Legal Challenges of the H1N1 Flu Pandemic

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Legal Challenges of the H1N1 Flu Pandemic

• Vincent Candiello, Esquire
• Post Schell, P.C.
• 17 North Second Street
• 12th FloorHarrisburg, PA 17101(717) 612-1624
• [phone] (fax)
• vcandiello_at_postschell.com

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H1N1 Flu Pandemic

• According to the CDC during the week of September
  13-19, 2009
• Physician visits for influenza-like illness is
  rising nationwide which is considered very
  unusual for this time of year.
• Twenty-six states (including PA) reporting
  widespread influenza activity.
• Almost all reported influenza viruses are of the
  H1N1 variety.

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H1N1 Flu Pandemic (contd.)

• The CDC reports that the virus seems to be
  causing serious health outcomes for
• healthy young people from birth through age 24
• pregnant women and
• adults 25 to 64 who have underlying medical
  conditions.

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H1N1 Vaccine

• On September 17, 2009, the CDC reported that
• Seasonal influenza vaccines are highly effective
  in preventing influenza disease.
• It expects the H1N1 vaccine to have a similar
  safety profile as seasonal flu vaccines.
• It expects rare and mild side effects including
  soreness, redness, or swelling where the shot was
  given, fainting (mainly adolescents), headache,
  muscle aches, fever, and nausea.

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Vaccination Multiplication?

• On September 30, 2009, the CDC recommends
  immunization not only for the H1N1 virus, but
  also opportunistic co-infection from pneumonia
  for individuals who are immuno-suppressed or have
  a history of pulmonary insufficiency.
• Pneumonia appears to be the cause of many of the
  deaths associated with H1N1.

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H1N1 Vaccine Fears

• Fears associated with the vaccine are related to
  a swine flu vaccine given in 1976 when
• More people died from the vaccination than from
  the flu.
• 500 cases of Guillain-Barre Syndrome (GBS) were
  reported.
• GBS attacks the nerve linings causing paralysis
  and inability to breathe.

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H1N1 Vaccine Effectiveness

• There is no empirical evidence demonstrating what
  actual percentage of the population will be
  immune, if immunized.
• No publicized empirical evidence on the lead time
  from immunization to immunity.
• On September 22, 2009, the Washington Post
  reported that the National Institute of Allergy
  and Infectious Diseases trials determined that
  76 of children over the age of 10 gained
  immunity with one dose of the injected H1N1
  vaccine.

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H1N1 Complacency?

• Like Y2K?
• Vaccine will not be available at all or available
  in time.
• Disease is not so bad anyway.
• I have managed to avoid the flu up to now.

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Mandatory Vaccinations?

• The New York Times reported on September 21,
  2009, that only 42 of health-care workers get an
  annual, seasonal flu shot.
• Only New York mandates all health-care workers
  get seasonal and swine flu vaccinations.
• Unions oppose mandatory programs.
• Will the vaccine even be available in timely
  manner?

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Mandatory Vaccines?

• Employers must recognize and accommodate
  legitimate refusals to taking the vaccine for the
  following
• Religious objections
• A risk of serious allergic reaction or
• Having a serious illness or an immuno-suppressed
  condition that renders taking the vaccine equal
  to or more dangerous to the employees health
  than it would be without taking the vaccine.

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Mandatory Vaccines?

• Those who are medically fragile should check with
  their doctor, including anyone who
• Has HIV/AIDS or another disease that affects the
  immune system
• Is being treated with drugs that affect the
  immune system, such as steroids, for 2 weeks or
  longer
• Has any kind of cancer
• Is getting cancer treatment with radiation or
  drugs or
• Recently had a transfusion or were given other
  blood products.

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CDC Employer Recommendations

• Prepare to implement multiple response measures
  to protect employees.
• Identify work-related exposure and health risks
  for employees.
• Ensure current personnel policies are compliant
  with prevailing federal, state, and local law.
• Tell sick employees to stay home until 24 hours
  after fever gone (usually 3-5 days absent) and
  allow them time to care for sick family members.

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CDC Multiple Response Measures

• Encourage respiratory etiquette and hand hygiene.
• Separate employees who become sick and tell them
  to go home.
• Routinely clean surfaces having hand contact.
• Encourage vaccinations.
• Cross train employees for business continuity.
• Minimize travel.

