Hosbrook v. Ethicon, Inc.

IN THE UNITED STATES DISTRICT COURT

FOR THE SOUTHERN DISTRICT OF OHIO

WESTERN DIVISION

PATRICIA HOSBROOK, :

Plaintiff,

Case No. 3:20-cv-88

v. :

JUDGE WALTER H. RICE

ETHICON, INC., et al.,

Defendants. :

AMENDED DECISION AND ENTRY1 OVERRULING IN PART AND

SUSTAINING IN PART DEFENDANTS’ MOTION TO DISMISS THE

CASE-SPECIFIC OPINIONS OF BRUCE ROSENZWEIG, M.D. (DOC.

#86) AND SUSTAINING DEFENDANTS’ MOTION FOR PARTIAL

SUMMARY JUDGMENT (DOC. #39)

Before the Court are two motions filed by Defendants, Ethicon, Inc., Ethicon

LLC and Johnson and Johnson (“Defendants” or “Ethicon”). The first motion filed

by Defendants is a Motion to Limit the Case-Specific Opinions of Bruce

Rosenzweig, M.D. (“Motion to Limit”), Doc. #86. Plaintiff, Patricia Hosbrook,

(“Plaintiff”), has filed a Response in Opposition to the Motion to Limit, Doc. #93,

and Defendants filed a Reply. Doc. #95.

Defendants’ second motion is a Motion for Partial Summary Judgment,

Doc. #39. Plaintiff has filed a Response in Opposition, Doc. #46. Defendants have

1 The only amendments are on page 11: page 11, line three, now reads “Defendants’

motion” instead of “Plaintiff’s motion” and line 8, last word, reads “was” rather than

“were.”

filed a Reply, Doc. #47 and a Notice of Supplemental Authority, Doc. #82.2 The

motions are now ripe for decision.

I. Background

On March 27, 2007, Plaintiff underwent surgery and had implanted a pelvic

mesh product manufactured by Ethicon known as “Prolift.” Doc. #34-1,

PAGEID#131. The surgery was performed by Silas Terry, Jr., M.D.3 at Livingston

Regional Hospital, located in Livingston, Tennessee. . Prolift contained a

synthetic mesh made of a polypropylene material and was used to treat pelvic

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

Following the surgery, Plaintiff experienced a number of physical problems

and underwent surgery on May 14, 2012, for the removal of extruded vaginal

mesh as well as a rectocele repair. Doc. #34-1, PAGEID#133. On November 16,

2012, she filed a “Short Form Complaint” (“SFC”), incorporating the First

Amended Master Complaint, against Defendants in Multidistrict Litigation (MDL)

proceedings in the United States District Court, Southern District, West Virginia.

., 844 F. Supp. 2d 1359

(U.S. Jud. Pan. Mult. Lit. 2012). Plaintiff has alleged numerous causes of action

2 , “Defendants Ethicon, Inc. and Johnson & Johnson’s Notice of Refiling Briefing

Related to Motion for Partial Summary Judgment,” Doc. #94.

3 Dr. Terry died on December 4, 2012. He was not deposed prior to his death.

against Defendants including strict liability, negligence, fraud and consumer law

violations. Doc. #1, PAGEID##1, 3-5; Doc. #66-1.

Pretrial matters in this case were handled in the MDL proceeding in the

Southern District of West Virginia against Defendants and other manufacturers of

the pelvic surgical mesh products. This case was then transferred to this district

for trial.

II. Motion to Limit, Doc. #86

A. Introduction.

Defendants’ Motion to Limit seeks an order precluding Dr. Rosenzweig from

testifying

(1)that Plaintiff would not have been injured if she had undergone a

traditional surgical procedure instead of Prolift implantation because

comparison to these alternatives is irrelevant; (2) about mesh

degradation and other alleged mesh deformations because there is

no evidence to link those opinions to Plaintiff’s case; (3) about lack of

informed consent based on insufficient product warnings because

such testimony is irrelevant, unreliable, and risks prejudice and

confusing the jury; and (4) about purported limitations on Plaintiff’s

current activity level, “poor” prognosis, and the need for future

surgery.

Doc. #86, PAGEID#17816

Defendants argue that the opinions of Plaintiff’s case-specific expert are

“speculative and unsupported by any evidence.” Plaintiff’s response to the

Motion to Limit is that the motion should be overruled because the MDL Court

“has repeatedly” held Dr. Rosenzweig’s general and case specific opinions on the

subjects raised by Plaintiff to be relevant and reliable. Doc. #93, PAGEID#17915.

