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Schmitt-Doss v. American Regent, Inc.

United States District Court, W.D. Virginia, Lynchburg Division

August 5, 2014



NORMAN K. MOON, District Judge.

This case is before the Court on a Motion for Summary Judgment and a Motion to Exclude Plaintiff's Experts, filed by American Regent, Inc. ("Regent") and Luitpold Pharmaceuticals, Inc. ("Luitpold") (collectively, "Defendants"), on June 23, 2014. Nancy A. Schmitt-Doss ("Plaintiff") filed her complaint pro se in this personal injury action in the Circuit Court of Amherst County on July 18, 2011. Plaintiff claims that Defendants failed to exercise due care in manufacturing and distributing vitamin B-12 injections she took, because those injections allegedly contained "foreign substances identified as cyanocobalamin which is a molecule of cyanide and poison to all people and creatures and... aluminum which is an ingredient in the Vitamin B-12 injection and is toxic to human beings." Compl. ¶ 3 (in State Court Record at 20, docket no. 8). Plaintiff avers that "as a direct and proximate cause" of the negligent manufacture and distribution of this vitamin B-12 injection, which she took at her doctor's direction, Plaintiff became "quite debilitated and ill, suffered extreme pain and mental anguish, and severe nerve damages and continues suffering on a daily basis...." Compl. ¶ 5.

On August 7, 2012, Defendants American Regent, Inc., Luitpold Pharmaceuticals, Inc. (collectively "Defendants"), and Daiichi Sankyo Co., Ltd. of Japan timely removed the case to this Court on the basis of diversity jurisdiction.[1] On December 13, 2012, this Court granted Daiichi Sankyo Co., Ltd. of Japan's motion to dismiss Plaintiff's claims for lack of personal jurisdiction and failure to state a claim upon which relief could be granted. The Court denied the Defendants' motion to dismiss the case for insufficient service of process. See Schmitt-Doss v. Am. Regent, Inc., No. 6:12-CV-00040, 2012 WL 6474038, at *1 (W.D. Va. Dec. 13, 2012) [ Schmitt-Doss I ].

After United States Magistrate Judge Robert S. Ballou resolved various discovery disputes, Defendants filed the two motions currently before this Court. Defendants claim that Plaintiff failed to timely file proper expert disclosures and that she presents no disputes of material fact. This Court should therefore dismiss Plaintiff's case for several reasons, Defendants contend. First, Defendants argue that Plaintiff has produced no expert testimony or other admissible evidence on the element of causation linking her personal injury to either product liability or any other breach of duty by Defendants. Second, to the extent Plaintiff asserts a failure to warn claim, the learned intermediary doctrine should preclude liability. Finally, Defendants argue that the statute of limitations for personal injury actions under Virginia law bars Plaintiff's claims. Both motions have been fully briefed, and I heard argument from Plaintiff and Defendants on July 17, 2014.

Since I find that Plaintiff has failed to present any dispute of material fact over whether her injuries were proximately caused by the vitamin B-12 injections, and that she failed to file her suit within the applicable statute of limitations, I will grant Defendants' Motion for Summary Judgment and deny as moot Defendant's Motion to Exclude Plaintiff's Experts.


This products liability matter arises from Plaintiff's allegation that she was given a pharmaceutical drug injection containing cyanide and aluminum. Beginning in February 2009 and continuing through July 2009, Plaintiff states that she received injections of a vitamin B-12 solution by the staff of Dr. Thomas E. Dobyns, of Madison Heights, VA.[3] According to Plaintiff's complaint, the drug was manufactured and distributed to medical professionals by the Defendants Regent and Luitpold. Plaintiff alleges that "Defendants willfully, intentionally and negligently allowed the Vitamin B-12 Injection solution to be distributed and dispensed to the Plaintiff containing foreign matter." Compl. ¶ 4. Specifically, Plaintiff alleges that the injections she received contained aluminum and "cyanocobalamin, which is a molecule of cyanide and poison." Plaintiff does not disclose how or when she discovered what ingredients those injections contained, or how her injections may have differed from other vitamin B-12 injections on the market.[4] As a result of these injections, Plaintiff states that she "bec[a]me quite debilitated and ill, suffered extreme pain and mental anguish, and severe nerve damages [sic] and continues suffering on a daily basis...." Plaintiff originally requested a jury trial, and she seeks $10 million in damages.

Defendants received the summons and complaint for this action from the Secretary of the Commonwealth on July 23, 2012. None of the Defendants are incorporated or reside in Virginia, and Defendants filed a notice of removal pursuant to 28 U.S.C. §§ 1441 and 1446 on August 7, 2012.[5] The case was transferred from Amherst County Circuit Court to this Court on August 8, 2012. On December 13, 2012, this Court allowed the suit to proceed forward with only Luitpold and Regent as defendants.

