True, not False: SCOTUS “Omnicare” Case Highlights Need for Clarity on Key Securities Class Action Issue

greeneddavisjGuest Commentary

Douglas W. Greene and Claire Loebs Davis, Lane Powell LLP

On November 3, 2014, the U.S. Supreme Court will hear oral argument in Laborers District Counsel Construction Industry Pension Fund v. Omnicare, Inc., which concerns the standard for judging the falsity of an opinion challenged in an action under Section 11 of the Securities Act of 1933. In the U.S. Court of Appeals for the Sixth Circuit decision under review (“2013 Omnicare decision”), the court held that a statement of opinion can be “false” even if the speaker genuinely believed the stated opinion. This holding is contrary to the U.S. Supreme Court’s decision in Virginia Bankshares, Inc. v. Sandberg, which held that a statement of opinion is a factual statement as to what the speaker believes—meaning a statement of opinion is “true” as long as the speaker genuinely believes the opinion expressed, i.e., if it is “subjectively” true.

We authored an amicus brief on a pro bono basis for Washington Legal Foundation (“WLF”) in Omnicare that emphasizes the importance of clarifying the standard for challenging “false” statements of opinion under all the federal securities laws, not just Section 11. WLF’s view that such clarification is needed was reinforced by an October 10, 2014 decision in a subsequently filed securities class action against Omnicare under Section 10(b) of the Securities Exchange Act of 1934. In re Omnicare, Inc. Sec. Litig. (“2014 Omnicare decision”). In the 2014 Omnicare decision, the Sixth Circuit appeared to embrace the proposition that a statement of opinion is not actionable if it is subjectively true—at least under Section 10(b)—but then held that the subjective falsity inquiry should be analyzed within the element of scienter. The opinion reflects the continued confusion that pervades analysis of this issue, jumbling subjective falsity with other concepts, and conflating the separate elements of falsity and scienter.

As part of its scienter analysis, the Sixth Circuit also grappled with another important question: whose state of mind counts for purposes of determining a corporation’s scienter? Although the Sixth Circuit believes the standard it enunciated constitutes a “middle ground” between restrictive and liberal tests among the federal circuit courts, its ruling misunderstands the nature of the scienter inquiry and conflicts with the Supreme Court’s 2011 ruling in Janus Capital Group, Inc. v. First Derivative Traders, and thus risks expanding corporate liability beyond the proper reach of Section 10(b).

After discussing the proper analysis of statements of opinion, and explaining errors in the 2013 Omnicare decision, we explain and analyze both holdings in the 2014 Omnicare decision. Continue reading

Ebola Vaccine and Treatment Makers Need Liability Protection

670px-ebola_virus_virionU.S. politicians and regulators, many of whom ordinarily trend toward hyper-caution on new drug reviews and approvals, are rushing forward with policies aimed at speeding up development of Ebola vaccines and treatments. These measures include coordinated research among public health officials and drug makers, Food and Drug Administration (FDA) pledges of regulatory assistance, and congressional interest in legislation to qualify Ebola-targeted products for an FDA priority-review program. Such cooperation is encouraging, but government also needs to take action on another R&D disincentive which, if left unaddressed, could completely undermine current efforts on Ebola and frustrate future cooperative management of unforeseen pandemics. Ebola vaccine and treatment manufacturers need to have protection from tort liability exposure.

Any medical procedure, pharmaceutical product, or vaccine may have adverse health risks in some instances. Drug manufacturers must consider those risks when deciding whether to invest millions of dollars for product R&D, and the Food and Drug Administration (FDA) must weigh those risks against the benefits when approving a treatment. Such risks, along with the high regulatory barriers and low economic incentives attendant to investing in rare diseases, likely have been factors that explain the dearth of Ebola vaccines and treatments.

The United States government has the motivation and the means to minimize or eliminate such liability risks. Federal health agencies are already directly involved in vaccine development, and they will no doubt also be the major purchasers of the resulting drugs. Those federal entities could include a provision in the R&D agreements or purchasing contracts that would substitute the government as a defendant in any resulting lawsuits against private businesses, or indemnify companies from tort liability. The former option is certainly superior to indemnification, which could require the vaccine and treatment producers to litigate cases and then seek reimbursement for the losses or settlements. The companies would also have to negotiate with the government over whether the indemnification would cover litigation costs, such as attorneys’ fees.

