Alivecor, Inc. v. Apple, Inc.

District Court, N.D. California·Decided February 13, 2024·No. 4:21-cv-03958·Unknown

Opinion

ALIVECOR, INC., Case No. 21-cv-03958-JSW Plaintiff, ORDER RESOLVING CROSS- v. MOTIONS FOR SUMMARY JUDGMENT; ALIVECOR'S MOTION APPLE, INC., TO EXCLUDE EXPERT REPORT AND TESTIMONY OF SARAH BUTLER; Defendant. ALIVECOR’S MOTION TO EXCLUDE CERTAIN OPINIONS AND TESTIMONY OF LAUREN J. STIROH, PH.D.; APPLE'S MOTIONS TO EXCLUDE THE TESTIMONY OF DR. ROOZBEH JAFARI AND DR. MICHAEL CRAGG; ALIVECOR’S MOTION TO STRIKE CERTAIN PORTIONS OF THE DECLARATION OF DR. STEPHEN WAYDO; AND ALIVECOR’S MOTION FOR LEAVE TO FILE SURREPLY Re: Dkt. Nos. 191, 192, 193, 214, 217, 221, 228, 243 Now before the Court are Plaintiff AliveCor, Inc.’s (“AliveCor”) Motion for Partial Summary Judgment (Dkt. No. 193) and Defendant Apple, Inc.’s (“Apple”) Cross-Motion for Summary Judgment (Dkt. No. 221). Also before the Court are a number of attendant evidentiary motions: AliveCor’s Motion to Exclude Certain Opinions and Testimony of Lauren J. Stiroh, Ph.D. (Dkt. No. 191); AliveCor’s Motion to Strike and Exclude the Expert Report and Testimony of Sarah Butler (Dkt. No. 192); Apple’s Motion to Exclude Dr. Roozbeh Jafari (Dkt. No. 214); Apple’s Motion to Exclude Dr. Michael Cragg (Dkt. No. 217); AliveCor’s Motion to Strike Certain Portions of the Declaration of in Further Opposition to Apple’s Motion to Exclude Dr. Roozbeh Jafari. The Court has considered the parties’ papers, relevant legal authority, supplemental authority submitted in response to the Court’s questions, the record in this case, and oral argument. For the following reasons, the AliveCor’s motions to exclude or strike are DENIED. Apple’s Motion to Exclude Dr. Jafari is GRANTED. AliveCor’s Motion for Leave to File a Sur- reply is DENIED. Apple’s Motion to Exclude Dr. Cragg is DENIED. AliveCor’s Motion for Partial Summary Judgment is DENIED. Apple’s Motion for Summary Judgment is GRANTED. The following facts are undisputed, unless otherwise indicated. A. The Apple Watch Provides Mechanisms for Heartrate Detection and Analysis. Apple released the Apple Watch with a photoplethysmography sensor (“PPG sensor”) to detect the wearer’s heartrate. Apple’s Workout Mode software converts the information picked up from the PPG sensor into useful metrics, including average heartrate value. The Workout Mode API1 reports information from one heartrate-interpreting algorithm at a time. From the Apple Watch’s launch until the release of watchOS 5, that algorithm was HRPO. HRPO reported an average heartrate value every five seconds, and it was particularly well-suited to determining heart rhythm in addition to heartrate. HRPO had drawbacks. In order to work reliably for heartrate detection, Workout Mode with HRPO required the Apple Watch wearer to select what kind of workout the wearer intended to perform. This required labor from Apple’s engineers for each specific exercise type, and it impaired Apple Watch’s reliability for wearers who engaged in multiple forms of exercise or whose exercise involved intervals. According to Apple, HRPO also drained the Apple Watch’s battery and occupied valuable storage space. The parties dispute whether Apple’s removal of HRPO was motivated by a desire to address these drawbacks or to cut out competition for medical monitoring apps on the Apple Watch. Whatever the underlying motivation, Apple replaced the heartrate reporting algorithm in Workout Mode with the Heart Rate Neural Network (“HRNN”) with the introduction of watchOS 5. HRPO remained on the Apple Watch, and Workout Mode would use HRPO values if HRNN failed to report a heartrate within the first minute of activation. After one minute of activation, Workout Mode switched to HRNN, and HRPO continued to run in the background. If HRNN reported a value within the first minute of activation of Workout Mode, HRNN values would be reported instead of HRPO values. The Apple Watch in watchOS 5 used HRPO for other purposes, including the High Heart Rate Notification feature (“HHRN,” not to