Dickson v. Ethicon, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF WEST VIRGINIA

CHARLESTON DIVISION

MARY DICKSON,

Personal Representative of the

Estate of VADA MAE SMITH, deceased,

Plaintiff,

v. CIVIL ACTION NO. 2:15-cv-02800

ETHICON INC., ET AL.,

Defendants.

MEMORANDUM OPINION AND ORDER

Pending before the court is a Motion for Summary Judgment [ECF No. 75] filed by the

defendants, Ethicon Inc. and Johnson & Johnson. On December 17, 2019, with leave of court, the

plaintiff, Mary Dickson, amended her complaint. [ECF No. 85]. On January 13, 2020, the

defendants filed a Supplemental Motion for Summary Judgment [ECF No. 90], which incorporates

their prior Motion for Summary Judgment [ECF No. 75]. The plaintiff has responded, and both

the Motion for Summary Judgment [ECF No. 75] and the Supplemental Motion for Summary

Judgment [ECF No. 90] are ripe for adjudication. For the sake of clarity, I FIND that the

Supplemental Motion for Summary Judgment [ECF No. 90] moots the Motion for Summary

Judgment [ECF No. 75]. I therefore DENY the defendants’ Motion for Summary Judgment [ECF

No. 75] as moot. And I GRANT in part and DENY in part the defendants’ Supplemental Motion

for Summary Judgment [ECF No. 90] for the reasons that follow.

I. Background

In this case, the plaintiff is the daughter and personal representative of the estate of Vada

Mae Smith, who was implanted with TVT for the treatment of stress urinary incontinence on

August 17, 2001. Am. Short Form Compl. [ECF No. 12] ¶¶ 9, 10. Ms. Smith filed suit against the

defendants in 2015. She subsequently passed away on September 13, 2016. On August 8, 2017,

this court entered an Order identifying Ms. Dickson as the Personal Representative of the Estate

of Vada Mae Smith, and granting Ms. Dickson’s motion to substitute for Ms. Smith as the plaintiff

in this case. This case resides in MDL No. 2327, one of the seven MDLs assigned to me by the

Judicial Panel on Multidistrict Litigation concerning the use of transvaginal surgical mesh to treat

pelvic organ prolapse (“POP”) and stress urinary incontinence (“SUI”).

The plaintiff has been proceeding in this matter pro se since April of 2018. I recognize the

difficulty of navigating multi-district litigation regarding products liability pro se. But pro se

plaintiffs must still observe scheduling orders and rules for discovery, as well as provide sufficient

evidence for their claims. This court specifically cautioned Ms. Dickson about proceeding pro se,

stating that the court, “expects pro se litigants to comply with the same time requirements,

scheduling orders, and other procedural rules required by counsel of record to observe, including

the Local Rules, the Federal Rules of Civil Procedure, and each of the Pretrial Orders entered in

this case” and that “failure to comply with all court orders and deadlines may result in the

imposition of monetary sanctions, as well as the dismissal of… [her] case with prejudice.” [ECF

No. 52].

Moreover, this court has afforded the plaintiff considerable flexibility throughout this

litigation. On October 6, 2017, the plaintiff filed a Statement of Intent to Proceed Without Counsel.

[ECF No. 27]. On October 12, 2018, this court entered an order staying the case until December

11, 2017 to afford the plaintiff an opportunity to obtain new counsel or provide the court with

certain information regarding her mother’s estate. [ECF No. 30]. This court subsequently entered

two additional stay orders to afford the plaintiff more time to retain counsel or provide the

requested estate information. [ECF No. 43] (Feb. 12, 2018); [ECF No. 47] (Mar. 22, 2018). The

court also granted leave for the plaintiff to amend her complaint after the scheduling order had

been entered.