On April 1, 2014, this Court issued a pretrial order and set certain deadlines. On April 15, 2014, the jury trial was set for September 3, 2014 - this later became a bench trial when Plaintiff withdrew her jury trial demand. On June 3, 2014, Defendants filed a motion to compel initial disclosures, to which Plaintiff responded with a motion to continue trial on June 9, 2014. After two continuance requests from Plaintiff due to poor health, Magistrate Judge Ballou granted in part and denied in part the motions on June 19, 2014, without oral argument. Judge Ballou denied Plaintiff's motion to continue the trial, finding no reason to do so. He compelled Plaintiff to provide initial disclosures within fourteen days of his order and extended other discovery and dispositive filing and hearing deadlines. The deadline to complete discovery became July 7, 2014. The deadline for expert disclosures remained June 16, 2014. As noted, Defendants filed their motion for summary judgment and motion to exclude Plaintiff's experts on June 23, 2014, and it has been fully briefed and argued.


The court should grant summary judgment if the pleadings, the discovery and disclosure materials on file, and any affidavits show that "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a); see also Celotex Corp. v. Catrett, 477 U.S. 317, 322 (1986). If the evidence of a genuine issue of material fact "is merely colorable or is not significantly probative, summary judgment may be granted." Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 249-50 (1986) (citations omitted). "As to materiality... [o]nly disputes over facts that might affect the outcome of the suit under the governing law will properly preclude the entry of summary judgment." Id. at 248. "The summary judgment inquiry thus scrutinizes the plaintiff's case to determine whether the plaintiff has proffered sufficient proof, in the form of admissible evidence, that could carry the burden of proof of [her] claim at trial.... In short, the summary judgment procedure allows the court to forecast the proof at trial to determine whether consequential facts are in dispute, and if not, to resolve the case without a trial." Mitchell v. Data Gen. Corp., 12 F.3d 1310, 1316 (4th Cir. 1993); Fed.R.Civ.P. 56(c)(2) (allowing objection on summary judgment if "material cited to support or dispute a fact cannot be presented in a form that would be admissible in evidence.").

In considering a motion for summary judgment under Rule 56, a court must view the record as a whole and draw all reasonable inferences in the light most favorable to the nonmoving party. See Reeves v. Sanderson Plumbing Prods., Inc., 530 U.S. 133, 150 (2000). If the nonmoving party bears the burden of proof, "the burden on the moving party may be discharged by showing' - that is, pointing out to the district court - that there is an absence of evidence to support the nonmoving party's case." Celotex, 477 U.S. at 325. If the moving party shows such an absence of evidence, the burden shifts to the nonmoving party to set forth specific facts illustrating genuine issues for trial. See Fed.R.Civ.P. 56(c); Celotex, 477 U.S. at 324. The trial court has an "affirmative obligation" to "prevent factually unsupported claims [or] defenses' from proceeding to trial." Felty v. Graves-Humphreys Co., 818 F.2d 1126, 1128 (4th Cir. 1987) (quoting Celotex, 477 U.S. at 323-24).


Federal courts sitting in diversity apply the substantive law of the forum state, including that state's choice of law rules. See Salve Regina Coll. v. Russell, 499 U.S. 225, 226 (1991) (citing Erie R.R. Co. v. Tompkins, 304 U.S. 64, 78 (1938)). For tort claims brought in Virginia, the substantive law of the place of the wrong governs the proceeding. See Frye v. Commonwealth, 345 S.E.2d 267, 272 (Va. 1986). Plaintiff's injury occurred in Virginia, so Virginia's law on products liability and personal injury applies.[6]

To establish actionable negligence under Virginia law, Plaintiff must show "the existence of a legal duty, a breach of that duty, and proximate causation resulting in damage." Atrium Unit Owners Ass'n v. King, 585 S.E.2d 545, 548 (Va. 2003). Plaintiff's complaint may be construed to make several claims under Virginia law. See generally Williams v. Ozmint, 716 F.3d 801, 805 (4th Cir. 2013) (citing Erickson v. Pardus, 551 U.S. 89, 94 (2007), and Smith v. Smith, 589 F.3d 736, 738 (4th Cir. 2009), and noting liberal construction of pro se complaint).

First, Plaintiff's complaint appears to make a claim of negligent manufacturing or breach of the implied warranty of merchantability. Compl. ¶¶ 3-4 (noting Defendants' "duty to exercise due care in the manufacture and distribution" of B-12 injections, and averring that "Defendants willfully, intentionally and negligently allowed the Vitamin B-12 Injection solution to be distributed and dispensed to the Plaintiff containing foreign matter, " identified as cyanide and aluminum); see, e.g., Ball v. Takeda Pharm. Am., Inc., 963 F.Supp.2d 497, 500-01, 504-05 (E.D. Va. 2013) (discussing complaint pleading negligent manufacturing and breach of implied warranty claims under Virginia law for alleged defects in a prescription drug). Liberally construed, Plaintiff's complaint may also claim that Defendants were negligent in distributing the product to her, in that they failed to properly warn her of dangers she argues are inherent in taking the vitamin B-12 injections. See Compl. ¶¶ 3-4.

Defendants argue that Plaintiff has not provided any admissible evidence to prove her liberally-construed claims for negligence, breach of implied warranty, or failure to warn, especially on the point of proximate causation. Defendants further advocate that all of Plaintiff's claims should be dismissed as barred by Virginia's personal injury statute of limitations, and any failure to warn claim as barred by the learned intermediary doctrine. Defendants assert that this Court should deem certain facts as admitted by Plaintiff due to her failure to timely respond to a request for admissions. Defendants also ask this Court to exclude any expert testimony Plaintiff may wish to proffer because she has failed to properly disclose proposed expert testimony under Federal Rule of Civil Procedure 26(a)(2).

