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Allowing visitors to post messages in one's Web site has become increasingly popular. However, recent cases have shown that doing so may subject the Web-site owner to liability for contribut

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

ory copyright infringement or defamation. Although the cases discussed below did not involve Web sites, the reasoning very likely applies to them as well.

In Religious Technology Center v.

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

Examples of combination products may in

etcom On-Line Communication Services, Inc. (907 F. Supp. 1361, N. Dist. Cal. 1995) the Court held that Netcom might be liable for contributory copyright infringement because of an infringing

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

posting made by a BBS user to a newsgroup through Netcom. The post was on Netcom's computer for only 11 days, but Netcom had taken no action during that period after the plaintiff told Netc

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

m that the post was infringing.

The message is that if you are informed that a post is infringing, the safest course of action is to remove the post immediately. What if you do not want to

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

Combination pro

remove the post? The Court did admit that there is no liability where one "cannot reasonably verify a claim of infringement, either because of a possible fair use defense, the lack of copyri

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

ht notices on the copies, or the copyright holder's failure to provide the necessary documentation." However, in Netcom's case, the Court allowed the lawsuit to proceed to determine if Netco

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

m had acted reasonably. In other words, if you decide to leave the post because you believe one of these defenses applies, you may well have to prove that your decision was reasonable.

In S

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

ratton Oakmont, Inc. v. Prodigy Services Co.(1995 N.Y. Misc. LEXIS 229) the Court held that Prodigy was liable as a "publisher" for a defamatory statement posted by a user because Prodigy ex

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

ercised editorial control over its bulletin boards by editing posts for "offensiveness and bad taste." However, the Court also found that bulletin-board operators who did not edit their boar

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

s would not be liable for defamatory postings made by their users.

Clearly, the safest course of action is to not edit your bulletin boards or Web sites at all (except, of course, to remove

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

Following aspects would a

any post that you have been told is infringing). Unfortunately, this means that you have to leave scurrilous material alone. You should also seriously consider placing a notice on your bull

dd to the challenges in developing combination products:

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

tin board or Web site (assuming you allow others to post there) stating that the area is not edited for content.

One potential problem is that the new Communications Decency Act (47 U.S.C.

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

223) requires a bulletin-board or Web-site operator to remove any communication that is obscene or indecent or depicts or describes sexual or excretory organs activities or organs that are p

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

tently offensive. However, it also contains a clause stating that no cause of action may be brought for any activity that the person takes in good faith to comply with the Act. Although this

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

area of law is unsettled, probably this means that you can remove posts violating the Communications Decency Act--but no others--without becoming liable for the content of other messages. I

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

Professional from academic institutions, pharmaceutical industries, health care indust

fact, the Act provides that "No provider or user of an interactive computer service shall be treated as the publisher or speaker of any information provided by another information content p

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

rovider." Arguably, this overrules the Stratton Oakmont, Inc. v. Prodigy Services Co. decision. However, this provision--which may be limited to "protection for 'Good Samaritan' blocking and

.

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

screening of offensive material"--has not yet been interpreted by the courts, and it is not clear how much protection it will provide. Editing for other reasons--e.g., because of disagreemen

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

Companies that provide selfless information through particip

t with the author's point of view--might bring classification as a "publisher" again

The foregoing article constitutes general information only and should not be relied upon as legal advice

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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