Litigation: Products Liability and Key Cases in 2013, Strategic Considerations, and Avoidance Techniques

Transcription

1 Litigation: Products Liability and Key Cases in 2013, Strategic Considerations, and Avoidance Techniques Philip J. Phillips, President, Phillips Consulting Group, LLC Brian W. Shaffer, Partner, Morgan, Lewis & Bockius LLP Marta L. Villarraga, PhD, Principal, Biomedical Engineering, Exponent, Inc. Moderated by Kai Peters, Partner, Gordon & Rees LLP

2 Hypothetical In 2005, ABC Corp. obtained FDA approval through the PMA process for a total hip replacement implant (Class III). Certain components of the implant were approved through the 510k process before ABC submitted its PMA. At the time of approval, ABC was aware that its implant design and manufacturing processes made the device susceptible to a nearly-invisible hairline crack that could in rare instances cause the parts to fracture after being implanted. FDA, however, was not told of this potential risk during the PMA process. In fact, one ABC employee modified the company s draft responses to certain questions from FDA during the approval process to omit any reference to the hairline crack. In 2008, John Doe, a 60 year-old retired assembly line worker, had hip replacement surgery, receiving ABC s implant. Also in 2008, Gary Barry, a 52 year-old horse trainer, had hip replacement surgery, receiving ABC s implant. In 2010, before either patient reported any post-operation problems, ABC became aware that a particular hinge could cause two parts of the implant to rub together, leading to debris and potential dislocation. Because there were only a handful of reports of such problems, ABC decided not to inform customers that this was a risk associated with the implant. However, ABC did submit adverse event reports to the FDA each and every time it became aware of a report of such issues. The implant s FDA-approved labeling did not make any reference to the possibility of a hairline fracture, debris or dislocation risks.

3 Hypothetical (continued) Mr. X, a sales representative for ABC had met with Dr. Y, Gary Barry s physician, on numerous occasions before Upon Dr. Y s request, Mr. X provided articles to Dr. Y regarding the benefits of the total hip replacement implant for uses outside of the FDAapproved labeling. Some of the articles referenced incidents involving the hairline fracture issue. In 2011, Mr. Barry s implant developed a hairline crack and fractured, causing damage to the surrounding bone and muscle. In 2011, Mr. Doe s hip replacement parts had worn together and began to discharge debris, with the parts ultimately dislocating from one another. The debris became lodged in Mr. Doe s surrounding leg muscles, causing pain and limiting Mr. Doe s range of motion. Both Mr. Doe and Mr. Barry underwent second hip replacement surgeries to replace the damaged ABC implants. ABC reported these adverse events to the FDA as soon as it became aware of them through reports from the respective physicians. In 2012, the FDA sent a warning letter to ABC, stating that, based on FDA s inspections of ABC s facilities precipitated by an alert from the sales representative Mr. X to the FDA regarding both issues, ABC had adulterated and misbranded its implant by concealing two known risks: (1) hairline fractures; and (2) discharge of debris and related dislocation. In 2013, Mr. Doe and Mr. Barry separately sued ABC, each asserting the following identical state law claims: Strict liability: defective design and manufacturing, and failure to warn Negligence: failure to report known risks associated with device to FDA

4 Preemption in Medical Device Product Liability Cases: 2013 Update Brian W. Shaffer Partner, Morgan, Lewis & Bockius LLP 4

5 Medical Device Preemption Update Riegel based Preemption Express preemption based on MDA to the FDCA Buckman based Preemption Implied preemption based on lack of private right of action to enforce FDCA Express and implied preemption in the hypothetical cases of Messrs. Barry and Doe Viability of Parallel Claims Recent Case Developments 5

6 Express Preemption Framework Under Riegel v. Medtronic, 552 U.S. 312 (2008) Express preemption 21 U.S.C. 360k(a) Two part analysis: 1. Specific federal requirements 2. Different or additional state law requirements Riegel: FDA s Pre-Market Approval ( PMA ) establishes specific federal requirements for: Design Labeling Manufacturing process 6

