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
May 30, 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
Bankruptcy Sales: Finding a Diamond In the Rough Image

There is no efficient market for the sale of bankruptcy assets. Inefficient markets yield a transactional drag, potentially dampening the ability of debtors and trustees to maximize value for creditors. This article identifies ways in which investors may more easily discover bankruptcy asset sales.

Judge Rules Shaquille O'Neal Will Face Securities Lawsuit for Promotion, Sale of NFTs Image

A federal district court in Miami, FL, has ruled that former National Basketball Association star Shaquille O'Neal will have to face a lawsuit over his promotion of unregistered securities in the form of cryptocurrency tokens and that he was a "seller" of these unregistered securities.

Why So Many Great Lawyers Stink at Business Development and What Law Firms Are Doing About It Image

Why is it that those who are best skilled at advocating for others are ill-equipped at advocating for their own skills and what to do about it?

A Lawyer's System for Active Reading Image

Active reading comprises many daily tasks lawyers engage in, including highlighting, annotating, note taking, comparing and searching texts. It demands more than flipping or turning pages.

Blockchain Domains: New Developments for Brand Owners Image

Blockchain domain names offer decentralized alternatives to traditional DNS-based domain names, promising enhanced security, privacy and censorship resistance. However, these benefits come with significant challenges, particularly for brand owners seeking to protect their trademarks in these new digital spaces.