NJ Judge Tosses Hormone Replacement Suit
4 CommentsBy Ed Silverman // July 11th, 2008 // 7:13 pm
A New Jersey state court judge granted summary judgment against the claims made by a woman who claims Wyeth’s Prempro and Premarin, and Pfizer’s Provera, caused her breast cancer. Her lawsuit, which charged the drugmakers failed to adequately warn against the risks associated with their meds, is the first in dozens of such cases and the outcome may call those into question.
In a 52-page decision, Superior Court Judge Jamie Happas ruled that Dora Bailey failed to provide the specific type of evidence necessary to overcome state law that presumes FDA-approved labeling on the three drugs was adequate.
Happas wrote that “the presumption of an adequate warning based on compliance with FDA regulations will be deemed rebutted only if the following proof is presented: deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or manipulation of the post-market regulatory process.” As the Drug and Device Law blog notes, to overcome this presumption, a plaintiff must show substantial evidence, not merely rely on expert testimony.
And so because Bailey was unable to refute the presumption of adequacy about the labeling, Happas granted summary judgment on claims under the state’s Product Liability Act. As a result, Bailey’s other claims - fraud, misrepresentation, and consumer fraud - were subsumed and no longer exist as separate bases of liability, the Drug and Device Law blog also points out. The judge dismissed a second case on the same grounds. READER NOTE: We learned of this very late in the day and so are unable to obtain comment right now from Bailey’s attorneys. When we do, will update accordingly.
UPDATE: On Monday, Wyeth issued this statement.
Hat tip to Drug and Device Law
Nathan
This is interesting: “Superior Court Judge Jamie Happas ruled that Dora Bailey failed to provide the specific type of evidence necessary to overcome state law that presumes FDA-approved labeling on the three drugs was adequate.”
This almost sounds as if New Jersey has some sort of “preemption doctrine” already in place. In my mind, this sounds like a nice compromise to preemption. FDA decisions on safety should be presumed to be adequate unless there is material evidence of “deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or manipulation of the post-market regulatory process”
Any thoughts Justice? I wonder why the original judge (or jury) didn’t use that standard?
Vince
Preemtion the ultimate shield for dangerous drugs. The judge I believe imposed this definition
Justice in MI
Yes/no, to Nathan. The proposal you suggest was _exactly_ what we’ve been fighting for in Michigan. FDA approval/compliance provides what is called a “rebuttable presumption” (of innoence). There are a number of states that have such a law - it is a very long way from preemption as is going forward. It’s been around a long time.
So if we arrived at that place nationally, it would be, in my view, a very good thing.
This language raises interpretive questions: ““deliberate concealment or nondisclosure of after-acquired knowledge of harmful effects or manipulation of the post-market regulatory process”
While it sounds good, and reasonable, does it mean in practice that FDA/DOJ must find felony fraud and prosecute it? If so, it is meaningless since, as we’ve discussed, that essentially never happens. Rather, settlements are made, remedial plans are put in place, etc..
Otherwise, this is precisely the balance between supporting FDA’s authority and the authority of legitimate claims to a hearing.
Justice in MI
Just a follow-on: As Ed notes, DDL suggests that plaintiff must have “substantial evidence” that a company did the relevant misdeeds. But where could the average get such evidence, other than through the discovery process? Not many places. Under preemption, that source will be gone.
As some may know, the pro-preemptions lawyers will be gathering for a big conference in Philly on July 14th and 15th. This will (I hope) generate ink about the issue.
From my perspective, the more the better. This is a policy that doesn’t stand up well to sunlight.