Cisson v. C.R. Bard, Inc. (In re C.R. Bard, Inc., MDL. No. 2187, Pelvic Repair Sys. Prods. Liab. Litig.)

• Decision Date: 14 January 2016
• Docket Number: Nos. 15–1102,15–1137.,s. 15–1102
• Citation: 810 F.3d 913
• Parties: In re C.R. BARD, INCORPORATED, MDL. No. 2187, PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION. Donna Cisson; Dan Cisson, Plaintiffs–Appellees, v. C.R. Bard, Incorporated, Defendant–Appellant, Samuel S. Olens, Attorney General of the State of Georgia, Intervenor. Federation Of Defense & Corporate Counsel ; Product Liability Advisory Council, Incorporated; Cook Biotech Incorporated ; Chamber of Commerce of the United States of America; Cook Incorporated; Cook Medical LLC, Amici Supporting Appellant, Public Justice; National Center for Health, Amici Supporting Appellees. In Re: C.R. Bard, Incorporated, MDL. No. 2187, Pelvic Repair System Products Liability Litigation. Donna Cisson; Dan Cisson, Plaintiffs–Appellants, v. C.R. Bard, Incorporated, Defendant–Appellee, Samuel S. Olens, Attorney General of the State of Georgia, Intervenor. Federation of Defense & Corporate Counsel ; Chamber of Commerce of the United States of America; Product Liability Advisory Council, Incorporated, Amici Supporting Appellee, Public Justice; National Center for Health, Amici Supporting Appellants.
• Court: U.S. Court of Appeals — Fourth Circuit

810 F.3d 913

In re C.R. BARD, INCORPORATED, MDL. No. 2187, PELVIC REPAIR SYSTEM PRODUCTS LIABILITY LITIGATION.

Donna Cisson; Dan Cisson, Plaintiffs–Appellees,
v.
C.R. Bard, Incorporated, Defendant–Appellant,

Samuel S. Olens, Attorney General of the State of Georgia, Intervenor.

Federation Of Defense & Corporate Counsel ; Product Liability Advisory Council, Incorporated; Cook Biotech Incorporated ; Chamber of Commerce of the United States of America; Cook Incorporated; Cook Medical LLC, Amici Supporting Appellant,

Public Justice; National Center for Health, Amici Supporting Appellees.

In Re: C.R. Bard, Incorporated, MDL. No. 2187, Pelvic Repair System Products Liability Litigation.

Donna Cisson; Dan Cisson, Plaintiffs–Appellants,
v.
C.R. Bard, Incorporated, Defendant–Appellee,

Samuel S. Olens, Attorney General of the State of Georgia, Intervenor.

Federation of Defense & Corporate Counsel ; Chamber of Commerce of the United States of America; Product Liability Advisory Council, Incorporated, Amici Supporting Appellee,

Public Justice; National Center for Health, Amici Supporting Appellants.

Nos. 15–1102
15–1137.

United States Court of Appeals, Fourth Circuit.

Argued: Sept. 16, 2015.
Decided: Jan. 14, 2016.

810 F.3d 917

ARGUED:Elliot H. Scherker, Greenberg Traurig, P.A., Miami, Florida, for Appellant/Cross–Appellee. Anthony J. Majestro, Powell & Majestro, PLLC, Charleston, West Virginia, for Appellees/Cross–Appellants. Julie Adams Jacobs, Office Of The Attorney General Of Georgia, Atlanta, Georgia, for Intervenor. ON BRIEF:Lori G. Cohen, R. Clifton Merrell, II, Sean P. Jessee, Atlanta, Georgia, Daniel I.A. Smulian, Greenberg Traurig, LLP, New York, New York; Brigid F. Cech Samole, Jay A. Yagoda, Greenberg Traurig, P.A., Miami, Florida; Melissa Foster Bird, Nelson Mullins Riley & Scarborough, Huntington, West Virginia, for Appellant/Cross–Appellee. Allison Van Laningham, Turning Point Litigation, Greensboro, North Carolina; Henry G. Garrard, III, Josh B. Wages, Blasingame, Burch, Garrard, Ashley PC, Athens, Georgia, for Appellees/Cross–Appellants. Samuel S. Olens, Attorney General, W. Wright Banks, Jr., Deputy Attorney General, Office of the Attorney General of Georgia, Atlanta, Georgia, for Intervenor. Debra Tedeschi Varner, McNeer, Highland, McMunn & Varner LC, Clarksburg, West Virginia; Stacy A. Broman, Meagher & Geer PLLP, Minneapolis, Minnesota, for Amicus Federation of Defense & Corporate Counsel. Chilton Davis Varner, Stephen B. Devereaux, Madison H. Kitchens, Atlanta, Georgia, Jeffrey S. Bucholtz, Paul Alessio Mezzina, King & Spalding LLP, Washington, D.C., for Amici Product Liability Advisory Council, Inc. and Chamber of Commerce of the United States; Hugh F. Young, Jr., Product Liability Advisory Council, Inc., Reston, Virginia, for Amicus Product Liability Advisory Council, Inc.; Kathryn Comerford Todd, Sheldon Gilbert, National Chamber Litigation Center, Inc., Washington, D.C., for Amicus Chamber of Commerce of the United States. Douglas B. King, Wooden & McLaughlin LLP, Indianapolis, Indiana, for Amici Cook Incorporated, Cook Medical LLC, and Cook Biotech Incorporated. Michael J. Quirk, Esther E. Berezofsky, Joseph Alan Venti, Williams Cuker Berezofsky, LLC, Philadelphia, Pennsylvania, for Amici Public Justice, P.C., and National Center for Health Research.

