Bloomberg BNA's Pharmaceutical Law & Industry Report helps you stay informed of regulatory and litigation developments affecting the pharmaceutical and biotech industries....
Nov. 9 — The FDA's approval of the first 3D-printed drug could lead to complicated product liability and intellectual property issues, attorneys told Bloomberg BNA recently.
The 3D printing of drug products could lead to problems with identifying the patented drug product and with identifying who is considered the manufacturer for product liability purposes, the attorneys said.
In August, the Food and Drug Administration approved Aprecia Pharmaceuticals Co.'s 3D-printed drug Spritam (levetiracetam) for oral use as a prescription adjunctive therapy in treating partial onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in adults and children with epilepsy (13 PLIR 1146, 8/7/15).
Spritam uses Aprecia's proprietary ZipDose Technology platform, which uses 3D printing to produce a porous formulation that rapidly disintegrates with a sip of liquid.
Aprecia said its 3D printing technology platform is proprietary and not available to the general public, so no one will be able to use the technology to print drugs at home, in hospitals or in pharmacies.
While 3D printing has been used to manufacture medical devices, this approval marks the first time a drug product manufactured with this technology has been approved by the FDA.
The technology for 3D printing, also known as “additive manufacturing,” has developed rapidly and the price of 3D printers has dropped substantially, according to a white paper from the law firm of Reed Smith. In fact, the white paper called 3D printing “quite possibly the next greatest chapter in the industrial revolution.”
Leanne M. Rakers, an attorney with Harness, Dickey & Pierce in St. Louis, told Bloomberg BNA Oct. 22 that 3D printing will allow pharmacists, hospitals and others to print drugs and being able to enforce patents will become difficult since the patented drug product will be harder to identify.
“The main intellectual property issue is being able to identify and enforce,” Rakers said. “If you can't identify and enforce, then it makes patent law pretty much obsolete. There are going to have to be new ways to keep up with this technology.”
Another liability issue is based on the question of who is responsible if the drug is printed incorrectly, Rakers said.
“You can imagine if the small pharmacy owner on the corner prints it incorrectly; how are you going to be able to trace it back to that pharmacy unless they come up with technology and ways to regulate how 3D printed drugs are going to be made,” Rakers said.
Rakers said there will have to be a way to track the product back to the person who printed it.
On the FDA regulation side, it's important to able to keep up with the technology and be able to implement ways to protect the consumers from potential health problems, Rakers said.
James Beck, an attorney with Reed Smith in Philadelphia, told Bloomberg BNA Nov. 4 that “determining who the manufacturer of a 3D printed drug is, is an interesting question for which there is no legal answer” and that is one of the reasons why 3D printing is such a “disruptive technology.”
“Anybody can operate the printer,” Beck said. “The person who is going to use the product can operate the printer if they have a 3D printer and they download files from the Internet.” In that situation, “the user could be considered the manufacturer,” he said.
Beck said he expects that whoever “pushes the start button” on the printer could be considered the manufacturer for product liability purposes. He said there is no case law on that yet, but he is watching the issue closely.
“It's conceivable that a plaintiff could say that a hospital running the printer is the manufacturer, but that could run into state statutes that basically declare that a hospital is performing a service and is not a product manufacturer and that anything else is incidental to the service,” Beck said
Beck said product liability issues aren't a problem when drug or device products are printed by traditional manufacturers. “The problem is going to be in all the other situations” where the person operating the printer is someone such as a pharmacist, doctor's office or hospital, he said.
Currently, software isn't considered a product so the software developer wouldn't be considered the manufacturer for product liability purposes, Beck said. That could change, though he said, as the “law has a way of changing to keep up with technological advances.
“A lot of the software is open source and is available for free on the Internet so you don't know who put it together,” Beck said.
Beck said it's “unlikely, but conceivable” that if there is a problem, the website from which the software is downloaded “could be charged with, if not product liability, then negligence, where you don't need a manufacturer.”
“In classic product liability law, it's key to determine the manufacturer,” Beck said. “Negligence is not key to anything and just has to do with who has a recognized duty of care to someone. So you could have negligence-based standards, which do not require the designation of a specific manufacturer.”
Additionally, Beck said it's possible that the manufacturer of the 3D printer could be held liable. “However, in that case, the 3D printer is more like a tool,” he said.
“You may have situations where there is no manufacturer in the classic sense in some of these cases. It just depends on how the 3D printer is used and who it's used by,” Beck said. “It's very complicated because 3D printers can be used in any number of ways by any number of entities and product liability law hasn't caught up to that yet.”
To contact the reporter on this story: Bronwyn Mixter in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Nancy Simmons at email@example.com
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)