Lowe v. Cerner Corp.
| Decision Date | 29 November 2022 |
| Docket Number | 20-2270 |
| Parties | RUBY L. LOWE, Power of Attorney for Michael A. Taylor, disabled, Plaintiff-Appellant, v. CERNER CORPORATION, Defendant-Appellee. |
| Court | U.S. Court of Appeals — Fourth Circuit |
Mikhael D. Charnoff, PERRY CHARNOFF PLLC, Arlington Virginia, for Appellant.
David Brent Dwerlkotte, SHOOK, HARDY &BACON, L.L.P., Kansas City, Missouri, for Appellee.
ON BRIEF:
Scott M. Perry, PERRY CHARNOFF PLLC, Arlington, Virginia, for Appellant.
Amy M Crouch, SHOOK, HARDY &BACON L.L.P., Kansas City, Missouri; Roman Lifson, Belinda D. Jones, CHRISTIAN &BARTON, L.L.P., Richmond, Virginia, for Appellee.
Before WILKINSON, Circuit Judge, and KEENAN and MOTZ, Senior Circuit Judges.
Vacated and remanded by unpublished opinion. Senior Judge Keenan wrote the majority opinion, in which Senior Judge Motz joined. Judge Wilkinson wrote a dissenting opinion.
Unpublished opinions are not binding precedent in this circuit.
In this product liability negligence action, Ruby L. Lowe, on behalf of her injured grandson Michael A. Taylor, filed suit against Cerner Health Services, Inc. (Cerner), the developer and seller of a software system used for entry of medical orders for patient care. Cerner sold its software system to the Virginia Hospital Center (VHC, or the hospital), where Taylor was a patient. Taylor suffered brain damage and resulting physical impairments at VHC after failing to receive "continuous pulse oximetry" as intended by his physician, who had entered an order for that care into the Cerner system used by VHC.
Lowe asserted negligence claims against Cerner under Virginia law, alleging that the Cerner software was negligently designed (the negligent design claim), and that Cerner negligently failed to warn system users of those design defects (the failure to warn claim). Lowe asserted that Cerner's negligent acts caused the failure to properly monitor Taylor's oxygen level, and that proper monitoring would have prevented Taylor's injuries. The district court awarded summary judgment to Cerner.
Upon our review, we hold that the district court erred in awarding summary judgment to Cerner on both claims. On the record before us, a jury reasonably could conclude that Cerner's software contained two design defects that did not comply with industry standards or satisfy reasonable consumer expectations. We also hold that the district court misstated Virginia law on proximate causation, which provides that there can be more than one cause of an injury and, contrary to the court's holding, did not require Lowe to eliminate other causes of the injury. Lowe presented sufficient evidence for a jury to conclude that the software defects were a proximate cause of Taylor's injuries. We also hold that the court erred in awarding summary judgment to Cerner on Lowe's failure to warn claim. That evidence likewise was sufficient for a jury to conclude that Cerner failed to warn users about the software design defects and that Cerner's failure to do so was a proximate cause of Taylor's injuries. We therefore vacate the district court's judgment and remand the case for trial on both claims.
We recite the facts, and reasonable inferences that can be drawn from those facts, in the light most favorable to Lowe as the nonmoving party. Betton v. Belue, 942 F.3d 184, 191 (4th Cir. 2019). On April 5, 2016, Dr. Alexandria Booth performed surgery on 25-year-old Taylor to remove his gall bladder. Because Taylor suffered from sleep apnea and other medical conditions, Dr. Booth intended that Taylor receive "continuous pulse oximetry" as he recovered from surgery.[1] Pulse oximetry measures a patient's oxygen level in the blood, and typically is measured by placing a monitoring device on the patient's finger. When a patient's oxygen level is monitored continuously, an alarm sounds when the patient's oxygen level falls below a certain percentage. The alarm alerts hospital staff and wakes the patient so that the situation can be addressed before injury occurs.
After Taylor's surgery, Dr. Booth entered an order for "continuous pulse oximetry" into the health record software developed by Cerner and used at VHC. Dr. Booth intended that this order be effective from the time she entered the order, at 4:34 p.m. on April 5, 2016, until Taylor's expected discharge from the hospital on April 6, 2016. As explained in more detail below, the order for continuous pulse oximetry did not take effect until 10:00 a.m. on April 6, 2016. Thus, Taylor was not provided continuous oxygen monitoring during the night of, or in the morning after, his surgery.
