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Digg It - Email Liability - Is Your Company Protected?
The dangers to companies posed by email content first got serious national attention in the Microsoft anti-trust trial. The legal implications of the Microsoft suit, and other trials where cases have hinged
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
on e-mail evidence, make it clear that companies, as well as individuals, are liable for what happens on their email system.
For example, in April 2002, an internal e-mail was sent from a KPMG executive to
For example, in April 2002, an internal e-mail was sent from a KPMG executive to
; 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
3 recipients stating that the firm had given a purposely incomplete list of tax shelter clients to the IRS, which prompted another KPMG executive to e-mail vice chairman Jeffrey Stein: "Given the sensitivity
lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.
of this situation, should we be putting all this in print?" Plaintiff lawyers uncovered the damaging e-mails, which led KPMG to admit to criminal wrongdoing and agree to pay $456 million.
In another case, W
In another case, W
here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe
all Street investment bank J.P. Morgan Chase & Co. was ordered to pay $2.1 million in fines to settle accusations that it failed to retain e-mails sought in investigations of stock research analyst misconduc
d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.
Combination pro
Combination pro
.
The most frequent cases, however, where e-mails are crucial exhibits are employee lawsuits against a company. These lawsuits include Sexual Harassment cases which often use as evidence e-mails by supervis
The most frequent cases, however, where e-mails are crucial exhibits are employee lawsuits against a company. These lawsuits include Sexual Harassment cases which often use as evidence e-mails by supervis
ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc
rs or other employees with lewd and sexually explicit content, discrimination cases which have used e-mails by employees containing racial or religious remarks or e-mails with comments on age, gender, or pre
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
gnancy of an employee, and in defamation cases which use e-mails by employees commenting on someone’s conduct, character, or performance.
The use of emails in lawsuits has become such a serious issue that m
The use of emails in lawsuits has become such a serious issue that m
nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically
ny companies in the insurance industry now offer policies for Internet and email liability. Coverage includes such items as damages associated with security breaches, as well as, libel, slander, and defamati
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
n of character. But, insurance aside, what can you do to protect you company?
Is it legal for a company to perform email auditing (sometimes called email monitoring), where email is checked after the actual
Is it legal for a company to perform email auditing (sometimes called email monitoring), where email is checked after the actual
ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi
transmission, and email interception (sometimes called email filtering), where email is intercepted and checked during transmission, on employee e-mail accounts? Well, yes and no. Cases in the United States
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
have proven that both are permitted if (a) done in a reasonable manner, (b) backed up by an email policy, and (c) backed by employee training that has been documented.
The best protection is a clear e-mail
The best protection is a clear e-mail
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
ecurity Policies and Procedures document that covers all the potential danger zones, then well-planned, regular training that includes all new employees and all new updates to policies. The Society for Human
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
Resource Management urges their members to establish a clear training program to ensure proper and effective use of email. One survey claims that 73% of companies do not offer Web training and 70% do not hav
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
e a written content security policy.
Another important protection companies can adopt is the addition of legal disclaimers in the footer of every e-mail. Since content sent via email carries the same weight
Another important protection companies can adopt is the addition of legal disclaimers in the footer of every e-mail. Since content sent via email carries the same weight
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
legally, as those sent on company letterhead, if the email address includes the name of a company, a disclaimer such as, "the views of this email and of Company X's employees do not necessarily reflect the
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
iews of Company X," should be built into the template of every company e-mail account.
Another good idea is to emphasize in training, and with intermittent e-mails/memos reminders, that employees must remem
Another good idea is to emphasize in training, and with intermittent e-mails/memos reminders, that employees must remem
y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products
ber that the email system is for business use, not personal use, and that their emails to others should be treated with the same respect as a company letter or memo. Also, it is a good idea to remind employe
.
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
s in writing that company email accounts belong to the company and are, therefore, not confidential for the employee, only the company. Employees should also be instructed to review what they have written be
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
ore they send their messages and not send messages without verifying the accuracy of the factual information to be conveyed and verifying that the information about to be sent is not confidential information
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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