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In this article we're going to do an overview of medical malpractice, what it is and what are the main causes of medical practice.

Medical malpractice, technic

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

ally and legally defined as "a specific legal term related to lawsuits alleging various different circumstances leading to damage to a patient." To put that int

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

Examples of combination products may in

English, medical malpractice is anything where a patient receives poor care from a physician leading to the patient developing problems because of this care.

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

These malpractice suits, stemming from this improper care, include misdiagnosis, mistreatment and any type of negligence. Not all errors are considered malprac

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

ice because there is always a certain amount of risk involved in medicine, especially when dealing with a patient who has serious medical problems to begin with

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

Combination pro

That is why malpractice suits have to be settled in a court of law because it is not so cut and dried.

The most common diseases that are usually involved in

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

malpractice suits are breast cancer, lung cancer, colorectal cancer, heart attack and appendicitis. The main cause of these malpractice suits is usually misdia

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

nosis either because the diagnosis was delayed for some reason, such as the equipment required wasn't available or a wrong diagnosis was made. Delays in diagno

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

tic testing too often lead to a patient's death. The severity of these delays explains why the monetary awards, when given, are so large.

In winning a malprac

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

tice suit there are several factors involved. The first is that the claim itself must be made before the statute of limitations expires. If a patient or the p

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

tient's family (assuming the patient has died) brings up the suit after too much time has passed then the case never even makes it to trial. So speed is probab

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

Following aspects would a

y the most important element in winning a malpractice suit. The actual statute of limitations varies depending on the type of lawsuit and where the lawsuit tak

dd to the challenges in developing combination products:

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

es place. Each state and country has its own rules.

The next thing is that malpractice has to be proven. It must be proven that the error, if an error occurr

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

d, was not an error that could have been reasonably avoided. If something unforeseen happens that could not have been accounted for then the likelihood of prov

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

ng malpractice is slim. For example, many surgeries and procedures have risks associated with them and therefore if something were to go wrong malpractice woul

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

d be difficult to prove as long as the patient received what is called "accepted standard of care."

The problem with many malpractice suits is that in too many

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

Professional from academic institutions, pharmaceutical industries, health care indust

cases the patient delayed seeing a doctor about a symptom. Usually they disregard it as just life's everyday aches and pains. Finally the pain gets bad enough

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

that the patient goes to see a doctor and by that time it is either too late to successfully treat the problem or the treatment itself needs to be more severe t

.

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

han it would have been had the patient seen the doctor right away. This of course leads to a greater risk that the treatment will not be successful. When it's

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

Companies that provide selfless information through particip

not, the patient or patient's family then sues for malpractice.

Maybe if both sides were a little more diligent medical malpractice suits wouldn't be so common

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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