Burks v. Allen
| Decision Date | 30 August 2018 |
| Docket Number | No. 2361, Sept. Term, 2016,2361, Sept. Term, 2016 |
| Citation | 238 Md.App. 418,192 A.3d 847 |
| Parties | Allen BURKS, et al. v. Cynthia ALLEN, et al. |
| Court | Court of Special Appeals of Maryland |
Argued by: Ronald U. Shaw (Shahida Ali-Schneider, Shaw & Morrow, PA, on the brief) Hunt Valley, MD, for Appellant.
Argued by: Justin P. Zuber (Miller & Zois, LLC, on the brief) Baltimore, MD, for Appellee.
Panel: Eyler, Deborah S., Wright, Berger, JJ.*
In the Circuit Court for Baltimore City, Cynthia Allen, individually and as Personal Representative of the Estate of Dennis Allen ("the Estate"), and seven of her adult children, appellees/cross-appellants,1 brought medical malpractice wrongful death and survival actions against Allen Burks, M.D., and the University of Maryland Medical Systems Corporation ("UMMS"), appellants/cross-appellees.2 The allegations arose out of Dr. Burks's treatment of Mr. Allen in March 2013, when he was an inpatient at the University of Maryland Medical Center ("UMMC"). Specifically, the Allens alleged that Dr. Burks breached the standard of care by treating Mr. Allen's elevated potassium levels with a formulation of Kayexalate3
combined with 35.8 percent sorbitol and by doing so without obtaining his informed consent; and that the medication caused him to develop ischemic colitis and ultimately to die. They alleged that UMMS was liable for Dr. Burks's negligence under the doctrine of respondeat superior .
Dr. Burks filed a pre-trial request for a Frye - Reed hearing, arguing that the Allens's theory that Kayexalate
can cause ischemic colitis is not generally accepted in the relevant medical community, and therefore their expert witness testimony on that issue was not admissible. The Allens opposed the request. The court held a hearing and ruled that a Frye
-
Reed hearing was not required but, even if it was and the court applied the Frye
-
Reed test to the evidence provided in the motion and opposition, the challenged evidence was admissible.
After a ten-day trial, the jury returned a verdict in favor of the Allens, awarding $2,000,000 in non-economic damages to the Estate, and $1,000,000 in non-economic damages to Mr. Allen's wife and each of his seven children, for a total of $10,000,000 in damages.
Dr. Burks filed a motion for new trial or, in the alternative, for remittitur. The court did not grant a new trial but granted a remittitur, reducing the non-economic damages award to $906,250 pursuant to the cap on non-economic damages in Md. Code (1974, 2013 Repl. Vol.), section 3-2A-09 of the Courts and Judicial Proceedings Article ("CJP").
Dr. Burks noted an appeal, presenting three questions, which we have rephrased slightly:
gluconate or calcium chloride and his failure to request a blood draw on the morning of March 18, 2013?
The Allens noted a cross-appeal, presenting one issue:
I. Does the cap on non-economic damages violate the equal protection clause of the 14th Amendment and Article 24 of the Maryland Declaration of Rights?
For the following reasons, we shall affirm the judgment of the circuit court.
On March 10, 2013, Dennis Allen, age 63, was transported by ambulance to Northwest Hospital Center in Randallstown for complaints of increasing "[w]eakness of the arms and legs." He was suffering from hepatitis C
, cirrhosis of the liver, end stage liver disease, renal failure, and congestive heart failure, and already had been hospitalized twice in 2013—both times at UMMC—for a total of twenty-eight days. Blood tests performed at Northwest Hospital Center revealed that Mr. Allen also was suffering from acute rhabdomyolysis, a condition in which muscle fibers break down, releasing muscle proteins into the bloodstream. Rhabdomyolysis causes muscle weakness and pain, can lead to kidney failure if untreated, and can cause elevated potassium levels, especially for patients with renal insufficiency.
Mr. Allen was transferred from Northwest Hospital Center to UMMC the next day and was admitted to the intermediate care unit. Dr. Burks was the attending physician assigned to him. His primary admission diagnoses were rhabdomyolysis
, chronic kidney disease, and hepatitis Ccirrhosis. Nephrology was consulted and from March 13 through 16, 2013, Mr. Allen underwent daily hemodialysis for his kidney failure. During that time, his bloodwork showed that his rhabdomyolysis was continuing to worsen. Mr. Allen did not receive dialysis on March 17, 2013.
