The United States District Court for the Southern District of Florida dismissed Norma Olmo’s hernia mesh lawsuit which alleged that the Bard Composix Kugel Hernia Patch was defective. Ultimately, the Court excluded the victims’ expert from testifying because the “Plaintiffs have not provided any admissible evidence that this alleged defect caused Ms. Olmo’s injuries.”  The Court ruled that the Plaintiff’s expert “opinions on testing and design no longer have a valid scientific connection, or “fit,” to the facts.” Id.

Davol Inc. and C.R. Bard, Inc. are the manufacturers of numerous hernia mesh medical devices made of polypropylene. There are currently thousands of medical device lawsuits pending against Bard / Davol.  C.R. Bard has now re-branded themselves as Bard Medical after they were purchsed by Becton, Dickinson and Company (BD). Bard has hired some of the top hernia mesh defense lawyers in an apparent attempt to get the mesh lawsuits dismissed or pay the surgical mesh victims peanuts. Norma Olmo and Nelson Olmo filed a hernia mesh lawsuit against Davol Inc. and C.R. Bard, Inc. alleging that the Bard mesh, Composix Kugel hernia patch (“CK Patch”), caused Normo Olmo serious injuries, complications and side effects.

“Bard Medical acting through their mesh attorneys filed a motion for summary judgment seeking to dismiss the Olmo’s Composix Kugel hernia patch (“CK Patch”) hernia mesh lawsuit. In particular, Bard’s mesh lawyers filed a “Motion for Summary Judgment and Motion to Exclude the Testimony of Plaintiffs’ Expert Dr. Paul Ducheyne, Ph.D.”  UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF FLORIDA CASE NO. 13-62260 NORMA OLMO and NELSON OLMO, Plaintiffs, v. DAVOL, INC. and C.R. BARD, INC., Defendants. OMNIBUS ORDER” Id.

Hernia mesh mess | Bard Davol hernia mesh lawsuit update & timeline

 Pertinent hernia mesh lawsuit facts from Olmo v. Bard / Davol

I have set forth some of the pertinent facts pertaining to the Olmo hernia mesh lawsuit. To understand and be an informed consumer, it is important that victims learn the underlying facts that can help determine the outcome of a mesh lawsuit.

  • “On August 4, 2005, Dr. Roberto Comperatore implanted Ms. Olmo with Bard’s extra-large Composix Kugel hernia patch (“CK Patch”)” Id.
  • “The top polypropylene layer of the CK Patch fixes against the abdominal wall under the hernia to encourage tissue growth and repair, and the smooth, bottom ePTFE surface faces the bowels to minimize adhesions.” Id.
  • “The extra-large CK Patch contains two PET memory recoil rings intended to provide stability
    to the device.” Id.
  • “The Instructions for Use (“IFU”) accompanying the CK Patch at issue contained an “ADVERSE REACTIONS” section cautioning that: Possible complications include seroma, adhesions, hematomas, inflammation, extrusion, fistula formation and recurrence of the hernia or soft tissue defect.” Id.
  • “In 2011, Ms. Olmo was experiencing abdominal pain and underwent an elective hernia repair in which Dr. Brian Weinstein explanted her CK Patch and replaced it with a different hernia mesh product.” Id.
  • “Dr. Weinstein observed that a corner of the CK Patch had lost fixation and folded under, causing “mesh erosion into the bowel.” Id.
  • “Dr. Weinstein did not observe any buckling in the explanted device, and he did not determine whether a ring break had occurred or what caused the fold.” Id.
  • “The hospital where Dr. Weinstein performed Ms. Olmo’s surgery discarded the explanted CK Patch, and neither the device itself nor pictures of it were available for expert examination.” Id.
  • Ms. Olmo filed this lawsuit on October 3, 2013. The case was transferred on October 21, 2013, to the U.S. District Court for the District of Rhode Island by the Judicial Panel on Multidistrict Litigation for coordinated pretrial proceedings.”
  • “On August 18, 2015, the operative First Amended Complaint was filed in this action, adding Ms. Olmo’s husband, Nelson Olmo, as a Plaintiff. On November 22, 2016, the case was remanded back to this Court for further proceedings. The claims remaining at this stage of the litigation are: negligence for design defect (Counts I & II), strict liability for design defect (Counts III & IV), failure to warn (Counts XI & XII), loss of consortium (XIII & XIV), and punitive damages. Id.; DE-MDL 4906 (withdrawing negligent and intentional infliction of emotional distress claims and breach of implied warranty claims); DE-MDL 5209 at 25 (withdrawing manufacturing defect claim).” Id.
  • “Defendants move for summary judgment as to each of the remaining claims.  They also seek to exclude the testimony of Plaintiffs’ expert witness, Dr. Ducheyne.” Id.

Judge overseeing hernia mesh lawsuit determines opinion of Victim’s experts are “unreliable.”