The plaintiff alleged the following claims against the defendants in her Amended Short

Form Complaint: negligence (Count I); strict liability – manufacturing defect (Count II); strict

liability – failure to warn (Count III); strict liability – defective product (Count IV); strict liability

– design defect (Count V); common law fraud (Count VI); fraudulent concealment (Count VII);

constructive fraud (Count VIII); negligent misrepresentation (Count IX); negligent infliction of

emotional distress (Count X); breach of express warranty (Count XI); breach of implied warranty

(Count XII); violation of consumer protection laws (Count XIII); gross negligence (Count XIV);

unjust enrichment (Count XV); punitive damages (Count XVII); and discovery rule and tolling

(Count XVIII). 1 Am. Short Form Compl. [ECF No. 12] ¶13. On December 17, 2019, the plaintiff

filed a Second Amended Short Form Complaint, adding two new counts: (a) “illegal, adulterated,

and misbranded device;” and (b) wrongful death. Second Am. Short Form Compl. [ECF No. 85].

I find it necessary to address certain issues with the Second Amended Short Form

Complaint here. On March 10, 2015, the plaintiff filed a Short Form Complaint, which included a

claim for loss of consortium. Short Form Compl. [ECF No. 1]. On February 22, 2017, the plaintiff

filed an Amended Short Form Complaint, which dropped Count XVI for loss of consortium. Am.

1 The defendants do not move for summary judgment on punitive damages (Count XVII) or

discovery rule and tolling (Count XVIII) because neither counts are a separate cause of action.

Short Form Compl. [ECF No. 12]. On December 17, 2019, the plaintiff filed a Second Amended

Short Form Complaint, which again added Count XVI for loss of consortium. Second Am. Short

Form Compl. [ECF No. 85]. It is clearly apparent from the filings and exhibits in this matter that

the addition of Count XVI for loss of consortium in the Second Amended Short Form Complaint

was inadvertent and improperly alleged. The court therefore DISMISSES Count XVI for loss of

consortium without prejudice.

Additionally, in both her Short Form Complaint and Amended Short Form Complaint, the

plaintiff alleged that Ms. Smith was implanted with a TVT device on August 17, 2001, in Virginia.

[ECF Nos. 1, 12]. In her Second Amended Short Form Complaint, the plaintiff alleges, for the first

time, that Ms. Smith was implanted with both a TVT device and a TVT-Obturator device (“TVT-

O”). [ECF No. 85]. The plaintiff alleges that the TVT-O device was implanted on September 27,

2006, at Greenbrier Valley Medical Center, Lewisburg, WV. On December 11, 2019, this court

entered an order [ECF No. 84] granting the plaintiff leave to amend her complaint in response to

her request “to add ‘wrongful death’ to Plaintiffs current charges in this Case.” See Pl.’s Mot. to

Amend Compl. [ECF No. 69]. Given the limited purpose of the leave to amend and the advanced

stage of litigation of the case, I FIND that the new allegations regarding TVT-O apply only to the

two new counts: (a) “illegal, adulterated, and misbranded device;” and (b) wrongful death.

On January 13, 2020, the defendants filed a Supplemental Motion for Summary Judgment

on the newly added claims in the Second Amended Complaint. [ECF No. 90]. On January 26,

2020, the plaintiff responded to the Supplemental Motion, attaching the affidavit of Dr. George

Nichols. [ECF No. 92]. The defendants subsequently, on February 3, 2020, filed a Motion to Strike

the Affidavit by Dr. George Nichols or in the Alternative Motion for Modification of the

Scheduling Order. [ECF No. 93]. With entering this Memorandum Opinion and Order, this court

also entered a separate Order denying the Motion to Strike and the Alternative Motion for

Modification of the Scheduling Order. Because discovery is not complete on the new claims added

in the Second Amended Complaint, this court construes the defendant’s Motion as a Motion to

Dismiss as to the plaintiff’s claim for “illegal, adulterated, and misbranded device.”

II. Legal Standard

A. Summary Judgment

To obtain summary judgment, the moving party must show that there is no genuine dispute

as to any material fact and that the moving party is entitled to judgment as a matter of law. Fed. R.

