[Drug and Device Law] Slamming the Door on Ghouls

It was a dark, non-stormy, and quiet Halloween night at our home. Maybe a lot of the kids in the neighborhood have grown up beyond trick-or-treating. We had way too much left-over candy. But this year we were smart because we bought candy we don't like. By contrast, last year we ended up with two extra bags of Kit-Kats. The consequences were catastrophic.

There was the usual mix of classic costumes, including witches, ghosts, and psycho-killers. There was also an interesting mix of more contemporary get-ups, such as Avatars, Iron Man, and Taser Boy. A couple of the trick-or-treaters looked especially ghastly and we had to ask who or what they were. "Lady Gaga" and "Snooki" were the responses. We hope we never look upon their like again.

For some reason, vampires, zombies, and ghouls remind us of plaintiff experts. They're horrible and mean us harm, but they are also, luckily, make-believe. As they say in the movies, it's only the wind. A recent Order out of the Prempro MDL makes plaintiff experts a little less frightening. Because we represent Pfizer in Prempro litigation, we cannot say a whole lot, so we'll give it to you plain and simple, leaving out the special effects and creepy music.

The name of the case is Ingram v. Wyeth, MDL No. 4:03CV01507-WRW (E.D. Ark. Sept. 16, 2010). As the Magistrate-Judge explains, the issue was "whether Drs. Parisian, Blume, and Austin can be designated as experts to testify about the reasonable standard of care that Defendants should have followed in the continuing testing of HRT after it was placed on the market." Order at 4. Parisian, Blume, and Austin are not qualified "to provide a jury with a reasonable standard of care or a custom and practice, for no other reason than one has not been shown to exist." Therefore, all that Parisian, Blume, and Austin could do was offer "a subjective opinion on what they believe Defendants could have done rather than what industry or governmental standards require them to do." Id. at 4 (emphasis in original). Parisian couldn't source any post-market duty to test in FDA regulations -- indeed, the court quoted Parisian's testimony in the Scroggin trial where she pretty much said the FDA did little to police drugs after they were out on the market. Id. at 5 n. 23. And the court wouldn't permit Blume to turn the PhRMA code into a standard of care under Arkansas law. Id. at 5. In short, all that the plaintiff experts were selling was an ipse dixit, and the court wasn't buying. Id. at 6 n. 25.

This opinion is important and useful because it applies to a type of plaintiff expert proffer we see again and again. Further, it applies to specific experts we see again and again. And if there is one thing one learns from watching horror movie franchises (e.g., Dracula, Friday the 13th, Halloween), it's that the villains keep coming back.

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Posted By Steve McConnell to Drug and Device Law at 11/01/2010 08:00:00 AM

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