Colacicco v. Apotex, Inc., Civil Action No. 05-5500.

CourtUnited States District Courts. 3th Circuit. United States District Court (Eastern District of Pennsylvania)
Writing for the CourtBaylson
Citation432 F.Supp.2d 514
PartiesJoseph C. COLACICCO, Plaintiff, v. APOTEX, INC., et al., Defendants.
Decision Date25 May 2006
Docket NumberCivil Action No. 05-5500.
432 F.Supp.2d 514
Joseph C. COLACICCO, Plaintiff,
v.
APOTEX, INC., et al., Defendants.
Civil Action No. 05-5500.
United States District Court, E.D. Pennsylvania.
May 25, 2006.

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Derek T. Braslow, Harris L. Pogust, Pogust & Braslow LLC, Conshohocken, PA, Derek Braslow, Sherman, Silverstein, Kohl, Rose and Podolsky, Pennsauken, NJ, for Plaintiff.

Arthur B. Keppel, Charles A. Fitzpatrick, III, Mylotte, David & Fitzpatrick, Broomall, PA, Andrew Thomas Bayman, Erica M. Long, S. Samuel Griffin, King & Spalding LLP, Atlanta, GA, David J. Stanoch, Joshua G. Schiller, Dechert LLP, Philadelphia, PA, for Defendants.

MEMORANDUM

BAYLSON, District Judge.


 TABLE OF CONTENTS
                 I. Introduction................................................................ 518
                 II. Background.................................................................. 518
                 A. Procedural Background................................................... 518
                 B. Allegations in the Complaint............................................ 519
                 III. Jurisdiction and Legal Standard............................................. 520
                 A. Jurisdiction............................................................ 520
                 B. Legal Standard.......................................................... 520
                 C. Applicable State Law.................................................... 520
                 IV. Contentions of the Parties.................................................. 521
                 A. Defendants.............................................................. 521
                 B. Plaintiff............................................................... 521
                 V. Federal Regulatory Process: Process to Obtain Approval from the FDA to
                 Market and Sell Prescription Drugs........................................ 522
                 VI. Preemption Issues........................................................... 523
                 A. Implied Preemption...................................................... 523
                 1. Deference to the FDA's Position that Plaintiff's Claims are
                 Preempted.......................................................... 525
                 a. The Government's Amicus Briefs.................................. 526
                 b. The Preemption Preamble......................................... 529
                 c. Weight Afforded to FDA's Position............................... 530
                 d. Inconsistency of the FDA's Position............................. 530
                 e. Retroactivity of the Preamble................................... 532
                 2. Other Evidence Supporting Implied Preemption......................... 535
                 B. Effect of Buckman Co. v. Plaintiffs' Legal Committee.................... 538
                

Page 518

 VII. Issues Arising Under State Law Claims....................................... 538
                 A. Duty of Care............................................................ 538
                 1. Defendant GSK: No Duty of Care Owed................................. 538
                 2. Defendant Apotex: Duty of Care Owed................................. 543
                 B. Learned Intermediary Doctrine........................................... 544
                 C. Reach of Hahn v. Richter................................................ 547
                 D. Individual Causes of Action............................................. 548
                 1. Non-negligence Claims............................................... 548
                 a. Breach of Implied Warranty (Count II)........................... 548
                 b. Fraud by Intentional Misrepresentation and Violation of New
                 York Consumer Protection Act (Count III)...................... 549
                 i. Fraud...................................................... 549
                 ii. Violation of New York Consumer Protection Law.............. 550
                 c. Infliction of Emotional Distress (Counts V and VI).............. 552
                 2. Claims Sounding in Negligence....................................... 553
                 a. Negligence (Count VII).......................................... 554
                 b. Negligence per se (Count VIII).................................. 554
                 c. Negligent Misrepresentation (Count IV).......................... 554
                 d. Strict Liability (Count IX)..................................... 555
                 VIII. Conclusion.................................................................. 555
                

I. Introduction

Presently before this Court are two Motions to Dismiss, pursuant to F.R. Civ. P. 12(b)(6), filed separately by Defendants Apotex, Inc. and Apotex Corp. ("Apotex") and Defendant GlaxoSmithKline ("GSK").

The threshold issue presented by these motions is preemption—whether regulations of a federal agency, promulgated pursuant to a federal statute, and implementing that statute, require the Court to dismiss this pharmaceutical products liability suit based on common law tort principles alleging that inadequate labeling of a prescription drug led to the suicide of Plaintiff's wife.

