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There are many factors that affect whether a lawyer will accept your case. First, despite what you may rea

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 in the newspapers, a medical malpractice case is not a guaranteed lottery ticket worth millions. Medic

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

Examples of combination products may in

l malpractice cases are among the hardest types of personal injury cases to win. The doctor prevails in mo

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

st cases that go to trial.

Since most cases take a number of years to resolve, the cost of preparing and p

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

esenting the case through trial is a major factor in whether a lawyer will accept your case. Medical mal

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

Combination pro

ractice cases are taken on contingency fee. When the case is resolved, the lawyer is reimbursed for her ex

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

penses and paid a percentage of the award or settlement as the fee.

These cases are very expensive to purs

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

e because they require the lawyer to gather the medical records, hire medical professionals to review the

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

records, write reports and testify as expert witnesses. The lawyer must also pay the costs of pretrial

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

reparation and trial. It simply does not make sense to pursue a case that has a potential value of $50,000

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

if the cost of pursuing and presenting the case is $20,000 or more. Consequently, many smaller cases ar

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

Following aspects would a

e not pursued, even if the negligence is clear.

If the case is particularly difficult, the attorney may as

dd to the challenges in developing combination products:

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

the client to put up at least some of the costs of the suit. This not only makes the case more economical

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

ly viable for the lawyer, it causes the client to feel more invested in the process. If the case is quit

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

strong, the attorney may be willing to front the costs himself.

You should not expect that the case will

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

ettle quickly. It will not. Most of these cases must be tried before a jury before compensation can be ob

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

Professional from academic institutions, pharmaceutical industries, health care indust

tained. This is primarily because, in many states, the doctor’s insurance company cannot settle the case

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

without the express consent of the physician. Since it is not the doctor who actually pays any judgment in

.

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

the case, the doctor has little risk if the case actually goes to trial. The doctor may want to preserv

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

Companies that provide selfless information through particip

his or her reputation for providing quality care, rather than accept a settlement that implies malpractice

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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