Second Circuit Rejects Claims Over Scientific Literature

The Second Circuit recently held that scientific opinions voiced during debate of unsettled questions generally cannot support false advertising or deceptive business practices claims. See ONY Inc. v. Cornerstone Therapeutics Inc., No.12-2414 (2d Cir. June 26, 2013).

Defendants in this case were various corporate sponsors, authors, and publishers of a scientific journal article comparing the effectiveness of several types of medical surfactants -- biological substances that line the surface of human lungs. Surfactants are critical to lung function: they facilitate the transfer of oxygen from inhaled air into the blood stream.  Plaintiff ONY and defendant Chiesi Farmaceutici are two of the biggest producers of surfactants for medical treatment.  These parties vigorously contested the relative effectiveness of their products – in the marketplace, in the scientific literature, and in this lawsuit. The parties agreed that two variables are particularly relevant to this comparison: mortality rate and length of stay. Mortality rate means the percentage of patients (typically infants) treated with a particular surfactant who do not survive. Length of stay refers to the amount of time a patient infant remains in the hospital for treatment.

The dispute stemmed from a study funded by Chiesi, carried out by a private research firm, and then promoted and ultimately published by three doctors, which concluded that Chiesi's surfactant product allegedly led to lower infant mortality rates than ONY's product. The doctors submitted their article to the Journal of Perinatology, a leading journal in the field of neonatology. .After the article’s publication, Chiesi issued a press release touting its conclusions and distributed promotional materials that cited the article’s findings.  Plaintiff complained that the article – and the distribution of selections from it – violated the Lanham Act and New York General Business Law § 349, and also constituted tortious injurious falsehood and interference with prospective economic advantage.

The district court concluded that plaintiff failed to state a claim based on publication of the article because the challenged statements were protected scientific opinion. The Second Circuit agreed, concluding that, as a matter of law, statements of scientific conclusions about unsettled matters of scientific debate cannot give rise to liability for damages sounding in defamation.

Plaintiff claimed that the article made statements about scientific findings that were intentionally deceptive and misleading, and that it therefore constituted false advertising. Plaintiff’s theory was that scientific claims made in print purport to be statements of fact that are falsifiable, and such statements can be defamatory or represent false advertising if known to be false when made. Plaintiff argued on appeal that the district court based its conclusion that the article’s statements were non-actionable solely on its determination that the assertions were statements of opinion, without conducting a more vigorous inquiry. 

The court of appeals noted that scientific academic discourse poses several problems for the fact-opinion paradigm of traditional First Amendment jurisprudence. Many conclusions contained in a scientific journal article are, in principle, “capable of verification or refutation by means of objective proof,” Phantom Touring, Inc. v. Affiliated Publ’ns, 953 F.2d 724, 728 n.7 (1st Cir. 1992). Indeed, it is the very premise of the scientific enterprise that it engages with empirically verifiable facts about the universe. At the same time, however, it is the essence of the scientific method that the conclusions of empirical research are tentative and subject to revision, because they represent inferences about the nature of reality based on the results of experimentation and observation. Importantly, those conclusions are presented in publications directed to the relevant scientific community, ideally in peer reviewed academic journals that warrant that research approved for publication demonstrates at least some degree of basic scientific competence. These conclusions are then available to other scientists who may respond by attempting to replicate the described experiments, conducting their own experiments, or analyzing or refuting the soundness of the experimental design or the validity of the inferences drawn from the results.

In a sufficiently novel area of research, propositions of empirical “fact” advanced in the literature may be highly controversial and subject to rigorous debate by qualified experts. Needless to say, courts are ill-equipped to undertake to referee such controversies. Instead, the trial of ideas plays out in the pages of peer-reviewed journals, and the scientific public sits as the jury.

Where, as here, a statement is made as part of an ongoing scientific discourse about which there is considerable disagreement, the traditional dividing line between fact and opinion is not entirely helpful. While statements about contested and contestable scientific hypotheses constitute assertions about the world that are in principle matters of verifiable “fact,” for purposes of the First Amendment and the
laws relating to fair competition and defamation, they are more closely akin to matters of opinion, and are so understood by the relevant scientific communities.

In that regard, said the court, it was relevant that plaintiff did not allege that the data presented in the article were fabricated or fraudulently created. If the data were falsified, the fraud might not be easily detectable by even the most informed members of the relevant scientific community. Rather, plaintiff here alleged that the inferences drawn from those data were the wrong ones, and that competent scientists would have included other data that were available to the defendant authors but that were not sufficiently taken into account in their analysis.

