Adverse drug cases can result from many different circumstances for physicians: negligence can arise in the failure to warn patients of the known risks of the drug, or using the drug that’s contraindicated by the patient’s condition.  Failure to detect the side effects when they initially appear, prescribing too much or too little of the drug, or giving the drug for too long are other examples that come up in malpractice cases.  Problems also may arise in situations where the pharmaceutical company’s labeling of the medication may fail to adequately warn of the drug’s dangerous propensities.


    Also, the pharmacist dispensing the prescription medication could be involved in events leading to claims.  And a nurse or other healthcare provider under the control of a physician could be involved if an error occurs in administering the medication.


    In many of these cases, as one can imagine, the issue of whether there was negligence is not difficult to prove.  After all, if a physician inadvertently writes 5000mg of antibiotics twice daily, when she meant to prescribe 500mg, the error is clear by anyone’s standards.  Similarly, where a physician correctly prescribes the medication but a nurse incorrectly administers ten times the prescribed dosage, one can also clearly see the failure to conform to good medical practice.  Because of the nature of these cases, they can be difficult to defend on the basis that the health care provider was not negligent.


    So these cases are often defended on the issue of causation.  In any malpractice action, even if one’s acts or omissions are found negligent, the plaintiff has to prove that the provider’s negligence actually caused the patient’s injury.  This point is well illustrated in situations such as the case of an elderly, seriously ill patient who has received an overdose of medication, and whose condition subsequently deteriorates.  Whether it can be said that this presumed negligence by a health care provider actually caused the worsening of the patient’s condition is often difficult to determine because of the complex medical situation that pre-existed. 


    The causation issue, therefore, is often a more successful vehicle for defending medication-related cases.  Nevertheless, one must not lose sight of the fact that causation defense is not a comfortable one on which to hang one’s hate.  It is easy to anticipate the perspective of a juror who sees that there is no causal link, but nevertheless wants to see a patient and their family compensated for clear acts of negligence.


    Medication-related cases are complicated circumstances for physicians.  The physician is obviously not the only person involved in drug treatment and some states will only place the blame on the lap of the actual wrongdoer.  But other states have shown a tendency to shift the responsibility to the physicians, even if arguably another individual or entity’s conduct contributed to the patient’s injury.  The rationale behind this is that since it is the physician’s responsibility to prescribe the drugs to patients, society should place the ultimate responsibility for errors involving those drugs on the physician.


    A recent case decided by a Texas appellate court illustrates this point.  In Rolen v. Burroughs Wellcome Company, an appellate court ruled that the responsibility for warning a patient about potential side effects of a prescription drug belonged with the physician rather than the pharmaceutical company.  That case involved an 80-year-old patient who was diagnosed with Stevens-Johnson syndrome and other ailments associated with allergic reactions to Zyloprim.  The court ruled that the physician had the duty to inform a patient, even though the package insert for Zyloprim identified Stevens-Johnson syndrome as an allergic reaction to the drug.


    Given the perspective, physicians have a duty to obtain informed consent from patients, which includes explaining the risks associated with any medication.  This process should be documented in the medical record, including the risks and benefits that were discussed.


    The advisability of communicating with the patient also carries over when a physician subsequently discovers adverse side effects from treatment previously given to a patient.  Physicians should err on the side of openness to the patient.  It is important that no inference of cover-up or concealment can be suggested later on.  Yet it is also important to explain only factually what has happened, and to avoid any conjecture as to why it happened.  Drawing conclusions about what caused an adverse event soon after it occurs, may be based more on guilt and anger than on comprehensive analysis and fact.  It could also greatly compromise the defense of any future legal action taken.  Focusing on concern for the patient’s condition and future care is the best way to comfort the patient and minimize the potential for any conflicts.

    Complexity of Drug Error Defense

    by Attorney Frank E. Reardon

    September 1995


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