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Case Study: Effectively Warning Patients About Medication Side Effects

May 09, 2017

Case Study: Effectively Warning Patients About Medication Side Effects

Harvey McCorkle was depressed and couldn’t sleep. Counting sheep and drinking warm milk didn’t help, so he went to his family physician who gave him some Lunesta samples.

Mr. McCorckle had a really weird dream the first night he took the Lunesta. The day after his second dose, he made a very bad calculation mistake at work. At 3 a.m. on the third night of taking Lunesta, Harvey McCorkle shot himself in the head. These are the basic facts underlying a 2014 Louisiana medical malpractice lawsuit, McCorkle v. Gravois , [152, So.3d 944 (1st Cir. 2014)]. Mrs. McCorkle believed that Mr. McCorkle killed himself as a direct result of taking the Lunesta samples.

The Physician’s Desk Reference (PDR) drug insert for Lunesta advised that the drug could cause serious side effects, such as “getting out of bed while not fully awake” and “doing activities that you do not know you are doing.” Patients, it said, should consult with their physicians if they have a history of depression or suicidal thoughts. 

The physician did not include the package insert when he gave Mr. McCorkle the samples. He did not discuss the package insert precautions about depression and suicidal thoughts. He did, however, tell Mr. McCorkle to come back or call if he had any problems. Mr. McCorkle didn’t call or go back to the doctor after his first two nights of Lunesta.

Nevertheless, Mrs. McCorkle thought that Mr. McCorkle had not been sufficiently warned. He did not know the risks of the drug, and so did not consent to the risks. At issue was whether the physician failed to meet the standard of care when he didn’t warn Mr. McCorkle about the suicide risk and did not direct him to read the drug insert.

Off-Label Definitions 

Off-label prescribing is often described as:

  1. Prescribing products for conditions other than those approved by the FDA, or
  2. Prescribing in a higher or lower dose than that approved by the FDA, or
  3. Prescribing for members of populations other than those in which the product was tested.

Does the PDR, Without More, Establish the Standard of Care?

The Food and Drug Administration has absolute authority to examine the scientific evidence of the safety of drugs. It informs the medical profession about the evidence underlying each prescription drug’s safety through the PDR and in the package inserts that accompany prescription medications.

The courts have repeatedly held that the FDA does not regulate, and should not interfere, with the practice of medicine. What part then, would a PDR warning play in a malpractice claim?

In most cases, the medical standard of care is judicially established by using multiple sources of evidence, including the PDR materials. Medical experts on each side of the malpractice lawsuit testify about the standard of care, in most cases using documents like the PDR to support their opinion.

PDR Warnings Count

Some Louisiana malpractice cases have come quite close to deeming the PDR as an authoritative scientific source that does not require expert testimony to establish medical negligence at trial. In Fournet v. Roule-Graham [783 So. 2d 439 (La. App. 5th Cir. 2001)], Ms. Fournet claimed that Dr. Graham negligently prescribed Provera to her. The PDR specifically said Provera was contraindicated in patients like Ms. Fournet, who had history of deep vein thrombosis, but Dr. Graham didn’t tell her that. Three days after the prescription, Ms. Fournet had a life-threating blood clot. Dr. Graham lost at the trial court, but she appealed. She did not win at the appeal level either. On one hand, the Fournet appeal court specifically discussed the trial expert’s testimony
that most OB/GYNs would prescribe Provera off-label to a patient with a history like Ms. Fournet’s. On the other hand, the Fournet appeal court could “see nothing in the record that convinces us the OB/GYN community is correct and the PDR is wrong.” It couldn’t ignore the fact that the PDR definitively stated
that Provera should not have been prescribed for a patient with DVT. Cited extensively and with approval were earlier decisions by other courts in which the PDR was an authoritative source sufficient, at least, to support a summary judgment motion to dismiss. No expert was needed to understand the plainly stated PDR warning evidence.

The vast majority of judgments have excluded PDR information from trial evidence on the standard of care unless it was accompanied by an expert’s testimony. However, the take-home lesson for medical practice was succinctly set forth in the Fournet decision – while the FDA does not dictate the practice of medicine, its PDR warnings reflect scientific evidence that should not be ignored.
What about the PDR in the McCorkle Case?

Three expert physicians testified that it was likely that Lunesta did in fact cause Harvey McCorkle to take his own life. The malpractice claim turned, however, on whether Mr. McCorkle had been sufficiently warned of the drug’s suicide risk by his doctor. Mrs. McCorkle never got to trial. She lost at the summary judgment level for a variety of reasons, especially because her own expert testified the Mr. McCorkle had been sufficiently warned.

Notably, the McCorckle court discussed the sharp distinction between PDR precautions and recommendations when compared to PDR clear warnings.

When there are clear PDR warnings, the court hinted that in some cases a jury could perceive the deviation from the standard of care as well as any expert.

The vast majority of Louisiana and federal courts have excluded PDR information from trial evidence on the standard of care unless it was accompanied by an expert’s testimony.

However, the McCorkle and Fournet cases are cautionary.

Consider Ethics as Well as the Law

The legal requirements only supply the prescriber with the floor of acceptable practice. Ethical decisions in healthcare are guided by how the facts satisfy another, non-legal set of principles: autonomy, beneficence, nonmaleficence and justice. Autonomy is the idea that individuals have a right to make their own choices.

Of course, there will always be a tension between the goal of a completely informed patient and the societal pressures on prescribers to complete a patient visit within a commercially reasonable time limit.

As a best practice, whenever practical, discuss any unambiguous and strong PDR warnings with the patient at the time a drug is prescribed.

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