Civ. P. 56(a). In considering a motion for summary judgment, the court will not “weigh the

evidence and determine the truth of the matter.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242,

249 (1986). Instead, the court will draw any permissible inference from the underlying facts in the

light most favorable to the nonmoving party. Matsushita Elec. Indus. Co. v. Zenith Radio Corp.,

475 U.S. 574, 587–88 (1986).

The nonmoving party nonetheless must offer some “concrete evidence from which a

reasonable juror could return a verdict” in his or her favor. Anderson, 477 U.S. at 256. Summary

judgment is appropriate when the nonmoving party has the burden of proof on an essential element

of his or her case and does not make, after adequate time for discovery, a showing sufficient to

establish that element. Celotex Corp. v. Catrett, 477 U.S. 317, 322–23 (1986). The nonmoving

party must satisfy this burden of proof by offering more than a mere “scintilla of evidence” in

support of his or her position. Anderson, 477 U.S. at 252. Likewise, conclusory allegations or

unsupported speculation, without more, are insufficient to preclude the granting of a summary

judgment motion. See Dash v. Mayweather, 731 F.3d 303, 311 (4th Cir. 2013); Stone v. Liberty

Mut. Ins. Co., 105 F.3d 188, 191 (4th Cir. 1997).

B. Dismissal for Failure to State a Claim

Federal Rule of Civil Procedure 8(a)(2) requires only “a short and plain statement of the

claim showing that the pleader is entitled to relief.” Fed. R. Civ. P. 8(a)(2). “When ruling on a

motion to dismiss, courts must accept as true all of the factual allegations contained in the

Complaint and draw all reasonable inferences in favor of the plaintiff.” Farnsworth v. Loved Ones

in Home Care, LLC, No. 2:18-CV-01334, 2019 WL 956806, at *1 (S.D.W. Va. Feb. 27, 2019)

(citing E.I. du Pont de Nemours & Co. v. Kolon Indus., Inc., 637 F.3d 435, 440 (4th Cir. 2011)).

To survive a motion to dismiss under Fed. R. Civ. P. 12(b)(6), the plaintiff’s factual

allegations, taken as true, must “state a claim to relief that is plausible on its face.” Robertson v.

Sea Pines Real Estate Co., 679 F.3d 278, 288 (4th Cir. 2012) (quoting Ashcroft v. Iqbal, 556 U.S.

662, 678 (2009)). The plausibility standard is not a probability requirement, but “asks for more

than a sheer possibility that a defendant has acted unlawfully.” Iqbal, 556 U.S. at 678 (citing Bell

Atl. Corp. v. Twombly, 550 U.S. 544, 556 (2007)). Although “the Complaint must contain

sufficient facts to state a claim that is plausible on its face, it nevertheless need only give the

defendant fair notice of what the claim is and the grounds on which it rests.” Hall v. DIRECTV,

LLC, 846 F.3d 757, 777 (4th Cir. 2017). Thus, “a Complaint is to be construed liberally so as to

do substantial justice.” Id.

C. Choice of Law

Under 28 U.S.C. § 1407, this court has authority to rule on pretrial motions in MDL cases

such as this. The choice of law for these pretrial motions depends on whether they involve federal

or state law. “When analyzing questions of federal law, the transferee court should apply the law

of the circuit in which it is located. When considering questions of state law, however, the

transferee court must apply the state law that would have applied to the individual cases had they

not been transferred for consolidation.” In re Temporomandibular Joint (TMJ) Implants Prods.

Liab. Litig., 97 F.3d 1050, 1055 (8th Cir.1996) (internal citations omitted). In cases based on

diversity jurisdiction, the choice-of-law rules to be used are those of the states where the actions

were originally filed. See In re Air Disaster at Ramstein Air Base, Ger., 81 F.3d 570, 576 (5th

Cir.1996) (“Where a transferee court presides over several diversity actions consolidated under the

multidistrict rules, the choice of law rules of each jurisdiction in which the transferred actions were

originally filed must be applied.”); In re Air Crash Disaster Near Chi., Ill., 644 F.2d 594, 610 (7th

Cir.1981); Carlson v. Bos. Sci. Corp., No. 2:13-CV-05475, 2015 WL 1956354, at *2 (S.D.W. Va.

Apr. 29, 2015). In re Digitek Prods. Liab. Litig., MDL No. 2:08–md–01968, 2010 WL 2102330,

at *7 (S.D.W.Va. May 25, 2010).