be confused with HRNN). HHRN alerts users if their heartrate is high during rest. Apple removed HRPO from the Apple Watch entirely in 2021. In the years since Apple replaced HRPO with HRNN in Workout Mode, the number of third-party apps using Workout Mode grew from . With watchOS 5, Apple also introduced the Irregular Rhythm Notification feature (“IRN”). IRN reports to the wearer that the wearer may be experiencing atrial fibrillation (“Afib”) if an abnormal rhythm is detected. Upon its release, IRN used inputs from , an algorithm that uses the PPG signals to generate tachograms. IRN now relies on a different heartrate algorithm, , which provides periodic, high-confidence measurements of the wearer’s heart rhythm when the wearer is completely still. IRN is FDA-approved and has been enabled by up to users. However, IRN does not work for individuals who have a diagnosis of Afib, and it does not work if the wearer is in motion. Both are available to third-party app developers through the Tachogram API. The Tachogram API generates tachograms 4-6 times per day, when the watch wearer is at rest. The wearer can obtain a tachogram upon demand by using Apple’s Breathe app, but third-party developers do not have a mechanism for activating the Tachogram API to generate a tachogram on demand or continuously. B. AliveCor Launched and Removed a Heart Rhythm Analysis App Feature. Two companies, AliveCor and a competitor Cardiogram, used Workout Mode with HRPO able to launch its heartrate analysis app because of the change from HRPO to HRNN, and Cardiogram remains unable to tell wearers if they have Afib. Apple contends that Cardiogram nevertheless provided continuous heartrate monitoring via the Workout Mode API after watchOS 5 and as recently as December 2021. AliveCor created the Kardia app to help users monitor and record heart-related health data. The Kardia app was free to use, but a premium version was available which required a paid annual subscription. AliveCor developed an algorithm, SmartRhythm, available in the premium version of the Kardia app, to send alerts to the wearer if they may be in Afib and to prompt the wearer to take an electrocardiogram (“ECG”). SmartRhythm worked in concert with AliveCor’s KardiaBand, a hardware replacement for the Apple Watch band that was equipped with ECG sensors. SmartRhythm was clinically validated to detect Afib. The KardiaBand was cleared by the Food and Drug Administration (“FDA”) as a medical device accessory for the Apple Watch. As of 2019, AliveCor had sold around 12,000 KardiaBands in the United States. The Kardia app had over 1600 daily users. When HRNN replaced HRPO in Workout Mode, AliveCor conducted internal tests that, according to AliveCor, demonstrated that SmartRhythm was no longer functioning properly. AliveCor trained SmartRhythm on HRNN, but it did not achieve the same accuracy as it had with HRPO. AliveCor thus withdrew SmartRhythm from its Kardia app and stopped selling KardiaBands in June 2019. Apple disputes that SmartRhythm’s performance was impaired by the switch to HRNN. AliveCor did not invest in retraining SmartRhythm because it feared that the watchOS would continue to change in ways that would degrade the available data’s suitability for heart rhythm analysis. AliveCor further opted not to use another of Apple’s heartrate algorithms because they did not suit AliveCor’s medical monitoring goals. For example, Tachogram API’s intermittent activation prevents a third-party app developer from continuously monitoring tachogram outputs was able to use continuously for the SmartRhythm feature of the Kardia app. The Kardia app remains available on iOS without SmartRhythm. C. The Current Action. AliveCor brings claims against Apple relating to its removal of third-party access to HRPO and AliveCor’s subsequent withdrawal of SmartRhythm. AliveCor alleges Monopolization and Attempted Monopolization under Section 2 of the Sherman Act, 15 U.S.C. §

Alivecor, Inc. v. Apple, Inc., (N.D. Cal. 2024).

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