Doe v. Bayer Corp.

• Decision Date: 25 March 2005
• Docket Number: No. 1:03 CV 00727.,1:03 CV 00727.
• Citation: 367 F.Supp.2d 904
• Court: U.S. District Court — Middle District of North Carolina
• Parties: Michael and Cynthia DOE, individually and as guardians ad litem of Minor Child Doe, Plaintiffs, v. BAYER CORPORATION, Individually and as Successor-in-Interest to Miles, Inc., an Indiana corporation; Bayer Biological Products, a division of Bayer Corporation, an Indiana corporation, Defendants.

367 F.Supp.2d 904

Michael and Cynthia DOE, individually and as guardians ad litem of Minor Child Doe, Plaintiffs, v. BAYER CORPORATION, Individually and as Successor-in-Interest to Miles, Inc., an Indiana corporation; Bayer Biological Products, a division of Bayer Corporation, an Indiana corporation, Defendants.

No. 1:03 CV 00727.

United States District Court, M.D. North Carolina.

March 25, 2005.

COPYRIGHT MATERIAL OMITTED

William Marc Graham, Jean Sutton Martin, Salisbury, NC, for Plaintiffs.

Richard W. Ellis, Paul K. Sun, Jr., Alex John Hagan, Andrew S. Chamberlin, Raleigh, NC, Bradley Reid Kutrow, Charlotte, NC, for Defendants.

MEMORANDUM OPINION AND ORDER

OSTEEN, District Judge.

Plaintiffs Michael and Cynthia Doe, individually and as Guardians Ad Litem of Minor Child Doe (collectively, "Does"), bring this diversity action against Defendant Bayer Corporation ("Bayer").¹ Plaintiffs assert several state-law causes of action against Defendant arising out of personal injuries to Minor Child Doe, allegedly caused by in utero exposure to thimerosal.

Defendant moves for dismissal under Rule 12(b)(1) of the Federal Rules of Civil Procedure for lack of subject matter jurisdiction because Plaintiffs have not exhausted their remedies in the U.S. Court of Federal Claims (the "Vaccine Court"), as required by 42 U.S.C. § 300aa-21(a-b). As an alternative to dismissal, Defendant asks that this proceeding be stayed until the proceeding in the Vaccine Court is resolved. Defendant asserts a second alternative motion for a more definite statement of Plaintiffs' claims under Rule 12(e) of the Federal Rules of Civil Procedure. Finally, Defendant moves for Plaintiffs to supplement the record.

For the reasons set forth below, the motions will be denied.

I. BACKGROUND

The complaint sets out the following facts, which are presented in the light most favorable to Plaintiffs.²

Plaintiffs Michael and Cynthia Doe are the natural parents of Minor Child Doe. (Compl.¶ 3.) In December 1994, while Cynthia was pregnant with Minor Child Doe, she was given an injection of HypRho-D, a medical product manufactured by Bayer.³ (Id. ¶ 22.) HypRho-D is an Rh-immune globulin compound that was administered to pregnant women to prevent Rh hemolytic disease in newborns, a result of a difference in Rh blood type between mother and child. (Def. Bayer's Mem. Supp. Mot. Dismiss, or Alt. Mot. Stay and/or Mot. More Definite Statement [hereinafter, "Bayer's Mot. Dismiss"] at 3 n. 3.) If this Rh incompatibility is left untreated, the mother's immune system can attack the red blood cells in the fetal bloodstream. (Id.) HypRho-D was typically injected into a pregnant woman at around 28 weeks' gestation. (Compl.¶¶ 16, 25.)

In manufacturing HypRho-D, Bayer included a preservative called thimerosal. (Id. ¶¶ 2, 16, 27, 31.) Thimerosal is an antiseptic compound that has been used as a preservative in various pharmaceutical preparations, including vaccines and Rh-immune globulin products like HypRho-D. (Id. ¶¶ 15-16.) Thimerosal consists of almost 50% organic mercury by weight. (Id. ¶ 15.) Mercury is toxic to humans, and a developing fetus may be especially sensitive to the effects of mercury exposure. (Id. ¶¶ 12-13, 20.) Prenatal exposure can cause harmful effects to the child's development, including severe neurological dysfunctions, developmental abnormalities, and neurodevelopmental disorders. (Id. ¶¶ 13, 21.) Once injected into a pregnant woman, thimerosal can be transported into the fetal blood stream, thus exposing the developing brain and other organs and tissues to organic mercury. (Id. ¶ 19.)

The Does allege Bayer knew or should have known of the dangerous effects of mercury exposure associated with thimerosal and had various duties to protect against injury. (Id. ¶ 37.) At the time, Bayer was aware that its product would be injected into pregnant women to prevent Rh hemolytic disease. (Id. ¶¶ 27-28.) Plaintiffs allege that Cynthia Doe's injection exposed Minor Child Doe to toxic levels of mercury and has caused him to suffer neurological damage. (Id. ¶ 34.) Specifically, he "has sustained mental, developmental and neurological incapacity and associated learning disabilities." (Id.) His damages include past and future medical expenses, as well as the expenses of "continual psychological, educational, occupational, rehabilitative and dietary therapies." (Id.) He also seeks recovery for loss of enjoyment of life, loss of future economic opportunity, and reduced future earnings capacity. (Id.) Also, as a result of the substantial and constant care Minor Child Doe requires, his parents have incurred injuries of their own. (Id.) They seek recovery for past and future medical expenses, the provision of past and future nursing care, emotional distress, and lost opportunities. (Id.)