If a plaintiff files her claim directly into the MDL in the Southern District of West Virginia,

which is the case here, I consult the choice-of-law rules of the state in which the implantation

surgery took place. See Sanchez v. Boston Scientific Corp., 2:12–cv–05762, 2014 WL 202787, at

*4 (S.D.W.Va. Jan. 17, 2014) (“For cases that originate elsewhere and are directly filed into the

MDL, I will follow the better-reasoned authority that applies the choice-of-law rules of the

originating jurisdiction, which in our case is the state in which the plaintiff was implanted with the

product.”). In this case, Ms. Smith received the implantation surgery in Virginia. Thus, the choice-

of-law principles of Virginia guide this court’s choice-of-law analysis.

Virginia’s choice-of-law principles dictate that courts must apply the substantive law of

the state where the alleged wrong occurred. Kraft Foods N. Am., Inc. v. Banner Eng’g & Sales,

Inc., 446 F. Supp. 2d 551, 566 (E.D. Va. 2006). Under this rule, courts select “the law of the place

where the wrongful act occurred, even when that place differs from the place where the effects of

injury are felt.” Milton v. IIT Research Institute, 138 F.3d 519, 522 (4th Cir. 1998); see also Diaz

Vicente v. Obenauer, 736 F. Supp. 679, 690 (E.D. Va. 1990) (holding that Virginia law applied

because the “tortious conduct—the legal injury—occurred” in Virginia, even though the plaintiffs

suffered the economic effects of the tort in Mexico). Here, Ms. Smith underwent implantation of

TVT in Virginia. Am. Short Form Compl. [ECF No. 12] ¶ 11. It is immaterial under the choice of

law standards that Ms. Smith was a West Virginia resident and received subsequent medical care

and treatment in West Virginia. See Dep. of Mary Dickson [ECF No. 75–1] 34–37. She may have

felt the effects of the implantation of TVT in West Virginia, but Virginia is the place where the

alleged wrongful act—the implantation—occurred. Therefore, I apply substantive law of Virginia.

D. Federal Rules of Civil Procedure Rule 26

Federal Rule of Civil Procedure 26(a)(2) governs the discovery disclosure rules for expert

witnesses. The Rule requires parties to disclose “to the other parties the identity of any [expert]

witness it may use at trial to present evidence.” Fed. R. Civ. P. 26(a)(2). “Unless otherwise

stipulated or ordered by the court, this disclosure must be accompanied by a written report—

prepared and signed by the witness—if the witness is one retained or specially employed to provide

expert testimony in the case….” Id. The report must contain the following:

(i) a complete statement of all opinions the witness will express and

the basis and reasons for them; (ii) the facts or data considered by

the witness in forming them; (iii) any exhibits that will be used to

summarize or support them; (iv) the witness's qualifications,

including a list of all publications authored in the previous 10 years;

(v) a list of all other cases in which, during the previous 4 years, the

witness testified as an expert at trial or by deposition; and (vi) a

statement of the compensation to be paid for the study and testimony

in the case.

Id. If a party fails to obey a court order to provide discovery then the court may issue further just

orders—such as, dismissing the action or proceedings in whole or in part. Fed. R. Civ. P. 37(b)(2).

III. Analysis

A. Strict Liability Claims – Counts II–V

I find that Counts II through V of the plaintiff’s complaint are not cognizable under

Virginia law. Virginia does not recognize strict liability claims for products liability torts. Evans

v. Nacco Materials Handling Grp., Inc., 810 S.E.2d 462, 469 (Va. 2018); Sensenbrenner v. Rust,

Orling & Neale, Architects, Inc., 374 S.E.2d 55, 57, n.4 (Va. 1988) (“Virginia law has not adopted

§ 402A of the Restatement (Second) of Torts and does not permit tort recovery on a strict-liability

theory in products-liability cases.”). Under Virginia law, “when alleging that a product suffered

from a design defect, a plaintiff may proceed under a theory of implied warranty of merchantability

or under a theory of negligence.” Evans, 810 S.E.2d at 469. Additionally, Virginia does not

recognize a tort for failure to warn based on strict liability. Petruska v. Cutech, Inc., No. 12617

1991 WL 835316, at *1 (Va. Cir. Ct. Nov. 21, 1991). The following claims brought by the plaintiff

are products liability torts based on a theory of strict liability: manufacturing defect (Count II);

failure to warn (Count III); defective product (Count IV); design defect (Count V). See Am. Short

Form Compl. [ECF No. 12] ¶13. I therefore GRANT the defendants’ Supplemental Motion for

Summary Judgment on Counts II, III, IV, and V.

