By Damian D. Capozzola, Esq.
The Law Offices of Damian D. Capozzola
Jamie Terrence, RN
President and Founder, Healthcare Risk Services
Former Director of Risk Management Services
California Hospital Medical Center
Elena N. Sandell, JD
UCLA School of Law, 2018
News: A 63-year-old man was admitted to a medical center with multiple ailments. A few days later, he developed bradycardia due to hyperkalemia. His physician treated the condition with Kayexalate, which was administered in a suspension solution containing 35.8% sorbitol. The physician did not inform the patient about the risks related to the drug. The patient developed ischemic colitis, which led to his death three days after receiving the drug.
The patient’s estate filed suit against the physician and the medical center, alleging that the physician breached the standard of care by treating the patient’s condition with Kayexalate without obtaining his informed consent. The jury found in favor of the plaintiff and awarded $10 million in damages, which was reduced to $906,250 by the court.
Background: On March 10, 2013, a 63-year-old man was transported to a nearby hospital. The patient was suffering from hepatitis C, cirrhosis, end-stage liver disease, renal failure, and congestive heart failure and had been complaining of weakness in his arms and legs. Blood tests revealed that the patient was suffering from acute rhabdomylysis, a condition that, if untreated, can cause muscle weakness and pain, elevated potassium levels, and kidney failure.
The next day, the patient was transferred to the intermediate care unit at a larger medical center. His initial bloodwork showed that the rhabdomylysis was worsening, and he was placed on dialysis. Approximately one week after his admission, the patient developed life-threatening bradycardia. The physician diagnosed the patient with hyperkalemia, an elevated level of potassium in the blood that can cause potentially life-threatening cardiac arrhythmia, and ordered emergency treatment.
The physician ordered a sodium polystyrene sulfonate medication called Kayexalate. Because Kayexalate causes constipation and sometimes fecal impaction, it usually is given in combination with an osmotic laxative such as sorbitol. The physician ordered the Kayexalate to be administered orally, in a suspension solution containing 35.8% sorbitol. However, the physician did not warn the patient of the risks and benefits of Kayexalate prior to its administration.
The patient was admitted to the ICU the next day. He was brought to surgery following several bloody bowel movements and severe abdominal pain. In the discharge summary, the physician annotated Kayexalate use as a possible cause of the patient’s suspected intestinal ischemia. The patient never regained consciousness from the surgery and died the following day.
The patient’s wife and children filed suit against the physician and the medical center. Three expert witnesses opined that the patient’s ischemic colitis and death were caused by the administration of Kayexalate and that the physician had breached the standard of care by not obtaining the patient’s informed consent prior to administration. The physician called four experts who asserted that there was no certain link between Kayexalate and ischemic colitis since medical literature establishes a very rare association — not necessarily a cause — between the drug and the condition.
The jury returned a verdict in favor of the plaintiffs, awarding a total of $10 million in damages. Because of the cap on noneconomic damages (pain and suffering, emotional distress, etc.), the award was reduced to $181,250 for the estate and $90,625 for the widow and each of the seven children, for a total of $906,250. The plaintiffs appealed the reduction, claiming that it violated their constitutional rights under the Equal Protection Clause. The appellate court upheld the reduction.
What this means to you: A classic battle is demonstrated by these circumstances: the battle of the experts. Since medical malpractice cases necessarily involve issues beyond the scope of laymen, experts are almost always critical to the legal process and to a jury’s determination. With this advanced knowledge, it is important to evaluate and select appropriate experts and work closely with them throughout litigation.
Working intimately with experts enables physicians to more objectively evaluate the circumstances and to establish and maintain a coherent and consistent narrative. Furthermore, physicians may use their own experts to evaluate the qualifications of and potentially disqualify an opposing party’s expert, causing significant and often irreparable damage to the opposition’s legal case.
In this case, both parties relied heavily on expert opinions to attempt to prove or disprove the causal link between the course of treatment chosen and the onset of the ischemic colitis that led to the patient’s death. During the litigation, the physician filed a motion seeking a Frye-Reed evidentiary hearing to exclude the plaintiff’s expert. (Note that federal courts and some state courts follow a different case called Daubert as the seminal opinion concerning the validity of expert testimony. Always check with counsel in your state concerning expert issues.) After the trial court denied the hearing, the physician appealed. The appellate court found that the denial caused no prejudice to the physician.