A. Statute of Limitations under Virginia Code §§ 8.01-230 and -243

Virginia law provides that personal injury suits must be filed "within two years after the cause of action accrues, " regardless of the "theory of recovery." Va. Code § 8.01-243(A). Virginia Code § 8.01-230 clarifies that a cause of action "shall be deemed to accrue and the prescribed limitation period shall begin to run from the date the injury is sustained... and not when the resulting damage is discovered...." Va. Code. § 8.01-230. State and federal courts interpreting these statutes have held that "in a personal injury action... it does not matter when a plaintiff discovered-or reasonably could have discovered-that she was injured, or when she could have discovered that her injury was caused by the defendant's product. Rather, the only question is when the injury occurred." Torkie-Tork v. Wyeth, 739 F.Supp.2d 887, 891 (E.D. Va. 2010); Locke v. Johns-Manville Corp., 275 S.E.2d 900, 904 (Va. 1981) (construing Va. Code §§ 8.01-230 and -243) ("[T]he running of the time is tied to the fact of harm to the plaintiff."). The personal injury statute of limitations applies to Plaintiff's negligence, breach of implied warranty, and failure to warn claims alike. See, e.g., Flick v. Wyeth LLC, No. 3:12-CV-00012, 2012 WL 4458181, at *2-3 (W.D. Va. June 6, 2012). The burden of proof to establish facts necessary to prevail on a statute of limitations defense rests with Defendants. Lo v. Burke, 455 S.E.2d 9, 12 (Va. 1995); Brown v. Plywood Panels, Inc., 67 F.3d 293, at *4 (4th Cir. 1995).

Defendants contend that Plaintiff's claims are all barred by Virginia's statute of limitations because she filed her complaint in state court on July 18, 2011, more than two years after her injury was sustained on April 16, 2009.[7] See Defs.' Reply on Defs.' Mot. for Summ. J. 3-4; Pl.'s Resp. on Defs.' Mot. for Summ. J. 3 ("Within two months of receiving the injections the Plaintiff was suddenly, on April 16, 2009, bedridden due to numbness, tingling, inability to move arms, hands, legs, and feet and in excruciating pain."). Plaintiff counters that her injuries "were not limited to one cause of action as the Vitamin B-12 injections continued for a period of 8 months causing additional permanent injuries, " and that the "discovery of the cause of the injuries" did not occur until sometime later. Pl.'s Resp. on Defs.' Mot. for Summ. J. 5.

Plaintiff also asks this Court to toll the statute of limitations, pursuant to Virginia Code § 8.01-229(A)(2)(b), because she claims she was incapacitated from April 16, 2009, through February 2010. Id. at 5-6. She could not "move her arms, hands, legs, and feet and [was] in significant pain for a period of a minimum of 12 months thusly rendering her incapacitated." Id. at 6. Once a person is deemed incapacitated under Virginia Code § 229, any time during which the person is adjudged to have been incapacitated does not count toward the time that passed between the action's accrual and the filing of suit. See, e.g., Calvert v. State Farm Fire & Cas. Co., No. 5:12-CV-00017, 2012 WL 2804838, at *8 (W.D. Va. July 10, 2012). If this Court excluded the twelve months in which Plaintiff claims she was incapacitated from the calculation of the statute of limitations, Plaintiff's claims would be timely filed under Virginia law. Plaintiff bears the burden to prove that incapacity should toll the statute of limitations. See Kumar v. The Glidden Co., No. CIV.A. 2:05CV499, 2006 WL 1049174, at *5 (E.D. Va. Apr. 13, 2006) (citing Charlotte Telecasters, Inc. v. Jefferson-Pilot Corp., 546 F.2d 570, 574 (4th Cir. 1976)).

Several courts in this district have relied on the definition of an "[i]ncapacitated person" given in Virginia Code § 64.2-2000[8] to determine whether a plaintiff is incapacitated for the purpose of tolling the statute of limitations. See, e.g., Calvert, 2012 WL 2804838, at *8-9; Kumar, 2006 WL 1049174, at *5; see also In re Zyprexa Products Liab. Litig., No. 04-MD-1596, 2011 WL 4357319, at *4 (E.D.N.Y. Sept. 16, 2011).

Section 64.2-2000 defines an "[i]ncapacitated person" as

an adult who has been found by a court to be incapable of receiving and evaluating information effectively or responding to people, events, or environments to such an extent that the individual lacks the capacity to (i) meet the essential requirements for his health, care, safety, or therapeutic needs without the assistance or protection of a guardian or (ii) manage property or financial affairs or provide for his support or for the support of his legal dependents without the assistance or protection of a conservator. A finding that the individual displays poor judgment alone shall not be considered sufficient evidence that the individual is an incapacitated person within the meaning of this definition. A finding that a person is incapacitated shall be construed as a finding that the person is ...

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