1 

IN THE UNITED STATES DISTRICT COURT FOR THE

NORTHERN DISTRICT OF ILLINOIS

EASTERN DIVISION

VERONICA MADSEN 

AND JAMES MADSEN

Plaintiffs, Case No. 20-CV-02345

v. 

C.R. BARD, INC. Judge John Robert Blakey

 

Defendant.

MEMORANDUM OPINION AND ORDER

In this product liability action, Plaintiff Veronica Madsen claims that she 

suffered injuries from Defendant C.R. Bard’s Align transobturator mesh product 

implanted in her during a February 2016 surgery to treat urinary stress incontinence 

and other conditions. She sues Defendant C.R. Bard for negligence (Count I); strict 

liability design defect, manufacturing defect and failure to warn (Counts II–IV); 

breach of express and implied warranty (Counts V, VI); and punitive damages (Count 

VIII). Her husband, Plaintiff James Madsen, also sues for loss of consortium (Count 

VII). Before the Court is Defendant C.R. Bard’s motion for summary judgment [151] 

and motions to exclude the opinion and testimony of general causation experts Alan 

Garely [82] and Anthony Brennan [84], and specific causation expert Michael 

Margolis [86]. For the reasons explained below, the Court grants in part, and denies 

in part, the motions [82], [84], [86], and [151]. 

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I. Background

A. Procedural History

This case originated from one of the many pelvic mesh multidistrict litigations

in Southern District of West Virginia (MDL 2187) each involving thousands of cases. 

The Court begins with a summary of this case’s procedural history in MDL 2187 

because it proves relevant to some of Defendant’s motions. 

Given the number of cases in each pelvic mesh MDL, the MDL Court separated

the cases into multiple waves based upon the product at issue, the defendants sued, 

each case’s timeline, and other considerations. The MDL Court initially placed this 

case in Wave 4 of the Bard MDL (MDL 2187) and then, after the parties’ unsuccessful 

settlement attempts, moved it to Wave 9 of the MDL 2187 in February 4, 2019. [50] 

(Pretrial Order 299). For Wave 9 (as with other waves), the MDL Court set a schedule 

for expert disclosures, Daubert motions, and dispositive motions. Id. Before the 

Wave 9 Daubert and dispositive motions deadline arrived, however, the MDL Court 

moved this case to Wave 13 of the Ethicon MDL.1 [63]. The MDL Court then 

transferred this case to this Court before the MDL Court decided any pending 

Daubert or dispositive motions for this case.

B. Medical History

Ms. Madsen began experiencing urinary stress incontinence in 2000 after she 

gave birth to her first child. [161-5] at 76:1–10. To treat her condition, a surgeon 

1 Ethicon is another manufacturer of mesh products that has been sued in the MDL. Although 

Plaintiffs’ suit here involves a Bard-manufactured product, the MDL Court placed Plaintiffs’ case on 

an Ethicon MDL wave for scheduling reasons. [63].

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performed a Burch colosuspension and cystoscopy surgery (“Burch procedure”) on

April 18, 2005. [161] ¶ 6. The Burch procedure improved her symptoms for about 

three months but then failed, suddenly and painfully. Id. ¶¶ 7–8. 

From then on, Ms. Madsen’s urinary stress incontinence progressively 

worsened, and on December 10, 2015 a gynecologist, Dr. Radha Krishna Upputuri, 

diagnosed her with abnormal uterine bleeding, uterine polyps, anemia, first degree 

cystocele, first degree uterine prolapse, urethral hypermobility, mild bladder 

prolapse, and stress urinary incontinence. [161] ¶ 11. Dr. Upputuri offered her

multiple treatment options including continued self-management, physical therapy, 

routine collagen injections, a pessary device, or implanting a mid-urethral mesh sling. 

Id. ¶ 12. As to the mid-urethral mesh sling, Dr. Upputuri discussed with her various 

risks and showed her videos of the procedure. Id. ¶¶40–43. Based upon 

conversations with Dr. Upputuri and her own research, Ms. Madsen elected to get a 

mid-urethral mesh sling. Id. ¶¶ 13, 44. 

Dr. Upputuri performed the implant surgery on February 4, 2016 using a mesh 

product developed, manufactured, and sold by Defendant C.R. Bard called the Bard 

Align TO system (hereinafter “Align product”). Id. ¶ 48. During the surgery, Dr. 

Upputuri also performed an operative hysteroscopy, a novasure uterine ablation, and 

a cystoscopy. Id. Ms. Madsen claims that after her February 2016 surgery, she began 

to experience a myriad of issues including leg pain, pain with intercourse, tightness 

in the pelvic floor, sciatic nerve pain, nerve pain in the inner thigh, pain when 

inserting a tampon, leg weakness, stomach issues, abdominal deformity and 

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numbness, and pelvic floor pain. Id. ¶ 55. She also continued to experience stress 

urinary incontinence that another doctor, Dr. Kimberly Kenton, attempted to treat 

further by implanting an autologous facial sling (i.e., a sling made of human tissue)

on August 22, 2016. Id. ¶ 59. Dr. Kenton did not remove any of the Align product;

nor did she see signs that it had eroded or become exposed. Id. ¶ 60. 

Despite this additional procedure, Ms. Madsen’s pain continued, and, on 

December 2, 2016, she filed this lawsuit against Defendant C.R. Bard claiming that 

the Align product caused her pain and symptoms. Id. ¶ 53. On August 20, 2019, 

while her lawsuit remained pending before the MDL Court, Ms. Madsen underwent 

surgery by a gynecologist, Dr. Dionysios Veronikis, who removed the Align product

to try to relieve her pain. [161] ¶ 63; [153-18] at 54:19–56:2. She also sought 

treatment from another doctor, Dr. Fitzgerald, for pelvic floor myofascial pain. [169] 

¶ 16.

C. Pelvic Mesh Implant Product History

In October 20, 2008, the Federal Drug Administration (“FDA”) issued a Public 

Health Notification regarding possible serious complications associated with 

transvaginal placement of surgical mesh to repair pelvic organ prolapse and treat 

stress urinary incontinence. [161] ¶ 14. Among other things, the notification 

reported complications such as “erosion through vaginal epithelium, infection, pain, 

urinary problems, and recurrence of prolapse and/or incontinence.” Id. ¶ 15. It also 

noted: “In some cases, vaginal scarring and mesh erosion led to a significant decrease 

in patient quality of life due to discomfort and pain, including dyspareunia.” Id. 

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Finally, it recommended that physicians inform patients of “the potential for serious 

complications and their effect on quality of life, including pain during sexual 

intercourse and scarring.” Id. ¶ 16. 

Next, on July 13, 2011, the FDA issued an updated notification that focused on 

the reported complications from use of pelvic mesh products for prolapsed organ 

repair surgery. Id. ¶¶ 17–18. On March 27, 2013, the FDA also updated its 

Urogynecologic Surgical Mesh Implant website section with additional information 

about the risks associated with using surgical mesh to treat stress urinary 

incontinence. Id. ¶ 21. Then, on April 29, 2014, the FDA issued two proposed orders 

regarding urogynecologic surgical mesh procedures. Id. ¶ 22. 

