Answers - Legal

You may have heard the term products liability in newspapers, political speeches, or from your friends. In a nutshell, the

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

term products liability is a legal term of art used to describe legal causes of action against manufacturers of products, a

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

Examples of combination products may in

d/or anyone in the chain of distribution, that sell a product which has a; manufacturing defect, design defect, or is other

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

wise defective due to the negligence of anyone in the chain of the distribution, and which causes injury to the user of tha

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

product.

A product could be defective if the manufacturer fails to warn of a risk known to them in using their product, a

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

Combination pro

d/or fails to provide a warning label on the product.

You may have heard of some of the infamous products liability cases

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

in the news recently such as; the SUV rollover cases; the asbestos cases; the defective tire cases, tobacco cases etc.

If

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

t were not for lawyers taking these types of cases to court, there would be many dangerous products on the market.

In some

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

types of products liability cases, the person who has been injured may realize that they were injured due to a defective p

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

oduct. In other types of cases the person injured may have not known that there were injured due to a defective product.

I

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

most products liability cases, expert testimony is required to prove that there was a manufacturing or design defect in a

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

Following aspects would a

product.

In California, products liability causes of action are strict liability actions so long as you can meet your burd

dd to the challenges in developing combination products:

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

n of proof. Strict liability means that you do not have to show negligence on the part of the manufacturer or anyone in the

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

chain of distribution to recover damages for defective product.

The bottom line is this; if you have been injured while u

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

ing a product, driving a car, or using certain types of medication, you should consult with the competent personal injury a

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

torney who can analyze the facts of your case to determine if you have a potential products liability cause of action.

You

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

Professional from academic institutions, pharmaceutical industries, health care indust

have the right not to be injured by a product that has a manufacturing or design defect.

If you feel that you have been i

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

jured due to a defective product in this state of California you may call my office for a free consultation and at 818-739-

.

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

1544 extension 10, or you may check out my personal injury website by clicking here now.

If you’re out some of this in the

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

Companies that provide selfless information through particip

California I highly recommend the consult with an attorney in your area.

By Norman Gregory Fernandez, ESQ. , Copyright 200

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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Answers - Products Liability in California; What You Should Know

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