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Ball v. Takeda Pharmaceuticals America, Inc.

United States District Court, E.D. Virginia

August 8, 2013

MONICA L. BALL, Plaintiff,

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For Monica L. Ball, Plaintiff: Jerrod M. Smith, LEAD ATTORNEY, Jerrod Myron Smith & Associates, Richmond, VA.

For Takeda Pharmaceuticals America, Inc., Takeda Pharmaceutical Company, Ltd., a Japanese Corporation, Defendants: Damon William Wright, LEAD ATTORNEY, Venable LLP, Washington, DC.


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John A. Gibney, Jr., United States 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 plaintiff's 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

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the 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 plaintiff's 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.


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.


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 plaintiff's use of Dexilant.

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The 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 plaintiff's 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 A. 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-cv-168-JAG-MHL ( " Takeda II " ). Takeda II alleged eight causes of action against these two defendants arising out of plaintiff's 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(d)(1), the Court quashed the plaintiff's discovery requests and issued a Protective Order. Takeda II (dkt. no. 17).

The defendants moved to dismiss Takeda II for failure to state a claim, and Ball sought leave to amend her complaint. Id (dkt. nos. 4 and 20). The Court denied Ball's motion to amend because a brief in support did not accompany her motion, see E.D. Va. Loc. Civ. R. 7(F), and because the sixty-three (63) page, 326-paragraph proposed amended complaint did not comply with Rule 8 of the Federal Rules of Civil Procedure. Takeda II (dkt. no. 22); see also April 26, 2013 Hr'g Tr. 24. The Court dismissed plaintiff's entire complaint without prejudice because the lawsuit contained numerous incomprehensible paragraphs and failed to offer a " short and plain statement of the claim showing that the pleader is entitled to relief." Takeda II (dkt. no. 22 (quoting Fed.R.Civ.P. 8(a)(2))). The Court dismissed with prejudice Count II (failure to provide precautions), Count VI (negligence regarding physician's standard of care), Count VII (fraud) and Count VIII (punitive damages). Id.

Plaintiff thereafter sought leave to file another amended Complaint, which the Court granted on May 9, 2013. Id. (dkt. no. 26). The current Amended Complaint, which is the subject of the defendants' motion to dismiss, levels four claims against Takeda: (1) negligence; (2) negligence per se; (3) breach of implied warranty; and (4) violation of the VCPA.

Although all of Ball's previous complaints and attempted amendments only

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named Takeda Pharmaceuticals America, Inc., and Takeda Pharmaceutical Company, Ltd., as defendants, the amended complaint, for the first time, seeks relief against not only these two Takeda entities but also seven others: Takeda Pharmaceuticals North America, Inc., Takeda Pharmaceuticals International, Inc., Takeda Pharmaceuticals, LLC, Takeda America Holdings, Inc., Takeda Global ...

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