But when the conclusions reached by experiments are presented alongside an accurate description of the data taken into account and the methods used, the validity of the authors’ conclusions may be
assessed on their face by other members of the relevant discipline or specialty.The appeals panel therefore concluded that, to the extent a speaker or author draws conclusions from non-fraudulent data, based on accurate descriptions of the data and methodology underlying those conclusions, on subjects about which there is legitimate ongoing scientific disagreement, those statements are not grounds for a claim of false advertising. Even if the conclusions that the authors drew from the results of their data could be actionable, such claims would be suspect when, as here, the authors readily disclosed the potential shortcomings of their methodology and their potential conflicts of interest

This analysis properly reflected a worry about the chilling impact on crucial and valuable research, including comparative effectiveness research, of lawsuits by competitors who are unhappy with or disagree with the results of such studies. Such a debate belongs in the marketplace of scientific ideas, not in the court room. 

CPSC Commissioners Testify At Hearing Regarding Database

Issues about the product complaint database set up by the U.S. Consumer Product Safety Commission bubbled over again last week.  We have posted on the topic before.

The CPSC-operated database allows consumers, government agencies, and others to submit reports of alleged injury or death allegedly caused by a product. Since the beginning of the database notion, there have been serious concerns about the accuracy and confidentiality of reports of alleged injury submitted and conveyed back to the public in the database. There has always been an apparent lack of attention to legitimate issues of a manufacturer's goodwill and reputation, to the costs of unnecessary panic among product consumers, and the mischief that some plaintiffs' lawyers might cause with unwarranted increase in litigation against manufacturers.  Obviously, false or inaccurate information does not serve the interests of consumers. And CPSC allows reports by parties who are more likely to have an agenda that goes beyond merely advising CPSC of an incident. The possibility that someone might attempt to seed the database with inaccurate or misleading information to provide ostensible support for lawsuits is a real concern for many observers.

As we noted, an anonymous company sued the CPSC last Fall over an apparently false report in the database.

Last week, Commissioner Anne Northup testified before a Subcommittee on Commerce, Manufacturing, and Trade of the House Energy and Commerce Committee at a hearing on “Oversight of the Consumer Product Safety Commission.” She addressed generally the issues with CPSC regulatory approaches. Commissioner Nord also testified, and she has reported that many of the complaints on the database were filed by law firms.

Chairwoman Mary Bono Mack, R-Calif., noted that the public database remains a source of controversy. Manufacturers continue to express their concern that most of the complaints are not vetted by the CPSC before they are made public, "opening the door to all kinds of mischief, whether to fuel law suits or to try and ruin a competitor’s brand."

Video of the hearing here.

Company "Doe" Files Suit Challenging the CPSC Database

Multiple reports indicate that an unnamed company filed a suit last week, under seal, to challenge aspects of the Consumer Product Safety Commission's new public database.

Readers may recall that the Consumer Product Safety Improvement Act of 2008 mandated the creation of a consumer product safety information database, and from the beginning, there was controversy about the absence of an adequate process for addressing false and inaccurate reports that will scare consumers, harm business, and generate no additional safety gains; the need to employ means to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports; the importance of not putting the governmental imprimatur on voluntary data that has not been verified; and the absence of a sufficient time period allocated for manufacturers to evaluate and respond to any proposed report.

The suit was reportedly filed in federal court in Maryland, and relates to material inaccuracies with respect to a report of alleged injury that found its way into the database.  The suit apparently asks that the CPSC be enjoined from keeping the complaint about one of the company's products in the public database.

Almost anyone can file a “report of harm,” including consumers; government agencies; health care professionals; child service providers; and public safety entities. Consumers could include not just the purchaser of the product but their personal injury attorney, with their own agendas.

Manufacturers have only a limited opportunity to review and dispute information in incident reports before they are published on-line in the CPSC database. Manufacturers have limited control over what information can be removed or amended once posted. The two dissenting votes at the time the CPSC commissioners approved the database made an unsuccessful attempt to amend the final rule so as to give manufacturers more time to comment on or respond to the inaccuracy of postings before they are published to the database and to the public.

The database is accompanied by a weak disclaimer stipulating that CPSC has not verified the accuracy of any report. Observers continue to worry that the agency has not paid sufficient attention to legitimate issues of a manufacturer's goodwill and reputation, to the costs of unnecessary panic among product consumers, and the mischief that plaintiffs' lawyers might cause with unwarranted increase in litigation against manufacturers.