These Proposed Orders stated, in part, that there exist other risks even 

without mesh exposure or extrusion including “vaginal scarring, shrinkage, and 

tightening (possibly caused by mesh/tissue contraction); pelvic pain; infection 

(including pelvic abscess); de novo dyspareunia; de novo voiding dysfunction (e.g. 

incontinence); recurrent prolapse; and neuromuscular problems (including groin pain 

and leg pain).” Id. ¶ 23. Overall, the FDA identified the following risks: “Damage to 

blood vessels, nerves, connective tissue, and other structures. This may be caused by 

improperly designed and/or misused surgical mesh instrumentation. Clinical 

sequalae include pelvic pain and neuromuscular problems; adverse tissue reaction. 

This may be caused by non-biocompatible materials.” Id. ¶ 24. 

On January 5, 2016, the FDA finalized its 2014 Proposed Orders and 

reclassified surgical mesh for transvaginal repair from a Class II to a Class III 

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medical device because the “general controls and special controls together are not 

sufficient to provide reasonable assurance of safety and effectiveness for this device, 

and these devices present a potential unreasonable risk of illness or injury.” [153-12] 

at 3; see also [161] ¶ 25.

As of Ms. Madsen’s February 2016 surgery with Dr. Upputuri, Defendant 

included an Instruction for Use (“IFU”) with its Align product that warned of certain 

complications, including: “Postoperative hematoma, seroma, abscess or fistula 

formation, or scarring which may occur following the implant procedure; Irritation at 

the operative wound site which may elicit a foreign body response that leads to wound 

dehiscence, inflammation and/or infection; Inflammation, sensitization, pain, 

dyspareunia, scarification, contraction, device migration and failure of the procedure

resulting in recurrence of incontinence.” [161] ¶ 28. 

Dr. Upputuri testified that he was aware of some of these risks at the time of 

Ms. Madsen’s surgery and the IFU’s warning remained consistent with his 

understanding of possible complications associated with implanting the Align 

product. Id. ¶¶ 31–39. Ms. Madsen also agrees that, prior to her surgery, Dr. 

Upputuri discussed with her various risks with the procedure, id. ¶¶ 40–42, and she 

signed a consent form confirming that she understood the reason for, and risks 

associated with, the procedure and her other treatment options. Id. ¶ 46. According 

to Plaintiffs, however, Dr. Upputuri did not warn Ms. Madsen of certain significant 

risks, including chronic pelvic pain, chronic pain with sexual intercourse, chronic 

vaginal infection, chronic urinary tract infections, chronic groin pain, chronic thigh 

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pain, chronic leg pain, chronic nerve pain, chronic foreign body reaction, degradation, 

and shrinkage. [169] ¶ 21. Plaintiffs also claims that, even if Bard’s IFU warned of 

some of these risks, Bard did not warn about—and therefore, Dr. Upputuri was not 

aware of—the rate and duration of risks associated with the Align product. Id. ¶ 23.

Also, as relevant to Plaintiffs’ claims and the parties’ arguments, the Align 

product is made from a polypropylene monofilament supplied by Phillips Sumika. 

[169] ¶ 40. Phillips Sumikia issued an information sheet listing the following 

suggested uses for this grade of polypropylene: woven industrial fabric and bags, rope 

and cordage, woven carpet backing, and geotextile fabrics. Id. In turn, Phillips 

Sumika’s polypropylene monofilament is made from a raw polypropylene product 

called Marlex HGX-030-01. Since 2004, the Material Safety Data Sheet (“MSDS”) for 

Marlex HGX-030-01 included the following warnings: (1) “Incompatibility with Other 

Materials: May react with oxygen and strong oxidizing agents, such as chlorates, 

nitrates, peroxides, etc.” and (2) “Do not use this material in medical applications 

involving permanent implantation in the human body or permanent contact with 

internal body fluids or tissues.” Id. ¶¶ 38–39. According to Plaintiffs, Defendant 

knew about the information sheet and MSDS. Id. ¶ 39.

II. Defendant’s Motions to Exclude Plaintiffs’ Experts

While this case was part of the MDL 2187, Plaintiffs designated Drs. Garely 

and Brennan as general causation experts and Dr. Michael Margolis as a specific 

causation expert. General causation examines whether the product at issue “had the 

capacity to cause the harm alleged,” while specific causation considers whether the 

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product “did, in fact, cause the harm alleged.” C.W. ex rel Wood v. Textron, Inc., 807 

F.3d 827, 831 (7th Cir. 2015) (emphasis in original) (internal citations omitted). Now 

Defendant Bard seeks to exclude certain testimony and opinions of all three experts 

pursuant to Federal Rule of Evidence 702 and Daubert v. Merrell Dow 

Pharmaceuticals, Inc., 509 U.S. 593–94 (1993). [82], [84], [86].

A. Legal Standard

Rule 702 permits expert testimony if the expert has the requisite “knowledge, 

skill, experience, training, or education” to support the opinion offered and (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. 

For the reliability prong, courts consider multiple factors, including whether 

the methodology has been tested, subject to peer review, and generally accepted in 

the relevant community. See Smith v. Ford Motor Co., 215 F.3d 713, 719 (7th Cir. 

2000) (citing Daubert, 509 U.S. at 593–94). Even if an expert is qualified to offer 

opinions on a subject, the “expert’s ultimate opinion must be grounded in the 

scientific process and may not be merely a subjective belief or unsupported 

conjecture.” Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009). In 

evaluating the relevance prong, a court must ensure that the proposed expert 

testimony “logically advances a material aspect of the proposing party’s case.” 

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Daubert, 43 F.3d at 1315. The party seeking to admit the expert testimony bears the 

burden of establishing admissibility under Rule 702. See Lewis, 561 F.3d at 705.

B. Motion to Exclude Opinions and Testimony of Dr. Anthony 

Brennan, Ph.D. [85] 

Dr. Brennan, Ph.D is a biomedical engineer and Professor of Material Science 

and Engineering at the University of Florida. Here, Plaintiffs did not produce an 

expert report for Dr. Brennan specific to this case, but instead adopted his October 9, 

2014 expert report produced for the MDL 2187 Wave 1 and 2 cases, [84-1]. The 2014 

Report states that Dr. Brennan has expert knowledge in numerous chemical fields 

and on “the design, manufacture, testing, clinical evaluation and distribution of 

medical devices for both short-term and long-term implantation.” [84-1] at 4. He also 

has evaluated “numerous explants to determine behavior in the human body.” Id. In

summary, Dr. Brennan opines that, from “a biomechanical viewpoint, the Bard mesh 

products and female pelvic tissue are not compatible.” [84-1] at 4.

In the Wave 1 and 2 cases, the MDL Court already excluded some of Dr. 

Brennan’s opinions based on Bard’s motion. See Wise, et al. v. C.R. Bard, 12-cv-1378, 

2015 WL 521202, at *9 (S.D. W. Va. Feb. 7, 2015). But the MDL Court also rejected 

many of Bard’s arguments. Id. Overall, the MDL Court ruled in Wise that Dr. 

Brennan could: (1) opine on the effect of polypropylene mesh on the human body and 

the effects it may have including inflammation and degradation; (2) rely on thirdparty testing performed by Polymer Solutions; (3) offer opinions that reference and 

rely on biocompatibility testing and the Marlex HGX-030-01 MSDS; and (4) opine 

about mesh pore size and the effect of physical stress on mesh. Id. at *9–11. It held, 

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however, that Dr. Brennan could not opine on how mesh performs inside the female 

pelvis to the extent he relies on tensile testing because “tensile testing is not intended 

to represent how mesh performs inside the female pelvis.” Id. at *11.