B. Consumer Protection Claims – Count XIII

I find that Count XIII is not cognizable under Virginia consumer protection laws. The

plaintiff asserts a claim for violation of state consumer protection laws (Count XIII). Am. Short

Form Compl. [ECF No. 12] ¶13. Although somewhat unclear from the plaintiff’s Complaint, I

presume this claim is brought pursuant to the Virginia Consumer Protection Act (“VCPA”), Va.

Code §§ 59.01–196–207. That statute, by its own terms, does not apply to federally regulated

products. Va. Code § 59.1–199(A); see also Ball v. Takeda Pharm. Am., Inc., 963 F. Supp. 2d 497,

507 (E.D. Va. 2013) (holding that VCPA did not apply to the plaintiff’s claim that a drug’s warning

label violated consumer protection laws because the drug-at-issue was regulated by the FDA); Ali

v. Allergan USA, Inc., No. 1:12–CV–115, 2012 WL 3692396, at *19 (E.D.Va. Aug. 23, 2012)

(granting motion to dismiss VCPA claim against medical device manufacturer because

“[r]epresentations about the LAP–BAND in marketing materials for the device are authorized and

regulated by the FDA under federal law”). In this case, TVT is an FDA-approved medical device

approved through the 510k clearance process, whose warnings and labels were regulated by the

FDA in accordance with federal law. Therefore, VCPA does not apply to the product-at-issue. The

defendants’ Supplemental Motion for Summary Judgment on Count XIII claiming a violation of

state consumer protection laws is thus GRANTED.

C. Fraud and Negligent Misrepresentation – Counts VI–IX

The plaintiff asserts three claims based on fraud: common law fraud (Count VI); fraudulent

concealment (Count VII); and constructive fraud (Count VIII). The defendants argue that under

Virginia law, the plaintiff’s fraud claims cannot survive summary judgment because they are based

on alleged misrepresentations made not directly to Ms. Smith, but rather to her through a third-

party, her implanting physician. See Def.’s Mem. in Supp. of Summ. J. [ECF No. 76] 18.

This court previously addressed this issue regarding fraud, fraudulent concealment, and

constructive fraud in another MDL case. See Scholl v. Ethicon, Inc., No. 2:12-cv-007398, 2016

WL 7242552, at *4 (S.D. W. Va. Dec. 14, 2016). In Scholl, this court held the following,

Virginia law requires proof of reliance by the injured party, as

opposed to reliance by a third party, in order to maintain an action

for fraud. Rich. Metro. Auth. v. McDevitt St. Bovis, Inc., 507 S.E.2d

344, 346 (Va. 1998) (noting that fraud claims require “reliance by

the party misled”). Establishing the element of reliance by the

injured party can be “problematic” in the medical device context

because any alleged misrepresentations are typically made to the

prescribing doctor or other learned intermediary. Robert E. Draim,

Va. Prac. Series Prods. Liab. § 6:7. Mrs. Scholl never interacted with

any representative of Ethicon, nor did she read or review any

materials created by Ethicon. The court has not found any evidence

that Mrs. Scholl “relied” on a misrepresentation by Ethicon, so this

element cannot be met and must be dismissed as a matter of law.

Id. The facts in this case are similar to those in Scholl. The plaintiff has not offered even a scintilla

of evidence that Ms. Smith relied on misrepresentation made to her directly from the defendants.

In her deposition, Ms. Dickson testified that she was present during Ms. Smith’s pre-operative visit

with the physician. Mary Dickson Dep. Tr. 29:3–20 [ECF 75–1] Ex. C. Ms. Dickson further

testified that to her knowledge, her mother never saw any brochures, documents, or pamphlets

from Ethicon or Johnson & Johnson. Id. at 25:9–11; 26:1–5; 29:20–22. The plaintiff has not

presented any evidence that Ms. Smith ever interacted with any representative of the defendants.

Merely showing that Ms. Smith’s physician relied on the defendants’ alleged misrepresentations

cannot establish the essential element of reliance for fraud, fraudulent concealment, and

constructive fraud. Therefore, there is not a dispute of material fact in this case that would allow

the plaintiff to recover on her fraud-based claims. Thus, the court GRANTS the defendants’

Supplemental Motion for Summary Judgment on Counts VI, VII, and VIII.

