Stinson v. Davol, Inc.

UNITED STATES DISTRICT COURT

SOUTHERN DISTRICT OF OHIO

EASTERN DIVISION

IN RE: DAVOL, INC./C.R. BARD,

Case No. 2:18-md-2846

INC., POLYPROPYLENE HERNIA

MESH PRODUCTS LIABILITY

LITIGATION

JUDGE EDMUND A. SARGUS, JR.

Magistrate Judge Kimberly A. Jolson

This document relates to:

Stinson v. C.R. Bard, Inc., et al.

Case No. 2:18-cv-1022

DISPOSITIVE MOTIONS ORDER No. 7

Defendants C.R. Bard, Inc. and Davol, Inc. seek summary judgment on each of Plaintiff

Aaron Stinson’s claims. For the reasons that follow, Defendants’ motion (ECF No. 89) is

GRANTED IN PART, DENIED IN PART, DENIED AS MOOT IN PART, and RESERVED

IN PART.

I. Background1

Plaintiff’s case is the third bellwether trial selected from thousands of cases in this

multidistrict litigation (“MDL”) against Defendants. The Judicial Panel on Multidistrict Litigation

described the cases in this MDL as “shar[ing] common factual questions arising out of allegations

that defects in defendants’ polypropylene hernia mesh products can lead to complications when

implanted in patients, including adhesions, damage to organs, inflammatory and allergic responses,

foreign body rejection, migration of the mesh, and infections.” (No. 2:18-md-02846, ECF No. 1

at PageID #1–2.) Plaintiff raises Maine law claims against Defendants based on the implantation

1 Docket citations are to the docket in the instant case, Case No. 18-cv-1022, unless otherwise

noted.

of Defendants’ PerFix Plug mesh.2 (ECF No. 17.)

The PerFix Plug is “a pre-formed, three-dimensional device constructed of a fluted outer

layer of Bard mesh and multiple inner layers of mesh attached at the tip” with a separate flat onlay

mesh patch, and is used for the repair of inguinal, or groin, hernia defects. (ECF No. 89-1 at

PageID #619.) The PerFix Plug is cone-shaped with eight pleats. (ECF No. 89 at PageID #563.)

The cone is filled with “two propeller-shaped pieces of polypropylene mesh, with a total of eight

triangular petals” to keep the plug from collapsing, and looks similar to a badminton shuttlecock.

(Id.) The flat onlay mesh has an incision and hole to “allow the spermatic cord to be threaded

through the mesh.” (Id.) The PerFix Plug is deployed using a “plug and patch” technique, which

is the most common method of inguinal hernia repair in the United States. (ECF No. 89-3 at

PageID #643.) Essentially, the plug is placed into an incision in the hernia defect and sutured in

place, and the onlay mesh is placed over the incision to act as a reinforcement. (ECF No. 89-2.)

When it was first introduced, the PerFix Plug was available in three sizes: small, medium,

and large. (ECF No. 89 at PageID #564.) An extra-large version was introduced in 1996. (Id.)

The PerFix Plug was developed as a line extension of the Marlex Mesh Dart, which was cleared

by the FDA via a 510(k) submission in August 1992. 3 (ECF No. 89-6 at PageID #872.) The

small, medium, and large sizes were introduced in April 1993 using a “no-510(k) rationale.” (ECF

No. 89 at PageID #564; ECF No. 89-6.) A no-510(k) rationale is when a 510(k) application does

not need to be submitted because the manufacturer has made changes that do not “significantly

affect the safety or effectiveness of the device.” (See Case No. 18-cv-1320, ECF No. 167,

2 At the time his PerFix Plug was explanted Plaintiff’s surgeon implanted another of Defendants’

products, a Bard Marlex Mesh. Due to Plaintiff’s recent health issues, the parties have reserved

briefing on any damages or injuries allegedly caused by the Bard Mesh.

3 The 510(k) process has been described previously in this MDL in Motions in Limine (“MIL”)

Order No. 4 (18-cv-01509, ECF No. 355 at PageID #18767–69).

Dispositive Motions Order (“DMO”) No. 3 at PageID #13611.) In 1996, the line was expanded to

add an extra-large PerFix Plug, also using a no-510(k) rationale. (ECF No. 89 at PageID #564;

ECF No. 89-7.) At the FDA’s request, Defendants submitted an “add-to-file” for the Marlex Mesh

Dart documenting Defendants’ decision not to submit a 510(k) application for the PerFix Plug,

which included details about the PerFix Plug’s design and construction and a summary of clinical

data regarding the PerFix Plug’s outcomes. (ECF No. 89-8.) After reviewing the submission, the

FDA determined that it “d[id] not appear that [Defendants] ha[d] significantly changed or modified

the design, components, method of manufacture, or intended use of the [PerFix Plug].” (ECF No.

89-9.) The FDA also stated that it is “[Defendants’] responsibility to determine if the change or

modification to the device or its labeling could significantly affect the device’s safety or

effectiveness and thus require submission of a new 510(k).” (Id.)

The parties disagree as to the relevance of Plaintiff’s medical history. In addition to

information about his 2015 hernia surgery (“implant surgery”) and subsequent complications (ECF

No. 89 at PageID #568–75), Defendants describe Plaintiff’s pre-implant medical history going

back to the early 1990s (ECF No. 89 at PageID #565–68).4 According to Defendants, these details

show that Plaintiff has a longstanding history of chronic pain, difficulty urinating, sexual

dysfunction, mental health issues, and weight gain that predate his 2015 implant surgery. (Id. at

PageID #565.) Plaintiff’s response instead includes his medical history starting with the 2015

implant surgery. (ECF No. 124 at PageID #4821–24.) The following is a chronological summary

of Plaintiff’s medical history as offered by the parties.

4 Plaintiff does not dispute the accuracy of Defendants’ description of his medical history.

However, he has filed a separate motion in limine to exclude evidence regarding the relevance

much of his pre-implant medical history (ECF No. 177), which the Court will address in a later

order.

In 1993 or 1994, Plaintiff was involved in an altercation and suffered what he described as

“horrific[]” injuries to his teeth, jaw, cheekbone, ribs, and eyes. (ECF No. 89-12 at PageID #1005.)

In September of 1995, Plaintiff suffered an accident at work in which he had an open fracture in

his left foot, “the plantar aspect of [his left] foot was severely lacerated and later required skin

grafting,” and he experienced a “large buck[et] handle tear of the medial meniscus” in his left knee

that required surgical repair. (ECF No. 89-13; ECF No. 89-12 at PageID #1006.) Beginning in

1999, Plaintiff sought treatment for back pain and pain that radiated into both thighs which

worsened when moving from lying down to standing. (ECF No. 89-3 at PageID #655.) In August

of 2000, Plaintiff sought treatment for right L5 nerve compression that radiated to his thigh and

foot, and he reported trouble sleeping. (Id.) A diagnostic study indicated bulging discs, stenosis,

L5 radiculopathy, and disc disease. (Id.) In December of 2000, Plaintiff sought treatment for

weakness in his right foot and radicular discomfort pain which responded to epidural steroid

injections. (Id.) He showed signs of a nerve injury and contemplated, but ultimately did not

undergo, back surgery. (Id.) In January of 2001, he reported discomfort over his right hip and

pain in his right leg. (Id.)

In late January 2001, Plaintiff sought treatment for abdominal pressure with difficulty

urinating and was found to have an enlarged prostate, and the doctor noted that he could not rule

out the possibility of cauda equina syndrome in light of Plaintiff’s spinal cord issues; upon

examination, Plaintiff walked slightly stooped and also reported tenderness in the suprapubic area

and back pain. (Id. at PageID #656.) From March of 2001 through April of 2003 Plaintiff

continued to report lower back pain and right leg pain and weakness which did not respond to

conservative treatment, and Plaintiff mentioned wanting to avoid back surgery. (Id.)

In January of 2004, Plaintiff sustained a lower back injury while at work which prevented

him from working. (ECF No. 89-14 at PageID #1028.) X-rays were negative for a compression

fracture but revealed mild degenerative changes. (Id.) Plaintiff reported that his pain gradually

improved, but described a burning and throbbing sensation localized to the left lower back which

worsened when attempting to sit or stand, with a pain level of 6 out of 10. (Id.) Plaintiff also

reported pain along his right inner thigh associated with movement, and difficulty lying on his

side. (Id.) Plaintiff attended physical therapy for this injury. (Id.)

Plaintiff testified that a doctor told him he had a small inguinal hernia on the right side in

the early 2000s and that it did not require treatment at that point, but the doctor instructed Plaintiff

to “keep an eye on it.” (ECF No. 89-12 at PageID #1008.) However, the notes from his July 30,

2015 visit with the surgeon who performed his initial hernia repair indicate that he had had the

hernia for approximately five years. (ECF No. 19-16 at PageID #1037.)

In October of 2013, Plaintiff reported radiating left knee pain with intermittent numbness

and tingling in his left foot, which had been a recurring issue since his 1995 injury and surgeries.

(ECF No. 89-3 at PageID #657.) The record from that visit also noted that Plaintiff “had little

interest in things, was feeling down, depressed, and hopeless.” (Id.) Beginning in January of

2015, pharmacy records show prescriptions for Gabapentin, Hydrocodone, and Ketorolac. (Id. at

PageID #658.)

In July of 2015 Plaintiff sustained an injury while working on a sailboat and testified that

he felt a tear at the location of his right inguinal hernia. (ECF No. 89-12 at PageID #1008.)

Plaintiff went to the emergency room and was referred to Dr. Amy Tan, a general surgeon. (Id. at

PageID #1009.) On July 30, 2015, Plaintiff saw Dr. Tan regarding the hernia, and she prescribed

hydrocodone-acetaminophen as needed for pain and discussed hernia repair with Plaintiff. (ECF

No. 89-16 at PageID #1039.) Dr. Tan gave Plaintiff illustrated literature on hernia repair, which

discussed expectations, a hernia repair overview, recovery and discharge, and risks and possible

complications. (ECF No. 89-18.) This pamphlet detailed risks and complications including,

among other things, chronic pain, urinary problems, nerve pain, and testicular pain or swelling.

(Id. at PageID #1081.) Dr. Tan discussed with Plaintiff the risks of the operation, including

“infection, bleeding, poor wound healing, scarring, and damage to adjacent structures.” (ECF No.

