Anyone following our blog knows that the issue of whether fracking activities cause earthquakes is one receiving a lot of press and has been the subject of various studies. A seismologist at the United States Geological Survey (USGS) has added to the mix with a recently published study examining earthquakes in the central and eastern United States. The study, entitled “Shaking from Injection-Induced Earthquakes in the Central and Eastern United States” and appearing in the Bulletin of the Seismological Society of America (Vol. 104, No. 5) (August 2014), evaluated the effects of 11 earthquakes that the study considered “generally acknowledged or suspected to be induced by fluid injection.” The study relied on the USGS’s “Did You Feel It?” database, in which private citizens report that they felt an earthquake and rate its intensity. Using the database, the report compared reports for the earthquakes suspected to be related to fracking to reports for known natural earthquakes of similar magnitude in the same area. Based on this comparison, the study concluded that earthquakes allegedly produced by fluid-injection from fracking operations may cause less damage overall than earthquakes naturally induced by seismic events.
While the conclusion of the study is interesting, it underscores the need to rely on sound science and evidence before making conclusions about what may or may not have caused a seismic event in the first place. In fact, perhaps the most striking aspect of the study is how the earthquakes that are allegedly attributable to fracking-related activity were chosen–the study merely states that the earthquakes in question are “generally acknowledged or suspected” to have been induced by fracking fluid or wastewater injection, without providing any further analysis. Therefore, it is not clear how it was determined that these earthquakes are attributable to fracking activities. Additionally, the study only analyzed the data for 11 earthquakes, which represents a small sample size. Finally, questions about the reliability of the data arise because the impact of the earthquakes is quantified solely based on the USGS’s “Did You Feel It?” database, which consists of the subjective reports of private citizens. Not only are the reports subjective, but because “Did You Feel It?” depends on voluntary reporting, the individuals who elect to report data to the USGS may not be representative of the broader population of residents. In fact, the reporting rate varied dramatically among the 11 earthquakes that were analyzed; for some earthquakes, the number of “Did You Feel It?” responses was as low as several hundred reports, while for other earthquakes there were over 66,000 reports recorded in the system. This wide variability in responses calls into question what motivates people to participate in the “Did You Feel It?” system after a given earthquake, and whether these motivations distort the data and render it unreliable. We will continue to monitor this hotly contested area as it develops.
The landmark 2010 Supreme Court opinion in Citizens United cemented what had been a progressive transformation of the First Amendment into what one scholar has dubbed “the darling of economic libertarians and corporate lawyers who have recognized its power to immunize private enterprise from legal restraint.” Tim Wu, The Right to Evade Regulation: How corporations hijacked the First Amendment, New Republic, June 3, 2013. Four years later, the First Amendment is still being used as a shield for corporations, most recently by the Pharmaceutical Research and Manufacturers of America (“PhRMA”), which filed an amicus brief in a False Claims Act (“FCA”) suit that charged drug makers with issuing off-label claims. See United States ex rel. Solis v. Millennium Pharm. Inc., et al., No. 2:09-cv-3010. In the complaint, the Relator claimed that the manufacturer’s off-label promotion violated the FCA because the Food, Drug, and Cosmetics Act (“FDCA”) forbids the promotion of drugs for uses that were not approved by the FDA, thus supposedly rendering any claims influenced by the manufacturers’ off-label promotion (such as Medicare reimbursement claims) false because they allegedly ask the government to pay for illegal activity. PhRMA asked the court to dismiss the suit, arguing that the case infringes upon the companies’ free speech rights.
In its brief, PhRMA maintained that “[i]nterpreting the FDCA to punish manufacturers for truthfully speaking about unapproved uses impermissibly restricts speech based on its content and identity of the speaker.” PhRMA—no stranger to corporate First Amendment arguments having made the argument for examining FDA rules through a First Amendment lens as early as 2002—makes its point in the wake of a stream of opinions that together exhibit an increased willingness of courts to recognize pharmaceutical advertising as commercial speech deserving of constitutional protection.
Though an earlier case that opined on the First Amendment and pharmaceutical advertising was decided in 2002, see Thompson v. Western States Med. Ctr., 535 U.S. 357 (2002), perhaps the most well-known of the opinions—Sorrell v. IMS Health Inc., 131 S. Ct. 2653 (2011)—involved a Vermont statute that restricted the access of pharmaceutical companies to information about prescriptions that the companies would use in their marketing. In a 6-3 opinion, the Supreme Court held that the law was an unconstitutional restriction on speech. The Second Circuit famously relied on this opinion in its 2012 Caronia decision, which found that a pharmaceutical sales representative could not be charged with misbranding a drug by promoting off-label use because to do so would be a violation of the First Amendment.
The use of the First Amendment to protect commercial speech has not been limited to pharmaceutical advertising. Indeed, various food trade groups invoked the First Amendment this summer in their challenge to Vermont’s genetically modified food labeling law and, as we have previously written (see here), federal courts have issued conflicting rulings with respect to whether requiring tobacco companies to place certain warning images on cigarette packages infringes upon the tobacco companies’ free speech. In any event, we can expect the commercial speech argument to continue as a new brand of defense against regulation.
The National Center for Homeopathy, a non-profit organization “dedicated to promoting health through homeopathy,” describes homeopathic medicine as a “safe, gentle, and natural system of healing” that is “extremely safe to use” and “has none of the side effects of many traditional medications.” They also say that homeopathic remedies are “made from natural substances” and are “FDA regulated.” According to the website, homeopathy is based on, among other things, the “Law of Similars,” meaning that “a medicine can cure a sick person if it can cause a similar sickness in a healthy person.” In addition, the “Minimum Dose” principle involves administration of the smallest amount of medicine needed. This is achieved by dilution of active ingredients to create remedies.
The National Institutes of Health, for one, does not seem to be buying it (probably literally as well as figuratively), stating that “there is little evidence to support homeopathy as an effective treatment for any specific condition.” The NIH specifically notes that: “key concepts of homeopathy are inconsistent with fundamental concepts of chemistry and physics;” “[m]any homeopathic remedies are so diluted that no molecules of the original substance remain;” “some products labeled as homeopathic can contain substantial amounts of active ingredients and therefore could cause side effects and drug interactions;” and, the FDA “does not evaluate [homeopathic] remedies for safety or effectiveness.”
Nevertheless, the FDA recognizes that the homeopathic drug market recently became “a multimillion dollar industry in the United States.” Indeed, there are numerous over-the-counter homeopathic remedies that purport to treat countless symptoms and ailments, many of them intended for infants and children. There are U.S. and foreign manufacturers that manufacture and market homeopathic remedies. [click to continue…]