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An allegation of harassment in the workplace is a growing phenomenon facing companies across the U.S. The following is an article derived from a 2003 seminar I attended at the National Business Aviation Association {NBAA} Convention in Orlando, FL. The full

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

name of the seminar was – Indecent Proposal in the Workplace – An Overview of Workplace Harassment & Employer Liability. The seminar was presented by Patricia Griffith and Ellen Ham of the Law Firm of Ford and Harrison in Atlanta.

True to its billing, att

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

orneys Griffith and Ham gave real life examples of harassment issues companies are dealing with today. Griffith noted that juries are awarding large settlement sums against companies as juries perceive a certain amount of workplace arrogance being displayed

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

by corporations. The attorneys defined workplace arrogance as a person who is in a position of authority over another person and abuses that authority. Because of the jury’s perception of company practices [namely indifference], they are inclined to award

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

large verdicts against the defendants, that is, the companies.

While many people think that the asking of sexual favors is the primary reason for the harassment, sexual innuendos garner many more complaints. In 2002, the EEOC reported that sexual harassmen

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

t complaints stayed level for the first time in three years. However, racial complaints – particularly those involving national origin – have doubled in the past ten years. Many complaints have been brought by Muslims who have perceived discrimination in th

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

e wake of the September 11th terrorist attacks on America.

Complaints of harassment are just as likely to be filed against co-workers as they are against supervisors. Interestingly, in the field of sexual misconduct, the definition of sexual harassment is

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

uch more clearly defined by determining what was consensual vs. what was currently not welcomed. Griffith stated, “…it is all based on what is currently unwelcome. Consent doesn’t matter. The consensual affair gone bad is what causes the problem.” In other

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

words, the sexual liaison may have been okay all the way up to that point, when it is no longer okay then problems erupt.

Griffith illustrated her point by giving an example of two co-workers who had an affair gone bad. The company ran into trouble when se

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

eking to correct the problem by transferring one of the employees to another department. Unfortunately, the transferred employee was a woman and she perceived discrimination; that is when the employee took action against the company. Juries, who ultimately

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

decide cases, are increasingly likely to sense discrimination even if the intent was otherwise.

To protect themselves, Griffith noted that companies should do the following:

* Establish a comprehensive anti-harassment policy. Zero tolerance for sexua

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

l, racial, and disability practices.

* Set up a user friendly complaint system. Designate two people to report the problem to someone other than their supervisor.

* Employee orientation. When new employees begin their jobs, that is the best time

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

for having them learn about the company's anti-harassment policy. Have the employee sign and date a release.

* Laminate and post your company's policy.

* Train your supervisors.

* Identify who is going to investigate the claim. It does no

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

t have to be with the same person who received the filed complaint.

* Prepare for your investigation. Review personnel files, attendance records, all paperwork, and identify all potential interviewees.

* Prepare an outline of key questions -- wh

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

t will you do if someone refuses to testify?

* Investigate promptly -- do not wait. Juries want proof that you investigated the matter immediately.

* Investigate thoroughly. Everyone and anyone connected to the case must be interviewed.

*

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

Provided interim relief -- don't leave the two people together.

* Take appropriate action.

* Communicate a decision: don't let the victim be in limbo.

* Document everything accurately.

The seminar was peppered with real life examples of h

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

arassment claims that caused the attendees to rethink how they might approach a particular situation. In addition, a ten question quiz was given to help us understand how harassment is viewed in the workplace today. Notably, many of those answers were subje

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

ctive and were dependent on what action a company took before the case went to trial. Griffith and Ham effectively communicated to the audience that a company's reputation and bottomline could suffer seriously if the aforementioned steps were not properly f

.

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

ollowed. Fortunately, it appeared that many of the attendees had learned some valuable lessons to bring back to their respective companies.

Tidbits:

There Are 3 Categories of Trouble for Companies:

A High Level of Management Action. Superv

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

isory Action. Negligent Inaction.

All three situations are indefensible in court!

Consensual v. Welcome

Simply because a person consents to something does not mean that it is welcomed! Juries today are distinguishing between the two

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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