Actual - Legal

To put it simply, Medical Malpractice is negligence on the part of a healthcare provider that resulted in injury. Medical Malpractice cases may result from misdiagnosis of a disease, failure to provide appropriate treatment for a k

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

nown disease, or unreasonable delay in treating a condition. The parties involved in a Medical Malpractice case are the Plaintiff, the Medical Malpractice Attorney, the Defense, and Expert Witnesses.

The Plaintiff is often the pat

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

Examples of combination products may in

ient, although an administrator or executor of the estate may also act as Plaintiff if the patient died as a result of the injury. Before a patient may file a Medical Malpractice case they must be able to prove that the physician o

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

care provider failed to provide adequate care and this failure was the direct cause of the injury. The Plaintiff must also present proof of damages such as whether there are physical or emotional damages.

MEDICAL MALPRACTICE ATTO

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

RNEY MUST AVOID FILING FRIVOLOUS LAWSUIT

It is the responsibility of the Malpractice Attorney to review all of the facts presented by the Plaintiff to avoid filing a frivolous lawsuit. If a judge determines that there is no legal

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

Combination pro

erit to claims made by the Plaintiff then the court may impose fines for both the Malpractice Attorney and the Plaintiff for tying up the court. If the Defendant feels he/she is the victim of a frivolous lawsuit they may counter su

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

e the Plaintiff to recuperate their court costs and may also seek punitive damages.

DEFENSE ATTORNEY PROCESS IN A MEDICAL MALPRACTICE

Usually the Defense consists of a physician, but in some instances a nurse may also be named as

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

a defendant depending on his/her involvement with the patient. The Defense is also allowed to call expert witnesses to support their case and the Attorney is usually assigned by the hospital or facility that employs the practitione

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

r. Both Attorneys for the Plaintiff and Defense are required to share information prior to the court date, and the parties may choose to settle out of court through negotiations.

EXPERT WITNESSES IN A MEDICAL MALPRACTICE CASE

Exp

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

rt witnesses must be carefully screened prior to trial. Usually a judge will call a hearing prior to the trial to determine if the “expert’s” testimony is reliable and relevant to the case. Some questions the judge will consider ar

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

e if the theory and/or technique proposed by the witness can be tested, and if it has been tested what the rate of error was for the results. A person cannot be considered an Expert in a Medical Malpractice case just because they h

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

Following aspects would a

ave a college degree. All Expert witnesses must prove they have sufficient knowledge or experience with the specific area in question before the court considers them reliable.

AWARDS AND FEES FROM MEDICAL MALPRACTICE AND STATUTE O

dd to the challenges in developing combination products:

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

LIMITATIONS

Every state has established Medical Malpractice statutes and it is important to become familiar with these laws prior to filing a Medical Malpractice case. With respect to Florida Medical Malpractice cases, the damage

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

s awarded to the Plaintiff will be reduced depending on how much of the injury was the Plaintiff’s fault. If a Plaintiff is determined twenty-five percent responsible for their injury, than the damages awarded to them will only be

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

eventy-five percent the original amount.

A Florida Medical Malpractice Attorney may only collect thirty percent in fees on the first $250,000 awarded to the Plaintiff and only ten percent on amounts greater than this. In contrast,

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

a Massachusetts Medical Malpractice Attorney fees are limited to forty percent of the first $150,000 awarded and only twenty five percent of damages awarded over $500,000. There is usually a statute of limitations that requires Me

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

Professional from academic institutions, pharmaceutical industries, health care indust

ical Malpractice claims to be filed within two years from the date the injury occurred, or within two years from when the injury should have been detected.

MEDICAL MALPRACTICE BACKGROUND CHECKS ON PHYSICIAN

Prior to committing yo

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

ur care to a particular physician you can check the physician’s background for prior Medical Malpractice cases. This information can be obtained from the Doctor’s office, the local hospital where the physician is employed, or an HM

.

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 physician participates with. You can also check with the American Medical Association to verify physicians training and certification status.

Some agencies will charge a fee to view their database. Depending on which state yo

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

Companies that provide selfless information through particip

u reside in, there are statutes in place to protect your well being. For example, in Florida a physician will be unable to receive their state license if they have been implicated and found guilty in three Medical Malpractice cases

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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