Learned Intermediary Doctrine, Direct-to-Consumer Advertising, and the Rise of Social Media – Life Sciences Blog Posting by Spencer Bomar
Like most individuals living in today’s world, medical device and pharmaceutical companies utilize social media. Social media provides companies with another way in which to communicate with consumers beyond traditional direct-to-consumer mass media. Social media, e.g. Facebook, YouTube, Pinterest, Instagram, Twitter, and LinkedIn, will likely prove to be an increasingly influential means of communication and source of information in the years to come.
How will social media, a more direct, profuse, and conceivably more detailed means of communication aimed at consumers affect the learned intermediary doctrine?
For years, a product manufacturer’s duty to warn has been distinguished when it comes to products that must be prescribed by physicians.1 Specifically, the manufacturer of a drug or medical device has a duty to provide adequate warnings to the prescribing physician, but not directly to patients.2 The rationale is that physicians are learned intermediaries with specialized knowledge of the individual patient in combination with the medical product prescribed.3 Therefore, it has long been held that product warnings should be provided to the doctor as a variable to consider in the context of reasonable medical judgment.
However, as manufacturers have gradually engaged in more direct-to-consumer advertising that influences consumers’ decisions to use a given medical product, some courts have taken exception to the learned intermediary doctrine.4 For instance, if a plaintiff establishes that an advertisement violated FDA requirements and that the advertisement was a substantial factor in causing the harm suffered, some courts apply an exception to the doctrine rather than automatically shielding manufacturers from failure to warn claims. The rationale here is that direct-to-consumer advertising can cause consumers to be falsely reassured and negatively affect communication with their doctors who consider patient histories when applying their medical judgment.
Direct-to-consumer advertising of pharmaceuticals is regulated under 21 C.F.R. §202.1, requiring a “true statement of information in brief summary relating to side effects, contraindications … and effectiveness”.5 Accordingly, companies are already required to include proper warnings in their advertisements.6 It takes little imagination to envision that some will argue that social media is the foremost, most effective means of direct-to-consumer marketing that a manufacturer can deploy considering its widespread use and the public’s reliance on same. To that end, social media will not go unnoticed by those who already believe an exception to the doctrine reasonable. Regulations are already in place, some courts already take exception to the rule, and legal scholars are already advancing the reasonableness of an exception to the learned intermediary doctrine.7
For now, most courts have not adopted a direct-to-consumer exception to the learned intermediary doctrine.8 However, with the rise and increased use of social media as a method of communication to consumers, the exception will most certainly be confronted when raised and may, ultimately, weaken.9 Consequently, this is a fluid area of the law in which to be acutely aware when defending medical products and raising the learned intermediary doctrine as a defense.
(1) The learned intermediary doctrine is almost universally applied to both prescription drugs and prescription medical devices. Ellis v. C.R. Bard, Inc., 311 F.3d 1272, 1279-80 (11th Cir. 2002)
(2) Sterling Drug v. Cornish, 370 F.2d 82 (8th Cir. 1966).
(3) Id.; Brown v. Roche Laboratories, 2013 WL 2457950 (N.D. Ga. 2013)(where Court held that because the patient’s doctor knew the risks of the medicine, but felt that the potential risks outweighed the potential benefits, the manufacturer could not be liable)
(4) See State ex rel. Johnson & Johnson Corp. v. Karl, 647 S.E.2d 899 (W. Va. 2007); Perez v. Wyeth Laboratories, 161 N.J. 1, 24 (1999).
(5) 21 C.F.R. §202.1(e)(1); Shapiro, The Learned Intermediary Rule and Direct-to-Consumer Advertising, available at http://blogs.law.harvard.edu/billofhealth/2014/11/20/the-learned-intermediary-rule-and-direct-to-consumer-advertising
(8) See e.g. Calisi v. Abbott Laboratories, CA NO. 11-10671-DJC (D. Mass. Feb. 25, 2013); Murthy v. Abbott Laboratories, 847 F. Supp. 2d 958 (2012); Centocor, Inc. v. Hamilton, 372 S.W.3d (2012); DiBartolo v. Abbott Laboratories, 914 F. Supp. 2d 601 (S.D.N.Y. 2012) ;Porter v. Eli Lilly & Co., 2008 WL 544739 at *6(N.D. Ga. 2008);
(9) See e.g. Baker v. Bayer Healthcare Pharmaceuticals, No. C13-0490 THE (N.D. Cal. Dec. 19, 2013)