Sykes v. Bayer Pharmaceuticals Corp.

• Decision Date: 12 February 2008
• Docket Number: Action No. 3:07-CV-660.
• Citation: 548 F.Supp.2d 208
• Court: U.S. District Court — Eastern District of Virginia
• Parties: Lisa SYKES, et al., Plaintiffs, v. BAYER PHARMACEUTICALS CORPORATION, Defendant.

548 F.Supp.2d 208

Lisa SYKES, et al., Plaintiffs, v. BAYER PHARMACEUTICALS CORPORATION, Defendant.

Action No. 3:07-CV-660.

United States District Court, E.D. Virginia, Richmond Division.

February 12, 2008.

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Clifford J. Shoemaker, Shoemaker & Associates, Vienna, VA, Lawrence R. Cohan, Anapol Schwartz Weiss Cohan Feldman & Smalley PC, Philadelphia, PA, for Plaintiffs.

David Alan Rudlin, William Paul Childress, III, Hunton & Williams LLP, Richmond, VA, Douglas Jennings Gunn, Watkins & Eager PLLC, Jackson, MS, Fred Marion Haston, III, Joseph Spurgeon Bird, III, Marc James Ayers, Bradley Arant Rose & White LLP, Birmingham, AL, Rachel Castillo Rosser, Eckert Seamans Cherin & Mellott LLC, Philadelphia, PA, for Defendant.

MEMORANDUM OPINION

JAMES R. SPENCER, Chief Judge.

THIS MATTER is before the Court on a Motion for Judgment on the Pleadings (Docket No. 90) by Bayer Pharmaceuticals Corporation and a Motion for Leave to File Amended Complaint (Docket No. 96) by Lisa and Seth Sykes, on behalf of their son, Wesley Sykes. For the reasons stated below, Bayer's Motion shall be GRANTED and Sykes' Motion shall be GRANTED IN PART AND DENIED IN PART.

I.

In 1995, Lisa received an injection of HypRho-D while she was pregnant with Wesley to prevent him from developing hemolytic disease of the newborn. HypRho-D, which is manufactured by Bayer, is an immune globulin, a "sterile solution containing antibodies derived from human plasma," 21 C.F.R. § 640.100, that suppresses the immune response of a Rhnegative pregnant woman to Rh-positive blood cells from her fetus that enter her circulation. Immune globulins are a type of "biological product" that is regulated by the Food and Drug Administration. See id. § 600.3(h). The FDA requires HypRho-D like `other immune globulins, to contain a preservative that, in the amount added to a recommended dose of the product, is not toxic. Id. § 610.15. Bayer's license for HypRho-D requires it to use thimerosal, a preservative that has been used to prevent the growth of microbes and fungi in vaccines for children since the 1930s. Thimerosal contains ethylmercury — by weight, about 50%. The Sykes allege that Wesley suffered serious neurological injuries and other symptoms of mercury poisoning because he was exposed to the mercury contained in the injection of HypRho-D that his mother received.

The Sykes sued Bayer, and two manufacturers of vaccines that Wesley received as an infant, in the Eastern District of Pennsylvania. Judge Lawrence Stengel granted summary judgment in favor of the vaccine manufacturers, ruling that the Sykes' claims against them were pre-empted by the National Vaccine Injury Compensation Act. See Sykes v. Glaxo-Smith-Kline, 484 F.Supp.2d 289 (E.D.Pa.2007). He also dismissed the Sykes' claim that Bayer failed to warn them about the risk of taking HypRho-D, ruling that it was pre-empted by federal law and regulations. Id. at 318. Judge Stengel did not resolve the Sykes' other claims against Bayer, transferring them to this Court. Those claims are that (1) Bayer is strictly liable for failing (a) to package HypRho-D in a single-dose vial, which allegedly would have obviated the use of thimerosal, and (b) to test whether thimerosal is safe; and (2) Bayer negligently designed and failed to test its product. Bayer asks the Court for judgment in its favor on those claims, and the Sykes ask the Court to allow them to amend their Complaint to add a variety of other claims against Bayer, manufacturers of thimerosal, and Dominion Electric, which allegedly released mercury into the air in Richmond.

II.

A motion for judgment on the pleadings under Federal Rule of Civil Procedure 12(c) is governed by the same standard that applies to a motion to dismiss for failing to state a claim under Rule 12(b)(6). Burbach Broad. Co. v. Elkins Radio Corp., 278 F.3d 401, 405-06 (4th Cir.2002). A motion to dismiss for failure to state a claim upon which relief can be granted challenges the legal sufficiency of a claim, not the facts supporting it. Conley v. Gibson, 355 U.S. 41, 45-46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957); see Goodman v. Praxair. Inc., 494 F.3d 458, 464 (4th Cir.2007). Thus, in ruling on a Rule 12(b)(6) motion, a court must regard as true all of the factual allegations in the complaint, Erickson v. Pardus, ___ U.S. ___, 127 S.Ct. 2197, 2200, 167 L.Ed.2d 1081 (2007), as well as any facts that could be proved that are consistent with those allegations, Hishon v. King & Spalding, 467 U.S. 69, 73, 104 S.Ct. 2229, 81 L.Ed.2d 59 (1984), and view those facts in the light most favorable to the plaintiff, Christopher v. Harbury, 536 U.S. 403. 406, 122 S.Ct. 2179, 153 L.Ed.2d 413 (2002).¹ The court may grant a Rule 12(b)(6) motion only if it "appears beyond doubt" that the party bringing the claim cannot prove any facts that would entitle it to relief. Conley, 355 U.S. at 46, 78 S.Ct. 99; accord Franks c, Ross, 313 F.3d 184, 192 (4th Cir.2002). But, the court does not have to accept legal conclusions that are couched as factual allegations. Bell Atl. Corp. v. Twombly, ___ U.S. ___, 127 S.Ct. 1955, 1964, 167 L.Ed.2d 929 (2007).

