November 2013

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About a year ago, we discussed precedent establishing that off-label use can be, and often is, the medical standard of care.  Conversely, that means that it could be considered medical malpractice not to prescribe certain off-label therapies.  All of a sudden, that issue has popped up again, with two cases in the last week, both dealing with the off-label use of drugs in the abortion context.

We stay away from politics on this blog – whether it’s the merits of Obamacare or the merits of  legal restrictions on medical abortion. But where legal questions associated with this sort of controversial issue impact matters relevant to drug/device defense, we will cautiously venture into such territory, as we did here (ACA could render medical monitoring cause of action unnecessary) and here (FDCA preemption in abortion litigation context).  This time, it’s off-label use.
We’ll polish off the lesser of the two off-label use decisions quickly.  In Planned Parenthood of Greater Texas Surgical Health Services v. Abbott, ___ F. Supp.2d ___, 2013 WL 5781583 (W.D. Tex. Oct. 28, 2013) (“Abbott”), stay granted in part on other grounds, ___ F.3d ___, 2013 WL 5857853 (5th Cir. Oct.  31, 2013), an “off-label protocol” for terminating pregnancy using drugs rather than surgery was, as with the other off-label uses we discussed in our earlier post, determined to be the medical standard of care, and conversely, the FDA-approved intended use of the same key drug (mifepristone, also known as RU-486) was obsolete.  As the court stated:

Abortion-performing physicians have since developed a medication-abortion protocol using mifepristone that, although varying significantly from the FDA protocol, has become the de facto standard of care in Texas.  This protocol, or one substantially identical, accounts for the vast majority of medication abortions performed nationwide since 2007.  The new protocol [is] endorsed by the American College of Obstetricians and Gynecologists.

Id. at *7 (footnote omitted).  We omitted a footnote.  We now add it back in, because it is more relevant to our product liability defense-related concerns than most of the opinion:

Continue Reading A New Off-Label Use Hot Spot

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Before there was reality television, there was a show about nothing.  In one memorable episode of that show, the characters become enamored with purportedly non-fat frozen yogurt from a shop in which one character has invested.

When the characters notice that they have gained weight after regularly
consuming the frozen yogurt, the character who has invested takes some of the frozen yogurt to be tested for the presence of fat.  After madcap hijinks ensue, the yogurt is determined to contain fat and the Mayor of New York, who also favored the frozen yogurt and believes he has developed high cholesterol, vows to clamp down on false advertising. That was “Seinfeld” and the investor, Kramer, lost his money as millions laughed.

In Burke v. Weight Watchers Int’l, Inc., No. 2:12-06742 (WJM), 2013 U.S. Dist. LEXIS 149249 (D.N.J. Oct. 17, 2013), the plaintiff used to like defendant’s diet ice cream bars—at least some of them—until she learned that each one might have 28 to 50 more calories than was listed on the package.  So, she sued as a putative class representative for all consumers of all of defendant’s diet ice cream ban under the New Jersey Consumer Fraud Act, express warranty, implied warranty, and unjust enrichment.  She will get at least one more chance to plead non-preempted claims, perhaps by shifting her focus to allegations based on how diet ice cream bars taste compared to real ice cream.  The Häagen Dazs dulce split Dazzler surely trounces the defendant’s Dark Chocolate Dulcé de Leché Ice Cream Bar (one of the ones plaintiff sued over but did not buy)–no matter how many hundreds of additional calories the former actually has, it is worth it for those not vulnerable to a diabetic coma.
Continue Reading Do We All Scream For Diet Ice Cream?

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