Baccaro v. Coloplast Corp.

KELLI LYNN COATES BACCARO and BRIAN SCOTT BACCARO, Plaintiffs, v. COLOPLAST CORP. and COLOPLAST MANUFACTURING US, LLC. Defendants.

No. 1:19-CV-1088

United States District Court, N.D. New York

July 22, 2021

STARK STARK LAW FIRM MARTIN PAUL SCHRAMA, ESQ. Attorneys for Plaintiffs

AARON LEVINE & ASSOCIATES AARON MAURICE LEVINE, ESQ. Attorneys for Plaintiffs

KING & SPALDING LLP-ATLANTA AARON PARKS, ESQ. GREGORY RUEHLMANN, ESQ. RADHA SATHE MANTHE, ESQ. ROBERT K. WOO, Jr ESQ. Attorneys for Defendants

KING SPALDING LAW FIRM-NEW YORK EMILY T. CHEN, ESQ. Attorneys for Defendants

KING & SPALDING LLP LISA H. SHUB, ESQ. STEPHEN LLOYD HUFFAKER ESQ. Attorneys for Defendants

MEMORANDUM-DECISION AND ORDER

DAVID N. HURD United States District Judge

I. INTRODUCTION..............................................................................4

II. BACKGROUND...............................................................................5

III. LEGAL STANDARD........................................................................8

A. Preclusion of Expert Testimony........................................................8

B. Summary Judgment.......................................................................9

IV. DISCUSSION...............................................................................10

A. Daubert Preclusion.......................................................................11

1. William Gold, M.D.....................................................................11

2. Bruce Rosenzweig, M.D...............................................................15

3. Neeraj Kohli, M.D......................................................................19

4. Jimmy Mays, Ph.D....................................................................21

5. Peggy Pence, Ph.D.....................................................................26

B. Summary Judgment.....................................................................30

1. Specific Causation......................................................................30

2. Manufacturing Defect.................................................................31

3. Failure to Warn.........................................................................32

4. Design Defect............................................................................34

a. Viability of Design Defect Claims for Medical Devices...............36

b. Proof of Safer Alternative Designs..........................................41

5. Fraudulent Concealment.............................................................45

6. Negligent Misrepresentation........................................................47

7. Gross Negligence........................................................................48

8. Punitive Damages......................................................................51

9. Loss of Consortium.....................................................................52

V. CONCLUSION...............................................................................52

I. INTRODUCTION

On September 4, 2019, wife-and-husband plaintiffs Kelli Lynn Coates Baccaro ("Kelli") and Brian Scott Baccaro ("Brian", collectively the "Baccaros" or "plaintiffs") filed a complaint against defendants Coloplast Corp. and Coloplast Manufacturing US, LLC (collectively "Coloplast" or "defendants"). Roughly speaking, Kelli blames defendants for producing a faulty vaginal mesh called the Altis Single Incision Sling System ("Altis"). Kelli was surgically implanted with an Altis to treat her stress urinary incontinence ("SUI"), which she claims has since caused her any number of debilitating and painful medical complications. For his part, Brian tags along with Kelli's claim, arguing loss of consortium due to Kelli's Altis implant.

In total, the Baccaros allege nine counts in their complaint, all coming under New York common law:^[1](I) negligence; (II) negligent misrepresentation; (III) gross negligence; (IV) design defect; (V) failure to warn; (VI) manufacturing defect; (VII) fraudulent concealment; (VIII) punitive damages; and (IX) loss of consortium.

On December 21, 2020, Coloplast filed a flurry of motions in an attempt to resolve this case in advance of trial. Defendants filed motions to preclude five of the Baccaros' expert witnesses under Federal Rule of Evidence ("Evidence Rule") 702 and Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), as well as a motion for summary judgment against the entirety of plaintiffs' complaint under Federal Rule of Civil Procedure ("Rule") 56. Those motions will now be considered on the basis of the submissions and without oral argument.

II. BACKGROUND

On November 16, 2018, Dr. Edward Marici ("Dr. Marici") implanted Kelli with an Altis to treat her SUI.^[2] Dkt. 48-2, Defendants' Statement of Material Facts ("DSMF"), ¶ 1. SUI is a not-uncommon condition in women forty-five years old or older that involves urine leaking from the woman's urethra in moments of stress or physical activity. Dkt. 59-3 ("Rosenzweig Report"), pp. 5-6.^[3] Altis is a kind of "mesh" woven together from five-millimeter thick strands of a substance called polypropylene. DSMF ¶ 18. Essentially, Altis is intended to support a woman's urethra to help mitigate the effects of SUI. Rosenzweig Report 14-15. The Food and Drug Administration ("FDA") has authorized Altis to be marketed for that purpose since November 5, 2012. Dkt. 48-11, pp. 2-3.

