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You may not know that this is a very widespread problem. Ever year people die from being misdiagnosed and treate

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

d for the wrong disease. The difference can be life and death! Many of these cases are never recognized and rep

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

Examples of combination products may in

rted. If you are the victim of a case like this, you may not be aware of your rights. This is why it is importa

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

nt to have a clear definition of medical malpractice. You don't want to have to take the word of the doctors. T

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

is is the reason so many cases go unreported.

Every physician must have insurance against these kinds of claims.

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

Combination pro

This is a way of protecting themselves. As the number of suits filed rises, the cost to keep this kind of insur

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

ance also rises, causing doctors financial hardships. In addition, the number of providers who sell this kind of

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

insurance has been decreasing. As a result, it is becoming harder for doctors to practice. Many must move to a

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

new location where their premiums are lower.

But what can we file a suit against? If a doctor does not treat a

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

roblem correctly, this can cause new problems to arise, and this would qualify. If, through the negligence of th

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

doctor, a diagnosis is given too late for the treatment to do any good, this too is something you can file again

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

Following aspects would a

st. If the doctor applies the wrong treatment for the wrong disease, this is also considered.

There is a variet

dd to the challenges in developing combination products:

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

of things that can go wrong when the patient is under anesthesia or undergoing surgery that are easily preventab

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

le by the doctor. The doctor may prescribe the wrong medication for the patient, or the incorrect dosage, and co

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

plications can arise. If this is the doctor's fault, you may be able to file a suit.

These suits are usually ex

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

ensive and complicated. Before filing, you must keep in mind that you will be required to present many documents

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

Professional from academic institutions, pharmaceutical industries, health care indust

. Your physical health and history will become a part of the lawsuit. This is why it is important to document e

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

erything that happens involving your health. Even things that seem unimportant may be vital to establishing who

.

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

is liable. You must be prepared to be under this kind of scrutiny by the court. You must also keep track of all

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

Companies that provide selfless information through particip

the medications you have taken, and it is good to document individual conversations you have had with your doctor

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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