The Amazon rainforest, prescription drugs, children's toys, stock market quotes; pornography, and sports statistics. At first glance these things have absolutely nothing in common. But to the approximately 53 million people around the world who use the Internet these things are just a finger tip away. As the Pennsylvania district Court astutely observed "it is no exaggeration to conclude that the content on the Internet is as diverse as Human thought".

The Internet, also known as the "information superhighway" or "cyberspace" is indisputably the wave of the future providing an inexpensive mode of communication with the capability of reaching literally millions of people.

As is historically the case, new technology that brings great promise carries with it potentially great problems if used indiscriminately. The Internet presents consumers, practitioners and medical device and pharmaceutical companies' with unequaled opportunities to exchange information about new medical advances, products and general information. It also provides a potent marketing opportunity. But with this new found freedom and access comes responsibility.

The Internet will change "business as usual" in the medical products industry. The only question is : How? The FDA is trying to answer this question with the help of the industry at large, but to date there is no uniform guidance for companies who are interested in talking advantage of the opportunities presented by the Internet. Does the mean that having a home page or "surfing" can be hazardous to your health? No. This article exams the genesis of the Internet and how it can be effectively and safely utilized by medical companies to maximize returns while minimizing liability.

THE INTERNET

Catching The Wave

"The Internet is not a physical or tangible entity, but rather a giant network which interconnects innumerable smaller groups of linked computer networks. It is thus a 'network of networks'". The Internet in its early form, originated in 1969 as an experimental project of the Advanced Research Project Agency ("ARPA") and was called ARPANET. The primary purpose of the net at that time was for military, defense contractors and university laboratories doing defense oriented work to communicate. As the Internet grew and grew, reasonable estimates are that 40 million people worldwide access the Internet, it encompassed not simply universities, but individuals, corporations, governments and other institutions worldwide. In fact, anyone with access to a modem ( a computer is no longer required equipment with the introduction of WebTV) can surf the Internet.

Moreover, the Internet is no longer simply a research tool for lab dwellers. It is the most flexible communications medium in the world allowing millions of people to exchange communications. Communication on the Internet occurs in six different modes: one-to-one messaging (e.g., "e-mail), one to many messaging, distributed message data bases, real-time communication (including the highly publicized "chat rooms"), real-time remote computer utilization, and remote information retrieval. Id. at 834. While a detailed explanation of these various communication methods is beyond the scope of this article, these methods enable the operator to direct the communication to an individual, a group of persons interested in a particular subject, or the world at large with a tap of the finger.

Information Caught In The World Wide Web

There are three primary methods to locate and retrieve information on the Internet. The most well-known and likely most used, is the "World Wide Web" or the "Web". The web "was created to serve as a platform for a global, online store" of information from a variety of sources around the world. Each of the computers storing the information is connected to the Internet throughout the Web, creating a single storehouse of information. Each document stored on the Web has an address and most contain "links". Links are short sections of text or image which refer to another document. When the highlighted text is selected by the user, the referenced document is automatically displayed. Thus, the browser can jump from cite to cite to cite effortlessly ultimately ending on a topic which conceivably could be quite different from where they began. Links can take the user from the original cite to other computers on the Internet connected to the Web. Many organizations have "home pages" on the Web. These are documents which not only display information about the organization, but also can provide links to other information relevant to the organization. Links not only make the Web unique they make it the most powerful communication tool since the telephone.

There are several ways to search for information on the Web. The most well-known are the services known as "search engines, like Yahoo, Magellan, Altavista, Webcrawler, and Lycos, for example. These services enable the user to type in a phrase or word and search for Web cites that contain certain categories of information. The Web, while appearing to be a single integrated system, in reality has no centralized control. No single entity administers the Internet. "It exists and functions as the result of the fact that hundreds of thousands of separate operators of computers and computer networks independently decided to use common data transfer protocols to exchange communications and information with other computers...." This open decentralized distributed nature provides virtual no entry barriers, unlike the private information services preceding it.

Similarly, once a provider posts its content on the Internet in an open data base it cannot prevent that content from entering into any community worldwide. The relatively recent explosion of Internet has spawned concern over limiting access to certain groups of users to certain types of materials. The most publicized cases are those involving the accessibility of pornographic materials to children. There a very few methods of determining who is trying to access a given cite and/or blocking access to cites. In fact, it is estimated that almost half of the information on the Web originates from outside the United States. Additionally, many organizations reject the idea of charging users for access to their information as contrary to the goal of providing truly "free" speech.