89-16 at PageID #1039.) She “also discussed the risks of damage to nerves and cord structures

that could result in pain, numbness, testicular damage or infertility.” (Id.) Dr. Tan explained the

risk of hernia recurrence, and that the risk is higher with any factors that increase abdominal

pressure including “coughing, straining, and heavy labor.” (Id.) Dr. Tan also discussed expected

postoperative course and recovery and answered Plaintiff’s questions, and Plaintiff ultimately

decided that “he would like to proceed with right inguinal hernia repair with mesh.” (Id.) Plaintiff

did not tell Dr. Tan about his prior spinal issues, which she testified that she “would have

considered if [she]’d known about the injury.” (ECF No. 89-17 at PageID #1063.)

Dr. Tan performed the hernia repair operation on August 5, 2015. (ECF No. 89-19.) She

repaired the hernia using an Extra-Large PerFix Plug. (Id.) In her operative report she described

mobilizing the ilioinguinal nerve and taking care not to entrap it. (Id. at PageID #1088.) On

August 12, 2015, Plaintiff indicated a 6.5 out of 10 pain level and requested pain medication, and

received a prescription for Hydrocodone-Acetaminophen. (ECF No. 89-3 at PageID #661.) At a

visit on August 18, 2015, Plaintiff was noted to have lost 16 pounds but to be in no acute distress

and recovering as expected without signs of early complications. (Id.) On August 24, 2015,

Plaintiff was given Toradol for pain. (Id.) On September 4, 2015, Plaintiff reported pain while

putting on pants. (Id.) Dr. Tan asked Plaintiff to return for a visit so she could “examine him and

evaluate for any potential problems because it is unusual to have leg pain from a hernia.” (ECF

No. 89-17 at PageID #1051.) At a follow-up visit on September 8, 2015, Plaintiff reported

shooting pain in his right leg that was worse with certain movements and positions. (Id. at PageID

#1052.) Dr. Tan noted that the hernia “looked like it was well healed” and that there was “nothing

that was tender in the area of the hernia.” (Id.) Dr. Tan saw no sign of a hernia recurrence at this

appointment. (Id.) Dr. Tan believed some of Plaintiff’s reported pain was “related to nerve root

pain from [Plaintiff’s] back” and suggested rest and anti-inflammatory medications. (Id.)

At another visit with Dr. Tan on September 21, 2015, Plaintiff reported that his shooting

leg pain had improved but was still present. (Id.) Dr. Tan examined Plaintiff and noted that the

hernia repair had healed well but that there was “a spot where pressure relieved the pain,” which

she testified was more indicative of a nerve issue. (Id.) Dr. Tan gave Plaintiff a nerve block

injection, and Plaintiff reported that the pain relief only lasted for about 24 hours. (Id. at PageID

#1052–53.) Dr. Tan testified that although it was brief, the pain relief from the nerve block

convinced her that Plaintiff was suffering from nerve pain. (Id. at PageID #1053.)

At another visit with Dr. Tan on October 15, 2015, Plaintiff reported that a prescription

anti-inflammatory medication did not provide much relief. (Id. at PageID #1054.) However, he

was prescribed Neurontin, a medication often used for nerve pain, by his family doctor and he felt

the Neurontin was helping the pain. (Id.) Dr. Tan recommended continued use of the Neurontin.

(Id.) At a later visit on December 21, 2015, Plaintiff reported to Dr. Tan that he felt the Neurontin

“controlled [his pain] reasonably well, but he was still having some limitation.” (Id.)

On January 27, 2016, Plaintiff saw Dr. Frederick Littlejohn at Northeast Pain Management

for complaints of right groin pain which was aggravated by certain positions and by coughing, and

rated his pain as ranging from 7 to 10 out of 10. (ECF No. 89-3 at PageID #664.) Dr. Littlejohn

noted that Plaintiff’s leg pain had dissipated, and most of his pain was in the inguinal and inner

thigh regions. (Id.) Based on the evaluation, Dr. Littlejohn concluded that Plaintiff “likely ha[d]

some impingement of the ilioinguinal or genitofemoral nerves in association with the spermatic

cord, possibly related to the surgery or scar tissue which may have developed after” his hernia

repair. (Id.) Dr. Littlejohn’s diagnosis was ilioinguinal neuritis and myofascial pain syndrome.

(Id.) On February 24, 2016, a left ilioinguinal nerve block was performed, and Plaintiff continued

to receive ilioinguinal nerve blocks. (Id.)

Plaintiff again saw Dr. Tan on March 21, 2016, and she recommended he continue the

nerve blocks. (ECF No. 89-17 at PageID #1054.) Dr. Tan discussed with Plaintiff the possibility

of a neurectomy operation, but she encouraged him to “exhaust treatment options through [the]

pain clinic before consideration of a neurectomy.” (Id.) Plaintiff continued regular nerve block

injections in March and April 2016 with an improvement in his symptoms. (ECF No. 89-3 at

PageID #665.) On April 22, 2016, Plaintiff and Dr. Littlejohn discussed the possibility that his

symptoms may be related to the problems with his lumbar spine. (Id.) At a follow-up visit with

Dr. Tan on June 23, 2016, Plaintiff reported pain that interfered with his driving, and also reported

pain with urination and trouble emptying his bladder. (ECF No. 89-17 at PageID #1055.) Dr. Tan

did not believe that “any bladder problems were from the nerves [related to] his hernia repair.”

(Id.) Dr. Tan did not find evidence of hernia recurrence. (Id.) Dr. Tan recommended a

neurectomy. (Id.)

On August 15, 2016, Plaintiff saw Dr. Frederick Radke, a general surgeon, for a possible

hernia recurrence. (ECF No. 89-3 at PageID #665.) Dr. Radke diagnosed right inguinodynia and

noted no signs of a recurrent hernia, but opined that inguinal nerve entrapment was the most likely

possibility for Plaintiff’s ongoing pain. (Id.) Dr. Radke administered ilioinguinal nerve blocks

and concluded, based on Plaintiff’s continuing pain, that Plaintiff may benefit from a right

paravertebral block. (Id. at PageID #667.) On February 14, 2017, Plaintiff received a lumbosacral

transforaminal epidural steroid injection and immediately experienced relief of his groin pain. (Id.)

In April of 2017, Plaintiff’s family doctor discussed with Dr. Radke the possibility of an

exploratory surgery to try to find a way to relieve Plaintiff’s pain. (Id.; ECF No. 89-21 at PageID

#1126.) On June 20, 2017, Dr. Radke performed an exploratory surgery to look for hernia

recurrence or nerve entrapment. (ECF No. 89-22 at PageID #1135.) Dr. Radke noted “[a] great

deal of scarring in the subcutaneous tissue” and found “a large ball approximately 2.5 cm in

diameter of rolled up mesh next to the pubic tubercle.” (Id. at PageID #1134.) Dr. Radke removed

the mesh, which was “slow going and extremely difficult” as the mesh was “very significantly

scarred.” (Id.) Dr. Radke then found Plaintiff’s hernia and noted that it was “not large and it was

unclear whether this was responsible for any of [Plaintiff’s] symptoms.” (Id.) Dr. Radke then

repaired the hernia with a flat piece of Bard Marlex Mesh, another of Defendants’ products. (Id.;

ECF No. 89-21 at PageID #1128.) At the end of Plaintiff’s surgery Dr. Radke opined that “the

large ball of mesh [was] likely . . . responsible” for Plaintiff’s pain. (ECF No. 89-22 at PageID

#1134–35.)

Dr. Radke testified that at the time of Plaintiff’s surgery, he did not know that the device

he removed was a PerFix Plug and instead thought it was a “sheet [of flat mesh] that had pulled

loose or something of that sort.” (ECF No. 89-21 at PageID #1130.) According to Dr. Radke, the

fact that it was a plug device and not a piece of flat mesh “explains the fact that [Plaintiff] had a

big ball of scar tissue because . . . part of the way [plug devices] work is by forming scar tissue

and healing the area.” (Id.) Dr. Radke also noted that the location where the mesh was found was

“a reasonable place for it to be” because “that’s where hernias occur,” and that he could not tell if

it was exactly where it should have been or not, but “it was at least close to where it was supposed

to be.” (Id. at PageID #1127–28.)

On June 28, 2017, Plaintiff reported to his family doctor that his neuropathic pain had

improved but was still present. (ECF No. 89-3 at PageID #669.) On July 26, 2017, Plaintiff

returned to his family doctor and complained of trouble urinating. (Id.) Plaintiff still had right

testicular and scrotal swelling and some right inguinal pain, but reported that it was much improved

from before. (Id.)

The crux of Plaintiff’s claims is that Defendants knew of certain risks presented by the

PerFix Plug device but marketed and sold the device despite these risks and without appropriate

warnings, causing Plaintiff’s injuries. Plaintiff alleges that the polypropylene in the PerFix Plug

degrades after implantation, which enhances the chronic inflammatory response in the body. (ECF

No. 124 at PageID #4826.) Plaintiff also claims that the PerFix Plug is susceptible to migration

and has a high incidence of chronic pain. (Id.) According to Plaintiff, Defendants downplayed

the rate and severity of complications caused by the PerFix Plug, even when faced with reports of

negative outcomes, which created an unreasonable risk of significant and permanent harm to

patients. (Id.)

On June 10, 2019, Plaintiff filed his third amended complaint. (ECF No. 17.) In the third

amended complaint, Plaintiff raises claims for (1) defective design (strict liability), (2) failure to

warn (strict liability), (3) manufacturing defect (strict liability), (4) negligence, (5) negligence per

se, (6) gross negligence, (7) state consumer protection laws5, (8) breach of implied warranty, (9)

breach of express warranty, (10) negligent infliction of emotional distress, (11) intentional

infliction of emotional distress, (12) negligent misrepresentation, (13) fraud and fraudulent

5 Prior to the filing of the Motion for Summary Judgment, the parties filed a stipulated dismissal

of Plaintiff’s claim under Maine consumer protection laws. (ECF No. 88.)

misrepresentation, (14) fraudulent concealment, and (15) punitive damages. (ECF No. 17.)

Defendants seek summary judgment on all claims. (ECF No. 89.) The motion is fully briefed,

and Defendants have filed evidentiary objections in response to Plaintiff’s brief. (ECF Nos. 89,

124, 144.)