At the trial court level, the physician sought to preclude the family from introducing expert opinion that stated there was a causal link between Kayexalate with sorbitol and ischemic colitis. The physician argued that while it was generally accepted in the medical community that Kayexalate and/or its combination with sorbitol could, in very rare cases, be associated with ischemic colitis, it was not generally accepted that the two drugs could actually cause the condition.
The plaintiffs responded by stating that a Frye-Reed evidentiary hearing was unnecessary because there was a general level of acceptance that Kayexalate with sorbitol could induce intestinal necrosis, as confirmed by the medical literature, FDA black box warnings on the drug, and the medical center guidelines.
The trial court determined that no evidentiary hearing was necessary and that the physician could testify but took a conservative approach and held a one-hour hearing on the matter, allowing both parties to introduce evidence.
While both parties presented expert testimony, the court based its decision on two factors. First, the physician identified ischemic colitis caused by Kayexalate in sorbitol as a likely diagnosis before the patient even entered surgery. This diagnosis was reported in the medical note transferring the patient from the intermediate care unit. The court determined that the physician knew of the risk associated with the drug and suspected his patient’s condition to be caused by the drug. The facility’s internal guidelines — which were available to all physicians — warned about ischemic colitis as a side effect of Kayexalate.
Informed consent is a frequently occurring issue among medical malpractice cases. All patients in hospitals sign, or have their legal representatives sign, consents for general care and treatment that cover issues such as medications, diagnostic testing, and basic treatments like dressing changes, stitches, and so on.
Kayexalate is a common drug used to treat mild hyperkalemia. It should not be used for very ill patients, and it takes longer to work than other possible treatments. As has been discussed, the physician chose a drug that could potentially harm the patient. But informed consent for prescribing the drug is not required. Even with FDA black box warnings, the physician is not mandated to obtain informed consent.
Adverse drug reactions occur in hospitals and at home frequently. It is the risk any patient assumes when using medications. A nurse administering or a pharmacist providing a drug should explain to the patient what the drug is, why it was prescribed, and what side effects the patient might experience. The patient may then refuse to take the medication if he or she determines that the risks outweigh the benefits.
If the physician feels there is an extraordinary risk to the patient if it is taken, the physician should address this directly with the patient and offer alternatives. However, there is no universal standard of care requiring a physician to obtain informed consent before prescribing medications. In this case, the mere administration of Kayexalate should never have occurred, with or without informed consent.
Another important issue raised and affirmed in this case is the state’s statutory maximum on noneconomic damages. More than half of the states have passed some form of law that limits the amount of noneconomic damages a patient may recover in the case of a medical malpractice verdict. Since noneconomic damages include items such as “pain and suffering,” this limitation can dramatically reduce a physician’s or medical provider’s exposure in the event that liability is found. Patients may still be able to recover unlimited economic damages, including those for past and present medical care which may constitute significant amounts for severely disabled younger patients. Under the Medical Injury Compensation Reform Act, for example, California limits noneconomic damages to $250,000 but permits unlimited economic damages.
In this case, the statutory maximum reduced the amount of the jury verdict to less than 10% of the total awarded. The plaintiffs appealed this reduction, claiming that the statute violated the Equal Protection Clause of the Fourteenth Amendment by discriminating against the injured and larger families. However, the appellate court upheld the statute and found that it did not create irrational or arbitrary classifications. Similar appeals brought by injured patients seeking to overturn these laws have been unsuccessful in many states.
These types of statutory maximums may be additionally beneficial for physicians and medical care providers by drastically reducing the amounts needed to settle medical malpractice claims out of court. When a patient is aware that the maximum recoverable is significantly less than what a jury would award — even given egregious circumstances — the patient may be willing to forgo the time, effort, and expense of a drawn-out legal battle and instead settle for the statutory maximum. Physicians and medical providers should thus consult with counsel and consider any applicable statutory maximums when evaluating medical malpractice cases.
Decided on Aug. 30, 2018, in the Court of Special Appeals of Maryland; Case Number 238 Md. App. 418, 192 A.3d 847; Trial Court Case Number 24-C-15-003384.