Higgins v. Boston Scientific Corporation

Background

Steven Higgins brought this qui tam action under the federal False Claims Act and the California False Claims Act on behalf of the United States and California. He alleged that Boston Scientific Corporation pursued FDA approval and sold defective Cognis and Teligen cardiac defibrillator devices, called the “C/T Devices,” and engaged in kickback schemes. The operative complaint alleged that Version 1 devices had serious defects and that Boston Scientific later released redesigned Version 2 devices.

Higgins had previously sought to substitute Dr. Lawrence Mayer for another affirmative expert witness. The court denied that request because Higgins had not been diligent in meeting the expert-disclosure deadline. The court did not then decide whether Dr. Mayer could later serve as a rebuttal expert.

The Parties’ Positions

Boston Scientific moved under Federal Rules of Civil Procedure 26 and 37 to strike Dr. Mayer’s report and exclude his testimony at trial. It argued that the report was not rebuttal evidence but instead a repackaged affirmative opinion that Higgins intended to use in his main case. Alternatively, Boston Scientific asked to designate another expert to respond to Dr. Mayer.

Higgins argued that Dr. Mayer’s report properly responded to the opinions of Boston Scientific’s medical expert, Dr. Kenneth Ellenbogen. Dr. Ellenbogen opined that Version 1 devices were safe and effective when properly implanted. Dr. Mayer analyzed mortality rates for patients implanted with Version 1 and Version 2 devices and concluded that Version 1 was associated with higher mortality.

Analysis

Rule 26 requires parties to disclose expert testimony according to the court’s schedule. Rebuttal testimony is evidence offered to explain, counter, or disprove the opposing party’s evidence on the same subject; it may not be used to establish the offering party’s main case. Rule 37 allows exclusion of undisclosed evidence unless the failure to disclose was substantially justified or harmless.

The court compared the two expert reports and concluded that Dr. Mayer’s report did not rebut Dr. Ellenbogen’s report. Dr. Ellenbogen addressed whether Version 1 was safe and effective based on his medical experience and did not offer an opinion about the safety or effectiveness of Version 2. Dr. Mayer, by contrast, performed a statistical comparison of mortality rates for the two versions. The court found that this comparison offered an affirmative theory that Version 1 was unsafe, rather than explaining, countering, or disproving Dr. Ellenbogen’s testimony.

The court also relied on Dr. Mayer’s deposition testimony and the history of the disclosures. That evidence showed that Dr. Mayer had originally been retained to perform a statistical comparison of the two device versions and that the later report differed primarily in the size of the data set. The court therefore found that Higgins was attempting to use rebuttal designation to introduce testimony that should have been disclosed as affirmative expert evidence.

Applying Rule 37, the court found that the failure to identify Dr. Mayer as an affirmative expert was neither substantially justified nor harmless. Higgins already had two other affirmative experts who supported the view that Version 1 devices were unsafe and ineffective. Allowing Dr. Mayer’s statistical analysis would prejudice Boston Scientific because it did not have an expert prepared to rebut that analysis. The court also found that Higgins had provided little explanation for missing the disclosure deadline and that the contentious history and late stage of the litigation weighed against a continuance.

Disposition

The court granted Boston Scientific’s Motion to Strike and Exclude the Testimony of Lawrence Mayer. It ordered that Dr. Mayer’s testimony be stricken and excluded. The court did not reach whether Boston Scientific had shown good cause to modify the scheduling order to add an expert responding to Dr. Mayer’s report. The order also stated that prior consistent orders remained in effect.