Last week, the Honorable Judge Scott W. Skavdahl of the District Court for the District of Wyoming issued a preliminary injunction blocking the Bureau of Land Management’s rules governing hydraulic fracturing (“fracking”) on federal and tribal lands.  As we previously reported, tribal, state, and industry filed lawsuits against the BLM’s new rules, and then moved for a preliminary injunction to block the rules from taking effect while the lawsuits are pending.  The plaintiffs include the states Wyoming, Colorado, North Dakota, and Utah; industry groups the Independent Petroleum Association of America and the Western Energy Alliance; and the Ute Indian Tribe, which has a 4.5 million acre reservation in northeastern Utah.

In the underlying lawsuits, the states argued that Congress did not empower the BLM to regulate water resources or underground injection.  They asserted that Congress gave exclusive authority to regulate underground injections to the EPA and the states by creating the Underground Injection Control Program (UICP).  The states then noted that in the Energy Policy Act of 2005, Congress expressly exempted fracking from the UICP. Therefore, they argued that the exemption from the UICP was an expression of Congressional intent to prohibit all federal regulation of fracking-related underground injection.

Taking a different approach, the plaintiff industry groups argued that the rule-making process was legally deficient, and that the final rules lack factual or scientific support.  Additionally, the groups claimed that the rules are ultimately unnecessary because they duplicate state standards.  Meanwhile, the Ute Indian Tribe maintained that the BLM’s rule is not consistent with the federal government’s trust obligation to the tribe.

After briefing and oral argument on the preliminary injunction, the court found merit in the plaintiffs’ arguments, ruling that they were likely to succeed on the merits of their case in the underlying action. In particular, the judge emphasized that the agency lacks authority to promulgate the regulations, and the rules themselves lack necessary evidentiary support.  Based on an extensive review of the governing statutes and regulations, Judge Skavdahl determined that Congress has “precluded federal agency authority to regulate hydraulic fracturing not involving the use of diesel fuels.” He observed that  “[i]t seems the BLM is attempting to do an end-run around” the Energy Policy Act of 2005, and admonished that “regulation of an activity must be by Congressional authority, not administrative fiat.”

Further, the judge criticized the rules’ lack of scientific basis.  He determined that the “BLM has neither substantiated the existence of a problem this rule is meant to address, identified a gap in existing regulations the final rule will fill, nor described how the final rule will achieve its stated objectives.”  Judge Skavdahl noted that even if potential impacts “warrant further study,” speculation alone “cannot justify comprehensive rulemaking.”

Finally, the court agreed that the BLM had not met its obligation to consult with the Ute Tribe on a “government-to-government basis in accordance with its own policies and procedures” before formulating and issuing the rules. Although the agency held consultation meetings with tribal representatives that were akin to its outreach to the general public, Judge Skavdahl found that they fell short of the “extra, meaningful efforts to involve tribes in the decision making process” that the Department of the Interior requires.

Upon determining that the plaintiffs were likely to succeed on the merits of the underlying case, Judge Skavdahl found that absent a preliminary injunction, they were likely to suffer irreparable harm from the implementation of the BLM’s rules. According to his analysis, the rules would both infringe on the sovereign authority of the states and tribes, and cause economic losses to all the plaintiffs. He likewise found that the balance of equities favors the plaintiffs, and that an injunction is in the public interest. Based on all of these factors, he enjoined the BLM from enforcing its fracking rules while the underlying lawsuit is ongoing.

We will continue to follow this case as it develops.




You can skip the long lines at the pharmacy counter for this one. A recent study has found that writing a prescription for mobile apps is an effective tool being used by physicians to get patients to adhere to their treatment plans.

According to IMS Institute for Healthcare Informatics, when physicians wrote prescriptions for apps, 30-day retention rates among patients jumped by 10% overall – and by 30% specifically for prescribed fitness apps. The report further noted, “If [mobile health application] access is streamlined with automatic log-in, upload and connectivity with provider healthcare systems, providers note an even greater potential for improved patient retention rates.” In other words, the more user-friendly the app is – on both the patient and provider side – the more likely the user is to continue to adhere to treatment.

So what does it mean for a physician to “prescribe” an app to a patient? For starters, healthcare providers have a seemingly endless array of options to choose from. Since 2013, the total number of mobile health apps has grown to 165,000, quadruple the number of such apps in existence just two years ago. Two-thirds of these are so-called wellness apps, which include fitness, lifestyle and stress, and diet and nutrition.

Another quarter are used for disease and treatment management, with just 9% of those specific to a particular disease. Within disease-specific apps, the five largest app categories are mental health (29%), diabetes (15%), blood and circulatory (8%), musculoskeletal (7%) and nervous system (6%). Only mental health and musculoskeletal were among the top five categories in 2013. [click to continue…]

Hammering home the potentially severe consequences of failing to disclose consequential information requested in discovery, the First Circuit has vacated a district court’s denial of a motion for a new trial made by an injured helicopter pilot who claimed his trial was prejudiced by the discovery misconduct of defendants. West v. Bell Helicopter Textron, Inc., No. 14-2168, 2015 WL 4979575 (1st Cir. Aug. 21, 2015).