Before GREGORY, AGEE, and DIAZ, Circuit Judges.

Affirmed by published opinion. Judge GREGORY wrote the opinion, in which Judge AGEE and Judge DIAZ joined.

GREGORY, Circuit Judge:

On August 15, 2013, a jury awarded Donna Cisson $250,000 in compensatory damages on a design defect and failure to warn claim against C.R. Bard, Inc. ("Bard"), and awarded an additional $1,750,000 in punitive damages. The punitive damages award was split pursuant to a Georgia statute, with seventy-five percent going to the State of Georgia and twenty-five percent going to Cisson. This was the first jury verdict arising from multi-district litigation involving more than 70,000 cases against the proprietors of transvaginal mesh medical devices used to treat pelvic organ prolapse and other pelvic issues, of whom Bard is one.

We address several issues on appeal. The first issue raised by Bard is the district court's refusal to admit evidence relating to Bard's compliance with the Food and Drug Administration's ("FDA") Section 510(k) product safety process ("510(k) process"). Second, Bard challenges the denial of its motion in limine asking the district court to exclude evidence and argument pertaining to a material data safety sheet ("MSDS") produced for polypropylene, a key material in the Avaulta Plus surgical mesh. Bard argues that the

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MSDS relied on by Cisson was hearsay outside any exception. Third, Bard appeals the district court's jury instruction on causation, arguing that under controlling Georgia law the court should have told jurors that causation must be demonstrated by expert testimony stated to a reasonable degree of medical probability. Bard also argues that, as a matter of law, the evidence Cisson presented to prove causation was insufficient to meet this more rigorous standard. Bard's final challenge on appeal is to the constitutionality of the punitive damages award, which it argues is excessive and in violation of the Due Process Clause. In a cross-appeal, Cisson argues that the district court committed constitutional error by failing to find that the Georgia split-recovery statute violates the Takings Clause. For the reasons that follow, we affirm the district court on all issues.

I.

Cisson was implanted with the Avaulta Plus, a transvaginal mesh medical device developed and marketed by Bard, on May 6, 2009, to address pelvic organ prolapse and stress urinary incontinence. The surgery was performed by Dr. Brian Raybon, a physician who had provided input to Bard during the development of the Avaulta Plus and who trained other physicians to use the device. Prior to her procedure, Cisson received warnings about a number of risks that could result from the surgical implant and signed a consent form acknowledging these warnings. Three months after the surgery, Cisson's doctor diagnosed "an adhesion band" of scar tissue running across her vagina that was taut like a "banjo string" and was causing Cisson pain. Dr. Raybon resected the mesh, which involved cutting out a thick band of scar tissue and mesh encased in the tissue. Three weeks after the resection surgery, Cisson returned to Dr. Raybon who said she was healing well and should return in a year. Instead, a few months later, Cisson went to a different doctor who referred her to Dr. John Miklos. Dr. Miklos explanted the Avaulta Plus from Cisson's body, although complete removal of the mesh was not possible.

Complaining that the surgical mesh marketed by Bard caused ongoing "loss of sexual feeling" and "severe pain with intercourse and otherwise," Cisson filed a lawsuit against Bard in March 2011 in the Northern District of Georgia. Bard already faced suits from other claimants dating back to 2009, and the Judicial Panel for Multidistrict Litigation had begun transferring these cases to the Southern District of West Virginia in 2010. In re Avaulta Pelvic Support Sys. Prods. Liab. Litig., 746 F.Supp.2d 1362 (J.P.M.L. 2010). Cisson's suit was added to these and would later become the first to reach a jury verdict.

On June 4, 2013, Bard won summary judgment on Cisson's claims for negligent inspection, marketing, packaging and selling, manufacturing defect, and breach of warranty. The district court allowed claims for design defect, failure to warn, and loss of consortium to proceed to trial. During the trial, Cisson focused both her design defect and failure to warn claims on several alleged dangers presented by the Avaulta Plus. Expert witnesses were brought to testify that the design of the device's arms, used to anchor the Avaulta Plus inside a patient's body, resulted in ongoing pain to a patient as long as the device was implanted. Experts also testified that the pores in the mesh component of the Avaulta Plus were too small and that the mesh was subject to shrinking after implantation, with the result being a rigid scar plate and increasing tension on

810 F.3d 919

internal tissue. Cisson's experts further testified that polypropylene, from which the monofilament used in the Avaulta Plus mesh was made, may be attacked by the patient's body, causing inflammation of the tissue and degradation of the mesh. Slides were presented to the jury that Cisson's expert, Dr. Bernd Klosterhalfen, testified showed the polypropylene of the Avaulta Plus in Cisson's body was being attacked, causing a scar plate to form.

Beyond presenting evidence that the Avaulta Plus had caused her injuries, Cisson also painted a picture of Bard as ignoring, and at times hiding from others, the warning signs that its product could cause injuries. There was substantial argument regarding a MSDS Bard received from Phillips Sumika Polypropylene Company ("Phillips"), the corporation that manufactured the polypropylene pellets used to extrude the Avaulta Plus mesh. The MSDS contained an explicit warning that polypropylene should not be used in short-or long-term human implantations. Internal e-mails showed that Bard executives knew about the MSDS, and that they sought to prevent their monofilament suppliers from learning of the warning....