Before addressing these subjects, the Court will first review the law concerning

Defendants’ motion.

B. Legal Analysis of Motion to Limit

A motion to limit testimony, or motion , is not addressed in the

Federal Rules of Evidence or the Federal Rules of Civil Procedure. The practice of

ruling on such motions has instead developed “pursuant to the district court’s

inherent authority to manage the course of trials.” , 469 U.S.

38, 41 n.4 (1984). The purpose of a motion is to allow the Court to rule

on issues pertaining to evidence in advance of trial in order to both avoid delay

and ensure an evenhanded and expeditious trial. See

., 326 F. Supp.2d 844, 846 (N.D. Ohio 2004) (citing

., 115 F.3d 436, 440 (7th Cir. 1997)). Pretrial orders also often

save the parties time and cost in preparing for trial and presenting their cases.

Courts are generally reluctant to grant broad exclusions of evidence in

, however, because “a court is almost always better situated during the

actual trial to assess the value and utility of evidence ., 2

F. Supp.2d 1385, 1388 (D. Kan. 1998); accord

Co., 519 F.2d 708, 712 (6th Cir. 1975). A court should not make a ruling

unless the moving party meets its burden of showing that the evidence in

question is clearly inadmissible. ., 326 F. Supp.2d at 846; 2 F.

Supp.2d at 1388. If this high standard is not met, evidentiary rulings should be

deferred so that the issues may be resolved in the context of the trial.

., 326 F. Supp.2d at 846.

C. Opinions of Expert Witnesses

Regarding expert witnesses, Fed. R. Evid. 702, provides as follows:

A witness who is qualified as an expert by knowledge, skill,

experience, training, or education may testify in the form of an

opinion or otherwise if:

(a) the expert's scientific, technical, or other specialized

knowledge will help the trier of fact to understand the

evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and

methods; and

(d) the expert has reliably applied the principles and methods to

the facts of the case.

Fed. R. Evid. 702.

In ., 509 U.S. 579 (1993), the

Supreme Court announced the standard for the admission of expert scientific

testimony in a case involving the prescription anti-nausea drug, Benedectin. It

held that the trial judge is to act as the gatekeeper and exclude expert witness

testimony if is it not both relevant and reliable. provided four non-

exclusive factors to assist in determining the reliability of the expert’s

methodology:

(1) whether the theory or technique has been tested;

(2) whether the theory or technique has been subjected to peer

review and publication;

(3) the known or potential rate of error of the method used and the

existence and maintenance of standards controlling the technique's

operation; and

(4) whether the theory or method has been generally accepted by the

scientific community.

, 509 U.S. at 593-94, 113 S.Ct. 2786. In ,

526 U.S. 137, 148, 119 S.Ct. 1167 (1999), the Court clarified by applying

Rule 702 to expert testimony based on technical or other specialized knowledge.

, however, made clear that reliability is “flexible” and that the four

factors are not a “definitive checklist or test” and must be tailored to the

facts of the particular case. ., (quoting , 509 U.S. at 593, 113 S.Ct. 2786.)

Accordingly, although the court has the ability to exclude expert witnesses if the

requirements of Rule 702 are not satisfied, it cannot weigh the facts or evaluate

the correctness of the expert witness’s conclusions. These tasks are for the jury.

., 725 F.3d 765 ((7th Cir. 2013)

1. Opinions about Alternative, Traditional Surgical Procedures

Defendants argue that the opinions of Dr. Rosenzweig concerning

alternative traditional surgical procedures are irrelevant to Plaintiff’s claims. They

assert that although Plaintiff is not required to do so, she can present proof of an

alternative product design for the Prolift. In this case, however, Plaintiff’s expert

offers proof of alternative traditional surgical when her claim is for an

allegedly defective or unreasonably dangerous under the Tennessee

Product Liability Act (“TPLA”), Tennessee Product Liability Act (“TPLA”) Tenn.

Code Ann §§ 29-28-101 through 29-28-108.4 Defendants assert that their position

is supported by ., 37 S.W. 3d 429 (Tenn. Ct. App. 2000) 5

as well as the TPLA statute, the relevant portion of which reads as follows:

A manufacturer or seller of a product shall not be liable for any injury

to a person or property caused by the product unless the product is

determined to be in a defective condition or unreasonably dangerous

at the time it left the control of the manufacturer or seller.

