Law.com Subscribers SAVE 30%

Call 855-808-4530 or email [email protected] to receive your discount on a new subscription.

Relearning the Learned Intermediary Doctrine

BY Brian Raphel
September 25, 2013

In'typical product liability cases, the manufacturer owes a duty to the eventual consumer to warn of any risks associated with the product. However, in the context of prescription drug cases, courts have recognized that the prescribing doctors, and not their patients, are in the best position to weigh the risks and benefits of a given drug for a particular patient. Accordingly, courts in nearly every state have embraced some form of the “learned intermediary doctrine,” which provides that a prescription drug manufacturer satisfies its duty to warn so long as it provides an adequate warning of the drug's potential risks to the plaintiff's prescribing doctor.

If the warning is adequate, or even if the doctor was somehow otherwise aware of the risk, then the manufacturer will not be liable, either because it satisfied its duty to warn or because there can be no proximate causation of the plaintiff's injury if the doctor already knew of the risk but prescribed the drug anyway.

This has made the deposition of the prescribing doctor a key event in these litigations. Many courts have granted motions for summary judgment in favor of prescription drug manufacturers when the record established that the prescribing doctor was aware of the risk associated with the drug. See, e.g., McClamrock v. Eli Lilly & Co., 2012 U.S. App. Lexis 24539, at *2 (2nd Cir. Nov. 29, 2012) (“Because [the plaintiff] would have the burden of establishing proximate cause at trial, his failure to offer any evidence that [his prescriber] was unaware that diabetes was a risk associated with [the drug] when he prescribed it warranted granting summary judgment in favor of [the defendant]“); Ebel v. Eli Lilly & Co., 2009 U.S. App. LEXIS 6710, *21 (5th Cir. March 30, 2009) (affirming ruling granting summary judgment where “[the plaintiff] presented no evidence to suggest that [the doctor] would have changed either his decision to prescribe [the drug] or his risk ' benefit analysis had he received some alternative warning.”).

This premium content is locked for Entertainment Law & Finance subscribers only

  • Stay current on the latest information, rulings, regulations, and trends
  • Includes practical, must-have information on copyrights, royalties, AI, and more
  • Tap into expert guidance from top entertainment lawyers and experts

For enterprise-wide or corporate acess, please contact Customer Service at [email protected] or 877-256-2473

Read These Next
Yachts, Jets, Horses & Hooch: Specialized Commercial Leasing Models Image

Defining commercial real estate asset class is essentially a property explaining how it identifies — not necessarily what its original intention was or what others think it ought to be. This article discusses, from a general issue-spot and contextual analysis perspective, how lawyers ought to think about specialized leasing formats and the regulatory backdrops that may inform what the documentation needs to contain for compliance purposes.

Hyperlinked Documents: The Latest e-Discovery Challenge Image

As courts and discovery experts debate whether hyperlinked content should be treated the same as traditional attachments, legal practitioners are grappling with the technical and legal complexities of collecting, analyzing and reviewing these documents in real-world cases.

Identifying Your Practice's Differentiator Image

How to Convey Your Merits In a Way That Earns Trust, Clients and Distinctions Just as no two individuals have the exact same face, no two lawyers practice in their respective fields or serve clients in the exact same way. Think of this as a "Unique Value Proposition." Internal consideration about what you uniquely bring to your clients, colleagues, firm and industry can provide untold benefits for your law practice.

Risks and Ad Fraud Protection In Digital Advertising Image

The ever-evolving digital marketing landscape, coupled with the industry-wide adoption of programmatic advertising, poses a significant threat to the effectiveness and integrity of digital advertising campaigns. This article explores various risks to digital advertising from pixel stuffing and ad stacking to domain spoofing and bots. It will also explore what should be done to ensure ad fraud protection and improve effectiveness.

Turning Business Development Plans Into Reality Image

This article offers practical insights and best practices to navigate the path from roadmap to rainmaking, ensuring your business development efforts are not just sporadic bursts of activity, but an integrated part of your daily success.