Loss Control Webinar Series. Medical Device Recalls Legal and Regulatory Implications

Transcription

1 Loss Control Webinar Series Medical Device Recalls Legal and Regulatory Implications

2 Medical Device Recalls Legal and Regulatory Implications August 2014 Paul J. (P.J.) Cosgrove

3 FDA Medical Device Recall Report FY 2003 to FY 2012 Medical device recalls increased by 97 percent from FY 2003 to FY Most frequent causes for recalls: device design, software, and non-conforming material or component issues.

4 Most frequent device Class I recalls were: 1. INFUSION PUMPS 2. AUTOMATED EXTERNAL DEFIBRILLATORS 3. VENTILATOR, CONTINUOUS 4. SYSTEM, TEST, BLOOD GLUCOSE, OTC 5. INTRODUCER, CATHETER 6. PUMP, INFUSION, IMPLANTED

5 What is a Medical Device Recall? Removal or correction of a marketed product that FDA considers to be in violation of the FDCA and against which the agency would initiate legal action, e.g., seizure. 21CFR 7.3(g) Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health. May recall an entire lot, model, or product line.

6 Recall Process

7 FDA Regulation of Recalls FDA expectations for voluntary recalls FDA mandatory recall authority Issues for companies to consider in recalls PR, reputational issues Legal issues

8 FDA classifies medical device recalls into 3 categories Class I (most serious type of recall) There is a reasonable chance that the product will cause serious health problems or death. 21 CFR 7.3(m)(1) Class II There is either a possibility that the device will cause temporary or reversible health problems, or there is a remote chance that the device will cause serious health problems. 21 CFR 7.3 (m)(2) Class III There is little chance that using or being exposed to the device will cause health problems. 21 CFR 7.3 (m)(2)

9 A recall is either a correction or a removal depending on where the action takes place. Correction Repair, modification, adjustment, labeling, destruction, or inspection (including patient monitoring) of a product without its physical removal to some other location. Removal A problem with a medical device by removing it from where it is used or sold.

10 Recall does not include a market withdrawal Firm s removal or correction of a distributed product which involves a minor violation that would not be subject to legal action by FDA or which involves no violation, e.g., normal stock rotation practices, routine equipment adjustments and repairs, etc. 21 CFR 7.3(j) stock recovery Firm s removal or correction of a product that has not been marketed or that has not left the direct control of the firm. 21 CFR 7.3(k)

11 Benefit to Company Proper execution of recalls Creates confidence in FDA that a company is willing to make remedies when needed. Decrease chances of FDA legal or administrative actions based on failure to recall timely or ineffectively.

12 Who recalls medical devices? In most cases, a manufacturer recalls a medical device on its own (voluntarily). Distributors can also recall.

13 When a company learns that it has a product that may pose risk, nonconformance, etc. recalls the device (through correction or removal) notifies FDA FDA reports through Medwatch, to state regulators, and to foreign governments

14 Legally, the FDA can require a company to recall a device. This could happen if a company refuses to recall a device that is associated with significant health problems or death.

15 What happens in a medical device recall? When a company recalls a medical device, it contacts directly the customers (and others, perhaps relevant professional societies) who received (or use, prescribe) the product, and takes steps to reach others who need to be notified; supplies information to help users identify the product and take steps to minimize health consequences; and takes action to prevent the problem from happening again.

16 FDA oversees each recall to make sure that the actions the company takes are adequate to protect the public health. FDA works with the recalling firm to obtain information about the product, the problem, the recall strategy, and the steps to prevent the problem from happening again; conducts audits to make sure the recall efforts are appropriate and effective; and makes sure the company takes necessary actions to prevent the problem from happening again.

