AK Elec Pension Fund v. Pharmacia Corp

CourtCourt of Appeals for the Third Circuit
DecidedJanuary 30, 2009
Docket07-4500
StatusPublished

This text of AK Elec Pension Fund v. Pharmacia Corp (AK Elec Pension Fund v. Pharmacia Corp) is published on Counsel Stack Legal Research, covering Court of Appeals for the Third Circuit primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
AK Elec Pension Fund v. Pharmacia Corp, (3d Cir. 2009).

Opinion

Opinions of the United 2009 Decisions States Court of Appeals for the Third Circuit

1-30-2009

AK Elec Pension Fund v. Pharmacia Corp Precedential or Non-Precedential: Precedential

Docket No. 07-4500

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Recommended Citation "AK Elec Pension Fund v. Pharmacia Corp" (2009). 2009 Decisions. Paper 1947. http://digitalcommons.law.villanova.edu/thirdcircuit_2009/1947

This decision is brought to you for free and open access by the Opinions of the United States Court of Appeals for the Third Circuit at Villanova University School of Law Digital Repository. It has been accepted for inclusion in 2009 Decisions by an authorized administrator of Villanova University School of Law Digital Repository. For more information, please contact Benjamin.Carlson@law.villanova.edu. PRECEDENTIAL

UNITED STATES COURT OF APPEALS FOR THE THIRD CIRCUIT

Nos. 07-4500 & 07-4564

ALASKA ELECTRICAL PENSION FUND; CITY OF SARASOTA FIREFIGHTERS' PENSION FUND; INTERNATIONAL UNION OF OPERATING ENGINEERS LOCAL 132 PENSION PLAN; NEW ENGLAND HEALTH CARE EMPLOYEES PENSION FUND; PACE INDUSTRY UNION-MANAGEMENT PENSION FUND; CHEMICAL VALLEY PENSION FUND OF WEST VIRGINIA, as Class Representatives, on behalf ofthemselves and all other similarly situated

v.

PHARMACIA CORPORATION; PFIZER, INC.; FRED HASSAN; DR. G. STEVEN GEIS; CARRIE COX

Alaska Electrical Pension Fund; City of Sarasota Firefighters' Pension Fund; International Union of Operating Engineers Local 132 Pension Plan; New England Health Care Employees Pension Fund; Pace Industry Union-Management Pension Fund; Chemical Valley Pension Fund of West Virginia,

Appellants in 07-4500

Pharmacia Corporation; Pfizer, Inc.; Fred Hassan; Dr. G. Steven Geis; Carrie Cox,

Appellants in 07-4564

APPEAL FROM THE UNITED STATES DISTRICT COURT FOR THE DISTRICT OF NEW JERSEY (D.C. Civil Nos. 3-03-cv-01519, 3-03-cv-01691, 3-03-cv-01808, 3-03-cv-01964, 3-03-cv-02149, 3-03-cv-02283) District Judge: The Honorable Anne E. Thompson Argued: November 21, 2008

Before: BARRY, CHAGARES, Circuit Judges, and RESTANI,* Judge

(Opinion Filed: January 30, 2009)

Eric A. Isaacson, Esq. (Argued) Arthur C. Leahy, Esq. Matthew P. Montgomery, Esq. Coughlin, Stoia, Geller, Rudman & Robbins 655 West Broadway Suite 1900 San Diego, CA 92101-0000

Peter S. Pearlman, Esq. Cohn, Lifland,Pearlman, Herrmann & Knopf Park 80 Plaza West One Saddle Brook, NJ 07663-0000

Counsel for Appellants/Cross Appellees

Gregg S. Levin, Esq. Joshua C. Littlejohn, Esq. Joseph F. Rice, Esq. Ann K. Ritter, Esq. Motley Rice 28 Bridgeside Boulevard P.O. Box 1792 Mount Pleasant, SC 29465-0000

Counsel for Appellant/Cross-Appellee Pace Industry Union- Management Pension Fund

* Honorable Jane A. Restani, Chief Judge, United States Court of International Trade, sitting by designation. 2 Jonathan M. Hoff, Esq. (Argued) Jason M. Halper, Esq. Joshua R. Weiss, Esq. Cadwalader, Wickersham & Taft One World Financial Center New York, NY 10038-0000