Now, Defendant Bard asks this Court to adopt the MDL Court’s decision to 

exclude Dr. Brennan’s opinions on tensile testing, [85] at 5–6, but it also asks the 

Court to reconsider the MDL Court’s decision as to every topic about which it held 

Dr. Brennan could opine, id. at 7–22. Namely, it asks the Court to bar Dr. Brennan

from: (1) opining on the effects that Bard’s Align product has on the human body 

because he has no expertise in urogynecology, id. at 11–13; (2) opining on 

inflammation responses, id. at 13–14; (3) opining on polypropylene, and its 

degradation and characteristics, id. at 14–16; (4) offering any opinion that relies on 

tests conducted by third-party Polymer Solutions, id. at 17–20, or on the Marlex 

HGX-030-01 MSDS and biocompatibility testing, id. at 22–23; and (5) offering an 

opinion on the mesh’s pore size or the effect of tension on mesh, id. at 21–22. 

After reviewing the MDL Court’s Wise opinion and Defendant Bard’s 

arguments, the Court finds no basis to revisit the MDL Court’s ruling. As a 

preliminary point, Plaintiffs insist that Defendant Bard violated the MDL Court’s 

scheduling order for Wave 9 by filing this motion rather than just relying on the MDL 

Court’s prior decision. [90] at 1–2. That is not quite right. Rather, as discussed 

above, this case moved through different waves of the MDL without the MDL Court 

deciding any Daubert or dispositive motions for this case, specifically. Further, 

although the MDL Court already issued the Wise opinion as to Dr. Brennan’s 2014 

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Report, that opinion only expressly applied to certain cases. See Wise, 2015 WL 

521202, at *9. Thus, Defendant did not violate an order in the MDL by filing a new 

motion to exclude Dr. Brennan in this Court. 

Nonetheless, even if the MDL Court’s decision in Wise does not control in this 

case, Defendant offers no compelling reason why this Court should not adopt the MDL 

Court’s Wise decision on Dr. Brennan. To the contrary, the Wise decision relates to 

the same 2014 expert report and the parties did not re-depose Dr. Brennan for this 

case, so the deposition testimony from Dr. Brennan that the MDL Court considered 

remains unchanged. Further, Dr. Brennan offers only general causation opinions, 

and Defendant points to nothing specific to this case that renders those general 

causation opinions irrelevant or inapplicable. Defendant’s new motion also does not 

point to any new case law that calls into question the MDL Court’s reasoning. Nor 

does the new motion explain how the MDL Court got it wrong or point to any 

argument that the MDL failed to consider—instead, it merely asks this Court to 

reconsider anew the same arguments. One of the main purposes of an MDL is to 

streamline and resolve issues common to numerous cases. It would frustrate that 

purpose if a court, in a case remanded out of the MDL, reconsidered, without cause, 

decisions that the MDL Court already made on common issues. 

Accordingly, this Court grants Defendant’s motion [84] to the extent that it 

asks the Court to adopt the MDL Court’s Wise decision, but otherwise denies it.2 

2 Defendant also argues here, [85] at 7, as it did with the MDL Court, that Dr. Brennan “conceded at 

his depositions” that he would not offer opinions on: (1) whether mesh degradation caused a plaintiff’s 

specific injuries or a plaintiff’s mesh had, in fact, degraded; (2) pathology of a plaintiff’s explanted 

mesh; (3) how mesh was implanted in a specific patient; (4) mesh he did not evaluate; (5) the design, 

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C. Motion to Exclude Opinions of Alan Garely

Dr. Alan Garely is a Clinical Professor of Obstetrics, Gynecology, and 

Reproductive Medicine at the Icahn School of Medicine at Mount Sinai in New York 

and board-certified in obstetrics, gynecology, female pelvic medicine, and 

reconstructive surgery. [82-4]. As with Dr. Brennan, Plaintiffs did not submit a new 

report for Dr. Garely in this case but rather adopted his May 12, 2017 expert report 

produced for the MDL 2187 Wave 3 and 4 cases, [82-4]. In his 2017 Report, Dr. Garely

opines about device-related complications for patients implanted with Defendant’s 

Align products and further opines that: (1) the Align product is defectively designed; 

(2) Defendant failed to adequately warn about known problems with the Align 

product; (3) clinical trials would have shown risks from the Align product; and (4) 

there exist alternative safer designs for the Align product. Id.

As with Dr. Brennan, the MDL Court excluded some of Dr. Garely’s opinions 

based upon a motion that Defendant filed in the Wave 3 and 4 cases. In re C.R. Bard, 

Inc. Pelvic Repair Sys. Prods. Liability Litig., 2018 WL 4212409 (S.D. W. Va. Sept. 4, 

2018). Namely, the MDL Court ruled that Dr. Garely may only testify about his 

review of internal corporate documents for the purpose of explaining the basis for his 

opinions and may not opine about Defendant’s knowledge, state of mind, or corporate 

conduct. It also ruled that Dr. Garely could not offer legal conclusions about the 

developing, manufacturing, or marketing of pelvic mesh; (6) IFU labeling adequacy on the products he 

examined; (7) FDA regulations on medical devices; (8 ) how to interpret the law; (9) Defendant’s state 

of mind or concern for patient safety; or (10) any medical opinions. Plaintiff does not dispute this. 

Because Dr. Brennan confirmed he will not offer such opinions, the Court denies as moot Defendant’s 

motion to bar Dr. Brennan from offering such opinions. Defendant may raise timely objections at trial 

should Dr. Brennan attempt to testify on these issues.

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adequacy of Defendant’s IFU warnings, such as his opinion that certain omissions 

“rendered the Align TO device not reasonably safe” or the Align product’s design was 

“unreasonably dangerous and defective.” Id. at *3. Finally, the MDL Court held that, 

although Dr. Garely’s medical expertise qualified him to testify about the risks of 

implanting the Align product and whether Defendant’s IFU outlined those risks, he

lacks the expertise and qualifications to opine about whether Defendant’s IFU 

complies with regulatory standards. Id. at *4.

Here, Defendant asks this Court to adopt the MDL Court’s Wave 3 and 4 ruling 

as to Dr. Garely. [83] at 7. In addition, it challenges Dr. Garely’s qualifications to 

opine about the alleged design defects of the Align product. Id. at 18–21. In response, 

Plaintiffs adopt the opposition brief filed by the other plaintiffs in Wave 3 and 4 of 

MDL. [91], [91-1] (attaching their prior-filed response as an exhibit). But, in doing 

so, Plaintiffs also acknowledge the MDL Court’s prior ruling and only state that this 

Court should deny Defendant’s motion to the extent it “has attempted to inject new

arguments at this late stage of these proceedings that it failed or chose not to raise 

previously with respect to” Dr. Garely. Id. at 2. As such, and for the reasons the 

Court discussed above as to Dr. Brennan, this Court adopts the MDL Court’s Wave 4 

and 5 rulings as to Dr. Garely. 

That still leaves Defendant’s argument to exclude Dr. Garely’s design defect 

opinions. As a preliminary point, Plaintiffs argue that this Court should not permit 

Defendant to “inject new arguments” that it failed to raise with the MDL Court. [91] 

at 1–2. But Defendant did raise this argument. See in re Bard Pelvic Support Sys. 