Tenn. Code Ann. § 29-28-105(a).

In response to Defendants’ argument, Plaintiff asserts that Dr. Rosenzweig

“simply informs the jury of what is now common knowledge to the medical

community: that a native tissue prolapse repair using biologic grafts rather than

synthetic mesh are safer surgical interventions than transvaginal mesh kits like

the Prolift.” Doc. #93, PAGEID#17915. Plaintiff also argues that the Prolift is both a

procedure and a product. “The Prolift is itself a vaginal procedure that uses a

polypropylene product as a support mechanism to treat POP.” . PAGEID#17916.

4 The alternative surgical procedures offered by Dr. Rosenzweig consist of the following:

(1) the use of sutures, including delayed absorbable sutures like PDS, in a uterosacral

ligament suspension and a sacrospinous fixation; an anterior and posterior colporrhaphy;

a sacrocolpopexy and a sacrohysteropexy; (2) autologous fascia lata; (3) repliform

cadaveric fascia. Doc. #44-1, PAGEID204.

5The Court does not find to be persuasive to Defendants’ position. The state

appellate court in involved claims regarding the design and manufacture by the

defendants of spinal system devices utilizing pedicle screws implanted in the plaintiffs.

The plaintiffs argued that summary judgment should not have been granted. The state

appellate court, however, specifically found that plaintiffs’ expert was not qualified “to

give expert opinions which clearly require medical expertise that he does not possess.”

As such, “his opinions, set out as bullet points, are not admissible pursuant to Tennessee

Rules of Evidence 702” and the motion for summary judgment was sustained, since no

evidence existed that the spinal system devices manufactured and implanted in the

plaintiffs were defective. . at 444.

According to Plaintiff, “Ethicon’s ‘Surgical Technique’ Guide for the ‘Prolift Pelvic

Floor Repair System’ clearly characterizes Prolift as a procedure.” .

Although Plaintiff may be correct that Dr. Rosenzweig’s four procedures are

intended to merely inform the jury that biologic grafts are safer than Prolift, the

fact remains that Prolift is a product and Plaintiff must establish under the TPLA

that it was “in a defective condition” or “unreasonably dangerous” at the time it

left the control of the manufacturer or seller. To introduce evidence of alternative

surgical procedures in a product liability case is irrelevant and would create

confusion for the jury. As to Plaintiff’s argument that the Prolift is both a product

and a procedure, thus making Dr. Rosenzweig’s testimony of alternative surgical

procedures relevant, the Court is not convinced since every medical product

intended to be implanted requires a surgical procedure. As stated by the MDL

Court, “alternative procedures/surgeries do not inform the issue of whether an

alternative design for a product exists.” In re

., 2017 WL 1264620, at *3 (S.D. W. Va. Mar. 29, 2017). Accordingly,

Defendants’ motion to exclude testimony from Dr. Rosenzweig regarding

alternative procedures is sustained.

2. Opinions Concerning Mesh Degradation and

Other Alleged Deformation

Defendants next argue that the opinions of Dr. Rosenzweig concerning

mesh degradation and other alleged deformation should be excluded since there

are no facts in support of these opinions. They argue that Plaintiff’s expert did not

conduct a medical examination of her, examine the explant mesh and that

nothing in the medical records support his opinions of degradation or

deformation. Because causation cannot be established as required by Tennessee

law, Defendants argue Rosenzweig’s opinions are “speculative, irrelevant[,]and

prejudicial,” Doc. #87, PAGEID#17826. To establish causation under Tennessee

law, Defendants cite to case law and assert that Plaintiff is required to “trace the

injury to some specific error in the construction or design of the [product].’

., 872 S.W.2d 908, 912 (Tenn. Ct. App. 1993) (quoting

, 541 S.W.2d 402, 404 (Tenn. 1976)). t, 868 S.W.2d

594 (Tenn. 1993) (“mere possibility of such causation is not enough”)

Defendants also rely on ., 29 F. Supp. 3d 691, 707-08

(S.D.W. Va. 2014). In , the MDL Court excluded Dr. Rosenzweig’s opinions

since he had not tested the plaintiff’s mesh yet opined, based on his background

and work, that degradation had occurred.

