Expert Testimony Missteps Lead to New Trial in Medical Device Patent Dispute

Trudell Med. Int’l Inc. v. D R Burton Healthcare, LLC

Authored by: Jeremy J. Gustrowsky

In a recent decision, the Federal Circuit ordered a new trial in the patent dispute between Trudell Medical International Inc. and D R Burton Healthcare, LLC, focusing on devices for oscillatory positive expiratory pressure (OPEP) therapy. Trudell, the owner of U.S. Patent No. 9,808,588, claimed that D R Burton’s OPEP products infringed several claims of its patent. While the jury found the patent valid, it did not find infringement—a result heavily influenced by the testimony of D R Burton’s expert, Dr. John Collins.

The heart of the issue was the improper admission of Dr. Collins’ noninfringement testimony. D R Burton failed to provide a timely expert report from Dr. Collins as required by the rules of civil procedure. His only declaration on noninfringement was submitted after the close of discovery, leaving Trudell with no chance to depose him on these opinions. The Federal Circuit found that this late disclosure was neither substantially justified nor harmless, and that simply allowing cross-examination at trial did not cure the prejudice to Trudell.

Additionally, the court found Dr. Collins’ testimony unreliable because it contradicted the district court’s claim constructions and was not based on sound methodology. For example, he misinterpreted the patent’s requirements regarding the device’s components and compared the accused products to figures in the patent rather than the actual claim language. This, the court said, further justified excluding his testimony.

As a result, the Federal Circuit reversed the district court’s decision to admit Dr. Collins’ testimony and ordered a new trial on infringement before a different judge, citing concerns about the appearance of fairness in the original proceedings. However, the court did not overturn the jury’s verdict on noninfringement outright, since the jury could have found Trudell failed to meet its burden even without Dr. Collins’ testimony. The case will now return to the district court for a new trial, this time with stricter adherence to expert disclosure rules.