Drug Company Blames Doctor

It's not a pretty aspect of human nature.  In fact, if you've done it, you're probably ashamed of yourself.  An authority figure accuses you of breaking a rule or a law.  Fearful of the consequences, you look around for someone else to blame.  The other person is usually someone who is weaker than you.  It may be a little brother or some other person who can't fight back.  The following is a case in point.

In 2008, Dr. Benjamin prescribed Botox to treat his 2 year old patient for lower-limb spasticity caused by cerebral palsy.  Initially, he ordered 6 units per kilogram of body weight.  In 2012, he decided to increase the dosage to 12.33 units per kilogram of body weight.  The day after the first injection of the increased dose, the patient’s face began swelling and he experienced respiratory difficulties, slurred speech, and vomiting.  
After several hospitalizations, physicians discovered that the Botox injection may have triggered the epileptic seizures that caused these symptoms.

Prior to Dr. Benjamin’s treatment of this patient, Allergan, the manufacturer of Botox, had determined that the maximum dose for a child should not exceed 8 units per kilogram of body weight.   Because Allergan failed to convey that information to treating physicians, Dr. Benjamin was not aware of the dosage limit.  Arguing that Allergan had a duty to advise physicians of dosage recommendations, the patient’s parents sued the manufacturer.

In its effort to escape liability, Allergan argued that because the physician was a “learned intermediary,” he alone had the duty to determine the appropriate dosage for his patient.  It claimed that he alone had the duty to warn the patient of the risks of treatment.

Allergan is not the first drug company to urge the court to shift liability to the health care provider.  Upjohn successfully asserted the same argument in a case involving the death of a man who took Ansaid, a non-steroidal anti-inflammatory drug used to control pain.  Because the drug was a sample given by the physician, its packaging did not contain any drug warnings.  Abbott labs also successfully relied on the learned intermediary in a case involving its concentrated sodium chloride medication.   

Despite these earlier cases, the Court ruled against Allergan.  It held that the learned intermediary doctrine did not apply because Allergan had not warned the physician of “the dangers inherent in the product.”  Dr. Benjamin testified that he would have passed the dosage warning on to the plaintiffs if he had known about it.  He also said that he currently includes that warning in his informed consent procedure.  The plaintiffs testified that they would not have consented to the drug if they had known about the dosage issue.  They said that their son’s spasms were not severe and did not warrant taking the risk of contracting epilepsy.   Significantly, at the time of this case, the FDA had not approved Botox to treat lower-limb spasticity in children.  Accordingly, Dr. Benjamin’s use of the drug was “off-label.”

Health care providers should be certain that they convey in writing to their patients all relevant risks of recommended drugs.  This duty to warn is especially important when the provider’s use of the drug is “off-label.” It is also important when giving the patient a sample of the drug.  Because the packaging of drug samples does not include warnings of drug interactions, the patient does not receive a copy of the manufacturer’s warnings. 

While it is a compliment for the court to consider you “learned,” it can be very expensive for the court to decide that you are a “learned intermediary.”  Don’t become a scapegoat.