Actual - Legal

What is medical malpractice? Well it is when a doctor messes up a

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

nd causes a worsened problem with a patient or god forbid makes a

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

Examples of combination products may in

mistake due to negligence or ignorance and then the patient dies.

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

In this case the legal professionals or lawyers sue. But too oft

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

n the lawyers are suing in cases that are not legitimate negligen

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

Combination pro

e cases and this is a huge cause for alarm. One has to ask what i

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

f we could sue lawyers for Legal Malpractice.

For instance when

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

hey sue the wrong parties, lie or make up false claims and file t

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

hem into court or give bad advice to their clients causing them t

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

lose a case that they clearly should have won? Shouldn’t we be a

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

le to sue the lawyers and make them pay for our losses? I mean th

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

Following aspects would a

at would be fair right?

And just think of all the horrible lawye

dd to the challenges in developing combination products:

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

s out there who should not be practicing law, because they are in

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

competent? What about them; I say we have legal mal practice laws

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

and these lawyers pay who mess up pay huge sums of money when the

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

y do. That would be the right things to do under the law.

We see

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

Professional from academic institutions, pharmaceutical industries, health care indust

to be living in legal hypocrisy these days as the lawyers get of

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

scott-free and the doctors pay super high premiums for medical m

.

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

alpractice insurance and these costs get passed onto the consumer

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

Companies that provide selfless information through particip

and patients while the lawyers run a muck. Consider this in 2006

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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