II. Governing Law and Legal Standard

In federal diversity actions, “state substantive law and federal procedural law apply to state

claims.” Range v. Douglas, 763 F.3d 573, 580 (6th Cir. 2014). Generally, the state law of the

transferor court applies in MDLs. See Wahl v. Gen. Elec. Co., 786 F.3d 491, 497–98 (6th Cir.

2015). In cases filed directly with the MDL court, MDL courts will apply the substantive state

law of the “originating jurisdiction,” including choice-of-law rules. Sanchez v. Bos. Sci. Corp.,

No. 2:12-cv-05762, 2014 WL 202787, at *4 (S.D. W. Va. Jan. 17, 2014) (quoting In re Watson

Fentanyl Patch Prods. Liab. Litig., MDL No. 2732, 2013 WL 4564927, at *2 (N.D. Ill. Aug. 27,

2013)). The originating jurisdiction is where the case would have been filed if the case

management order permitting direct filing did not exist. Wahl v. Gen. Elec. Co., 983 F. Supp. 2d

937, 943 (M.D. Tenn. 2013). In a medical device case, this is where the device was purchased,

prescribed, and implanted. E.g., Sanchez, 2014 WL 202787, at *4. There is no dispute that the

action would have been filed in Maine absent Case Management Order No. 2 permitting direct

filing with this Court. (ECF No. 17 at PageID #108; ECF No. 89 at PageID #577–78.) Thus,

Maine choice-of-law rules apply.

Under Maine choice-of-law rules, Maine law applies to this case. Maine applies the

Restatement (Second) of Conflict of Laws approach, the most significant relationship analysis, to

tort law claims. Collins v. Trius, Inc., 663 A.2d 570, 572–73 (Me. 1995). Here, all pertinent events

took place in Maine. Plaintiff lives there, the surgeries occurred there, and his alleged injuries

occurred there. See Restatement (Second) of Conflict of Laws § 145(2) (1971). The parties do

not dispute the application of Maine law.

Under the Federal Rules of Civil Procedure, summary judgment is appropriate when “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). “The moving party bears the burden of

showing that no genuine issues of material fact exist.” RJ Control Consultants, Inc. v. Multiject,

LLC, 981 F.3d 446, 452 (6th Cir. 2020) (citing Celotex Corp. v. Catrett, 477 U.S. 317, 325 (1986)).

The burden then shifts to the nonmoving party, who “must set forth specific facts showing that

there is a genuine issue for trial.” Anderson v. Liberty Lobby, Inc., 477 U.S. 242, 250 (1986). “In

order for the non-movant to defeat a summary-judgment motion, there must be evidence on which

the jury could reasonably find for the [non-movant].” Clabo v. Johnson & Johnson Health Care

Sys., Inc., 982 F.3d 989, 992 (6th Cir. 2020) (alteration in original) (quoting Bard v. Brown County,

970 F.3d 738, 748 (6th Cir. 2020)). The court must “consider the evidence in the light most

favorable to the nonmoving party and draw all reasonable inferences in that party’s favor.”

Johnson v. City of Saginaw, 980 F.3d 497, 506 (6th Cir. 2020) (quoting Quigley v. Tuong Vinh

Thai, 707 F.3d 675, 679 (6th Cir. 2013)). The ultimate question is “whether the evidence presents

a sufficient disagreement to require submission to a jury or whether it is so one-sided that one party

must prevail as a matter of law.” Anderson, 477 U.S. at 251–52.

III. Analysis

Defendants argue that Plaintiff fails to demonstrate genuine disputes of material fact exist

for trial. Defendants raise arguments for each of Plaintiff’s claims: manufacturing defect; design

defect; failure to warn; negligence; negligence per se; gross negligence; negligent

misrepresentation, fraud, fraudulent misrepresentation, and fraudulent concealment; breach of

express warranty; breach of implied warranty; intentional infliction of emotional distress and

negligent infliction of emotional distress; certain damages; and any claims regarding Plaintiff’s

current Bard mesh. (ECF No. 89.)

A. Manufacturing Defect Claim

Defendants first argue that Plaintiff has “proffered no evidence, expert or otherwise, that

the PerFix Plug implanted in him was defectively manufactured in that it departed from its intended

design.” (ECF No. 89 at PageID #578.) However, the parties proposed, and the Court agreed, that

summary judgment briefing on Plaintiff’s manufacturing defect claim would be deferred pending

further discovery. Therefore, the Court RESERVES JUDGMENT on Plaintiff’s manufacturing

defect claim.

B. Strict Liability Design Defect Claim

Defendants next argue that Plaintiff’s strict liability design defect claim fails for three

reasons: that comment k to the Restatement (Second) of Torts § 402A applies here and precludes

Plaintiff’s claim; that Plaintiff cannot carry his burden on this claim because he fails to show that

the risks of the PerFix Plug outweighed its benefits nor has he presented a feasible alternative

design; and that the design of the PerFix Plug did not cause Plaintiff’s injuries. The Court will

address each argument in turn.

1. Comment K

Comment k to the Restatement (Second) of Torts § 402A pertains to “unavoidably unsafe

products,” and states:

There are some products which, in the present state of human knowledge,

are quite incapable of being made safe for their intended and ordinary use. These

are especially common in the field of drugs. An outstanding example is the vaccine

for the Pasteur treatment of rabies, which not uncommonly leads to very serious

and damaging consequences when it is injected. Since the disease itself invariably

leads to a dreadful death, both the marketing and the use of the vaccine are fully

justified, notwithstanding the unavoidable high degree of risk which they involve.

Such a product, properly prepared, and accompanied by proper directions and

warning, is not defective, nor is it unreasonably dangerous. The same is true of

many other drugs, vaccines, and the like, many of which for this very reason cannot

legally be sold except to physicians, or under the prescription of a physician. It is

also true in particular of many new or experimental drugs as to which, because of

lack of time and opportunity for sufficient medical experience, there can be no

assurance of safety, or perhaps even of purity of ingredients, but such experience

as there is justifies the marketing and use of the drug notwithstanding a medically

recognizable risk. The seller of such products, again with the qualification that they

are properly prepared and marketed, and proper warning is given, where the

situation calls for it, is not to be held to strict liability for unfortunate consequences

attending their use, merely because he has undertaken to supply the public with an

apparently useful and desirable product, attended with a known but apparently

reasonable risk.

Restatement (Second) of Torts § 402A (1965). According to Defendants, although the Supreme

Judicial Court of Maine has not formally adopted comment k, the Court should apply it in this

case. (ECF No. 89 at PageID #579–81.) Defendants point to Doe v. Solvay Pharmaceuticals, Inc.,

in which the United States District Court for the District of Maine noted that the Supreme Judicial

Court “has not directly faced the application of strict liability principles to prescriptive drugs;

however, because the Maine Legislature modeled its strict liability statute on § 402A of the

Restatement (Second) of Torts, Maine courts have looked to the Restatement for interpretive

guidance.” Doe v. Solvay Pharms., Inc., 350 F. Supp. 2d 257, 267 (D. Me. 2004), aff’d on other

grounds, 153 F. App’x 1 (1st Cir. 2005). Defendants also note that other courts across the country

have applied comment k in the context of prescription drugs and medical devices. (ECF No. 89 at

PageID #580.) Defendants argue that Plaintiff’s alleged injuries “are inherent risks of prescription

medical devices such as the PerFix Plug that doctors and patients have accepted for decades given

the benefits of polypropylene mesh in the repair of hernias.” (Id.) Defendants claim that Plaintiff’s

implanting and explanting physicians agree that “Plaintiff’s alleged complications are risks in any

hernia surgery, with or without mesh, and are not particular to the PerFix Plug.” (Id. at PageID

#580–81.)

Plaintiff argues that Defendants’ comment k argument fails because Maine has not adopted

comment k, and because comment k “anticipates that it will apply primarily to new and

experimental prescription drugs, not medical devices that have been on the market for decades.”

(ECF No. 124 at PageID #4830.) Even if comment k applies, Plaintiff contends that Defendants’

arguments still fail because Defendants could have made the PerFix Plug safer, the risks of the

PerFix Plug are not reasonable, and the PerFix Plug was not accompanied by proper warnings.

(Id. at PageID #4831.)

“Even if comment k accurately reflects Maine common law,” evidence of a safer

alternative defeats a claim that a product is unavoidably unsafe under comment k. Violette v. Smith

& Nephew Dyonics, Inc., 62 F.3d 8, n.3 (1st Cir. 1995). As the Court addresses below in Section

III.B.2.b, there is a genuine issue of material fact as to whether Plaintiff has presented evidence of

a safer alternative. Further, the language of comment k itself states that it only applies if a product

is “properly prepared and marketed, and proper warning is given.” Restatement (Second) of Torts

§ 402A (1965). As the Court addresses below in Section III.C, there is a genuine issue of material

fact as to whether the PerFix Plug was accompanied by adequate warnings. Therefore, the Court

declines to apply comment k in this case.

2. Burden to Establish Design Defect

a. Risk-Utility Test

In design defect claims, whether under a theory of negligence or strict liability, Maine law

requires a plaintiff to prove that “the product was defectively designed thereby exposing the user

to an unreasonable risk of harm.” Stanley v. Schiavi Mobile Homes, Inc., 462 A.2d 1144, 1148

(Me. 1983) (internal citations omitted). Such proof involves “an examination of the utility of its

design, the risk of the design and the feasibility of safer alternatives.” Id. Defendants claim that

Plaintiff cannot meet his burden to prove that the PerFix Plug’s risks outweighed its utility.

Defendants note that the PerFix Plug was developed in collaboration with surgeons to address a

need for a plug-shaped device so that surgeons would not have to “hand-shap[e] plug devices using

[flat] Bard Marlex Mesh.” (ECF No. 89 at PageID #582.) Defendants point to Dr. Tan’s testimony

that she used the PerFix Plug as her “standard first-line product,” and “[t]he only time [she] used

others was when there was a specific issue that required it.” (Id.; ECF No. 89-17 at PageID #1045.)

Dr. Tan testified that she used the PerFix Plug in at least 90 percent of the estimated 275 inguinal

hernia repairs she has done using mesh. (Id. at PageID #1058–59.)

