a formal regulation in order to be considered, and (2) that such a position is subject to a level of deference approximating that set forth in Skidmore v. Swift & Co., 323 U.S. 134 (1944)." Slip op. at 38.

12. The FDA's positions about what might happen in the context of a particular drug warning claim might be entitled to "more" deference. "The FDA’s view that “the imposition of liability under state law for defendants’ alleged failure to warn would interfere with FDA’s accomplishment of regulatory objectives,” id. at 22, is in our view entitled to at least as much deference, if not more, as the FDA’s view of its preemption authority." Slip op. at 38-39.

13. "We see no inconsistency between the FDA’s preamble to the 2006 amendments and its long-held position that it has the responsibility to determine whether a warning is required." Slip op. at 40. But the court does not decide any other agency inconsistency claim. Id. at 40-41.

The court's rationale appears to be applicable to any and all SSRI suicide cases. Hear Hear!


Anonymous said...

Narrow indeed. The court took no position on the key issues regarding preemption as a doctrine.

"Thus, we
do not decide whether the FDA?s mere approval of drug labeling
is sufficient to preempt state-law claims alleging that the
labeling failed to warn of a given danger, whether FDA approval
of drug labeling constitutes minimum standards in the absence of
the FDA's express rejection of a specific warning." (p. 33)

Supremacy Claus said...

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.

Anonymous said...

I would expect Supremacy Claus claim of a vast left wing conspiracy in the White House. That's how silly the notion is of the FDA Psychopharmacology Committee being bullied by left wing extremists.

First, is there ANY DATA to support the notion that SSRI decrease the risk of suicide in this country. With approximately a billion of us taking the stuff, suicide rates have remained unchanged in this country. Are you suggesting that suicide rates and SSRI usage has been linked together? Hardly. Even the drug companies don't argue this.

Second, go back and look at the minutes of these meetings over the years. First of all, everyone on these freaking committees has some financial stake - directly or indirectly - in the drugs they are passing judgment upon. These people fought the science for years before finally caving.

Finally, if you don't think the difference between 4% and 2.5% is meaningful, I assume you also think these drugs should be taken off the market because they are not efficacious. In less than half the cases do they have any impact on the user. So we should keep a drug on the market that works 1/3 or the time yet we should have no concern about someone taking a drug causing almost twice as many suicides? That's insane. In fact, if you are correct that SSRI reduce suicide risk (they don't but I'll play along) then they are killing more people on the drug then the data indicates because some are being saved decreasing the placebo comparisionn, while leading others to suicide.

Suggesting that this respponsible decision killed 1000 people is wrong and reckless.

Yes, Vioxx was a great drug too. I know, the cases settled for billions because the American people as so dumb. Do you think there have been any dangerous drugs in the history of mankind, Supremacy Claus?

Supremacy Claus said...

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.

Anonymous said...

From BMJ editorial, 3/8/08

"The two accompanying observational studies show a lack of connection between antidepressant prescribing rates and suicide rates in adolescents and young adults in the United Kingdom.1 2 Suicide rates declined when antidepressant use steadily increased but continued to decline when the use of antidepressants fell sharply in 2003 and 2004."

Supremacy Claus said...

Here is the editorial of this extreme left wing, biased propaganda rag, notorious, in the medical profession.


Only 3% of adolescents who committed suicide had anti-depressants in their bodies. This is much lower rate than found in alive adolescents.

I do not appreciate your selective quoting, and from a biased, left wing propaganda rag, devoid of any credibility.

As you know, even with extreme symptoms, under Brit twit Commie Care, no one gets any care. Adequate care is so rare in England, no conclusion may be drawn. One needs a private investigator to find one's primary care doctor. Specialist care just never happens under that Commie regime. So, in the extreme rarity of care, no effect will ever be evident.

Anonymous said...

So we should "defer to the expert judgment of scientists" (as at the FDA) .... unless they happen to be scientists whose poltical views we presume we know and we opt to detest

Very objective standard.

Supremacy Claus said...

It is settled law in 6 or more Supreme Court decisions. The clinical decision has presumptive validity. The most famous such case was, of course, Roe v Wade.

There are two experts, the patient, and the clinician who gets to know the patient. Their decisions have the sole validity. All others, all removals from the market, all black box warnings, all guidelines by quasi-governmental organizations, all weak cases in med mal, all regulation of that encounter, all violate these Supreme Court holdings, and are lawless.

Anonymous said...

Just to be clear - so no FDA whatsoever?

That would certainly take a bite out of preemption?

Supremacy Claus said...

You will not believe this.

I am among those who want 1) the FDA gone entirely; 2) all patent terms reduced to 5 years, publish smaller studies of effectiveness and safety, get sued is misleading; 3) end all tort reform, unleash torts on the legal system and government, by ending all lawyer self-dealt immunities, including repealing the Eleventh Amendment or, at least, reverse Hans by federal statute, end incompetent lawyering and judging.

The lawyer rent seeking has kept our growth at 3% when it should be 9% a year.

Anonymous said...

Dear Supramcy Clause:

"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." For someone who would scream that assocation is not causation, I find this statement funny.

The Vioxx cases were very weak on causation in individual cases. No question. But let's not obscure that in a minority of filed cases Vioxx killed people. Since a zillion cases were filed, that small minority is a lot of families who lost someone they love because a company put obscene profits over human beings.

Supremacy Claus said...

The ghoulish experiment was done by the left wing extremists and the craven collaborators at the FDA. They deterred the family doctors. The deaths jumped. They interrupted a trend of greater anti-depressant use in adolescents and rapidly dropping suicide rates. That cannot be ignored in the annals of left wing mass murder, with scienter.

Anonymous said...

Right Wing Santa Claus,

You had me at "get rid of the FDA." I think that is a fair summary of the reasonableness of your views. I think I'm past this dialogue.

Karen Carpender wrote a wonderful song, saying that what "the world needs now, is love sweet love." If she were still with us, I suppose she would change the words to "what the world needs now, if more SSRIs with 30% efficacy." (I don't know that that flows quite as well. But screw it. It is what we all need.)

Scienter. I'm just a little curious, how often a day do you use this world.

Supremacy Claus said...

The FDA serves no useful purpose. It impedes progress by delaying approvals, and then taking medications off the market for rare side effects. It is run by academic scientist. These are junior to real world clinicians and scientists in experience, intelligence, income.

Personal remarks show frustration in the traverse.

Anonymous said...