Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more Medmarc Medical Device Webinar June 27, 2019 Beth S. Rose, Esq. Sills Cummis & Gross P.C. Partner (973) 643-5877 | brose@sillscummis.com One Riverfront Plaza Newark, NJ 07102 Paul Farquharson, Esq. Semmes, Bowen & Semmes Partner (410) 576-4742 | pfarquharson@semmes.com 25 S. Charles Street, Suite 1400 Baltimore, MD 21201 0 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Areas of Discussion • Significance of Evidentiary Issue • Regulatory Primer/Federal Law • Framing the Issue • Evolving Case Law • Regulatory Developments • Predictions 1 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Significance of Evidentiary Issue 99% vs. 1% See January 2009 U.S. Government Accountability Office Report at 6. 2 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
The New York Times Op Ed May 4, 2019 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices. Tighten approval standards . Regulatory loopholes — some of which date to the dawn of device regulation and were not meant to be permanent — enable companies to bring new or “updated” medical devices to market without testing them in human trials first. Companies need only to convince regulators that their products are similar to ones that are already approved, even if the other products are decades old or were subsequently pulled from the market. 3 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Regulatory Primer: Medical Device Amendments of 1976 • Classifies medical devices – Class I – low risk/general controls – Class II – moderate risk/special controls – Class III – higher risk/Pre-Market Approval (PMA) • Grandfathers pre-1976 devices • New devices subject to 510(k) review; required showing is substantial equivalence to predicate device 4 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Regulatory Primer: Safe Medical Device Act (SMDA) OF 1990 Substantial Equivalence Defined New device . . . “(i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics and the information submitted that the device is substantially equivalent to the predicate device contains information . . . that demonstrates that the device is as safe and effective as a legally marketed device, and (II) does not raise different questions of safety and effectiveness than the predicate device.” 21 U.S.C. § 360c(i)(1)(A) 5 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Regulatory Primer: FDA Guidance – July 28, 2014 Because devices are classified according to the level of regulatory control necessary to provide a reasonable assurance of safety and effectiveness , classification of a new device through the 510(k) process requires FDA to determine the issues of safety and effectiveness presented by the new device , and the regulatory controls necessary to address those issues.” FDA, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications 6 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Regulatory Primer: Current FDA Website A claim of substantial equivalence does not mean the devices must be identical. “ Substantial equivalence is established with respect to : intended use, design, energy used or delivered, materials, performance, safety, effectiveness, labeling, biocompatibility, standards and other applicable characteristics.” FDA, Premarket Notification 510(k) 7 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Medtronic, Inc. v. Lohr, 518 U.S. 470, 493-94 (1996) • “[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post-1976 device to a pre-1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.” • Class II devices have never been formally reviewed under the MDA for safety or efficacy. 8 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Riegel v. Medtronic, Inc. 552 U.S. 312, 322-23 (2008) “. . . Lohr also rejected the manufacturer’s contention that § 510(k) approval imposed device specific requirements. We regarded the fact that products entering the market through § 510(k) may be marketed only so long as they remain substantial equivalents of the relevant pre-1976 devices as a qualification for an exemption rather than a requirement .” 9 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Contrary Post- Lohr Case Law • Buckman Co. v. Plaintiff’s Legal Committee 531 U.S. 341, 349-50 (2001) (recognizing that both PMA and 510(k) processes are designed to “ensure… that medical devices are reasonably safe and effective.”) • Otero v. Zeltig Aesthetics, Inc . 2018 2018 WL 3012942 at *3 (C. Dist. Cal. June 11, 2018) (rejecting interpretation of Lohr that only FDA approved Class III devices, not FDA 510(k) cleared Class II devices, undergo safety and efficacy review by the FDA) 10 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Framing the Issue: New Jersey Verdicts • Hrymoc, et al. v. Ethicon, Inc. et al. – December 2017 verdict • $6M compensatory; $10M punitive • McGinnis v. C.R. Bard, Inc. et al . – April 2018 verdict – $35M compensatory; $33M punitive • Evidence of FDA evidence/510(k) process excluded in both trials 11 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Framing the Issue: Dueling in limine Motions • Plaintiffs move to bar/defendants move to admit… – Evidence related to the FDA’s oversight and clearance of the medical device at issue… including the manufacturer’s compliance with FDA’s design and labeling requirements • Stated rationale for exclusion of evidence – 510(k) process did not involve a review of the product’s safety and effectiveness – FDA standards for design and labeling of medical devices cleared through the 510(k) process did not qualify as “government standards” under the North Carolina Product Liability Act. 12 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Framing the Issue: Exploitation of Court Ruling Opening statement: “[Bard] didn’t think [it]had to do a clinical study in actual patients….” (27T50:10-12.) “This is what they knew and I’m going to say it again. They didn’t think they needed to do a clinical study with this to see what happened in actual women. ” (27T52:9-12 (emphasis added)) 13 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Arguments Advanced by Plaintiffs • FRE 401/402 – Relevance – Whether the design and warnings of the device were reasonable, because: • 510(k) process does NOT address whether device is safe and effective • 510(k) process does NOT impose any federal requirement in and of itself 14 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Arguments Advanced by Plaintiffs (Cont’d.) • FRE 403 – Prejudice, potential for confusion outweighs probative value – Substantial mini-trial on the 510(k) process and FDA enforcement – Confusing and misleading the jury to believe that FDA has made safety determination – Experts would be offering legal conclusions – Admission of 510(k) evidence would delay the trial 15 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Arguments Advanced by Defendants • Regulatory history relevant to reasonableness of product design and labeling • Important to place manufacturer’s conduct into context before the jury • Defense prejudiced by inability to respond to various claims ( e.g. failure to conduct clinical trials before marketing products) • Provides defense to punitive damages claims 16 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
Weight of Authority Favors Exclusion of 510(k) Evidence • Cisson v. C.R. Bard, Inc., 810 F. 3d 913 (4 th Cir. 2016) • Huskey v. Ethicon, Inc., 848 F. 3d 151 (4 th Cir. 2017) • Eghayem v. Boston Scientific , 873 F. 3d 1204 (11 th Cir. 2017) • Campbell v. Boston Scientific, 882 F. 3d 70 (4 th Cir. 2018) 17 | Current Regulatory and Litigation Developments in the 510(k) Process: Everything you need to know and more
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