2011年5月4日水曜日

Fifth Circuit: No, you can't prove Requip causes gambling

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What happens is Vegas should stay in Vegas - and should not be turned into a product liability suit.  That's the takeaway from Wells v. SmithKline Beecham Corp., No. 09-50244, slip op. (5th Cir. March 22, 2010).  Somebody who had been gambling (and losing) for more than thirty years tried to claim that a cheap cialis for Parkinson's disease causes him to lose still more after he began taking the drugs.



As the Fifth Circuit, observed, none of plaintiff's three experts could say that the drug caused gambling:  Expert #1 ("we don’t have enough data to suggest causality"); Expert #2 ("has a cause-and-effect relationship been established . . .?  No.”).  Expert #3 ("I cannot say [the drug] directly causes [pathological gambling].  What I can say is that there is an association between the two variables. . . .  [T]hat’s different than talking about the issue of causation.”).  Slip op. at 6.



Umpire Daubert says, "strike three, your out."



Amazingly, the plaintiff appealed.  The Fifth Circuit rung the plaintiff up again:

While “[w]e . . . understand that in epidemiology hardly any study is ever conclusive, and we do not suggest that an expert must back his or her opinion with published studies that unequivocally support his or her conclusions,” here there is simply too great an analytical gap between the data and the opinion proffered.  And the bases for the experts’ conclusions pass none of the applicable Daubert tests:  that [the drug] causes problem gambling is not generally accepted, has not been subjected to peer review and publication, and is not backed by studies meeting requisite scientific standards. Without the expert testimony, Wells cannot prove general causation – and judgment must be entered for GSK.
Slip op. at 8-9 (footnotes and other stuff omitted).  "[T]he scientific knowledge is not yet there."  Id. at 9.



And don't bet on baseball, either.



We're told that congrats to Marcy Greer, Stephanie Smith, and Stacey Martinez of Fullbright & Jaworski, and to Cindy Bennes of Phillips Lytle.

2011年5月3日火曜日

HIV/AIDS Update - Tentative approval for abacavir sulfate scored tablets for oral suspension, 60 mg

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You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On March 4, 2011, the Food and Drug Administration (FDA) granted tentative approval for abacavir sulfate scored cheap cialis for oral suspension, 60 mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in pediatric patients. Reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR), this product is manufactured by Cipla Limited of Mumbai, India.

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.

You can find a complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration


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