4th Circuit Affirms $2 Million Award In 1st Pelvic Mesh Trial, Says 510(k) Not Probative

RICHMOND, Va. — (Mealey’s)  In an expedited appeal, the Fourth Circuit U.S. Court of Appeals on Jan.14 affirmed a $2 million verdict in the first pelvic mesh multidistrict litigation case to go to trial and affirmed the trial court’s exclusion of the device’s 510(k) clearance as compliance with a federal regulation (In Re:  C.R. Bard, Incorporated, Donna Cisson, et al. v. C.R. Bard, Incorporated, No. 15-1102, 4th Cir.). 

(Cisson opinion available.  Document #28-160121-005Z.

Defendant C.R. Bard had asked the court to expedite the appeal to resolve the 510(k) issue that Bard said may be dispositive of almost 11,000 pelvic mesh cases pending against it in the MDL in the U.S. District Court for the Southern District of West Virginia.   The 510(k) defense has been raised some of the other six pelvic mesh defendants who have not settled their cases, and one of them, Cook Medical Inc., submitted an amicus curiae brief to the Fourth Circuit. 

In 2009, Donna Cisson was implanted with an Avaulta Plus transvaginal mesh device to treat her pelvic organ prolapse and stress urinary incontinence.  Three months later, she was diagnosed with a painful adhesion band of scar tissue running across her vagina. 

Cisson’s doctor surgically removed a thick band of scar tissue and surgical mesh from the Avaulta device.  A few months later, Cisson saw another doctor, who explanted as much of the mesh as he could. 

1st Trial, Mistrial, Retrial

Cisson sued C.R. Bard, and her suit was transferred into the Bard pelvic mesh MDL and was chosen as the first bellwether trial.  The first trial ended in a mistrial.  The retrial ended with a jury finding of design defect and failure to warn, a compensatory award of $250,000 and a punitive damages award of $1,750,000. 

Bard appealed and Cisson cross-appealed, arguing that a Georgia law taking 75 percent of the punitive award is unconstitutional. 

Bard’s first appeal issued was that the trial court erred in granting Cisson’s motion in limine excluding all evidence that Bard complied with the Food and Drug Administration’s 510(k) process.  Judge Joseph R. Goodwin excluded 510(k) evidence under Federal Rule of Evidence 402 for lack of relevance and under Rule 403 for being substantially more prejudicial than probative. 

510(k) Of Little Or No Value

The Fourth Circuit panel affirmed Judge Goodwin’s Rule 403 ruling and said it did not need to address the Rule 402 reason.  “While some courts have found evidence of compliance with the 510(k) equivalence procedure admissible in product liability cases, the clear weight of persuasive and controlling authority favors a finding that the 510(k) procedure is of little or no evidentiary value,” the panel said.  Citing U.S. Supreme Court medical device law, the panel said the 510(k) process, in which the FDA finds a device substantially equivalent to an earlier device, is an exception rather than a requirement. 

The panel said the Supreme Court found that state law product liability claims against 510(k)-cleared devices are not preempted because the process “does not amount to a safety regulation requiring device producers to meet any established design standards.” 

An FDA statement about 510(k) devices, the panel said, does not surmount the Supreme Court’s finding that the process is not a finding of a device’s safety.  “Bald assertions by the FDA do little to alter the analysis of the basic question:  How much information does 510(k) clearance provide a jury about the safety of the underlying product, and is the value of this information substantially outweighed by the possibility of prejudice in a particular case?” 

Mini-Trial Would Confuse Jury

The panel agreed that evidence about the 510(k) status would have required a “mini-trial” with expert testimony that would mislead and confuse the jury.  It said that “could easily inflate the perceived importance of compliance and distract the jury from the central question before it — whether Bard’s design was unreasonable based on any dangers it posed versus the costs required to avoid them.” 

“While 510(k) clearance might, at least tangentially, say something about the safety of the cleared product, it does not say very much that is specific,” the panel wrote.  

The panel also rejected Bard’s argument that 510(k) compliance would mitigate against punitive damages.  The panel said the 510(k) status was “something less than a safety requirement,” exempting Bard from having to use the lengthy and costly premarket approval process.  

Material Data Safety Sheet

In its second appeal issue, Bard said the court erred when it overruled its objection to the introduction of a material data safety sheet (MSDS) for the polypropylene used to make the mesh in the Avaulta Plus device.  The panel reversed the District Court’s ruling as to hearsay exceptions but affirmed the decision to admit the evidence as non-hearsay. 