William A. Dreier, Esq. Steven A. Karg, I, Esq. Robert Mahoney, Esq. Norris, McLaughlin & Marcus 721 Route 202-206 P.O. Box 5933 Bridgewater, NJ 08807-0000

Counsel for Appellees/Cross Appellants

OPINION OF THE COURT

BARRY, Circuit Judge

In this securities fraud class action, plaintiffs allege that defendants violated §§ 10(b) and 20(a) of the Securities Exchange Act of 1934 by making, with scienter, materially false statements about a clinical study of Celebrex, a popular anti-inflammatory medication. In particular, defendants are alleged to have misled investors by distorting the study’s results with the intent to show that Celebrex had a better safety profile than similar medications. Finding the action to be untimely, the District Court granted summary judgment to defendants. This appeal and cross-appeal followed.

I. Factual Background

Celecoxib, known and marketed commercially as Celebrex, is an anti-inflammatory prescription drug sold by defendant

-3- Pharmacia Corporation. Substantially more expensive than many other nonsteroidal anti-inflammatory drugs (“NSAIDs”), Celebrex’s promise was rooted in the hope that it would cause fewer gastrointestinal (“GI”) side-effects than the less costly NSAIDs.1 To help the hope become a reality, defendants2 commissioned a long-term clinical study of Celebrex’s effect on the GI system, the Celecoxib Long-term Arthritis Safety Study (“CLASS study”). This litigation focuses on the aftermath of that study.

According to the complaint, the results of the CLASS study were a disappointment to defendants: Celebrex did not show the desired reduction in GI side-effects as compared to the other drugs studied. Fearing a decrease in sales and stock price, defendants allegedly undertook to distort the results of the study so that it would appear that Celebrex possessed a better GI safety profile than, in fact, it did. Towards this end, in April 2000, defendants released only the results from the first six months of the CLASS study; those results, divorced from the entire set of data, were capable of positive construction.

Defendants released the truncated results of the CLASS study with great fanfare, declaring that the study “shows that Celebrex has a truly exceptional safety profile,” and that “the long- term outcome data paints a clear and compelling picture of Celebrex’s safety versus NSAIDs.” (Joint App. (“JA”) 59, 64.) Some documents issued by defendants noted that the CLASS study lasted a full thirteen months, but the reason for excising the last seven months from the analysis was not revealed.

1 Unlike traditional NSAIDs, which inhibit both the COX-1 and COX-2 enzymes, Celebrex is a selective COX-2 inhibitor. Because the inhibition of COX-1 enzymes often leads to negative GI side-effects, it was hoped that selective COX-2 inhibitors would not possess the harmful side-effects associated with traditional NSAIDs. 2 Defendants include Pharmacia Corp., Pfizer, Inc., and individual defendants Fred Hassan, Steven Geis, and Carrie Cox.

-4- Scientists affiliated with defendants then drafted an article based on the truncated results and submitted it for publication to the Journal of the American Medical Association (“JAMA”). As would become known only later, however, neither defendants nor the article’s authors informed JAMA that the data in the article was incomplete. In September 2000, JAMA published the article, which reached the following conclusion: “The overall incidence of GI symptoms experienced by patients taking [Celebrex] was significantly lower than by those taking NSAIDs, as was the rate of withdrawal [from the study] due to GI intolerability.” (Id. at 45.)

Defendants hoped to convince the FDA to allow Celebrex to be marketed without the standard GI warning label required for other NSAIDs, and so submitted the complete data from the CLASS study to the FDA in June 2000. FDA staff members, in preparation for hearings on the warning label issue, reviewed the data. On February 6, 2001, the reports of those staff members were published on the FDA’s website, alongside defendants’ own report. Defendants’ report defended the decision to use only the truncated data, asserting that data after the six-month point was biased in favor of the comparator drugs:

The GI safety data presented are for the six-month treatment timepoint based on the analysis of risk factors prespecified in the protocol. In brief, a disproportionate withdrawal of patients at high risk of an ulcer complication from the entire study was observed after six months (depletion of susceptibles).

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