The Internet is thus a method of communication that can reach millions of people in a second; that is accessible to people of every age and socio-economic status, but which lacks any centralized control. "It is no exaggeration to conclude that the Internet has achieved and continues to achieve, the most participatory marketplace of mass speech that this country -- indeed the world -- has yet seen . . . ."

III
FREEDOM TO SPEAK IS NOT FREEDOM TO ADVERTISE

Constitutionality Of Traditional Commercial Speech

Though the Internet provides a potent marketing opportunity, first amendment law regarding commercial speech has developed where the means of speech was more traditional than the Internet.

The First Amendment to The United States constitution provides that "Congress shall make no law... abridging the freedom of speech, or of the press...." The United States Supreme Court has emphasized that the loss of First Amendment freedoms, for even minimal periods of time unquestionably constitutes irreparable injury, and statutes that attempt to regulate the content of speech presumptively violate the First Amendment. However, speech has been divided up and some types of speech which get lesser legal protection e.g., --obscenity, fighting words, and in certain circumstances, commercial speech.

The Supreme Court first considered the question of whether there is First Amendment protection for purely commercial speech, that is speech that "does no more that propose a commercial transaction," in Virginia State Board of Pharmacy v. Virginia Citizens Consumer Council, Inc., 425 U.S. 748, 762 (1976). The issue there was whether a Virginia law banning a pharmacist from advertising a particular drug at a particular price violated the First Amendment. In its opinion, the Court reaffirmed that speech does not lose its First Amendment protection because money is spent to project it (as in a paid advertisement of one form or another); or because it is carried in a form that is "sold" for profit; or because it involves a solicitation to purchase or otherwise pay or contribute money. Rather, the Court explained, the issue was whether the speech at hand was so removed from any "exposition of ideas" and from 'truth, science, morality, and arts in general, in its diffusion of liberal sentiments on the administration of government'" that it lacked all protection. The Court concluded the advertisement at issue constituted protected speech.

In so holding the Court recognized that commercial speech, even purely commercial speech which does not report any newsworthy fact or make even generalized observations in commercial matters, is nonetheless important speech. For example, regarding commercial speech about prescription drugs, the Court noted:

As to the particular consumer's interest in the free flow of information, that interest may be keen, if not keener by far, than his interest in the day's most urgent political debate . . . . Those whom the suppression of prescription drug price information hits the hardest are the poor, the sick, and the particularly aged. A disproportionate amount of their income tends to be spent on prescription drugs; yet they are the least able to learn, by shopping from pharmacist to pharmacist, where their scarce dollars are best spent.

Virginia's arguments in support of the statute were labeled "highly paternalistic" by the high court for assuming that the public could not make an informed decision about the products being advertised. The proper alternative to this approach, the Court opined, is to recognize "that this information is not in itself harmful, that people will perceive their own best interests only if they are well enough informed, and that the best means to that end it to open the channels of communication rather than to close them."

This being said, the Court reiterated that while commercial speech, like other speech, is protected, "we of course do not hold that it can never be regulated in any way." For example, non-content based restrictions in time, place and manner are permissible provided that they serve a significant governmental interest and leave open ample alternative channels of the information. Likewise, commercial speech, like any other type of speech, that is false, misleading, or untruthful has never been protected. The Court further left open the possibility that a state may regulate commercial speech that is not necessarily false, but "only deceptive or misleading".

In Bates v. State Bar Of Arizona, 433 U.S. 350 (1977) the court revisited its earlier decision in Virginia State Board of Pharmacy in the context of considering a ban on attorney advertising, specifically the prices at which services would be provided. In its opinion, the Court recognized that commercial speech "serves to inform the public of the availability, nature and prices of products and services, and thus performs an indispensable role in the allocation of resources in a free enterprise system.

The Court next considered the constitutionality of a New York Public Service Commission regulation completely banning an electric utility form advertising to promote the use of electricity in Central Hudson Gas & Electric Corp. v. Public Service Comm' n of New York, 447 U.S. 557 (1980). In its opinion the Court defined commercial speech as "expression solely related to the economic interests of the speaker and its audience" and stated that its past decisions have recognized "the common sense distinction between speech proposing a commercial transaction, which occurs in an area traditionally subject to government regulation and other varieties of speech." "The Constitution therefore accords a lesser protection to commercial speech that to other constitutionally guaranteed expression".