Plaintiff does not specifically address Defendants’ citations to Tennessee

law and causation. Instead, she asserts that in a recent case similar to the one

before this court, the district court correctly found that Dr. Rosenzweig’s opinions

were admissible regarding mesh degradation. In .,

1:19-cv-1000, 2020 WL 353576, January 21, 2020 (M.D. N.C.), the defendant

manufacturer sought to exclude Dr. Rosenzweig’s opinions on mesh degradation

since he had never physically examined the plaintiff or examined her mesh

products. In overruling defendant’s motion to exclude, the court noted that

plaintiff’s expert “relied on Mrs. Armstead’s medical records and testing results,

as well as her medical history.” . at *3. The court further found that “Dr.

Rosenzweig employed a differential diagnosis methodology that involved ruling

in possible causes for symptoms and conditions and then eliminating possible

causes until reaching one that could not be ruled out or determining one is most

likely.” . at 3.

Dr. Rosenzweig’s methodology involved five steps: (1) reviewing Mrs.

Armstead’s records and test results; (2) reviewing her medical

history; (3) reviewing and applying the scientific literature to

determine possible causes of her symptoms; (4) applying clinical

experience to determine possible causes; and (5) applying his

experience and the literature to eliminate possible causes. Id. This is

the same method that Dr. Rosenzweig uses in his practice to

determine the cause or causes of his patients’ medical conditions. Id.

at 3–4. This methodology ‘has widespread acceptance in the medical

community, has been subject to peer review, and does not frequently

lead to incorrect results.’ (citation omitted)

.

The district court found that Dr. Rosenzweig could testify regarding

his case specific opinions.

This Court agrees with and its holding that not conducting a

physical examination of the plaintiff or the excised mesh is “relevant in

considering whether to admit Dr. Rosenzweig’s testimony” but “it is not

determinative.” at *4. The reliability of an expert’s opinion is “primarily a

question of the validity of the expert’s methodology, not the quality of the data

used or the conclusions produced.” ., 732 F.3d

796, 806 (7th Cir. 2013). At the very least, this fact of non-examination of Plaintiff

is admissible for the weight to be given to the doctor’s testimony.

Defendants’ motion to exclude the opinions of Dr. Rosenzweig on the

subjects of mesh degradation and “other alleged deformation” is overruled.

3. Opinion Regarding the Lack of Informed Consent

Dr. Rosenzweig has opined that the product label for the Prolift device did

not sufficiently list certain risks. Because these risks were not on the product

labeling, Plaintiff’s expert asserts that neither Dr. Terry, nor Plaintiff was

adequately informed, thus creating a “lack of informed consent.” Defendants,

however, argue that Dr. Terry (1) could have given warnings regarding the device

to his patient and that it is speculative to assume that this did not occur; (2) under

Tennessee law, a health care provider has a duty to disclose “appropriate

information” to a patient to enable the patient to give informed consent to the

treatment or the procedure, Tenn. Code Ann. § 29–26–118; and (3) medical device

manufacturers are not required to warn of risks that are apparent to the physician

who use it, Tenn. Code Ann § 29-28-105(d). In response, Plaintiff asserts that the

MDL Court has found Dr. Rosenzweig competent to testify on the adequacy of the

product warnings. ., 29 F. Supp. 3d 691, 704 (S.D. W.Va.

2014) (“I therefore FIND that Dr. Rosenzweig is qualified to testify generally on the

adequacy of the TVT-O’s product warnings and marketing materials.”);

., 2014 WL 3361923, at *8 (S.D. W.Va. July 8, 2014) (“I therefore FIND

that Dr. Rosenzweig is qualified to testify generally on the adequacy of the TVT–

O’s product warnings and marketing materials.”).

Any opinion that Dr. Rosenzweig states concerning what warnings that

Defendants should have given will be subject to cross-examination and go to the

weight and not the admissibility of the evidence. Although such evidence may not

be compelling since Plaintiff’s doctor is deceased and was not deposed, this is a

determination for the jury and not the Court. Accordingly, Dr. Rosenzweig can

testify on the subject of warnings.

