The legal implications of printing out new body parts

Concerns aplenty as it’s revealed we’ll be able to 3D print new organs by 2023

It is no news that 3D printing has the potential to change our world as much as the internet has over the last two decades.

The industry — at least in the domestic market — is barely a few years old, but the technology is already signalling an age where we can assemble, out of thin air as it were, tools and toys at the push of the button.

Daihatsu, a Japanese manufacturer of small cars and a subsidiary of Toyota, announced on 20 June 2016 that it would begin offering car buyers the opportunity to customise their vehicles with 3D-printed parts. For drivers with more modest budgets, this offers the kind of individual tailoring of vehicles hitherto restricted to the luxury limousines and sports cars of the super-rich.

Earlier this year as well, The Economist reported the emergence of recent advancements in bioprinting, and the possibility of having 3D printed human body parts like kidneys, ears and livers. As yet, such “bioprinting” remains largely experimental. But bioprinted tissue is already being sold for drug testing, and the first transplantable tissues are expected to be ready for use in a few years time.

However, uncertainty remains about the legal implications these advancements present. Apart from the apparent intellectual property implications (the manufacture of counterfeit goods may infringe copyrights, trademarks or patent rights) there is a more nuanced implication on product liability in tort law, and even the implications on DNA evidence for printed body parts.

How does it work?

There are at least seven core technology types of 3D printers mostly focused on making products out of plastics (polymers), metals, ceramics and wood. 3D printing, or ‘additive manufacturing’, is a process of making 3D solid objects from a digital file.

The creation of a 3D printed object is achieved using additive processes. In an additive process, an object is created by laying down successive layers of material until the object is created. Each of these layers can be seen as a thinly sliced horizontal cross-section of the eventual object.

It starts with making a virtual design of the object you want to create. This virtual design is for instance a CAD (Computer Aided Design) file. This CAD file is created using a 3D modelling application or with a 3D scanner and it is believed that with the way technology is fast developing, future versions of smartphones will probably have integrated 3D scanners.

3D designs can be created through a CAD software or they can be obtained from third parties, such as on online platforms that provide printable designs. What is more, if you have a 3D printer at home, you can download the blueprint and re-create your own products.

Where does product liability lie?

3D printing presents challenges with regard to potential tort liability. English law imposes civil liabilities for parties involved in the manufacture and distribution of defective goods. Apart from the common law tort of negligence which requires a proof of negligence following the popular case of Donoghue v Stevenson, the tort of product liability is governed by the Consumer Protection Act 1987 (CPA), which implements an EU directive in this area of law and gives consumers a right to recover damages from manufacturers or importers of a defective product which causes death, or harm to the claimants or their properties.

The CPA imposes strict liability on manufacturers of defective products and this means that claimants can sue for compensation without having to prove that the manufacturer was negligent. It is merely necessary to prove that the product was defective, and that any injury or damage was most likely caused by the product. Subject to some statutory defences, manufacturers and distributors may be liable to compensate claimants for death or injury that results from defective products.

However, the advent of 3D printing has multiplied the number of possible “products” and scrambled the traditional “manufacturer”-based chain-of-sale concept on which strict liability has been based. International law firm Reed Smith in a white paper highlighted the possible scenarios which 3D printing engages:

1. Defective original product used to create the digital design;
2. Defective original digital design;
3. Defective digital file;
4. Corrupted copy of downloaded digital file;
5. Defective 3D printer;
6. Defective bulk printing material used in 3D printer;
7. Human error in implementing the digital design; and
8. Human error in using the 3D printer and/or materials.

In other words, it will be more difficult for claimants to prove which party in the supply chain should bear the liability for the defective product. Accordingly, the parameters of tort liability may need to be redefined once again to account for new technologies and new supply chains, where traditional “manufacturing” processes are carried out by entities elsewhere in the chain of sale.

Leave me your DNA and I’ll 3D print out your face

The developments in 3D printing also have great implications for our privacy, genetic surveillance and forensic evidence analysis. EVERY year about 120,000 organs, mostly kidneys, are transplanted from one human being to another. But a lack of suitable donors, particularly as cars get safer and first-aid becomes more effective, means the supply of such organs is limited. One promising approach is to print them — through bioprinting.

Living cells could be sprayed through the nozzles of inkjet printers without damaging them. Today, using multiple print heads to squirt out different cell types, along with polymers that help keep the structure in shape, it is possible to deposit layer upon layer of cells that will bind together and grow into living, functional tissue.

Already 3D bioprinting allows orthopaedic surgeons to print artificial bone from a scan of the patient, printing existing surgical materials to precisely the right shape to replace missing or damaged bone. For example, the technique has been recently used to create skull implants for people with head trauma and a titanium heel to replace a heel bone that had been eaten away by cancer.

But amidst these innovations lurks the implication for our privacy and forensic evidence analysis. On 1 June 2013, working with the DNA bits left behind by strangers — from cigarette butts and fingernails to used coffee cups and chewing gum — a Brooklyn artist created life-sized masks by using a 3D printer after feeding the DNA samples into a computer programme.

Whether we find this cool or creepy, DNA-profiling experimenting and bioprinting raises a number of legal issues that we should all be concerned about. To what degree does the DNA we leave behind in public spaces belong to us? Does a facial mask without a name raise the same issues as a photo? In either case, what exactly is our expectation of privacy?

Similarly, when it becomes possible to have printed ears, skins, fingers and livers, to what degree will the finger prints and blood samples from these ‘objects’ represent the personality of the individuals involved? How will the proliferations of creating human body parts in our rooms be regulated? And what probative value should be accorded to DNA evidence and finger prints found in crime scenes?

Concluding thoughts

It may be argued that 3D printing is the single most important innovation in the last two decades. The possibility of being able to create entire human organs lends credence to this point. For kidneys, Roots Analysis, a medical-technology consultancy, reckons that that should be possible in about six years. Livers, which have a natural tendency to regenerate anyway, should also arrive reasonably soon. Hearts, with their complex internal geometries, will take longer.

However, despite the huge benefits that these innovations promise, its workability depends largely on a strong regulatory system and the ability of the law to anticipate these changes. Possibilities abound, but the law must need to keep pace with the changes quickly.

Omotayo Akorede is a final year law student at Bangor University.