Advice Pool - Legal

In this article we're going to go over filing a malpractice lawsuit, who can file, how to file and what is involved in proving malpractice.

Like it or not,

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

malpractice lawsuits are a fact of life. The statistics of how many malpractice lawsuits that are filed each year in the United States alone is staggering.

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

Examples of combination products may in

But the statistics are for another article.

So what does someone do if they feel they are the victim of malpractice?

For starters, they'd better file thei

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

r claim early. That means getting a lawyer who specializes in malpractice and have him process the necessary paperwork. There is a statute of limitations o

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

malpractice suits and filing even one day past the deadline can mean your suit never even makes it into court.

When getting together with your lawyer there

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

Combination pro

is an enormous amount of information that you will need to provide him with. Most of it, if this is a medical malpractice lawsuit, can be obtained from you

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

r patient files. If the patient has died because of the malpractice then the family member responsible will be able to get access to the files.

Aside from

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 information in the files there is other information that the lawyer should be provided with. Any actions the patient took prior to the actual treatment

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

hould be noted. Sometimes it's what's not in the file that can mean the difference between winning a losing a case. For example, if the patient tried to ge

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

t certain tests done but for some reason they kept getting put off, not because of the patient, this information may not be in the file. A call to a doctor'

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

s office to make an appointment for tests that had to be put on hold won't necessarily be in the file. Anything the patient or patient's family can remember

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

Following aspects would a

about all events leading up to treatment may be helpful.

Then, after the lawsuit is filed there is the matter of getting a hold of witnesses. These are pe

dd to the challenges in developing combination products:

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

ple who are going to testify, hopefully on your behalf. The defense, of course will get their own witnesses to refute whatever claims are made.

Eventually,

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

a court date is set for trial. The main duty of the prosecution is to prove that a case of malpractice exists. The duty of the defense, in the case of med

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

ical malpractice, is to show that a "standard of care" was given and that whatever happened was something that was out of their control.

Needless to say, th

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

is is a very long and expensive process. Some malpractice suits can take years to settle. Think about the current Vioxx problem. This is a suit that can g

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

Professional from academic institutions, pharmaceutical industries, health care indust

on for a very long time. That's why in the cases of many malpractice lawsuits the two parties try to agree on a settlement to keep the case from going to t

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

rial. Sometimes they are able to come to an agreement but many times they are not.

Ultimately, the jury must decide if a case of malpractice exists and if

.

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

so, what kind of damages the patient is entitled to. Sometimes this is actually the hardest part of the decision making process. Whatever money the plainti

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

Companies that provide selfless information through particip

ff gets usually goes to cover medical, or unfortunately, sometimes funeral costs.

Malpractice is an ugly part of life, but it's a part of life just the same

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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