Defendants argue that Plaintiff’s medical expert Dr. David Grischkan opines that certain

problems are caused by the PerFix Plug, but “offers no opinion that the PerFix Plug performs

worse than other plug and patch devices on the market,” and that his opinions amount to a criticism

of polypropylene mesh generally. (ECF No. 89 at PageID #583.) Defendants assert that these

problems, such as chronic inflammation and chronic pain, are “well-known risks of hernia repair

with mesh, regardless of the mesh product or design.” (Id.) Therefore, “Plaintiff has no competent

expert evidence supporting any increased risk for the PerFix Plug compared to other synthetic

hernia mesh devices indicated for an inguinal hernia like Plaintiff had in 2015.” (Id. at PageID

#584.) According to Defendants, although another surgeon such as Dr. Grischkan may have

chosen a different technique or device to repair Plaintiff’s hernia, “that is not the same thing as

proof that the design of the PerFix Plug increased its risks such that they exceeded the device’s

benefits.” (Id.)

In response, Plaintiff agrees that part of the theory of his case relies on the argument that

polypropylene is unsafe generally and is not biocompatible. (ECF No. 124 at PageID #4832–33;

4836–37.) Additionally, Plaintiff alleges that the PerFix Plug is unsafe because it is prone to

migration, it tends to contract after implantation, it involves a high incidence of chronic pain, and

re-operating or explanting the PerFix Plug is difficult and risky. (Id. at PageID #4833–35.)

Defendants’ criticisms of Dr. Grischkan’s opinions as condemnations of polypropylene

mesh generally are not well taken. In MIL Order No. 30, the Court noted that the history and

safety of polypropylene mesh generally is directly relevant to the claims in this MDL and is part

of the case’s “story.” (Case No. 18-cv-1320, ECF No. 303 at PageID #17326.) The same holds

true here. The safety of polypropylene mesh is a central issue in this case, and in this MDL

generally, and Dr. Grischkan’s opinions demonstrate a genuine issue of material fact as to whether

the PerFix Plug’s risks outweighed its utility because of, among other things, its use of

polypropylene mesh.

In addition to Plaintiff’s claims regarding the safety and biocompatibility of polypropylene

generally, Plaintiff presents evidence regarding contraction (ECF No. 97-11 at PageID #2757–58),

mesh pore size (id. at PageID #2758), and chronic pain (id. at PageID #2758–59). Although the

PerFix Plug may have some of these characteristics in common with other mesh devices, that does

not mean that Plaintiff has not shown a genuine issue of material fact exists regarding the risks of

the PerFix Plug. Defendants’ contention that any evidence of the risks of the PerFix Plug must

relate to a design unique to only the PerFix Plug is not well taken. Defendants present no

compelling authority nor argument that Plaintiff must show that the risks of the PerFix Plug

outweigh the risks of all other plug and patch hernia mesh devices on the market.

b. Feasible Alternative Design

Defendants claim that Plaintiff also cannot carry his burden to show that a feasible

alternative design would have prevented his injuries, or that “the alternative design was

1) reasonably available to the manufacturer at the time; and 2) its cost, any impairments on the

design’s utility, and any new dangers posed by the alternative design were outweighed by its

utility.” (ECF No. 89 at PageID #585.) Defendants point to “the widespread consensus among

courts” that in the medical device context, “the existence of an altogether different product or a

different surgical technique does not satisfy the burden to identify a feasible alternative design.”

(Id. at PageID #586.) See Barnes v. Medtronic, PLC, No. 2:17-CV-14194, 2019 WL 1353880

(E.D. Mich. Mar. 26, 2019) (Rejecting the plaintiff’s proposed alternative treatment methods or

alternative types of hernia mesh, instead of an alternative production practice for the defendant’s

product, as insufficient as a matter of law.); Mullins v. Johnson & Johnson, 236 F. Supp. 3d 940

(S.D.W. Va. 2017) (Rejecting evidence of an alternative surgical procedure and an entirely

different product, and finding that the plaintiffs “must provide evidence of an alternative, feasible

design for the product at issue.”) (emphasis in original); Schmidt v. C.R. Bard, Inc., No. 2:11-CV-

00978-PMP, 2013 WL 3802804 (D. Nev. July 22, 2013) (Finding that a non-mesh inguinal hernia

repair was not an alternative design to the mesh device at issue and did not meet the plaintiff’s

burden to support a design defect claim.); Linsley v. C.R. Bard, Inc., No. CIV.A.98-2007, 2000

WL 343358 (E.D. La. Mar. 30, 2000) (Finding that alternative techniques for hernia repair, as

opposed to an alternative design for hernia mesh device, were not sufficient evidence to create an

issue of material fact to support a design defect claim.). Defendants claim that Dr. Grischkan has

not offered any feasible alternative designs for the PerFix Plug, and instead simply opined that Dr.

Tan should have performed a primary tissue repair without a mesh device. (ECF No. 89 at PageID

#586.) A primary repair is an entirely different procedure and therefore, according to Defendants,

it does not qualify as a feasible alternative design. (Id. at PageID #586–87.)

Similarly, Defendants claim that Dr. Grischkan’s other suggestions such as using ePTFE

or biologic devices are not feasible alternative designs, because they are completely different

devices that entail completely different repair procedures. (Id. at PageID #587.) Defendants also

argue that Dr. Julia Babensee’s opinions on possible alternative features of hernia mesh devices in

general “do not include any opinions on how the risks of the PerFix Plug would be reduced with

any design change.” (Id.)

In Plaintiff’s response, he argues that there is no requirement under Maine law to present

evidence of the feasibility of safer alternative designs. However, in so arguing, Plaintiff quotes

language from St. Germain v. Husqvarna Corp. and Stanley v. Schiavi Mobile Homes which states

that “[s]uch proof [of defective design] will involve an examination of the utility of its design, the

risk of the design and the feasibility of safer alternatives.” St. Germain v. Husqvarna Corp., 544

A.2d 1283, 1285 (Me. 1988) (quoting Stanley, 462 A.2d at 1148) (emphasis added). Therefore, in

explicit plain language, proof of design defect under Maine law clearly involves an examination

of the feasibility of safer alternative designs. See also Espeaignnette v. Gene Tierney Co., 43 F.3d

1 (1st Cir. 1994) (quoting Stanley and analyzing the evidence of the possibility and practicality of

the plaintiff’s proposed alternative design); Walker v. Gen. Elec. Co., 968 F.2d 116, 119 (1st Cir.

1992); Canning v. Broan-Nutone, LLC, 480 F. Supp. 2d 392, 404 (D. Me. 2007), as amended (Mar.

27, 2007); Taylor v. Ford Motor Co., No. CIV. 06-69-B-W, 2008 WL 879411, at *12 (D. Me.

Mar. 28, 2008), report and recommendation adopted, No. CV-06-69-B-W, 2008 WL 2224887 (D.

Me. May 27, 2008); Moores v. Sunbeam Prod., Inc., 425 F. Supp. 2d 151, 156 (D. Me. 2006);

Elwell v. Conair, Inc., 145 F. Supp. 2d 79, 91 (D. Me. 2001).

Plaintiff’s expert Dr. Babensee identifies features such as a larger pore size or lighter mesh

weight that could increase the PerFix Plug’s safety. (ECF No. 91-3 at PageID #1310–11.) Dr.

Babensee also identifies specific products, including some of Defendants’ own products, as safer

alternatives. (Id. at PageID #1311–13.) Defendants claim that the different devices or designs

suggested by Dr. Babensee and Dr. Grischkan involve different procedures than those required for

polypropylene devices. (ECF No. 144 at PageID #5926.) However, an alternative design would,

by its nature, be different from the PerFix Plug. If the procedure and device were exactly the same,

it would not be an alternative design. Defendants also claim that proposing the use of alternative

materials does not constitute a proper alternative design for the PerFix Plug. However, as the

Court discussed previously in Section III.B.2.a, a central theory of Plaintiff’s case is the danger of

heavyweight, small-pore polypropylene mesh. Therefore, the fact that some of Plaintiff’s

proposed alternatives feature different materials does not defeat his claim. Additionally, whether

the products, materials, or designs at issue were feasible or available is a question of fact for the

jury. Plaintiff has made a sufficient showing regarding safer alternative designs to survive

summary judgment on this element of his design defect claim. Similarly, whether Plaintiff’s

proposed alternative designs would have prevented his injuries is a question for the jury. However,

the Court does find persuasive Defendants’ arguments and the caselaw holding that the availability

of entirely different non-mesh procedures does not support Plaintiff’s design defect claim as an

alternative design. See Mullins, 236 F. Supp. 3d at 944; Barnes, 2019 WL 1353880 at *2; Schmidt,

2013 WL 3802804 at *2; Linsley, 2000 WL 343358 at *3.

3. Causation

Next, Defendants argue that Plaintiff’s design defect claim fails because the design of the

PerFix Plug did not cause Plaintiff’s injuries. Under Maine law, “to prevent a summary judgment,

[a] plaintiff [is] required to present evidence . . . that the defect caused the harm.” Guiggey v.

Bombardier, 615 A.2d 1169, 1172 (Me. 1992). Defendants argue that Plaintiff’s claim fails unless

Dr. Grischkan identifies a specific design defect in the PerFix Plug that allegedly caused Plaintiff’s

injuries. Defendants further argue that “Plaintiff cannot establish proximate cause if the same

injury would have occurred regardless of a change in the product design.” (ECF No. 89 at PageID

#588.) According to Defendants, Dr. Grischkan has not identified any defects specific to the

PerFix Plug, as opposed to three-dimensional mesh products or polypropylene mesh generally.

Defendants also argue that Plaintiff and his experts ignore other plausible explanations for

his post-implant pain. Defendants point to Plaintiff’s medical history, which includes

“longstanding complaints of pain in addition to pain directly related to his preexisting hernia.” (Id.

at PageID #590.) The inguinal hernia brochure that Dr. Tan gave to Plaintiff before his implant

surgery explains that “80% of patients with severe groin pain [after inguinal hernia repair] had

pain before the operation.” (ECF No. 89-18 at PageID #1085.) Additionally, prior to his explant

surgery, the explanting surgeon said that “it [wa]s [his] opinion that [Plaintiff] is suffering from a

nerve entrapment,” and that “everyone has had this suspicion [all] along.” (ECF No. 89-28 at

PageID #1197.) According to Defendants, Plaintiff’s alleged injuries are “simply a risk of any

hernia repair surgery and not the result of some alleged defect in the design of the PerFix Plug.”

