3d printing of medical devices – what the future …...1 3d printing of medical devices – what...

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1 3D Printing of Medical Devices – What the future holds for regulating and litigating medical device failures for point of service manufacturers and users Daniel Tranen, Esq. Wilson Elser, LLP A Medmarc Webinar July 24, 2019 © 2018 Wilson Elser. All rights reserved.

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Page 1: 3D Printing of Medical Devices – What the future …...1 3D Printing of Medical Devices – What the future holds for regulating and litigating medical device failures for point

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3D Printing of Medical Devices – What the future holds for regulating and litigating medical device failures for point of service manufacturers and users

Daniel Tranen, Esq.Wilson Elser, LLP

A Medmarc WebinarJuly 24, 2019

© 2018 Wilson Elser. All rights reserved.

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Our Hypotheses:

1. That FDA will have difficulty regulating non-traditional point of service 3D printing and use of medical devices by hospitals, doctors and others.

2. That non-traditional point of service manufacturing of medical devices, made possible by the advent of 3D printing, will so disrupt traditional product liability law that we will see something completely different in the next 5-10 years as courts grapple with the impact of this new technology.

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What is 3D Printing and How is it Developing?

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© 2018 Wilson Elser. All rights reserved.

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The Overall Progress

• Global Market for additive manufacturing hit $7.3 Billion in 2017.• It has an annual growth of over 20%.• Over 10% of the market is in medical and dental technologies.• The 3D Printed medical device market will reach $2 billion by

2022.• Yet, the FDA has only offered its “initial thoughts on an emerging

technology” according to former director Gottlieb.

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© 2018 Wilson Elser. All rights reserved.

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Point of Service 3D printing

3D Printing in Healthcare

3200%Increase in the number of hospitals in the US with a centralized 3D printing facility 2010-2016(using Materialise Mimics technology)

16Number of hospitals out of the top 20 as ranked by US News and World Report that have implemented a medical 3D printing strategy (using Materialise Mimics technology)

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© 2018 Wilson Elser. All rights reserved.

The Chart was originally published in Medical Additive Manufacturing/3D Printing Annual Report 2018, by SME, http://www.sme.org/uploadedFiles/Medical_Additive_Manufacturing/2018-SME-Medical-AM3DP-Annual-Report.pdf

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The Devices

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© 2018 Wilson Elser. All rights reserved.

• Surgical Instruments

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The Devices

• Anatomical Modeling

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© 2018 Wilson Elser. All rights reserved.

Picture taken from http://libcat.org/anatomy-models-for-medical-students

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The Devices

• Precision Prosthetics and Implants

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© 2018 Wilson Elser. All rights reserved.

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The Devices

• Active & Wearable Devices

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© 2018 Wilson Elser. All rights reserved.

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The Devices

• Tissue (bone, heart valves, skin, ears) • Organs and Organoids

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© 2018 Wilson Elser. All rights reserved.

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The Players

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© 2018 Wilson Elser. All rights reserved.

• Traditional manufacturers • Research Institutes • Hospitals• Government• Non-profit/NGOs• New Market Players

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The Traditional Distribution System

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© 2018 Wilson Elser. All rights reserved.

• Medical Devices designed/manufactured at a central facility, then shipped to a healthcare provider, usually through a distribution system

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FDA Permits Sale of Medical Devices through Three Pathways

• 510(k) clearance • More than 90% of the medical devices• By finding “substantial equivalence” to pre-1976 devices

• PMA (Premarket Approval)• Considerably more lengthy and rigorous and expensive than 510(k)• Broad federal preemption of tort claims

• Investigational devices• Less frequently encountered • Distributed pursuant to investigational device exemptions (IDE)

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© 2017 Wilson Elser. All rights reserved.

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FDA Regulates Three Classes of Medical Devices

• Class I: lowest level of risks; general controlsBandages, Gloves, hand-held surgical instruments, etc.

• Class II: some risks; general controls + special controlsAcupuncture needles, powered wheelchairs, infusion pumps, air purifiers, surgical drapes, knee replacements, hip replacements, etc.

• Class III: support or sustain human life; general controls + special controls + premarket approval

Replacement heart valves, implanted cerebella stimulators, pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, etc.

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© 2017 Wilson Elser. All rights reserved.

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FDA has “Cleared” a Variety of 3D Printed Medical Devices Manufactured by Traditional Medical Device Manufacturers

• Cranial implants/bone filler (OPM/Tissue Regeneration Systems)• Knee implants (Stryker, Conformis)• Ankle implants (Zimmer Biomet)• Spinal implants (Medicra, EIT, SiBone, Stryker, Captiva Bone)• Bone Scaffold Platform (Osseo)• Dentures (Dentica)• Pills (Aprecia)

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The Traditional Product Liability Standard When a Medical Device is Alleged to be Defective

• Suits are filed against Designers/Manufacturers of medical devices based upon three general theories:– Defective Design;– Defective Manufacture; and/or– Defective Warning.

• These claims are traditionally brought on a “strict liability” standard; this means that a plaintiff need only prove – a defect;– causation; and – damages.

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Point-of-Care Manufacturing and Use of Medical Devices Eliminates Traditional Manufacturers, Sellers and Distributors

• POS manufacturing and use abandons the traditional framework

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© 2018 Wilson Elser. All rights reserved.