In commercial speech cases, the Court set forth the four-part analysis in effect today:

(1) The Court must determine whether the expression is protected by the First Amendment. For commercial speech to come within that provision, it at least must concern lawful activity and not be misleading;

(2) The Court must determine if the governmental interest is substantial;

If both inquiries are answered affirmatively, then

(3) The Court must determine whether the regulation directly advances the governmental interest asserted; and

(4) Whether the regulation is not more extensive than is necessary to serve that interest.

These First Amendment principles underlie any discussion of promotion on or regulation of the Internet.

Unique Attributes of Commercial Special on the Internet

Recently the United States Supreme Court affirmed the Pennsylvania District Court's ruling that certain provisions of the Communications Decency Act of 1996 (designed to prohibit minors from accessing pornographic material on the Internet), were unconstitutionally vague and therefore violated the free speech and due process clauses of the Constitution. In a supporting opinion filed in the lower court, Judge Dalzell had pointed out four related characteristics of the Internet that were determinative in the decision and are key to understanding how revolutionary this new communications medium is: (1) the Internet poses very low barriers to entry; (2) these barriers are identical for both speakers and listeners; (3) as a result of these low barriers astoundingly diverse content is available in the Internet; and (4) the Internet provides significant access to all who wish to speak and even creates a relative parity among speakers.

THE FEDERAL FOOD, DRUG AND COSMETIC ACT AND CORRESPONDING
REGULATION OF LABELING AND ADVERTISING

A. The FDA's Jurisdiction And Authority

In addition to the general first amendment considerations, in the medical device and pharmaceutical context, commercial speech is regulated by the Food and Drug Administration (FDA).

The Federal Food, Drug, and Cosmetic Act of 1938 provides the statutory framework for the regulations enacted by the FDA governing the advertising and promotional activities relating to regulated pharmaceutical products. The Act also gives the FDA jurisdiction over drug labeling for prescription and non-prescription drugs and restricted medical devices However, the regulations enacted by the FDA to exercise this authority are different for drugs and medical devices.

The policies for the promotion and advertising of drugs are more specific than those for any other product category regulated and fall within the authority of the FDA's Center for Drug Evaluation and Research (CDER), while the regulations pertaining to medical devices originate from the FDA's Center for Devices and Radiologic Health (CDRH). Because the policies developed by CDER are expansive, they have also provided the basis for the policies established by CDRH.

The regulations focus on two different methods of disseminating product information: "labeling" and "advertising". The definition of a communication as one or the other is critical to an analysis of how that communication will be regulated. Correspondingly, one of the major issues facing the FDA and the industry is how to define the hybrid communications that occur on the Internet. An examination of the regulatory scheme is the first stepping stone on the path to dealing with this dilemma.

B.Labeling Regulations

FDA regulations governing the promotion of pharmaceutical prescription drugs are set forth in 21 C.F.R. §§ 201 and 202. As previously mentioned there are currently no similar regulation for medical devices, although it is clear under the FDCA when a medical device will be deemed to be "misbranded" as noted below.

A label is a "display of written, printed or graphic material upon the immediate container of any article." Labeling includes "all written printed, or graphic matter (1) upon any article of any of its containers or wrappers, or (2) accompanying such article." Labeling in the case of drugs is further expansively defined in the regulations to include brochures, booklets, mailing pieces, detailing pieces, file cards, bulletins, calendars, price lists, catalogs, house organs, letters, motion picture films, film strips, lantern slides, sound recordings, exhibits, literature, and reprints and similar pieces of printed audio or visual matter descriptive of a drug and references published or for use by medical practitioners , pharmacists, or nurses, containing drug information supplied by the manufacturer, packer or distributor of the drug and which are disseminated by or on behalf of its manufacturer, packer, or distributor.

The FDA defines "labeling" to include written and even oral information used to supplement or explain a product regardless of whether the information accompanies the product. As a result, the term labeling has been interpreted to include reprints of scientific studies, medical textbooks and educational seminars and there are various FDA "guidances" concerning these issues. The FDA regulates the content of labeling by reference to the approved package insert and will only allow statements of approved indications on the insert. If the labeling of the drug include unapproved indications, it will be deemed to be misbranded. In short, labeling requires full disclosure.

