Gareis v. 3M Company

Background

Louis Gareis and Lillian Gareis sued 3M Company and Arizant Healthcare, Inc. for injuries that Louis Gareis alleged he suffered through use of the Bair Hugger patient-warming system during surgery. The case was identified as the first bellwether case in the Bair Hugger multidistrict litigation.

Before trial, the Court granted in part defendants’ motion for summary judgment on the plaintiffs’ claims for negligence, failure to warn, unfair and deceptive trade practices, misrepresentation, and unjust enrichment. On May 30, 2018, a jury returned a verdict for defendants on the remaining strict-liability design-defect claim. The jury found that the plaintiffs had not proved that the Bair Hugger was unreasonably dangerous for its intended use, that a reasonably safer alternative design existed, or that Louis Gareis’s injury would not have occurred without use of the device.

The plaintiffs moved for a new trial under Federal Rule of Civil Procedure 59. The Court explained that a new trial requires a legal error or other problem that caused a miscarriage of justice, and that the moving party must show prejudice—meaning a meaningful effect on the result.

Plaintiffs’ Arguments About Pretrial Rulings

The plaintiffs first argued that the Court should not have applied South Carolina substantive law. They also argued that the Court incorrectly applied that law when it granted in part defendants’ summary-judgment motion and dismissed the negligence, failure-to-warn, unfair-and-deceptive-trade-practices, misrepresentation, and unjust-enrichment claims.

The Court rejected both arguments and denied the new-trial motion as to those grounds. It did not identify an error in its decision to apply South Carolina law or in its decision on the dismissed claims.

Excluded Evidence

The plaintiffs challenged the exclusion of three categories of evidence: defendants’ knowledge of the Bair Hugger’s risks and utility; evidence of multiple alternative designs; and evidence about the Bair Hugger’s filtration system, internal contamination, and heater-cooler recalls.

The Court first held that the plaintiffs had not shown prejudice from excluding the evidence. It also held that the exclusions were proper. Under South Carolina’s risk-utility test for a design-defect claim, a plaintiff must identify a design flaw, present evidence of a reasonable alternative design, and show how that alternative would have prevented the product from being unreasonably dangerous. The Court stated that this test focuses on the condition and design of the product, not the manufacturer’s mental state. Evidence of what defendants knew about the product’s risks and utility therefore did not address an element of the strict-liability claim and was irrelevant.

The Court found that the plaintiffs cited no South Carolina authority requiring admission of additional alternative designs. It also found that the plaintiffs gave no reason to reverse the rulings excluding evidence about the filtration system or heater-cooler recalls. The Court therefore denied the motion as to these evidentiary exclusions.

Admitted Expert Evidence

The plaintiffs challenged six instances of expert evidence and testimony that they said had not been properly disclosed under Federal Rule of Civil Procedure 26. Rule 26 requires disclosure of an expert’s opinions, supporting information, and exhibits, and requires supplementation when a report becomes materially incomplete or incorrect. Evidence may be excluded for a disclosure violation unless the failure was substantially justified or harmless.

1. Airflow visualization video. The Court held that plaintiffs had notice of the video through the multidistrict litigation’s science day, prior filings, a deposition, an expert report, and other materials. The Court therefore found no disclosure violation. It also held that any violation would have been harmless.

2. Saarinen study. The Court allowed testimony and a video concerning the study because the plaintiffs’ expert had cited it, defendants’ expert had heard the plaintiffs’ expert discuss it at trial, and defendants’ expert report addressed the underlying airflow phenomenon. The Court held that admitting the evidence did not violate Rule 26 and was not sufficiently prejudicial to justify a new trial.

3. Michael Keen and electrocautery machines. The Court found that the plaintiffs had objected to a different question than the one they described in their motion. The Court also found that the plaintiffs identified no relevant questioning or testimony about whether electrocautery machines blow air into an operating room. The argument therefore did not support a new trial.

4. Michael Keen and the computational-fluid-dynamics study. The Court had allowed Keen to testify only about differences between the operating room modeled in the plaintiffs’ expert’s study and Louis Gareis’s actual operating room, which Keen had personally observed. The Court found no error in allowing that testimony and held that the plaintiffs had not shown prejudice.

5. Dr. Hannenberg and American Society of Anesthesiologists scores. The plaintiffs argued that Dr. Hannenberg had not disclosed testimony about these scores in his report or deposition. The Court stated that, even if allowing the testimony had been error, the plaintiffs had not attempted to show prejudice. A new trial was therefore unwarranted.

6. Food and Drug Administration reference. Before trial, the Court had excluded references to the Food and Drug Administration’s clearance of the Bair Hugger and to an agency letter concerning an association between infections and similar devices. During trial, defense counsel began asking a question about the agency’s examination of that issue, but the witness never answered, the plaintiffs objected, and the Court restricted further questioning. The Court held that there was no testimony to strike and that its instructions that lawyers’ questions are not evidence cured any possible prejudice.

The Court also declined to order a new trial based on other alleged evidentiary errors that the plaintiffs mentioned but did not explain in their supporting memorandum. The Court stated that the plaintiffs’ references to alleged errors in the jury instructions and special verdict were too unclear for the Court to rule on.

Disposition

The Court denied the plaintiffs’ Motion for a New Trial, ECF No. 482, and ordered that judgment be entered accordingly.