4. Opinions about Plaintiff’s Prognosis and the

Need for Future Surgery are Unsupported by the Evidence

Defendants’ final argument is that Dr. Rosenzweig’s opinions about

Plaintiff’s prognosis are unsupported by the evidence. In support of this

argument, Defendants cite to Plaintiff’s deposition testimony taken in April of

2017. In this testimony, Plaintiff states that she had successful revision surgery in

2012 and, at least at that point in time, had no further complications or

interference in her life. Dr. Rosenzweig has examined Plaintiff’s medical records

and has testified as an expert witness concerning other plaintiffs who have

undergone these procedures. Based on these facts, Dr. Rosenzweig’s testimony

regarding Plaintiff’s prognosis and the need for any further surgery goes to the

weight of the evidence, a determination for the fact finder and not the Court.

Accordingly, Defendants’ motion to exclude testimony from Dr. Rosenzweig

regarding Plaintiff’s prognosis and future surgery is overruled.

III. Motion for Partial Summary Judgment, Doc. #39

A. Standard of Review

Summary judgment must be entered “against a party who fails to make a

showing sufficient to establish the existence of an element essential to that

party=s case, and on which that party will bear the burden of proof at trial.”

, 477 U.S. 317, 322 (1986). The moving party always bears

the initial responsibility of informing the court of the basis for its motion and

identifying those portions of the record which it believes demonstrate the absence

of a genuine issue of material fact. Id. at 323; see also , 930

F.2d 1150, 1156 (6th Cir. 1991).

“Once the moving party has met its initial burden, the nonmoving party

must present evidence that creates a genuine issue of material fact making it

necessary to resolve the difference at trial.” ., 61

F.3d 1241, 1245 (6th Cir. 1995); see also , 477 U.S.

242, 250 (1986). Once the burden of production has so shifted, the party opposing

summary judgment cannot rest on its pleadings or merely reassert its previous

allegations. It is not sufficient to “simply show that there is some metaphysical

doubt as to the material facts.” .,

475 U.S. 574, 586 (1986). Rule 56 “requires the nonmoving party to go beyond the

[unverified] pleadings” and present some type of evidentiary material in support

of its position. , 477 U.S. at 324. “The plaintiff must present more than a

scintilla of evidence in support of his position; the evidence must be such that a

jury could reasonably find for the plaintiff.”

, 18 F.3d 337, 341 (6th Cir. 1994).

Summary judgment shall be granted “if the movant shows 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). “Summary judgment will not lie if the

dispute about a material fact is ‘genuine,’ that is, if the evidence is such that a

reasonable jury could return a verdict for the nonmoving party.” , 477

U.S. at 248. In determining whether a genuine dispute of material fact exists, a

court must assume as true the evidence of the nonmoving party and draw all

reasonable inferences in favor of that party. Id. at 255. If the parties present

conflicting evidence, a court may not decide which evidence to believe.

Credibility determinations must be left to the fact-finder. 10A Wright, Miller &

Kane, Federal Practice and Procedure Civil 3d ' 2726 (1998). In determining

whether a genuine dispute of material fact exists, a court need only consider the

materials cited by the parties. Fed. R. Civ. P. 56(c)(3). “A district court is not . . .

obligated to wade through and search the entire record for some specific facts

that might support the nonmoving party=s claim.” ,

889 F.2d 108, 111 (6th Cir. 1989), cert. denied, 494 U.S. 1091 (1990). If it so

chooses, however, the Court may also consider other materials in the record. Fed.

R. Civ. P. 56(c)(3).

B. Legal Analysis

1. Introduction

Under Ohio’s choice-of-laws rules, the “law of the place of injury controls

unless another jurisdiction has a more significant relationship to the lawsuit.”

, 660 F.3d 943 (6th Cir. 2011) (citing

, 15 Ohio St. 3d 339, 474 N.E. 2d 286, 289 (1984)); 1 Restatement

(Second) of Conflict of Laws, §§ 6, 145 and 146. Because the surgical implant of

the pelvic mesh product occurred in Tennessee, and no other state has a more

significant relationship to this claim, the substantive law of Tennessee applies.

Defendants assert in their Motion for Partial Summary Judgment that all of

Plaintiff’s claims, with the exception of strict liability for design defect, should be

dismissed. Defendants contend that dismissal is appropriate because (1) the TPLA,

Tenn. Code Ann §§ 29-28-101 through 29-28-108, subsumes all of Plaintiff’s claims,

other than those permitted by the statute; (2) Plaintiff has no evidence that she has

a claim of strict liability for a manufacturing defect, “strict liability for defective

product, or for strict liability for failure to warn; and (3) a claim under the

Tennessee Consumer Protection Act, Tenn. Code Ann. §§ 47-18-109(a)(1), does not

apply in this case and is also barred by the Act’s five-year statute of repose.

