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Jurors in the Johns v Bard five-week hernia mesh bellwether trial took just two hours to deliver a crushing blow to all counts for Steven Johns and his legal team.
Johns was implanted with a Ventralight ST coated polypropylene hernia mesh in 2015. He claimed “persistent, debilitating pain,” and emotional distress.
His was the first bellwether trial of thousands still ahead against Bard in both Multidistrict litigation and in state court in Rhode Island.
The plaintiff contended Bard knew components of the mesh were dangerous and unsafe and not suitable for permanent implantation in the human body because the PGA fibers create an increased inflammatory response and the ST coating resorbs too quickly.
Johns and his legal team argued the mesh was defective in its design and manufacture and that there was a failure to warn his surgeon about its complications.
Johns’ doctor has testified that had he been fully informed by Bard Davol, he would not have used this mesh on his patient. Bard contended that additional warnings would not have avoided the Johns’ injury.
Bard had argued its Ventralight polypropylene mesh, made with polyglycolic acid fibers (PGA) and a bioresorbable coating called Sepra Technology (ST) was safe and doctors were adequately warned about its small complication rate.
The plaintiffs filed seven claims against manufacturer C.R. Bard. The trial was heard before Chief U.S. District Judge Edmund Sargus in Columbus, Ohio in this Bard hernia mesh MDL.
Generally, the claims are separate but under Utah law (Mr. Johns is from Utah) the claims are hyphenated.
In explaining the loss for the plaintiff, Mr. Johns attorney Kelsey Stokes told MND;
"This case was a Defense pick with an injury profile that is not typical of the over 14,000 cases in this MDL. We look forward to trying the next case, which is in January 2022."
These are the questions that were before the seven jurors.
On the jury verdict form:
No. 1:
“Do you find in favor of Mr. Johns on his Negligence-Failure to Warn claim against Bard and Davol? No, they answered.”
No. 2:
“Do you find in favor of Mr. Johns on his Negligence-Design Defect claim against Bard and Davol? No”
No. 3:
“Do you find in favor of Mr. Johns on his Strict products Liability-Failure to Warn claim against Bard and Davol? No.”
No. 4:
“Do you find in favor of Mr. Johns on his Strict Products Liability-Design Defect claim against Bard and Davol? No.”
No. 5:
“Do you find in favor of Mr. Johns on his Breach of Express Warranty claim against Bard and Davol? No.”
No. 6:
“Do you find in favor of Mr. Johns on his Fraud claim against Bard and Davol? No.”
No. 7:
“Do you find in favor of Mr. Johns on his Negligent Misrepresentation claim against Bard and Davol? No.”
Johns received the Ventralight ST after experiencing an abdominal bulge in 2014. The treatment for his diagnosed ventral hernia with diastasis recti was to implant the Ventralight ST Mesh during laparoscopic surgery in August 2015. Mr. Johns was in severe pain from the condition. The surgery was the treatment to fix the separation of the rectum abdominus or six-pack muscles.
Several months later, his symptoms returned, and Johns underwent a second laparoscopic surgery in October 2016, where his surgeon removed adhesions. A third surgery repaired a hernia recurrence.
It was not entirely clear to jurors that adhesions found during surgery had caused his complications.
The MDL is Davol Inc/C.R. Bard Inc Polypropylene Hernia Mesh Products Liability Litigation, No. 18-md-02846, U.S. District Court, Southern District of Ohio. The Johns case is No. 18-cv-01509. Johns v C.R. Bard et al.
Lawyers involved for the plaintiff: David Butler (Taft Stettinius and Hollister), Timothy O’Brien (Levin Papantonio Rafferty), Jeff Grand, Alex Alvarez, Xavier Navarro, Kelsey Stokes (Fleming Nolan Jez), Shannon Pennock, Robert Price (Levin Papantonio), Brett Vaughn (Hollis Law), Andrea Giovannone, and Jon Olivito.
For the defense, Eric Alexander, Michael Brown, and Marilyn Mobourg of Reed Smith. Bill Kloss was local counsel with Vorys, Sater, Seymour, Pease.
Past mesh trials have shown the longer a trial takes, the verdict may be less likely to yield favorable results for the plaintiff.
That is what happened during the longest pelvic mesh trial in Kansas City, Missouri trial for Eve Sherrer, who suffered from both a Bard and Boston scientific mesh. Her trial began in December 2015, and stopped for the holiday, eventually going to the jury by February 1, 2016.
At the time, court watchers speculated that jurors are bored and perhaps even angry they were kept from their homes so long listening to complicated scientific explanations. Some attorneys told MND that in the future they would work on shortening presentations to the jury.
The Johns case was a defense pick. Both defense and plaintiff select certain cases they want to be bellwethers and go to trial.