Even going into Kelli's implantation surgery, Dr. Marici knew that Altis carried certain risks, and he told Kelli about each one. DSMF ¶ 4. Nevertheless, after weighing Coloplasts' warning materials, his own education and experience, and discussions with other doctors, Dr. Marici thought Altis was the appropriate treatment for Kelli's SUI. Id. ¶¶ 4-5, see Id. ¶ 2 (noting that Dr. Marici selected Altis for plaintiffs surgery). Dr. Marici stands by his decision to implant Kelli with Altis, and he testified that he would still consider using Altis to treat a patient with Kelli's symptoms today. Id. ¶ 3.

Safe to say, though, the Baccaros would disagree. On February 5, 2019, roughly three months after her first surgery, Kelli went under Dr. Marici's knife again because her Altis had become exposed after implantation. Dkt. 48-14, p. 2. On February 19, 2019, Dr. Marici conducted a third surgery, apparently to repair the same problem. Dkt. 48-15, p. 2.

On September 20, 2019, a different doctor performed surgery on Kelli again to treat the erosion of her Altis sling. Dkt. 48-16, p. 2. Still, Kelli's problems persisted. Kelli had a fifth and-thus far-final surgery to address erosion of her Altis mesh on June 12, 2020. Dkt. 48-17, p. 2. Kelli's surgeries hoped to treat her ongoing symptoms of pain, bleeding, repeated urinary tract infections, urinary incontinence, chronic pelvic inflammation, and pain during sexual intercourse. Dkt. 63-2 ("Gold Report"), p. 3.^[4]

But even before Kelli's last two surgeries, the Baccaros had already apparently had enough and filed the present complaint on September 4, 2019. Dkt. 1. The parties proceeded through discovery, and each side disclosed the experts they intend to call at trial.

Among the Baccaros' expert disclosures, five in particular need some introduction: (1) William Gold, M.D. ("Dr. Gold") intends to establish specific causation; (2) Bruce Rosenzweig, M.D. ("Dr. Rosenzweig") intends to establish general causation and identify alternate product designs for Altis; (3) Neeraj Kohli, M.D. ("Dr. Kohli") intends to offer similar testimony to Dr. Rosenzweig; (4) Jimmy Mays, Ph.D. ("Dr. Mays") intends to testify concerning the capacity of polypropylene-the fibers Altis is made from-to oxidize and break down once implanted in the body; and (5) Peggy Pence, Ph.D. ("Dr. Pence"), a microbiologist, intends to testify concerning the process of creating a medical device.

On December 21, 2020, Coloplast moved to exclude the opinions and testimony of all five of the Baccaros' expert witnesses. Dkts. 49-53. The same day, defendants filed a motion for summary judgment against plaintiffs' complaint. This decision follows.

III. LEGAL STANDARD

A. Preclusion of Expert Testimony

Evidence Rule 702 permits an expert to give an opinion if each of four conditions are met: (1) the expert possesses specialized knowledge that will be of use to a trier of fact in understanding the evidence or determining a fact; (2) that "testimony is based on sufficient facts or data;" (3) "the testimony is the product of reliable principles and methods;" and (4) the expert has reliably applied those principles and methods to the facts of the case. FED. R. EVID. 702. As a result, a district court must assess whether: (1) the witness is qualified to offer expert testimony; (2) the opinion is based on reliable data and methodology; and (3) the expert's testimony on a particular issue will assist the trier of fact. Bee v. Novartis Pharm. Corp., 18 F.Supp.3d 268, 300 (E.D.N.Y. 2014) (citing Nimely v. City of N.Y., 414 F.3d 381, 396-97 (2d Cir. 2005)).

In considering reliability, the Supreme Court in Daubert endorsed a flexible approach. In re Mirena IUS Levonorgestrel-Related Prods. Liab. Litig. (No. II), 982 F.3d 113, 123 (2d Cir. 2020) (citing Daubert, 509 U.S. at 597). The Daubert standard does not provide a checklist or a test, but instead looks at experts case-by-case. In re Mirena, 982 F.3d at 123.

That case-by-case approach considers: (1) whether the expert's theory or technique is testable; (2) whether that technique has been subjected to peer review and publication; (3) a technique's rate of error and whether standards exist to govern the technique's operation; and (4) whether a particular technique or theory is generally accepted...