Fracking Suit Dismissed Due to “Missing Links in the Chain of Causation”

Hydraulic fracturing (“fracking”) has been subject to a considerable amount of media coverage over the past few months, and we have been monitoring the regulatory and litigation landscape closely here at Weil.  Most of the fracking-related litigation to date has alleged water and environmental contamination/pollution under a variety of legal theories.  A Colorado state judge has recently signaled that plaintiffs in these types of suits may face significant problems in proving the requisite element to the vast majority of the common law claims asserted.

In Strudley v. Antero Resources Corp. et al., No. 2011-CV-2218 (2d Jud. Dist. Ct. May 9, 2012), the plaintiffs’ toxic tort action was premised on allegations that the defendants’ drilling of three natural gas wells in Silt, Colorado contaminated the air and the plaintiffs’ water supply, forcing the plaintiffs “to flee and abandon their home.”  The injuries complained of included “nasal sinus congestion,” “nosebleed[s],” and “an aversion to odors.”  The complaint named Antero Resources Co. (an oil and gas exploration and production company), Calfrac Well Services, Ltd. (a fracking, tubing, cementing, and well services provider) and Frontier Drilling LLC (a drilling operations and drilling equipment services provider) as defendants, and asserted claims for negligence, negligence per se, nuisance, strict liability, trespass, and the creation of a medical monitoring trust.  The plaintiffs sought compensatory damages, punitive damages, diminution of value of the Strudley property, the cost of medical monitoring, and litigation fees and costs.

Last year, the defendants requested a Lone Pine order during case management proceedings, which would require the plaintiffs to detail their injuries and damages and show minimal evidence of causation prior to discovery.  The court granted this request, noting that it was “[c]ognizant of the significant discovery and cost burdens presented by a case of this nature.”  Judge Ann B. Frick’s Lone Pine order, dated November 10, 2011, instructed the plaintiffs to provide the Court and the defendants with (1) detailed expert opinions that would relay both general and specific causation, (2) studies that found contamination on the plaintiffs’ property, (3) each plaintiff’s medical records, and (4) the identification and quantification of contamination of the plaintiffs’ real property attributable to defendants’ operations.   Judge Frick determined that this prima facie showing requirement did not prejudice the plaintiffs because “ultimately they would need to come forward with this data and expert opinions in order to establish their claims.”

On February 23, 2012, the plaintiffs submitted a variety of maps, photos, medical records, and air and water sample analysis reports, as well as a doctor’s affidavit, which opined that “sufficient environmental and health information exists to merit further substantive discovery.”  (emphasis added by the court).  The defendants submitted the results of a Colorado Oil and Gas Conversation Commission investigation, which concluded that the plaintiffs’ well water was not affected by oil and gas operations in the vicinity.  The defendants also submitted wind pattern and air emission-control equipment evidence supporting their contentions that the plaintiffs could not have been exposed to harmful levels of chemicals, as well as sworn testimony that their activities were conducted in compliance with applicable laws and regulations.

The court found that the plaintiff’s “sole” expert, Dr. Kurt, “makes no opinion as to whether exposure was a contributing factor to plaintiffs’ alleged injuries or illness,” and that while the air and gas tests do show “detectable levels” of certain gases and chemicals, none of this data or expert analysis states “with any level of probability that a causal connection does in fact exist between plaintiffs’ injuries and plaintiffs’ exposure to defendants[’] drilling activities.”  The court noted that “perhaps most significantly,” Dr. Kurt failed to “draw a conclusion that [p]laintiffs’ alleged injuries or illnesses were in fact caused by such exposure (specific causation).”  Accordingly, the court found that due to the “missing links in the chain of causation,” the plaintiffs failed to make a prima facie claim for injuries, the defendants’ motion to dismiss should be granted, and the plaintiffs’ claims should be dismissed with prejudice.   

Antero’s spokesman indicated that the company was “pleased” with the decision, since plaintiffs “have to come with damages, not just allegations.”  The Western Slope Colorado Oil and Gas Association “applauded” the decision, lauding it as a “symbolic victory.”

Judge Frick’s dismissal of Strudley highlights a fracking plaintiff’s most difficult obstacle—causation.  Without evidence supporting this causal connection, plaintiffs will face significant difficulties in asserting claims commonly asserted in environmental toxic tort actions.  Strudley also highlights the use of Lone Pine orders, frequently used in earlier years to manage complex mass tort cases.

We will continue to keep you posted on any notable developments regarding this topic here at the Product Liability Monitor.

