Higgins v. Boston Scientific Corporation

Background

Dr. Steven Higgins brought this case on behalf of the United States and California under the federal False Claims Act and California’s equivalent statute. The False Claims Act permits a private person to pursue claims on the government’s behalf when the government declines to do so. Higgins alleged that Boston Scientific Corporation fraudulently induced the Food and Drug Administration (FDA) to approve Version 1 Cognis and Teligen implantable defibrillators by failing to disclose information about defects in their header setscrews and lead connections.

According to Higgins, medical providers then submitted claims for payment to federal health insurance programs and California Medicaid for devices that were defective, misbranded, or not medically necessary. He also alleged that Boston Scientific continued misleading the FDA after the devices were approved. The United States and California declined to intervene in 2016. The court later allowed Higgins to amend his complaint, denied a renewed motion to dismiss, and ultimately considered Boston Scientific’s motion for summary judgment. The magistrate judge had excluded testimony from one of Higgins’s experts, and the court affirmed that decision while the other motions were pending.

Summary-judgment standard

The court explained that summary judgment must be granted when there is no genuine dispute about a fact that could affect the result and the moving party is entitled to judgment as a matter of law. The court viewed disputed facts in the light most favorable to Higgins, the party opposing summary judgment.

Claims and theories

Higgins’s theories depended on proving that Boston Scientific caused third parties to submit false claims by fraudulently inducing the FDA to approve or continue approving the devices. The court identified the relevant fraudulent-inducement elements as: a false record or statement, knowledge that the statement was false, materiality, and a claim seeking government payment or forfeiture of money.

“Materiality” means that the statement had a natural tendency to influence, or was capable of influencing, the government’s payment or approval decision. The court emphasized that the False Claims Act’s materiality requirement is demanding.

Initial FDA approval

Higgins identified several alleged misrepresentations concerning the FDA’s May 2008 approval of Version 1 devices. He argued that Boston Scientific falsely said that no follow-up data from the European COGENT trial was yet available, falsely stated that incomplete lead insertion was no longer an issue after physician training, falsely reported that there had been no unanticipated adverse device effects, and omitted three adverse events from a clinical-report appendix.

The court found fact disputes about whether some of those statements or omissions were false or misleading. It found, however, that no reasonable jury could find them material to the FDA’s approval decision:

- The FDA received COGENT data before approving the devices, so the earlier statement about unavailable follow-up data could not have been material. - The FDA received the underlying information about adverse events and nevertheless approved the devices, which strongly indicated that any statement about unanticipated events was not material. - The FDA had data showing that training reduced, but did not eliminate, connection problems, so the statement about training could not have been material even if it was false. - The three allegedly omitted events were similar to events already reported, and Higgins offered no evidence that including them would have changed the FDA’s decision.

The court also rejected Higgins’s argument that Boston Scientific concealed information by placing it in a lengthy appendix or classifying some events as “noise.” The events were reported to the FDA, and the court concluded that the theory treating the information as improperly “buried” did not apply in this regulatory setting. The court separately found that Boston Scientific had no established legal duty to report five additional events that occurred after the clinical report was submitted but before approval.

Continued FDA approval

Higgins also argued that Boston Scientific fraudulently obtained the FDA’s continued approval by failing to report an August 2008 training document as a labeling change and by failing to report device issues as five-day medical-device reports.

The court assumed, for purposes of its analysis, that the failure to report the training document could have been an omission. It nevertheless found no evidence that the omission was material because FDA staff had reviewed the document, flagged it for possible further review, and did not determine that it violated the labeling rules.

The court also found that Boston Scientific had submitted medical-device reports and that the FDA had reviewed them by February 2009. The FDA did not recommend a recall until July 2009 and did not find that Boston Scientific violated the reporting requirement. The court viewed this delay, as well as the FDA’s later receipt of the full information through the Version 2 submission, as further evidence that the alleged reporting failures were not material.

Ruling

The court held that Higgins had not presented evidence allowing a reasonable jury to find that any Boston Scientific misrepresentation or omission was material to the FDA’s initial or continued approval of the devices. Because materiality was an essential element of every theory of liability, the court concluded that no reasonable jury could find Boston Scientific liable under any of them.

The court declined to decide the parties’ motions to exclude expert testimony because, even assuming that only Higgins’s expert testimony was admissible, Higgins still could not prove materiality. The court ordered that Boston Scientific Corporation’s motion for summary judgment was GRANTED and directed that judgment be entered accordingly.