(ECF No. 89 at PageID #591.)

Plaintiff responds that Dr. Grischkan’s differential diagnosis is evidence of causation.

(ECF No. 124 at PageID #4842–43.) Plaintiff also again argues that there is no requirement under

Maine law to prove that a safer alternative design would have prevented Plaintiff’s injuries.

As to Defendants’ argument that Dr. Grischkan ignored other potential causes for

Plaintiff’s pain, Plaintiff points to Dr. Grischkan’s differential diagnosis, in which he considered

other potential causes of Plaintiff’s injuries such as hernia recurrence, neuroma/nerve entrapment,

and Plaintiff’s previous spinal issues. (ECF No. 97-11 at PageID #2763–65.) Based on his

“education, training, experience, and review of the medical records and depositions, as well as the

relevant medical literature,” Dr. Grischkan concluded that “[t]he design of the [PerFix Plug]

caused an excessive inflammatory response with massive scarring, chronic inflammation and

severe pain.” (Id. at PageID #2765.) As to Defendants’ argument that Plaintiff “has not identified

a single defect specific to the PerFix Plug that proximately caused Plaintiff’s injuries” (ECF No.

89 at PageID #590), Dr. Grischkan’s report points to the “dense segment of polypropylene that

constitutes the PerFix Plug” as the cause for “anatomical distortion in the right groin as well as the

severe consequential pain suffered by [Plaintiff].” (ECF No. 97-11 at PageID #2764.) Dr.

Grischkan also discusses issues with the weight and pore size of the polypropylene in the PerFix

Plug. The Court addressed Defendants’ contention that any alleged defects must be exclusive to

the PerFix Plug, and not present in other mesh products or polypropylene mesh generally, in

Section III.B.2.a. Defendants certainly may challenge Dr. Grischkan’s causation opinions on

cross-examination, but the fact that Defendants disagree with his conclusions is not grounds for

summary judgment.

Accordingly, Defendants’ motion for summary judgment on Plaintiff’s design defect claim

is GRANTED as it relates to alternative procedures as feasible alternative designs, but is otherwise

DENIED.

C. Failure to Warn Claim

Defendants argue that Plaintiff’s failure to warn claim fails because 1) the learned

intermediary doctrine applies and therefore its duty to warn applied to the implanting physician,

not to Plaintiff directly, 2) the PerFix Plug Instructions for Use (“IFU”) was adequate as a matter

of law, and 3) Plaintiff cannot establish that an inadequate warning proximately caused his injuries.

1. Learned Intermediary Doctrine

Defendants argue that “although Maine has not expressly addressed the applicability of the

learned intermediary doctrine,” this Court should apply the learned intermediary doctrine in this

case. (ECF No. 89 at PageID #592.) Defendants claim that “for more than fifteen years, the First

Circuit has predicted that Maine courts would adopt the doctrine if given the opportunity.” (Id.

(citing Doe v. Solvay Pharms., Inc., 153 F. App’x 1, 3 (1st Cir. 2005); Novak v. Mentor Worldwide

LLC, 287 F. Supp. 3d 85, 95 (D. Me. 2018); Doe v. Solvay Pharms., 350 F. Supp. 2d at 270; Herzog

v. Arthrocare Corp., No. CIV. 02-76-P-C, 2003 WL 1785795, at *8 (D. Me. Mar. 21, 2003)).)

Defendants also point to the fact that a Maine Superior Court adopted the learned intermediary

doctrine in a case involving a prescription drug. (ECF No. 89 at PageID #592 (citing Tardy v. Eli

Lily & Co., No. CV-03-538, 2004 WL 1925536 (Me. Super. Aug. 3, 2004)).)

Plaintiff correctly notes that federal courts should be reluctant to “speculate on any trends

of state law,” especially to “a plaintiff in a diversity case, like this one, who has chosen to litigate

his state law claim in federal court.” Combs v. Int’l Ins. Co., 354 F.3d 568, 577 (6th Cir. 2004).

However, the fact that Maine’s highest court has not had a chance to adopt the learned intermediary

doctrine is not dispositive. In determining whether to apply the learned intermediary doctrine, this

Court may look at “the decisional law of . . . [Maine] trial courts, although a federal court is not

bound by lower court determinations if convinced by other data that the state’s highest court would

determine otherwise. . . . In addition, consideration may be given to . . . decisions from other

jurisdictions or the ‘majority’ rule.” Bailey v. V & O Press Co., 770 F.2d 601, 604 (6th Cir. 1985).

As the court pointed out in Tardy, “Maine has not explicitly adopted the learned intermediary

doctrine. However, the ‘overwhelming majority’ of jurisdictions nationwide” apply the doctrine.

Tardy, 2004 WL 1925536 at *2. The District Court for the District of Maine and the First Circuit

Court of Appeals have also “applied the learned intermediary rule to [] medical device case[s] on

the assumption that Maine would adopt the rule.” Doe v. Solvay Pharms., 350 F. Supp. 2d at 271

(citing Violette, 62 F.3d at 13). This Court finds the reasoning in Tardy and in the numerous

federal trial and appellate court decisions applying Maine law to be persuasive. Therefore, the

Court finds that the learned intermediary doctrine should apply in this case.

2. Adequacy of IFU

Defendants argue that “Plaintiff cannot carry his burden to establish that the PerFix Plug

IFU was inadequate in terms of its presentation of the risk of the alleged injuries at issue in this

case.” (ECF No. 89 at PageID #593.) According to Defendants, the IFU described all relevant

risks in a way that was consistent with Dr. Tan’s understanding, and that Dr. Tan believed the IFU

was reasonable and adequate. (Id.) In her deposition, Dr. Tan stated that from a practitioner’s

point of view, she found the risks listed in the IFU to be satisfactory. (ECF No. 89-17 at PageID

#1071.) Dr. Tan also testified that she was aware of, and warned Plaintiff of, the complications

that he allegedly experienced. (Id.) Defendants acknowledge that Dr. Grischkan criticized the

“lack of definitions in terms of the potential serious complications” in the PerFix Plug IFU. (ECF

No. 89 at PageID #594; ECF No. 89-20 at PageID #1094.) However, Defendants point to Dr.

Grischkan’s later testimony in which he was asked if he knew what the standard was for which

descriptors were included and answered that he “wouldn’t know what the standards are.” (ECF

No. 89 at PageID #594; ECF No. 89-20 at PageID #1095.) According to Defendants, Dr.

Grischkan’s general criticisms do not outweigh the fact that Plaintiff’s implanting physician found

the warnings in the IFU to be adequate. (ECF No. 89 at PageID #594.) Therefore, Defendants

argue, there can be no dispute of material fact that the warnings for the PerFix Plug were adequate.

Plaintiff argues that the PerFix Plug’s IFU is inadequate because it fails to warn about

certain risks associated with its use, such as chronic inflammation and chronic pain. (ECF No.

124 at PageID #4847.) Plaintiff points to reports received by Defendants regarding chronic pain

(Case No. 18-md-2846, ECF No. 337-2 at PageID #3868–70) and the fact that Defendants

considered adding “pain” to the list of adverse reactions associated with the PerFix Plug but did

not do so (Id. at PageID #3873). Plaintiff also presents evidence that degradation of polypropylene

in the body can cause excessive scarring and fibrosis which can lead to pain (ECF No. 97-15 at

PageID #2969), and evidence that the PerFix Plug is susceptible to contracture (ECF No. 97-11 at

PageID #2757–58), which was not warned about in the IFU. Plaintiff contends that this evidence

shows that the PerFix Plug’s IFU was inadequate. The Court agrees that Plaintiff has demonstrated

that there is a genuine issue of material fact as to whether the PerFix Plug’s IFU was inadequate.

3. Causation

Next, Defendants argue that Plaintiff cannot meet his burden to prove that any inadequate

warnings caused his injuries. Defendants claim that “if the treating physician is aware of the risks

[a] plaintiff claims to have suffered—regardless of the source of this knowledge—then any failure

to warn in the product labeling cannot be the proximate cause of [a] plaintiff’s injury as a matter

of law.” (ECF No. 89 at PageID #595.) As previously noted, Dr. Tan testified that she was aware

of the risks of hernia repair with the PerFix Plug, including the risk of the specific injuries Plaintiff

claims to have suffered. (See ECF No. 89-17 at PageID #1064–65, 1068, 1071, 1073.) Defendants

also note that the IFU was not Dr. Tan’s only source of information about the PerFix Plug.

Defendants emphasize Dr. Tan’s “decades of experience with the PerFix Plug [and] the inguinal

hernia repair pamphlet from the American College of Surgeons that Dr. Tan gave Plaintiff” that

discussed the risks and rates of complications following a hernia repair using mesh. (ECF No. 89

at PageID #597.) According to Defendants, “the record is clear that Dr. Tan knew every relevant

risk, negating any chance of Plaintiff carrying his burden on proximate cause for alleged failure to

warn.” (Id.) Defendants further argue that just because Dr. Tan testified that she would have

“considered additional hypothetical information if it were somehow available to her, she did not

testify that she would have changed her course of treatment in response.” (ECF No. 89 at PageID

#598 (emphasis in original).)

Plaintiff shows a genuine issue of material fact as to whether the PerFix Plug had inadequate

warnings that proximately caused Plaintiff’s injuries. During her deposition, Dr. Tan testified that

she would have expected the device’s IFU to include warnings of any increased risk specific to the

PerFix Plug of chronic pain, mesh contraction, and increased fibrotic reaction. (ECF No. 124-1 at

PageID #4895–96.) Dr. Tan also testified that any such warnings would have factored into her

decision to use the PerFix Plug for Plaintiff’s surgery, and she would have discussed those risks

with Plaintiff before his surgery. (Id. at PageID #4896.) Defendants claim that because Dr. Tan

knew that inguinal hernia surgeries carry a risk of chronic pain, any failure to mention chronic pain

in the PerFix Plug’s IFU could not be the proximate cause of Plaintiff’s injuries. But according to

Plaintiff, the risks created by certain properties of the PerFix Plug carry a risk of chronic pain

above and beyond other types of inguinal hernia repair devices. Dr. Tan testified that if she had

known about any increased risk, it would have affected her decisions regarding Plaintiff’s course

of treatment. There is a genuine issue of material fact as to whether any deficient warnings were

the cause of Plaintiff’s injuries.

