Companies providing instructions for 3D printed medical devices and drugs and companies printing them face potential liability.
As part of our focus on emerging technology series, we have covered 3D printing in previous posts. This emerging technology will likely result in product liability and personal injury lawsuits. Right now to our knowledge, there is only one a drug that involves 3D printing, SPRITAM, that is FDA approved. FDA has increased its attention to 3D printing in recent years, including hosting meetings and issuing guidance documents.
We recently learned of a group, Thieves Vinegar Collective (“TVC”), venturing into this area as well, albeit in a different way than the makers of SPRITAM; in particular, they are operating outside the FDA approval and regulatory process. TVC aims to provide free medicine for everyone, quite a laudable mission. The group has a set of instructions for creating an “Apothecary MicroLab.” It also provides an “instruction packet” for EpiPencil and an outline for Daraprim (treats toxoplasmosis and may prevent malaria and other kinds of infections per a quick Google search). So the company is selling instructions for how to make the drugs. We applaud the innovation and the end goal, increasing access to life-altering medications, but this raises fascinating legal issues that would keep us up at night if we were the company’s in-house counsel.
One might reflexively think the company can avoid various types of product liability claims; however, we believe TVC could get embroiled in medical device litigation and face pharmaceutical lawsuits if people were injured by 3D printed products created using its plans. Specifically, manufacturing defect, design defect, and plain old negligence claims seem ripe for litigation against TVC is someone downloads their instructions and were injured by the end product or someone else was injured by a product created using the instructions. Following is a look at how companies providing the instructions for 3D printing drugs and medical devices and those who print them, particularly outside of FDA’s regulatory oversight.
I. Companies providing instructions for and actually performing 3D printing of drugs and medical devices could face manufacturing defect claims.
Put simply, the product may have been effectively and safely designed, but a problem during the construction of the item caused it to become unsafe. Sometimes only specific batches of the item are affected by the defect. Manufacturing defects happen when something goes wrong while the device or the drug is being made. A batch of the drug could be contaminated with bacteria. A machine in the manufacturing plant might malfunction and cause the plastic on a medical device to be made too short. The products simply were not made according to the company’s specifications.
We would expect companies like TVC to argue they are not manufacturing the drugs or devices and therefore manufacturing defect claims would not apply. An initial question then is, what is a manufacturer?
Section 820.3 of the Code of Federal Regulations (“CFR”) defines a medical device manufacturer as “any person who designs, manufactures, fabricates, assembles, or processes a finished device. The manufacturer includes but is not limited to those who perform the functions of contract sterilization, installation, relabeling, remanufacturing, repacking, or specification development, and initial distributors of foreign entities performing these functions.” There are certainly arguments on both sides as to whether TVC comes within this definition. More information about the company’s conduct may be necessary to know for sure. On the drug side, it seems clearer that TVC has some exposure. Section 205.3 of the CFR defines a drug manufacturer as “anyone who is engaged in manufacturing, preparing, propagating, compounding, processing, packaging, repackaging, or labeling of a prescription drug.” Product liability lawyers at KBA and across the country will likely be grappling with these definitions in the near future.
Assuming companies providing instructions for 3D printing drugs and medical devices or those actually doing the printing can be considered manufacturers or otherwise subject to manufacturing defect claims, they face significant liability and other risks. Various industry standards apply to the manufacture of products generally and specifically, drugs and devices. These products are regulated by the FDA. It notes, “The Food and Drug Administration (FDA) regulates the quality of pharmaceuticals very carefully. The main regulatory standard for ensuring pharmaceutical quality is the Current Good Manufacturing Practice (CGMPs) regulation for human pharmaceuticals.” Failing to follow industry standards is the primary reason we sue companies.
There are serious consequences for failing to follow these standards. “If a company is not complying with CGMP regulations, any drug it makes is considered “adulterated” under the law.” The company (and its executives) face serious enforcement issues.
While FDA cannot force a company to recall a drug, companies usually will recall voluntarily or at FDA’s request. If a company refuses to recall a drug, FDA can warn the public and can seize the drug. FDA can also bring a seizure or injunction case in court to address CGMP violations even where there is no direct evidence of a defect affecting the drug’s performance. When FDA brings a seizure case, the agency asks the court for an order that allows federal officials to take possession of “adulterated” drugs. When FDA brings an injunction case, FDA asks the court to order a company to stop violating CGMPs. Both seizure and injunction cases often lead to court orders that require companies to take many steps to correct CGMP violations, which may include repairing facilities and equipment, improving sanitation and cleanliness, performing additional testing to verify quality, and improving employee training. FDA can also bring criminal cases because of CGMP violations, seeking fines and jail time.
The Code of Federal Regulations is a collection of regulations. Regulations are rules or directives that federal agencies like the United States Food and Drug Administration (“FDA”) and Environmental Protection Agency promulgate, or put into effect through a legal process. One may say they are not technically “laws” because they were not passed by the legislature (Congress) and signed by the executive (President), but that’s an oversimplification. The bottom line is, if you do not follow them, you can find yourself in significant trouble, even in jail.
TVC and similarly situation companies, as well as the people who download TVC’s instructions and 3D print drugs and devices, are therefore at serious risk from a product liability standpoint as well as a regulatory enforcement perspective. If the instructions are flawed in some way, such as the specifications being inaccurate, the 3D printing equipment fails, or some contaminant gets into the mix, that could give rise to manufacturing defect claims. Certainly, the people making the product according to TVC’s instructions would be at risk, but TVC’s liability, from a manufacturing defect, might be more attenuated and difficult to prove. The company that made the 3D printer could get dragged into it as well if there was a problem with the printer.
