Current Regulatory and Litigation Developments in the 510(k) - - PowerPoint PPT Presentation

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

Paul Farquharson, Esq.

Semmes, Bowen & Semmes Partner

Areas of Discussion

• Significance of Evidentiary Issue
• Regulatory Primer/Federal Law
• Framing the Issue
• Evolving Case Law
• Regulatory Developments
• Predictions

Significance of Evidentiary Issue

99% vs. 1%

See January 2009 U.S. Government Accountability Office Report at 6.

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.

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

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)

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

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

• r delivered, materials, performance, safety,

effectiveness, labeling, biocompatibility, standards and other applicable characteristics.”

FDA, Premarket Notification 510(k)

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.

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.”

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)

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

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.

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))

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

Arguments Advanced by Plaintiffs

(Cont’d.)

• FRE 403 – Prejudice, potential for confusion
• utweighs 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

Arguments Advanced by

Defendants

• Regulatory history relevant to reasonableness
• f 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

Weight of Authority Favors Exclusion of 510(k) Evidence

• Cisson v. C.R. Bard, Inc.,

810 F. 3d 913 (4th Cir. 2016)

• Huskey v. Ethicon, Inc.,

848 F. 3d 151 (4th Cir. 2017)

• Eghayem v. Boston Scientific,

873 F. 3d 1204 (11th Cir. 2017)

• Campbell v. Boston Scientific,

882 F. 3d 70 (4th Cir. 2018)

Stemming the Tide: Limiting Instructions

• Winebarger v. Boston Scientific,

2015 WL 5567578 (W. D.N.C. Sept. 22, 2015)

(510(k) is only pre-market criteria for Class II device)

• In re Bard IVC Filter Products Liability Litigation

2018 WL 582, 542 (D. Ariz. Jan. 29, 2018)

(Exclusion of FDA from trial is prejudicial to defendant)

• In re Cook Medical, Inc.

2018 WL 6617375 (S.D. Inc. Dec. 18, 2018)

(510(k) regulations are not safety regulations)

Regulatory Developments: Changes to 510(k) Process

• The Safety and Performance Based Pathway
• Identification of Older Predicate Devices

Public Interest

• Netflix
• Background
• Impact
• The Danger Within
• The New York Times
• May 4, 2019

– 80,000 Deaths. 2 Million Injuries. It’s Time for a Reckoning on Medical Devices.

• Impact

What the Public Is Seeing & Hearing

• “Industry has captured the FDA.”
• “The problem with devices is we built a system that

doesn’t work.” - Dr. Kessler

• “Kickbacks are legal.”
• “Dark money and secret funding.”
• “Device Industry is much more powerful than Big

Pharma.”

• “They’re paying for the research so they get the results

they need.”

Safety and Performance Pathway

• Final Guidance Published

– February 1, 2019 – List of Older Predicated Devices: TBD

• “Well Understood Devices”
• Expansion of Abbreviated 510(k) Program

Safety and Performance Pathway

• Attempt to Strengthen and Modernize Process
• FDA: Less burdensome but still robust

– Is this possible?

• More Efficient Review

– Faster – Less Expensive – Impact on admissibility?

Substantial Equivalence

• Remains the basis for approval
• Must identify predicate device

Substantial Equivalence (Cont’d.)

• So what’s changed?
• Use of objective safety and performance-based

criteria

– Reflect current technological principles – No need to review data from direct comparative testing – Data to demonstrate same level of performance

FDA To Limit Use of Pathway

• Future Guidance

– Detail types of devices – Detail applicable performance criteria

• Will Maintain and Publish

– A list of device types appropriate for the pathway on FDA’s website

• Intent to Make Pathway the Primary Framework

Older Predicate Devices

• FDA Website Identification

– Accepting Comments – Identify Devices With Predicates Older Than 10 Years – Suggesting This Will Improve Safety And Performance

• Industry Reaction

Safety and Performance and FDA Involvement

• FDA To Identify Devices
• FDA To Identify Testing Data
• FDA Suggesting Increased Safety
• FDA Suggesting Efficiency and Speed To

Market

• Closer to PMA or Not?

– Preemption Opportunity?

Predictions

• Increase Chances of Admissibility?
• Decrease Chances of Admissibility?
• Potential For New Run at Preemption?
• Burden on Industry?

– Older But Safe Devices Abandoned? – Increased Need For PMA?

• Cost to Consumers?

Questions