General Surgery Expert’s Opinion on Biological Mesh Admitted Due to Reliance on Facts and Data

In this product liability case, the plaintiffs alleged that the defendant failed to adequately warn practitioners about the side effects of a hernia repair mesh product.

Wendy Ketner, M.D.

Written by
— Updated on April 25, 2022

General Surgery Expert’s Opinion on Biological Mesh Admitted Due to Reliance on Facts and Data

Court: United States District Court for the Eastern District of Michigan, Southern Division
Jurisdiction: Federal
Case Name: Avendt v. Covidien Inc.
Citation: 262 F. Supp. 3d 493

The defendant then retained a general surgery expert witness to support its claim for summary judgment. The expert opined on the considerations physicians make before deciding on the use of a hernia mesh. 

Facts

The plaintiffs—a husband and wife—filed a product liability suit against the defendant. The plaintiffs claimed the defendant failed to alert practitioners about the side effects of a hernia repair mesh device. The husband used the device to treat his recurring hernia. Additionally, the plaintiffs alleged that the defendant failed to sufficiently monitor the side effects of the device.

The plaintiffs contended that the product caused a chronic non-healing wound that was infected and needed further surgery. The defendant sought to proffer testimony of a general surgery expert witness to support its claim for summary judgment.

The Defendant’s General Surgery Expert Witness

The general surgery expert witness was a director of the cosmetic surgery branch at a medical school. The expert directed the general surgery/plastic surgery residency program at the university. He was also the head of the wound clinic at the university. The general surgery expert witness testified at his deposition on scientific guidelines for using biological mesh. He also opined on the considerations clinicians take when choosing the use of biological mesh for clinical presentations.

Additionally, the general surgery expert witness engaged in experiments investigating the implantation of biological hernia grafts. He primarily observed long-term histological and mechanical effects of an abdominal wall explant in a single case study. The expert has published articles on therapeutic guidelines for the use of biologics for hernia replacements, especially on the cross-linking of biomaterials. He claimed biologics are demonstrated when a clinician is unable to assess the wound condition in a complicated hernia setting. This is not demonstrated in any clearly contaminated abdominal wound.

The General Surgery Expert’s Opinion

The expert claimed clinicians must consider the features of the drug selected in the light of the specific conditions of each case and each surgical situation. Conditions can include case comorbidity, sterile or polluted area, etc. The expert stated that cross-linking is a natural procedure that reduces the number of patients. The graft’s form, its thickness and pores, will influence the rate at which the graft will occur.

The expert, as a clinician and not a cross-linking specialist, stated that the defendant’s product was a “partially cross-linking” drug. The drug was intended to maximize the number of collagen links between porcine dermis collagen fibers. He claims the treating doctor’s use of the product to patch the victim’s hernia was “off-label.” The use was “off-label” on the grounds of the instructions throughout the mesh. The expert claimed the surgeon’s off-label use of the mesh in the victim’s case was acceptable. He opined that the deficiency was one of recovery due to the prevalence of seroma—which hindered cellular absorption into the injury—and the prevalence of potential infection in the wound.

Discussion

The court noted that the general surgery expert was sufficiently qualified due to his training, education, and extensive experience. The expert was qualified to offer an opinion on the considerations clinicians make before deciding on the use of a hernia mesh. His opinions were based on sufficient facts and data and used a reliable methodology. The expert’s opinions were relevant as they would assist the finder of fact.

Ruling

The court admitted the general surgery expert witness’s testimony.

Key Takeaways for Experts

Not only is your training and experience critical, it’s also important to use a reliable methodology when forming your opinions. In this case, the expert based his opinions on sufficient facts and data. Your qualifications and methodology are crucial when it comes to meeting admissibility standards before the court.

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