Ball v. Takeda Pharmaceuticals America, Inc.

963 F. Supp. 2d 497, 2013 WL 4040395, 2013 U.S. Dist. LEXIS 112143
CourtDistrict Court, E.D. Virginia
DecidedAugust 8, 2013
DocketCivil Action No. 3:13-cv-00168-JAG
StatusPublished
Cited by16 cases

This text of 963 F. Supp. 2d 497 (Ball v. Takeda Pharmaceuticals America, Inc.) is published on Counsel Stack Legal Research, covering District Court, E.D. Virginia primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Ball v. Takeda Pharmaceuticals America, Inc., 963 F. Supp. 2d 497, 2013 WL 4040395, 2013 U.S. Dist. LEXIS 112143 (E.D. Va. 2013).

Opinion

MEMORANDUM OPINION

JOHN A. GIBNEY, JR., District Judge.

In this prescription drug product liability case, the plaintiff, Monica Ball, alleges that she suffered infertility and contracted Stevens-Johnson syndrome as a result of taking Dexilant, a drug manufactured, marketed, and distributed by the defendants (collectively, “Takeda”).

Nearly three years after sustaining her claimed injuries, and following repeated (and mostly unsuccessful) efforts to amend her claims against the defendants, Ball has not advanced her lawsuit beyond the initial pleadings stage. In the most recent Amended Complaint, Ball raises four causes of action against nine defendants: (1) negligence; (2) negligence per se; (3) breach of implied warranty; and (4) violation of the Virginia Consumer Protection Act (“VCPA”), Va.Code § 59.1-200 et seq. Seven of the nine defendants were only recently added as parties to the Amended Complaint. The defendants seek partial dismissal of Counts I and III, and complete dismissal of Counts II and IV.

The Court will dismiss the entire case. Ball’s claims pertaining to Stevens-Johnson syndrome fail as a matter of law because Takeda disclosed the risk of developing this illness in Dexilant’s packaging. The Court dismisses the plaintiffs negligent design and negligent manufacturing claims because Ball does not articulate the factual basis for these claims. Ball’s “failure to test” claim fails because Virginia law does not recognize this claim. The Court dismisses the negligence per se claim because plaintiff has not identified [500]*500the specific law or regulation she believes the defendants violated. The VCPA claim fails as a matter of law because the Act does not apply to transactions in federally-regulated prescription drugs.

In addition, Ball faces another problem: she has not identified an expert witness as required by the Court’s pretrial order. Without expert testimony, even if she could state viable products liability claims against the defendants, she could not prove her case. Ball seeks an extension of time to disclose an expert,- but good cause does not exist for extending the deadline., Accordingly, the Court denies plaintiffs motion for an extension of the expert disclosure deadline and dismisses the entire case.

Various other motions relating to discovery and other matters are pending and will be denied.

I. MATERIAL FACTS

In addressing the motion to dismiss, the Court assumes Ball’s well-pleaded allegations to be true, and views all facts in the light most favorable to her. T.G. Slater & Son v. Donald P. & Patricia A. Brennan, LLC, 385 F.3d 836, 841 (4th Cir.2004).

Takeda manufactures and distributes Dexilant, a drug used to treat acid reflux disease and other gastrointestinal ailments.1 In September 2010, Ball’s doctor prescribed 60 milligrams of Dexilant to treat her gastric problems. Ball alleges that Dexilant caused her fallopian tubes to close, as well as the development of a condition known as “Stevens-Johnson Syndrome.” Stevens-Johnson syndrome is a painful disorder that may cause the skin to die and shed.

According to Ball, medical studies and scientific research have shown impaired fertility (including damage to the fallopian tubes) following the use of ingredients found in Dexilant. Ball contends that, even though Takeda knew or should have known of the potential injuries that could result from using Dexilant, the drug’s packaging inserts lacked any information or warning of the drug’s potential to cause fallopian tube closure or Stevens-Johnson syndrome.

Although the plaintiff refers repeatedly to the package insert in her complaint and arguments, the Court has experienced difficulties in pinning Ball’s counsel down about the precise contents of the insert. Accordingly, the. Court ordered Ball to produce the relevant package insert, but she has not done so. Takeda, however, has proffered the insert,' and Ball agrees that the insert produced by Takeda is the one relevant to this case. Because she refers to it frequently in her case, the Court will consider the package insert in ruling on the motion to dismiss.

II. PROCEDURAL HISTORY

This case has an unnecessarily protracted history.

On September 28, 2012, Ball initially filed suit against Takeda Pharmaceuticals America, Inc., and Takeda Pharmaceutical, Ltd., in the Circuit Court of Henrico County, Virginia. See Ball v. Takeda Pharms. Am., Inc., Case No. CL12-2755. On October 25, 2012, the defendants removed the matter to this Court. Case No. 3:12-cv-758-JAG (“Takeda I ”).

In Takeda I, the complaint alleged nine causes of action against the two defendants arising out of plaintiffs use of Dexilant. [501]*501The defendants moved to dismiss the complaint, after which plaintiff twice unsuccessfully sought to amend her lawsuit. See Takeda I (dkt. nos. 20, 21, 23, 24, 26). The Court denied the plaintiffs motions to amend because each proposed amended complaint failed to provide the defendants with fair notice of the facts and legal bases upon which liability rested. See Bell Atl. Corp. v. Twombly, 550 U.S. 544, 555, 127 S.Ct. 1955, 167 L.Ed.2d 929 (2007).

Ball’s counsel refused to participate in the required Rule 26(f) conference, failed to propound initial disclosures in compliance with the Court’s Initial Pretrial Order, became uncooperative with defense counsel, and generally resisted the orderly progression of the case. Counsel also ignored the Rules of Civil Procedure. On March 1, 2013, and without first seeking leave of Court, see Fed.R.Civ.P. 15(a)(2), Ball filed another proposed amended complaint. Takeda I (dkt. no. 33). Plaintiff did not seek leave to amend until nearly a week later on March 7, 2013. Id. (dkt. no. 34). Because the failure to follow the rules had become so egregious, the Court granted the defendants’ motion for sanctions and dismissed the action without prejudice on March 15, 2013. See id. (dkt. no. 39).

That same day, Ball filed a new lawsuit in this Court against Takeda Pharmaceuticals America, Inc., and Takeda Pharmaceutical, Ltd. See Case No. 3:13-ev-168-JAG-MHL (“Takeda II”). Takeda II alleged eight causes of action against these two defendants arising out of plaintiffs use of Dexilant: (1) failure to warn; (2) “failure to provide precautions;” (3) breach of implied warranty; (4) breach of express warranty; (5) negligence;- (6) “negligence regarding physician’s standard of care concerning Stevens-Johnson Syndrome;” (7) fraud; and (8) punitive damages. Unfortunately, plaintiffs inability to comply with the rules persisted. Contemporaneous with the service of Takeda II, Ball also served written discovery on the defendants (including an excessive number of interrogatories) prior to the parties’ Fed.R.Civ.P. 26(f) conference. Because this filing was improper, see Fed.R.Civ.P. 26

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Bluebook (online)
963 F. Supp. 2d 497, 2013 WL 4040395, 2013 U.S. Dist. LEXIS 112143, Counsel Stack Legal Research, https://law.counselstack.com/opinion/ball-v-takeda-pharmaceuticals-america-inc-vaed-2013.