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CDC Multiple Response Measures

• If Flu Season Worsens
• Actively screen employees coming to work.
• Consider extending sick time.
• Consider modified work duty or schedules for
  employees at enhanced risk.
• Plan for continuance of essential business
  functions.
• Increase social distance telecommuting, use of
  conference calls.

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Identify Work-Related Exposure

• Classify Employee Risk Using Occupational Risk
  Pyramid
• Very high to high for health-care employees.
• Medium for employees having high-frequency
  contact with the general population.
• Low for employees having minimal occupational
  contact with the general public and other
  coworkers.

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Identify Work-Related Exposure

• Establish hierarchy of controls for risk
• Engineering Controlsuse of physical barriers,
  such as clear plastic sneeze guards.
• Administrative Controls--
• Create policies to encourage sick employees to
  stay at home without fear of reprisal.
• Minimize face-to-face contact.
• Establish cleaning practices to minimize exposure.

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Identify Work-Related Exposure

• Require use of Personal Protective Equipment
  (PPE)
• Selected based on hazards to employee
• Consider all mucous membrane exposure
• Properly fitted
• Consistently and properly worn
• Regularly maintained and, if necessary, replaced
  and
• Properly removed and disposed of to avoid
  contamination.

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Identify Work-Related Exposure

• Develop respiratory protection program
• In writing, with worksite-specific procedures and
  elements for required respirator use.
• Program administered by trained administrator.
• Certain elements may be required or voluntary.
• Program must have procedure for respirator
  selection and fit testing.

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Identify Work-Related Exposure Respiratory
Protection Program

• Program must have procedures for cleaning
  storing, inspecting, discarding and/or
  maintaining respirators.
• Program must provide training in the proper use.
• Program must have procedure for regular
  evaluation.
• Employer must provide respirators it requires.
• Program must provide medical surveillance for
  those having difficulty with respirator use.

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Occupational Safety and Health Concerns

• Occupational Safety and Health Administration has
  issued guidance to employers on the steps that
  need to be taken to reduce risk of exposure to
  employees in the workplace.
• See http//www.osha.gov/Publications/influenza_pa
  ndemic.html

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Legally Compliant Personnel Policies--FMLA
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Is the FMLA in play?

• CONTINUING TREATMENT 825.115
• Period of Incapacity
• More than 3 consecutive, full calendar days of
  incapacitation AND
• In-Person visits to health care provider
• 2 or more times within 30 days of the first day
  of incapacity OR
• At least once, resulting in a regimen of
  continuing treatment under the supervision of the
  health care provider.
• In both instances the first in-person visit must
  be within 7 days of the first day of incapacity.

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Coverage Under The FMLA

• Needed To Care For A Family Member Or Covered
  Servicemember 825.124
• Physical and/or psychological care
• Even if additional family members available or
  not providing actual care (comfort or reassurance
  sufficient)

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Do they have to ASK for leave?

• 825.300 Eligibility Notice
• Notify employee within 5 business days of
  employee request or employer knowledge of need
  for FMLA-qualifying leave
• Examples of information included
• Whether the leave may be designated FMLA leave
• Certification requirement
• The right to substitute paid leave
• Premium payments and consequences of failure to
  pay and/or return
• Key employee status

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Employer Notice Requirements

• 825.300 Designation Notice
• Written notice within 5 business days (absent
  extenuating circumstances)
• Amount of leaveif known, of hours/days/weeks
• Leave that does not qualify
• Any fitness-for-duty requirements

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General Rule

• 825.305
• Notice of certification requirement
• Request within 5 business days of notice of need
  for leave
• Employee must provide employee with at least 15
  days to provide certification.
• Complete and sufficient requirementnotify of
  problems in writing
• 7 calendar days to cure deficiencies, unless not
  practicable
• Certification each subsequent leave year for
  conditions lasting beyond a single leave year.

