Update Nov Dec 2013 - (Page 43)

FDLI Activities cases are settled rather than fully litigated, as companies would prefer to settle on favorable terms and are not typically in the business of establishing First Amendment precedent. Samp explained, however, that in this case, "reminder" mailings account for the vast majority of Adheris's business and therefore the case is unlikely to be settled. The case raised many important First Amendment issues, such as regulating conduct versus speech as well as privacy concerns, because the case involves patient-specific information. As Samp observed, the refill reminders were truthful speech that is not likely to be argued was misleading, so the case is an important test of the ability of the federal government to restrict truthful speech. He further explained that patients who receive refill reminders from pharmacies are more likely to take their medications, demonstrating a public health benefit to the practice. (With 2013 revisions to HIPAA regulations, pharmacies and their business associates may no longer send reminder letters to customers if they are compensated for doing so, unless customers opt into the service. The regulation makes an exception if the pharmacy is paid only for the cost of printing/mailing a reminder, which, given the current business model, is likely not the case.) Adheris filed for preliminary injunction, claiming that the 2013 revisions violate the First Amendment by prohibiting truthful speech about matters of significant importance to consumers, and on a second claim that the new regulations violate the Administrative Procedure Act. At the time of the conference, HHS had yet to file a response, but Samp suggested likely defenses might include protecting patient privacy and an argument that privacy trumps First Amendment interests. Another potential claim could be that the reminder service is conduct, not speech, and that the First Amendment is not even implicated in the case. Samp concluded that the Adheris case, on all of these counts, will be worth watching. Peters closed the session with a review of key preemption cases in 2013. His presentation focused on cases that had implications for labeling, advertising and promotion. In providing an overview of general principles of preemption, he explained its source in the Supremacy Clause and distinguished the two types-express and implied preemption. In covering background on medical device cases, he explained that 510(k) cleared products do not have preemption generally whereas PMA-cleared products typically have express preemption. A review of cases demonstrated the split in decisions in this area. In Stengel v. Medtronic, Inc., decided in January 2013, the Ninth Circuit held that the state law claims escaped preemption as they constituted "parallel claims" to federal law post market FDLI Photography from FDLI's 2013 Advertising and Promotion Conference by Valter Schleder approval reporting requirement duties imposed by the Medical Device Amendments and were valid "failure to warn" claims under Arizona law. Peters, however, suggested a comparison with In Re: Medtronic, Inc. Sprint Fidelis Products Liability Litigation, a 2010 case where the Eighth Circuit affirmed a preemption ruling under similar circumstances. Peters also reviewed another pair of recent federal district court medical device cases-Caplinger v. Medtronic, Inc. (February 2013), an Arizona district court case, and Ramirez v. Medtronic, Inc. (August 2013), an Oklahama district court case-that showed the courts split on the question of whether an off-label promotion claim was preempted. Shifting to a discussion on recent cases related to pharmaceuticals, Peters discussed Teva Pharmaceuticals USA, Inc. v. Superior Court where the California Court of Appeals held in January 2013 that federal law did not preempt the plaintiff's state law claims that the generic drug manufacturer did not update their products' safety labels to conform with the equivalent brand-name drug labeling and claims that the manufacturer failed to communicate the required changes to healthcare professionals, e.g. through a Dear Doctor letter. Peters also raised the 2013 case Mutual Pharmaceutical Co., Inc. v. Bartlett, where the Supreme Court held that a design defect claim brought under state law was pre-empted by federal law under Pliva, Inc. v. Mensing but left open the possibility that claims that parallel the federal misbranding statute may not be preempted. Through these examples, Peters demonstrated that, like the First Amendment jurisprudence, recent preemption cases provide another opportunity to seek clarity. FDLI November/December 2013 Update 43

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Update Nov Dec 2013