Accordingly, Defendants’ motion for summary judgment as to Plaintiff’s failure to warn

claim is DENIED.

D. Negligence Claim

To succeed on a claim of negligence, a plaintiff must prove that the defendant owed the

plaintiff a duty of care, that the defendant breached that duty, and that the breach was the actual

and legal cause of the injury suffered by the plaintiff. Adams v. Buffalo Forge Co., 443 A.2d 932,

938 (Me. 1982). Under Maine law, actions “predicated upon negligence in the manufacture or

design of a product” are not distinguished from other types of negligence actions. Id. Defendants

claim that Plaintiff’s negligence claim relies on the same evidence as his strict liability claims and

must fail for the same reasons, reasons which the Court has already addressed. Defendants also

reiterate their argument that any alleged defects must be specific to the PerFix Plug, which the

Court has also addressed above. Additionally, Defendants argue that “Plaintiff cannot establish

the key additional element of a negligence claim that any defect in the PerFix Plug’s design,

manufacture, or warnings was a result of [Defendants’] negligence.” (ECF No. 89 at PageID

#599.)

As to Defendants’ argument that Plaintiff cannot show that any defect was a result of

Defendants’ negligence, Plaintiff has presented expert opinions that polypropylene is unsafe for

use in the human body, and that the risks of polypropylene, and therefore of the PerFix Plug’s

design, have been “known by the medical research community and discussed in the scientific

literature for years before [Plaintiff] was implanted with the PerFix Plug.” (ECF No. 124 at PageID

#4853; see Case No. 18-cv-1320, ECF No. 71-1.) According to Plaintiff, “[t]his evidence shows

intention, recklessness and, at bare minimum, negligence, and creates a genuine dispute of material

fact for trial on [Plaintiff’s] negligence claim.” (ECF No. 124 at PageID #4854.) The Court agrees

that Plaintiff has shown that a genuine issue of material fact exists as to his negligence claim.

Accordingly, Defendants’ motion for summary judgment as to Plaintiff’s negligence claim is

DENIED.

E. Negligence Per Se Claim

Defendants argue that Plaintiff’s negligence per se claim must fail because Maine does not

recognize an independent cause of action for negligence per se. (ECF No. 89 at PageID #600.)

Plaintiff responds that he does not intend to pursue a standalone negligence per se claim and

Defendants’ arguments on that point are moot. (ECF No. 124 at PageID #4854.) Therefore,

Defendants’ Motion for Summary Judgment as to Plaintiff’s negligence per se claim is DENIED

AS MOOT.

F. Gross Negligence Claim

Defendants argue that Maine does not recognize an independent cause of action for gross

negligence. (ECF No. 89 at PageID #600.) Additionally, Defendants contend, even if a claim for

gross negligence did exist under Maine law, because Plaintiff’s argument sounds in failure to warn,

a gross negligence claim would fail for the same reasons. (Id.) Plaintiff disputes Defendants’

interpretation of Maine law, and points to Goucher v. Dineen and Leadbetter v. Family Fun

Management, Inc. In Goucher, the Supreme Judicial Court of Maine denied an appeal from a

verdict in favor of the plaintiff where the “[p]laintiff’s complaint included claims of abuse of

process and gross negligence.” Goucher v. Dineen, 471 A.2d 688, 688 (Me. 1984). In Leadbetter,

the court denied a motion for summary judgment as to the plaintiff’s claims for recklessness,

negligence, and gross negligence. Leadbetter v. Family Fun Management, Inc., No. CV-17-173,

2018 WL 1881962 (Me.Super. Feb. 06, 2018).

“In Maine ‘gross negligence’ has no specific legal meaning in civil proceedings.”

Flewelling-Rafford v. Com. Union-York Ins. Co., No. CIV.A. CV-00-67, 2001 WL 1715955, at *1

(Me. Super. June 5, 2001) (citing Beaulieu v. Beaulieu, 265 A.2d 610, 611-12 (Me.1970)). Maine

law does not recognize differing degrees of negligence, and “[t]he concept of ‘gross negligence’

is ‘a synonym for willful and wanton injury’ and has been described as ‘the equivalent of wanton

or reckless misconduct.’” Leadbetter, 2018 WL 1881962 at *7 (citing Bouchard v. Dirigo Fire

Ins. Co., 114 Me. 361, 365, 96 A. 244, 246 (1916); Blanchard v. Bass, 153 Me 354, 361, 139 A.2d

359, 363 (1958)).

Plaintiff’s arguments as to the existence of a gross negligence claim are not persuasive. In

Goucher, the court mentioned the plaintiff’s claim of gross negligence a single time. The opinion

contains no analysis of a gross negligence claim, but does reject the defendant’s challenge to an

award of punitive damages. Goucher, 471 A.2d at 689. At the time Goucher was decided, an

award of punitive damages under Maine law was determined by weighing aggravating and

mitigating factors, including whether the defendant’s conduct was “intentional, wanton, malicious,

reckless, or grossly negligent.” Hanover Ins. Co. v. Hayward, 464 A.2d 156, 158 (Me. 1983)

(internal citations omitted). This leads the Court to believe that the “gross negligence” mentioned

in Goucher was a factor in the award of punitive damages rather than a standalone claim. In

Leadbetter, the court likewise offered no analysis of gross negligence as a claim in its own right.

As Defendants point out, the court recharacterized the plaintiff’s claim for gross negligence as “the

equivalent of wanton or reckless misconduct” and allowed the claim to proceed. Leadbetter, 2018

WL 1881962 at *7. Accordingly, Defendants’ motion for summary judgment as to Plaintiff’s

gross negligence claim is GRANTED.

G. Negligent Misrepresentation, Fraud, Fraudulent Misrepresentation, and

Fraudulent Concealment Claims

Defendants argue that 1) Plaintiff’s fraud and misrepresentation claims collapse into his

failure to warn claims, 2) Plaintiff’s claim for fraud and fraudulent misrepresentation

independently fail, 3) Plaintiff’s fraudulent concealment claim fails, and 4) Plaintiff’s negligent

misrepresentation claim fails. The Court will address each argument in turn.

1. Fraud and Misrepresentation Claims as “Repackaged” Failure to Warn

Claims

Defendants claim that Plaintiff’s claims related to fraud and misrepresentation are simply a

“repackaging” of his failure to warn claims. Defendants made this argument and relied on the

same caselaw in Milanesi (see Case No. 18-cv-1320, ECF No. 57 at PageID #411–12), and the

Court rejected Defendants’ argument (Case No. 18-cv-1320, ECF No. 167 at PageID #13631–32).

The Court adopts the same reasoning here. The cases cited by Defendants “do[] not stand for the

proposition that all fraud-based claims are ‘repackaged’ failure-to-warn claims if they address the

same conduct; the operative issue is whether Plaintiff[ is] attempting to do an end-run around the

learned intermediary doctrine by focusing on Defendants’ statements to [Plaintiff], not [Dr. Tan].”

(Id. at PageID #13632.)

2. Fraud and Fraudulent Misrepresentation Claims

Defendants next argue that even if Plaintiff’s fraud claims do not collapse into his failure to

warn claims, Plaintiff cannot establish the elements of a fraud claim. (ECF No. 89 at PageID

#602.) According to Maine law:

To sustain a fraud claim, a party must show: (1) that the other party made a false

representation (2) of a material fact (3) with knowledge of its falsity or in reckless

disregard of whether it is true or false (4) for the purpose of inducing him to act in

reliance upon it, and (5) he justifiably relied upon the representation as true and

acted upon it to his damage.

Guiggey, 615 A.2d at 1173. According to Defendants, Plaintiff has not identified any false

representations made by Defendants and has in fact admitted that he did not communicate with

Defendants whatsoever, nor rely on any alleged misrepresentations. (ECF No. 89 at PageID #602.)

Additionally, Defendants claim that Plaintiff has not identified any misrepresentation that

Defendants made to Dr. Tan, that she relied on any misrepresentation in deciding how to treat

Plaintiff, or how Plaintiff was injured by any such misrepresentation and reliance. (Id.)

Defendants also argue that Plaintiff cannot bring suit based on an alleged misrepresentation to Dr.

Tan. (Id. at PageID #603.) In support of this argument, Defendants cite to Herzog v. Arthrocare

Corp. which reasoned that surgical tools are not marketed to the general public, but “manufacturers

and sellers of surgical products make their representations directly to surgeons and other medical

personnel. Thus, the standard patient would not be able to show that he or she had received false

statements of fact, let alone that he or she had relied on such statements when deciding to undergo

a surgical procedure.” Herzog, 2003 WL 1785795 at *9. Further, the court disagreed with “the

[plaintiffs’] suggestion that a misrepresentation to a surgeon about a surgical tool would support a

misrepresentation claim by the patient.” Id. at *10.

Plaintiff responds that Defendants’ arguments are mistaken, and that Defendants made a

false representation in the IFU when they failed to disclose the risks discussed in Section III.C.2

of this opinion. (ECF No. 124 at PageID #4856.) Plaintiff argues that “[t]he presence in the

scientific literature of the PerFix Plug’s risks, the knowledge of those risks by the medical research

community, and Defendants’ refusal, despite this information, to change the design or marketing

of the PerFix Plug create a genuine dispute of material fact as to whether Defendants knew or

recklessly disregarded the falsity of their representation in the IFU.” (Id.) As to Defendants’

argument that Plaintiff cannot bring a suit based on an alleged misrepresentation to Dr. Tan,

Plaintiff points to In re Neurontin to show that “a consumer injured by a fraudulent

misrepresentation to his doctor has a claim based on third party reliance.” In re Neurontin Mktg.,

Sales Pracs. & Prod. Liab. Litig., 618 F. Supp. 2d 96, 110 (D. Mass. 2009). Plaintiff claims that

Defendants’ reliance on Herzog is misplaced because that case involved unique claims based on a

surgical tool not marketed to the general public. (ECF No. 124 at PageID #4858.) Plaintiff instead

likens this case to the scenario discussed in footnote 14 of that opinion, where the court discusses

a hypothetical in which “the plaintiff was the actual ‘user’ of the product, but not the one to whom

a misrepresentation was made,” such as “the wife of the purchaser of an automobile who is

permitted by him to drive it.” Herzog, 2003 WL 1785795 at *10, n.14 (internal citation omitted).

