Final Verdict: Drug Did Not Cause Heart Attack
Advertisements for new miracle drugs seem to be everywhere, but this rarely reflects the reality of the lengthy and complex process a drug must go through in order to be prescribed and marketed in the United States. In 2018, the FDA approved only 59 new drugs, and yet this was a record for the greatest number of drugs approved by the FDA in a single year. In order to have their drug approved, a pharmaceutical manufacturer must show that the drug is safe for clinical use with a series of trials and studies.
Just because a drug has been approved for market use, however, doesn’t mean it is completely without risks or is safe for every conceivable situation. The approval process should identify risks and side effects that physicians should consider before prescribing. No matter how safe a drug may be for a particular treatment, using it for the wrong condition, at the wrong time, or in the wrong dosage can still cause severe harm.
Thus, when harm occurs, it seems only natural to look at whether the use of a particular drug may have been to blame. This is particularly common when the adverse effect closely follows the use of a drug. But just because two things are related in time doesn’t mean one caused the other. Even if a drug was contraindicated by the best medical standard of care, it may still not have been the root cause of the adverse outcome, or it may not have caused any harm at all.
In 2011, 41-year-old administrative assistant Lisa Walker arrived at Medstar Southern Maryland Hospital with respiratory distress. The physician’s assistant, Arian Ahmadzai, administered a drug called labetalol for blood pressure. Unfortunately, she suffered a series of heart attacks shortly thereafter, and lack of oxygen to the brain resulted in brain damage. She tragically passed away a few days later.
Lisa’s husband James sued on behalf of her estate, arguing that the use of labetalol was contraindicated and that it was an overdose. His medical malpractice attorney asserted that the use of labetalol caused a drop in her blood pressure which resulted in the cardiac arrest. In 2016, the case went to trial, but the jury was unable to reach a decision and so the case was brought back to trial in Prince George’s County in June 2017.
During the second trial, which lasted for three weeks, James again argued that Lisa’s death was the result of the use of labetalol, claiming medical malpractice and wrongful death. However, the defense brought experts who pointed out that Lisa was already suffering from respiratory distress secondary to an infection in her throat, which ultimately brought on the heart attack. They argued that there is no evidence or mechanism whereby labetalol can result in cardiac arrest, and that Ahmadzai had not violated any standard of care by administering it.
Prior to trial, James had settled with the hospital. He demanded more than $600,000 from Ahmadzai. However, the jury deliberated for only three hours before determining that no medical malpractice had taken place, and returned a verdict for the defense. Cohen & Cohen