Who Is Liable? Legal Implications of 3D- Printed Pharmaceuticals

February 23, 2016

In August of 2015, the Food and Drug Administration (FDA) approved its first 3D-printed pharmaceutical drug. It’s not surprising that almost immediately, attorneys began to warn of two potential legal issues; one concerning product liability, and the other dealing with intellectual property. Aprecia, the company that “prints” the drug known as Spritam, uses a 3D printing process (“ZipDose” technology) to create “a porous formulation that rapidly disintegrates with a sip of liquid.” Now that the FDA has approved this method of producing pharmaceuticals, we can expect other companies to follow Aprecia’s lead. Intellectual property (patent law) and strict liability (tort law) are two areas of law that may be implicated with the proliferation of 3D-printed drugs. With each of them comes limitations in the courts’ ability to apply the existing standards to this new technology in the event a suit is brought.
Aprecia asserts that they have an “exclusive, worldwide license” for this specific 3D printing technology. The intellectual property issues are implicated due to Aprecia maintaining its control over the proprietary printing process, thus rendering it off-limits for individuals, hospitals, and pharmacies to use. Leanne Rakers, with Harness, Dickey & Pierce out of St. Louis, imagines there will be issues with identification and enforcement of patents with this new technology. The supposition by some experts is that companies can tightly package the medication in its powder form, thus allowing custom-ordered and custom-created medications, and eventually evolve into patients printing medications at home. The process has been deemed analogous to iTunes where patients can download “recipes” and print a pharmaceutical cocktail specific to their needs. Rakers explains that enforcing the patents will be difficult or “nearly impossible” because the drug is in powdered form prior to printing and then is subsequently consumed. Pharmaceutical manufacturers brand and patent the drugs in order to recoup the money invested to develop them. Companies that make generic medications are then able to copy these formulations after the patent expires in 20 years. With the printer being able to manufacture a pill from powder, some developers say it will allow “remote communities to manufacture any drug they need,” with the manufacturer being local pharmacies. This poses an issue with being able to identify the medication and who owns the patent to that particular chemical compound. Rakers sums up the issue by stating, “If you can’t identify and enforce, then it makes patent law pretty much obsolete.
Another issue this new technology exposes consumers to is the inability to know who is responsible for any injury resulting from incorrectly printed drugs. This particular context does not currently exist in Tort law, specifically, products liability cases. The law will need to find a way to protect consumers by regulating who prints the drug, thus holding the correct person responsible. As further explained by James Buck, with Reed Smith out of Philadelphia, an individual could find a way to print the drug, thus stepping into the shoes (legally speaking) as a manufacturer.

Additionally, Buck laments the scary proposition that “whoever ‘pushes the start button’ on the printer could be considered the manufacturer for product liability purposes.”  

In a products liability case, the plaintiff needs to identify who the manufacturer is. Beck explains that a plaintiff could charge the hospital who runs the printer as the manufacturer, but could lose under state statutes defining hospitals as service providers, which are insulated under the “incidental to service” argument. So, who do you charge? Consider the following potential defendants: the manufacturer of the printer, the developer of the software, the person who made the software available for download, the person who pushes the button, the pharmaceutical company, and the list goes on. According to Rakers, the FDA will need to implement regulations in two ways; ensure proper tracking of the “person who printed it, and the holder of the drug’s patent.”