Plaintiffs have filed an additional claim in the Vaccine Court. According to the Does, this claim is for "significant aggravation" of Minor Child Doe's preexisting injuries, allegedly caused by childhood vaccinations. (Pls.' Resp. Def.'s Mot. Dismiss & Supporting Mem. Law [hereinafter, "Pls.' Resp."] at 6-7.) In this court (the "District Court"), Plaintiffs contend the thimerosal in HypRho-D was the cause of the child's preexisting condition, and in the Vaccine Court they contend the thimerosal in his post-birth vaccinations significantly aggravated that preexisting condition. (Id.)

II. ANALYSIS

Plaintiffs bring multiple causes of action: negligence, negligent failure to warn, negligent misrepresentation, intentional misrepresentation and fraud, and unfair and deceptive trade practices, all in relation to the sale and distribution of HypRho-D. They also allege negligent infliction of emotional distress; inadequate design or formulation; breach of express warranty of merchantability; breach of implied warranties; gross negligence; and fraudulent, malicious, and willful or wanton conduct entitling them to punitive damages. They also seek recompense for the parents' loss of Minor Child Doe's services, comfort, society, and companionship, as well as for past and future medical and hospital expenses, and "loss of the services earnings and earning ability" of the child. (Compl.¶ 99.)

Bayer asserts several arguments in its motion for dismissal. First, they argue that the District Court lacks subject matter jurisdiction because Plaintiffs have not yet exhausted their remedies in the Vaccine Court. Second, they argue that if this proceeding is not dismissed for want of subject matter jurisdiction, it should be stayed pending resolution of the Vaccine Court proceeding. Lastly, they move for a more definite statement of Plaintiffs' claims. These arguments will be addressed separately.

A. Exhaustion of Administrative Remedies in the Vaccine Court

Bayer argues that Plaintiffs' claims are governed by the National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-10 et seq. (the "Vaccine Act" or the "Act"), and may not be brought in a federal district court until remedies in the Vaccine Court are first exhausted. (Bayer's Mot. Dismiss at 6-15.) Plaintiffs counter their claims are not for vaccine-related injuries, so are not governed by the Vaccine Act. (Pls.' Resp. at 5.)

1. Standard of Review

When a defendant's motion to dismiss challenges a federal court's subject matter jurisdiction pursuant to Rule 12(b)(1), the plaintiff bears the burden of proving that such jurisdiction exists. Adams v. Bain, 697 F.2d 1213, 1219 (4th Cir.1982). When determining the existence of subject matter jurisdiction, a court may consider the pleadings as evidence and may also look to evidence outside the pleadings without treating the inquiry as one for summary judgment. Evans v. B.F. Perkins Co., 166 F.3d 642, 647 (4th Cir.1999). A court should dismiss an action for want of federal subject matter jurisdiction "only if the material jurisdictional facts are not in dispute and the moving party is entitled to prevail as a matter of law." Id. (quoting Richmond, Fredericksburg & Potomac R.R. Co. v. United States, 945 F.2d 765, 768 (4th Cir.1991)).

2. The Vaccine Act

The Vaccine Act creates a no-fault, administrative compensation scheme for people injured by vaccines. See 42 U.S.C. §§ 300aa-1 et seq. The scheme was created to ease the burden on both injured parties and vaccine manufacturers. Shalala v. Whitecotton, 514 U.S. 268, 269-70, 115 S.Ct. 1477, 1478, 131 L.Ed.2d 374 (1995). For injured parties, whose only mode of redress was the civil tort system or negotiated settlement with the vaccine manufacturer, recovery for their injuries took months or years and required substantial expenses for attorneys and court fees. H.R.Rep. No. 99-908, at 6 (1986), reprinted in 1986 U.S.C.C.A.N. 6344, 6347. For vaccine manufacturers, the costs of tort liability and the lack of affordable insurance to guard against this risk significantly reduced incentives to enter or remain in the vaccine market. Id. at 6-7, 1986 U.S.C.C.A.N. at 6347-48. To address these problems, the Act allows injured parties to file a petition for compensation against the U.S. Government, rather than the vaccine manufacturer. Doe 2 v. Ortho-Clinical Diagnostics, Inc., 335 F.Supp.2d 614, 620-21 (M.D.N.C.2004). Petitioners follow a simplified procedure to prove causation before a specialized judge, or Special Master. Shalala, 514 U.S. at 270, 115 S.Ct. at 1478. Once causation is shown to a satisfactory level, the Special Master awards damages (subject to maximum caps), paid out of a special compensation fund financed by a tax on vaccines. See 42 U.S.C. § 300aa-10(a).

The Vaccine Act requires that claims of more than $1,000 brought against "a vaccine administrator or manufacturer" to recover for any "vaccine-related injury or death" must be brought in Vaccine Court first. 42 U.S.C. § 300aa-11(a)(2)(A). No civil action may be filed in state or federal court until the Vaccine Court has issued a judgment on the matter and the claimant has...