This breaking news post is from Bexis only, as Wyeth – a major HRT defendant – is a big Herrmann client.
The New Jersey state court judge in Middlesex County has just issued a couple of good rulings. In Bailey v. Wyeth the court granted summary judgment against the plaintiff’s claims for
failure to warn, design defect, fraud, negligent misrepresentation and consumer fraud violations.
The warning claim failed as a matter of law because the plaintiffs could not overcome the NJ statutory presumption of adequacy that applies to FDA-approved labeling. Slip. op. at 28-34. Bailey is one of the few decisions really delving into how this presumption works.
[T]he presumption of an adequate warning based on compliance with FDA regulations will be deemed rebutted only if the following proof is presented: (i) deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects (“Perez/Rowe exception”) or (ii) manipulation of the post-market regulatory process.
Id. at 30. There must be “substantial evidence” to overcome the presumption. Id. at 31. Mere expert opinions are not enough. Id. The presumption applies to all labeling. Id. at 31-32. It does not disappear when controverted. Id. at 32-33.
The plaintiffs failed to produce any evidence that anything was withheld prior to FDA approval or that there was any post-approval “manipulation.” Id. at 33-34. Mere failure to test does not rise to “manipulation.” Id. at 34-38. Neither does ghostwriting of truthful articles qualify as “manipulation.” Id. at 38-39.
Nor does the fact that a drug was prescribed for off-label – with the knowledge of both the defendant and the FDA – use overcome the statutory presumption of adequacy. Id. at 39-43.
[T]he FDA had the regulatory authority to require a specific breast cancer warning in the labeling of Provera, Premarin or Prempro and was sufficiently knowledgeable on this issue to determine whether such a warning was necessary. The FDA’s decision not to include a more specific breast cancer warning in its labeling guidelines or guidance was both deliberate and informed. Any flaws in the FDA process are the responsibility of the United States Congress and the executive branch to correct, as they are in the best position to evaluate the pharmaceutical regulatory process.
Id. at 47.
Because the statutory presumption of adequacy was not rebutted, the defendants were entitled to summary judgment on all informationally-based claims under the state’s Product Liability Act. Id. at 48. Other claims – fraud, misrepresentation, and consumer fraud – were subsumed by the Act and no longer exist as separate bases of liability. Id. at 48-56.
The Bailey opinion also drew a number of juicy regulatory conclusions. The court held that the changes being effected right to alter drug labeling is limited to new information not previously available to the FDA. Id. at 9. It also confirms that off-label use is legal, ethical, commonplace, and often the represents the medical standard of care. Id. at 10-11. There’s also an interesting discussion of what the different types of FDA advisory letters mean. Id. at 18-19.
Finally, the Bailey court also excluded a plaintiff’s FDA expert’s (William Schultz) opinions as improper legal conclusions. Slip op. at 7 n.11.
In Deboard v. Wyeth, the court, in a letter opinion, granted summary judgment on the same grounds as Bailey.