As opposed to Herzog, Plaintiff contends that this case does not involve a unique surgical tool

meant for use by a surgeon “but, instead, a medical device implanted by a surgeon but meant for

use by a patient, such as [Plaintiff].” (ECF No. 124 at PageID #4858.)

Defendants challenge Plaintiff’s reliance on In re Neurontin, a case from the District of

Massachusetts that was decided based on Massachusetts law. According to Defendants, Herzog

is dispositive and clearly establishes that Plaintiff cannot bring a misrepresentation claim on Dr.

Tan’s behalf, nor was he the ultimate “user” of the PerFix Plug. (ECF No. 144 at PageID #5940.)

In Herzog, the court noted that surgical tools are not marketed to the general public, and

“manufacturers and sellers of surgical products make their representations directly to surgeons and

other medical personnel.” Herzog, 2003 WL 1785795 at *9. Similar to the situation in Herzog,

the PerFix Plug is a medical device not marketed to the general public. The conclusion in In re

Neurontin was based on Massachusetts law, and this case is based on Maine law. The Court does

not agree with Plaintiff’s attempt to distinguish Herzog by claiming that he was the ultimate user

of the PerFix Plug. The Court finds that this case is analogous to Herzog and agrees that a

misrepresentation to Dr. Tan about the PerFix Plug does not support a misrepresentation claim by

Plaintiff. Accordingly, Defendants’ motion for summary judgment as to Plaintiff’s fraud and

fraudulent misrepresentation claim is GRANTED.

3. Fraudulent Concealment Claim

Next, Defendants argue that Plaintiff’s fraudulent concealment claim must fail. Under

Maine law:

[T]o prevail on a claim for fraudulent concealment, a plaintiff must prove, by clear

and convincing evidence, (1) a failure to disclose, (2) a material fact, (3) when a

legal or equitable duty to disclose exists, (4) with the intention of inducing another

to act or refrain from acting in reliance on the non-disclosure, and (5) the plaintiff

in fact relied upon the non-disclosure to the plaintiff’s detriment.

Picher v. Roman Cath. Bishop of Portland, 2013 ME 99, ¶ 3, 82 A.3d 101, 102–03 (internal

citations omitted). According to Defendants, Plaintiff’s claim for fraudulent concealment must

fail because there is no special relationship between the parties, Plaintiff has not identified any

intentional material omission by Defendants, Plaintiff has never communicated with Defendants,

and Plaintiff cannot bring a fraudulent concealment claim on Dr. Tan’s behalf. (ECF No. 89 at

PageID #603–04.)

According to Plaintiff, Defendants owe a duty to users of their products and because

Plaintiff was implanted with the PerFix Plug, Defendants owed him a duty. (ECF No. 124 at

PageID #4859 (citing Canning v. Broan-Nutone, LLC, No. CIV 05-15-B-W, 2007 WL 1112355,

at *17 (D. Me. Mar. 30, 2007)).) Additionally, Plaintiff points to scientific literature and evidence

that the medical research community knew of the PerFix Plug’s risks to show that Defendants

“knew, or should have known, about the risks of the PerFix Plug and that their failure to adequately

warn about those risks would harm patients such as [Plaintiff].” (Id. at PageID #4859–4860.)

Plaintiff points to that same evidence in arguing that there is a genuine issue of material fact as to

whether Defendants acted intentionally in failing to disclose the risks of the PerFix Plug in its IFU.

(Id. at PageID #4860.) Plaintiff again relies on In re Neurontin to support his argument that he

can bring a claim based on third party reliance where Dr. Tan “relied on the PerFix Plug’s

incomplete and inadequate IFU.” (Id.)

According to Defendants Plaintiff’s reliance on Canning v. Broan-Nutone to support his

claim that Defendants owe a duty to “those who use their products” is misplaced, because Canning

was a case about negligence and that plaintiff did not bring a fraud claim. (ECF No. 144 at PageID

#5942.) Defendants claim that the standard for when they owe a duty is much more stringent for

a fraud claim than it is for a negligence claim. (Id.) Defendants also raise the same arguments

against Plaintiff’s third party reliance claim as discussed above. (Id.) The Court agrees with

Defendants that the same principles regarding third party reliance as discussed in Section III.G.2

of this opinion also apply to Plaintiff’s fraudulent concealment claim. Accordingly, Defendants’

motion for summary judgment as to Plaintiff’s fraudulent concealment claim is GRANTED.

4. Negligent Misrepresentation Claim

Under Maine law, negligent misrepresentation has been defined as follows:

One who, in the course of his business, profession or employment, or in any other

transaction in which he has a pecuniary interest, supplies false information for the

guidance of others in their business transactions, is subject to liability for pecuniary

loss caused to them by their justifiable reliance upon the information, if he fails to

exercise reasonable care or competence in obtaining or communicating the

information.

Chapman v. Rideout, 568 A.2d 829, 830 (Me. 1990) (emphasis omitted) (quoting Restatement

(Second) of Torts § 552(1) (1977)). According to Defendants, because Plaintiff was not involved

in any business transaction with Defendants, has not communicated with Defendants, and has not

identified any misrepresentation or false information provided by Defendants, his claim for

negligent misrepresentation must fail. (ECF No. 89 at PageID #604–05.)

Plaintiff responds that he is not asserting a claim for negligent misrepresentation for

pecuniary loss as described in § 522 of the Restatement. Instead, Plaintiff is asserting a negligent

misrepresentation claim for physical harm as described in § 311. (ECF No. 124 at PageID #4861.)

According to § 311:

(1) One who negligently gives false information to another is subject to liability for

physical harm caused by action taken by the other in reasonable reliance upon such

information, where such harm results

(a) to the other, or

(b) to such third persons as the actor should expect to be put in peril by the

action taken.

(2) Such negligence may consist of failure to exercise reasonable care

(a) in ascertaining the accuracy of the information, or

(b) in the manner in which it is communicated.

Restatement (Second) of Torts § 311 (1965). In response to Defendants’ arguments that Plaintiff

has not identified any misrepresentations made by Defendants, Plaintiff points to the allegedly

false information in the PerFix Plug IFU. (ECF No. 124 at PageID #4862.)

Defendants dispute that a cause of action for negligent misrepresentation arising under

§ 311 exists in Maine. (ECF No. 144 at PageID #5943.) In Dow v. Maier, a Maine trial court

stated that § 311 was “potentially applicable” in a medical malpractice case and noted that

comment b to § 311 specifically references the physician-patient relationship. Dow v. Maier, No.

CIV.A. CV-93-276, 2000 WL 33675683, at *3 (Me. Super. Mar. 15, 2000). Comment b states

that:

The rule stated in this Section finds particular application where it is a part of the

actor’s business or profession to give information upon which the safety of the

recipient or a third person depends. Thus it is as much a part of the professional

duty of a physician to give correct information as to the character of the disease

from which his patient is suffering, where such knowledge is necessary to the safety

of the patient or others, as it is to make a correct diagnosis or to prescribe the

appropriate medicine. The rule is not, however, limited to information given in a

business or professional capacity, or to those engaged in a business or profession.

It extends to any person who, in the course of an activity which is in furtherance of

his own interests, undertakes to give information to another, and knows or should

realize that the safety of the person of others may depend upon the accuracy of the

information.

Restatement (Second) of Torts § 311 cmt. b (1965). However, since Dow, it appears that no other

courts applying Maine law have relied on § 311. Defendants argue that even if this Court were to

find that § 311 applies here, Plaintiff never communicated with Defendants, and has not shown

that Defendants communicated any false information to Dr. Tan, but instead only criticizes the

lack of information in the IFU. (ECF No. 144 at PageID #5943–44.) Instead, Plaintiff simply

criticizes the lack of information in the IFU. (Id.) Defendants also claim that Plaintiff has not

proven that Dr. Tan relied on any false information and that Plaintiff was injured as a result. (Id.

at PageID #5944.) Therefore, Defendants contend that a claim for negligent misrepresentation

under § 311 still fails.

The Court declines to apply § 311 in this case. The only case Plaintiff cites to in support

of his argument that § 311 applies, Dow v. Maier, is a 23-year-old trial court decision which stated

that § 311 was “potentially applicable” in a medical malpractice case, not a products liability case.

See also Engren v. Johnson & Johnson, Inc., No. CV 21-10333-RGS, 2021 WL 4255296, at *5,

n.9 (D. Mass. Sept. 17, 2021) (polypropylene mesh products liability case in which federal court

declined to apply § 311 when it had not been adopted by the Massachusetts state courts). As for

§ 522, Plaintiff was not involved in a business transaction with Defendants, nor did he ever

communicate directly with Defendants. And for the same reasons stated in Section III.G.2, an

alleged misrepresentation to Dr. Tan does not support a claim for negligent misrepresentation by

Plaintiff. Accordingly, Defendants’ motion for summary judgment as to Plaintiff’s negligent

misrepresentation claim is GRANTED.

H. Breach of Express Warranty Claim

Similar to their arguments regarding Plaintiff’s misrepresentation claims, Defendants claim

that the breach of express warranty claim must fail because Plaintiff has admitted that he never

communicated with Defendants. (ECF No. 89 at PageID #605.) According to Maine law, express

warranties are created by:

(a) Any affirmation of fact or promise made by the seller to the buyer which relates

to the goods and becomes part of the basis of the bargain creates an express

warranty that the goods shall conform to the affirmation or promise.

(b) Any description of the goods which is made part of the basis of the bargain

creates an express warranty that the goods shall conform to the description. In the

case of consumer goods sold by a merchant with respect to such goods, the

description affirms that the goods are fit for the ordinary purposes for which such

goods are used.

(c) Any sample or model which is made part of the basis of the bargain creates an

express warranty that the goods shall conform to the sample or model.

11 M.R.S. § 2-313. Defendants claim that Plaintiff has not communicated with Defendants, nor

did any affirmation or promise become the basis of any bargain between Plaintiff and Defendants.

