Edwards Lifesciences Corporation v. Meril Life Sciences Pvt. Ltd.

Background

Edwards Lifesciences Corporation sued Meril Life Sciences Pvt. Ltd. for patent infringement, trademark infringement, and unfair competition. Both companies manufacture artificial heart valves. Edwards alleged that Meril falsely advertised the safety and effectiveness of its Myval valve, including by misrepresenting clinical-trial results. Edwards also alleged that Meril willfully infringed the PARTNER trademark by using “PARTNER THE FUTURE” in a way likely to confuse consumers.

The court had previously granted summary judgment of no patent infringement, concluding that Meril’s activities fell within the statutory safe harbor for certain activities related to regulatory submissions. The claims remaining for trial were trademark infringement and unfair competition.

Rulings on Motions in Limine

A motion in limine asks the court to decide before trial whether particular evidence or arguments may be presented to the jury. The court also considered motions under Federal Rule of Evidence 702, which governs the admission of expert testimony, and Federal Rule of Civil Procedure 37, which can restrict evidence when a party fails to make required disclosures.

Meril’s Motion in Limine No. 1

Meril sought to prevent Edwards from presenting liability theories, damages theories, calculations, documents, and testimony that Meril said were not timely disclosed during discovery. The court denied Meril’s motion. It found that Meril had not shown harm from the allegedly late disclosures. Among other things, Meril’s own physician expert had addressed three allegedly new false statements, and Meril had received notice of Edwards’ requests for goodwill and corrective-advertising damages before the close of fact discovery.

Meril’s Motion in Limine No. 2

Meril sought to exclude evidence of unrelated alleged bad acts under Rules 403 and 404(b) of the Federal Rules of Evidence. The court granted the motion in part and denied it in part.

The court granted the motion as to evidence that Meril allegedly copied Edwards’ intellectual property. Edwards could not present evidence about Meril’s MAGMA trademark dispute, Meril’s Instructions for Use for the Myval valve, or visual similarities between the Myval and Edwards’ SAPIEN 3 valve. The court found that this evidence had limited relevance to Edwards’ trademark claims and risked confusing or prejudicing the jury.

The court denied Meril’s request to prevent Edwards from arguing that Meril fabricated data presented at cardiovascular conferences. The court found that alleged fabrication was direct evidence relevant to whether Meril intentionally falsified advertised data and whether the data was important to consumers.

Meril’s Motion in Limine No. 3

Meril sought to exclude a report that it had filed with the Polish Center for Testing and Certification. The court granted the motion in part and denied it in part.

Edwards could not use the report to argue that Meril’s statement that Myval was “CE APPROVED” was misleading, or to support the materiality and tendency-to-deceive elements of its false-advertising claim. The court was concerned that the evidence would lead to a confusing trial about whether Polish regulators should have approved Myval, and the record did not show how the regulators made their decision or what information they considered important.

However, Edwards could refer to the average 12-month Kansas City Cardiomyopathy Questionnaire score in the report as evidence that Meril’s representations at a 2019 conference were false. Edwards could do so without elaborating on the regulatory approval process.

Edwards’ Motion in Limine No. 1

Edwards sought to prevent references at trial to another court’s prior ruling excluding or limiting expert testimony, including a ruling involving Edwards’ damages expert, Michael Wagner. The court tentatively granted Edwards’ motion, without prejudice to Meril raising the issue again depending on Wagner’s testimony at trial. The court explained that prior expert-evidence rulings could receive undue weight from jurors and could create confusing side trials about the earlier case.

Edwards’ Motion in Limine No. 2

Edwards sought to exclude Meril’s evidence about its costs or profit margin for Myval and related products, arguing that Meril had not properly produced financial documents. The court found no basis to exclude that evidence under Rule 37. It found that Meril produced the documents on time after a discovery order and that Edwards had not shown harm from the timing. The court also stated that a new motion to compel, rather than a motion in limine, would have been the proper method for challenging the substance of Meril’s production. The excerpt does not state an express final grant or denial of this motion.

Testimony of Nimesh Desai and Joseph Bavaria

Meril sought to preclude portions of testimony from Edwards’ medical experts, Nimesh Desai, M.D., Ph.D., and Joseph Bavaria, M.D. The court granted in part and denied in part Meril’s motion.

The court granted the motion as to opinions that Desai and Bavaria had not disclosed in their expert reports, including new opinions elicited during depositions. The court also excluded Desai’s attempt to adopt Bavaria’s entire 60-page report without providing independent analysis. The court found that these disclosures did not comply with the required expert-report rules and that Edwards’ deposition questioning was not substantially justified or harmless.

Desai could explain differences and patterns in the clinical-trial data presented at specified medical conferences, to the extent he was qualified to do so. But neither Desai nor Bavaria could testify that Meril intentionally presented false data, and Desai could not testify that Meril’s explanation about typographical errors was scientifically false.

The court also excluded Desai’s opinions that Meril violated professional, ethical, or Good Clinical Practice obligations to preserve underlying clinical-study data. The court considered those issues too disconnected from the questions the jury would decide and found that presenting them would risk confusion and wasted time.

Finally, Bavaria could not testify that Meril was a “copier” or give expert opinions about the harm Meril allegedly caused to Edwards’ reputation or brand. The court found that Bavaria’s opinions on those subjects were not based on specialized medical or scientific expertise and largely summarized evidence that Edwards’ lawyers could present and argue themselves.

Michael Wagner’s Damages Testimony

Meril sought to exclude Wagner’s opinions about loss of goodwill, future corrective advertising, and disgorgement of Meril’s foreign profits. The court granted in part and deferred in part the motion.

The court excluded Wagner’s opinion that Edwards spent approximately $1.7 billion building goodwill in its PARTNER trademark and SAPIEN product line. It found unreliable Wagner’s inclusion of research and development costs and clinical-trial costs because he did not identify a reliable economic or marketing method supporting their inclusion. Wagner also could not testify about those research, development, or clinical-trial expenses.

The court granted the motion as to Wagner’s testimony about the total cost of Edwards’ future advertising campaign. The court found that his calculations relied on estimates supplied by Edwards and basic arithmetic that counsel could explain to the jury, rather than specialized expertise.

The court deferred ruling on Wagner’s opinion about the amount of Meril’s sales and profits to be disgorged. The parties agreed that, if there were a liability verdict, disgorgement would be addressed by the court after trial.

Disposition

The order resolved the specified motions as described above and stated that the court would continue issuing rulings on remaining motions in limine on a rolling basis. Judge Haywood S. Gilliam, Jr. signed the order on January 27, 2022.