Furthermore, in Virginia negligent misrepresentation is not a separate cause of action from

constructive fraud. Baker v. Elam, 883 F. Supp. 2d 576, 581 (E.D. Va. 2012). “[T]he essence of

constructive fraud is negligent misrepresentation.” Id. (quoting Richmond Metropolitan Auth. v.

McDevitt Street Bovis, Inc., 507 S.E.2d 344, 347 (Va. 1998)). A plaintiff’s inability to establish

constructive fraud thus precludes her from recovering for negligent misrepresentation. As

previously explained, the plaintiff here cannot as a matter of law prove reliance on the defendants’

misrepresentation—an essential element of constructive fraud—ergo Ms. Dickson cannot

demonstrate a negligent misrepresentation claim under Virginia law. Thus, the court GRANTS

the defendants’ Supplemental Motion for Summary Judgment on Count IX.

D. Medical Causation Expert – Counts I, X, XI, XII, XIV, XV

The defendants’ Supplemental Motion for Summary Judgment regarding the plaintiff’s

remaining tort and contract claims—negligence (Count I); negligent infliction of emotional

distress (Count X); breach of expressed warranty (Count XI); breach of implied warrant (Count

XII); gross negligence (Count XIV), and unjust enrichment (Count XV)— turns on the issue of

causation. Def.’s Mem. in Supp. of Mot. for Summ. J. [ECF No. 76] 7. “Under any theory of

tortious injury, one requisite element of a claim is a causal connection between defendant’s

conduct and a plaintiff’s injury.” Hartwell v. Danek Medical, Inc., 47 F. Supp. 2d 703, 707 (W.D.

Va. 1999). It is undisputed that Ms. Dickson refused to produce an expert up until January 26,

2020 when she filed an affidavit by Dr. George Nichols. See Pl.’s Correspondence to Court [ECF

No. 69]; Affidavit by Dr. George Nichols [ECF No. 92]. The defendants argue that because the

plaintiff has not timely or properly produced a competent expert opinion that links TVT to Ms.

Smith’s alleged injuries and death, the plaintiff has failed to offer even a scintilla of evidence of

causation. Id. And thus, according to the defendants, awarding summary judgment on the

plaintiff’s negligence, warranty, and unjust enrichment claims is appropriate. I agree.

Under Virginia law, “[p]roof of legal causation in a medical device case must be by expert

testimony and the expert’s opinion must be stated in terms of reasonable probability.” Hartwell v.

Danek Med., Inc., 47 F. Supp. 2d 703, 707–08 (W.D. Va. 1999); Rohrbough v. Wyeth

Laboratories, Inc., 916 F.2d 970, 972 (4th Cir.1990). Cases that involve issues that are medically

complex and outside common knowledge and lay experience require expert testimony to assist the

fact finder. In re Lipitor (Atorvastatin Calcium) Mktg., Sales Practices & Prod. Liab. Litig. (No

II) MDL 2502, 892 F.3d 624, 645–46 (4th Cir. 2018). In In re Lipitor, the court distinguished

injuries whose proximate cause was within common knowledge—such as a “gunshot wound to

the head of an otherwise healthy person who died shortly thereafter”—from injuries that required

an expert to determine proximate cause—such as diabetes. Id.

In this case, the plaintiff has not properly offered a competent expert opinion regarding

causation, either general or specific, as to TVT. The deadline for the plaintiff to disclose testifying

expert witnesses was August 28, 2018, and thus has long since passed. [ECF No. 55]. Rule 26

requires “a party [to] make these disclosures at the times and in the sequence that the court orders.”

Fed. R. Civ. P. 26(2)(D). “[A] scheduling order under Rule 16(b) is not a frivolous piece of paper,

idly entered, which can be cavalierly disregarded by counsel without peril. . . . Indeed, a scheduling

order is the critical path chosen by the trial judge and the parties to fulfill the mandate of Rule 1 in

‘securing the just, speedy, and inexpensive determination of every action.’” Price v. Marsh, No.