Posted in Mass Tort

FDA Committee Approves New Weight Loss Drug

As any reader of The Monitor knows, we’ve followed the FDA’s ups and downs on new weight loss drug applications and approvals — or rather lack thereof (see here and here).  For the second time this year, the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee voted last week 18-4 with one abstention in favor of approving a new weight loss drug, this time Arena’s diet drug, Lorqess.  In February, an FDA advisory committee voted in favor of Vivus Inc.’s Qnexa, but the agency has failed to act on the approval.   

With Lorqess’s approval, Arena is now vying to be the first new diet drug approved by the FDA in over a decade.  Representatives for the company stated that they expect a final decision from the agency by the end of June.

Like Qnexa before it, Arena’s drug was initially rejected by the commitee in June 2010, citing modest weight loss and concerns over a possible increased risk of tumors in rodents and links to valvular heart disease.  FDA’s concerns over links between diet drugs and heart disease led to a recommendation in March that companies that make obesity drugs should rule out excessive cardiovascular risk prior to drug approval.  Given that the FDA recommendation came after Arena’s development of Lorqess, Arena’s clinical trials were not designed to monitor heart disease risks, an issue the panel was willing to overlook.  In addition, Arena’s additional data provided to the FDA assuaged safety concerns and showed that the drug resulted in a 5% weight loss in some patients, with others called “responders” seeing a weight loss of 11% (or 25 pounds in total).      

The FDA appears to be particularly vigilant with regard to approval of any new weight loss drug and even dietary supplements - possibly due in part to the Phen Fen aftermath - despite the pending applications from Qnexa, Lorqess and a third called Contrave.  Makers of Contrave announced in 2011 that the FDA’s increased data requirements for approval were too onerous and as a result, that it would not market the drug in the U.S.  However, the stakes are high for the American public — earlier this week at the CDC’s Weight of the Nation conference, the CDC and Duke University warned that obesity could affect 42% of Americans by 2030.  That’s a lot of potential prescriptions.

Posted in Pharmaceutical Law, Uncategorized

Supreme Court Permits Generics “Use” Challenge

A recent Supreme Court opinion may make it easier for generic drug manufacturers to bring their products to market.  The opinion - Caraco Pharmaceutical Laboratories, Ltd. et. al. v. Novo Lordisk A/S et al. – interprets federal legislation to allow generic manufacturers to challenge patent infringement suits by brand name manufacturers that might have previously thwarted the introduction of generic versions of drugs until use patents by the brand name manufacturers expired.

Ordinarily, when a brand name manufacturer releases a new drug to the market, it files what is known as a New Drug Application (or NDA) with the FDA which at the same timeprotects not only the chemical compound of the drug but also its intended uses – both in terms of which diseases it treats and how it may be used in treatment.  While the compound patent expires fairly quickly  – to allow cheaper, generic versions of the drug to be developed –  the use patents often remain in place for a longer period of time and thereby preclude other manufacturers from marketing generic versions for overlapping uses.  Continue reading »

Posted in Legislation, Pharmaceutical Law, Supreme Court

Not Your Average Breath Spray: New Aerosol Provides Seconds Of Instant “Intoxication”

A few months ago, my colleague Chris Barraza discussed recent efforts by the FDA to examine dietary supplements.  One such supplement was called Aeroshot, a form of inhalable caffeine.  It would appear that Aeroshot has been taken one step further.  A new product called WAHH Quantum Sensations has hit the market in Europe.  The product, developed in part by one of the scientists who developed Aeroshot, is an aerosol about the size of lip-stick that delivers a small amount of alcohol per spray.  As discussed in recent media coverage, the product “tricks the brain” into feeling intoxicated for a few seconds.  The effect wears off quickly, however, “leaving the user sober and able to carry on with their day.” Continue reading »

Posted in Uncategorized

Repetitive Class Actions Continue to Pose Problems

As my colleague Jeremy Grabill previously posted, defeating class certification under Rule 23 in federal court usually will not prevent plaintiffs from seeking certification in state court.  See Smith v. Bayer Corp., 131 S. Ct. 2368 (2011).  Last week, the Seventh Circuit, applying Smith v. Bayer Corp., emphasized exactly what my colleague referred to as the “pesky problems” putative class actions continue to pose for defendants.  

In 2006, a putative class commenced a lawsuit against Sears, Roebuck, and Company for allegedly deceptive marketing in connection with dryers.  The named plaintiff, Steven Thorogood, argued that he only purchased the dryer from Sears because of the words “stainless steel,” which he interpreted to mean that the dryer was entirely stainless steel.  He later learned that the drum of the dryer was made of ceramic-coated steel, which he claimed rusted and stained his clothes.  The Illinois district court originally certified the class but the Seventh Circuit reversed, finding that there were no common issues of law or fact because it was “inconceivable that all or even many other members of the proposed class had the same understanding of Sears’ advertising as Thorogood claimed to have.”  Continue reading »

Posted in Class Action Law Suits