Advertising Regulations

An "advertisement" is defined to include "advertisements in published journals, magazines, other periodicals, and newspapers, and advertisements broadcast through media such as radio, television, and telephone communication systems." Advertisements, unlike labels, do not require full disclosure. Likewise, while the FDA will review advertising at the request of the company, it does not require pre-clearance of advertising, since such a requirement would constitute impermissible prior restraint of free speech.

The requirements for advertising a drug or medical device are set forth in 21 U.S.C. Section 352. Under Section 352(r) medical device advertising must contain:

(1) the "established" name of the product in type at least half the size of the trade name;

(2) a brief statement of the intended uses and warnings, precautions, side effects and contraindications; and

(3) when needed, a description of the device's components.

Under section 352(n), advertisements of prescription drugs must contain:

(1) the "established" name of the product in type at least half the size as that used for the trade or brand name;

(2) the formula showing quantitatively each ingredient of such drug to the extent required for the labels under section 352(e); and

(3) such other information "in brief summary" relating to side effects, contraindications, and effectiveness.

There are comprehensive regulations enacted by the FDA governing advertisements set forth in 21 C.F.R. Section 202 et seq. and in the various "guidances" issued interpreting those regulations. In addition to the above requirements, the regulations state that advertisements must reflect "fair balance"; cannot promote unapproved uses; cannot omit material information so as to be misleading; and cannot make comparative claims with a competitor's product without "substantial" evidence from a controlled trial to support the claim. The FDA not only looks at the advertisements actual language, but will consider its "theme" in determining whether it is false or misleading in any respect.

The rules governing advertising of drug promotion apply to all media including broadcasting and the Internet as well as other forms of emerging technology. However, the advertising regulations further distinguish between print and electronic advertising such as radio, television and presumably the Internet. Advertisements communicated through these media must disclose the product's major risks in either the audio or audio and visual parts of the presentation. However, in alternative to the "brief summary" required, the company may circulate the approved package label. This is known as the "adequate provision" requirement.

Is Promotion of a Product on the Internet "Labeling" or "Advertising"?

The FDA is currently grappling with this issue while trying to decide how to regulate the promotion of pharmaceuticals on the Internet. At a July 11, 1996 Health Industry Manufacturer's Association (HIMA) meeting, Byron Tart, the director of the CDRH, stated that device information on the Internet "likely" constituted labeling. He further advised that "a good test for [firms seeking to utilize the Internet] would be to say, 'Would I send the information I'm putting on the Internet out on hard copy?'" Another FDA spokesperson advised that the country flags used to distinguish between products approved for use in other countries, but not in the U.S., is disfavored. Indeed, "the bottom line" the staffer stated is "try not to promote your device for an unapproved use if you control that home page."

Soon after this meeting, in September 1996, the FDA issued a Federal Register notice announcing a public meeting to discuss issues related to the promotion of FDA-regulated medical products on the Internet. The FDA set out several issues which it felt needed to be addressed by the industry and other interested partes before any decisions could be made on regulation of the Internet. The list demonstrates the depth and breadth of the issues confronting the regulators:

€ Presentation of Product Information :

(1) How should product information be presented to ensure that Internet users will know that product information is available and where it is available?

(2) Does it matter where on the web site the information is located ? If so, where should it be located?

(3) How should product information be clearly distinguished from other information on the Internet, e.g., disclosure statements?

(4) How should product information be displayed on the Web in order to meet the fair balance requirement of 21 C.F.R. 202.1(e)(5)(ii)?

€ Direct -To-Consumer Promotion:

(1) Is it necessary to distinguish between promotion directed to health professional and consumers on the Internet?

(2) If yes, how should websites clearly make the distinction between professional-directed and consumer-directed promotions?

€ Links Between Websites:

(1) Should links from websites posted or sponsored by a regulated company and containing information about FDA-regulated products be permitted? Why or why not?

(2) If yes, what parameters, if any, should be established for links from such websites to other websites, without violating the act?

(3) Is there any benefit to a screen that informs the user he is about to be switched to a new website?

€ Investigational Product Information:

(1) To what extent should information about investigational products or investigational uses be presented by the sponsoring company on its website?

(2) Is there a way to distinguish between the presentation of this information for economic (stockholders), educational (researchers and professionals), or promotional uses?

€ Chatrooms and News Groups:

(1) Do FDA-regulated companies maintain these now and if so why and what are the experiences with information dissemination i.e., any false or misleading information being exchanged?

(2) Should parameters be established for company participation in , or sponsorship of, chatrooms and news groups that discuss that company's product? If so, what should they be?