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Prods. Liab. Litig., Case No. 2:10-MD-2187, [4562] at 16–19. And although the MDL 

Court stated it granted Defendant’s motion in full, see 2018 WL 4212409, its opinion 

did not address or discuss this argument. Accordingly, the Court will address it on 

the merits.

According to Defendant, Dr. Garely opines that the Align product design was 

defective based upon: (1) his review of Bard internal documents and communications; 

(2) the fact that the mesh was not medical grade and became brittle and hardened; 

(3) problems patients have experienced after he and other surgeons implanted it; (4) 

problems with the device’s sheath getting stuck in patients’ obturator canal; and (5) 

comparisons to other products. Id. at 18. Defendant argues that Dr. Garely is not a 

biomaterials engineer and his general experience as a urogynecologist does not 

render him qualified to evaluate the adequacy of the mesh used in the Align product. 

Id. at 18–21.

In response, Plaintiffs—adopting the response filed by other plaintiffs in the 

MDL Court—argue that Dr. Garely is qualified to offer opinions on the Align product 

design based upon his extensive experience using pelvic repair devices and treating 

patients who experienced complications from those devices. [91-1] at 20. Plaintiffs

also argue that he has published and presented articles on pelvic repair mesh devices; 

performed one of the first transvaginal mesh sling operations in the United States;

taught other surgeons on how to perform such surgeries; and worked with 

manufacturers in developing pelvic mesh products. Id. In addition, Plaintiffs argue 

that Dr. Garely would not testify about whether the Align product poses greater risks 

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than other products, but instead he will focus on the Align product’s design for 

transobturator implantation compared to retropubic implantation. Id. at 21.

The Court agrees with Plaintiffs that Dr. Garely’s experience performing 

transvaginal mesh operations and treating patients who experienced complications 

after such surgeries qualifies him to opine on the Align product’s design from a 

clinical perspective. But the same cannot be said to the extent Dr. Garely intends to 

opine on the biomechanics or engineering of the mesh or how it may react 

physiologically within a human body. In fact, Dr. Garely agreed in his deposition 

that he did not consider himself “an expert in how polypropylene is absorbed and used 

by the human body” and he is “not a physiological expert in how polypropylene reacts 

in a woman’s body.” [83] at 18 (quoting [82-2] at 271:6–12). 

That being said, the current record fails to provide clear definition as to which 

opinions cross this requisite line on a pretrial basis. Accordingly, Dr. Garely may

opine about the Align product’s design to the extent he can tie his opinions to his

clinical expertise. But the Court grants Defendant’s motion [82] to the extent Dr. 

Garely seeks to opine about the general biomechanics or physiology of how 

polypropylene mesh behaves in the human body. Defendant will need to raise timely 

objections at trial if it believes Dr. Garely offers design opinions that extend beyond 

a clinical perspective.

D. Motion to Exclude Specific Causation Opinions of Dr. Michael 

Margolis

Dr. Margolis is a pelvic surgeon and urogynecologist who is board certified in 

female pelvic medicine and reconstructive surgery. [157-4]. He has observed many 

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transvaginal surgeries involving mesh products, and extensively studied these 

procedures. Id. He also has performed hundreds of procedures to explant (i.e. 

remove) mesh products, including the Align product. Id. He has been offered as both 

a specific and general causation expert in numerous transvaginal mesh cases. 

Here, Plaintiffs designated Dr. Margolis as a specific-causation expert to opine 

on whether Defendant’s Align product caused Ms. Madsen’s alleged injuries. [157-2] 

at 2. Dr. Margolis submitted his first specific causation report in May 2017 before 

Ms. Madsen had her 2019 mesh explant surgery with Dr. Veronikas. [157-3]. In this 

2017 report, Dr. Margolis opines that: (1) Defendant failed to warn Dr. Upputuri

about known problems with the Align product, id. at 15–16; (2) Defendant should 

have known about characteristics of the Align product—including mesh degradation, 

chronic foreign body reaction, fraying and particle loss, mesh roping and curling, loss 

of pore size, shrinkage/contraction, and scar tissue formation—that made it not 

suitable for permanent implantation into the pelvic floor, id. at 18; (3) Ms. Madsen

developed de novo conditions after her Align product implantation, which could only 

have been caused by “the polypropylene Align TO product and its effects, including 

shrinkage/contraction as well as others, on Mrs. Madsen’s surrounding tissues,” id. 

at 18–22; and (4) Dr. Upputuri’s treatment of Ms. Madsen met the standard of care, 

id., at 20. 

Dr. Margolis also submitted a supplemental causation report in 2021 after Dr. 

Veronikas performed the surgery to explant Ms. Madsen’s Align mesh. [157-4]. In

it, he adds that Dr. Veronikis’ findings and the post-explant pathology report for the 

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explanted mesh confirm his initial opinions. Id. at 20–21. Namely, Dr. Margolis 

opines that Dr. Veronikis found urethral scarification, and the pathology report 

shows that the Align product contracted 50–80 percent while implanted in Ms. 

Madsen, and the explanted mesh and surrounding tissue showed “surrounding 

fibrosis, chronic inflammation and foreign body giant cell reaction.” Id. Overall, Dr. 

Margolis concludes that “contraction/shrinkage of the Align TO product was the cause 

of Mrs. Madsen’s de novo” symptoms and, despite Dr. Veronikis’ removal of the mesh, 

some of Ms. Madsen’s symptoms and pain “will likely be permanent.” Id. at 21.

Defendant now moves to exclude Dr. Margolis’ opinions, [86], detailing 

numerous arguments that the Court addresses below.

1. General Causation Opinions

First, Defendant argues that Dr. Margolis impermissibly offers general 

causation opinions when Plaintiffs only designated him as a specific-causation expert. 

[157] at 10–11. Defendant argues that the MDL Court already addressed this issue 

with respect to Dr. Margolis for other cases in Wave 4 and 5 of MDL 2187 (in which 

this case belonged for some time), holding that “because the plaintiffs disclosed Dr. 

Margolis as a specific causation expert only, he may not offer general causation 

testimony.” In re C.R. Bard, Inc., MDL No. 2187, 2018 WL 4215636 (S.D. W. Vir. 

Sept. 4, 2018); see also id. at 6 n.5; [168] at 2–3.

In response, Plaintiffs state that they do not intend to elicit general causation 

opinions from Dr. Margolis. But, they argue, Dr. Margolis relied upon Plaintiffs’ 

general causation experts’ opinions in rendering his specific causation opinions and 

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he should be permitted to testify about his review of and reliance on those general 

causation opinions. [163] at 2–3. 

A specific causation opinion (i.e, whether a product caused plaintiff’s injuries) 

necessarily rests in part on general causation (i.e. whether the product can cause such 

injuries) since something can only cause an injury if it has the capacity, generally, to 

cause such an injury. Thus, to an extent, Plaintiffs’ argument appears reasonable. 

