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Aybrey v. Center for Clinical Research

September 26, 2008


The opinion of the court was delivered by: Judge Nora Barry Fischer



Plaintiff George Aubrey (hereinafter "Plaintiff" or "Aubrey") filed the instant civil action against Defendants Robert Gale Martin, M.D. (hereinafter "Dr. Martin"),*fn1 Carolina Eye Associates, P.C. (hereinafter "CEA"), Donald Sanders, M.D. (hereinafter "Dr. Sanders"), and Center for Clinical Research, Inc. (hereinafter "CCR"), alleging fraudulent misrepresentation against each Defendant separately and civil conspiracy against all Defendants collectively. Pending before this Court are Motions for SummaryJudgment by Defendants (Docket Nos. 44, 47).



At the outset, the Court notes Plaintiff's violation of Rule 56.1(c) of the Local Rules of this Court ("L.R. 56.1(c)").*fn2 In support of their Motion for Summary Judgment, Dr. Sanders and CCR (hereinafter referred to collectively as "Sanders Defendants") submitted a Statement of Undisputed Material Facts (Docket No. 49). Similarly, Dr. Martin and CEA (hereinafter referred to collectively as "Martin Defendants") filed a Statement of Undisputed Material Facts in support of their Motion for Summary Judgment. (Docket No. 45). In response, Plaintiff filed a Counter Statement of Facts. (Docket No. 52). In his Counter Statement of Facts, Plaintiff neither admitted nor denied the facts set forth by Defendants in their respective Statements of Material Facts; rather, Plaintiff responded by asserting twenty-one additional averments, derived mostly from the Deposition of Davis Brown, M.D. (Docket No. 52). Local Rule 56.1(E) ("L.R. 56.1(E)") sets forth the consequences for failure to comply with L.R. 56.1(c) as follows:

Alleged material facts set forth in the moving party's Concise Statement of Material Facts or in the opposing party's Responsive Concise Statement, which are claimed to be undisputed, will for the purposes of deciding the motion for summary judgment be deemed admitted unless specifically denied or otherwise controverted by a separate concise statement of the opposing party.

W.D.Pa. L. R. 56.1E (2008). Thus, for the purposes of the instant motions, the facts, as set forth in the Sanders Defendants' Statement of Material Facts (Docket No. 49) and those asserted in the Martin Defendants' Statement of Material Facts (Docket No. 45) are deemed admitted by Plaintiff, in accordance with L.R. 56.1(E). See Jankowski v. Demand, Civ. Action No. 06-00618, 2008 WL 1901347, at *1 (W.D.Pa. April 25, 2008); GNC Franchising LLC v. Kahn, Civ. Action Nos. 05-1341; 06-00238, 2008 WL 612749, at *1 (W.D.Pa. Mar. 3, 2008); Ferace v. Hawley, Civ. Action No. 05-1259, 2007 WL 2823477, at *1 (W.D.Pa. Sept. 26, 2007) (citing Benko v. Portage Area School Dist., Civ. Action No. 03-233J, 2006 WL 1698317 (W.D.Pa. June 19, 2006); Smith v. Burrows Corp., Civ. Action No. 00-1972, 2005 WL 2106594 (W.D.Pa. Aug. 31, 2005); Loving v. Borough of East McKeesport, Civ. Action No. 02- 1727, 2005 WL 3560661 (W.D.Pa. Dec. 29, 2005). After careful consideration and for the reasons that follow, the Court grants Defendants' Motions for Summary Judgment.


Sunrise Technologies International, Inc. (hereinafter "Sunrise") was a corporation located in California that developed, manufactured, and marketed laser systems for application in ophthalmology.*fn4 (Docket No. 49 at ¶ 4). Utilizing Laser Thermal Keroplasty ("LTK") technology, Sunrise developed an ophthalmologic laser instrument called the "Sun 1000," which later, with labeling refinements, evolved into the "Hyperion LTK." (Docket No. 45 at ¶¶ 1, 16; Docket No. 49 at ¶ 18). These instruments were intended to be used by eye doctors to correct hyperopia, known more commonly as "farsightedness." (Docket No. 45 at ¶1; Docket No. 49 at ¶ 6).