7 Parallel Claims: Express Preemption Framework Under Riegel Riegel: [Section] 360k does not prevent a State from providing a damages remedy for claims premised on a violation of FDA regulations; the state duties in such a case parallel, rather than add to, federal requirements. Medtronic v. Lohr, 518 U.S. 470 (1996): 510(k) clearance does not establish specific federal requirements 7

8 Implied Preemption Framework Under Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341 (2001) There is no private right of action to enforce the FDCA 21 U.S.C. 337(a) Buckman: Federal government, not private litigants, authorized to enforce the MDA FDA has: Extensive enforcement authority Complete enforcement discretion to achieve balance of statutory objectives No Fraud on the FDA claim concerning 510(k) device State law claims that directly or indirectly seek to enforce manufacturer s obligations under the FDCA and related regulations would conflict with federal scheme, and therefore such claims are impliedly preempted 8

9 The Case of Mr. Barry Implant developed a hairline crack and fractured; ABC was aware of this risk prior to the PMA approval process and thus should have disclosed during the PMA process Because implant went through PMA process, claims asserting defective design, manufacturing process, and insufficient warnings will be expressly preempted under Riegel State law negligent failure to warn FDA claim should be impliedly preempted under Buckman: Liability for failure to report known risks associated with device to FDA during clearance/approval process is nothing more than an attempt to enforce the FDCA 9

10 The Case of Mr. Barry Is anything left of Mr. Barry s case? Riegel and Buckman create a narrow gap through which a plaintiff's state-law claim must fit if it is to escape express or implied preemption. The plaintiff must be suing for conduct that violates the FDCA (or else his claim is expressly preempted by 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman). Riley v. Cordis Corp., 625 F. Supp. 2d 769, 777 (D. Minn. 2009) Claim that Mr. Barry s particular implant was defectively manufactured Medical Malpractice 10

11 The Case of Mr. Doe Implant began to discharge debris, a risk that ABC became aware of in 2010, after PMA approval; however, ABC failed to alert doctors or consumers of this risk once company became aware of it Because implant went through PMA process, claims asserting defective design, manufacturing process, and insufficient warnings will be expressly preempted under Riegel Is state law negligent failure to warn FDA claim impliedly preempted under Buckman? May depend on where Mr. Doe sues What is a parallel claim? 11

12 The Case of Mr. Doe Ninth Circuit s recent en banc decision in Stengel v. Medtronic, 2013 WL (9th Cir. Jan. 10, 2013) MDA does not expressly preempt state law failure to warn claim that parallels FDA-imposed duty to monitor the product after pre-market approval and to discover and report any complaints about performance Parallel state law duty exists for manufacturers to produce a product with an adequate warning Stengel court distinguishes Buckman as concerned exclusively with alleged fraud on the FDA ; thus under Stengel Mr. Doe s negligent failure to warn claim may not be preempted if viable under state law (at least at pleading stage) Opposite result if Mr. Doe is in the Sixth or Eight Circuits, Marsh v. Genentech, 693 F.3d 546 (6th Cir 2012); In re Medtronic, 623 F.3d 1200 (8th Cir. 2010) 12

13 Current State of Play Parallel Claims Bausch, 630 F.3d 546 (7th Cir. 2010) Permit discovery into alleged parallel claims before pleading of specific defect Discovery permitted because of confidentiality of PMA materials Rejects implied preemption Buckman argument 13

14 Current State of Play Parallel Claims Wolicki-Gables, 634 F.3d 1296 (11th Cir. 2011) Parallel claim must be stated in initial pleadings Rejects claims based on: Off-label use Res ipsa/malfunction doctrine 14

15 Current State of Play Parallel Claims Bryant, 623 F.3d 1200 (8th Cir. 2010) Affirmed dismissal of Master Consolidated Complaint Narrow gap for parallel claims No need for discovery regarding manufacturing defect Conceded below Different result if an individual claim? 15