Yet, Dr. Margolis’ expert report does much more than reference Plaintiffs’ general 

causation experts’ opinions to explain the basis for his specific causation opinion. For 

example, he opines: (1) about “common complications associated with polypropylene 

mesh implants,” [157-4] at 16; (2) that, based on Defendant’s internal documents, 

Defendant likely knew that its Align product “could cause” various complications, id. 

at 18–19; and (3) that “C.R. Bard’s Inc.’s Align TO product is not suitable for the 

intended use as an implant for pelvic organ prolapse in patients,” id. at 19. In doing 

so, he discusses general complications with Align mesh implantation that he agrees 

Ms. Madsen did not suffer. Further, he states that, in formulating his specific 

causation opinions, he relied upon Plaintiffs’ general causation experts’ opinions as 

well as “materials listed in my previously disclosed general expert report” in MDL 

2187, Defendant’s internal documents, scientific literature and depositions. Id. at 16. 

Thus, Dr. Margolis’ report ostensibly offers his own broad-sweeping general causation 

opinions beyond those of Plaintiffs’ general causation experts.

Because Plaintiffs did not designate Dr. Margolis as a general causation 

expert, consistent with the MDL Court’s ruling in Wave 4 and 5, he may not offer his 

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own broad general causation opinions. Instead, Plaintiffs must establish general 

causation through their general causation experts. Dr. Margolis may rely on those 

general causation opinions to reach his specific causation opinions, however, and Dr. 

Margolis may reference those opinions to the extent he relied upon them in reaching 

his specific causation opinions. But his testimony must remain focused on specific 

causation. Defendant will need to raise timely objections at trial if it believes that 

Dr. Margolis’ testimony crosses the line.

2. Dr. Margolis’ Specific Causation Opinions

Defendant also attacks the reliability of Dr. Margolis’ specific causation 

opinions, arguing that he failed to conduct a reliable differential diagnosis on 

causation. [157] at 13–19. 

A differential diagnosis is a method whereby a physician “systematically 

compares and contrasts clinical findings from a patient’s medical history to determine 

which of two or more diseases with similar symptoms is the one from which the 

patient is suffering.” Myers v. Ill. Central R. Co., 629 F.3d 639, 644 (7th Cir. 2010). 

A differential diagnosis remains a reliable method under Daubert. See Ervin v. 

Johnson & Johnson, Inc., 492 F.3d 901, 904–05 (7th Cir. 2007). A court should not 

exclude a specific causation conclusion just because an expert failed to rule out every 

possible cause and flaws “typically go to the weight of the testimony, not its

admissibility.” Wheeler v. C.R. Bard, Inc., 19-cv-8273, 2022 WL 971394, at *12 (N.D. 

Ill. Mar. 31, 2022). Nonetheless, if a differential diagnosis wholly “fails to take serious 

account of other potential causes,” then a court may exclude it for lacking reliability. 

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Id. (quoting Sanchez v. Boston Sci. Corp., 12-cv-5762, 2014 WL 4851989, at *3 (S.D. 

W. Va. Sept. 29, 2014)). 

Defendant argues that Dr. Margolis’ initial 2017 Report, issued before Ms. 

Madsen’s explant surgery, “fails to take serious account of other potential causes” of 

Ms. Madsen’s pain, focuses upon a “perceived temporal relationship” between her 

reported symptoms and implantation of the Align mesh, and then merely assumes 

that the mesh caused her symptoms. [157] at 13–14. Defendant also faults Dr. 

Margolis for not personally examining Ms. Madsen or the Align product implanted in 

her. Id. Defendant further insists that Dr. Margolis’ 2021 Supplemental Report 

constitutes an impermissible post hoc attempt to justify an unreliable opinion and, 

regardless, Dr. Margolis lacks qualifications to opine about the pathology report on 

the explanted mesh, id. at 17–19.

As a preliminary point, Defendant’s focus on Dr. Margolis’ 2017 Report is

misplaced since Dr. Margolis supplemented his Report in response to developments 

in Ms. Madsen’s medical history and treatment. The Court must assess whether Dr. 

Margolis’ opinions and testimony, as currently formulated and supported, have 

sufficient reliability for a jury to hear.

Focusing on the Supplemental Report, Dr. Margolis discusses the new 

symptoms that Ms. Madsen experienced after her Align product implant surgery, 

including sudden, sharp vaginal pain when inserting a tampon and during 

intercourse, bilateral groin and pelvic nerve pain, numbness and pain in the medial 

aspect of both thighs, and bilateral obturator internus pain. [157-4] at 20. He further 

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explains why mesh shrinkage, inflammation, and scar tissue buildup causes such 

pain. Id. at 20–21. His written report does not specifically detail all the alternative 

causes that he considered and rejected, but he explained in more detail during his 

deposition the other causes that he ruled out and why. [157-6]. For example, he 

explained why he ruled out her other surgeries, myofascial pelvic floor pain 

syndrome, and prior pelvic floor dysfunction. Id. at 116:3–117:5, 118:20–24, 120:10–

21.

Further, Defendant’s argument about Dr. Margolis’ reliance of the 2019 

pathology report lacks merit. Defendant argues that Dr. Margolis lacks qualifications 

to analyze a pathology report’s findings on the explanted mesh because he is not a 

biomedical/biomechanical engineer or a material scientist. [157] at 18. But Dr. 

Margolis’ opinions about the pathology report focus on the mesh from a clinical 

perspective—i.e., that it was physically smaller than when initially implanted and

showed tissue with “surrounding fibrosis, chronic inflammation and foreign body 

giant cell reaction,” and what symptoms he believes such conditions can cause, based 

on his clinical expertise. [157-4] at 14. Defendant fails to explain why such opinions 

would require engineering expertise. 

Defendant also argues that Dr. Margolis’ opinion that the mesh contracted

lacks reliability because he did not personally view the explanted mesh and does not 

know how it was handled after removal, but instead just read a few lines of the 

pathology report and glanced at a photograph of the mesh included in that report. 

Defendant insists that a jury remains just as capable as Dr. Margolis to read those 

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lines and look at the photograph. [157] at 19. These arguments may make good 

fodder for cross-examination, but they do not establish that Dr. Margolis’ opinion lack 

reliability under FRE 702. Further, even if a jury could read mesh size 

measurements on the report, Dr. Margolis’ opinion is not merely about the size of the 

mesh after explant, but the clinical significance of those measurements from a 

specific causation perspective.

Dr. Margolis’ Supplemental Report and deposition testimony show that he 

engaged in a sufficiently thorough differential diagnosis to pass muster under 

Daubert and FRE 702. 

3. Dr. Margolis’ Standard-of-Care Opinions

Next, Defendant asks the Court to bar Dr. Margolis from opining on whether 

Ms. Madsen’s treating physicians met standards of care because he lacks knowledge 

on the standards of care applicable in Illinois and Missouri (where Ms. Madsen had 

her relevant surgeries). [157] at 16–17. In response, Plaintiffs state that they do not 

intend to elicit standard-of-care opinions from Dr. Margolis but reserve the right to 

do so if Defendant attempts to argue that the implanting or explanting provider 

breached the standard of care. [163] at 12. Further, they argue that Dr. Margolis is 

qualified to offer such opinions because he is a board-certified surgeon licensed in four 

states. Id. at 11. 

Dr. Margolis has not established that his board-certification in four states 

other than Illinois and Missouri renders him qualified to opine on the standard of 

care applicable to physicians in Illinois and Missouri. As Defendant emphasizes and 

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Plaintiffs acknowledge, [157] at 17, [168] at 7, Illinois applies a “similar locality” 

standard of care rule and only permits an out-of-state physician to opine on standard 

of care if he or she establishes: (1) familiarity with the standards of care applicable 

to qualified physician in the same or similar locality of treatment; or (2) that there 

exists an applicable nationally uniform standard. See Jackson v. Graham, 753 

N.E.2d 525, 532–33 (Ill. App. Ct. 2001). Dr. Margolis’ report establishes neither.

