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Actual - Stress At Work Claims - An Employer's Guide To Avoiding The Pitfalls
1. Prolonged stress built up over the course of time through exposure to an excessive workload, long working hours or the breakdown of a working relationship can go unnoticed until too late.
The question for employment/personal injury lawyers is when will an employer
The question for employment/personal injury lawyers is when will an employer
According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product
be liable for a psychiatric illness that is induced by workplace stress? The answer in legal terms is no different to the question of liability for any other injury: when the risk of injury, in this case a psychiatric illness, is foreseeable. Was it foreseeable that th
; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.
Examples of combination products may in
Examples of combination products may in
s particular employee would suffer a psychiatric illness and not just work-related stress?
SUTHERLAND v HATTON: THE 16 POINT PLAN
2. In Sutherland v Hatton 2002 IRLR 263 the Court of Appeal laid down guidelines as to how courts should deal with negligence claims made
SUTHERLAND v HATTON: THE 16 POINT PLAN
2. In Sutherland v Hatton 2002 IRLR 263 the Court of Appeal laid down guidelines as to how courts should deal with negligence claims made
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
against employers by employees with psychiatric injuries.
3. The Court of Appeal stated that an employer will escape liability for an employee's psychiatric injury unless it was reasonably foreseeable that the employee in question would suffer such an injury as a res
3. The Court of Appeal stated that an employer will escape liability for an employee's psychiatric injury unless it was reasonably foreseeable that the employee in question would suffer such an injury as a res
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
lt of occupational stress. That of course is not a new principle.
4. The Court made it very clear that there are no occupations which are so intrinsically stressful that psychiatric injury is always reasonably foreseeable.
5. In the view of the Court the answer to th
4. The Court made it very clear that there are no occupations which are so intrinsically stressful that psychiatric injury is always reasonably foreseeable.
5. In the view of the Court the answer to th
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
question of foreseeability will depend upon the relationship between the particular demands of a job and the particular characteristics of the employee concerned. Foreseeability is whether this kind of harm to this particular employee was reasonably foreseeable i.e. i
ucts have become life saving products for the pharmaceutical companies who doesnt have many innovative molecules in their product pipeline and have been inc
njury to health attributable to stress at work. The Court therefore set out and listed a number of factors which were relevant to the issue of foreseeability and these factors were split into two groups.
6. The first group related to the demands of the job and include
6. The first group related to the demands of the job and include
easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi
the following considerations:-
The nature and extent of the work done by the employee;
Whether the employee's workload is much greater than is normal for the kind of job which he or she performs;
Whether the employee's work is particularly inte
The nature and extent of the work done by the employee;
Whether the employee's workload is much greater than is normal for the kind of job which he or she performs;
Whether the employee's work is particularly inte
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
lectually or emotionally demanding;
Whether demands being made of the employee are unreasonable when compared with the demands made of others in comparable jobs;
Whether there are signs that others doing the same job are suffering harmful levels of stre
Whether demands being made of the employee are unreasonable when compared with the demands made of others in comparable jobs;
Whether there are signs that others doing the same job are suffering harmful levels of stre
and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ
ss;
Whether there is an abnormal level of sickness absenteeism in the employees job or department.
7. The second group of factors reflected the view of the Court of Appeal that the most important question centres on what the employer knew, or ought reasonably t
Whether there is an abnormal level of sickness absenteeism in the employees job or department.
7. The second group of factors reflected the view of the Court of Appeal that the most important question centres on what the employer knew, or ought reasonably t
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
have known, about the circumstances of the individual employee in question. The Court stated that the following factors might be relevant:
Whether there are signs from the employee of impending harm to health;
Whether the employee has a particular probl
Whether there are signs from the employee of impending harm to health;
Whether the employee has a particular probl
ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.
Following aspects would a
Following aspects would a
m or vulnerability;
Whether the employee has already suffered from illness attributable to stress at work;
Whether there have recently been frequent or prolonged absences that are uncharacteristic of the employee and whether there is reason to think tha
Whether the employee has already suffered from illness attributable to stress at work;
Whether there have recently been frequent or prolonged absences that are uncharacteristic of the employee and whether there is reason to think tha
dd to the challenges in developing combination products:
Which markets to tap where the combination products can do fairly well?
Which combination prod
Which markets to tap where the combination products can do fairly well?
Which combination prod
t these are attributable to stress at work.
FACE VALUE
8. An employer will be entitled to assume that an employee can cope with the normal pressures of a job unless the employer knows of something specific about the job or the individual concerned that should make th
FACE VALUE
8. An employer will be entitled to assume that an employee can cope with the normal pressures of a job unless the employer knows of something specific about the job or the individual concerned that should make th
cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin
employer consider the issue of psychiatric injury. The employer is not obliged to make intrusive enquiries and is generally entitled to take what he is told by his employees at face value.
DUTY TO TAKE REASONABLE STEPS
9. A duty to take steps only arises where signs
DUTY TO TAKE REASONABLE STEPS
9. A duty to take steps only arises where signs
tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
What would be the developing cost?
How to tackle the risks encountered during combination product developmen
that an employee might suffer psychiatric illness from stress at work are plain enough that any reasonable employer would realise that he should act.
10. The employer will only be in breach of duty if he has failed to take the steps which are reasonable in the circums
10. The employer will only be in breach of duty if he has failed to take the steps which are reasonable in the circums
t?
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel
tances, bearing in mind the magnitude of the risk of harm occurring, the gravity of the harm which may occur, the costs and practicability of preventing it, and the justifications for running the risk.
11. The size and scope of the employer's operation, its resources
11. The size and scope of the employer's operation, its resources
ping new procedures for reviewing their safety, efficacy and quality.
Professional from academic institutions, pharmaceutical industries, health care indust
Professional from academic institutions, pharmaceutical industries, health care indust
nd the demands it faces are relevant in deciding what is reasonable (rather like the test for unfair dismissal); these include the interests of other employees and the need to treat them fairly, for example, in any redistribution of duties.
12. An employer can only be
12. An employer can only be
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
reasonably expected to take steps which are likely to do some good: the court is likely to need expert evidence on this (probably from a Consultant Psychiatrist or Occupational Health Consultant).
13. An employer who offers a confidential advice service including coun
13. An employer who offers a confidential advice service including coun
.
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de
selling or treatment is unlikely to be found in breach of duty except where he has been placing unreasonable demands on an individual where the risk of psychiatric injury was clear.
14. One step an employer is not obliged to take, even where that step would be the onl
14. One step an employer is not obliged to take, even where that step would be the onl
elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.
Companies that provide selfless information through particip
Companies that provide selfless information through particip
reasonable and effective one available, is to demote or dismiss an employee in order to remove him or her from a stressful situation. In the view of the Court an employer will not be in breach of duty simply by allowing a willing employee to continue in his or her job
tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products
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