II. Design defect claims would likely apply to companies or individuals providing 3D printing instructions and doing the printing.
Generally, design defects are problems or risks present when the product is designed as opposed to made. The item may adequately serve its designed purpose but may also carry a fatal flaw that causes injuries. A defective drug may include a chemical compound that causes cancer, for example, when there was a safer alternative chemical that could and should have been used. A defectively designed medical device may fail because of how it was made to function, such as a pump that allows air to get into the blood or an artificial hip that includes metal that causes allergic reactions. The hernia mesh litigation provides another example of design defect claims – many of the mesh were made with material that can cause or contribute to infections or made in such ways that they migrate – move around the body – and perforate, or cut, internal organs.
TVC is in a sense creating the design by virtue of its instructions. Presumably, TVC is developing the instructions from other sources for the chemical compounds for the drugs or the engineering specifications for devices, but it is involved in the chain and therefore at risk. Certainly the person operating the 3D printer is exposed to this type of product liability lawsuits too, especially if they modify the instructions in any way.
Additionally, drugs and devices come with labeling – details about the product and how to use it, including warnings. The design of a product includes its labeling. Therefore, design defect claims include labeling based claims. They can be strict liability claims, which means the defendant is liable regardless of its intent or conduct, or they can be claims sounding in negligence.
Failure to provide warnings or adequate instructions is a frequent claim in all product liability lawsuits and especially medical device and pharmaceutical litigation. Labeling should include warnings about risks. This is a common issue in medical device and drug lawsuits. Invokana is one such example on the drug side.
The instructions and warnings aspect of 3D printing is particularly interesting. They would include about the product itself, but also concerning how to make the product. Additionally, there is an entire body of law regarding who should be liable for warnings when someone makes a “copy-cat” of a drug for example. Generic drugs are essentially copy-cat drugs.
Pharmaceutical companies spend years creating a chemical compound that affects the body in a way to cure or treat a medical condition. If FDA approves it, the companies get to be the only company that can sell the drug for many years; that refers to our patent system. Once the patent expires, other companies can make a copy of the drug and sell them. Those are generic drugs.
Generic drugs can be different than the brand drug (the original drug that was once patented) in many ways. The generic only has to: 1) have the same active ingredient, the thing that affects the body in the desired way; 2) be the same strength; 3) be in the same dosage form (e.g., tablet, liquid); and 4) be deviled to the patient via the same route of administration (how it gets into the body – oral, inhaled, etc.).
3D printed drugs may be analogized to generic drugs. That raises a host of legal issues, including a concept called, innovator liability. Only a few states allow patients to sue the company that made the original, patented drug for injuries caused by a generic drug, which is what innovator liability is all about. That’s an issue in the Zofran litigation.
Additionally, for companies operating outside of FDA’s oversight – companies that do not bring these products to market through the 510(k) clearance or Pre-Market Approval process (“PMA”) for medical devices for example – there are legal protections that would not be available to them. Specifically, it a 3D printed medical device was not approved via the PMA process, it is difficult to imagine how preemption could apply, but that could lead back to legal issues analogous to the innovator liability and generics issues.
III. Everyone involved in the 3D printing of drugs and medical devices is at risk of negligence claims.
Negligence is simply doing something a reasonable person would not do or not doing something a reasonable person would do that causes an injury. The elements of the claim are: duty, breach, causation, and damages. Unlike strict product liability claims, negligence includes consideration of the defendant’s knowledge and conduct. When it is particularly bad, it is gross negligence, which can result in punitive damages being awarded.
Drivers should stop at stop signs. That duty is imposed by law – traffic statutes – and common practice. Driving through a stop sign is a breach of that duty. If a driver does so and hits another car and the person in that other car gets thrown from the vehicle and hits her or his head, you have your causation and damages elements satisfied.
In the drug and device context, negligence can occur in how the product is designed, made, and sold. It can be the nature of the product, such as being contaminated, or with respect to the information provided about the product. Negligence claims cover a broad spectrum of conduct, including all the things discussed herein. This is TVC’s greatest exposure. Mistakes in the instructions, failing to provide adequate instructions or warnings, for example, could give rise to negligence claims.
IV. How post market surveillance plays into 3D printing of drugs and devices is interesting and yet to be seen.
After a product is sold and on the market, companies must pay attention to “safety signals” and take steps to address them. We general often call this, post-market surveillance. Failing to do this properly often leads to lawsuits.
“Safety signals” are events or information that suggests there are risks associated with a product. For example, they can be adverse events – serious injuries caused by the product – or articles published in scientific journals suggesting potential adverse events. There are many ways companies learn about “safety signals,” including attending conferences with doctors, sales representatives talking to physicians, reviewing medical journals, and receiving complaints or adverse events from people who use the product.
When companies hear these things, they have to investigate them and they may have to implement corrective and preventive actions. In other words, they have to look into it and do something about it to make sure other people don’t get hurt. They do this by changing the product labeling to include warnings, sending our notices to product users, issuing recalls (which often really only means the first two things, not actually pulling the products from the shelves), changing the instructions to make them easier to understand and follow, otherwise changing the design of the product, or removing it from the market.
We wonder how TVC and similarly situation companies as well as the individuals printing the products will comply with these obligations related to their 3D printed drugs and devices. That is another area of exposure for them all because failing to do this properly can be a basis for the product liability claims discussed herein.