Nonetheless, Defendant’s motion remains moot at this stage since Plaintiffs

represent that they do not intend to elicit a standard-of-care opinion from Dr. 

Margolis. 

4. Other Opinions

Fourth, and finally, Defendant asks the Court to bar Dr. Margolis from opining 

on the following topics because, according to Defendant, Dr. Margolis testified at his 

deposition that he would not opine on them: (1) IFU labeling; (2) human factors; (3) 

engineering; (4) material science/biomaterials; (5) chemistry or biomechanics of pelvic 

mesh design; (6) FDA regulations; (7) Defendant’s quality assurance and complaint 

handling; (8) Defendant’s conduct; (9) Ms. Madsen’s medical bills; (10) life care 

planning; (11) Ms. Madsen’s future medical care; and (12) other topics “outside the 

margins” of his report. [157] at 8. 

Plaintiffs do respond to this request or dispute that Dr. Margolis testified he 

would not offer such opinions. [163]. Thus, the Court grants Defendant’s motion as 

agreed as to topics (1)–(11), although Defendant will bear the responsibility to raise 

timely objections during trial if it believes questions to Dr. Margolis call for such 

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testimony. The Court denies, however, Defendant’s motion as to topic (12) since other 

topics “outside the margins” of his report lacks sufficient clarity for a pretrial ruling. 

Instead, Defendant must raise timely objections at trial if it believes that Dr. 

Margolis attempts to opine on topics beyond those properly disclosed in discovery.

In sum, the Court grants in part, and denies in part, Defendant’s motion to 

exclude Dr. Margolis’ opinions and testimony [86]. Dr. Margolis may not offer broad 

general causation opinions but may offer his specific causation opinions that 

Defendant’s Align product caused Ms. Madsen’s alleged injuries. Further, the Court 

denies as moot Defendant’s motion to bar Dr. Margolis’ standard-of-care opinions,

and grants as agreed Defendant’s motion to bar Dr. Margolis from opining about (1) 

IFU labeling; (2) human factors; (3) engineering; (4) material science/biomaterials; 

(5) chemistry or biomechanics of pelvic mesh design; (6) FDA regulations; (7) 

Defendant’s quality assurance and complaint handling; (8) Defendant’s conduct; (9) 

Ms. Madsen’s medical bills; (10) life care planning; and (11) Ms. Madsen’s future 

medical care.

III. Defendant’s Motion for Summary Judgment

A. Legal Standard

Summary judgment is appropriate where the movant shows through 

“materials in the record, including depositions, documents, electronically stored 

information, affidavits or declarations, stipulations . . . admissions, interrogatory 

answers, or other materials” 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. In 

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resolving a motion for summary judgment, the court has “one task and one task only: 

to decide, based on the evidence of record, whether there is any material dispute of 

fact that requires a trial.” Waldridge v. Am. Hoechst Corp., 24 F.3d 918, 920 (7th Cir. 

1994) (citations omitted).

To withstand a motion for summary judgment, the nonmovant 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). The Court must construe the record “in the 

light most favorable to the nonmovant” and avoid the “temptation to decide which 

party’s version of the facts is more likely true.” Payne v. Pauley, 337 F.3d 767, 770 

(7th Cir. 2003). If the evidence is “merely colorable, or is not significantly probative,” 

Anderson, 477 U.S. at 249 (citations omitted), or merely raises “some metaphysical 

doubt as to the material facts,” summary judgment may be granted, Matsushita Elec. 

Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586 (1986).

B. Analysis

First, Defendant asks the Court to grant summary judgment on Plaintiffs’ 

claims for strict liability and negligent manufacturing defect, breach of express or 

implied warranties, and negligent inspecting, marketing, packaging, and selling

because Plaintiffs previously conceded them. [152] at 6. In response, Plaintiffs agree, 

[161] ¶ 56 (response). Thus, the Court grants as agreed Defendant’s motion for 

summary judgment on: (1) negligence (Count I) based on a manufacturing defect, or 

negligent inspecting, marketing, packaging, and selling; (2) strict liability

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manufacturing defect (Count III); (3) breach of express warranty (Count V); and (4) 

breach of implied warranty (Count VI).

That leaves negligent and strict liability design defect (Counts I and II); 

negligent and strict liability failure to warn (Counts I and IV), loss of consortium 

(Count VII), and punitive damages (Count VIII). Defendant argues that these fail as 

well, because Plaintiffs cannot establish that any alleged defect in the Align product 

proximately caused Ms. Madsen’s alleged injuries. Defendant also argues that the

failure to warn claims fail as a matter of law because the implanting surgeon, Dr. 

Upputuri, knew of the potential risks of which Plaintiffs complain. Finally, Defendant 

argues that Plaintiffs cannot satisfy the heightened culpability standard required 

under Illinois law for punitive damages. 

1. Causation

Under Illinois law, which the parties agree applies,3 a plaintiff bringing a 

product liability claim under either a negligence or strict liability theory must prove 

that the defendant’s product proximately caused the alleged harm. See Clark v. River 

Metals Recycling, LLC, 929 F.3d 434, 439 (7th Cir. 2019) (strict liability); Malen v. 

MTD Prod., Inc., 628 F.3d 296, 307 (7th Cir. 2010) (negligence). Further, when the 

action involves “specialized knowledge or expertise outside the layman’s knowledge,” 

3 In actions filed directly into MDLs, courts apply the choice-of-law rule of the “originating jurisdiction.” 

Dobbs v. Depuy Orthopedics, Inc., 842 F.3d 1045, 1048–49 (7th Cir. 2016). Here, the parties agree that 

the “originating jurisdiction” is Illinois because Ms. Madsen had her Align implant surgery in Illinois. 

[152] at 9; [161] ¶ 49. Illinois’ choice-of-law rule applies the “most significant relationship” test from 

the Restatement (Second) of Conflicts of Torts. See Townsend v. Sears, Roebuck & Co., 879 N.E.2d 

893, 899–902 (Ill. 2007). Under this test, a court applies the laws of the state where the injury occurred 

unless a party can show “a more or greater significant relationship to another state.” Id. at 903. Again, 

the parties agree that, under this test, Illinois law applies. [161] ¶¶ 1, 4, 49. 

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Illinois law requires a plaintiff to present expert testimony to establish causation. 

Baltus v. Weaver Div. of Kidd & Co., 557 N.E.2d 580, 586 (Ill. App. Ct. 1990).

At times, parties dispute whether the product at issue is sufficiently complex 

or specialized to require expert testimony on causation. See Clark, 929 F.3d at 440 

(discussing when a product may be “so simple that no expert is needed to tell people 

how to use them”). This case presents no such issue, however, since a polypropylene 

mesh product used for a transvaginal mesh procedure indisputably falls “outside the 

layman’s knowledge.” Baltus, 557 N.E.2d at 586. Instead, the parties dispute 

whether Dr. Margolis’ expert opinions on specific causation suffice to create a 

disputed issue of fact to overcome summary judgment.

