The FDA recently announced plans to implement new pharmaceutical labelling guidelines over the next several years that will require drug labels to more fully address potential effects on mothers, unborn babies and breastfed infants, as well as the drug’s implications for men and women of reproductive age.  This more comprehensive labeling scheme will replace the former protocol under which medications were labeled with letter ratings to indicate the level of risk to pregnant women, but without any additional information.  The new guidelines will allow doctors and patients to make more informed decisions about medication use before, during, and after pregnancy.

For pharmaceutical companies, compliance with the new rules will require a good deal of work in order to update and change labels to contain all of the newly required information.  The clarity these new labels will provide, however, will likely be beneficial to manufacturers and consumers alike.  According to the FDA, pregnant women take an average of three to five medications per pregnancy, including medications that are introduced during pregnancy as well as medications that were taken before pregnancy and continued.  Without comprehensive information about both the potential benefits and the potential adverse effects of a medication a woman is considering, many women are left to blindly navigate the pitfalls of either taking drugs that pose an unnecessary risk of harm to themselves or their babies, or of foregoing needed treatments due to lack of reassurance.  Not only does this mean that many women are not receiving optimized care, but it also means that pharmaceutical companies stand to miss out on reaching a segment of their target consumer population.  Not only that, but companies may face situations where their drugs could be misused in a way that leads to injury and potential liability.

The new labelling scheme can’t entirely eliminate the possibility that some pregnant and nursing women may still choose to avoid certain medications out of fear, despite information that suggests the benefits far outweigh the risks, while others may choose to take medications that are not needed despite even serious risks.  But, the new labels will ensure that women are making the choices that are right for them as individuals, after having the opportunity to understand the potential consequences of their decisions and to seek informed guidance from their doctors.  The guidelines will also ensure that manufacturers both uncover and disclose critical information about their products’ use among new mothers, providing pharmaceutical companies with an opportunity to  even more effectively serve the needs of this population as well as provide appropriate warnings.  We will continue to monitor activity in this area as it develops.


We have been covering developments relating to how courts are interpreting Rule 23’s implicit ascertainability requirement, and have noted that different courts facing the issue have articulated varying standards for how much evidence plaintiffs must offer to prove ascertainability in consumer fraud cases. For a refresher, see our posts here, here, here, and here.  As recently discussed, the Third Circuit’s decision in Carrera has proved to be a controversial one in that it seemed to raise the ascertainability bar for consumer fraud plaintiffs—too high, according to some.  Specifically, while the Carrera court  found that class members could theoretically be ascertained through a mix of loyalty and reward card purchases, online sales, and affidavits, the court still held that the plaintiffs’ methods for determining the identity of its class members in that instance were insufficient.  Many are left wondering what level of practical proof would be enough.  We may soon learn how the Ninth Circuit will answer this question in the Jones v. ConAgra Foods appeal.

Earlier this year, the Northern District of California denied class certification in a putative class action regarding allegedly misleading labeling on three different food products.  Jones v. ConAgra Foods, No. C 12-01633 CRB (N.D. Cal. June 13, 2014). Plaintiffs sued ConAgra Foods and attempted to certify three different classes (both 23(b)(2) and 23(b)(3)), one relating to each food product.  The crux of Plaintiffs’ claims is that the products at issue were labeled “All-Natural” when they in fact contained synthetic ingredients.  We have covered this issue extensively.

The court’s analysis noted that sister courts have taken varying approaches to ascertainability, stating that while “some courts have concluded that the ascertainability requirement cannot be met in the case of low-cost consumer purchases that customers would have no reliable way of remembering,” other courts “have found such classes ascertainable, largely out of a concern that to find otherwise would render a vast number of consumer class actions dead on arrival.” [click to continue…]

We have been covering plaintiffs’ war against countless food and beverage products bearing “natural” labels for years.  These cases have been frustrating at times, like when the FDA declined to clarify what “natural” means (see my related post here) and when we have seen incomprehensible inconsistencies from one court to the next, even within the same jurisdiction.  One of the cases that I wrote about back in June (see here) is now back in the spotlight; this time, it is much better news for the defense bar.

My June blog post about Brazil v. Dole Packaged Foods noted the difficulties in reconciling that court’s order certifying a class of consumers with another court’s dismissal of plaintiffs’ claims in Astiana v. Ben & Jerry’s Homemade, especially since both cases were pending in the Northern District of California.  In Brazil, the plaintiff alleged that certain fruit products were improperly labeled as containing “all natural fruit” because the liquid the fruit was in contained synthetic citric and ascorbic acid.  In Astiana, plaintiffs claimed that some Ben & Jerry’s ice cream flavors were mislabeled and falsely promoted as “all natural” since they contained synthetically alkalized cocoa.  It did not seem to make any sense that the Brazil class was certified while the Astiana plaintiffs had their claims dismissed.

But now the world makes a little more sense.  Since June, the Brazil court decertified the class as to damages and was allowing plaintiffs to proceed only as a class for injunctive relief.  And, just this week, the court granted Dole’s motion for summary judgment, concluding that: “there is insufficient evidence that the ‘All Natural Fruit’ label statement on the challenged Dole products was likely to mislead reasonable consumers and that the label statements were therefore unlawful on that basis.”  Order at 6.

The court explained that the plaintiff’s claims under California’s Unfair Competition Law, False Advertising Law, and Consumers Legal Remedies Act were subject to the reasonable consumer standard which requires plaintiffs to produce evidence that a significant portion of consumers, acting reasonably in the circumstances, could be misled.  Order at 8.  The court found that the plaintiff, who only presented evidence that he was misled by Dole’s label, had not presented enough evidence to create a genuine dispute of material fact and therefore could not survive summary judgment.  Id. at 8-9.  The plaintiff tried to avoid summary judgment by arguing that, in the Ninth Circuit, plaintiffs are not required to present surveys or expert testimony regarding consumer expectations to survive summary judgment.  While the court agreed with the plaintiff that such proof is not required, it pointed out that the Ninth Circuit does require plaintiffs to present more than a few examples of deception.  Id. at 8, 11.  Here, with just one example of deception, the court granted Dole’s motion and dismissed the plaintiff’s claims.

While Dole had to expend a lot of resources defending these claims, it is nice to write about once-frustrating “natural” case that has a happy ending (unless you are a consumer that bought fruit in juice and thinks that “all natural fruit” refers not only to the fruit chunks, but also to the liquid in the package).  Let’s consider it an early holiday present to defendant manufacturers hauled into the “natural” war.

Another Record-Breaking Year For False Claims Act Recovery

December 9, 2014

DOJ recently announced that it recovered $5.7 billion under the False Claims Act in fiscal 2014.  The staggering haul bested the previous record of $4.9 billion set in fiscal 2012, and easily surpassed DOJ’s $3.8 billion take in fiscal 2013.  DOJ’s record-breaking tally is even more remarkable because, for the first time in recent memory, the financial industry was the leading source of civil […]

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EPA’s Long-Awaited Fracking-Wastewater Rules Move A Step Closer To Publication

December 4, 2014

New regulations are on the horizon for wastewater produced as a byproduct of hydraulic fracturing (“fracking”). In 2012, fracking operations produced over 280 billion gallons of wastewater.  This water can be sent to treatment plants, re-injected deep into the earth in “disposal wells,” or processed and re-used in fracking operations.  In response to the growth of fracking, […]

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