Thousands of lawsuits against C.R. Bard allege that the company’s surgical mesh products have harmed patients. Cases involving mesh used to repair hernias have been consolidated in the Southern District of Ohio. In a recent decision, that court considered whether a surgeon’s expert testimony about specific causation should be admitted or excluded.
MDL Litigation
When similar lawsuits from around the country end up in federal court, they may be consolidated for pretrial proceedings using multidistrict litigation (MDL) procedures. Consolidation allows plaintiffs to coordinate and share discovery. It also enables a single court to resolve pretrial issues that are common to each of the individual cases. Consolidation arguably promotes the efficient and uniform determination of pretrial motions, although whether it actually does so is the subject of much debate.
Since cases are often removed from state courts that require early designation of expert witnesses, it can be difficult for an MDL judge to resolve Daubert issues efficiently. Different plaintiffs often designate different experts. While procedures vary, a plaintiffs’ steering committee will typically select expert witnesses and other plaintiffs’ lawyers will either adopt those experts or reject them and designate their own.
Experts who testify about general causation can have a far-reaching impact on pending cases. General causation is the concept that a product or substance is capable of causing harm to a patient. When a court grants summary judgment because the consolidated plaintiffs have no admissible expert evidence that a product or substance is capable of causing an alleged harm, all the plaintiffs may lose their cases.
Specific causation focuses more narrowly on opinions that pertain to each specific plaintiff. For that reason, the decision to admit or not to admit specific causation testimony might only affect a specific plaintiff, not the entire universe of plaintiffs who have been consolidated in the MDL.
Specific Causation Expert
Steven Johns is the plaintiff in the first case selected for trial in the Bard MDL. A Bard mesh was implanted in Johns to correct a hernia. Additional surgeries followed that Johns attributed to the failure of the mesh. Johns brought claims under Utah law alleging manufacturing and design defects in the mesh as well as a failure to warn of risks associated with the product.
Johns designated Dr. David Grischkan as a specific causation expert. Dr. Grischkan opined that the Bard mesh at issue caused Johns to suffer adhesions when its coating failed. The coating covers one side of the polypropylene mesh. The coating is designed to decay slowly so that the mesh will be gradually absorbed into the organ against which it is placed. That slow decay, which Bard advertised as occurring over “less than 30 days,” is intended to safeguard against the risk that the mesh will cause adhesions. The formation of adhesions may result in organs and tissues sticking together.
According to Dr. Grishkan, the coating failed to decay slowly. Instead, the mesh was rapidly absorbed into Johns’ organs, quickly exposing them to the polypropylene mesh. Dr. Grishkan noted that Bard’s own studies show that the coating can disappear in less than seven days, which is not enough time to avoid the formation of adhesions during the healing process. Dr. Grishkan’s determined that adhesions attributable to Bard’s product caused Johns’ pain and distress, leading to surgery to remove and replace the mesh.
Expert Qualifications
Bard filed a Daubert motion to exclude Dr. Grishkan’s testimony. Bard complained that Dr. Grischkan is a surgeon, not an expert in mesh design. He did not claim expertise in the chemicals used to coat the mesh that was implanted into Johns and, according to Bard, was unqualified to opine that the coating disintegrated too rapidly.
Parsing Dr. Grischkan’s proposed testimony, the court agreed that the doctor’s experience using mesh products to repair hernias did not qualify him to explain why the coating failed to perform as advertised. He had no experience using the coated product. Nor did he have experience with bioengineering or biochemistry. He could not say how the particles in the coating are broken down by the human body. His review of animal studies and other literature fell short of making him an expert on the coating used on the Bard mesh product.
The court nevertheless recognized that Dr. Grishkan did not need to explain how the coating failed to express an opinion that it failed and that the failure injured Johns. Dr. Grishkan has years of personal experience using a variety of mesh devices to repair hernias. He has personally observed the damaging effects caused by polypropylene mesh. He is capable of recognizing complications caused by mesh when he sees them. His training and experience qualified him to testify about the ways in which polypropylene mesh causes complications after its implantation.
Reliability of Expert Methodology
Dr. Grishkan performed a differential diagnosis to rule out other possible causes of Johns’ continuing medical problems. The rapid absorption of Bard’s polypropylene mesh was the only cause he could not rule out. Dr. Grishkan was qualified to make a differential diagnosis.
The court rejected Bard’s attack on the reliability of Dr. Grishkan’s differential diagnosis. Bard made no showing that Dr. Grishkan inappropriately ruled out other potential causes. Nor did Bard identify potential causes that Dr. Grishkan failed to consider. Rather, Bard complained that Dr. Grishkan “ruled in” the fast absorption of its polypropylene mesh as a potential cause of adhesions when he had no basis for doing so.
The court recognized that Dr. Grishkan relied on medical records that supported his view of the speed at which the mesh was absorbed. Surgical findings made clear that the coating failed to protect Johns’ organs from adhesions and therefore did not serve its intended purpose. Reliance on those facts to form an opinion was a reliable methodology.
Bard also complained that Dr. Grishkan improperly relied on Bard’s internal documents. The court concluded that Dr. Grishkan based his opinion largely on his experience and a review of Johns’ medical records. Experts have wide latitude to consider a variety of facts when they form opinions. The fact that Dr. Grishkan bolstered his opinion with information he found in Bard’s corporate documents did not render his methodology unreliable.
Future Pain and Medical Care
The court agreed, however, that Dr. Grishkan’s opinion about Johns’ ongoing pain and need for future surgery was speculative. Johns’ adhesions were corrected with the same Bards’ mesh. While Dr. Grishkan thought that Johns’ current pain might result from a similar failure of that product, his opinion was not based on a new medical examination. Dr. Grishkan’s opinion that similar problems likely have similar causes did not strike the court as being based on a reliable methodology.
Accordingly, the court allowed Dr. Grishkan to testify that Johns suffered from adhesions caused by the absorption of the Bard mesh and that Johns needed another surgery because the mesh was absorbed too quickly. However, the court did not allow Dr. Grishkan to testify that any problems Johns had after that surgery are related to implantation of another mesh of the same design.
Adequacy of Warnings
Dr. Grischkan also proposed to testify that Bard’s warnings were insufficient to alert doctors about the risks associated with the surgical mesh. The warnings indicate that the coating disappears in “less than 30 days.” Yet Bard’s internal documents show that that the coating can be completely absent within seven days. Dr. Grischkan opined that doctors would want to know that information before deciding whether to take the risk of implanting the product.
Dr. Grischkan’s report stated that any reasonable surgeon would understand Bard’s warning to mean that the coating would remain intact during the healing period and that implantation was therefore safe. Because that representation was contrary to experience, and because Bard’s warning failed to mention various complications that could arise from implanting the mesh, Dr. Grischkan regarded the warning as deficient.
The court concluded that Dr. Grischkan had sufficient experience with surgical mesh to testify about the warning’s adequacy. He could not testify about the adequacy of the warnings from a legal or regulatory perspective, but he could explain whether the warnings adequately disclosed risks that a surgeon would want to understand before deciding to use the product.