16 Recent Case Law Riegel Express Preemption Bass (5th Cir.) pleading parallel claims Walker (4th Cir.) performance Cornett (N.J.) off-label use Buckman Implied Preemption Riley (D. Minn.) fraud on the FDA and off-label use Caplinger (W.D. Okla.) off-label use Attempts to Circumvent Riegel and Buckman Stengel (9th Cir.) (en banc) 16

17 Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) Decided: January 31, 2012 Author: Judge Haynes Affirmed in part, Reversed in part 12(b)(6) dismissal PMA approval is a question of law the Court need not accept the Complaint s allegations regarding PMA approval Trident system received PMA approval Previous 510(k) clearance of shell component irrelevant 17

18 Parallel claim: Bass v. Stryker Corp., 669 F.3d 501 (5th Cir. 2012) Manufacturing defect resulting from violation of federal regulations is not preempted Claim was based on FDA warning letter Current Good Manufacturing Practices ( CGMP ) violations can be basis of parallel claim if they are alleged to have caused injury Parallel claims not impliedly preempted under Buckman Reversed dismissal of claims based on failure to comply with federal requirements for: Negligent manufacture Breach of implied warranty State consumer protection law 18

19 Walker v. Medtronic 670 F.3d 569 (4th Cir. 2012) Decided: January 25, 2012 Author: Judge Duncan Affirmed grant of summary judgment in favor of Medtronic 19

20 Walker v. Medtronic 670 F.3d 569 (4th Cir. 2012) No parallel claims: Flow accuracy specification in PMA is not a formal performance standard Not promulgated as standard by FDA pursuant to 21 U.S.C. 360d Adherence to flow accuracy specification is not a Condition of Approval [A]lleged deviation from manufacturing performance specifications for a device that has received premarket approval is not the same thing as noncompliance with the FDA or its regulations MDA preempts state law claims for negligence, strict liability, and breach of warranty 20

21 Cornett v. Johnson & Johnson, 211 N.J. 362 (2012) Decided: August 9, 2012 Author: Judge Cuff, J. (temporarily assigned) Setting: Motion to Dismiss Master Complaint 48 claimants Stent used off-label Dismissal of most claims affirmed as preempted State law claims based on federal requirements as measure of reasonableness or wrongfulness of conduct impliedly preempted under Buckman BUT narrow fraud on FDA claims based on deliberate nondisclosure of material information not impliedly preempted 21

22 Cornett v. Johnson & Johnson, 211 N.J. 362 (2012) We also hold the failure to warn claim as to approved and off-label uses is preempted, except to the extent plaintiffs base the claim on allegations of deliberate nondisclosure or fraudulent representations of known adverse information apart from defendants failure to comply with FDA disclosure requirements or promotion of off-label uses outside the safe harbor. Note: Safe Harbor refers to FDA s current permission for a manufacturer of a Class III device to disseminate to healthcare providers peer-reviewed articles or reference publications concerning the safety, effectiveness, or benefit of a use not described in the approved labeling provided that the manufacturer also apply for approval for the new use or certify that it intends to do so 22

23 Cornett v. Johnson & Johnson, 211 N.J. 362 (2012) Claims not expressly preempted under Riegel: Failure to warn claim for approved use if nondisclosure or misrepresentation but not based on failure to comply with FDA disclosure requirements (e.g., failure to disclose post-marketing information to general public) Failure to warn claim for off-label use to the extent defendants improperly promoted that device Breach of express warranty claim for voluntary statements to third parties that deviate from the approved label and packaging information material 23

24 Riley v. Cordis Corp. 625 F. Supp. 2d 769 (D. Minn. 2009) Decided: June 5, 2009 Author: Judge Schiltz Granted motion for judgment on the pleadings Treatment of failure to warn claim: Buckman impliedly preempts any claim that, but for the defendant s fraudulent statements to the FDA, that the [defendant s] stent would not have been approved Claim that FDA was fraudulently deprived of the knowledge it needed to make an informed decision was just a thinly veiled way to claim fraud on the FDA 24

