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Lemon law protects a consumer who has unknowingly purchased an automobile product that does not meet stipulated performance standards. An automobile with a defect, which serious

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

ly impairs its performance and safety is termed a lemon. Lemon law is so called because 'lemon' in slang means bad.

Lemon laws are state laws in US. While, broadly the same in

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

Examples of combination products may in

ll states, they differ in details. These details are important as they can affect the outcome of a legal case. In Georgia the Lemon law, in statute books, is known as the Motor

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

ehicles Warranty Rights Act. It is administered by the Office of Consumer Affairs and seeks redressal of violated consumer rights.

When are you eligible under the Georgia Lemon

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

law?

The answer to three questions below will decide your eligibility to file a case.

(1) Who falls under this law? Firstly, individuals who have purchased, leased or transfe

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

Combination pro

red a vehicle primarily for personal use. Secondly, a sole proprietorship, partnership or corporation that owns or leases not more than three new motor vehicles for commercial u

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 and has ten or less employees and a net income, after taxes, of $100,000 per year or less under federal law.

(2) Which vehicles fall under this law? All new motor vehicles p

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

urchased or leased and registered in Georgia with the purpose of transporting people and property over public highways. Demonstrator vehicles are also eligible provided they are

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

new and carry a manufacturer's warranty as a condition of sale.

(3) Which vehicles do not fall under this law?
- Vehicles not self-propelled
- Vehicles that had a t

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

tled owner other than the dealer and yourself
- Used vehicles
- Vehicles purchased under 'as is' condition. This implies you bought the vehicle knowing its condition a

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

the time of purchase
- Trucks having a gross vehicle weight rating of 10,000 pounds and more

When is your vehicle eligible under Lemon law?

(1) Under Georgia law your ca

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

Following aspects would a

must be presented for repair of serious defect within the first year of purchase or before 12,000 miles. This is called the "lemon law rights period" and vehicles submitted for

dd to the challenges in developing combination products:

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

repair outside this period are ineligible under this law.

(2) The manufacturer must be allowed at least one repair of a serious defect in the braking or steering systems during

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

the "lemon law rights period"; at least two repairs of other serious defects during the first 24 months or 24,000 miles with at least one failed repair attempt during the "lemon

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

law rights period"; at least three repairs on any other malfunctioning in the first 24 months or 24,000 miles, with at least on e failed attempt during the "lemon law rights pe

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

iod". This period can be extended under special circumstances.

(3) The vehicle must have been out of service for repairs for at least 30 days during the first 24 months or 24,0

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

Professional from academic institutions, pharmaceutical industries, health care indust

0 miles with at least 15 days during the "lemon law rights period"

Legal Proceedings

Firstly, you must have all documents relating to repair attempts. These include diagnosis

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

f the defect, details of work done and parts replaced and the dates and the odometer readings when the vehicle was presented for repairs. Keep a record of the days your vehicle

.

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

as out of service. Remember manufacturers have won many cases due to lack of attention to details on the part of the consumer.

Do not approach the manufacturer without an attor

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

Companies that provide selfless information through particip

ey. Alternatively you can consult the state run OCA. They will provide all relevant information and, if needed, will also help set up an arbitration hearing. All this comes free

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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