Back in July, I posted on the Colorado Court of Appeals’ decision in Strudley v. Antero Resources Corp. et al.  There, Plaintiffs alleged negligence, negligence per se, nuisance, strict liability, and trespass as a result of defendants’ fracking activities near their homes.  Defendants requested a Lone Pine order, which would require plaintiffs to present prima facie evidence on causation prior to full discovery.  Although the trial court granted Defendants’ request and the case was ultimately dismissed for failure to prove a prima facie case, the Colorado Court of Appeals reversed, finding that the case was not so unduly complex that it necessitated the issuance of a Lone Pine order.

Just last week, the Colorado Supreme Court issued an order agreeing to review the Colorado Court of Appeals’ decision rejecting the use of a Lone Pine order in the fracking suit.  Specifically, Defendants argued that the Court of Appeals’ ruling inappropriately overrides trial courts’ efforts to manage streamlined discovery under the Rules of Civil Procedure.  Defendants claimed that the Court of Appeals “discounted the importance of Rule 26(a)(1) disclosures in modern discovery,” which can “only fulfill[] its purpose when all parties make the required information available through their disclosures.”  Defendants argued that the Strudley’s failed to comply since they failed to include any evidence showing that they were exposed to or injured by hazardous substances in the air or water that was caused by Defendants’ fracking activities.  Defendants therefore argued that by rejecting the trial court’s use of a Lone Pine order, the Court of Appeals “reverted to an outdated mode of litigation where evidence is revealed only after lengthy and expensive discovery.”  Defendants claimed that this decision would impact future fracking litigation since it would effectively have a “chilling effect on Colorado trial courts’ efforts to assertively lead the management of cases to ensure that justice is served.”

As argued by Defendants in their petition, a Lone Pine order can be a useful modern tool for companies by weeding out cases and claims by requiring plaintiffs to present prima facie evidence through experts prior to full discovery.  This can save companies a tremendous amount of time and money by streamlining discovery, which can typically become burdensome in complex mass tort and toxic tort cases.

With limited decisions issued thus far, every decision on fracking provides guidance and clarity on how courts will handle various fracking related issues and allow the oil and gas industry to better predict and prepare for possible fracking related litigations.  Procedural tools and tactics such as a Lone Pine order can be particularly helpful to defendants, especially since one of the main hurdles in fracking suits may be proving the element of causation through experts and scientific research.

We will continue to monitor this litigation and will report back once the Colorado Supreme Court tackles this topic and issues a decision on this controversial issue.

In about a week, the comment period will expire on the FDA’s solicitation for feedback regarding disclosures in direct-to-consumer, or “DTC,” prescription drug advertising.   Back in February, the FDA published a notice in the Federal Register to announce its Office of Prescription Drug Promotion’s plan to conduct research investigating the impact of different approaches to disclosure of risks in direct-to-consumer advertising.

As most people have probably noticed, the package insert accompanying a prescription medication contains a lot more information than what is discussed in a television advertisement for the same drug.  This is because prescription drug advertising regulations only require television advertisements to present the prescription drug’s “major” risks.  What is required to be included is referred to as the “major statement.”  Even though a drug’s package insert contains much more information, the FDA’s notice states that there is concern that the major statement required for advertisements is too long and “may result in reduced consumer comprehension, minimization of important risk information and, potentially, therapeutic noncompliance due to fear of side effects.”  The notice also states that, on the other hand, others are concerned that major statements “do not include adequate risk information or leave out important information.”

The FDA believes that a possible “resolution” to these conflicting concerns would be to have the major statement only include risks that are “serious and actionable” but also warn that there are other risks not included in the advertisement.  The FDA’s notice includes an example of the warning that advertisements might be required to include: “This is not a full list of risks and side effects. Talk to your doctor and read the patient labeling for [drug name] before starting it.”  The FDA refers to this as a “limited risks plus disclosure” approach and it wants to research whether such an approach would “promote improved consumer perception and understanding of serious and actionable drug risks” and how “overall drug risk and benefit perceptions are affected by these changes.”

The notice outlines the proposed study, but the gist is that participants who self-identify as having been diagnosed with a particular medical condition will view one of four versions of an advertisement online: one version includes the major statement, a second version includes the major statement plus the disclosure about additional risks, a third version includes a shortened statement of risks (and no additional disclosure), and a fourth version includes a shortened statement of risks as well as an additional disclosure about other risks.  Participants would then respond to questions designed to assess their perception and understanding of the drug’s risks and benefits.