In or about 1997, Sunrise hired Dr. Sanders, the president and sole shareholder of CCR, to act as a consultant to Sunrise and assist in obtaining approval of the Sun 1000 from the Food and Drug Administration ("FDA"). (Docket No. 49 at ¶¶ 2,7). Dr. Sanders was responsible for setting up clinical trials to test the efficacy of the Sun 1000 in correcting farsightedness and presenting the data obtained from the clinical trials to the FDA. (Docket No. 49 at ¶¶ 7-8). The Sanders Defendants did not conduct clinical trials themselves. (Docket No. 49 at ¶ 9). Rather, they assisted Sunrise in setting up the trials and hiring eleven investigators to participate in the clinical studies of the Sun 1000. (Docket No. 49 at ¶ 8). Additionally, the Sanders Defendants did not create or collect data from those clinical trials. (Docket No. 49 at ¶ 9). The data from the clinical trials was collected and complied by a third-party, Bio-Reg Associates, Inc. ("BioReg"), and then transmitted to the Sanders Defendants. (Docket No. 49 at ¶ 11; Aubrey Depo. at 297:20-25). For the services that he performed as a consultant, Dr. Sanders received stock options in Sunrise. (Docket No. 8 at 3).

Among the eleven clinical investigators hired to perform clinical trials with the Sun 1000 was Dr. Martin, the president and sole shareholder of CEA. (Docket No. 45 at ¶ 1; Docket No. 52 at ¶ 5). Dr. Martin only performed clinical trials using the Sun 1000; he did not perform trials on the Hyperion LTK and had no involvement with the FDA approval of that system. (Docket No. 45 at ¶17). In total, the clinical studies submitted to the FDA by Sunrise focused on 612 eyes; Dr. Martin conducted clinical studies using the Sun 1000 laser on approximately fifteen patients, for a total of twenty-five eyes. (Docket No. 45 at ¶¶ 2-3). CEA technicians submitted Dr. Martin's data directly to Bio-Reg, which compiled the information and supplied it to Sunrise for presentation to the FDA. (Id. at ¶¶ 5-6). For his participation in the clinical trials and for a cash investment in Sunrise, Dr. Martin received a number of stock options, some of which he exercised; Dr. Martin did not receive shares of stock as compensation. (Id. at ¶¶ 9-10).*fn5

Aubrey made his first purchase of Sunrise stock in 1999, based on the recommendation of an unknown stockbroker he met at a restaurant in Palm Beach, Florida, in the summer of 1999, and the advice of another broker he met at a securities convention in Arizona in September or October of that same year. (Docket No. 49 at ¶ 21). On July 22, 1999, Sunrise presented the data from all the clinical studies on the Sun 1000 to the FDA Opthalmologic Device Panel ("ODP") for approval. (Docket No. 45 at ¶ 12; Docket No. 49 at ¶ 16). Dr. Sanders assisted in presenting the data to the FDA; Dr. Martin was neither present at the ODP hearing nor did he make any presentation of data to the FDA. (Docket No. 49 at ¶ 11; Docket No. 45 at ¶¶ 7, 14). At this time, the FDA disapproved the Sun 1000. (Docket No. 45 at ¶ 13; Docket No. 49 at ¶ 17). The value of Sunrise stock dropped after the ODP hearing. (Docket No. 8 at 7).*fn6

In January of 2000, six months after the FDA's denial of approval for the Sun 1000, Sunrise agreed to modify the laser's label to show that its impact in correcting farsightedness was only temporary and resubmitted its data to the FDA. (Docket No. 45 at ¶ 15; Docket No. 49 at ¶ 18). The laser was ultimately approved by the FDA on July 30, 2000; however, it differed slightly from the Sun 1000, and was known as the "Hyperion LTK."*fn7 (Docket No. 45 at ¶ 16; Docket No. 49 at ¶ 18). Aubrey continued to invest in Sunrise, buying and selling shares between 1999 and 2002. (Docket No. 49 at ¶ 31). Aubrey makes claims against Defendants for fraudulent misrepresentation and conspiracy related to the work Defendants performed to assist Sunrise in obtaining approval from the FDA for the Sunrise technology. (Docket No. 49 at ¶ 5).


Plaintiff commenced the instant action by filing a Praecipe for Writ of Summons on June 23, 2004, in the Court of Common Pleas of Butler County. (Docket No. 1). Plaintiff subsequently filed a Complaint in that court on January 4, 2007. The matter was then removed to this Court pursuant to 28 U.S.C. ยง1441, et seq. on February 1, 2007, and was assigned to Judge Thomas M. Hardiman. (Docket No.1). The Sanders Defendants filed an Answer to the Complaint on February 9, 2007. (Docket No. 8). The Martin Defendants filed Answers on February 5, 2007, (Docket Nos. 3, 4), and Amended Answers on February 16, ...

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