Defendant asserts two arguments in support of its position. First, it points to 

its motion to exclude Dr. Margolis’ specific causation opinions. [152] at 11–12. The 

Court, however, already addressed and rejected those arguments above. Second, 

Defendant argues that, even if the Court does not exclude Dr. Margolis’ specific 

causation opinions, Plaintiffs still fail to create a triable issue of fact on proximate 

causation. Id. at 12. According to Defendant, Dr. Margolis only offers broad 

generalized opinions that the Align product caused Ms. Madsen’s pain and symptoms

and fails to “link” her “pain and symptoms to the alleged defects” in the Align product. 

Id. at 13. 

In so arguing, Defendant relies on Johnson & Johnson & Ethicon, Inc. v. 

Batiste, another transvaginal mesh case in which Dr. Margolis testified as a specific 

causation expert. See 05-14-00864-CV, 2015 WL 6751063 (Tex. App. Nov. 5, 2015). 

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In Batiste, a Texas appellate court reversed a jury verdict against the 

defendant-manufacturer, finding that the plaintiff “failed to offer legally sufficient 

evidence that any alleged defect” in the transvaginal mesh product “was the 

producing cause of her injuries.” Id. at *1. It emphasized that, although the plaintiff

offered evidence of general causation—namely that the mesh product could rope, curl, 

fray, or degrade causing erosions, infections, obstructions, contractions, damage to 

adjacent organs, inflammation, scarring, pain, and loss of function—Dr. Margolis’ 

opinion did not establish that any of those things happened in her case. Id. at *7–10.

Defendant insists that here, just as in Batiste, Dr. Margolis only opines that 

the Align mesh can curl, fray, rope or break down, but does not opine that it did in 

Mrs. Madsen’s case. Id. Further, even though Defendant concedes (as it must) that

Dr. Margolis opined that the mesh contracted while implanted in Ms. Madsen, it 

argues that this does not suffice because Dr. Margolis does not establish “that fibrotic 

bridging”—i.e., excessive scarring—caused any of Mrs. Madsen’s pelvic pain or other 

symptoms.” Id. at 13.

Based upon the record, this Court disagrees. As a preliminary point, the 

Batiste decision came after the benefit of a trial in which the defendant presented its 

own competing witnesses and evidence. Further, the Texas appellate court’s decision 

turned on the specifics of that plaintiff’s procedure, and her pre-existing conditions 

and post-procedure symptoms. Thus, even if Dr. Margolis’ specific causation opinions 

in that case failed to establish proximate cause or overcome the competing evidence 

that the defendant offered at trial, that does not mean that his specific causation 

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opinions in this case fail to create a disputed issue of fact to survive summary 

judgment. 

In addition, contrary to Defendant’s insistence and as discussed above, Dr. 

Margolis opines that the mesh explanted from Ms. Madsen in 2019 not only showed 

shrinkage/contraction, but also showed evidence of tissue inflammation and excessive 

scarring. He also opined that Ms. Madsen’s symptoms pointed to mesh contraction 

and excessive scarring and discussed why he excluded other potential causes. While 

Defendant’s critiques of Dr. Margolis remain valid points for cross examination, Dr. 

Margolis’s testimony more than suffices to create a disputed issue of fact on 

proximate causation.

Further distinguishing this case from Batiste, Plaintiffs also provide additional

causation evidence through Ms. Madsen’s explanting surgeon, Dr. Veronikis, and 

pelvic floor specialist, Dr. Fitzgerald. [169] ¶¶ 9–15. The parties dispute the 

substance and legal significance of Dr. Veronikis’ and Dr. Fitzgerald’s deposition 

testimony, see id., but Dr. Veronikis’ deposition transcript confirms that he believes, 

based upon his examination of Ms. Madsen, that her Align implantation procedure

likely caused at least some of her reported symptoms and pain, see [153-18] at 58:11–

66:9. Likewise, Dr. Fitzgerald’s deposition transcript confirms that she believes, 

based on her examination of Ms. Madsen, that Ms. Madsen’s pelvic floor myofascial 

pain and dysfunction was related to the Align implantation procedure.4 See [161-3] 

4 Defendant also argues that Plaintiffs may not rely on Dr. Veronikis or Dr. Fitzgerald to provide 

causation opinions because Plaintiff failed to properly disclose them as causation experts in accordance 

with Fed. R. Civ. P. 26(a)(2)(B). [152] at 14. As Defendant correctly notes, the Seventh Circuit has 

emphasized that treating physicians may only testify about causation to the extent they made those 

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at 40:1–13, 41:14–19, 43:17–22, 57:19–60:1. As Defendant notes, these physicians’ 

treatment opinions may not suffice to establish that the Align product’s design caused 

Mrs. Madsen’s injuries, [152] at 14, but their treatment opinions still provide

evidence that the Align implant procedure, rather than one of Ms. Madsen’s preexisting conditions or other procedures, caused some of her post-implant pain and 

symptoms.

Plaintiffs have offered sufficient evidence on causation through Dr. Margolis 

and her treating physicians to withstand Defendant’s motion for summary judgment 

on this basis.

2. Failure to Warn 

Next, Defendant argues that Plaintiffs’ failure to warn claims fail as a matter 

of law because, according to Defendant, Ms. Madsen’s implanting physician, Dr. 

Upputuri, knew of the potential risks. [152] at 15–18. 

Under the learned intermediary doctrine, medical device manufacturers must 

warn physicians, not patients, about a prescription medical device’s “known 

dangerous propensities.” Hansen v. Baxter Healthcare Corp., 764 N.E.2d 35, 42 (Ill. 

2002). In addition, manufacturers have no obligation to warn of risks “already known 

determinations “in the course of providing treatment.” Meyers v. Nat’l R.R. Pass. Corp., 619 F.3d 729, 

735 (7th Cir. 2010). Here, Defendant does not dispute that Drs. Veronikis and Fitzgerald treated Ms. 

Madsen. [169] ¶¶ 15–16. But it insists that neither determined, as part of their treatment, “that the 

design of the Align caused the injuries” and thus they cannot offer causation opinions. [152] at 14. 

Not so. While neither formed opinions about the Align product’s design, per se, they both testified that, 

in treating Ms. Madsen, they determined that the Align product procedure likely caused at least some 

of her symptoms and pain. They may testify as to those opinions without running afoul of Rule 

26(a)(2)(B). See id. If Defendant believes that they offer causation opinions at trial that they did not 

form while treating Ms. Madsen, then it must raise timely objections. 

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to the medical community.” Id. But the learned intermediary doctrine does not shield 

a manufacturer “if the warnings it gave to physicians are inadequate.” Id. 

Defendant maintains that Dr. Upputuri knew of the risks of using the Align 

product because he reviewed the product’s IFU, and read the FDA’s communications

that, according to Defendant, adequately warned of risks. [152] at 16–17 (citing [153] 

¶¶ 22–39). Plaintiffs disagree and contend that Dr. Upputuri only knew of some of 

the risks, reviewed the IFU, and may have reviewed some of the FDA publications. 

[160] at 7–8. But, they argue, Dr. Upputuri did not know about, and the IFU did not 

disclose, “several significant risks including the risk of chronic pelvic pain, chronic 

pain with sexual intercourse, chronic vaginal infection, chronic urinary tract 

infections, chronic groin pain, chronic thigh pain, chronic leg pain, chronic nerve pain, 

chronic foreign body reaction, degradation, and shrinkage.” [160] at 7–8 (citing [161] 

SAMF ¶ 21). They also argue that the IFU failed to warn of the “the rate and duration 

of risks,” which was as high as 30–50 percent. Id. at 8 (citing [161] SAMF ¶ 122). 

