Toxic Tort Litigation Blog : Toxic Tort Lawyer & Attorney : Epstein Becker Green Law Firm : Product Liability, Contamination, Pollution

The Second Circuit yesterday rendered its much-anticipated decision in United States v. Caronia, the most important Food Drug and Cosmetics Act enforcement case pending in the country. Not only did  the court’s 2-1 holding determine that the First Amendment bars the criminal prosecution of pharmaceutical manufacturers or their sales representatives for truthful, non-misleading speech promoting the lawful, off-label use of an FDA-approved drug affect criminal FDA enforcement cases, it also has great potential impact on False Claims Act cases.

Stuart Gerson, an Epstein Becker & Geen partner in Washington, D.C., who has defended a number of significant  False Claims Act cases (and qui tam cases), opined  this morning that "the Caronia decision is revolutionary, dealing the government a very hard blow in its effort to quash all off-label promotion, and incidentally to try to limit off-label use, irrespective of the fact that such use is a lawful matter to be decided by doctors and patients. And that is the point, since such use is lawful, making truthful statements about such use would infringe allowable speech."

According to Gerson, the Second Circuit "read the FDCA in a hyperliteral way, holding that the misbranding provisions of the Food Drug and Cosmetics Act do not prohibit such truthful promotion of an off-label prescription drug that otherwise is approved, and thus avoided having to make what it also held would have been the constitutional determination that blocking such speech would have violated the First Amendment."  Caronia adopts a view that pharmaceutical companies and trade associations have attempted to advance for years. Gerson believes that the issue  might well reach the Supreme Court.

In any event, Caronia will stand as an important precedent, not only in criminal cases like this one, but in civil fraud cases as well where the government and qui tam relators have argued that off-label promotion is tantamount to false certification and hence a violation of the federal False Claims Act.

Given the importance of the case, it is likely that rehearing en banc will be sought and, perhaps, a petition filed by the government with the Supreme Court. However, it also may be the government’s strategy to follow a policy of non-acquiescence and litigate the point in other circuits, hoping to create a split. In any event, this is a case that pharmaceutical and medical device companies need to watch closely.
 

In an earlier article, we discussed the danger posed to an impartial jury system by the “Googling Juror.” In his article titled “Lawyers’ Use of Internet to Influence Jurors” (New York Law Journal, 6/12/12), Michael Hoenig cautions that “the danger to fair trials posed by Internet-surfing jurors is exacerbated by lawyer ‘advertising’ of their prowess or success on websites, by publishing case-specific information on firm sites or blogs or other Internet outlets, and by skillfully weaving inaccurate, misleading or self-serving messages, and ‘depositing’ them where straying jurors can ‘find’ them.” 

Hoenig concludes that these can be purposeful stratagems or innocent puffing. He points out that despite First Amendment protections, courts can and should restrict prejudicial speech by attorneys. He cautions that lawyers must be diligent in reviewing whether their adversaries (or agents) might be depositing messages about case facts or party litigants, or extraneous, non-admissible information on websites, blogs or other internet locations with the expectation that a straying juror would find the information. Even if the specific facts of a case at trial are not discussed, prospective or sitting jurors can still peruse the attorney’s website, noting biographical information, the firm’s specialties, featured clients and the “war stories,” crusades or victories many firms describe. Hoenig believes that this information likely will be passed to other jurors.

Lawyers do have First Amendment rights to a wide range of speech but they are also subject to reasonable restrictions as officers of the court. Further, lawyers are bound by ethical rules. Rule 3.6 of the Model Rules of Professional Conduct prohibits an attorney from making an “extrajudicial statement that the lawyer knows or reasonably should know will be disseminated by means of public communication and will have a substantial likelihood of materially prejudicing an adjudicative proceeding in the matter.” Rule 8.4 prohibits “conduct involving dishonesty, fraud, deceit or misrepresentation” and also states, “a lawyer or law firm shall not: (a) violate or attempt to violate the Rules of Professional Conduct, knowingly assist or induce to do so, or do so through the acts of another.”   The article discusses the facts of some of the cases that are emerging in this important area of the law

Thus, it is essential that trial counsel perform their own internet investigation concerning both the subject matter of their upcoming trials, and their adversaries' internet materials, to determine whether prejudicial information available to prospective jurors has been posted.