Legal Blog

Opioid Manufacturers in Louisiana: The “Learned Intermediary” Doctrine

Written by Kristin Lausten

As the opioid crisis continues unabated, pharmaceutical companies and opioid manufacturers are facing an increasing number of lawsuits. Dozens of states, counties, and city governments have sued opioid manufacturers seeking money damages for what they claim are the government-paid costs caused by alleged false and misleading marketing practices. The US Justice Department has recently decided to join the lawsuits. See the report here.

In addition to consumer protection lawsuits, there a host of other legal claims being made against the pharmaceutical companies including wrongful death and personal injury. In this article, we discuss the learned intermediary doctrine as a possible defense to opioid-related tort claims in Louisiana.

Louisiana Insurance Defense: The Learned Intermediary Doctrine in Louisiana

Louisiana recognizes the learned intermediary doctrine as a product liability defense with respect to drug manufacturers. See, Mikell v. Hoffman-LaRoche, Inc., 649 So.2d 75 (La. App. 1st Cir. 1994).

The learned intermediary doctrine relates to the duty of a drug manufacturer to adequately warn of known risks with respect to the drug in question. The learned intermediary doctrine provides that, with respect to the duty to warn, a drug manufacturer can rely on the warnings given by the physician to his or her patient. The doctor has the responsibility to advise the patient; the doctor is a “learned intermediary.” That is, the drug manufacturer has no duty to warn the patient directly. If the manufacturer provides sufficient warning to the physician, then the manufacturer has fulfilled its duty and any tort or wrongful death liability is cut off. As stated by the Mikell court:

Generally, a drug manufacturer has no duty to warn the consumer directly of any risks or contraindications associated with its product. The obligation to the consumer is fulfilled when the prescribing or treating physician is informed of any potential side effects or risks from the drug’s use so that they may intelligently decide on its use and advise the patient. The doctor acts as an informed intermediary, and the decision to use the drug in a particular circumstance rests with the doctor and the patient, not the manufacturer.

Note that, for the learned intermediary doctrine to act as a bar to liability, the warning provided to the physician must be adequate. See Kampmann v. Mason, 921 So. 2d 1093 (La. App. 5th Cir. 2006) (summary judgment defeated where defendant failed to provide evidence that warning to physician was sufficient/adequate; “That element is essential to the learned intermediary defense.”)

Note also that drug manufacturers should be careful about what their representatives and agents say. It is possible for verbal statements contradicting the written warnings to remove a given case from the protection of the learned intermediary doctrine. See Brown v. Glaxo, Inc., 790 So. 2d 35 (La. App., 1st Cir. 2000).

Louisiana Insurance Defense: The Learned Intermediary Doctrine with Respect to Opioids

The learned intermediary doctrine has already been used as a defense against tort liability for manufacturers of opioids. For example, in the case of Foister v. Purdue Pharma, LP, 295 F. Supp. 2d 693 (US Dist. ED Kentucky 2003), the doctrine was successfully used to defend Purdue Pharma against failure to warn tort claims with respect to OxyContin. After a lengthy review of Kentucky law and the actual warnings provided to the physicians by Purdue Pharma, the district court concluded that all the claims made by the various plaintiffs were covered by the warnings. As such, the court held that “application of the learned intermediary defense bars the claims of all plaintiffs to this action.”

It is to be noted that the hysteria caused by news reporting and politicians is causing cases like Foister to come under severe challenge. In Tug Valley Pharmacy v. All Plaintiffs Below, 773 SE 2d 627 (W. Va. Supreme Court 2015), a divided West Virginia Supreme Court arguably gutted that State’s “wrongful conduct” rule and/or the doctrine of in pari delicto. Bad facts are making bad law.

Defending Against Opioid Cases in Louisiana: Contact New Orleans Attorney Kristin M. Lausten

The author may be contacted at:

Kristin M. Lausten

New Orleans, Louisiana
Telephone: 504.377.6585

This article is provided as an educational service for general informational purposes only. The material does not constitute legal advice or rendering of professional services.