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FDA’s Guidance on 3D Printing

• FDA has not adopted any regulations specifically for 3D printed medical devices

• FDA’s “leapfrog” guidance, Dec. 2017– FDA’s initial thoughts about 3D printed medical devices– Focuses on considerations of 510(k) review– Requirements on design, manufacturing and testing– No mention of POS manufacturing and use

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© 2018 Wilson Elser. All rights reserved.

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What is the Future of Regulation for POS Additive Manufacturing of Medical Devices?

• With the decentralization of manufacturing processes and design files does FDA have the resources to regulate?

• Will POS manufacturing by medical professionals be seen as the “practice of medicine”and regulated locally?

• What happens when hospitals start selling 3D printed medical devices to third parties?

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3D Printing Promises a Wide-Range of Litigation

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© 2018 Wilson Elser. All rights reserved.

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The 3D Printed Device Failed – Who is at Fault?

• Predicate device was defectively designed;• Computer aided design (“CAD”) file was defectively designed;• A defect was introduced into the CAD file during copying, sharing or uploading;• The CAD file became corrupted;• There is a defect in the 3D printer;• There is a defect in the raw materials used in the printing process;• There was human error in the printing process;• There was human error in the post 3D printing production process;• There was human error in implementing the digital design;• There was human error in the selection or use of the raw materials;• There was human error in the image scanning (for custom device failures); and/or• There was a labeling/warning error or insufficiency (by someone).

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The Disconnect between the Current Law and Current Conditions with POS 3D Manufacturing and Use

• Under traditional PL law – almost all of those errors could be ascribed to one or two entities/persons – that is the foundation of the strict liability standard.

• With POS manufacturing and use – many different people could have a hand in the actual defect. Will it be fair and reasonable hold any one person (or all persons) involved to a strict liability standard?

• End result: a probable return to a much harder to prove negligence standard – not a bad thing from a defense perspective.

• However: because of the difficulties of proof, the Plaintiff’s Bar will be pushing back – what will happen?

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What Does Current Legal Precedent Tell Us?

• Buckley v. Align Technology, Inc., 2015 U.S. Dist. LEXIS 133388 (N.D. Cal. Sept. 29, 2015)– Product: 3D printed custom-fitted dental aligners– Allegation: manufacturer is also a patient evaluator, thus learned

intermediary defense does not apply– Court: additive manufacturer is separate from the treater in this instance,

so learned intermediary defense was applicable.

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© 2018 Wilson Elser. All rights reserved.

Id. at *4

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More Legal Precedent

• Corley v. Stryker Corp., 2014 U.S. Dist. LEXIS 92002 (W.D. La., Feb. 25, 2014)– Product: customized, non-3D-printed, cutting guide designed and manufactured

from patient imaging date (MRI/CT).– Allegation: “the software used in creating each cutting guide [was] a necessary

part of the cutting guide.” Court: software is part of the product design– Court found that software use to create customized product could be part of the

product’s “design” for purposes of finding a design defect

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© 2018 Wilson Elser. All rights reserved.

Id. at * 10.

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If the CAD file a “product,” then this might Shoehorn the CAD Designer into a role as a Strict Liability Defendant…

• If the CAD file is “a product” sold to the POS 3D printing manufacturer, then strict liability may apply to:

• Defective original design;• Defective digital file; or• Or possibly, a corrupted copy of downloaded original file

• However, computer code (in non-PL cases) has been held not to be a “good” or “tangible” or “a material thing”. See, e.g., America Online, Inc. v. St. Paul Mercury Ins. Co., 207 F. Supp.2d 459 (E.D. Va. 2002), aff’d, 347 F.3d 89 (4th Cir. 2003).

• Also, the Restatement (Third) Product Liability §19 restricts “products” to “tangible personal property distributed commercially…”

• Meanwhile, electricity and navigational maps have been held to be “products”, although not tangible.

• What do we do about open-sourced CAD files? 25

© 2018 Wilson Elser. All rights reserved.

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The Litigation Challenges

• What is the actual product “design?”– Is it the predicate device (if there is one)– Is it the software?– Is it the scanned image (for custom products)?

• Who is the product designer?• Whether printing a device is “manufacturing” or a “service?”• Who are the “manufacturers?”• What is the “product?”• Is labeling necessary? Who is responsible to label/warn?• Do “learned intermediaries” come into play?

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© 2018 Wilson Elser. All rights reserved.

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Our Best Guess for the Future of Product Liability Law with 3D Manufacturing:

• Traditional manufacturers who use 3D printing for cost savings and customization will be treated and regulated the same as always.

• Product failures in the POS manufacturing and use context will see a fight over what standard is appropriate (negligence or strict liability) with negligence standard being used in most cases.

• Strict liability will make a comeback in limited circumstances, especially where the defect can be easily identified.

• Use of organic based medical devices with patient-specific customization will see a hybrid development in the law between medical malpractice and product liability until another, better standard is found.

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Risk Management Suggestions in Light of this Uncertainty

• If you are somewhere in the design/manufacturing process: identify the risks.

• Without useful FDA Guidance – look to emerging industry standards – especially for manufacturing.

• Non-traditional “manufacturers” may need to diversify insurance.• Attention give to use of indemnity/hold harmless agreements.• Following the regulatory and legal developments.• POS manufacturing AND SALE of medical devices to third parties

requires a heightened risk analysis.

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© 2018 Wilson Elser. All rights reserved.

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QUESTIONS OR COMMENTS

Daniel E. TranenWilson Elser, LLPSaint Louis, [email protected]

© 2018 Wilson Elser. All rights reserved.