2:12-cv-05442, 2013 WL 5409811, at *2 (S.D. W. Va. Sept. 25, 2013) (Goodwin, J.) (internal

citation omitted) (quoting Marcum v. Zimmer, 163 F.R.D. 250, 253 (S.D. W. Va. 1995)).

Under Rule 37(c)(1), “[i]f a party fails to provide information or identify a witness as

required by Rule 26(a) or (e), the party is not allowed to use that information or witness to supply

evidence on a motion, at a hearing, or at a trial, unless the failure was substantially justified.”

Because “[t]he purpose of Rule 26(a) is to allow litigants ‘to adequately prepare their cases for

trial and to avoid unfair surprise,’ . . . a party who fails to comply with the expert witness disclosure

rules is prohibited from ‘us[ing] that information or witness to supply evidence . . . at a trial, unless

the failure was substantially justified or is harmless.’” Bresler v. Wilmington Trust Co., 855 F.3d

178, 190 (4th Cir. 2017) (quoting Russell v. Absolute Collection Servs., Inc., 763 F.3d 385, 396

(4th Cir. 2014); Fed. R. Civ. P. 37(c)(1)). Thus, “[t]he Rule 37(c) advisory committee notes

emphasize that the ‘automatic sanction’ of exclusion ‘provides a strong inducement for disclosure

of material that the disclosing party would expect to use as evidence.” Southern States Rack &

Fixture, Inc. v. Sherwin-Williams Co., 318 F.3d 592, 595 n.2 (4th Cir. 2003) (quoting Fed. R. Civ.

P. 37(c) adv. committee note (1993)).

Prior to filing an affidavit on January 26, 2020, the plaintiff had made it clear that she did

not plan on “using expert witnesses” to prove her case. Pl.’s Correspondence to Court [ECF No.

69] (“I will not be deposing witnesses, or using expert witnesses, due to no money to pay them.”).

I recognize the difficulty of navigating multidistrict litigation regarding products liability pro se.

But pro se plaintiffs must still provide sufficient evidence for their claims in a timely manner that

complies with discovery deadlines. I further note that it would be highly prejudicial to the

defendants to allow the affidavit of Dr. Nichols to apply to the claims alleged in the Amended

Short Form Complaint, when up until January 26, 2020 the defendants had operated under the

reasonable assumption that Ms. Dickson did not intend to use an expert witness. I therefore exclude

any consideration of Dr. Nichols’ Affidavit in evaluating Counts I, X, XI, XII, XIV, XV.

Causation between the TVT and Ms. Smith’s death and injuries is an essential element of

each of the plaintiff’s negligence, warranty, and unjust enrichment claims. The plaintiff must

demonstrate that TVT implanted in Ms. Smith was defective and that that defect caused her

injuries. Both arguments require specialized knowledge and expertise. The absence of qualified

expert testimony in this case would allow the fact finder to engage in impermissible post hoc

reasoning—the plaintiff did not suffer injuries; the plaintiff received the implant of TVT; the

plaintiff then began to suffer injuries and subsequently died ergo TVT’s faulty design,

manufacturing, warnings, or implantation caused the injuries. See McCauley v. Purdue Pharma

L.P., 331 F. Supp. 2d 449, 464 (W.D. Va. 2004). Although this line of reasoning is tempting to a

layperson, it is too superficial. In Virginia, causation of complex medical diagnoses requires more

than a mere temporal link between an implant and symptoms. Therefore, the court GRANTS the

defendants’ Supplemental Motion for Summary Judgment on negligence (Count I), negligent

infliction of emotional distress (Count X), breach of expressed warranty (Count XI), breach of

implied warranty (Count XII), gross negligence (Count XIV), and unjust enrichment (Count XV).

E. New Claims Alleged in the Second Amended Complaint

The plaintiff added two new counts in her Second Amended Complaint: (a) “illegal,

adulterated, and misbranded device” and (b) wrongful death. The prior scheduling order [ECF No.

55] does not apply to these new claims, added on December 17, 2019. The parties have not had

the opportunity to engage in proper discovery on these two new claims.

(1) “Illegal, Adulterated and Misbranded Device”

I construe the defendants’ Supplemental Motion for Summary Judgment as a motion to

dismiss for failure to state a claim pursuant to Federal Rule of Civil Procedure 12(b)(6) with regard

to the plaintiff’s claim for “illegal, adulterated and misbranded device.”

