Wednesday, December 03, 2008

Defendants Oppose Certiorari in Colacicco

The defendants in the combined Colacicco appeal to the Supreme Court filed their oppositions to allowance of appeal today. Here’s a copy of Pfizer’s brief, and here’s a copy of the brief filed jointly by GSK and Apotex.

To the surprise of absolutely nobody, we can report that both briefs oppose a grant of certiorari in these SSRI/suicidality appeals.

Initially, we’d invite anybody who doesn’t think that plaintiffs in product liability litigation aren’t asking state courts to ignore FDA decisions to read the statements of fact in either of these briefs. The causation claims plaintiffs advance in these cases have been rejected by the FDA time and time again.

Ditto for the concept of “overwarning.” The proposition that too many warnings can have detrimental health effects by deterring the use of beneficial drugs isn’t something made up by the Bush administration. The SSRI record detailed in these briefs indicates FDA concern about overwarning back in 1991. Moreover, as we’ve already noted, there’s solid epidemiological evidence (only the largest increase in history in pediatric suicide rates coming hard on the heels of the addition of a pediatric suicide warning) indicating that the FDA’s concern about overwarning is 100% legitimate – certainly where SSRIs are concerned.

Beside our usual rants, here’s a brief description of the arguments that the defendants make in opposition to certiorari in Colacicco. First, Pfizer’s contentions:
  • There’s no disagreement among appellate courts (a well-established basis for Supreme Court review) on preemption in SSRI litigation.
  • No matter what the outcome in Wyeth v. Levine, preemption is proper in SSRI/suicide cases because of the extent of the FDA’s consideration of the scientific evidence and the Agency’s repeated determinations that there the science did not support a warning that SSRIs cause suicide in adults.
  • The Third Circuit’s opinion properly based its analysis on the FDA’s regulations as they stood on the date of the plaintiff’s alleged injury.
  • The doctrine of primary jurisdiction prevents plaintiffs from evading a definitive FDA regulatory record by arguing that the FDA was somehow defrauded.
  • Buckman preemption likewise prevents plaintiffs from evading a definitive FDA regulatory record by arguing that the FDA was somehow defrauded.
  • There was no “hypothetical misbranding” - nor is an actual misbranding prosecution a prerequisite to preemption - given the FDA’s prior conclusions on the lack of scientific evidence that SSRIs cause suicide in adults.
  • The FDA’s repeated rejection of adult suicide warnings on SSRIs cannot be construed as a “failure to regulate.”
And now – GSK/Apotex’s contentions (some of these are a little different because, while Pfizer sought summary judgment, GSK/Apotex moved for dismissal – that means what’s in the appellate record varies between the cases):
  • Given the FDA’s determination that there was no scientific evidence of causation, simultaneous compliance with the FDA’s directives and plaintiff’s purported common-law duties is impossible, and thus the Third Circuit’s determination was correct.
  • To allow this sort of tort action to continue would place state-law juries in the position of second-guessing FDA decisions regarding the proper warnings for drugs.
  • The doctrine of primary jurisdiction required plaintiffs to prosecute a citizen’s petition before the FDA before suing manufacturers who comply with FDA labeling requirements.
  • Preemption leaves plaintiffs with remedies against other parties and would leave the FDA's authority to prosecute non-complying drug manufacturers intact.
  • Congress explicitly recognized the applicability of conflict preemption in the 1962 amendments to the FDCA.
  • Courts do not share concurrent jurisdiction with the FDA over drug labeling, therefore there should be no preemption test that would delve deeply into internal FDA decision making.
  • Preemption is not affected by “what if” speculation concerning hypothetical “changes being effected” submissions.
  • This case involves a unique situation, due to the sheer magnitude of FDA regulatory action on the SSRI/suicide issue, and being unique, is not certworthy.

1 comment:

Joseph Jenkins said...

I believe the supreme court's decision in the case of generic pharmaceutical company's being held responsible for babies being born with heart defects caused by ssri anti depressants was corrupted. I think they were paid off! If they make a profit how can they not be held accountable?