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News: A psychiatrist prescribed her patient multiple psychoactive medications to deal with his anxiety and other psychological issues. Despite the medications, the patient’s conditions continued to worsen.
The physician increased the dosages of multiple medications without, as the patient’s family later alleged, adequate monitoring of the patient. At one point, the psychiatrist prescribed the patient 80 mg per day of Celexa. The FDA, however, had previously issued a warning informing physicians that Celexa should not be prescribed at a dose higher than 40 mg per day due to the risk of cardiac abnormalities. Nonetheless, the physician did not adhere to the FDA warning and did not monitor the patient. The patient died on Nov. 12, 2013, as a result of cardiomyopathy. The coroner concluded that the patient had toxic levels of Celexa and another drug that the psychiatrist had prescribed.
On May 16, 2018, a jury returned a $2 million verdict in favor of the plaintiff. The jury concluded that the clinic was 53% liable and the psychiatrist was 47% liable. The jury awarded the decedent $1 million for emotional distress and suffering while he was still alive and his parents $1 million for loss of companionship.
Background: The patient was a 46-year-old male who suffered from anxiety and other psychological disorders. In 2009, a psychiatrist took the patient under her care and prescribed a litany of medications to treat schizoaffective disorder and severe anxiety. These medications included Clozaril, Celexa, Xanax, Haldol, and Cogentin. The physician steadily increased the dosage of his medication in the years that followed despite no indication that the medications were working to ease his psychological issues.
In 2011, the FDA issued a warning about Celexa, stating that at high doses Celexa may cause cardiac abnormalities. The FDA warning also affirmed that a high dosage of Celexa did not increase its efficacy. Consequently, the FDA warned physicians that they should not prescribe Celexa at a dose higher than 40 mg per day. This warning specifically informed physicians that they should consider more frequent ECGs for patients who are taking concomitant medications, as in this case.
Nevertheless, the psychiatrist failed to heed the FDA warning. In 2012 and 2013, the physician prescribed Celexa at a dosage of 80 mg per day in addition to the patient’s other medications. According to the lawsuit, the patient dutifully took all of his medications but kept reporting that his psychological issues were worsening.
The patient died on Nov. 12, 2013, from toxic levels of Celexa and Cloziral. His parents brought suit against the clinic and the physician, contending that the physician negligently prescribed Celexa in excess of 40 mg per day in contravention to the FDA warning advising against such high doses, that the physician failed to advise the patient or his parents of the FDA’s warnings, and that the physician failed to monitor his cardiac health. Specifically, the parents alleged that the physician should have recommended that the patient undergo cardiac evaluations including an ECG examination. The plaintiff alleged that these failures constituted actions below the standard of care.
The physician categorically denied the allegations and contended that the patient’s obesity, poor eating habits, and sedentary lifestyle were the actual and proximate causes of his cardiomyopathy and death.
The jury found in favor of the plaintiff, finding the physician 47% liable and the clinic 53% liable. The jury concluded the plaintiffs suffered a loss of companionship and emotional distress, awarding them $1,000,000, and concluded that the patient endured pain and suffering, awarding the decedent $1,000,000. The parents used the award to establish a foundation that is committed to ensuring that hospitals and physicians understand, follow, and communicate drug warnings.
What this means to you: Medical care providers, including physicians, clinics, and hospitals, are responsible for keeping up-to-date about any newly discovered side effects or dangers inherent in the drugs they prescribe to their patients. Ongoing treatment using medication is not simply a matter of prescribe and forget. Rather, the privilege to prescribe drugs brings with it a duty to stay informed about any warnings and to proactively monitor a patient’s response to those drugs. A physician who continues to prescribe medication without continuing to monitor developments pertaining to those medications, especially those in FDA warnings, may fall below the standard of care as reasonable physicians in similar circumstances would heed new developments and warnings.