The plaintiff asserts a claim for “Illegal, Adulterated, and Misbranded Device[,]” claiming

that the device implanted in Ms. Smith by Dr. Lassere in 2001 was provided to Dr. Lassere before

it was cleared by the FDA on October 26, 2001. As far as this court is aware, there is not an

independent cause of action or claim for “illegal, adulterated, and misbranded device.” I thus

construe the claim—as the defendants have—as an attempt by the plaintiff to assert a claim for

violation of the Federal Food, Drug, and Cosmetic Act (“FDCA”), 21 U.S.C. § 331(b), which

prohibits the “adulteration or misbranding of any . . . device . . . in interstate commerce.”

The Supreme Court has expressly held: “The FDCA leaves no doubt that it is the Federal

Government rather than private litigants who are authorized to file suit for noncompliance with

the medical device provisions” of the FDCA. Buckman Co. v. Plaintiffs’ Legal Committee, 531

U.S. 341, 349, n. 4 (2001). Federal courts have consistently held that private citizens cannot assert

claims for violation of the FDCA. See, e.g., Phelps v. Wyeth, Inc., 857 F. Supp. 2d. 1114, 1126 (D.

Or. 2012) (holding that “failure to comply with the FDCA cannot form the basis for a state-law

claim” and, therefore, “Plaintiffs cannot sue to enforce the federal statute.”); Brinkman v. Shiley,

Inc., 732 F. Supp. 33, 35 (M.D. Pa. 1989) (“The FDCA does not create or imply a private right of

action for individuals injured as a result of violations of the Act.”); Mylan Labs., Inc. v. Matkari,

7 F.3d 1130, 1139 (4th Cir. 1993) (holding that plaintiff was “not empowered to enforce

independently the FDCA”).

The plaintiff, therefore, has not alleged a plausible claim upon which relief can be granted.

The defendants’ Motion is GRANTED pursuant to Rule 12(b)(6) of the Federal Rules of Civil

Procedure on the plaintiff’s allegations of “Illegal, Adulterated and Misbranded Device” and the

claim is DISMISSED with prejudice.

(2) Wrongful Death

The defendants requested summary judgment on the plaintiff’s wrongful death claim based

on her lack of an expert witness. As previously discussed, the defendants filed a Motion to Strike

the Affidavit of Dr. Nichols or in the Alternative Motion for Modification of the Scheduling Order.

[ECF No. 93]. Simultaneous with this Memorandum Opinion and Order, I entered a separate Order

denying the defendants’ Motion to Strike and their Alternative Motion for a Modification of the

Scheduling Order. Because I did not strike the affidavit and the court intends to issue a new

scheduling order for the wrongful death claim, I find the defendants’ Motion for Summary

Judgment premature. Therefore, I DENY the Motion as to the wrongful death claim.

IV. Conclusion

The defendants’ Motion for Summary Judgment [ECF No. 75] is DENIED as moot. The

defendants’ Supplemental Motion for Summary Judgment [ECF No. 90] is GRANTED on the

following claims: negligence (Count I); strict liability — manufacturing defect (Count II); strict

liability — failure to warn (Count IID); strict liability — defective product (Count IV); strict liability

— design defect (Count V); common law fraud (Count VI); fraudulent concealment (Count VII);

constructive fraud (Count VHI); negligent misrepresentation (Count IX); negligent infliction of

emotional distress (Count X); breach of express warranty (Count XI); breach of implied warranty

(Count XII); violation of consumer protection laws (Count XIII); gross negligence (Count XIV);

and unjust enrichment (Count XV). The defendants’ Motion [ECF No. 90], construed as a motion

to dismiss, is GRANTED as to the plaintiff's claim for “illegal, adulterated and misbranded

device.” The defendants’ Motion [ECF No. 90] is DENIED as to the plaintiff's claim for wrongful

death. The plaintiffs newly alleged claim for loss of consortium is DISMISSED without

prejudice. I FIND that the new allegations regarding TVT-O apply only to the remaining new

count: (a) wrongful death.

The Clerk is directed to send a copy of this Order to counsel of record and any

unrepresented party.

ENTER: March 27, 2020

Me

G

ow STATES DISTRICT JUDGE

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