The relevant facts can be condensed to the following. On December 22, 2008, plaintiff, Kurt West, a helicopter pilot employed by JBI Helicopter Services, experienced a sudden engine shutdown while flying a Bell 407 helicopter from a small airport in Connecticut back to JBI’s facilities in New Hampshire. West managed to negotiate a “hard” landing, and, as a result of the accident, allegedly suffered gastrointestinal problems and post-traumatic stress disorder interfering with his ability to fly. He commenced an action against the manufacturer of the helicopter, Bell Helicopter Textron, Inc. (“Bell”), the manufacturer of the engine, Rolls-Royce Corporation (“Rolls-Royce”), and the manufacturer of the electronic control unit, defendant Goodrich Pump & Engine Control Systems, Inc.

At trial, the parties advanced very different theories to explain the engine’s sudden shutdown. West argued the shutdown was caused by a phenomenon referred to as false overspeed solenoid activation, or “FOSSA.” The solenoid is an electrical switch coupled with a valve through which fuel must flow before reaching the engine. The Bell 407 helicopter was equipped with a mechanism intended to prevent the engine from rotating too quickly, or going into “overspeed.” When an electrical current reaches the solenoid, the switch activates and shuts the valve, causing less fuel to get into the combustion chamber, thereby slowing the engine speed until it returns to normal. The defense disagreed that West’s accident had anything to do with FOSSA and told the jury that the engine could not have shut down for the reasons West alleged.

The jury returned a defense verdict on September 30, 2013, after which West moved for a new trial asserting that he had been prejudiced by a variety of errors. On January 23, 2014, while West’s motion was pending, Rolls-Royce issued a “Commercial Engine Bulletin” applicable to the type of engine and electronic control system in West’s helicopter. The bulletin described an “adapter” the defendants had developed to be installed on Bell 407s, which “modifies the overspeed protection system to reduce the likelihood of a false overspeed activation,” or FOSSA. The same day, Bell issued its own “Allert Service Bulletin” for its 407 helicopters, which also addressed FOSSA and advised that “Bell Helicopter has been made aware of a potential condition where a false engine overspeed protection system could occur.” Bell’s bulletin also directed the installation of an overspeed adapter and provided instructions for installation.

Two weeks after these bulletins were released, West filed a second post-trial motion, this time seeking a new trial based upon Federal Rule of Civil Procedure 60(b)(2) and 60(b)(3). The district court denied all of West’s motions.

On appeal, the First Circuit addressed only the resolution of the Rule 60(b)(3) new trial motion. Rule 60(b)(3) provides that the court may relieve a party from a final judgment, order or proceeding for “fraud (whether previously called intrinsic or extrinsic), misrepresentation, or misconduct by an opposing party.” West argued that following issuance of the bulletins, it was clear the helicopter’s circuit design was defective. Moreover, he argued, the technical nature of the information in the bulletins, detailed fixes, and government approval of them, coupled with the short passage of time between the conclusion of trial and their issuance, compelled the inference that the defendants knew about and failed to disclose information regarding the defect during discovery or at trial: “In West’s view, at least some of the defendants had to have been engaged in efforts to identify the defect, design and test a solution, and prepare documentation long before trial began.” Id. at *7. West claimed this failure to disclose constituted misconduct during the course of discovery which substantially interfered with the preparation and presentation of his case, thus entitling him to a new trial.

In deciding the appeal, the court relied upon precedent from the case Anderson v. Cryovac, Inc., 862 F.2d 910 (1st Cir.1988), where it was recognized that a party’s failure to disclose materials requested in discovery can constitute “misconduct” for purposes of Rule 60(b)(3). The court elaborated that misconduct in this context can cover even accidental omissions and need not be predicated on “evil” purpose. Id. at *9. However, discovery misconduct alone does not warrant a new trial. Rather, a complaining party must demonstrate that the alleged discovery misconduct “substantially…interfered with [his] ability fully and fairly to prepare for and proceed at trial. Id. at *10 (quoting Anderson, 862 F.2d at 924). Anderson also set forth a burden-shifting framework according to which a moving party who makes a showing that his opponent intentionally suppressed evidence is entitled to a presumption that such evidence would have damaged the moving party. The burden then shifts to the non-moving party to prove its misconduct did not result in any substantial interference. West argued, and the court agreed, that the trial court erred in failing to shift the burden to show no substantial interference to defendants:

“But, after assuming West could fly through the turbulence of the first hurdle and show culpable misconduct, the district judge misconstrued and misapplied the next stage of the Anderson test. Having assumed the defendants culpably withheld their knowledge of the defect addressed by the Bulletins, the district judge should have gone on to presume the defendants’ misconduct substantially interfered with West’s trial preparation. He did not do this, though. Rather than shift the burden to the defendants to prove by clear and convincing evidence that the withheld material was inconsequential like Anderson requires, the judge erroneously placed the burden on West to show that disclosure of the information would likely have made a difference in the trial’s outcome.”

Id. at *11. [click to continue…]

FDA Issues New Food Safety Rules

September 25, 2015

The United States has seen more than its fair share of foodborne illness outbreaks in recent years.  There was the 2008 salmonella outbreak in peanut butter, which resulted in the shocking discovery that the Peanut Corporation of America was knowingly distributing contaminated food; the 2011 listeria outbreak in cantaloupes, which ultimately became one of the […]

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District Court Denies Class Certification For Lack of Predominance In Common Defect Case

September 22, 2015

Defeating class certification is always a hot topic of interest for companies facing large consumer class actions. A class may be certified under Rule 23(b)(3) only if it meets the four prerequisites found in Rule 23(a) – including numerosity, commonality, typicality, and adequacy of representation – and the two additional requirements found in Rule 23(b)(3) […]

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