25 Riley v. Cordis Corp. 625 F. Supp. 2d 769 (D. Minn. 2009) Failure to warn claim is preempted, with one exception: Off Label promotion may survive implied preemption: If [the defendant] promoted off-label use of the stent in a manner that was no authorized by the FDCA, then [the defendant s] conduct would violate federal law, and thus 360k(a) would not expressly preempt a state-law claim based on this conduct. But such a claim would be impliedly preempted under Buckman, because promoting the off-label use of an FDAapproved medical device is not unlawful under traditional state tort law which had predated the federal enactments in question Plaintiff might be able to state a failure to warn claim escaping preemption if they plead (1) [defendant] affirmatively promoted the offlabel use of the [device] in a manner that violated federal law, and (2) that, while promoting the device in violation of federal law, [defendant] failed to include adequate warnings and directions about the off-label use it was promoting 25

26 Caplinger v. Medtronic 2013 WL , (W.D. Okla. Feb. 6, 2013) Decided: February 6, 2013 Author: Chief Judge Miles-Lagrange Motion to dismiss granted Where fraudulent inducement, misrepresentation, constructive fraud, and negligence claims depend on off-label promotion, these claims are impliedly preempted under Buckman as these are inherently FDCA-based concepts: [F]raudulent misrepresentation/fraud in the inducement claim is not based on conduct that would give rise to a recovery under state law even in the absence of the FDCA. The conduct plaintiff complains of how defendants are promoting and marketing to physicians the off-label use of [the product] is governed by the FDCA. To determine whether said conduct is improper would require reliance on the requirements of the FDCA Off-label use does not limit express preemption under Riegel either, thus alleged illegal promotion does not make all the plaintiff's claims parallel [A]llegations of promotion of off-label use of a device in violation of federal law does not automatically immunize a plaintiff's claims from being subject to a preemption analysis under 360k(a) 26

27 Stengel v. Medtronic, 2013 WL (9th Cir. Jan. 10, 2013) Decided: January 10, 2013 En Banc panel decision, Author: Judge Fletcher Reversing grant of motion to dismiss failure to warn claims (overruling prior 9th Cir. affirmance) Timeline: 1999: Defendant obtains PMA approval for spinal pain pump 2000: Stengel has spinal pain pump installed ~ : Defendant became aware of paralysis risks 2005: Stengel suffers ascending paralysis, allegedly caused by the spinal pain pump 2007: FDA warning letter stating that Defendant misbranded its spinal pain pump by concealing known risks 2008: Defendant sends correction letters and recalls device 27

28 Stengel v. Medtronic, 2013 WL (9th Cir. Jan. 10, 2013) Claims based on post-approval monitoring and reporting are not impliedly preempted under Buckman The failure to warn claim at issue is a state-law claim that is independent of the FDA s pre-market approval process that was at issue in Buckman Failure to warn claim that medical device correction notice should have been sent to physicians, whether or not required by FDA, is not expressly preempted Our sister circuits have uniformly held that, in cases dealing with violations of the MDA outside the pre-market approval process, the MDA does not preempt state-law causes of action for damages in which the state-law duty parallels the federal-law duty under the MDA Arizona duty is found to parallel federal-law duty imposed by MDA 28

29 Contact Information Brian W. Shaffer Partner, Morgan, Lewis & Bockius LLP

30 FDA Regulatory Considerations and Litigation Philip J. Phillips President, PCG, LLC

31 My Perspective Scientist rely on evidence/driven by data Medical device regulatory consultant Advisor industry, consumer and professional organizations, FDA, and Congress (>80%) Educator (10-15%) Expert witness (<10%) Former FDA regulator cautious

32 Risk Mitigation Measures I. Maintain an accurate and thorough administrative record related to all regulatory matters II. Strive to comply with all FDA requirements III. Remain vigilant throughout the total product lifecycle

33 Managing the Administrative Record For every administrative action taken by FDA, there is an accompanying administrative record (21 CFR 10.3(a)) that may become public Future assertions will be made and conclusions drawn based on the administrative record that is created today Correct inaccuracies Introduce a defense as appropriate for company decisions and actions Recognize that most contributors to the administrative record do not have FDA delegated decision-making authority

