This guest post is by Reed Smith‘s Matt Jacobson. Matt is interested in the intersection between 3D printing and product liability, and the article he discusses is just too much to pass up. As always our guest posters are 100% responsible for their content, deserving of all the credit and any blame.
Walter White, the high school chemistry teacher turned methamphetamine “manufacturer” and main protagonist in the TV show Breaking Bad, has been called a lot of things. Drug king pin. Villain. Criminal mastermind. Heisenberg. Visionary?
For the handful of you who have not seen Breaking Bad or are not regular readers of this blog (Walter White appears in at least three prior posts), Walt was a depressed high school chemistry teacher diagnosed with stage III lung cancer. Wanting to ensure his family’s financial security after his death, he gets into the business of manufacturing methamphetamines and drug dealing. Before he is pulled deeper into the illicit drug trade and his character evolves from teacher/family man into murderer/crime lord, Walt turns an RV into a rolling meth lab.
So visionary may not be the right word, at least not until now. Spoiler alert—it’s been almost seven years since Walter White’s death (yes we believe he really did die) and now a group is following in Walt’s footsteps, manufacturing drugs at home using a micro (not meth) lab—well that is not exactly what it is doing, but it provides good imagery. So imagine, that instead of meth, Walt manufactures a drug for opiate overdose (might actually be good for his business) or to treat infections in HIV patients. And instead of beakers in the RV, Walt uses a few mason jars and a 3D printer. If this had been the story’s line, the show’s creators may have had to change the title to Breaking Good, which doesn’t seem to have as nice of a ring to it.
Ok, back to reality. Recently, an article appeared in 3D Printing Industry about a group trying to do just that. The group calls itself Four Thieves Vinegar Collective (taking the name from an alleged plague cure) and according to its website, its mission is “free medicine for everyone.” Following the footsteps of 3D printed gun proselytizer Defense Distributed, Four Thieves recently released instructions for building an “Apothecary MicroLab,” a DIY kit claimed to be able to synthesize a variety of medications.
As they say on TV, do not try this at home. Beyond a glass of warm milk for insomnia and salted water to gargle when your throat is sore, making your own medicine at home is a really bad idea, with potentially adverse consequences. For those, however, with a (morbid) curiosity, the article explains the kit’s makeup:
[A] small mason jar mounted inside a larger mason jar with a 3D printed lid. Furthermore, the kit contains a 3D printed stepper motor, syringe pump, coupler and shredded shaft which are connected using small plastic hoses. A thermistor is then attached through the lid to circulate fluids to induce the chemical reactions necessary to manufacture various medicines. The whole process is automated using a computer.
Apparently, “the 3D printed chemical reactor kit has successfully produced Naloxone (aka Narcan), a drug for opiate overdoses, Cabotegravir and Daraprim, drugs used to treat infections in people with HIV, and Mifepristone (aka RU486), and misoprostol,” two pharmaceuticals that can be used to terminate pregnancies.
Four Thieves Vinegar Collective is not selling the drugs itself—it is providing instructions on how to make the medications. The drugs themselves are also not 3D printed—although some of the parts in the kit are made using a 3D printer. So maybe this is not a modern day Walter White situation after all. But this article did raise questions. There is already one pharmaceutical drug being (legally) manufactured using a 3D printer. With an aging population and disease not going away anytime soon, 3D printing of medicines in our own homes might be in our future. Some might even say it is only a matter of time. Will the law—both regulatory and the product liability system—is ready for it?
Because this blog not only geeks out about good TV shows, but also about the law and 3D printing, consider some of the product liability implications that are raised by 3D printing drugs out of a person’s home.
Injuries caused by an improperly manufactured or tainted 3D printed drug is an issue. This may be the result of an error in the instructions being used, problems with the 3D printer, quality control issues in the person’s home where the drug is “printed,” or how the person synthesizes the drug—in other words, any situation in which a mistake occurs at any point in the process used to print the drug can create a manufacturing defect. Manufacturing defects are an infrequently litigated product liability claim where FDA-approved drugs are at issue. However, in the case of 3D printing homemade drugs, it may very well be the main focus of litigation. If a person makes a drug in his or her house using a 3D printer, who does that person blame if the drug causes injury? Would the person making the drug be considered the manufacturer for strict liability purposes? Under section 402A of the Restatement (Second) of Torts, the seller or manufacturer must be engaged in the business of selling the product. The home drug maker may or may not be in the business of drug manufacturing. It would depend on whether the that person also distributes the basement drugs to others. So who would be liable? A potential defendant may be the manufacturer of the 3D printer with a plaintiff claiming the “defect” arose because of some aspect of the printer. Another potential party may be the entity who provided the instructions for making the drug with a claim for “defective instructions.” That could include the Four Thieves Vinegar Collective itself. Product liability law may need to evolve to address these issues, but it is clear that printing drugs from your home will blur the distinctions between the user and the manufacturer of the drugs.