The answer is "yes"—when Congress passed the Federal Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. § 355(a), the law which gives the Food and Drug Administration ("FDA") control over the regulation of the prescription drug industry, it vested the FDA with authority to regulate the specifics of drug labeling, making important judgments of what is required for safety of the consuming public, what new drugs may appear in the marketplace, and what warnings their instructions and labels must carry. The analysis that follows will reveal many conflicting court decisions on this topic. Fundamentally, a series of Supreme Court decisions point this Court in the direction of deference, and require dismissal of this case. Accordingly, both Defendants' motions to dismiss will be granted.

II. Background

A. Procedural Background

Plaintiff Joseph Colacicco ("Plaintiff") filed his original complaint on October 21, 2005, alleging the suicide death of his wife, Lois, resulted from the Defendant drug manufacturers' failure to warn of the increased risk of suicidal behavior linked to the anti-depressant Paxil and/or its generic equivalent. On November 22, 2005, Defendant GSK filed its Motion to Dismiss (Doc. No. 5) ("Def. GSK Mem."). Plaintiff filed a Response (Doc. No. 9) on December 20, 2005, and GSK filed a Reply brief (Doc. No. 11) on December 27, 2005. Defendant Apotex filed a Motion to Dismiss (Doc. No. 10) on December 26, 2005 ("Def. Apotex Mem."), to which Plaintiff responded on

Page 519

February 7, 2006 (Doc. No. 19). By letter dated March 2, 2006, this Court asked counsel to answer questions that arose from its review of the briefs to date. All parties responded on March 13, 2006.(See Doc. No. 26 by Plaintiff, Doc. No. 27 by Defendant GSK, and Doc. No. 28, by Apotex) ("Supp. Mem."). Oral argument was held on March 17, 2006, at which Plaintiffs counsel withdrew Count I (breach of express warranty). On March 22, 2006, we again asked counsel by letter to answer additional questions that had surfaced, to which counsel responded on March 27, 2006 (See Doc. No. 33 by Apotex, Doc. No. 34 by GSK, and Doc. No. 38 by Plaintiff) ("2nd Supp. Mem."). Plaintiff filed an Amended Complaint on March 24, 2006 (Doc. No. 32), which asserted in Count III (fraud and violation of consumer protection law against GSK only) what had in the original complaint been plead as two counts against both Defendants-Count III (fraud) and Count X (violation of consumer protection law).1 Both Defendants GSK and Apotex filed a Response to the Amended Complaint and Supplemental Brief in Support of their Motions to Dismiss, on March 31, 2006 (Doc. Nos. 39 and 40, respectively), and Plaintiff filed a memorandum in opposition to the renewed motions to dismiss on April 6, 2006 (Doc. No. 41). ("3rd Supp. Mem."). Then, due to the novel preemption issues presented in this case, the Court requested that the FDA file an amicus brief, which it did on May 10, 2006 (Doc. No. 45). See Brief for United States as Amicus Curiae Supporting Defendants, Colacicco v. Apotex, Civ. No. 05-5500, Doc. No. 45 (E.D.Pa. May 10, 2006) ("Colacicco Amicus"). Finally, the parties each submitted a response to the amicus brief on May 17, 2006 (Does. No. 48, 49, 50) ("4th Supp. Mem.").

B. Allegations in the Complaint

According to the Complaint, Plaintiffs wife, Lois Ann Colacicco, complained to her oncologist on October 6, 2003 of mild fatigue and depression. She was prescribed Paxil,2 an anti-depressant drug manufactured by Defendant GSK. Soon thereafter, she began taking the generic version of the drug, paroxetine hydrochloride, which is a bio-equivalent of Paxil and manufactured by Defendant Apotex.3 On October 28, 2003, after twenty-two days of ingesting the drug, Lois Colacicco committed suicide in her home.