34 Strive for Compliance Market products only for their indications for use as established through the regulatory processes Off-label promotion is a major issue that is not always easy to recognize, e.g. general to specific use. Document the basis for all decisions Fulfill all post-market responsibilities Design validation, post-approval studies, section 522 studies and MDR Document the basis for all device changes or modifications (manufacturing, device design and labeling) and seek FDA premarket authorization as required. Educate the workforce (particularly sales reps)

35 Remain Vigilant Recognize that perception is reality Understand your regulatory responsibilities Know the limits and take corrective action if and when they are exceeded Know what needs to be reported to FDA and what does not Consider what should be reported when there are no requirements to do so Establish and maintain complaint handling procedures Investigate all complaints and fulfill responsibilities Do not become myopic what affects your competitors can easily affect you

36 Conclusion Medical device companies are litigation targets, whether for product liability, false claims, antikickback, or off-label promotion. Establishing a corporate culture of compliance with FDA requirements, documenting your efforts to comply, and being vigilant, particularly in the post-market period, will advantage your company if it become a target for litigation.

37 Technical Aspects in Products Liability: Strategic Considerations and Avoidance Techniques Marta L. Villarraga, PhD Principal, Biomedical Engineering Exponent, Inc.

38 Topics Risk Management: FMEA CAPA Surgical Technique Inspection SOPs

39 Risk Management: FMEA Facts: FMEA had a failure mode generally described as Fracture of the implant in situ The RPN (risk priority number) for this failure mode was low, with the RPN driven by a low likelihood of occurrence Mitigation was addressed as warning of potential fracture Other hip replacements from ABC company had the same failure mode in their FMEA and similar RPNs At the time of the initial FMEA, no published case reports existed on incidents involving the hairline fracture issue

40 Risk Management: FMEA Considerations: Who was part of the team that conducted the FMEA? Was anyone in that team aware of and had documented previously the fact that the implant design and manufacturing processes made the device susceptible to a nearly-invisible hairline crack, though in rare instances? What data was available to indicate that implant design and manufacturing processes made the device susceptible to a nearly-invisible hairline crack that could in rare instances cause the parts to fracture after being implanted? Were there any surgical technique related triggers? What mitigation measures were associated with this general fracture failure mode?

41 CAPA Facts: There was NO CAPA opened for either (1) hairline fractures or (2) discharge of debris and related dislocation. Each of the MDRs associated with Mr. Barry and Mr. Doe documented the information known at the time, including technique related issues, and did not launch any full investigations at the time FDA noted in its warning letter that a CAPA should have been opened

42 Considerations: CAPA What type of justification was documented as to the path followed to not launch a CAPA? What type of information could have been considered in a CAPA? If any of the implants were returned: metallurgical analyses If any tissue samples were obtained: implant debris analyses Pertinent clinical information of cases being investigated Summary of reported cases in the literature Lot history record review for pertinent cases Similar reports in other hip implants by ABC company

43 CAPA What were FDA s observations regarding why a CAPA would have been required? FDA found records that ABC engineers were examining and testing for possible problems that were not disclosed to the FDA

44 Surgical Technique Facts: Surgical technique similar to other ABC hip implants Use of XYZ tool required as in other implants Not described that use of XYZ tool was to prevent pre-stressing implant component (the one susceptible to the hairline fracture) Not described that proper use of XYZ tool will minimize chances of dislocation Considerations: Surgeon training Case study reports of hair line fractures and details of surgical technique

45 Inspection SOPs Facts: Manufacturing steps similar to other ABC hip implants Inspection steps the same as in other hip implants Inspection SOPs the same as in other hip implants Manufacturing validation: lower yields than other implants Training of technicians for inspections of this implant was enhanced Considerations Manufacturing records, including inspection training Process control data from manufacturing

46 Device Performance: Multifactorial Device factors Patient factors Surgical factors