1. Managing multi-patient incidents … or … Slewing the class action dragon Barry Glaspell tel 416-367-6104 email bglaspell@blg.com @glaspell

2. 1.1What is a multi-patient incident? Individual, or series of related, events injure or increase risk many patients injured because of health care management Increased risk neither anticipated by health care professionals nor recognized at time of incident Dudzinski, DM et al. (2010) The Disclosure Dilemma- Large-Scale Adverse Events, New England Journal of Medicine, 363, 978-986 Examples: privacy breaches, errors disclosed by diagnostic reviews, sterilization failures, infectious disease outbreak

3. 1.2Challenges of multi-patient incident Typically involves retrospective detection of potential harm to multiple patients Often do not know if actual harm occurred Most patients experience no harm or near miss Pool of potentially affected patients may be large & not readily identifiable Probability of harm and severity vary on a case-by-case basis

4. 1.3Challenges of multi-patient incident Often urgent re clinically significant cases Balance between conducting timely, and thorough, risk assessment Risk assessment and notification are resource intensive and multidisciplinary Balancing harm from potential risk against harm from inappropriate disclosure

5. 1.4Should patients be notified? Harm to patient = disclose Some unidentified patients may have been harmed but risk not yet assessed/quantified For most/all patients the event did not reach them or the event reached them but did no harm How to decide whether, when and who to notify?

6. 1.5Importance of process Pittman Estate v. Bain (1994 Sup. Ct.) Conduct look-back in timely fashion Use medical/scientific knowledge to ascertain risk Design effective program based upon administrative capabilities and reasonable priorities to warn blood recipient in timely manner Notify patient or patient’s physician “in a manner and in a time commensurate with the risk to their health”

7. 1.6Should patients be notified? Conduct risk assessment Multidisciplinary: may include clinical specialties, epidemiologist, microbiologist, etc. Ascertain likelihood of clinical consequences (how likely?) and severity of consequences (how bad?) Consider whether external experts should weigh in Create list of potentially affected patients Involvement of IT, facilities, etc. Be wary of over- or under-notification

8. 1.7Should patients be notified? Consult more broadly in close calls Ethics, legal, patient representative Would a reasonable patient in these circumstances want to know? Urgency determined by ability to prevent, identify or mitigate future harm through clinical testing or treatment Where intervention to mitigate the risk is possible (e.g. availability of prophylactics), urgency is highest Urgency impacts ability to thoroughly assess risk at the outset

9. 2.1Example One: PHI privacy breaches

10. 2.2PHI privacy breach examples Faxers (old technologies die slowly) Snoopers (facilitated by electronic health record) Carriers of USB/digital portables Uploaders (on intranet or even internet) usually inadvertently, often for only short period Profit-seekers

11. 2.3PHI privacy breach: Should patients be notified? In Ontario, PHIPA statutory disclosure duty If PHI “stolen, lost, or accessed by unauthorized persons” Notify “the individual” Notice often leads to class action “At the first reasonable opportunity” Timing issue Involvement of Privacy Commissioner PHIPA s. 65 damages

12. 2.4PHI privacy breach: How to notify? Letter by mail or registered? Press release? Statement on website? Individual interview

13. 2.5PHI privacy breach: Class action examples  HIROC Subscriber 1: Lost but then found USB key  HIROC Subscriber 2: Nurse snooper case (several of these class actions in NS and NL)  Ontario Court of Appeal to be asked whether PHIPA s. 65 damages for privacy breach provide complete code; no common law intrusion on seclusion claim

14. 2.6 PHI privacy breach: Class action concerns  Hospitals increasing harvesting PHI for profit or as part of business practice/strategy  Where there are profits, PHI privacy class actions have much greater momentum  Hospitals increasingly being found vicariously liable for misconduct  For example, John Hopkins gynaecologist surreptitiously photographed/recorded with pen-cam examinations of 9K patients

15. 2.7 PHI privacy breach: Class action concerns  We face new technologies  Hospital departments under pressure to generate revenue  Lots of folks in hospital over whom we have more exposure than control  Trying to get digital portables out of hospital, stop using faxes for PHI transmission  Not want to pay patients to settle unless can show clear economic loss from PHI privacy breach

16. 3.1 Example Two: Diagnostic reviews

17. 3.2Diagnostic review examples Imaging: MRI, CT, X-Ray HIROC Subscriber 3 Specimen Pathology New Brunswick Hospital

18. 3.3Diagnostic reviews: Should patients be notified? When? In contrast with other reviews (e.g., dirty instruments), these reviews can often be done without notifying patients But should we notify? Pathology/radiology tests have baseline error rates Some errors more obvious than others; some require context; a lot of judgment involved Many errors will have been caught in follow up If clinically significant error found, must notify At what point in a review process do we notify patients that their images/specimens are under review? Ethical issues re notice to next of kin

19. 3.4Diagnostic reviews: How should patients be notified? Minimize unnecessary patient distress Medium, manner and content of disclosure important Potential exists for claim of ‘negligent notification’

20. 3.5Diagnostic reviews: How should patients be notified? In person vs by phone vs by letter Consider volume of patients affected, urgency, required follow up testing/treatment, relationship to care providers Who authors the notification? Level of detail and clarity of language Availability of follow up support Multidisciplinary: Clinical, legal, ethics, privacy, communications, IT