Injuries could be caused by a failure to provide adequate or accurate warnings regarding a dangerous side effect or a failure to provide adequate instructions regarding the safe and appropriate use of the drug—or possibly the above-described “Micro Lab,” or even the 3D printer. For FDA-regulated prescription drugs and medical devices, the learned intermediary doctrine provides that a manufacturer need only warn a prescribing doctor about known or knowable risks. It is not obligated to warn the end user. Because physicians are typically warned about drugs through medical literature and via manufacturer-created warning labels/disclosures that accompany the drugs, the learned intermediary doctrine will not apply to 3D printed homemade drugs. Such drugs would need to be accompanied by adequate warnings directed to the consumers themselves. These warnings should disclose the reasonably foreseeable risks of the medication (e.g., adverse reactions) and dosage requirements. In the 3D printing context, if no traditional product “manufacturer” exists, it is likely that a duty to warn (perhaps only in negligence) will ultimately be imposed on some other entity involved in the supply chain. But if a person is 3D printing drugs from home who would be responsible for providing the warnings? Would it be the person or company who is providing the instructions on how to synthesize the drug? If the instructions are downloaded from a website, a plaintiff may find it virtually impossible to identify this person, let alone find them to effectuate a lawsuit.
As far as we can tell, the FDA has not yet issued any statements about the “Apothecary MicroLab” or 3D printing drugs from your home. The FDA did issue a statement about Four Thieves Vinegar Collective’s other product, the EpiPencil (a homemade epinephrine autoinjector that can be built for $30), saying with remarkable understatement that it was a “potentially dangerous practice.” For the most part, the FDA has been silent on the 3D printing of drugs (no matter where it happens), with the exception of the one 3D printed drug that it approved.
As to 3D printing drugs at home, how the FDA intends to approach this subject is very unclear. A lot of questions are raised with no answers as of yet. If manufacturing occurs at a non-traditional “manufacturing” site, such as a person’s home, how will or should the FDA regulate that site? Should the site be subject to all of the FDA’s requirements and standards and will the FDA take enforcement action because a 3D printed drug is technically adulterated when it is not manufactured under quality compliant conditions? Will instructions to print drugs have to be FDA approved? Will the FDA regulate the printer or just the finished product? To resolve these and other issues, the FDA may need to modify its regulations, and in the short term issue a few guidance documents and exercise its enforcement discretion for some FDA rules and regulations. FDA’s requirements will be key for safety, but also for preemption purposes, which may depend on the FDA imposing requirements on 3D printing of medications.
There likely would be no way to have quality control measures in place for every home that is 3D printing medications. Certainly, the FDA could not enforce its inspection procedures in every household that was 3D printing drugs. On its website, Four Thieves Vinegar Collective says that quality control issues are not the same when making small quantities of a drug as opposed to an industrial scale. That is doubtful, at best. While it may be easier to control quality if you are only making one pill, quality control is still a huge issue when it comes to medications. A person’s home is not nearly as clean as a drug lab. A person likely would not have records of the formulation of the product, synthesis of the substance, and the specifications of the products readily available to ensure all are met. Also each drug that is 3D printed, or even a sampling, would not be tested, let alone retested, before use. Each 3D printer would have to be calibrated before use. Microbiological factors may also come into play, such as evaluating the raw material for sterility, endotoxins, and environmental concerns. These same issues also effect recalls, and recalls probably would be limited to 3D printers and centrally manufactured products or become voluntary. There are good reasons why the FDA exists.
Like the fictional character Walter White, 3D printing drugs from your home is still not a reality. Four Thieves Vinegar Collective and other organizations like it are making it more likely that it could happen sometime in the future, whether legal or not. A lot of potential uses of 3D printing drugs exist, from helping soldiers on the battlefield to people in less developed countries. Until the technology and legal issues are dealt with, there are still a lot of risks and dangers associated with 3D printing medications. Right this moment, making any kind of drug yourself is far from advisable. But for now, thinking about all these product liability issues is what get us high. And we can only wonder if Walter White’s lawyer Saul Goodman would have advised him of these risks? Certainly not.