While a significant amount of time will likely pass before regulatory requirements are changed for prescription drug advertisements, these are developments that drug manufacturers should watch closely.  One of the reasons this study is significant is because of the impact that direct-to-consumer advertising has on the learned intermediary doctrine, a powerful defense for drug manufacturers.  As defendant manufacturers are well aware, the learned intermediary doctrine provides that a prescription drug manufacturer’s duty to warn runs to the doctor (the “learned intermediary”) not the patient or public.

The learned intermediary doctrine is widely accepted in courts across the United States—it has been applied in 48 states (including by federal courts predicting state law), Puerto Rico, and the District of Colombia.  Nevertheless, critics of the doctrine argue that the justifications for its use have been rendered obsolete by, among other things, direct-to-consumer advertising.  Such critics contend that drug makers, by marketing their products directly to consumers, are usurping the traditional role of the prescribing physician.  For example, a prescriber may simply grant a patient’s request for a drug instead of using his or her judgment to weigh the benefits and risks of drugs and considering the individual patient’s circumstance to determine which drug should be prescribed.

At least one state supreme court has relaxed the doctrine and carved out a direct-to-consumer “exception” to the learned intermediary doctrine.  See Perez v. Wyeth, 161 N.J. 1, 734 A.2d 1245 (N.J. 1999).  The exception presumes that a patient’s active participation in his or her own drug prescription (i.e. by approaching his or her physician about a medication after seeing an advertisement for it) undermines that patient’s reliance on the physician, or learned intermediary.  But while the Perez court held that prescription drug manufacturers marketing their products directly to consumers could not use the learned intermediary doctrine to shield themselves if their advertising failed to provide adequate warnings, the court also held that a manufacturer’s adherence to the FDA’s major statement requirement created a rebuttable presumption that the warnings provided were adequate.  Even though Perez has not had the tremendous impact that plaintiffs surely hoped for, it signals an important jurisdiction’s willingness to entertain challenges to the applicability of the learned intermediary doctrine in an era where health care is evolving.  Moreover, it places tremendous significance on the major statement requirement, a requirement for which the FDA is clearly contemplating a change.  If the FDA ultimately implements any changes to the major statement requirements for direct-to-consumer drug advertisements, it may very well impact the learned intermediary doctrine in at least those jurisdictions that agree that direct-to-consumer advertising changes the calculus in a failure to warn analysis.

Many folks may not be familiar with the suburban Town of Flower Mound, Texas, located about 20 miles northwest of Dallas.  But to those who follow developments relating to hydraulic fracturing (“fracking”), like us here at the Product Liability Monitor, the Town is becoming more of a household name.  The reason – concern about a purported “cancer cluster” in the Town, particularly among children.  In 2010, Flower Mound convinced state officials to conduct a study of data between 1997 and 2008, which concluded that the number of cancer cases among children was not higher than in other parts of Texas.  According to the Texas Department of State Health Services’ press release on the study, ”the occurrence of leukemia, non-Hodgkin’s lymphoma and childhood brain cancers in two ZIP codes in Flower Mound, Texas, is within the expected ranges for males and females.”  The press release further explained that ”The number of individual cancer cases can fluctuate significantly from year to year, particularly with rarer cancers and in such small geographic areas. An annual increase or decrease doesn’t necessarily indicate a longer-term trend.”

To the extent the prior study resolved the issue, it now appears that it has resurfaced in light of a recent research analysis done by professor Rachel Rawlins at the University of Texas. According to Rawlins, the 2010 state study was flawed. [click to continue…]

Chevron Continues Its Attack Against Fraudulent Ecuadorian Judgment, Targeting U.S. Law Firm

April 7, 2014

Recently, we wrote about Chevron’s successful efforts to convince a U.S. federal judge to block any potential attempts to enforce a $9 Billion judgment against the company arising out of a judgment in Ecuador that Chevron claims was obtained through fraud and coercion.  The unique aspect of this successful move was that Chevron went on […]

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Indian Drug Makers Remain Under The Microscope At FDA

April 4, 2014

During a trip to India last month, FDA Commissioner Margaret Hamburg announced that FDA would continue to increase its presence in the country while improving collaboration with drug manufacturers and regulatory counterparts in the Indian government.   The visit came on the heels of a series of bans imposed by FDA in 2013 on  imports […]

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