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• Legally Compliant Personnel PoliciesThe FLSA

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Deductions for Absences - 13(a)(1)

• Exempt employees
• Absences of one or more full days due to sickness
  or disability
• Provided employer has a bona-fide plan, policy,
  or practice of making deductions after PTO has
  been exhausted

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Deductions for Absences - 13(a)(1)

• What is the problem?
• Improper deductions result in loss of the salary
  basis requirement for exempt status
• an employee will be considered to be paid on a
  salary basis . . . if the employee regularly
  receives each pay period on a weekly, or less
  frequent basis, a predetermined amount
  constituting all or part of the employees
  compensation, which amount is not subject to
  reduction because of variations in the quality or
  quantity of the work performed. 29 C.F.R.
  541.602(a)

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Deductions for Absences - 13(a)(1)

• What is a bona fide plan?
• Wage and Hour Division has approved employer
  leave plans which provide for five (5), paid sick
  days per year require a one-year waiting period
  before employees are eligible for paid leave
  provide for five (5) paid, vacation days and one
  (1) paid, sick day (where vacation days may be
  used for sick leave) together with a one-year
  waiting period for eligibility

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Deductions for Absences - 13(a)(1)

• What is a bona fide plan?
• No bright-line test
• Fact-specific inquiry
• No specific of days or minimum amount of time
  for a waiting period

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Deductions for Absences - 13(a)(1)

• What is a bona fide plan?
• AT A MINIMUM
• Must have a defined sick leave benefit plan
• Must communicate the plan to all employees
• Must administer the plan impartially
• Not designed to evade requirement that exempt
  employees be paid on salary basis test

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Deductions for FMLA Absences 13(a)(1)

• Pro-rata deductions from an employees salary for
  partial-day absences covered by the FMLA are
  permitted
• Does not affect exempt employee status

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• Legally Compliant Personnel Policies-ADA-ADAAA

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The Pre-Amendment ADAThe Basics

• Applies to employers with 15 or more employees
• qualified individuals with disabilities
• no discriminating in recruitment, hiring,
  promotions, training, pay, social activities, and
  other privileges of employment and
• must make reasonable accommodation(s) to the
  known physical or mental limitations of otherwise
  qualified individuals with disabilities, unless
  doing so would impose an undue burden

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ADAAA Broadening the Scope of Coverage

• Disability
• Question of whether an impairment is a disability
  under the ADA should not demand an extensive
  analysis
• Congress includes a non-exhaustive list of major
  life activities major bodily functions
• Thinking, working, concentrating
• Digestive, bowel, and reproductive functions

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ADAAA Major ProvisionsEpisodic Impairments and
Those in Remission

• Employers and courts must determine whether the
  condition would substantially limit a major life
  activity when active.
• Certain conditions like epilepsy or
  post-traumatic stress disorder may now be
  protected under the ADA.
• E.g. Employer terminates an employee who, in the
  past, suffered occasional seizures. At the time
  of termination, the employee was seizure-free for
  over one year.

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September 23, 2009 ADAAA Proposed Regulations

• The proposed regulations confirm that an
  impairment
• Can be "substantially limiting" even where it
  does not "significantly or severely restrict" the
  performance of any major life activity.
• Is to be considered regardless of whether such
  impairment is episodic or in remission.
• Is to be considered without mitigating measures
  (e.g., medications, prosthetics, etc.) except for
  the interactive process (accommodation) or in
  performing a direct threat analysis.

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ADA Compliance

• Employers may not ask
• Any medically related question prior to
  conditional hire, including whether applicant has
  had H1N1 flu.
• Any question about the amount of time an
  applicant took off at last job or the reasons
  therefor.

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ADA Compliance

• Employers may ask current employees about whether
  they would be able to come to work during a
  pandemic. EEOC has a permissible questionnaire
  on its website.
• http//www.eeoc.gov/facts/h1n1_flu.html

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Medical Objections to Immunizations

• A direct threat under the ADA is defined as a
  significant risk of substantial harm to the
  individual or others in the workplace that cannot
  be reduced or eliminated through reasonable
  accommodation. Such a finding should be made by
  a physician familiar with H1N1 Flu.

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ADAAA Coverage

• Regarded As
• Employee has a claim if he can establish that he
  suffered an adverse action prohibited by the ADA
  because of an actual or perceived impairment
  regardless of whether the impairment limits or is
  perceived to limit a major life activity

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ADAAA Coverage The Flu

• Regarded As
• Excludes transitory or minor impairments with
  actual or expected duration of 6 months or less.
• Not likely that H1N1 flu a disability but
  resulting complications could be.
• Likely that some conditions making one medically
  fragile are disabilities which implicates
  accommodations to avoiding mandatory
  vaccinations.

