Answers - Legal

Medical malpractice is the third leading cause of death in America. 98,000 deaths occur each year by preventable

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

medical mistakes. There are many types of medical professionals that are negligent and may be responsible for a l

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

Examples of combination products may in

ved ones injury, disability, or death. These include but are not limited to physicians, physician assistants, nur

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

ses, pharmacists, hospitals, or skilled nursing facilities. When medical professionals make mistakes the law requ

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

res that they are held accountable for it.

Medical Malpractice is defined as “professional negligence where the h

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

Combination pro

althcare provider deviates or departs from the accepted standard of care, causing an injury. 90% of medical malpr

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

actice cases don’t get filed, and you should be aware of the many ways you can be victimized by medical malpractic

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

. The following is a list of common examples of medical related malpractice:

• Misdiagnosis of an illness, fa

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

ilure to diagnose or delay of a diagnosis
• Birth Injuries
• Oxygen deprivation is one major cause and

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

so it mechanical trauma. This may occur when the baby assumes an unusual position at the time of birth or when th

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

baby is too large to pass through the birth canal easily.
• Surgical Complications
• Mishandling of m

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

Following aspects would a

edications
• Prescription Errors
• Failure of hospital staff or a pharmacist to dispense the right med

dd to the challenges in developing combination products:

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

cine to the right patient in the correct amount
• Inappropriate or substandard treatment
• Failure to

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

provide treatment
• Failure to follow-up on a patient
• Failure to informed consent
• Anesthesia

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

related complications
• Failure to safely administer anesthesia
• Failure to prevent patient injuries

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

such as falls ) on medical facility property
• Failure to follow Advance Directive

An advance directiv

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

Professional from academic institutions, pharmaceutical industries, health care indust

e tells your doctor what kind of care you would like to have if you become unable to make medical decisions.

If y

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

u or a loved one has suffered as a result of medical malpractice, you should consider seeking legal advice immedia

.

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

tely. You may be entitled to monetary compensation that will cover your future medical costs and pain & suffering.

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

Companies that provide selfless information through particip

There are many qualified medical malpractice attorneys near you that can help you get the compensation you deserve

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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