Actual - Legal

A malpractice statute of limitations is defined as the length of time, after the incident in q

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

uestion, that an individual is allowed to file a claim for medical malpractice.

Specifically,

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

Examples of combination products may in

the length of time in question varies based on the state in which the incident occurred. For

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

instance, the statute of limitations in Pennsylvania for a medical malpractice case is genera

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

ly two years. This means that an individual has two years from the date of the incident to fi

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

Combination pro

le a claim for medical malpractice. After this date, from a legal standpoint, the plaintiff h

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

as no right to his claim. But, as with most rules, there are exceptions.

The so-called “disco

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

ery rule” is an example in which a state’s malpractice statute of limitation may not begin exa

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

ctly from the time of the original incident. For example, if a doctor makes a mistake during

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

surgery, but the damages from this error do not make themselves known for a period of time the

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

eafter, the statute of limitations may not begin until symptoms, discomfort or some sort of pr

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

Following aspects would a

oblems are apparent.

In response to rising damage awards and insurance premiums coming in par

dd to the challenges in developing combination products:

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

t as a result of the discovery rule, Pennsylvania enacted a new statute in 2002 that put a cap

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

on the length of time a victim is allowed to file a claim for malpractice, no matter what the

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

circumstances. The statute is known as the “statute of repose,” and it is applicable to incid

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

ents arising after March 20th, 2002. This statute prevents any claim from being brought again

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

Professional from academic institutions, pharmaceutical industries, health care indust

st a physician or caregiver if it has been more than seven years since the incident in questio

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

.

Exactly what triggers the beginning of the limitations periods is subject to debate, and as

.

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

mentioned earlier, statutes of limitations vary from state to state. Patients are encouraged

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

Companies that provide selfless information through particip

to seek the legal counsel of a medical malpractice attorney before proceeding with any claims

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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