Top Articles

Massachusetts General Law 93A, titled Regulation of Business Practices for Consumers Protection, is designed to protect those consumers who would otherwise be unaware of their legal rights. Mass. Gen. Law 93A. As it was originally drafted, 93A did not create a private right to sue

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

, an issue which was quickly addressed by the legislature, and now both consumers and businesses can use 93A as a basis for enforcing their rights through private law suit. Unlike some other states, the Massachusetts consumer protection statute provides for an express, rather than an impli

; 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, right to sue for businesses who feel they have been victim of a deceptive or unfair act. It is often easy to spot a consumer protection issue with standard businesses, such as: bait and switch advertising, failure to disclose defects, price-fixing, faulty warranty claims and un-bargai

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

ed for return/refund policies. It becomes much more difficult to determine when a consumer protection claim based upon Mass. Gen. Law 93A exists when the business involved is only involved in electronic commerce, and especially when that business is not located within the state.

When eva

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

uating a potential consumer protection claim, it is necessary to keep in mind that the required elements are different for a business and a consumer. A consumer must follow certain procedural and substantive requirements outlined in section 9 of the act. Among other elements, section 9 re

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

Combination pro

uires a 30 day demand letter, a showing that they are in fact a consumer, an unfair or deceptive practice, and a showing of damages.

Businesses, especially online businesses, differ substantially in their required elements. Section 11 sets out the requirements for a business 93A claim,

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

and requires that a business show:

That they are a "business" – [involved in the conduct of any trade or commerce];

That the defendant engaged in an "unfair method of competition" or the defendant's actions were "unfair" or "deceptive;"

That these actions occurred

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

rimarily and substantially within Massachusetts (the burden is on the defendant to disprove this presumption as a defense); and

That these actions resulted in a loss to the business plaintiff of money or property, real or personal, for money damages to issue; or

That these

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

actions "may have the effect of causing such loss of money or property.”

Mass. Gen. Law 93A Because of the openness of the internet, and the anonymity involved, it can be extremely difficult to demonstrate that a certain method was either unfair or decep

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

ive. More difficult, especially in the context of an online business, is demonstrating that a certain act has the effect of causing damages or loss. Since online transactions vary in amount and since the market is continually expanding, it can be extremely difficult to demonstrate actual

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

loss, or even potential for loss. Since each element must be present before filing a claim, the prudent advocate will research the facts of the case prior to initiating a 93A claim. Without the properly pled elements, most judges will discard with the case at the first possible opportuni

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

Following aspects would a

ty.

In addition, online businesses present unique jurisdictional issues that may confuse the use of 93A for consumer protection purposes. In order for there to be any hope of applying 93A to an online business, the “unfair or deceptive act” must have primarily or substantially occurred wi

dd to the challenges in developing combination products:

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

hin the Commonwealth of Massachusetts. When neither the deceptive/unfair act, nor the harm takes place in MA, a consumer protection claim will be barred based upon 93A, even if the victim is a Massachusetts resident or business. In the recent Massachusetts Superior Court case of Fill

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

ore v. Leasecomm Corp., the judge dismissed a consumer protection claim brought by a Massachusetts company against a California company because the allegedly deceptive sales tactics and the unfair contracts were all consummated in California. Fillmore v. Leasecomm Corp., 18

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

Mass. L. Rptr. 560, 2004 WL 3091642 (Mass. Super. Ct. Nov. 15, 2004). In Fillmore, the plaintiff’s pleadings failed the ‘center of gravity’ test applied for jurisdictional purposes, and the claim was therefore dismissed. When deciding whether or not to file a consumer protection

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

laim in Massachusetts, it is best first to look at the act, the harm and the jurisdiction. The more that occurred within Massachusetts jurisdiction, the more likely the claim will be allowed to proceed. However, Massachusetts courts do find in favor of Massachusetts companies when all t

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

Professional from academic institutions, pharmaceutical industries, health care indust

he elements, including the jurisdictional ones are met. If a contract was to be performed in Massachusetts, and the damages took place in Massachusetts, then the jurisdictional element will be met and the court will find for the claimant, as the Massachusetts appeals court did in Auto S

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

ine Car Wash Sys. v. Nice 'n Clean Car Wash, Inc. In Auto Shine, the parties frequently met in Massachusetts, and the misrepresentation originated in Massachusetts. The court held in favor of the plaintiff for double damages, as there was a willful and knowing violation of

.

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

Mass. Gen. Laws ch. 93A 58 Mass. App. Ct. 685 (Mass. Appeals Ct. 2003).

Filing a consumer protection claim presents a substantially increased level of evidence and jurisdiction requirements when your client is a business. Beware of the consequences and

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

Companies that provide selfless information through particip

otential wasted time you may use when filing a claim without having every element met. Simply because Massachusetts provides for an express right for businesses to file claims, doe not mean that judges will be willing to overlook even the smallest discrepancies in the pleading requirements

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

HTTP = HTML link (for blogs, profiles,phorums):
<a href="http://www.toparticles.org.ua/article/130581/toparticles-How-Massachusetts-General-Law-93A-Affects-Online-Businesses.html">How Massachusetts General Law 93A Affects Online Businesses</a>

BB link (for phorums):
[url=http://www.toparticles.org.ua/article/130581/toparticles-How-Massachusetts-General-Law-93A-Affects-Online-Businesses.html]How Massachusetts General Law 93A Affects Online Businesses[/url]

MySpace has turned out to be one of the most effective social networking sites to generate targeted online traffic.

If you are a homeowner then you can utilise the equity on your property and make your home pay for your needs and wants by availing secured personal loans. A secured personal loan is a type of loan which demands collateral against the loan taken. It is specially crafted to fulfill all your personal needs and desires.

If you are forced to evacuate from a major category hurricane, which is approaching a shoreline near you, perhaps you should consider that you will want to call your broker and have definite points at which the stocks you own will be sold if they go down or if they go up. Consider if you will that you may be out of touch from your broker and your stocks or mutual funds for a while.

Tags

Links

Top Articles - How Massachusetts General Law 93A Affects Online Businesses

Related Articles: