Alivecor, Inc. v. Apple, Inc.

CourtDistrict Court, N.D. California
DecidedFebruary 13, 2024
Docket4:21-cv-03958
StatusUnknown

This text of Alivecor, Inc. v. Apple, Inc. (Alivecor, Inc. v. Apple, Inc.) is published on Counsel Stack Legal Research, covering District Court, N.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

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

Opinion

1 2 3 4 UNITED STATES DISTRICT COURT 5 NORTHERN DISTRICT OF CALIFORNIA 6 7 ALIVECOR, INC., Case No. 21-cv-03958-JSW Plaintiff, 8 ORDER RESOLVING CROSS- 9 v. MOTIONS FOR SUMMARY JUDGMENT; ALIVECOR'S MOTION 10 APPLE, INC., TO EXCLUDE EXPERT REPORT AND TESTIMONY OF SARAH BUTLER; 11 Defendant. ALIVECOR’S MOTION TO EXCLUDE CERTAIN OPINIONS AND 12 TESTIMONY OF LAUREN J. STIROH, PH.D.; APPLE'S MOTIONS TO 13 EXCLUDE THE TESTIMONY OF DR. ROOZBEH JAFARI AND DR. 14 MICHAEL CRAGG; ALIVECOR’S MOTION TO STRIKE CERTAIN 15 PORTIONS OF THE DECLARATION OF DR. STEPHEN WAYDO; AND 16 ALIVECOR’S MOTION FOR LEAVE TO FILE SURREPLY 17 Re: Dkt. Nos. 191, 192, 193, 214, 217, 221, 18 228, 243 19 20 Now before the Court are Plaintiff AliveCor, Inc.’s (“AliveCor”) Motion for Partial 21 Summary Judgment (Dkt. No. 193) and Defendant Apple, Inc.’s (“Apple”) Cross-Motion for 22 Summary Judgment (Dkt. No. 221). 23 Also before the Court are a number of attendant evidentiary motions: AliveCor’s Motion to 24 Exclude Certain Opinions and Testimony of Lauren J. Stiroh, Ph.D. (Dkt. No. 191); AliveCor’s 25 Motion to Strike and Exclude the Expert Report and Testimony of Sarah Butler (Dkt. No. 192); 26 Apple’s Motion to Exclude Dr. Roozbeh Jafari (Dkt. No. 214); Apple’s Motion to Exclude Dr. 27 Michael Cragg (Dkt. No. 217); AliveCor’s Motion to Strike Certain Portions of the Declaration of 1 in Further Opposition to Apple’s Motion to Exclude Dr. Roozbeh Jafari. 2 The Court has considered the parties’ papers, relevant legal authority, supplemental 3 authority submitted in response to the Court’s questions, the record in this case, and oral 4 argument. For the following reasons, the AliveCor’s motions to exclude or strike are DENIED. 5 Apple’s Motion to Exclude Dr. Jafari is GRANTED. AliveCor’s Motion for Leave to File a Sur- 6 reply is DENIED. Apple’s Motion to Exclude Dr. Cragg is DENIED. AliveCor’s Motion for 7 Partial Summary Judgment is DENIED. Apple’s Motion for Summary Judgment is GRANTED. 8 BACKGROUND 9 The following facts are undisputed, unless otherwise indicated. 10 A. The Apple Watch Provides Mechanisms for Heartrate Detection and Analysis. 11 Apple released the Apple Watch with a photoplethysmography sensor (“PPG sensor”) to 12 detect the wearer’s heartrate. Apple’s Workout Mode software converts the information picked up 13 from the PPG sensor into useful metrics, including average heartrate value. 14 The Workout Mode API1 reports information from one heartrate-interpreting algorithm at 15 a time. From the Apple Watch’s launch until the release of watchOS 5, that algorithm was HRPO. 16 HRPO reported an average heartrate value every five seconds, and it was particularly well-suited 17 to determining heart rhythm in addition to heartrate. 18 HRPO had drawbacks. In order to work reliably for heartrate detection, Workout Mode 19 with HRPO required the Apple Watch wearer to select what kind of workout the wearer intended 20 to perform. This required labor from Apple’s engineers for each specific exercise type, and it 21 impaired Apple Watch’s reliability for wearers who engaged in multiple forms of exercise or 22 whose exercise involved intervals. According to Apple, HRPO also drained the Apple Watch’s 23 battery and occupied valuable storage space. 24 The parties dispute whether Apple’s removal of HRPO was motivated by a desire to 25 address these drawbacks or to cut out competition for medical monitoring apps on the Apple 26 Watch. Whatever the underlying motivation, Apple replaced the heartrate reporting algorithm in 27 1 Workout Mode with the Heart Rate Neural Network (“HRNN”) with the introduction of watchOS 2 5. HRPO remained on the Apple Watch, and Workout Mode would use HRPO values if HRNN 3 failed to report a heartrate within the first minute of activation. After one minute of activation, 4 Workout Mode switched to HRNN, and HRPO continued to run in the background. If HRNN 5 reported a value within the first minute of activation of Workout Mode, HRNN values would be 6 reported instead of HRPO values. 