Plaintiff’s response does not address Defendants’ argument that the TPLA

subsumes all of her claims other than those permitted by the statute. Nor does she

argue that she has any evidence of a manufacturing defect, strict liability for

defective product, or that she has a claim under the Tennessee Consumer

Protection Act. Plaintiff does, however, argue that she has a valid cause of action

against Defendants based on strict liability for failure to warn, Count III.

Defendants’ Motion for Partial Summary Judgment is sustained.

Specifically, the Court finds, pursuant to Rule 56 of the Federal Rules of Civil

Procedure, that there is no genuine dispute of a material fact and that Defendants’

Motion for Partial Summary Judgment should be sustained as a matter of law for

Counts I, II, III, IV, VI, VII, VIII, IX, X, XI, XII, XIII, XIV and XV.

2. TLPA Claims

Defendants have filed a Motion for Partial Summary Judgment as to the

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

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

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); and unjust enrichment (Count XV).6

6 In addition to Count V, strict liability for design defect, Defendants have not moved for

summary judgment on certain damages incorrectly designated as claims: Count XVI, loss

of consortium, Count XVII, punitive damages and Count XVIII, discovery rule and tolling.

Doc. #66-1.

Defendants argue, and Plaintiff does not contest, that Plaintiff’s SFC is a

product liability action governed by the TPLA. This state statute defines a product

liability action as one which

includes all actions brought for or on account of personal injury,

death or property damage caused by or resulting from the

manufacture, construction, design, formula, preparation, assembly,

testing, service, warning, instruction, marketing, packaging or

labeling of any product. ‘Product liability action’ includes, but is not

limited to, all actions based upon the following theories: strict liability

in tort; negligence; breach of warranty, express or implied; breach of

or failure to discharge a duty to warn or instruct, whether negligent,

or innocent; misrepresentation, concealment, or nondisclosure,

whether negligent, or innocent; or under any other substantive legal

theory in tort or contract whatsoever;

TPLA, §§ 29-28-102.

Defendants contend that because Plaintiff has alleged a product liability

action as defined by the TPLA, the only potentially viable claims pled are her

claims for strict liability for design defect, Count V, manufacturing defect, Count II

and failure to warn, Count III.7 All of Plaintiff’s remaining claims are subsumed

under the TPLA, the exclusive remedy for product liability claims. Accordingly,

it makes no difference whether the complaint is couched in terms of

negligence, strict liability or breach of warranty, it has generally been

held in the State of Tennessee that in order for a plaintiff to recover

under any theory of product liability, the plaintiff must establish that

the product was defective and unreasonably dangerous at the time

the product left the control of the manufacturer.

7 Plaintiff has also pled a claim styled “strict-liability defective product,” Count IV. The

Court will address this claim, along with Count II, manufacturing defect, separately.

., 655 F. Supp. 22, 23 (E.D.Tenn.1985). ,

. , Inc., 2011 WL 12088, at *1, *3 (E.D. Tenn.

Jan. 4, 2011) (plaintiff’s claims for negligence, strict liability, breach of express and

implied warranties, negligent misrepresentation, fraud, and deceit were product

liability actions under the TPLA and subject to its statute of repose);

., 737 F.3d 378 (6th Cir. 2013) (plaintiffs' attempts to

characterize failure-to-warn claim as tort and contract causes of action “fall within

the purview of the TPLA” and are barred against brand name drug

manufacturers); ., No. 2:09-CV-142, 2011 WL

4397494, at *4 (E.D. Tenn. Aug. 31, 2011) (the TPLA “was written to provide the

exclusive remedy for injuries caused by products . . .”).