According to Plaintiffs, Dr. Upputuri testified that, if he had known that any risk was 

higher than 3 percent, he may not have used the Align product. Id. (citing [161] 

SAMF ¶ 24). 

As Defendant correctly notes in reply, Illinois law does not require a 

manufacturer “to provide a warning listing every possible risk imaginable associated 

with the product.” [167] at 7. But Illinois does require manufactures to reasonably

warn about any “dangerous condition” and potential injuries. Huskey v. Ethicon, Inc., 

29 F. Supp. 3d 736, 742 (S. D. W. Va. 2014) (citing Happel v. Wal-Mart Stores, Inc., 

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766 N.E.2d 1118, 1123 (Ill. 2002) and Kennedy v. Metronic, Inc., 851 N.E.2d 778, 783 

(Ill. 2006)) (applying Illinois law in another transvaginal mesh case alleging failure 

to warn). In general, the adequacy of warnings remains a fact question that a jury

(not a court) should resolve, “unless the movant demonstrates conclusively that there 

remains no triable issue.” Wheeler, 2022 WL 971394, at *5 (quoting Werckenthein v. 

Bucher Petrochemical Co., 618 N.E.2d 902, 908 (Ill. App. Ct. 1993)) (denying 

summary judgment on a failure to warn claim in another transvaginal mesh case 

against Defendant Bard because there existed disputed issues of fact on the adequacy 

of its warnings).

Here, the record confirms that Defendant has not demonstrated conclusively 

that there remains no triable issue on the adequacy of its warnings. First, while the 

IFU lists some complications with implantation including “scarring which may occur 

following the implant procedure”, “inflammation, sensitization, pain, dyspareunia, 

scarification, contraction, device migration and failure of the procedure resulting in 

recurrence of incontinence,” [161] ¶ 161, it does not list all of the injuries of which 

Ms. Madsen complains, nor does it discuss the rate or severity of possible 

complications. Thus, a disputed issue of fact remains as to whether it adequately 

disclosed the likelihood of a risk or potential severity of the possible complications. 

Further, while Defendant argues that the FDA’s communications provided further 

warnings, [17] at 7, it remains in dispute which FDA publications Dr. Upputuri 

reviewed prior to Ms. Madsen’s surgery and whether the FDA’s publications absolved 

Defendant from having to also warn of such risks. [161] ¶¶ 14–25 (response). 

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Accordingly, the Court denies Defendant’s motion for summary judgment on the 

failure to warn claims. 

3. Punitive Damages

Finally, Defendant seeks summary judgment on Plaintiffs’ claim for punitive 

damages, arguing that Plaintiffs cannot establish that it acted with the heightened 

culpability required under Illinois law. [152] at 19–20. 

Under Illinois law, a plaintiff may seek punitive damages for torts “committed 

with fraud, actual malice, deliberate violence or oppression, or when the defendant 

acts willfully or with such gross negligence as to indicate a wanton disregard for the 

rights of others, or for conduct involving some element of outrage similar to that found 

in crime.” Homewood Fishing Club. v. Archer Daniels Midland Co., 605 N.E.2d 1103, 

1110 (Ill. App. Ct. 1993).

Here, in support of their punitive damages claim, Plaintiffs point to Phillips 

Sumika’s information sheet recommending non-medical uses for the grade of 

polypropylene that Defendant used, such as “Woven industrial fabric and bags, rope 

and cordage, woven carpet backing, and geotextile fabric.” [160] at 11 (citing [161] 

SAMF ¶ 40). Plaintiffs also point to the Marlex HGX-030-01 MSDS for the raw 

polypropylene material that Phillips Sumika used, which warned about degradation

and incompatibility with other materials and cautioned against use “in medical 

applications involving permanent implantation in the human body or permanent 

contact with internal body fluids or tissues.” Id. (citing [161] SAMF ¶ 39). Plaintiffs 

contend that Defendant was aware of the information sheet and MSDS yet 

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disregarded them and even attempted to conceal the source of the raw polypropylene. 

Id. They argue that these facts, if proven at trial, establish “such gross negligence as 

to indicate a wanton disregard of the rights of others.” Id. 

In response, Defendant insists that the MSDS and information sheet “do not 

speak to whether a raw material is appropriate for a particular use in a finished 

product.” [167] at 8. It also argues that the MSDS remains irrelevant because the 

Occupational Safety and Health Administration regulates MSDSs, which shows that 

their “purpose is to assure safe and healthful working conditions for employees in the 

workplace.” Id. It also attacks the validity of the MSDS warning, contending it has 

no scientific basis. Id. In making such arguments, however, Defendant fails to cite 

to anything in the record. Instead, it relies merely upon a Fifth Circuit decision in 

another transvaginal mesh case that upheld a district court’s exclusion of the MSDS 

because the plaintiffs in that case “did not provide any science behind the MSDS.” 

Id. (citing Johnson v. Arkema, Inc., 685 F.3d 452, 462–63 (5th Cir. 2012)).

Initially, even though the Johnson court excluded the MSDS, the first 

bellweather transvaginal mesh case, Cisson v. C.R. Bard, Inc., allowed the plaintiff 

to offer the MSDS “for the limited purpose of showing that the statement was made 

and that Bard was aware of it,” 11-CV-00195, 2013 WL 5700513 (S.D. W. Va. Oct. 18, 

2013), aff’d sub nom. in re C.R. Bard, Inc., MDL No. 2187, Pelvic Repair Sys. Prods. 

Liab. Litig., 810 F.3d 913 (4th Cir. 2016). And the MSDS remains at issue in this 

case. 

Case: 1:20-cv-02345 Document #: 171 Filed: 09/27/22 Page 34 of 35 PageID #:94769
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Additionally, Plaintiffs’ claim for punitive damages does not rely on the truth

of the MSDS, but instead focuses on how Defendant allegedly disregarded it and 

attempted to conceal it. Construing the evidence in the light most favorable to 

Plaintiffs, a reasonable jury could find that, regardless of whether the MSDS 

warnings were true, Defendant disregarded public safety by ignoring the 

polypropylene’s MSDS and attempting to conceal it, rather than evaluating the 

underlying bases of its warnings. This, in turn, could support a viable claim for 

punitive damages. See Wheeler, 2022 WL 971394, at *10 (denying, for similar 

reasons, a summary judgment on a plaintiff’s punitive damages claim against 

Defendant Bard in a transvaginal mesh case).

IV. Conclusion 

For the foregoing reasons, the Court grants in part, and denies in part,

Defendant’s motions to exclude the expert opinions and testimony of Dr. Brennan

[84], Dr. Garely [82], and Dr. Margolis [86], and motion for summary judgment [151]. 

Plaintiffs may proceed to trial on negligence (Count I) based on design defect and 

failure to warn; strict liability design defect (Counts II); strict liability failure to warn 

(Count IV); loss of consortium (Count VII); and punitive damages (Count VIII). 

Dated: September 27, 2022 Entered:

____________________________

John Robert Blakey

United States District Judge

Case: 1:20-cv-02345 Document #: 171 Filed: 09/27/22 Page 35 of 35 PageID #:94770