Providers must be diligent in routinely checking for FDA warnings, known as black box warnings, for all medications they prescribe. Moreover, physicians should consider the consequences, including the potential for an adverse reaction and the potential for side effects, whether merely ordering an increase in dosage or prescribing a new medication. A physician should not think that ordering an increase in dosage is a less consequential action than prescribing a new medication. Rather, physicians must understand that prescribing excessive doses may cause significant damage and produce liability as it did here. Before increasing a dosage for a known and used medication, physicians should ensure that the FDA has not promulgated any updated warnings.
Further, it is not the patient’s duty to monitor and keep updates on FDA warnings — it is the medical care provider’s responsibility. Both the hospital and the outside pharmacy where the patient purchased his prescriptions have a duty to patients, in addition to the physician prescribing medications. Pharmacists are required to review medication profiles on inpatients in hospitals and clients who purchase medication from retail pharmacies.
Pharmacists are the keepers of the FDA black box warnings and are duty-bound to question unusual dosing, drug interactions, and the impact of black box warnings on patients and clients receiving medications from their pharmacy. Pharmacists are required to question physicians about medication orders that pose a threat to the well-being of patients and can refuse to fill controversial doses or dangerous combinations of drugs. Most often, a simple phone call to the prescribing physician resolves the issue. If, however, the physician fails to respond to warnings, the pharmacists can proceed to fill the prescription but can be held liable if efforts are not made to advise physicians and warn patients.
Another important lesson from this case is that a patient’s failure to improve may not justify an increase in the dosage of medications. To the contrary, this case reflects that a physician owes a standard of care requiring an intellectual inquiry into whether an increase in dosage will likely result in increased efficacy and, further, whether the increased efficacy is worthwhile given the harms present in an increased dosage, if any.
Physicians must be especially cautious when prescribing multiple medications to one patient or when prescribing any new medication to a patient who already takes a multitude. This is known as polypharmacy and is particularly dangerous when prescribing multiple psychoactive and psychotropic medications. Here, the physician prescribed Celexa, Clozirol, Xanax, Haldol, and Cogentin. All of these medications may trigger severe side effects, and the combination of multiple medications may exacerbate such side effects. The plaintiff’s attorney asserted that physicians must be cautious of any effect these medications may cause when combined together. As such, physicians should consider seriously whether multiple medications should be prescribed and whether the potential benefit is worth the unknown risk of combining medications. Physicians should avoid the gut reaction that adding one more medication to a patient’s otherwise robust medication regimen is inconsequential.
While it was the physician who prescribed the excessive medication, the clinic was assigned greater liability.
This is a valuable lesson for hospitals, clinics, and medical centers and demonstrates the need for policies and monitoring of physicians’ prescribing tendencies. When new or updated FDA warnings arise, hospitals should circulate this information to physicians to protect patients and to protect the hospital from potential malpractice. Hospital ignorance is not a defense to a death caused by the excessive prescribing of medications with known side effects at high doses.
The peer review process, required in all healthcare institutions where physicians practice, includes a duty to monitor all aspects of physician performance, with a focus on positive patient outcomes, patient safety, physician competency, and frequency of adverse events that result in litigation. The hospital pharmacists can and should participate in this process by providing data from their department that can pinpoint a safety issue of concern involving a physician.
In short, medical care providers involved in any aspect of the chain of prescribing medications must be diligent in checking for newly updated warnings for any medications the physicians have currently prescribed and possibly change a patient’s regimen based on these updated warnings. Physicians must exercise increased prudence when treating patients who are taking multiple medications in order to prevent such instances and to foster a patient’s overall health and well-being.
Decided on May 16, 2018, in the Court of Common Pleas of Pennsylvania, Fifth Judicial District, Allegheny County; Case Number GD-15-017525.
Financial Disclosure: Author Greg Freeman, Editor Jill Drachenberg, Editor Jesse Saffron, Editorial Group Manager Terrey L. Hatcher and Nurse Planner Kay Ball report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Consulting Editor Arnold Mackles, MD, MBA, LHRM, discloses that he is an author and advisory board member for The Sullivan Group and that he is owner, stockholder, presenter, author, and consultant for Innovative Healthcare Compliance Group.