Paxil is one of a class of drugs known as Selective Serotonin Reuptake Inhibitors ("SSRIs"), which are prescribed for the treatment of depression and anxiety. Plaintiff alleges that despite ample peer-reviewed scientific literature published from the mid-1990s onward linking SSRIs to an increased risk of suicidality, at the time of Plaintiffs decedent's death the FDA—approved label did not warn of an association between Paxil (manufactured by GSK) and/or its generic equivalent (manufactured by Apotex) and suicidality.4

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Plaintiff filed suit against both Defendants GSK and Apotex, asserting the liability of either or both based on a failureto-warn theory. Plaintiff contends the warnings, which were disseminated to doctors and the public by GSK, were inadequate to inform adult users of the risk of suicide associated with the drug. He asserts the labeling was prepared solely by Defendant GSK and copied verbatim by Defendant Apotex, which was required as part of the process to obtain approval from the federal FDA to manufacture the generic version of the drug. Alternately, Plaintiff asserts Defendant Apotex manufactured the drug which caused Lois Colacicco's death, and failed to warn adult users of the risk of suicide posed by the drug.

III. Jurisdiction and Legal Standard

A. Jurisdiction

This Court has diversity jurisdiction over this complaint pursuant to 28 U.S.C. §...

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67 practice notes
  • Chemical facility anti-terrorism standards,
    • United States
    • Federal Register December 28, 2006
    • December 28, 2006
    ...approved under a Federal program? See Geier v. American Honda Motor Co., 529 U.S. 861, 882 (2000); Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006). For a state or local regulation, the question will often be whether the state measure would require activity that could interfer......
  • Part II
    • United States
    • Federal Register December 28, 2006
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    ...approved under a Federal program? See Geier v. American Honda Motor Co., 529 U.S. 861, 882 (2000); Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E.D. Pa. 2006). For a state or local regulation, the question will often be whether the state measure would require activity that could interfer......
  • CONTE v. WYETH INC., No. A116707
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    • California Court of Appeals
    • January 21, 2009
    ...by extensive studies of the drug's safety and effectiveness. (21 U.S.C. § 355(a)-(i); see Colacicco v. Apotex, Inc. (E.D.Pa.2006) 432 F.Supp.2d 514, 522.) Approval of the New Drug Application will be denied if clinical testing data and other information do not show that the drug is safe and......
  • O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • January 30, 2008
    ...federal law"); accord Dobbs v. Wyeth Pharmaceuticals, 530 F.Supp.2d at 1289 (W.D.Okla.2008) (same Effexor); Colacicco v. Apotex, Inc., 432 F.Supp.2d 514 (E.D.Pa.2006) (same Paxil); Dusek v. Pfizer, Inc., 2004 WL 2191804, at *8-10 (S.D.Tex. Feb. 20, 2004) (same Zoloft); Needleman v. Pfizer, ......
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65 cases
  • CONTE v. WYETH INC., No. A116707
    • United States
    • California Court of Appeals
    • January 21, 2009
    ...by extensive studies of the drug's safety and effectiveness. (21 U.S.C. § 355(a)-(i); see Colacicco v. Apotex, Inc. (E.D.Pa.2006) 432 F.Supp.2d 514, 522.) Approval of the New Drug Application will be denied if clinical testing data and other information do not show that the drug is safe and......
  • O'Neal v. Smithkline Beecham Corp., No. CIV S-06-1063 FCD/DAD.
    • United States
    • United States District Courts. 9th Circuit. United States District Courts. 9th Circuit. Eastern District of California
    • January 30, 2008
    ...federal law"); accord Dobbs v. Wyeth Pharmaceuticals, 530 F.Supp.2d at 1289 (W.D.Okla.2008) (same Effexor); Colacicco v. Apotex, Inc., 432 F.Supp.2d 514 (E.D.Pa.2006) (same Paxil); Dusek v. Pfizer, Inc., 2004 WL 2191804, at *8-10 (S.D.Tex. Feb. 20, 2004) (same Zoloft); Needleman v. Pfizer, ......
  • Knipe v. Smithkline Beecham, Civil Action No. 06-3024.
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    ...in the 2006 Preamble. See, e.g., In re Zyprexa Prods. Liab. Litig., 489 F.Supp.2d 230, 273-74 (E.D.N.Y.2007); Colacicco v. Apotex, 432 F.Supp.2d 514, 531 (E.D.Pa.2006); Dobbs v. Wyeth Pharms., 530 F.Supp.2d 1275, 1288 (W.D.Okla.2008); Sykes, 484 F.Supp.2d at 315. Such an inconsistency, unde......
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    ...allegedly failed to meet." Id. (citing GrovePage 30 Fresh Distribs., 720 F. Supp. at 716); see also Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 554 (E.D. Pa. 2006) ("Here, Plaintiff's negligence per se claim is premised on the alleged violation of the FDCA."). "[T]he FDCA does not preem......
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