Sykes v. Galxo-Smithkline

Decision Date28 March 2007
Docket NumberNo. CIV.A. 06-1111.,CIV.A. 06-1111.
Citation484 F.Supp.2d 289
PartiesLisa SYKES, et al., Plaintiffs, v. GLAXO-SMITHKLINE, et al. Defendants.
CourtU.S. District Court — Eastern District of Pennsylvania

Roda, Roda & Nast PC, Lancaster, PA, John H. Kim, The Kim Law Firm, Houston, TX, Lawrence R. Cohan, Anapol Schwartz Weiss Cohan Feldman & Smalley, Philadelphia, PA, Michael L. Williams, Williams, Love, O'Leary, Craine & Powers, P.C., Portland, OR, for Plaintiffs.

Barclay A. Manley, Fulbright & Jaworski L.L.P., Houston, TX, Barry H. Boise, Matthew J. Hamilton, Pepper Hamilton LLP, Reetu Dandora, Reed Smith LLP, Rachel Castillo Rosser, Eckert Seamans Cherin & Mellott LLC, Philadelphia, PA, Marcy Hogan Greer, Fulbright & Jaworski L.L.P., Austin, TX, Daniel J. Thomasch, Lauren Elliot, Orrick Herrington & Sutcliffe LLP, New York City, Douglas J. Gunn, Watkins & Eager PLLC, Jackson, MS, Fred M. Haston, III, William F. Goodman, III, Bradley, Arant, Rose & White, Birmingham, AL, for Defendants.

OPINION

STENGEL, District Judge.

                TABLE OF CONTENTS
                  I.  Introduction ...................................................................292
                 II.  Background .....................................................................292
                III.  Judgment on the Pleadings v. Summary Judgment ..................................295
                 IV.  Rule 12(c) Judgment on the Pleadings Standard ..................................296
                  V.  Federal Preemption of State Law Claims .........................................296
                      A.  Preemption in General ......................................................296
                      B.  Express Preemption of Defective Design Claims under the Vaccine Act ........297
                          1.  Vaccine Act in General — Congress's Dual Concern .................297
                          2.  The Parties' Arguments .................................................298
                          3.  Section 22(b) — Against the Backdrop of Product Liability Law and
                                Its Legislative History ..............................................299
                          4.  Plaintiffs' Strict Liability Defective Design Claims against GSK and
                                Wyeth Are Barred .....................................................301
                          5.  Plaintiffs' Negligent Defective Design Claims Against GSK and
                                Wyeth Are Barred .....................................................303
                      C.  Failure to Warn Claims Under the Vaccine Act 303
                          1.  The Vaccine Act's Modification of State Law Failure to Warn Claims .....303
                          2.  Parties' Arguments .....................................................304
                          3.  Direct Warning Claims ..................................................304
                          4.  Remaining Failure to Warn Claims .......................................304
                      D.  Conflict Preemption Under the FDCA and FDA Regulations .....................306
                          1.  Recap of Conflict Preemption ...........................................306
                          2.  Overview of Regulatory Process to Obtain Approval from the FDA
                                of a Biological Product ..............................................307
                          3.  The FDA's Preemption Position Regarding Plaintiffs' Failure to
                                Warn Claims and the Deference to Be Given That Position ..............308
                              a.  FDA's Position of Preemption Stated in the Preemption
                                    Preamble .........................................................308
                              b.  FDA's Preemption Position as Applied in This Case ..................310
                              c.  What Deference Should be Given to FDA Position? ....................313
                          4.  Conclusion .............................................................318
                     E.  Plaintiffs' Remaining Claims Against Bayer ..................................318
                 VI.  Transfer of Venue Motions ......................................................321
                VII.  Conclusion .....................................................................324
                
I. INTRODUCTION

Eleven-year old Wesley Sykes suffers from neurological injuries which his parents believe were caused by products made by the defendants.1 When Wesley's mother was pregnant with Wesley she received an injection of an immune globulin2 and during Wesley's first three years of life he received injections of various pediatric vaccines. These medications have two things in common — they were manufactured by a defendant in this action and they contained the preservative thimerosal.

