Win and Loss for Bard as Avaulta Pelvic Mesh Case Readies for Court

Jane Akre
November 23, 2016
Bard Avaulta

Bard Avaulta

Mesh Medical Device News Desk, November 22, 2016 ~ The plaintiff can pursue a punitive damage but not a negligence claim in this Bard Avaulta defective pelvic mesh case that is being readied for trial or to be remanded back to state court.

While mesh trials have not been in the courtroom or the headlines for some months now, there is quiet wrangling going on behind the scenes in a Bard Avaulta case.

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph R. Goodwin, Charleston, WV

Judge Joseph Goodwin of the U.S. District Court for the Southern District of West Virginia, where nearly 100,000 pelvic mesh cases are consolidated in multidistrict litigation, had asked mesh manufacturer, C.R. Bard to come up with 50 cases it could prepare for trial. At the same time, he also asked the plaintiffs side to come up with 50 Bard defective product cases.

These are Wave One and Wave Two cases, being prepared for trial or to be remanded back to state court.

In an order issued November 15, Judge Goodwin granted one summary judgment motion in favor of Bard and another motion in favor of the plaintiffs in a Wave One case.

The case is that of Donna Kaiser v. C.R. Bard Inc. (2:12-cv-03655).

Surgeons, WikiCommons

Surgeons, WikiCommons

Kaiser was implanted with the Avaulta Solo Anterior Synthetic Support System in Pembroke Pines, Florida by Dr. Harvey Samowitz at Memorial Hospital West.

In her seven count case, filed July 25, 2012, she alleges design defect, manufacturing defect, a failure to warn, negligence breach of express and implied warranties, loss of consortium and punitive damages.


Protesters, fed court Charleston WV

Pelvic Mesh Protesters, fed court, Charleston, WV

In Doc #209, Judge Goodwin denied Bard’s Motion for Partial Summary Judgment on punitive damages. Summary Judgment resolves issues before trial and makes them go away. (Here is Doc #209)

In issuing the order, Judge Goodwin said the question of punitive damages is often interlocked with factual determinations which at this stage are “frequently muddled enough on the point that genuine issues of material fact remain. That is the case here.”

In other words, it’s best for a jury to decide these things.

The plaintiffs will be able to seek punitive damages that punish a company, if and when the case goes to trial.

On the same day, Judge Goodwin granted Bard’s Motion for Summary Judgment (Doc #210 Here) on manufacturing defect, breach of implied and express warranty, negligent inspection, packaging, marketing and selling.

Basically how the mesh is marketed will not be allowed to be presented to a jury, while everything else stands. Judge Goodwin said the plaintiffs' attorney failed to make a case that Bard negligently inspected and marketed Avaulta.

Bard Avaulta Solo Anterior Synthetic Support System, Zagrum Medical

Bard Avaulta Solo Anterior Synthetic Support System, Zagrum Medical

The plaintiff is represented by Wagstaff & Cartmell. Defendant lawyers are Reed Smith and Nelson Mullins Riley & Scarborough.

The other counts can be pursued such as:

  1. Negligence (excluding negligent inspection, marketing, packaging and selling, which was concluded not to be a separate claims under the applicable law);
  2. Strict Liability – Defective Design;
  3. Strict Liability – Failure to Warn;
  4. Loss of Consortium; and
  5. Punitive Damages.

Based on the applicable state law, plaintiffs attorneys had to abandoned the claims for manufacturing defect and breach of warranty.


Judge Goodwin reminds both sides there are currently 58,000 open cases pending in this multidistrict litigation and 8,000 defective product cases that name C.R. Bard Inc. are pending.

In order to try and get through the massive numbers of cases, Judge Goodwin decided to conduct pretrial discovery and motions practice on a case-by-case basis so that once a case is ready for trial, it can promptly move onto his court or be remanded back to another.

Last year Bard agreed to settle 3,000 mesh cases for $200 million and 6,254 cases are now listed as closed in this federal consolidated court case. In 2014, Bard agreed to a $21 million settlement to resolve 500 defective product lawsuits.

Bard, based in Georgia, manufactures various medical devices including:

Avaulta Plus™ BioSynthetic Support System

Avaulta Solo™ Synthetic Support System

Faslata® Allograft

Pelvicol® Tissue

PelviSoft® Biomes

Pelvitex™ Polypropylene Mesh

The Bard litigation was consolidated in January 2012 in multidistrict litigation in the Southern District of West Virginia before Judge Goodwin.

The Avaulta was taken off the market in June 2012 after the FDA required mesh manufacturers to conduct a three-year post-approval monitoring of women already implanted with the mesh product to assess their condition. The company said it was making a business decision not to invest in the clinical trials for the Avaulta. ###


Seven Causes of Action Kaiser Case:

  1. Strict product liability, failure to warn
  2. Strict Liability – without warnings and instruction and being defective in design they were placed in the stream of commerce while the Defendant acted with conscious and deliberate disregard of the foreseeable harm caused by pelvic mesh products
  3. Negligence – Defendant (Def) failed in its duty to properly manufacture, compound, test, inspect, package, label, distribute, market, examine, maintain supply, provide proper warnings and prepare for use and sell the product. Injuries resulted to plaintiff.
  4. Breach of Implied Warranty- Def. warranted its pelvic mesh products were fit and safe for ordinary use or correcting POP (pelvic organ prolapse) and SUI (stress urinary incontinence). Therefore Def. breached the implied warranty of merchantability and fitness for a particular purpose. Instead it is defective, eroded, caused dense scarring and otherwise failed to function causing permanent injuries.
  5. Breach of Express Warranty –Def. relied on sales agents and brochures to assure the general public the products were safe, effective, fit and proper for their intended use, which was untrue, says the plaintiff.
  6. Negligent Misrepresentation – Def. made representation that the mesh for POP and SUI was safe with no reasonable ground for believing that to be true and its own data showed the products to be defective and dangerous. Those representations were made to the physicians who relied on the assurances the mesh was safe to use.
  7. Loss of Consortium- filed on behalf of the spouse who has lost an intimate relationship with his wife due to the Def's negligent conduct.
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