3D Printed Medical Implants: Should Laws and Regulations Be Revolutionized to Address This Revolutionary Customized Technology?
Previously on this blog, Wilson Elser attorneys have written several posts about 3D printing technology and the law. We have predicted that this new technology has the potential to change the landscape of product liability law. This is happening, and especially so with respect to implantable medical devices, which are revolutionizing the health care industry with their unlimited potential for customization.
While there are still no published opinions for product liability cases involving 3D printed medical implants (or any 3D printed medical devices for that matter), we recently had the opportunity to defend a manufacturer client on product liability and negligence causes of action asserted against its 3D printed, custom-made orthopedic prosthesis. We obtained summary judgment for the client.
Our case was likely one of the first cases filed in California against a 3D printed medical device. The case was decided within the traditional regulatory and legal framework, as neither the courts nor the FDA has adopted any new rules to address the unique features of the 3D printing technology. This, however, will change once more and more 3D printed medical devices are involved in suits and the courts are called upon to conduct more in-depth examinations of the design, manufacture and labeling of these devices.
The design and manufacture of a 3D printed medical implant differs from its traditional counterpart in several ways, the most significant of which is the involvement of some new players, thereby converting the traditional manufacturer’s role from fabrication to post-manufacture processing. Taking knee replacements as an example, the manufacture of a 3D printed knee implant includes the following steps:
- First, the surgeon takes a CT scan of the patient’s injured knee and sends the CT scan to a CAD [Computer Aided Design] designer.
- The CAD designer then uses the CT scan to create a three-dimensional digital model of a knee prosthesis, conforming to the exact anatomical parameters of that patient’s knee.
- The digital model, which is usually referred to as “the CAD design,” is then sent to a 3D printer to produce the actual knee implant.
Only after these three steps are completed does the traditional medical device manufacturer enter the process to conduct sterilization, quality inspection, packaging and labeling of the printed implant, and then ships the final product to the surgeon.
For traditional medical devices (as opposed to their 3D versions), the above process is heavily regulated by the FDA. Compliance with FDA regulations offers tremendous protection to the manufacturers against product liability claims. The extent of the protection varies depending on the FDA’s classification of the device at issue. With respect to Class III medical devices, which are required to pass the FDA’s Premarket Approval (pursuant to section 360(k) of the Food, Drug & Cosmetic Act) before entering the U.S. market, the FDA’s approval preempts any state law claims for design and warning defects, to the extent that the state law claims attempt to impose duties in addition to, or different from, those under the federal law. With respect to Class II medical devices, which must go through the FDA’s Premarket Notification (i.e., the section 510(k) clearance) to be marketed in the United States, the FDA’s clearance, although not determinative, is given great deference by the judge at motion hearings in deciding issues of design or warning defect, and is influential with juries if the case gets past summary judgment. Similarly, both judges and juries attach considerable weight to evidence showing that the manufacturing process of a medical device has been in compliance with the FDA regulations when facing the issue of whether the device was properly manufactured.
All of these defense theories may change when applied to a 3D printed medical implant, in at least the following respects:
- First, the additional players in the manufacturing process − the CAD designer and the 3D printer − may not be regulated by the FDA, although they play important design and manufacturing roles. This begs a key question in litigation: Is FDA compliance still a defense? Or, to take it one step further, should the FDA extend its regulation to the CAD designers and the 3D printers?
- Second, the present case law stands for the proposition that strict liability design defect claims are barred as a matter of law against implantable medical devices, for public policy reasons. With 3D printed implants, where the CAD design process allows a product’s design to be modified for each individual patient, is it still fair to impose a blanket ban on strict liability design defect claims?
- Third, while the Instructions for Use (IFU) of the final implant are reviewed and approved/cleared by the FDA, what about the IFU of the 3D printer, which directly affects the quality of the implant?
On top of all that, it may not even be proper for a 3D printed medical implant to inherit the FDA classification of its traditional predicates (which is currently the case), given that the CAD design and 3D printing processes may create additional risks to the end users.
At present, we don’t know the answers to any of these questions. What we do know is that in the area of 3D printed medical devices, both the courts and the FDA lag behind technology. Our current regulatory system is designed to regulate mass-produced medical devices. As such, is it sufficiently equipped to protect consumers against the newly created risks presented by these 3D printed, individualized products? If the 3D printed medical device market continues to grow at the same exponential rate as it has, our legal and regulatory institutions may soon find themselves in dire need of new rules. Revolutionary changes in technology may well require correspondingly revolutionary changes in regulation and products liability law. Practitioners in the field are well advised to stay closely tuned to these coming developments.
Jianlin Song contributed to this post.