By Mary Nold Larimore and Nancy Menard Riddle
“You can’t handle the truth!” Apparently, the Food and Drug Administration is in sync with Jack Nicholson’s character, Col. Jessup, in “A Few Good Men,” when the FDA pursues criminal liability against pharmaceutical companies for speaking the truth to prescribers, otherwise known as off-label promotion. At the annual DRI Drug and Device Conference, Rita McConnell, Medtronic Inc., and Lisa Baird, Reed Smith LLP, provided an excellent recap of the current state of the law when the First Amendment of the Constitution, which guarantees the right of free speech, intersects with FDA regulations restricting what a company can and cannot say in promoting its products.
The recent case of Amarin Pharma, Inc. v. United States FDA, 119 F. Supp. 3d 196 (S.D. N.Y. 2015) represents a successful attack on government restrictions that jeopardize a company and its sales representatives when it makes “completely truthful and non-misleading statements about its product to sophisticated healthcare professionals.” Id. at 212. It turns out the court agreed that prescribers can “handle the truth,” and Amarin obtained the unimaginable, an injunction against any FDA action alleging unlawful off-label promotion for very specific statements that the court agreed were both “presently truthful and non-misleading.”
Advising a client on how to proceed in this arena is complex. Departing from the FDA-approved label in any respect in the promotion of pharmaceuticals will continue to be high risk on both the criminal and civil side and will be met with strong resistance from the FDA. But brave and courageous libertarians, take heart. The tide may be turning in favor of the First Amendment. U.S. v. Caronia has also held that “the government cannot prosecute pharmaceutical manufacturers and their representatives for speech promoting the lawful, off-label use of an FDA-approved drug.” 703 F.3d 149, 169 (2d Cir. 2012). The Second Circuit construed the “misbranding provisions of the FDCA as not prohibiting and criminalizing the truthful off-label promotion of FDA-approved drugs.” You will want to consider taking a page from the Amarin playbook by specifically seeking an injunction against the FDA before engaging in any off-label promotion.
Here are some other exciting developments in drug and device law.
‘Lies, Damned Lies and Statistics’
Moving from the subject of truth to the arena of “Lies, Damned Lies and Statistics,” Bruce Parker’s deep knowledge (and yes, we dare say love) of epidemiology and statistics was on display in his joint presentation with Dominik Alexander on “Meta-Analysis: Recycling Garbage or an Important Tool for Evaluating the Evidence?” Meta-analysis is a statistical tool that is used to combine the data contained in many epidemiology studies into one large “meta-analysis.” Those of us who regularly practice in this area might be aware of meta-analysis as a tool that can be used to take numerous studies that establish there is absolutely no statistical association between a product and a disease to try to prove to a jury that there actually is one. (Do we sound skeptical?) On the flip side, the presenters discussed the impact of publication bias on the results of a meta-analysis, due to the fact that it is much easier to get a study published when it shows that there is an association between a potential risk factor and a disease than to get a study published that does not show an association. Publication bias means that because the available pool of published studies is necessarily biased toward a positive association, the ultimate conclusion of the meta-analysis is biased.
While some claim that a meta-analysis is the gold standard for evidence-based reviews when applied to high-quality studies, all meta-analyses are not created equal. Indeed, there will always be a lot of “junk” in the medical literature, and tomorrow’s meta-analysis may fall into that category. There is an emerging set of scoring systems that peer-reviewed journals are adopting to help evaluate the quality of a meta-analysis, looking at both methodology and bias. You will want to evaluate any meta-analysis that your client is relying upon or attacking based on these criteria.
3D printing of medical devices and pharmaceuticals
“High-Tech Team Printing Organs in Space” was the headline in Inside Indiana Business last month for a report on an Indiana company that “has created cardiac and vascular structures in zero gravity using a 3D bioprinter.” 3D printing, also known as additive manufacturing, has been used for some time now in the medical device arena. Bioprinting is a specific type of additive manufacturing where cells or tissues are the material used in the printing process. As of December 2015, the FDA has cleared more than 85 3D-printed medical devices such as orthopedic and cranial implants, dental restorations and external prostheses. And in March 2015, the FDA approved the first drug manufactured using 3D printing technology, Aprecia’s Spritam.
It follows that the legal system will be called upon to adjudicate product liability disputes involving this new technology. Angela R. Vicari, Kaye Scholer LLP, discussed a number of interesting issues.
How does this new technology fit within the current definition of “product?” Are digital files that serve as a blueprint for manufacturing the device/pharmaceutical a “product” for strict liability purposes? What about bioprinted tissues and organs? Traditionally, human blood and tissue are excluded from the definition of “product” under the Restatement (Third) of Torts: Prod. Liab. §19(c) and legislation and caselaw in many states limit the liability of sellers of human blood and tissue.
How will “point-of-care” device manufacturing affect current liability standards? What about a situation where 3D printing is used at a hospital to create devices matched to the patient’s anatomy or patient-specific pharmaceuticals? Is the hospital providing a product or a service?
How will the FDA regulate 3D-printed drugs and medical devices? On May 10, 2016, the FDA issued its first Draft Guidance, “Technical Considerations for Additive Manufactured Devices.”
Law often lags behind science and technology, but the future is here. Attorneys must be prepared to analyze this new technology in light of current product liability law, keep abreast of changes in relevant regulations, legislation and caselaw, and work to help shape the law to address and balance the interests of our clients with public policy.•
• Mary Nold Larimore is a partner at Ice Miller LLP and experienced in product and commercial litigation. Contact her at [email protected] Senior counsel Nancy Menard Riddle’s primary practice is litigation, with a focus on the defense of pharmaceutical and medical device manufacturers, toxic tort litigation, medical malpractice, risk management and general liability. Contact her at [email protected] The opinions expressed are those of the author.