A recent U.S. Government Accountability Office report on the database found that of 1,800  published reports, manufacturers noted that 160, nearly 10%, had materially inaccurate information.

 

Update on CPSC Database Issues

We have posted before about one of the more controversial aspects of the Consumer Product Safety Improvement Act, the to-be-created publicly accessible database of product safety information.

The CPSIA mandates that the database be completed by March, 2011. The agency views its task as the creation of a public portal and a publicly accessible, searchable database of consumer product incident reports. Through the public portal, consumers will theoretically be able to report potential product safety hazards to CPSC in ways that are supposed to improve the quality, value, and accuracy of the data collected. Manufacturers will be able to investigate and respond to product hazard reports more quickly, and to share information with both CPSC investigators and with the public through the public database. And consumers are supposed to be able to use the public portal and database to find more information about hazards in order to keep their families safe.

Unless done very carefully, the database will be of little use to the average consumer, but subject to potential mischief in the hands of plaintiff lawyers.

Since last Fall, the CPSC has held various meetings and a two-day public workshop to gather stakeholder input on the new database. A number of affected groups have submitted comments on the implementation of the new product safety database, including the Soap and Detergent Association.  A common theme for the comments is the need for the CPSC to focus on verifying and ensuring the accuracy of safety incident reports submitted to the commission. Factual accuracy and veracity are two fundamental elements underpinning a credible incident database. 

CPSC needs to develop a process for addressing false and inaccurate reports that will scare consumers, harm business, and generate no additional safety gains. The commission needs to employ means to prevent the submission of fraudulent reports of harm while not discouraging the submission of valid reports.  CPSC also needs to think about specific disclaimers it should make with regard to the accuracy of the information contained in the public database, and not put the governmental imprimatur on voluntary data that has not been verified.  A sufficient time period should also be allocated for manufacturers to evaluate and respond to any proposed report.    

California Enacts E-Discovery Reform

California Gov. Arnold Schwarzenegger has signed into law a new enactment governing e-discovery in that state.  Readers of MassTortDefense know what a significant issue electronic discovery has been in products litigation, particularly since the amendments to the Federal Rules of Civil Procedure more specifically focused on e-discovery issues. Rather than a device to uncover relevant facts for the litigation, e-discovery often is about plaintiffs’ attempt to find some alleged misstep by the defendant that will bring sanctions.

The Governator signed the Electronic Discovery Act, establishing new rules and procedures for litigants who seek electronically stored information.  The law is designed to make discoverable only  those reasonably accessible sources of electronic data, and it provides that litigants shouldn't be sanctioned for losing data through the ordinary operation of an electronic system. The law establishes that a party may move for a protective order from an electronic discovery request on the grounds that the information sought is inaccessible, though it gives courts discretion to require limited discovery in those cases if the demanding party shows good cause, subject to specified restrictions in specified circumstances.

California courts may also limit electronic discovery from accessible sources if they determine that the information sought could be obtained by other means, is duplicative, or if the expense of
the discovery outweighs its likely benefit. While the Electronic Discovery Act allows courts to
impose sanctions on parties which fail to comply adequately with discovery requests, the courts shall not impose sanctions on a party (or any attorney of a party) for failure to provide electronically stored information that has been lost, damaged, altered or overwritten as the result of the routine, good faith operation of an electronic information system.

The new law also requires discovered materials to be produced in the form in which they are kept in the ordinary course of business.

MassTortDefense noted that a survey by the U.S. Chamber of Commerce Institute for Legal Reform of chief legal officers at Fortune 100 companies revealed that:

-On average, 45‐50% of respondents’ civil litigation costs in 2007 related to discovery activities.

-Discovery of ESI accounted for, on average, a significant share (between 33‐39%) of total discovery costs.

-Costs associated with e‐discovery vendors were reported in 63% of large cases. When used, e‐discovery vendors accounted for, on average, 10‐12% of total costs.

-About 61% of case respondents felt that certain discovery requests received from the opposing party were designed to impose undue settlement pressure by increasing the costs to continue the litigation.

-In both state and federal court, the company respondents reported that more than half of their civil litigation matters involved the receipt of discovery requests that sought information beyond the claims or defenses at issue.

- About 31% of company respondents reported that at least 40% of the time ESI requested from them by the opposing party is not reasonably accessible.

This bill is to take effect immediately as an urgency statute.