21. 3.6Diagnostic reviews: How to notify Mass mailing immediately triggers call from press and class counsel interest If low numbers, best to call in and personally communicate, usually followed by a letter Do you notify in waves? (preferably not, but may be unavoidable)

22. 3.7 Diagnostic reviews: How to notify Reviews usually focus on most recent cases as that is where most clinically significant upside If patients receive notice of review, then also need follow up notice re whether clinical change. Gap needs to be as small as possible Also may have to review other records of that patient Need to ensure no miscommunication of “all clear” results

23. 3.8 Diagnostic review: Class actions  Dr. Menon (Miramichi) – NBCA (2-1) certified class action saying “duty of competence” is a common issue  Dr. Tsatsi (Saskatchewan) -- defamation actions often side-by-side

24. 3.9 Diagnostic reviews: Class action concerns  New technologies read images -- and in huge volumes  If radiologist overusing, asleep at the switch, not reviewing, may be visited on Hospital  After NL Cameron Inquiry into hormone receptor/tamoxifen issues, hospitals overly proactive, to be out front of media  Resource allocation issues, how far back do you go

25. 4.1 Example Three: Sterilization failure/“reusable” syringe

26. 4.2 Sterilization: Should patients be notified? Only know actual harm if test patients, e.g., for blood-borne pathogens Literature research, consult expert re risk of harm Statistical analysis of risk of harm and numbers involved What threshold does one apply? 1 in million risk of HIV? 1 in 100,000 risk of Hep B?

27. 4.3 Sterilization: Should patients be notified? Ultimately a medical decision Involve public health If material risk of harm, proceed with notice/testing protocol HIROC Subscriber 4: TRUS biopsy class action; no transmission of disease found

28. 4.4Sterilization failure: How to notify Generally avoid registered mail, as self- identifying, embarrassing Personal contact best if low numbers Letters may become unavoidable Avoid overstating and understating, fine balance Offer to pay out-of-pocket expenses Set up testing facility, ease the pain for patients Speed up results May need counselors to address stress issues

29. 4.5 Sterilization: Class action examples  2500 women had biopsies at NB colposcopy clinic, told may be at risk of HIV/other infections, standard sterilizing procedures weren't always followed over 14-year period  Registered letter offering blood tests to check for HIV, hepatitis C and hepatitis B as a precaution  Emphasized risk of infection is "very, very small”  Hospital says: “I am very confident there will not be a single case of infection acquired through this process"

30. 4.6 Sterilization -- Class action concerns  Over-notification in Ontario has been materially reduced after HIROC Subscriber 4 settlement  Case by case analysis  Notice should be based on legitimate patient safety issues

31. 5.1 Example Four: Infectious disease outbreak

32. 5.2 Infectious disease examples  SARS  C.difficile  Pseudomonas  TB  MRSA (Methicillin-resistant Staphylococcus aureus)

33. 5.3 Infectious disease outbreak  Often outbreak not determinable without regard to baseline  Does one have to notify after the fact if has no clinical significance at that point?

34. 5.4 Infectious disease outbreak -- Class action settlements  HIROC Subscriber 5: c.difficile -- settled @ $45K per patient  HIROC Subscriber 6: pseudomonas -- settling @ $69K per patient  HIROC Subscriber 7: TB -- settling @ $6K per patient

35. 6.1 Example Five: Not completed or inappropriate procedure

36. 6.2 Not completed /inappropriate examples  HIROC Subscriber 8: Tompkins metroplasty out of date procedure  HIROC Subscriber 9: Ortho-voltage -- underdosage of radiation re skin cancer  Chemo under-dosage -- manufacturer sued

37. 6.3 Not completed /inappropriate procedure  Patients thought procedure done  Was not done, or not completely done  Prompt personal notice should be given with an opportunity to fix (where possible) and explanation

38. 6.4 Not completed /inappropriate results  HIROC Subscriber 8: Tompkins metroplasty class action settled at almost $100K per patient  HIROC Subscriber 9: orthovoltage underdose of radiation; class action abandoned; 3 individual actions recently issued  Chemo under-dosage -- manufacturer sued -- ongoing

39. 7.1 Working together on class actions  What we do on one case/issue affects the rest  Co-ordinating efforts, choosing best fact cases to argue legal issue  Sharing our knowledge  Pooling our resources  Tell us what you are doing, seeing, so we can manage risk, anticipate class action exposure and address before claim issued

40. 7.2 Managing the media  Assume will be covered by press  Class counsel track the press  Counsel need to be involved as part of media strategy; risk/benefit analysis of various strategies pre-emptive press release (not usually a good idea press release/statement in response to inquiries website statement  Assure patient privacy  Patient care is job 1

41. 7.3 Index patient as tip of iceberg  Class of other persons affected  Greater concern about preserving records and witness memories  Usually have document preservation memo to staff in place prior to litigation  Ongoing limitation issues, tolling agreements will often be necessary, with CMPA counsel  Class actions shift focus over years, from date of issuance, to date of certification, to date of trial

42. 7.4 Initiation of review/notice Subscribers are to inform HIROC from day one Considerable risk management experience on these issues Every multiple patient situation unique, needs careful reflection Need plan/resources for follow-up in place if going to do disclosure Stress of receiving reasonable notice should no longer be compensable in negligence claim Lakeridge v. Healey ONCA Compare PHIPA re mental distress