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• Legally Compliant Personnel PoliciesTitle VII

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Religious Objections to Vaccination

• Employees may also legitimately decline the
  vaccination for religious reasons in which case
  the accommodation analysis is triggered.
• To invoke a religious objection to vaccination,
  the employee must have a sincerely held and bona
  fide religious belief that is grounded in a
  theological framework.
• Sincerely held personal, ethical, cultural or
  ideological beliefs that are secular in nature
  are, as a general rule, not enough.

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Religious Objections to Immunizations

• If an objection is raised on religious grounds,
  you must understand
• Questioning religious beliefs is difficult at
  best. If employer has bona-fide doubt, limited
  inquiry permissible. Markedly inconsistent
  conduct/comment critical.
• Religious observances/practices is a matter of
  employee motivation.
• A request for an accommodation must be made.

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Religious Objections (contd.)

• An employer is not required to accommodate an
  employee's religious beliefs and practices if
  doing so would impose an undue hardship on the
  employers' legitimate business interests. An
  employer can show undue hardship if accommodating
  an employee's religious practices requires more
  than ordinary administrative costs, diminishes
  efficiency in other jobs, infringes on other
  employees' job rights or benefits, impairs
  workplace safety, causes co-workers to carry the
  accommodated employee's share of potentially
  hazardous or burdensome work, or if the proposed
  accommodation conflicts with another law or
  regulation.
• http//www.eeoc.gov/types/religion.html

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Medical and Religious Objections

• A declination form, which provides that employees
  were provided the opportunity to receive the H1N1
  Flu vaccine, were advised of the potential
  effects of the vaccine, and were allowed to
  either agree or decline to receive the vaccine.
• A declination will be accepted only for
  legitimate medical and religious reasons
  identified above.

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• Legally Compliant Personnel PoliciesUnion Issues

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Union Issues

• Should you decide to go forward with a
  comprehensive anti-infection program that
  includes vaccination, you should provide any
  union with a copy of the proposed policy in
  advance of its effective date, and invite the
  union to meet with you to discuss the policy.
  Subject likely to be a mandatory subject for
  bargaining.

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Union Issues (contd.)

• But Virginia Mason Hospital implemented a
  mandatory influenza infection control program
  that required employees to be immunized, take
  anti-viral prophylaxis medication, and/or wear
  PPE at all times when in patient areas. ALJ
  dismissed the unfair labor practice finding such
  a program an inherent management right that
  went to the core purpose of the employer.
• Reliance on case is problematic in light of
  appeal to new Obama-appointed NLRB.

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Best Practices
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Best Practices

• Establish Rapid Response Team Representing Key
  Management Functions
• Operations
• Information Technology
• Human Resources
• Accounting
• Safety/Security
• Occupational Health
• Create Pandemic Response Plan
• Assess Exposure Risk
• Establish Employee Health Education Program
  covering

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Best Practices

• What health precautions to take at work and at
  home not reporting to work when employee or
  family member sick leaving work promptly when
  recognized symptoms occur.
• Identification of cleaning protocols, i.e.,
  disposal of contaminated paper products and
  cleaning up after sick employees.
• Methods to limit the face-to-face interactions of
  employees in groups whether in movement from
  place to place, working sessions, or in breaks.

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Best Practices

• Communication protocols reporting and
  investigation maintenance of confidentiality
  and rumor control.
• Identification of key functions and cross
  training necessary to ensure continuity of the
  same.
• Identification of essential personnel needed to
  run facility, unless shutdown mandated by local
  authorities.

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Best Practices

• Development of electronic communication protocols
  between employees, suppliers, and/or customers
  via conference calls, video conference, remote
  access, etc.
• Depending on risk assessment, develop written
  respiratory protection program.
• Conduct Key Policy Review
• Personnel policies
• IT policies for information access and
  maintenance
• Security policies for orderly shutdown of
  business and securing assets

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Best Practices

• Train Employees
• Questions? Comments?
• Thank you!