Answers - Legal

Q: I was a manager at a small company for many years. This company had a couple of lawsuits filed by disgruntled employees. Now I am in the process of establishing my own business. How can I preve

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

nt lawsuits by employees?

A: You can’t. Our legal system allows individuals to file lawsuits, meeting a fairly minimal threshold, when they believe they have been wronged. And while employers may

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

Examples of combination products may in

and often do ultimately prevail, even winning can represent a significant expense to your company – one that most would prefer to avoid if at all possible.

While it’s not possible to completely eliminate all law

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

suits by employees, there are a few things employers can do to reduce their numbers, which will pay dividends not only financially, but also in terms of morale, productivity and corporate image.

Follow th

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

e Law While that may be an obvious admonition, it still trips up far too many. Ignorance of the law is no defense, and it certainly isn’t bliss. For even the smallest employer, having a lawyer or HR expe

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

Combination pro

rt review your company’s hiring and compensation practices, as well as your personnel policies, is likely to cost far less than even one lawsuit. While there still may be gray areas where you later end up on the w

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

rong side of the law, you can eliminate many of the most obvious violations without too much difficulty or expense.

Don’t Sweat the Small Stuff We all know that people are human, and that in mos

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

t cases there is latitude to be more flexible when addressing employee shortcomings. When an employee is punished for a minor infraction, is the problem that the work is not getting done, or that the rule is being

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

broken? If it’s just the latter, then you may want to rethink your disciplinary practices, or instruct your supervisors to lighten up. When you give an inch, you’ll find that most employees will go the extra mile

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

.

Honor Your Promises When you make a promise, your employees should be able to count on it. Whether it concerns salary, training, advancement potential, retirement and pension benefits or their

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

ability to avoid layoffs, your employees expect you to communicate honestly and keep your promises. When that doesn’t happen, the response may be, “See you in court.”

Follow the Golden Rule Eve

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

Following aspects would a

n if you’re now the owner or a member of the leadership team, you probably were an employee once. Never forget how you were treated when you were an employee, and use that as a lesson (whether good or bad) about h

dd to the challenges in developing combination products:

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

ow you treat your employees. Ensure that your employees know that verbal abuse, threats, sabotage and bullying of any kind will not be tolerated. Employees treated with honesty, dignity and respect are much more l

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

ikely to return the favor – to their coworkers and to their employers.

Allow Graceful and Dignified Exits Not every employee works out – terminations are just a fact of life. Although the law in

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

most employment settings is “employment-at-will,” when employees perceive their termination as unfair and irrational, it becomes much more likely that they will consider a lawsuit. Clearly articulating your expec

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

tations, giving adequate notice of performance deficiencies, using progressive discipline and being honest about the reasons when termination is the only option will make a difference in how employees view their t

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

Professional from academic institutions, pharmaceutical industries, health care indust

ermination. It should be a rarity, not the norm, when you immediately escort terminated employees off the premises, or make it difficult for them to find new employment.

While following these principles does not

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

mean that you will never have a lawsuit filed against your organization, failure to heed them makes it much more likely that you will one day face the aggravation and expense of defending a lawsuit.

Paula Bran

.

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

tner, Program Director of Workplace Fairness, has worked as an attorney in the area of employment discrimination and civil rights law for over 13 years. Founded in 1994 as the National Employee Rights Institute, W

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

Companies that provide selfless information through particip

orkplace Fairness is a nonprofit organization that provides information, education and assistance to individual workers and their advocates nationwide and promotes public policies that advance employee rights.

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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