17 What information must be supplied to the FDA in a recall submission? 1. Product Information 2. Codes/Product Identification Number 3. Recalling Firm Information 4. Manufacturer Information 5. Identify firm responsible for violation/problem 6. Reason for Recall 7. Health Hazard Assessment 8. Volume 9. Distribution 10. Recall Strategy

18 Customer Notification Methods 1. Press Release Where the product may pose a significant health hazard and recalled product is in the hands of consumers Consult local District Recall Coordinator before issuance of a press release Should be issued through the Associated Press (AP). For those recalls where FDA believes a Press Release is warranted, the Agency will issue a Press Release if the firm has failed to do so, or if the firm-initiated press release is not adequate. 2. Recall Communication

19 Customer Notification Methods 2. Recall Communication Recall notifications and envelopes should be flagged in large bold print "URGENT: MEDICAL DEVICE RECALL or CORRECTION. Notification letter should include the following information: product identification description of problem depth of recall (e.g. wholesale, retail, or user level) instructions to customer

20 RECALL COMMUNICATIONS FDA,Office of Risk Communication Advisory Cmte., Recommended Practices for Recall Communications 1. scant data on consumer responses to specific FDA recalls. 2. Recall Fatigue v. definitive advice system that the American public relies upon when it comes to their choices of which medicines and devices they seek to relieve their symptoms and cure their diseases - the FDA, their doctor, their pharmacist, their local TV news station, the manufacturer of drugs and devices, Google, academic medicine, patient advocacy groups.

21 Litigation Flood A voluntary recall of a product will result in lawsuits.

22 Litigation Tactics Ps attorneys will often try to use a recall to attempt to prove: 1. The existence of a defect; 2. The cause of the injury; 3. The extent of the risk created by the product; 4. The manufacturer s notice or knowledge of the dangers of the product before the recall; 5. The foreseeability of the use to which the product; or 6. The basis for an aware of punitive damages.

23 Litigation Tactics When plaintiffs attempt to admit recall documents at trial, object! 1. hearsay; 2. prejudice; 3. relevancy; 4. subsequent remedial measures; and 5. authentication

24 Litigation Tactics Fed. R. Evid subsequent remedial measures Exceptions: Ownership/Control Impeachment Feasibility Majority view- feasibility is not controverted unless the defendant affirmatively raises it. Notice A defendant seeking to exclude evidence of a product recall likely will concede ownership and notice.

25 Recall Notice Insufficient to Establish Defect or Causation in Medical Device Case Hughes v. Stryker Sales Corp., CIV.A WS-N, 2010 WL (S.D. Ala. May 13, 2010) aff'd sub nom. Hughes v. Stryker Corp., 423 F. App'x 878 (11th Cir. 2011) P alleged that a manufacturing defect in her prosthetic hip replacement led to its failure and caused plaintiff to undergo additional hip surgery. Four months after P received her prosthetic hip, the manufacturer sent a product recall notice about manufacturing variances and the potential risk that the device may fail to achieve biological fixation.

26 Hughes v. Stryker Sales Corp., CIV.A WS-N, 2010 WL (S.D. Ala. May 13, 2010) P did not designate any expert witness on product defect or causation. Manufacturer moved for summary judgment. P argued that the manufacturer s admission in the product recall notice coupled with medical records were sufficient to create triable issues of defect and causation without expert testimony. Relied on Rule 407 and content of recall notice.

27 Hughes v. Stryker Sales Corp., CIV.A WS-N, 2010 WL (S.D. Ala. May 13, 2010) Federal law bars P from using a defendant s remedial measures to prove negligence. Fed. R. Evid Because the prosthetic hip devices can fail for a plethora of reasons wholly divorced from, and independent of, any defect, the recall notice was insufficient to demonstrate causation. Plaintiff does not explain how the mere fact of a product recall gives rise to a reasonable inference that the actual device implanted in [plaintiff] had defect. District Court granted manufacturer s summary judgment motion.

28 Cothren v. Baxter Healthcare Corporation, No. 3:10-cv-347, 2011 WL (May 31, 2011) P asserted product liability claims against manufacturer based on the injuries allegedly suffered from dialysis machine. P claimed injuries were consistent with the injuries itemized and noted in two recall notices manufacturer had issued with respect to such devices. Manufacturer moved for summary judgment focusing on whether the plaintiff satisfied the essential element of a defect.

29 Cothren v. Baxter Healthcare Corporation, No. 3:10-cv-347, 2011 WL (May 31, 2011) P argued any layman can review the two recall notices, the press release and the plaintiff s symptoms and based on common sense, find that the defendant was negligent. District Court disagreed, and found expert testimony was required. District Court reasoned recall notices do not constitute admissible evidence to establish liability. (citing Drury v. Cardiac Pacemakers, Inc., No. 8:03cv933, 2003 WL (M.D. Fla. June 3, 2003) (fact of recall alone does not establish causation). District Court granted manufacturer s summary judgment motion.

