The Learned Intermediary Doctrine

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The Learned Intermediary Doctrine

• Janet Gilligan Abaray
• Burg Simpson Eldredge Hersh Jardine
• Cincinnati, Ohio

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The Learned Intermediary Doctrine

• The learned intermediary doctrine is itself an
  exception to the manufacturers traditional duty
  to warn consumers directly of the risks
  associated with a product. And now courts have
  developed multiple exceptions to the exception.
  

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Origins of the Learned Intermediary Doctrine

• 1925The Eighth Circuit first suggested that a
  manufacturers duty to the ultimate consumer
  would be limited in the case of prescription
  drugs.
• 1948The first court concluded that a
  manufacturers duty to warn was satisfied by
  providing warnings to a prescribing physician.
• 1967Eighth Circuit was the first court to coin
  the term learned intermediary.

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From Patients to Consumers

• Direct-to-consumer advertisements have turned
  patients into consumers.
• 1990sFDA issued guidelines to remove some
  restrictions on direct-to-consumer
  advertisements.
• 198912 million a year spent on
  direct-to-consumer advertising. Currently that
  figure has risen to over 4 billion a year.
• In recent years, only four additional state high
  courts have adopted the learned intermediary
  doctrine, and none of them considered the effect
  of direct-to-consumer advertising.

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The Learned Intermediary Doctrine
JustificationsOutdated Unpersuasive

• Manufacturer difficulty in providing warnings to
  the ultimate user
• Patients reliance on treating physicians
  judgment in selecting appropriate drugs
• It is the physicians who exercise their
  professional judgment in selecting appropriate
  drugs
• Physicians are in the best position to provide
  appropriate warnings to their patients and
• Direct warnings to ultimate users would interfere
  with the doctor/patient relationship.

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Premise One Manufacturer difficulty in providing
warnings to the ultimate user

• 4 billion a year spent on direct-to-consumer
  advertisingmanufacturers can hardly say that
  they lack effective means to provide warnings.
• Drug manufacturers can provide warnings and
  instructions on
• Labels, pamphlets in the box, or brochures sent
  to hospitals, doctors offices, and pharmacies.
• Also, pharmacists can and already do tape
  warnings on pill bottles, include printed
  instructions and warnings with dispensed
  medications.

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Premise Two Patients reliance on treating
physicians judgment in selecting appropriate
drugs

• With the advent of direct-to-consumer advertising
  and websites like WebMD, patients come to the
  doctor already well informed, and often
  self-diagnosed with a prescription in mind.
• Selection of drugs are often dictated by price
  and insurance coverage.

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Premise Three It is the physicians who exercise
their professional judgment in selecting
appropriate drugs

• Yet drug manufacturers spend over 4 billion
  advertising to consumers, clearly with the intent
  of influencing prescriptions.
• Direct-to-consumer advertising suggests that
  consumers are active participants in their health
  care decisions. And often go to the doctor
  knowing which prescription they are going to ask
  for.

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Premise Four Physicians are in the best position
to provide appropriate warnings to their patients

• In a study conducted by the FDA in 1997, only
  one-third of 1,000 patients had received
  information from their doctors about the
  dangerous side effects of drugs they were taking.
  
• Managed care has reduced the time allotted per
  patient, and physicians have considerably less
  time to inform patients of the risks and benefits
  of a drug.

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Premise Five Direct warnings to ultimate users
would interfere with the doctor/patient
relationship.

• Creating an informed consumer does not harm the
  doctor/patient relationship.
• Informing patients promotes discussion and
  understanding.
• Patients still must see a doctor to obtain
  prescriptions, making the doctor the ultimate
  control for prescription medications.

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Learned Intermediary DoctrineExceptions to the
Exception

• Courts have recognized the following exceptions
• Vaccines
• Oral Contraceptives
• Contraceptive Devices
• Drugs Advertised Directly To Consumers
• Overpromoted Drugs
• Drugs Withdrawn From the Market

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Learned Intermediary DoctrineExceptions to the
Exception

• Given the plethora of exceptions to the learned
  intermediary doctrine we ascertain no benefit in
  adopting a doctrine that would require the
  simultaneous adoption of numerous exceptions in
  order to be justly utilized.
• State Ex Rel. Johnson Johnson Corp. v. Karl
  (2007), 220 W. Va. 463, 477, 647 S.E.2d 899, 913.

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Proximate Cause

• PhysiciansEven if I had the adequate warning I
  would still have prescribed the drug.
• Direct-to-Consumer Advertisingit is the patient
  as well as the physician who decides whether to
  take a certain drug.
• Duty to WarnA patients decision must be as
  equally informed as a physicians decision.
• CausationWe must ask whether the patient would
  have still taken the drug had she known of the
  undisclosed risk.

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The Learned Intermediary Doctrine

• Outdated Unpersuasive
• The U.S. medical-legal jurisprudence is based on
  images of health care that no longer exist.
• With the advent of direct-to consumer advertising
  and websites like WebMD the justifications other
  courts have used for the learned-intermediary
  doctrine are outdated and unpersuasive.