Ischemia Research and Ed. Found. v. Pfizer, Inc. CA6

CourtCalifornia Court of Appeal
DecidedFebruary 26, 2013
DocketH034653
StatusUnpublished

This text of Ischemia Research and Ed. Found. v. Pfizer, Inc. CA6 (Ischemia Research and Ed. Found. v. Pfizer, Inc. CA6) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ischemia Research and Ed. Found. v. Pfizer, Inc. CA6, (Cal. Ct. App. 2013).

Opinion

Filed 2/26/13 Ischemia Research and Ed. Found. v. Pfizer, Inc. CA6 NOT TO BE PUBLISHED IN OFFICIAL REPORTS California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions not certified for publication or ordered published, except as specified by rule 8.1115(b). This opinion has not been certified for publication or ordered published for purposes of rule 8.1115.

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SIXTH APPELLATE DISTRICT

ISCHEMIA RESEARCH AND H034653 EDUCATION FOUNDATION, (Santa Clara County Super. Ct. No. CV026653) Plaintiff and Appellant,

v.

PFIZER INC., et al.,

Defendants and Appellants.

Plaintiff Ischemia Research and Education Foundation (IREF) appeals from the trial court‟s order granting a new trial to defendant Pfizer Inc. (Pfizer) on liability and defendant Dr. Ping Hsu (Hsu) on damages after a jury returned a $38 million verdict in IREF‟s favor in IREF‟s misappropriation of trade secrets action against Pfizer and Hsu. IREF contends that (1) the trial court‟s order is void because the statutory period for ruling on the new trial motions had expired before the court issued its order, (2) the statutory provision permitting a trial court to grant a new trial for insufficiency of the evidence is unconstitutional, (3) the trial court‟s order was an abuse of discretion, and (4) the trial court‟s decision not to award exemplary damages (an issue upon which it granted IREF a new trial) was an abuse of discretion. Pfizer and Hsu have filed protective cross- appeals. We reject IREF‟s contentions and affirm the trial court‟s order. Therefore, we need not address the cross-appeals. I. Factual Background IREF is a nonprofit corporation that collects and analyzes data from clinical trials, which it stores in databases. Dr. Dennis Mangano is a physician, the founder of IREF, and its “principal scientist.” Beginning in 2001, he also served as IREF‟s chief executive officer (CEO). Mangano is very experienced in conducting clinical trials. There are three types of clinical trials. A pharmaceutical company may sponsor a trial; the National Institutes of Health (NIH) may sponsor a trial; or an independent entity, such as IREF, may initiate a trial. Mangano formed a group of physician investigators, called McSPI, who represented the leading cardiac surgery centers. McSPI is an acronym for multi- center study of perioperative ischemia. Perioperative means before, during, or after surgery. Ischemia refers to an organ‟s lack of oxygen. Mangano‟s plan was to have these investigators contribute data to a database. The McSPI investigators joined together and did an observational study of 2,417 1 cardiac artery bypass graft (CABG) surgery patients. An observational study simply observes the history of patients as they go through surgery and during their hospitalization thereafter, while a clinical trial tests a drug or technique. The McSPI investigators collected 3,000 pieces of data per patient in this study, and this data was used to create a database called EPI-1. “EPI” stands for epidemiology. It took IREF two years to input and check the accuracy of this data. EPI-1 was owned by IREF, and no other database contained this type of information at this level of detail. After all of the data was inputted and checked, the EPI-I database was “locked” so that it could provide a basis for publishable work. EPI-1 was locked in 1995. Clinical trials of a drug called acadesine were conducted by IREF between 1990 and 1994. Acadesine was intended to help the body protect itself from a heart attack. The clinical trials of acadesine involved CABG patients. IREF was paid $30 million by

1 There were 24 centers, and each of them observed approximately 100 patients.

2 Gensia, the developer of acadesine, to do these clinical trials of the drug. IREF also 2 received the right to publish the research without constraints. IREF‟s agreements provided that IREF would have joint ownership over the placebo data, which involved 2,700 patients. The acadesine studies collected 2,000 pieces of data per patient. IREF was granted the right to the acadesine databases created from these clinical trials, which 3 included all 4,000 patients involved in the trials. IREF participated in a second observational study of CABG patients known as the EPI-2 study. The EPI-2 observational study was a worldwide, 70-center study of over 5,000 CABG patients in 17 countries that collected more than 11,000 pieces of data per patient. The EPI-2 database was locked in late 2001. There are no other databases in the world that contain this kind of information. IREF stored all of its databases on a server, which was kept in a locked room and was password-protected. This server contained the EPI-1 database, the EPI-2 database, 4 and the acadesine databases. Pfizer is a pharmaceutical company. In 1999, Pfizer5 was developing two drugs, parecoxib and valdecoxib. Valdecoxib was also known by the brand name Bextra. Bextra and parecoxib are nonsteroidal anti-inflammatory drugs (NSAIDs) called COX-2

2 IREF always insisted on the right to publish the research it did on behalf of a company. 3 Mangano testified at trial that Schering-Plough owned the acadesine databases “with rights to publish by IREF.” He explained that Schering-Plough had acquired ownership of the databases in 2007 with the exclusion of the rights involved in this litigation. 4 There are five acadesine databases. 5 The original developer of parecoxib and Bextra was Searle, which merged with Pharmacia and then became part of Pfizer. Although the entity involved was, at some points, Searle, and, at other points, Pharmacia, Pfizer is the entity that inherited any liability. For ease of reference, we will refer to the developer of parecoxib and Bextra as Pfizer regardless of whether it was actually Searle or Pharmacia at the time in question.

3 6 inhibitors. Pfizer wanted to be able to market Bextra and parecoxib to be used for acute pain, such as after surgery. The United States Food and Drug Administration (the FDA) requires clinical trials of drugs before it will consider approving them. Clinical trials are done to determine both whether a drug is effective and whether it has dangerous side effects. Pfizer contracted with IREF in 1999 and paid IREF more than $4 million for IREF‟s assistance in designing and conducting one of Pfizer‟s studies of Bextra and parecoxib. This study was a clinical trial called CABG I that was conducted in 2000. The CABG I contract obligated IREF to utilize its databases to provide responses to questions from Pfizer regarding CABG I. IREF referred to this as “productive access” to its databases. Under its contract with Pfizer, IREF received the right to the placebo data and the right to publish the results of the study, as was IREF‟s normal practice to require. CABG I was conducted using McSPI. Over $2 million of the money paid to IREF by Pfizer went to the McSPI investigators. The amount that IREF retained amounted to $4,368 per patient. Pfizer employee Dr. Richard Charles Hubbard was in charge of CABG I, and Pfizer employee Dr. Michael Snabes was also involved in CABG I. 7 Hsu was an employee of IREF from 1999 to 2004. Hsu was a biostatistician, and he served as IREF‟s director of biometrics. When he began working for IREF, he signed

6 Parecoxib is a slightly different form of the same molecule in Bextra. Parecoxib is given as an injection, while Bextra is given in tablet form. Once the body metabolizes them, they are identical. COX stands for “Cyclooxygenase.” Traditional NSAIDs are nonselective, which means that they inhibit both COX-1 and COX-2. COX-2 inhibitors are NSAIDs that are selective and inhibit only COX-2. COX-1 is an enzyme that protects the lining of the stomach. Thus, the potential advantage of a COX-2 inhibitor is that it possibly would not damage the stomach‟s lining.

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