The panel said Cisson introduced the MSDS not as evidence about the polypropylene but to show that Bard was aware that the manufacturer recommended it not be used for long-term human implants.  It said Cisson used it for that purpose and in a way that did not prejudice Bard. 

Noting testimony by a Bard executive that the company received the MSDS, ignored it and took steps to keep the manufacturer in the dark about the polypropylene’s use, the panel said Cisson showed that Bard’s conduct showed indifference to consequences to patients. 

The panel also said that in its appeal, Bard overstates the importance of the MSDS to Cisson’s case.  In addition, it said Cisson also presented substantive evidence other than the MSDS that the polypropylene in the Avaulta Plus device caused her injuries. 

Causation Jury Instruction

Bard’s third appeal issue was that the court erred in instructing the jury on causation because it did not reflect Georgia law requiring expert testimony.  The panel said Bard seeks to impose a causation standard for medical malpractice in a products liability case. 

Besides, the panel said, Cisson presented ample expert and nonexpert testimony for the jury to find a design defect. 

Finally, Bard argued that the 7-to-1 ratio of punitive damages to compensatory damages was excessive under U.S. Supreme Court case law, which recommended a 4-to-1 ratio.  The panel said the Supreme Court did not create such a bright line for punitive damage ratios.  

Plaintiff’s Cross-Appeal

In her cross-appeal, Cisson argued that the Georgia state law garnishing 75 percent of the punitive damage award violated the takings clause of the Fifth Amendment to the U.S. Constitution.  She said she has a vested property interest in the punitives award. 

Cisson, the panel said, does not explain how the Georgia law exceeds the state’s authority by defining the right to punitive damages.  

Circuit Judge Roger L. Gregory wrote the opinion.  The other panel members were Circuit Judges G. Steven Agee and Albert Diaz. 


Bard is presented by Elliott H. Scherker, Lori G. Cohen, R. Clifton Merrell II and Sean P. Jessee of Greenberg Traurig in Atlanta, Daniel I.A. Smulian of Greenberg Traurig in New York, Brigid F. Cech Samole and Jay A. Yagoda of Greenberg Traurig in Miami and Melissa Foster Bird of Nelson, Mullins, Riley & Scarborough in Huntington, W.Va. 

Cisson is represented by Anthony J. Majestro of Powell & Majestro in Charleston, W.Va., Allison Van Laningham of Turning Point Litigation in Greensboro, N.C., and Henry G. Garrard III and Josh B. Wages of Blasingame Burch Garrard Ashley in Athens, Ga. 

Intervenor State of Georgia is represented by Julie Adams Jacobs and Samuel S. Olens of the Attorney General’s Office in Atlanta. 

Amicus Counsel

Amicus curiae Federation of Defense and Corporate Counsel is represented by Debra Tedeschi Varner of McNeer, Highland, McMunn & Varner in Clarksburg, W.Va., and Stacy A. Broman of Meagher & Geer in Minneapolis.  Amici Product Liability Advisory Council Inc. and U.S. Chamber of Commerce are represented by Chilton Davis Varner, Stephen B. Devereaux and Madison H. Kitchens of King & Spalding in Atlanta and Jeffrey S. Bucholtz and Paul Alessio Mezzina of King & Spalding in Washington, D.C. 

Product Liability Advisory Council is also represented by Hugh F. Young Jr. of the Council in Reston, Va.  The Chamber of Commerce is also represented by Kathryn Comerford Todd and Sheldon Gilbert of the National Chamber Litigation Center Inc. in Washington. 

Amicus Cook Medical LLC, another pelvic mesh defendant, is represented by Douglas B. King of Wooden & McLaughlin in Indianapolis.  Amicus Public Justice P.C. and National Center for Health Research are represented by Michael J. Quirk, Esther E. Berezofsky and Joseph Alan Venti of Williams Cuker Berezofsky in Philadelphia.

 [Editor's Note: Lexis subscribers may download the document using the link above. The document(s) are also available at or by calling the Customer Support Department at 1-800-833-9844 .]

For all of your legal news needs, please visit subscribers may search all Mealey Publications.

Non-subscribers may search for Mealey Publications stories and documents at or visit

Mealey's is now available in eBook format!

For more information about LexisNexis products and solutions, connect with us through our corporate site.