Thus, at this stage of these proceedings, the Court must decide whether the Sykes are entitled to offer evidence to support their claims, not whether they will ultimately prevail. See Scheuer v. Rhodes, 416 U.S. 232, 236, 94 S.Ct. 1683, 40 L.Ed.2d 90 (1974), abrogated on other grounds by Harlow v. Fitzgerald, 457 U.S. 800, 102 S.Ct. 2727, 73 L.Ed.2d 396 (1982). In doing so, the Court may consider "official public records" that are relevant to the Sykes' claims without converting Bayer's motion to one for summary judgment. See Gasner v. County of Dinwiddie, 162 F.R.D. 280, 282 (E.D.Va.1995); see also Tellabs, Inc. v. Makor Issues & Rights, Ltd., ___ U.S. ___, 127 S.Ct. 2499, 2509, 168 L.Ed.2d 179 (2007) (holding that a court, in deciding a Rule 12(b)(6) motion, may consider a document that is incorporated by reference into the complaint).

III.

First, the Sykes claim that Bayer is strictly liable for Wesley's injuries. In general, however, courts applying Virginia law² have not applied the doctrine of strict liability in product liability cases. See Sensenbrenner v. Rust, Orling & Neale, Architects, Inc., 236 Va. 419, 374 S.E.2d 55, 57 n. 4 (1988) ("Virginia ... does not permit tort recovery on a strict-liability theory in products-liability cases."); St. Jarre v. Heidelberger Druckmaschinen A.G., 816 F.Supp. 424, 427 (E.D.Va.1993) (Payne, J.) (stating that "it is beyond question that Virginia does not recognize a cause of action for strict liability in tort"). Only in cases that involve abnormally dangerous activities does Virginia impose strict liability. See Richmond, Fredericksburg & Potomac R. Co. v. Davis Indus., Inc., 787 F.Supp. 572, 575 (E.D.Va.1992) (Ellis, J.) (emphasizing that only activities, not substances, can be "abnormally dangerous"). Thus, the Sykes' strict-liability claim for injuries allegedly caused by HypRho-D, a substance, fails as a matter of law.

Second, the Sykes claim that Bayer acted negligently by failing to package HypRho-D in a single-dose vial, alleging that changing the design of the product's packaging would have eliminated the need to use a preservative. But, the FDA requires that every immune globulin "shall be a 16.5 ± 1.5 percent solution of globulin containing 0.3 molar glycine and a preservative." 21 C.F.R. § 640.103(a) (emphasis added). The Sykes acknowledge that "the FDA required the use of some preservative in Bayer's single-dose presentation of [HypRho-D]." Pl's Resp. Opp. Bayer's Mot. J. Pleadings at 13. Since a premise of the Sykes' design — defect claim — that Bayer could have avoided using a preservative by packaging HypRho-D differently — is false, the claim, as it is stated in the Sykes' Complaint,³ fails.

Third, the Sykes argue that Bayer failed to conduct testing on HypRho-D to determine whether the mercury in thimerosal, in the quantity contained in a recommended dose of the HypRho-D, was dangerous. But, the Virginia Supreme Court has stated that a product may be "unreasonably dangerous" in three ways, "if it is defective in assembly or manufacture, unreasonably dangerous in design, or unaccompanied by adequate warnings concerning its hazardous properties." Morgen Indus., Inc. v. Vaughan, 252 Va. 60, 471 S.E.2d 489, 492 (1996). By implication, any other type of product-liability claim cannot succeed.⁴

While the Sykes' claim might be regarded as a species of manufacturing-defect claim,⁵ their allegation that Bayer failed to test HypRho-D generally — not that it failed to test a particular dose or batch of its product — differentiates their claim from a typical manufacturing — defect claim. See, e.g., Matthews v. Ford Motor Co., 479 F.2d 399 (4th Cir.1973) (applying Virginia law). See generally Restatement (Third) of Torts: Product Liability § 2(a) (1997) (stating that a product "contains a manufacturing defect when the product departs from its intended design"); Spahn, Gary J., et al, Va. Prac. Prods. Liab. § 4:1 (2007) (stating that a manufacturing defect is a "fail[ure] to conform to [its] intended design"). Since the Sykes have not alleged that Lisa received an injection of HypRho-D that was not made as Bayer intended, the Court cannot regard the Sykes' "failure to test" claim as a manufacturing-defect claim. Thus, since Virginia recognizes only three ways in which a product may be unreasonably dangerous (and the Sykes' "failure to test" claim cannot plausibly be classified as a design-defect or failure-to-warn claim), this claim cannot succeed.

Accordingly, since each of the claims in the Sykes' Complaint fails as a matter of law, Bayer's Motion for Judgment on the Pleadings shall be GRANTED.

IV.

The Sykes want to amend their Complaint to add claims against Bayer for failure to warn, failure to test, negligent design,⁶...