Thimerosal is an organic compound which is approximately 50% mercury by weight. Wesley's parents, the plaintiffs in this case, claim that the thimerosal-containing products caused Wesley's various injuries. They filed this lawsuit against the manufacturers of the vaccines, Smith-Kline Beecham Corporation d/b/a Glaxo-SmithKline ("GSK") and Wyeth, Inc., f/k/a American Home Products Corporation, and the manufacturer of the immune globulin product, Bayer Pharmaceutical Corporation. The defendants have moved to dismiss the entire state law Complaint based on preemption grounds. The two sources for the preemption of the plaintiffs' state law claims are: (1) the National Childhood Vaccine Injury Compensation Act of 1986 ("Vaccine Act"), 42 U.S.C. § 330aa-1, et seq., and (2) the Food, Drug and Cosmetic Act ("FDCA"), 21 U.S.C. 301, et seq., and the Food and Drug Administration ("FDA") regulations promulgated under that statute. In addition, or in the alternative, the defendants have moved to transfer the case to the Eastern District of Virginia.

II. BACKGROUND

In 1995, Lisa Sykes was pregnant with her son, Wesley. During her pregnancy, Mrs. Sykes received from her physician a dose of Bayer's immune globulin blood product, HypRho-D. Mrs. Sykes's antepartum shot of HypRho-D contained thimerosal. Wesley Sykes was born on January 27, 1996. Between February 1996 and September 1998 Wesley received the following vaccines: (1) one dose of Wyeth's thimerosal-containing Diphteria and Tetanus Toxoids and Acellular Pertussis ("DTaP") vaccine (marketed under the trade name ACEL-IMUNE®); (2) one dose of Wyeth's thimerosal-containing Haemophilus influenzae type b ("Hib") vaccine (marketed under the trade name HibTITER®); (3) three doses of Wyeth's thimerosal-containing Diphteria and Tetanus Toxoids and Pertussis ("DTP")-Hib combination vaccine (marketed under the trade name TETRAMUNE®); and (4) three doses of GSK's thimerosal-containing Hepatitis B vaccine (marketed under the trade name Engerix-B®).3 According to the Complaint, the ante-partum injection of HypRho-D and the vaccination of Wesley with the defendants' products resulted in neurological and neuro-developmental injuries to Wesley. In particular, the plaintiffs allege that the mercury contained in the thimerosal preservative in each of the products was toxic and led to Wesley's injuries.

The defendants' vaccines and Bayer's immune globulin are "biological products," as that term is defined in FDA regulations. See 21 C.F.R. § 600.3(h). For all biological products containing a preservative, the FDA must be satisfied that the preservative is safe before the product can be marketed:

Any preservative used shall be sufficiently nontoxic so that the amount present in the recommended dose of the product will not be toxic to the recipient, and in the combination used it shall not denature the specific substances in the product to result in a decrease below the minimum acceptable potency within the dating period when stored at the recommended temperature. Products in multiple-dose containers shall contain a preservative ....

21 C.F.R. § 610.15 (emphasis added). Thimerosal has been used as a preservative in a number of biological products since the 1930s to prevent the growth of microbial contaminants. In childhood vaccines, thimerosal has been used to "deter[] microbial and fungal growth, thereby maintaining safety, purity and potency of vaccines" both during and after the manufacturing process. See Ex. I to GSK's Mot. to Take Judicial Notice,4 U.S. Food and Drug Administration Center for Biologics Evaluation and Research, Thimerosal in Vaccines at 2 (updated Nov. 16, 2006), available at http://www.fda.gov/cber/ vaccine/thimerosal.htm. See also Owens v. Am. Home Prods. Corp., 203 F.Supp.2d 748, 755 (S.D.Tex.2002).

The GSK product in question, Engerix-B® vaccine, contained thimerosal as a preservative. It was approved by the FDA for distribution and sale in the United States. The vaccine was distributed with labeling information approved by the FDA. The vaccine's label disclosed that the vaccine contained "thimerosal (mercury derivative)" as part of the formula, as well as the concentration of the preservative. At all relevant times, the disclosure and description of thimerosal in the label, and the use of thimerosal as an ingredient, could not be changed without FDA approval. See 21 C.F.R. § 601.12 (requiring FDA approval before any changes in the manufacturing methods and labeling of a biological product become effective).

All of the Wyeth products administered to Wesley contained thimerosal as a preservative. ACE L-IMUNE®, HibTTER®, and TETRAMUNE® were marketed in multi-dose presentations at the time of Wesley's vaccination, and the FDA mandates that all childhood vaccines "in multi-dose containers shall contain a preservative." See 21 C.F.R. § 610.15. The FDA approved Wyeth's vaccines at issue with thimerosal as an ingredient, and Wyeth complied with federal law and regulations regarding the labeling of the vaccines. In the labels submitted and approved by the FDA, Wyeth disclosed the presence and concentration of thimerosal in the vaccines.

Bayer's HypRho-D is a prescription biological product that works by suppressing the immune response of Rh negative pregnant women to Rh positive blood cells from the fetus that enter the mother's circulation. The FDA requires that every immune...

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