In this case, Ethicon argues, and the Court agrees, that there is no genuine

dispute of a material fact and that Defendants’ Motion for Partial Summary

Judgment should be granted as to the following claims of Plaintiff, since they are

subsumed under the TPLA: (1) negligence based claims, Count I (negligence),

Count X (negligent infliction of emotional distress) and Count XIV (gross

negligence); (2) claims sounding in fraud, Count VI (common law fraud), Count VII

(fraudulent concealment), Count VIII (constructive fraud), Count IX (negligent

misrepresentation) and Count XIII (consumer protection); (3) warranty based

claims, Count IX (breach of express warranty) and Count XII (breach of implied

warranty) and (4) unjust enrichment, Count XV.8

3. Lack of Proof of a Manufacturing Defect Claim and Plaintiff’s Claim for

“Strict Liability-Defective Product”

Plaintiff has pled a claim for “strict liability - manufacturing defect,” Count

II, and a claim styled “strict liability - defective product,” Count IV. Although

cognizable under the TPLA, no expert witness has opined that the implanted

product deviated from any of Defendants’ specifications. Tenn. Code Ann § 29-28-

102(6). Also, Plaintiff’s response does not address either of these two claims.

Accordingly, the Court finds that there is no genuine dispute of a material fact as

to Counts II and IV and that Defendants’ motion for summary judgment as to

these two claims is sustained.

4. Failure to Warn, Count III

Defendants also move for summary judgment on Count III, failure to warn.

They contend that because Tennessee recognizes the learned intermediary

8In addition to finding that certain of Plaintiff’s claims are subsumed by the TPLA, the

Court also finds that Plaintiff’s claims for misrepresentation, unjust enrichment, consumer

and warranty-based claims are barred because they are either inapposite to the facts as

alleged in the SFC or barred by the applicable statute of limitations. Specifically,

Plaintiff’s negligent misrepresentation claim applies only to businesses or professionals

supplying false information, , 382 S.W. 325, 344-46 (Tenn. 2012), and her

claim for unjust enrichment is legally irrelevant in a tort-based product liability suit. With

respect to the statute of limitations, Plaintiff’s consumer-based claim, § 47-18-109, Count

XIII, is barred by a five-year statute of limitation from the date of the transaction, in this

case March 27, 2007, the date of Plaintiff’s surgery, to November 16, 2012, the filing of the

SFC. Finally, Plaintiff’s breach of warranty claim is barred by the four-year statute of

limitations in Tenn. Code Ann. §§ 47-2-725(l), since the date is calculated from the date of

Plaintiff’s surgery, March 27, 2007, to the date of the filing of her SFC.

doctrine, the physician and not the patient is the user of the product and the one

to be warned of any hazards. ., 347 S.W.3d 686,

701(Tenn. 2011); ., 890 S.W.2d 425, 430 (Tenn. 1994). As

explained by the Tennessee Supreme Court in , a prescription drug case,

the “makers of unavoidably unsafe products who have a duty to give warnings

may reasonably rely on intermediaries to transmit their warnings and

instructions.” . at 429 (citations omitted). Plaintiffs, however, must still establish

a causal connection between the warning given to the user and the injuries

sustained.

In ., 956 F.2d 1319 (6th Cir. 1992), the Sixth Circuit

reviewed Tennessee law in a case involving the alleged inadequacy of a warning

label in a gas explosion. The Court held that summary judgment must be granted

when a plaintiff fails to show proximate cause between the injury and the

allegedly defective labels. The Court reiterated that under Tennessee law, a two-

part test exists: “1) the plaintiff must establish the product is unreasonably

dangerous by reason of defective warning and 2) the plaintiff must prove that the

inadequate labelling proximately caused the claimed injury. (citations omitted) If

either part is not met, the plaintiff fails to meet its burden.” . at 1329.

Unfortunately for Plaintiff, the physician in this case, Plaintiff’s doctor, is the

intermediary. As noted above, Dr. Terry is deceased and was not deposed.

Accordingly, there is no evidence before the Court that he read any warnings

much less relied on them. Without this evidence of causation, the Court can only

conclude that the warnings given by Defendants were not a factor in the injuries

sustained by Plaintiff. Accordingly, there is no genuine dispute of a material fact

and Defendants’ motion for summary judgment on Count Ill, failure to warn, is

sustained.

IV. Conclusion

Accordingly, for the reasons stated above, Defendants’ Motion to Dismiss

the case-specific opinions of Bruce Rosenzweig, M.D., Doc. #86, is SUSTAINED in

part and OVERRULED in part. Defendants’ Motion for Partial Summary

Judgment, Doc. #39, is SUSTAINED and Counts I, Il, III, IV, VI, VIL, VIII, IX, X, XI, □□□

XIV and XV are dismissed.

Count V, design defect, remains for trial.

□□ slend Sere Sow sl coe:

Date: April 23, 2021

WALTER H. RICE

UNITED STATES DISTRICT JUDGE

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