Plaintiff, Defense lawyers and the judge all effectively agreed that the victim’s expert, Dr. Ducheyne was a duly qualified bioengineering expert fully qualified to testify as an expert in the mesh litigation. Nonetheless, the Federal Court Justice presiding over the Olmo surgical mesh lawsuit determined that the Plaintiff had not shown that it is more likely then not that Dr. Ducheyne utilized methodology for his expert opinion is reliable.

“Dr. Ducheyne is by all accounts qualified to testify as a bioengineering expert in this case, and Defendants do not contest his general qualifications. However, Plaintiffs have not established by a preponderance of the evidence that Dr. Ducheyne’s stated methodology for forming his opinion that a ring break occurred in Ms. Olmo’s CK Patch is sufficiently reliable.” Id.

The judge determined that the plaintiff’s expert did not perform tests to establish his theory concerning the Composix Kugel hernia patch (“CK Patch”) The expert did not provide proper scientific studies to support his conclusions regarding the Bard Composix Kugel hernia patch (“CK Patch”)

“Dr. Ducheyne did not conduct any tests to support his ring-break theory. Nor did he perform work to rule out the alternative theory that Ms. Olmo’s CK Patch lost fixation without a ring break. Dr. Ducheyne is not aware of any scientific studies or literature concluding that the folding described in this case evidences a ring break. And Dr. Ducheyne has not pointed to any evidence that the engineering or medical communities would accept the premise that the folding described by Dr. Weinstein is only possible with a ring break.”

“Dr. Ducheyne’s specific opinion—that one or both rings in Ms. Olmo’s CK Patch broke—does not satisfy the requirements of Daubert.”

“The remainder of the report is devoted almost entirely to explaining why Dr. Ducheyne believes that Bard’s product testing and design of the CK Patch were unsatisfactory, and it does not explain why folding necessarily leads to the conclusion
that a ring break occurred. Dr. Ducheyne’s deposition testimony does little to fill in the analytical gap.”

Court excludes Victim’s expert testimony and determines that his opinions do not fit to the facts of the case

This case is a setback to hernia mesh victims across the United States. Anytime, a federal Court justice refuses to allow a highly respected and credentialed expert to testify on behalf of a mesh victim, it is a setback for surgical mesh victims nationwide. “Dr. Ducheyne’s testimony is Plaintiffs’ only evidence of a ring break in Ms. Olmo’s CK Patch, and his general opinions are limited to testing and design with relation to ring break and its consequences. Because the Court finds that Dr. Ducheyne’s specific opinion must be excluded, his general opinions on testing and design no longer have a valid scientific connection, or “fit,” to the facts of his case. See Daubert, 509 U.S. at 591–92 (describing “fit” requirement). Thus, his general opinions must be excluded as well.” Id.

“However, Plaintiffs have not shown that they can support their theory of causation. Without Dr. Ducheyne’s testimony, Plaintiffs have no evidence of a ring break. Nor have they pointed to evidence to support an alternative theory that the CK Patch buckled with an intact ring. In fact, Dr. Weinstein testified that he did not observe a buckle in Ms. Olmo’s CK Patch, but instead observed a loss of fixation, which Plaintiffs also claim that the warnings were inadequate because they should have informed of changes in ring-weld strength, a recall of the product due to complaints of ring breaks, and the extent of testing performed on the ring-weld strength in relation to buckling and fracturing. These arguments are irrelevant without evidence of a ring break. Plaintiffs have not established how information regarding changes in ring-weld strength is relevant without evidence that a ring break caused the alleged injuries. Nor could Defendants have warned of the recall, which occurred after Ms. Olmo’s implant. And Plaintiffs have not pointed to any evidence that knowledge of alleged inadequacies in Defendants’ ring-weld testing would have changed Dr. Comperatore’s decision to implant the CK Patch in Ms. Olmo. These alleged deficiencies in Defendants’ warnings therefore do not save Plaintiffs’ failure to warn claims.” Id.

 Victims’ Design defect claims “must fail.”

“Plaintiffs have not provided sufficient evidence to support their design defect claims under a theory of either strict liability or negligence because they have not demonstrated that they can prove causation. Plaintiffs’ claimed design defect is the presence of a memory recoil ring subject to breaking, buckling, or both. See DE-MDL 5209 at 10, 45–46. As detailed at length above, Plaintiffs have not provided any admissible evidence that this alleged defect caused Ms. Olmo’s injuries. Furthermore, Dr. Comperatore testified that the complications that Ms. Olmo experienced—folding, adhesions, and fistulas—were known risks of any hernia patch, with or without a ring, at the time of the implant. Thus, Plaintiffs have not established that an unreasonably dangerous condition of the CK Patch proximately caused Ms. Olmo’s injuries, and their design defect claims must fail.” Id.

Court conclusion

  • “Defendants’ Motion to Exclude the Testimony of Plaintiffs’ Expert Dr. Paul
    Ducheyne, Ph.D.  is GRANTED.”
  • “Defendants’ Motion for Summary Judgment  is GRANTED.”
  • “Summary judgment is entered in favor of Defendants and against Plaintiffs.
    The Court will enter a separate Final Judgment consistent with this Order.” Id.