A dozen or more actions poised to be heard naming C.R. Bard and its family of hernia meshes. Together, nearly 14,000 cases are pending in the Columbus, Ohio federal court and another 14,000 are waiting to go to trial in state court in Providence, Rhode Island.
Steven Johns v CR Bard (Case No. 2:18-md-2846) is filed in the Southern District of Ohio in Multidistrict Litigation (MDL 2846) before Judge Edmund A. Sargus.
Ventralight ST is a polypropylene mesh, marketed as Marlex, similar to Bard’s three hernia meshes that are the subject of defective product actions - Ventralex, Prefix, and 3D Max. Together, nearly 14,000 cases naming Bard are pending in the Columbus, Ohio court and another 14,000 waiting to go to trial in state court in Providence, Rhode Island.
Ventralight ST was cleared for market by the Food and Drug Administration under the 510(k) clearance process (K101851) in July 2010. It remains on the market.
C.R. Bard is the largest manufacturer of surgical mesh devices, including pelvic mesh, in the United States. Ethicon (Johnson & Johnson) and Atrium Medical are also facing thousands of product liability actions. Some of the actions also name Davol, a subsidiary of Bard.
According to the court, assuming the last defense witness finishes her testimony Tuesday, the case should go into closing arguments at 8:30 am Wednesday.
The Johns Case
Steven Johns says he suffers from pain, has had a hernia recurrence and adhesions. He has undergone surgery to remove the mesh and replace it with a new Ventralight ST.
The Johns case is a defense pick.
Last spring, Judge Sargus ruled the defense experts cannot say the mesh “is in no way defective” or that the warnings about the risk are sufficient.
The last defense witness on the stand today is Dr. Maureen Reitman, a materials scientist with a specialty in polymers testifying about the design and materials used in Ventralight ST.
Ventralight ST, made of polypropylene (PP), is also composed of polyglycolic acid (PGA) and a bioresorbable coating called Sepra Technology (ST). Plaintiffs contend the ST coating is absorbed too quickly by the body and that PGA fibers induce an inflammatory response.
Dr. Reitman was the last witness for the defense.
Trial Highlights
Some of the highlights of Johns v Bard five-week includes:
*Material Safety Data Sheet – The MSDS accompanies raw materials, as required by OSHA as they go through production to warn workers about any potential toxic exposure.
The Bard Marlex MSDS says:
“Do not use this material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids and tissues.”
One court insider says the MSDS was an ancillary issue regarding notice as the judge would not allow an expert to discuss it.
*Polypropylene Degrades Invivo – While polypropylene mesh is intended to be implanted permanently, electron microscopes have found it does degrade in the body. Besides degrading, polypropylene can adhere to nearby organs and cause pain when it shrinks or migrates. Infections are common, as are bowel obstruction, fistulas, and seromas. Often removing the mesh is the only treatment. However, that presents additional complications and leaves the hernia unrestrained.
*Mesh Protective Coating Absorbs – Bard says its protective coating lasts 30 days, but studies have found that the body absorbs it in five days. The coated side of the mesh is placed against bowels and other organs to prevent erosion.
In a deposition, the Johns implanting physician Dr. Jensen said that he expects Bard to provide accurate information about the device, including its risks and benefits. He testified that no one from Bard or Davol ever informed him that the ST hydrogen barrier could be resorbed within seven days. Had he known that he said, he “would not have used the Ventralight ST in Steven Johns.”
Bard objected to hearsay evidence from Dr. Jensen that the company had changed the ST formulation to double the resorption time from seven to fourteen days because seven days was insufficient to allow the product to work. (Jensen Depo. ECF No. 75-2)
Bard’s First Trial Settled
On the eve of a trial last April, the case of Timothy and Lori Rudd v Davol (PC-2018-0482) was settled. Mr. Rudd had been implanted with Bard’s Ventralex six years earlier to repair an umbilical hernia. The Rudds were represented by Jonathan Orent and Don Migliori of Motley Rice.
The Rudds live in Rhode Island, where Bard is headquartered. Davol is a wholly-owned subsidiary of Bard, which supplies Davol with the materials used in making the Ventralex patch. The Ventralex ST Hernia Patch remains on the market.
Bard, headquartered in Murray Hill, New Jersey, is owned by Becton, Dickinson.
Learn More:
Casetext Johns v C.R. Bard
Ventralight ST, FDA 510(k)
https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K101851
https://www.accessdata.fda.gov/cdrh_docs/pdf10/K101851.pdf
Mesh News Desk, July 25, 2021, First Bard Hernia Mesh Bellwether Trial Early August
Ohio Case Management order
Bard Ventralight ST mesh, product brochure
