In the ever-extending period of working from home and social distancing, we have spent some time watching various exemplars of the “superhero” genre and noted that the uber kitschy afterschool and weekend morning staple of our youth is not being recreated. (If Stevie Mac is from the Pleistocene, then our youth was in the
Consumer Fraud
No Fourth-Party Payor Liability in New Jersey

In their unending quest to make a plaintiff out of everyone, some creative members from the other side of the “v.” have concocted a claim that we call “fourth-party payor” liability. Regular blog readers are certainly familiar with “third-party payor” actions brought – entirely for economic losses – by insurers, pension funds, and other organizations…
Guest Post − How Much Is Too Much Deference To FDA Warning Letters in Consumer Class Actions?

Today’s guest post is by Camille L. Fletcher and Joshua Kipnees, both with Patterson Belknap. We actually sought out this guest post, which is rare. We first saw it on one of Patterson’s in-house firm blogs, and it was one of those rare law firm posts that did more than describe a…
Nutty Cosmetic Class Crushed

We may not know much about skin care, but we know a thing or two about labeling claims. Whether for a drug, a device, a food, a cosmetic, or some other product, it is necessary to apply some common sense in determining what is or is not in a product’s labeling should give rise…
Trying To Make A Food Labeling Claim Stick

Our last post talked about carbohydrate-rich Thanksgiving food. Today, we are talking about a putative class action on the labeling of certain diet foods, particularly in regard to “net carbs” and sugar alcohols. This was not planned. Colella v. Atkins Nutritionals, Inc., No. 17-cv-5867 (KAM), 2018 WL 6437082 (E.D.N.Y. Dec. 7, 2018), on the…
SDNY TKOs MMA Fighter’s Fraud Claims vs. Dietary Supplements

For at least forty years we’ve been hearing that soccer is going to supplant baseball, basketball, or football among America’s top three sports. It hasn’t happened. Maybe we heirs of Washington, Jefferson, Ruth, Rice, and Chamberlain have limited enthusiasm for one-nil scores and players diving and mimicking death throes in a cheap effort to extract…
Federal Court Rules That 510(k) Clearance Relates To Safety And Effectiveness

A myth that has regrettably gained some traction lately is that the FDA’s clearance of a medical device under the 510(k) substantial equivalence process is unrelated to safety and efficacy. One notably unfair manifestation of this myth is the entry of orders in limine in a number of recent medical device cases excluding evidence of…
Off-Label Marketing MDL Winds Down With Some Summary Judgment

We have written extensively on the travesty of the Neurontin trilogy (like here and here) and noted how the plaintiffs’ efforts to fit cases based on alleged off-label promotion of the prescription SSRIs Celexa and Lexapro into the same rubric have not been as successful. Today’s case addresses what we understand to be some…
Vast – Or at Least Half-Vast – Conspiracy Claim Dismissed

Imagine a conspiracy so vast that it includes not only your usual plaintiff-side fantasy of the FDA conspiring with a drug company, but also high FDA officials, President Obama, Robert Mercer (noted Trump supporter and reputed Breitbart financier), a number of other investors, and just for good measure President and Hillary Clinton.
Larry Klaman…
The Learned Intermediary Rule in Consumer Protection Claims

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes. See Andren v. Alere, Inc., 2016 WL 4761806, at *9 (S.D. Cal. Sept. 13, 2016) (where “misrepresentations and omissions claims are based on a failure to warn” the learned intermediary rule applies” to claims under the two major California consumer protection statutes (CLRA & UCL)). Since we haven’t addressed this issue recently (one guest post from 2007), we thought it would be a good idea to examine more generally decisions that also apply the learned intermediary rule to consumer fraud claims. Andren is definitely not an outlier, although in a lot of states precedent is not extensive.
We’ll start with California. We know of several other cases reaching essentially the same result. One of them, Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3-4 (C.D. Cal. June 13, 2013), is mentioned in Andren. Saavedra, a multi-plaintiff case also applying the laws of Massachusetts and Missouri (in addition to California), found the learned intermediary rule applicable to all three states’ consumer protection statutes, based on uniform precedent:
Every case that this Court has found, and that the parties have identified, that has specifically addressed the questions has found that the learned intermediary doctrine applies to consumer protection claims predicated on a failure to warn.
Id. at *3. Thus, Saavedra “concur[ed] with the great weight of authority and conclude[d] that the learned intermediary doctrine applies to the consumer protection claims at issue.”
Another relevant California case was not cited in Andren − the appellate decision in In re Vioxx Class Cases, 103 Cal. Rptr. 3d 83 (Cal. App. 2009). Vioxx held that the individual actions of learned intermediary prescribers physicians precluded class certification in cases under the same statutes:
[A]ll physicians are different and obtain their information about prescriptions from myriad sources. . . . [P]hysicians consider many patient-specific factors in determining which drug to prescribe, including the patient’s history and drug allergies, the condition being treated, and the potential for adverse reactions with the patient’s other medications − in addition to the risks and benefits associated with the drug. When all of these patient-specific factors are a part of the prescribing decision, the materiality of any statements made by [defendant] to any particular prescribing decision cannot be presumed.
Id. at 99 (footnote omitted). Thus, the Vioxx court presumed, albeit without holding, that the learned intermediary rule applied so that the physicians – rather than patients – are the recipients of information from manufacturers of prescription medical products. For other similar California law cases, see Weiss v. AstraZeneca Pharmaceuticals, 2010 WL 3387220, at *5 (Cal. App. Aug. 30, 2010) (similar result in unpublished affirmance of UCL/CLRA class certification denial); In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2012 WL 865041, at *20 (S.D. Ill. March 13, 2012) (denying class certification under UCL “[b]ecause [the drug] is a prescription medication, [so] the question of uniformity must consider representations made to each putative class member and her prescribing physician”) (applying California law); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 751 F. Supp.2d 277, 288 (D. Mass. 2010) (applying learned intermediary prescriber-centric causation principles to UCL; denying summary judgment) (applying California law); In re Paxil Litigation, 218 F.R.D. 242, 246 (C.D. Cal. 2003) (rejecting argument that the learned intermediary rule “becomes irrelevant under [the UCL]”).Continue Reading The Learned Intermediary Rule in Consumer Protection Claims