30 Recall Found Admissible DiCosolo v. Janssen Pharm., Inc., 951 N.E.2d 1238 (IL App (1st) 2011) Estate of patient, who died while using a prescription transdermal pain patch, brought product liability action. Trial court did not abuse its discretion in admitting evidence of manufacturer s recall of patches. The recall letter which showed decedent's patches came from a specific lot that was recalled due to a leak defect was not used for the purpose of claiming the patch was in fact defective. The recall letter, along with the additional evidence of a defect, including decedent s excessive, lethal fentanyl blood level, and the slick film on decedent s skin, amounted to evidence of defect.

31 State Evidentiary Rules Maine and Texas Rules of Evidence provide that a written notification by a manufacturer of any defect in a product produced by such manufacturer to purchasers is admissible against the manufacturer on the issue of the existence of the defect, to the extent that it is relevant. Me. R. Evid. 407(b); Tex. R. Evid. 407(b).

32 Texas Case Example Alza Corp. v. Thompson, CV, 2010 WL (Tex. App. Apr. 1, 2010) Recall letters are admissible as some evidence that the defect existed when the product left the manufacturer. The defect referenced in the recall is the same defect as alleged in the instant case, and thus, the recall is relevant. While evidence that a product fell within a recall is evidence of a defect, the converse is not true: evidence that a manufacturer did not recall a product or evidence that the product at issue fell outside the recall is no evidence that the product is not defective.

33 If Recall Evidence Is Admitted The manufacturer should have the right to introduce all communications with the FDA to show that it was aware of, and agreed with, the strategy.

34 Expert Testimony (Clinical, Regulatory (FDA Regulation, QSR Compliance) 1. Recall of the product and conduct with respect to initiating and conducting that recall, was appropriate, reasonable, and effective in providing public health protection by removing products that may not have been in conformance with established specifications ( non-conforming ). 2. Simply because a product lot is subject to a recall does not mean that every individual product within that lot is non-conforming and, with respect to the company s product, the overwhelming majority of recalled product was not, in fact, non-conforming. 3. Determination of whether (1) an individual purchased and used product subject to the voluntary recall of certain lots, (2) an individual further used product that the company identified as within particular lots that contained a sub-set of non-conforming product, and whether (3) an individual incurred alleged damages due to non-conforming product that, in fact, was caused by the non-conformance (as opposed to some other reason), requires detailed individual inquiry of each such individual and his or her product usage.

35 Recall Authorities FDA Guidance for Industry: Product Recalls, Including Removals and Corrections FDA Guidance for Industry: Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers FDA Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s Draft FDA Guidance for Industry and Food and Drug Administration Staff: Applying Human Factors and Usability Engineering to Optimize Medical Device Design U.S. Department of Health and Human Services, Labeling Regulatory Requirements for Medical Devices (HHS Publication FDA ) James R. Callan and John W. Gwynee, Human Factors Principles for Medical Device Labeling, FDA CDRH (September 1993) Regulatory Procedures Manual October 2013: Chapter 7 Recall Procedures FDA Medical Device Recall Report, FY2003 to FY2012 HHS/FDA Office of the Commissioner Risk Communication Advisory Committee Hearing Transcript (2/29/2008)

36 Negligent Recall v. Failure-to-Recall Matter of state Law E.g., Georgia recognizes a negligent recall claim based on the manner in which notice is provided. See Blossman Gas Co. v. Williams, 189 Ga.App. 195, 199, 375 S.E.2d 117, (1988). E.g., Missouri: there is no recognized duty to recall, we hold such a duty cannot arise as a result of [defendant's] voluntary undertaking to recall certain of its [products]. Furthermore, Missouri case law on failure to warn suggests that, in order to pursue a negligent recall claim, the defect in the [product] would have had to exist at the time the product left [defendant's] control and entered the stream of commerce.

37 QUESTIONS Paul J. (P.J.) Cosgrove Ulmer & Berne LLP