Plan B "Chutzpah"

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  • 05/11/2012

For those of you following the Plan B saga, here’s the transcript of the April 27th, 2012 hearing in New York Federal Court.  

The April 27th hearing was supposed to be about whether Teva could intervene (to protect its 3 year exclusivity based on additional actual use/label comprehension studies FDA had acquired) and the court's order to show cause why the USG should not be held in contempt, but it also touched on the plaintiff's motion for a preliminary injunction/summary judgment and the government's motion to dismiss the case (which the judge denied orally at the hearing). 

The most amusing part of the transcript is when the government tries to argue that none of the plaintiffs are 13, so the court can't give relief as to them.  There were 13 years old when the case began, but the case has gone on so long they have reached the age of majority.  

The judge is scathing of the government's argument, saying "Do you know how long this agency -- your agency has done nothing and then you have the chutzpah to come in here and say that thirteen-year-olds who started the case are of age now." (See page 55.)

The judge is pretty scathing of Secretary Sebelius, referring to her logic as "totally ludicrous" (page 12).  He says that if Teva had appealed Sebelius's decision they would have won (page 24), but then later the DOJ lawyer points out that the Sebelius decision is not appealable, since it resulted in a complete response, which is not final agency action -- which the court finds odd (pages 38-43), at one point saying it seems like "blowing smoke."  

Later on the judge says, "this whole thing is an artificial construct at odds with common sense” (page 54) and wonders how the argument could be made with astraight face” (page 55).  The judge also talks about how the no one can satisfy the Sebelius criteria because there are not enough 11 year olds who are having sex (pages 43-44). Ouch.

The judge also calls the FDA to task for not denying the citizens petition as soon as he remanded it to them (in 2009), and he thinks that as soon as the agency told Teva they needed to do more studies, FDA should have denied the Citizens petition. (This conversation begins on page 50.)



Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.

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