7 The Apple Watch in watchOS 5 used HRPO for other purposes, including the High Heart 8 Rate Notification feature (“HHRN,” not to be confused with HRNN). HHRN alerts users if their 9 heartrate is high during rest. 10 Apple removed HRPO from the Apple Watch entirely in 2021. In the years since Apple 11 replaced HRPO with HRNN in Workout Mode, the number of third-party apps using Workout 12 Mode grew from . 13 With watchOS 5, Apple also introduced the Irregular Rhythm Notification feature (“IRN”). 14 IRN reports to the wearer that the wearer may be experiencing atrial fibrillation (“Afib”) if an 15 abnormal rhythm is detected. Upon its release, IRN used inputs from , an algorithm that 16 uses the PPG signals to generate tachograms. IRN now relies on a different heartrate algorithm, 17 , which provides periodic, high-confidence measurements of the wearer’s heart rhythm 18 when the wearer is completely still. IRN is FDA-approved and has been enabled by up to 19 users. However, IRN does not work for individuals who have a diagnosis of Afib, and it 20 does not work if the wearer is in motion. 21 Both are available to third-party app developers through the 22 Tachogram API. The Tachogram API generates tachograms 4-6 times per day, when the watch 23 wearer is at rest. The wearer can obtain a tachogram upon demand by using Apple’s Breathe app, 24 but third-party developers do not have a mechanism for activating the Tachogram API to generate 25 a tachogram on demand or continuously. 26 B. AliveCor Launched and Removed a Heart Rhythm Analysis App Feature. 27 Two companies, AliveCor and a competitor Cardiogram, used Workout Mode with HRPO 1 able to launch its heartrate analysis app because of the change from HRPO to HRNN, and 2 Cardiogram remains unable to tell wearers if they have Afib. Apple contends that Cardiogram 3 nevertheless provided continuous heartrate monitoring via the Workout Mode API after watchOS 4 5 and as recently as December 2021. 5 AliveCor created the Kardia app to help users monitor and record heart-related health data. 6 The Kardia app was free to use, but a premium version was available which required a paid annual 7 subscription. AliveCor developed an algorithm, SmartRhythm, available in the premium version 8 of the Kardia app, to send alerts to the wearer if they may be in Afib and to prompt the wearer to 9 take an electrocardiogram (“ECG”). 10 SmartRhythm worked in concert with AliveCor’s KardiaBand, a hardware replacement for 11 the Apple Watch band that was equipped with ECG sensors. SmartRhythm was clinically 12 validated to detect Afib. The KardiaBand was cleared by the Food and Drug Administration 13 (“FDA”) as a medical device accessory for the Apple Watch. 14 As of 2019, AliveCor had sold around 12,000 KardiaBands in the United States. The 15 Kardia app had over 1600 daily users. 16 When HRNN replaced HRPO in Workout Mode, AliveCor conducted internal tests that, 17 according to AliveCor, demonstrated that SmartRhythm was no longer functioning properly. 18 AliveCor trained SmartRhythm on HRNN, but it did not achieve the same accuracy as it had with 19 HRPO. AliveCor thus withdrew SmartRhythm from its Kardia app and stopped selling 20 KardiaBands in June 2019. Apple disputes that SmartRhythm’s performance was impaired by the 21 switch to HRNN. 22 AliveCor did not invest in retraining SmartRhythm because it feared that the watchOS 23 would continue to change in ways that would degrade the available data’s suitability for heart 24 rhythm analysis. 25 AliveCor further opted not to use another of Apple’s heartrate algorithms because they did 26 not suit AliveCor’s medical monitoring goals. For example, Tachogram API’s intermittent 27 activation prevents a third-party app developer from continuously monitoring tachogram outputs 1 was able to use continuously for the SmartRhythm feature of the Kardia app.

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Alivecor, Inc. v. Apple, Inc., Counsel Stack Legal Research, https://law.counselstack.com/opinion/alivecor-inc-v-apple-inc-cand-2024.