On March 18, 2013, Dr. Burks arrived at UMMC sometime between 7 a.m. and 8 a.m. He had ordered routine laboratory tests for Mr. Allen to be performed in the early morning hours, but the results were not available.5
Shortly after noon, Mr. Allen experienced a precipitous drop in heart rate, setting off the heart monitor alarms. Dr. Burks ordered an immediate EKG, which was performed at 12:18 p.m. It showed bradycardia (an abnormally slow heart rhythm) and life-threatening heart rhythms. Dr. Burks made a preliminary diagnosis of hyperkalemia, i.e. , an elevated level of potassium in the blood. Hyperkalemia results when the kidneys are not able to excrete potassium in the urine. A potassium level over 5.5 mmol/L is hyperkalemic.6 If left untreated, excess potassium can interfere with the electrical signals in the heart, causing a fatal cardiac arrhythmia
.
At 12:25 p.m., Dr. Burks ordered a stat blood draw to evaluate Mr. Allen's potassium level. Given the emergency nature of the problem, he decided to begin the treatment protocol for hyperkalemia while awaiting the lab results.
There are three phases to the hyperkalemia treatment protocol: stabilization, redistribution, and removal. The first phase addresses the danger of a fatal arrhythmia
by stabilizing the heart muscle. Either calcium gluconate or calcium chloride is administered intravenously for this purpose and works within 2 to 3 minutes. In the redistribution phase, potassium in the blood stream is moved back into the cells to prevent it from interfering with the heart rhythm. Insulin
, which works within 20 minutes, and sodium bicarbonate and albuterol, which work within 30 minutes, are prescribed in combination to achieve redistribution. Because insulin lowers blood sugar, dextrose is administered to counteract that effect. Insulin and dextrose are given intravenously; sodium bicarbonate is given orally; and albuterol is given through a nebulizer.
The third phase of the hyperkalemia treatment protocol is removal of the excess potassium from the body. There are three treatments by which potassium can be removed: diuretics, which cause the potassium to be excreted in the urine; hemodialysis
, which removes the potassium directly from the bloodstream; and sodium polystyrene sulfonate ("SPS"), usually referred to by its brand name, Kayexalate,7 which removes the potassium through the stool. Diuretics are not an option for a patient in renal failure, such as Mr. Allen. Dialysis begins to work within 30 minutes of being initiated and is very effective to remove potassium from the body. The potassium stops being removed when the dialysis is stopped, however.
, approved by the FDA in 1958 to treat hyperkalemia, is an "ion-exchange resin" medication, also known as a "cation exchange resin." The resin contains sodium ions that are exchanged for potassium ions in the bloodstream in the colon. The potassium ions bind to the resin and then are excreted in the stool. Because Kayexalate produces constipation and sometimes fecal impaction, it usually is given in combination with sorbitol, an osmotic laxative. Osmotic laxatives increase the amount of water secreted into the bowels, which softens the stool, making it easier to pass. Kayexalate begins to work within 2 hours after it is administered. It reaches peak effectiveness approximately 4 to 6 hours after being administered and can continue to work for up to 24 hours. It can be administered either in an oral suspension formula or by enema.
At 12:37 p.m., Dr. Burks used a UMMC electronic order set for hyperkalemia to order calcium
gluconate stat, insulin stat, dextrose stat, sodium bicarbonate stat, and Kayexalate.8 At 12:54 p.m., he ordered albuterol. At some time between 12:18 p.m. and 1:00 p.m., he also ordered a stat nephrology consult so hemodialysis could be started.
Dr. Burks was advised by a UMMC pharmacist that calcium
gluconate was not available due to a nationwide shortage. As we shall discuss, there was conflicting evidence at trial as to whether Dr. Burks gave an oral order to substitute calcium chloride
for calcium gluconate. In any event, neither drug was administered. It is undisputed that the failure to administer those drugs did not cause any injury to Mr. Allen.
At 12:55 p.m., and continuing for 10 to 15 minutes, Mr. Allen received albuterol
via a nebulizer. At 1:09 p.m., insulin and dextrose were administered intravenously. At 1:15 p.m., Mr. Allen was given sodium bicarbonate and 30 milligrams of Kayexalate orally. The Kayexalate was in a suspension solution containing 35.8 percent sorbitol. Dr. Burks did not inform Mr. Allen about the risks and benefits of Kayexalate prior to its being administered.
At 1:26 p.m., Mr. Allen's lab results were returned, revealing that his blood-potassium level was 7.3 mmol/L. That confirmed the diagnosis of hyperkalemia. A blood potassium level of 7.3 mmol/L is considered dangerously high and can quickly lead to a fatal arrhythmia
. At 1:30 p.m., a nephrologist assessed Mr. Allen and ordered hemodialysis on a stat basis. Dialysis began at 2:45 p.m. and was completed at 5:45 p.m. Mr. Allen had two bowel movements during dialysis....
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