(3) Should companies be allowed to correct what is in their belief misinformation about unapproved uses of the products presented in the chatrooms or new groups?

€ International Issues:

(1) How can the promotion of multinational company's products be accomplished without violating the act?

(2) What factors should be considered to determine whether a company is trying to promote a product approved in another country but not in the United States over the Internet?
(3) What policies and regulations have other countries established for dissemination of information on the Internet?

Several industry groups submitted comments and suggestions to the FDA. In a well- reasoned letter, Marlene Tandy, Director and Counsel, Technology and Regulatory Affairs for HIMA argued that "[t]he potential for FDA regulation of the Internet raises serious First Amendment free speech concerns a well as the spectre of agency intrusion over the practice of medicine." She further points out that the majority of written material concerning a product from the manufacturer is not labeling under the law.

The Internet Medical Association comprised of Internet users, services provides, and software developers urged the FDA to develop voluntary guidelines under which regulated entities could categorize information they provide, through search engines and other controlled portals, to ensure that information is obtained in proper context.

The FDA meeting took place on October 16-17, 1996. In his opening remarks William Schultz the Deputy Commission of Policy at the FDA, stated that with the increased popularity of the Internet it was "not surprising" that questions have arisen about how the laws pertaining to drug and device advertising would apply to the Internet. While advising that the " FDA has no question but that they do apply" he recognized that "the Internet raises some new and important and very different issues regarding the regulation of promotion." Schultz also made it clear that FDA was not interested in ways to change the existing regulations, but rather to focus on "what is the appropriate way to apply the current statute to this new method of advertising."

While the FDA is developing its formal policy regarding promotion on the Internet, companies have been advised to "ask themselves whether the information they seek to post would permissible on "hard copy." CDRH has taken the approach that promotional information on a company home page is "more like labeling," but product claims appearing elsewhere on-line is advertising and will be so regulated.

V.
PRODUCTS LIABILITY LAW AND THE INTERNET

Regardless of how the FDA ultimately decides to regulate promotion on the Internet, companies wishing to avail themselves of the enormous potential benefits of using the Internet should also be aware of the risks attendant with that medium from a litigation standpoint. The risk involved in the Internet will not go unnoticed by creative plaintiff's attorneys for too long.

Most plaintiffs' attorneys subscribe to the old adage "when one door closes, another one opens". We therefore may find that the Internet revives some -- and eliminates some -- old legal doctrines which have either been established for years or recently discarded. This article focus on three potential areas of liability which should be considered by anyone promoting a medical product on the Internet: (1) Failure to Warn and the Learned Intermediary Doctrine; (2) Over Promotion; and (3) Off-Label Unapproved Usage.

A. Product Liability Law: The Basics

There are essentially four theories upon which a plaintiff may seek recovery for injuries resulting from a defective product: strict liability, negligence, breach of warranty and fraud.

The Restatement of the Law of Torts Second sets out the legal requirements for the strict liability theory. Section 402A provides that "one who sells any product in a defective condition unreasonably dangerous to the user or consumer or to his property is subject to liability for physical harm thereby caused to the ultimate user or consumer or to his property" if the seller is engaged in selling that product and the product reaches the consumer "without substantial change in the condition in which it is sold". Strict liability in products law, however, is not absolute liability since a finding of liability depends on a finding of a "defect."

Section 395 of the Restatement sets out the standard for showing negligence in a products action: "A manufacturer who fails to exercise reasonable care in the manufacture of a chattel which, unless carefully made, he should recognize as involving an unreasonable risk of causing physical harm to those who use it for a purpose for which the manufacturer should expect it to be used and to those whom he should expect to be endangered by its probable use, is subject to liability for physical harm caused to them by its lawful use in a manner and for a purpose for which it is supplied."

Comment K to Section 402A provides a safe harbor for prescription drugs and medical devices providing that certain products, including drugs and by case law medical devices, are incapable for being made safe for their intended and ordinary use, but are nonetheless extraordinarily important and useful products. As a result, "such a product, properly prepared and accompanied by proper directions and warning is not defective, nor unreasonably dangerous." Many courts have used "comment k" as it is usually referred to, to deny claims against drug manufacturers based on defective design of the products.

The Restatement is drafted by the American Law Institute (ALI) and is a "restatement" of common law in various areas. The ALI Is not a law making body, although its writings are influential and frequently cited in court opinions making law in the products area. The ALI is in the process of revising the Restatement Second and issuing the Rest