Opinion ID: 2968817
Heading Depth: 3
Heading Rank: 2

Heading: kaplan method

Text: Central to the Switch Study was Dr. Kaplan’s personal method of converting patients from other pain medications to Kadian (hereinafter, the “Kaplan Method”). J.A. 1950-51. The Kaplan Method involved adding Kadian to a patient’s shorteracting pain medication, and once Kadian reached a certain level, weaning the patient off of the other drug. Id. at 243. After hiring him to perform the Switch Study, Alpharma asked Dr. Kaplan to train its sales representatives so that they could present the Kaplan Method to other physicians, in an effort to increase the number of Kadian prescriptions. Id. at 201, 1950. He agreed, and the training presentation took place in August 2005. Id. at 1950. Even though Parks told Dr. Royal that “part of why [Dr. Kaplan] is so successful in convincing doctors to really give Kadian a fair trial is his discussion of conversion,” J.A. 6 496, she nonetheless complained about the Switch Study and the 2005 training for three reasons. First, Parks did not believe that the other sales representatives fully understood the Kaplan Method. She claims she was “inundated with calls and emails” from sales representatives with questions about it. J.A. 988. In an email to her supervisors, Mike Slesinski and Peter Hill, Parks stated that she was “happy that the talk was met with such enthusiasm” but was “hesitant to give any info on the lecture without talking to management” and could not “handle the huge volume of requests that seems to be building up.” Id. at 989. Parks proposed a conference call with the sales representatives to discuss the Kaplan Method because, as she explained in her deposition, she wanted “to clear up the confusion . . . to be able to ensure that the reps did understand the [Kaplan Method] because it was a serious matter and could endanger patient’s [sic] safety.” Id. at 811. Parks also claims that she complained to Hill about these concerns during field rides with him, but Hill recalls Parks saying only positive things about the Kaplan Method. See id. at 1880. Second, Parks says that she complained to her superiors that the Kaplan Method encouraged an “off-label” use of the drug. Br. of Appellant 16. An “off-label” use is one that has not been approved by the federal Food and Drug 7 Administration (“FDA”). See United States ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39, 43-44 (D. Mass. 2001). Although physicians may prescribe drugs for off-label usage, federal regulations prohibit drug manufacturers from marketing their drugs for off-label purposes. See id.; 21 U.S.C. §§ 331(a), (d); see also Washington Legal Foundation v. Henney, 202 F.3d 331, 332-33 (D.C. Cir. 2000) (providing background on offlabel use and promotion of pharmaceutical drugs). Parks alleges that she complained to supervisors Slesinski, Hill, and Craig LaFay that representatives were simplifying the Kaplan Method and thus promoting an off-label conversion, but none of them recalls Parks expressing these concerns or ever using the terms “illegal,” “fraudulent,” or “off-label.” J.A. 1903-04, 1880, 1891. Parks admits that she did not put in writing her concerns that Alpharma’s marketing practices were off-label or fraudulent, see id. at 819, 821, and never used the terms “illegal” or “fraudulent” in conversation, but rather used the term “off-label,” see id. at 789-90. Finally, Parks says that she voiced concerns about the manner in which the Switch Study and Kaplan Method were presented. She claims that the study revealed that converting patients to Kadian who were also on morphine would result in increased, not reduced, costs. J.A. 1948. An abstract prepared by a third party failed to mention this fact, id. at 274-78, and 8 Parks says that she expressed her disapproval that Alpharma had decided to “bury” such results, id. at 1948. Parks also says that she spoke with Dr. Stephen Sun, a member of the Alpharma medical affairs division, who told her that the Switch Study was a “failure” and that he did not want the results to be released. Id. Parks claims that she sent an email “to prove” to her supervisor that the pharmacoeconomic results had been buried. Id. at 1949. That email, however, simply states, “This [Abstract] Poster has been presented now. It is my understanding that [a nurse from Dr. Kaplan’s office] may present it herself . . . at a District teleconference.” Id. at 281. Aside from her own testimony, Parks presents no other evidence that she expressed her disapproval with Alpharma’s handling of the Switch Study abstract, and no reasons why she believed Alpharma was responsible for the alleged “burying,” when a third party actually prepared the abstract.