At 5:01 a.m. on April 6, 2016, the hospital nursing staff checked Taylor's vital signs, which were normal. Pursuant to hospital guidance, another check of Taylor's vital signs should have occurred around 9:00 a.m., but did not. Around 10:30 a.m., Dr. Booth found Taylor unresponsive and in respiratory distress. Taylor suffered a "respiratory arrest," which caused "hypoxia," a deficiency of oxygen reaching the tissues of the body, and brain damage. As a result, Taylor cannot walk, bathe, or use the bathroom independently. The parties do not dispute that if Taylor's oxygen level had been monitored continuously, his resulting hypoxia and brain damage would not have occurred.
Taylor's grandmother, Lowe, filed an action alleging medical malpractice against Dr. Booth's employer and VHC. The parties to that action later entered into a settlement agreement. Lowe also filed the present action against Cerner, seeking $50 million in damages.[2] Lowe alleged that there were two design defects in Cerner's electronic ordering software, and that Cerner failed to warn users of those defects. Lowe asserted that these defects, and Cerner's failure to warn users of its product of those defects, caused Dr. Booth inadvertently to enter the continuous pulse oximetry order as beginning at 10:00 a.m. the day after Taylor's surgery, instead of immediately after the surgery.
As alleged by Lowe, the first defect relevant to this appeal related to the software's "order entry screen," on which a physician enters specific information about the medical care that the hospital staff is required to administer to the patient. On the order entry screen, the "start time" for these orders appeared automatically as the date and time of entry. The order entry screen also contained drop-down menus to direct the frequency and recurrence of the particular care directed. For the frequency, Dr. Booth chose "daily," and for the recurrence, she selected "once." Unbeknownst to Dr. Booth, her selection of "once" triggered an automatic start time of 10:00 a.m. that VHC had implemented based on when its pharmacy filled medication orders. Despite this 10:00 a.m. start time, however, the order entry screen continued to display the start time for continuous pulse oximetry as April 5, 2016, at 4:34 p.m. This feature was "hardcoded" into the software developed by Cerner, meaning that VHC could not alter the order entry screen's start time display.
After inputting the above instructions on the order entry screen, Dr. Booth next selected "add to order session," which electronically moved those orders to the "unsigned orders list." The unsigned orders list contained the second, related design defect alleged by Lowe.
The unsigned orders list displayed all the orders entered by a physician, and Cerner's software required that the physician approve the list before those orders would take effect. The last of the 30 orders entered by Dr. Booth for Taylor's care appeared on the list as "Pulse oximetry: Continuous Once As Ordered; start on 4/6/2016 at 10:00."
However, the unsigned orders list contained detailed information for each order in a "stacked" format, displaying the details of only the first few orders. Thus, a physician was required to scroll across "multiple computer screens" to review the details of each order. If the physician did not review the details of each order, she nevertheless could electronically sign, or approve, all the pending orders as a group.
Dr. Booth stated that she did not see the 10:00 a.m. start time for the pulse oximetry order on the unsigned orders list, and instead relied on the start time shown on the order entry screen. According to Dr. Booth, she did not expect the start time for the continuous pulse oximetry order to "change[]" between the order entry screen and the unsigned orders list. Therefore, Dr. Booth electronically accepted all the orders, including the continuous pulse oximetry with the improper 10:00 a.m. start time.
Dr. Booth had practiced medicine as a surgeon for 16 years, and had been using Cerner's software at VHC for several years. Dr. Booth also stated that she had used a different software program at another medical center and had not encountered the same start time problem at that other location.
After Lowe filed suit against Cerner, the parties engaged in extensive discovery. Cerner later moved for summary judgment and Lowe moved for partial summary judgment seeking to prevent Cerner from asserting at trial that any third-party's conduct was the sole or superseding cause of Taylor's injuries. Lowe submitted for the court's consideration testimony and reports from several expert witnesses, including the deposition testimony of Taylor's surgeon, Dr. Booth. Lowe also presented testimony and reports prepared by two of her designated expert witnesses in the field of use of electronic health records: Ross Koppel, Ph.D., a...
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