(ECF No. 89 at PageID #606.) Defendants claim that Plaintiff also has not identified any such

communications from Defendants to Dr. Tan. (Id.) Therefore, according to Defendants, “Plaintiff

has not established even one element of his burden, and summary judgment is appropriate.” (Id.)

Defendants argue that there can be no express warranty because Plaintiff and Defendants

never communicated directly. (ECF No. 89 at PageID #606.) However, as Plaintiff points out,

there is not always a need for privity between the parties to prove an express warranty. (ECF No.

124 at PageID #4863.) Even if a plaintiff does not purchase a product directly from a

manufacturer, there may still be liability when the plaintiff is “a person who [the manufacturer]

might reasonably have expected to use, or be affected by,” the product. Sullivan v. Young Bros.

& Co., 91 F.3d 242, 250 (1st Cir. 1996). “The need for a plaintiff to show reliance has been

obviated in certain cases, such as that in which a surgeon relies upon a manufacturer’s express

warranties in choosing a medical device for implantation into a plaintiff.” Unicomp, Inc. v.

Elementis Pigments, Inc., No. CIV97-55-P-H, 1999 WL 1995400, at *23 (D. Me. Feb. 10, 1999).

As for Defendants’ argument that Plaintiff has shown no affirmation or promise that

became the basis of a bargain between Defendants and Dr. Tan, Plaintiff points to the IFU for the

PerFix Plug as “a description of the goods” which “creates an express warranty that the goods shall

conform to the description” consistent with § 2-313(b). (ECF No. 124 at PageID #4863.) In

McLaughlin v. Denharco, Inc., a sales brochure for a product constituted an express warranty and

the basis for a bargain because the plaintiff viewed and considered promotional materials before

deciding to purchase the product over other products. McLaughlin v. Denharco, Inc., 129 F. Supp.

2d 32, 39 (D. Me. 2001). Dr. Tan testified that she expected the information contained in the

PerFix Plug’s IFU to be both accurate and up to date, and that she relied on manufacturers such as

Defendants to provide her with accurate information about the risks of their devices. (ECF No.

124-1 at PageID #4883–84.) Dr. Tan also testified that the risks of a product weigh into her

decision to use that product. (Id. at PageID #4890, 4892, 4893, 4895.) Therefore, Plaintiff has

presented enough evidence to show that a genuine dispute of material fact exists as to whether the

IFU created a basis for a bargain. Accordingly, Defendants’ motion for summary judgment as to

Plaintiff’s claim for breach of express warranty is DENIED.

I. Breach of Implied Warranty Claim

According to Defendants, because Plaintiff “cannot prove a defect specific to the PerFix

Plug that caused his injuries,” he cannot show a breach of implied warranty. (ECF No. 89 at

PageID #606–07.) Maine law recognizes two types of implied warranty: the implied warranty of

merchantability, and the implied warranty of fitness. Plaintiff is only bringing a claim for breach

of implied warranty of merchantability. (ECF No. 124 at PageID #4864.) The implied warranty

of merchantability is defined as follows:

(1) Unless excluded or modified by section 2-316, a warranty that the goods shall

be merchantable is implied in a contract for their sale if the seller is a merchant with

respect to goods of that kind. Under this section the serving for value of food or

drink to be consumed either on the premises or elsewhere is a sale.

(2) Goods to be merchantable must at least be such as

(a) Pass without objection in the trade under the contract description; and

(b) In the case of fungible goods, are of fair average quality within the

description; and

(c) Are fit for the ordinary purposes for which such goods are used; and

(d) Run, within the variations permitted by the agreement, of even kind,

quality and quantity within each unit and among all units involved; and

(e) Are adequately contained, packaged and labeled as the agreement may

require; and

(f) Conform to the promises or affirmations of fact made on the container

or label if any.

(3) Unless excluded or modified by section 2-316, other implied warranties may

arise from course of dealing or usage of trade.

11 M.R.S. § 2-314. To show a breach of the implied warrant of merchantability, a plaintiff must

show that a product “because of defects either did not work properly or w[as] unexpectedly

harmful.” Lorfano v. Dura Stone Steps, Inc., 569 A.2d 195, 197 (Me. 1990) (internal quotation

omitted). Defendants argue that because Maine law requires a product to be defective for a

plaintiff to succeed on a breach of implied warranty claim, and Plaintiff cannot show that the

PerFix Plug was defective, his claim for breach of implied warranty fails. (ECF No. 89 at PageID

#606.) However, as the Court discussed in Section III.B, there is a genuine issue of material fact

as to Plaintiff’s defect claim. Accordingly, Defendants’ motion for summary judgment as to

Plaintiff’s breach of implied warranty claim is DENIED.

J. Intentional Infliction of Emotional Distress and Negligent Infliction of Emotional

Distress Claims

Defendants seek summary judgment on Plaintiff’s claims for intentional infliction of

emotional distress and negligent infliction of emotional distress. (ECF No. 89 at PageID #607–

10.) Plaintiff responds that he does not intend to pursue these claims at trial and Defendants’

arguments are moot. (ECF No. 124 at PageID #4865.) Therefore, Defendants’ Motion for

Summary Judgment as to Plaintiff’s intentional infliction of emotional distress and negligent

infliction of emotional distress claims is DENIED AS MOOT.

K. Damages

1. Punitive Damages

Defendants argue that they are entitled to summary judgment on certain of Plaintiff’s

claims for damages. First, Defendants claim that Plaintiff cannot establish that Defendants acted

with malice, and therefore cannot recover punitive damages. (ECF No. 89 at PageID #610.)

Plaintiff responds that “[w]hen viewed in the light most favorable to Mr. Stinson, the evidence

shows that Defendants knew the significant and potentially deadly risks of the PerFix Plug years

before Mr. Stinson’s implant surgery but disregarded and downplayed those risks and refused to

warn surgeons or patients about them.” (ECF No. 124 at PageID #4865.) According to Plaintiff,

there was enough scientific evidence that heavyweight, small pore polypropylene mesh was

causing many complications by the early 2000s. (Id. at PageID #4866.) Plaintiff also points to

several specific actions or inactions on Defendants’ part: (1) Defendants’ failure to conduct animal

studies involving the PerFix Plug or Marlex Dart; (2) Defendants’ failure to conduct

post-marketing clinical observational studies regarding the PerFix Plug before Plaintiff’s implant;

(3) Defendants’ failure to change the design of the PerFix Plug; (4) Defendants’ failure to include

warnings about the risks of migration, chronic pain, and excessive contracture in the IFU; and (5)

Defendants’ actively minimizing the risk of chronic pain in the PerFix Plug marketing literature.

(Id. at PageID #4868–70.)

Mere negligence cannot support an award of punitive damages. Tuttle v. Raymond, 494

A.2d 1353, 1360 (Me. 1985) (internal citations omitted). To recover punitive damages, a plaintiff

must show by clear and convincing evidence that the defendant acted with malice. Waxler v.

Waxler, 1997 ME 190, ¶ 15, 699 A.2d 1161, 1165. To prove malice, the plaintiff must show that

“the defendant’s conduct was motivated by actual ill will or was so outrageous that malice is

implied.” Id. (quoting Fitzgerald v. Gamester, 658 A.2d 1065, 1070 (Me.1995)). As described at

length above, viewing the facts in the light most favorable to Plaintiff, Plaintiff has shown that a

genuine issue of material fact exists as to whether the PerFix Plug contained defects and

Defendants knew about those defects prior to Plaintiff’s implant surgery. Plaintiff has presented

evidence that by the early 2000s the medical research community was aware that heavyweight,

small pore polypropylene mesh caused inflammation and scarring, which resulted in chronic pain

and other serious complications. (ECF No. 97-11 at PageID #2760.) Plaintiff has also presented

evidence that Defendants received reports of an increased risk of chronic pain and considered

adding additional warnings to the product but declined to do so. (Case No. 18-md-2846, ECF No.

337-2 at PageID #3868–70; 3873.) Plaintiff has alleged that “Defendants not only sold a defective

product, but that Defendants knew the product would cause injuries to users of the product, yet

continued to market the product as safe for its intended purpose.” Miller v. Zimmer Biomet Inc.,

No. 2:17-CV-00265-JDL, 2017 WL 5914695, at *7 (D. Me. Nov. 30, 2017), report and

recommendation adopted, No. 2:17-CV-265-JDL, 2017 WL 6540030 (D. Me. Dec. 20, 2017).

Therefore, there is a genuine issue of material fact as to whether Defendants’ conduct “was

motivated by actual ill will or was so outrageous that malice is implied.” Waxler, 1997 ME 190,

¶ 15. Accordingly, Defendants’ motion for summary judgment as to Plaintiff’s claim for punitive

damages is DENIED.

2. Causation

Defendants next argue that “Plaintiff’s damages should likewise be limited to the claimed

injuries he supports with causation testimony.” (ECF No. 89 at PageID #612.) However, due to

ongoing developments regarding Plaintiff’s health, the parties have asked that the Court defer

ruling on this issue. Accordingly, the Court RESERVES JUDGMENT as to this part of

Defendants’ motion.

L. Claims Regarding Plaintiff’s Current Bard Mesh

In their Motion, Defendants argue that they are entitled to summary judgment on any

claims regarding Plaintiff’s current Bard Marlex Mesh. (ECF No. 89 at PageID #613–14.)

However, due to ongoing developments regarding Plaintiff’s health, the parties have asked that the

Court defer ruling on this issue. Accordingly, the Court RESERVES JUDGMENT as to this part

of Defendants’ motion.

IV. Objections

Defendants also raise objections to seven exhibits cited in Plaintiff’s response brief under

Federal Rule of Civil Procedure 56(c)(2). (ECF No. 144-2.) The Court did not rely on any of

these exhibits in its summary judgment opinion. Thus, there is no need at this time to resolve

Defendants’ objections that “the material cited to support or dispute a fact cannot be presented in

a form that would be admissible in evidence.” Fed. R. Civ. P. 56(c)(2).

V. Conclusion

For the reasons set forth above, Defendants’ motion for summary judgment (ECF No. 89)

is GRANTED IN PART, DENIED IN PART, DENIED AS MOOT IN PART, and

RESERVED IN PART.

IT IS SO ORDERED.

3/14/2023 s/Edmund A. Sargus, Jr.

DATE EDMUND A. SARGUS, JR.

UNITED STATES DISTRICT JUDGE