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
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
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
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
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
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
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]”).
When we think of prescription medical devices, we usually think of the sorts of devices that are implanted during surgery and tend to end up in litigation—artificial joints, pacemakers, surgical meshes, and bone cements, to name a few. Devices according to the FDCA also include “in vitro reagent[s] . . . intended for use in the diagnosis of disease or other conditions.” There are a whole slew of diagnostic devices that are used to test blood, tissue, or other stuff from the body to provide useful health information. Some of them get used directly by health care professionals, some can be purchased over-the-counter, and some need a prescription for the patient to use it at home. We know that plaintiffs sue over just about every kind of device under a range of theories, but we do not recall seeing consumer fraud claims over prescription diagnostic devices. That is what we have in Andren v. Alere, Inc., No. 16cv1255-GPC(NLS), 2016 U.S. Dist. LEXIS 124252 (S.D. Cal. Sept. 13, 2016), and we thought the issues were interesting enough to spend a little time sharing them with devoted readers.
Andren is a decision on a motion to dismiss a purported class action complaint brought by two plaintiffs, each of whom claimed to have suffered thrombotic events from inadequate anticoagulation as a consequence of inaccurate readings on a defendant’s test kit, which checks blood clotting times for people on anticoagulation therapy. We have some guesses about why they did not just pursue product liability claims for personal injury and some of the hurdles that they would stumble over on the way to class certification. None of that really mattered yet, because they tried to assert claims sounding in fraud and Fed. R. Civ. P. 9(b) requires heightened pleading for such claims. Some background on the device is in order first. Unlike the court, which had a discussion of what beyond the complaint it could consider—which we will omit here—we can say that the defendant recently elected to discontinue and withdraw the device that plaintiffs claim to have used, which followed the earlier recall of lots of the product made since 2008 because of issues with accuracy in certain patient populations or settings. Plaintiffs’ allegations were not limited to the particular device they used and were predictably broad. They alleged that the defendant and its predecessors received thousands of complaints of “malfunctions,” including some number that results with their devices differed significantly from what independent laboratories found on the same samples. Id. at **3-4. They alleged that FDA issued warning letters about adverse event reporting and other issues after 2005 and 2006 inspections of defendant’s predecessor in 2005 and 2006—well before the device at issue was cleared or sold. Id. at **4-5. In April 2014, the test strips portion of the test kit were recalled. In December 2014, the monitor portion and other products in the line were recalled. The recalls were because readings with the kits were sometimes significantly lower than they would have been if tested by laboratories. Id. at **5-6.
They way that these readings (of the International Normalized Ratio or “INR”) work is numbers that are lower than the expected range for someone on anticoagulation therapy (with the range depending on the underlying condition and other factors) should result in increased anticoagulation therapy. Having too much anticoagulation therapy can put a patient at risk for undesired bleeding. Each plaintiff claimed that their readings from the defendant’s test kits were incorrectly high, so they either failed to take a dose of anticoagulation on a certain day or reduced his regular dosage of anticoagulation over time—with each plaintiff apparently taking these actions without consulting health care providers. Id. at **7-9. So, the alleged product issues here were the opposite of the reason for the recalls. And then the plaintiffs claimed to have suffered a stroke (not specified as ischemic or hemorrhagic, but the former is about seven times more common and this one was apparently followed by transient ischemic attacks) or a transient ischemic attacks. Id. Based on the recounting of the medical allegations, then, the plaintiffs claimed the sort of injuries that were also the opposite of the risk implicit in the recall.
Back in October, all of the Philadelphia Reed Smith bloggers participated in an in-house CLE presentation attended by colleagues and clients. Our portion of the presentation dealt with third party litigation funding. There are several different funding models, but all are united by a common theme: funding companies, aided by plaintiffs’ lawyers, identify vulnerable litigants
There is a lawyer we worked with at another firm who had a standard move, kind of the way that Jerry Seinfeld had a standard “move” – and, come to think of it, with a similar intention. (“The Move” shows up in “Fusilli Jerry,” the 107th episode of Seinfeld.) In the face or fear of a hostile action against our client, this lawyer would file a declaratory judgment action in a friendly federal court. The concept, of course, was to seize the initiative and do some forum-shopping. Sometimes the action would be preemptive and sometimes it would be reactive. One would think that the timing would make a difference. But as today’s case, Monster Beverage Corp., v. Herrera, 2016 U.S. App. LEXIS 9012 (9th Cir. May 17, 2016), demonstrates, that ain’t necessarily so. We discussed the Monster case a couple of days after Labor Day in 2013, when Monster survived an attack on its preemptive preemption position. Here it is just a couple of days after Memorial Day in 2016, and the Ninth Circuit has ended the case on grounds of Younger abstention and the Anti-Injunction Act. That’s a long passage of time. The judicial process, especially the appellate phase (doubly so in the Ninth Circuit), can take a while. What happened in the interim?
First, please enjoy this reminder of what the Monster case was about. The San Francisco City Attorney wrote a letter to Monster informing it of an investigation into whether Monster’s marketing of its energy drinks was deceptive and bad in various other ways. Needless to say, the City Attorney’s beef was really with the federal regulatory regime that already governed what Monster could and could not say about its products. But San Francisco has been known to try to conduct its own foreign policy, so why should federal regulations stand in the way of its persistent effort to impose a nanny-state on its benighted citizens? Monster filed a preemptive declaratory judgment action in C.D. Cal. (good idea to drag the San Francisco City Attorney down to SoCal), seeking to shut down the investigation because it was preempted by federal law. Then the San Francisco City Attorney filed a complaint in San Francisco Superior Court, which Monster removed to federal court on grounds of federal question (preemption again), which the federal court remanded after rejecting the preemption argument. For those of you keeping score at home, that means there was a federal case in Dodger-land and a state case in Giant-land.
The San Francisco (honestly, by this point we are tired of writing the city name out in full, but Boranian warned us that we’d be jeered if we abbreviated the city’s name in any way) City Attorney, as is the case with all Bay Area denizens forced to contemplate anything south of Big Sur, must have seen the C.D. Cal. case as a vast annoyance. That was certainly the idea behind Monster’s maneuver. Not surprisingly, then, the City Attorney filed a motion to dismiss the declaratory judgment action in C.D. Cal., arguing that the preemption argument stood no chance. The federal court denied that motion to dismiss. That is the ruling we applauded back in September 2013.