Answers - Legal

Medical malpractice occurs when a health care provider who by an action or omission deviates from the accepted norms of practice in medicine leading to injury/ death

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

to a patient.

Many deaths occur due to medical malpractice. A health care provider is not just the doctor or the surgeon but includes nurses, dentists, therapists,

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

Examples of combination products may in

ospitals, clinics etc. Medical malpractice law is derived from the general negligence law. Various laws have evolved in the US, England, Australia and other countri

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

s, which are similar in concept for control of medical malpractice.

Claims are made for negligence, misdiagnosis, improper medication etc. Claims can even be made wh

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

re informed consent of the patient is taken. Claims can also be made against corporations, hospitals, clinics for the mistake of their employees based on vicarious li

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

Combination pro

bility. The patient has the right to claim economic and non-economic damages.

However in medical malpractice cases, the burden of proof lies with the plaintiff (pati

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

nt). Hence the patient should hire a good lawyer. Three things have to be proved by the plaintiff:

• The health care provider failed to provide adequate and reason

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

ble care to the patient.

• This failure to provide adequate care to the patient has resulted in damage or loss to the patient.

• The health care provider is liable

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

o pay the damages or loss.

The damages are of two types, compensatory and punitive. Compensatory damages are of two types economic and non-economic damages. Econom

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

c damages are monetary losses like, medical care, medicines and loss of wages. These damages can be in the past or future. Non-economic damages are the ones like los

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

of organ or vision, pain, disfigurement, embarrassment emotional stress etc. Punitive damages are very rarely awarded.

Medical malpractice cases are complicated be

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

Following aspects would a

ause when the patient is admitted he is already injured or ill and hence the damage caused by negligent medical care has to be assessed independently of the earlier i

dd to the challenges in developing combination products:

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

lness or injury.

A further obstacle in medical malpractice case is that expert witness is to be provided by the plaintiff. Very few doctors are willing to testify ag

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

inst another doctor even when the case of negligent care is clear. On the other hand the defendant lawyers have a pool of doctors to defend the case of negligent medi

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

al care. Usually medical malpractice attorney firms provide expert testimony on the care provided by the health care provider. Some medical malpractice lawyer firms p

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

ovide free case evaluation and take medical malpractice cases on contingent basis that is until the firm wins the case for the client, the client need not pay for the

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

Professional from academic institutions, pharmaceutical industries, health care indust

services of the lawyers. In medical malpractice cases it is vital to obtain the medical records as early as possible by the patient or his representative.

Most healt

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

care providers take medical malpractice insurance. There has been an ongoing debate by doctors and their medical malpractice insurance companies against excessive jur

.

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

awards. Generally insurance companies rarely go to trial where large penalties are involved. However it must be remembered that the insurance companies and health

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

Companies that provide selfless information through particip

are providers are willing to fight it out against spurious medical malpractice claims. The procedure for filing a medical malpractice claim varies from state to state

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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