The federal government indemnified manufacturers in contracts for a smallpox vaccine after the September 11, 2001 terrorist attacks. The companies argued that the proposed indemnification was insufficient, and in April 2003, Congress added expanded liability protections to the Homeland Security Act of 2002. For the one-year period of the national smallpox vaccination program (2003-2004), individuals allegedly harmed by a government-purchased smallpox vaccine could only sue the federal government under the Federal Tort Claims Act. Congress could consider the passage of a similar law for Ebola vaccines. Continue reading

Washington Post Parrots Activists’ Skewed Spin of FDA’s “GRAS” Process

The ScreamJust below the fold in the print and digital versions of this morning’s Washington Post blares the headline “Food additives on the rise as FDA scrutiny wanes.” The story dutifully advances the perspective of professional activists that the Food and Drug Administration’s (FDA) “generally recognized as safe” (GRAS) process for food additives is perilously broken. Food nanny organizations such as Center for Science in the Public Interest and the Natural Resources Defense Council have ramped up their attacks on GRAS over the past several years, assisted by a 2010 Government Accountability Office (GAO) report calling for changes to the process.

As explained in a Washington Legal Foundation Legal Backgrounder by Hyman, Phelps & McNamara attorneys Roberto Carvajal and Nisha Shah, the GRAS process dates back to 1958, when Congress determined that certain uses of substances in foods that were generally recognized as safe need not go through formal FDA approval. For nearly four decades, FDA applied that exception very narrowly, but the Clinton-era agency leadership altered that interpretation in 1997. They concluded that narrow application of the GRAS exception deeply strained agency resources and chilled food industry innovation. The agency’s new approach permitted food processors to self-report new uses of certain substances and provide FDA with the science supporting the GRAS conclusion. In response to the critical 2010 GAO report, the agency acknowledged that while the GRAS process could be improved, “FDA believes that the GRAS concept has continuing utility as a practical tool for distinguishing between substances and new uses of substances that merit a full pre-market safety evaluation by FDA and those that do not.”

FDA’s resolve on the GRAS process seems to be weakening, however. The Post article features a troubling front-page quote from FDA’s Deputy Commissioner Michael Taylor: “We simply do not have the information to vouch for the safety of many of these chemicals.” He goes on to proclaim later in the article, “We aren’t saying we have a public health crisis.” But of course Deputy Commissioner Taylor understands that when FDA uses the term “public health crisis,” even when denying the existence of one, it sounds alarm bells. FDA’s latest statements could be setting the stage for regulatory action against such common, widely-used ingredients as caffeine and sodium, which the agency has long considered GRAS.

For those who might be interested in learning more about the GRAS process from a far different perspective than the Washington Post provided today, watch WLF’s free July 10 Web Seminar, The Future of FDA’s “GRAS” Designation in an Era of Increased Scrutiny. The Powerpoint presentation utilized by our speakers, Keller and Heckman LLP’s Melvin Drozen and Evangelia Pelonis, is available here.

Quick Take: Some Possible Impacts of SCOTUS’s POM Wonderful Decision on State-law Food Labeling Class Actions

food-courtIn some of our commentaries on food labeling class actions (collected under the “Food Court” tag), we have lamented how such lawsuits end-run the federal Food Drug and Cosmetic Act’s (FDCA) prohibition on private enforcement. Defendants have argued that the FDCA preempts lawsuits brought under laws such as California’s Sherman Law or Unfair Competition Act. Regrettably, judges have rejected this argument, and have found preemption only if a lawsuit would impose labeling requirements beyond what Food and Drug Administration (FDA) regulations would require.

Plaintiffs and defendants in these suits expressed significant interest when the U.S. Supreme Court agreed in January to review a U.S. Court of Appeals for the Ninth Circuit decision, POM Wonderful LLC v. Coca-Cola Co. There, the Ninth Circuit ruled that the FDCA precluded POM’s federal Lanham Act suit charging that a Minute Maid Blueberry Pomegranate juice’s name and label were misleading. While POM Wonderful involved the interplay between two federal statutes, rather than between federal and state statutes, some opined that a broadly written Supreme Court opinion could either help state-law food labeling suit defendants defeat those claims or add powerful credence to plaintiffs’ arguments that the FDCA does not impede their private enforcement actions.

The High Court decided POM Wonderful on June 12. In an opinion authored by Justice Kennedy, the Court unanimously reversed the Ninth Circuit. While the ruling could inspire more Lanham Act lawsuits between  competitors, it is unlikely to have a major impact on the types of class actions being filed in The Food Court and elsewhere.

Justice Kennedy stated baldly that “this is not a pre-emption case,” and thus “the state-federal balance does not frame the inquiry.” POM Wonderful therefore will not impact arguments that the FDCA preempts state-law class actions challenging food labels. Justice Kennedy also observed “this is a statutory interpretation case,” and focused the Court’s analysis on whether the FDCA and the Lanham Act were complementary or conflicting. Continue reading

Environmentalists for Foreign Energy Dependence Strike Again

california_expensive_gas_200That special-interest activism has negative consequences is a message Washington Legal Foundation has been communicating for 35 years.

The consequences are sometimes subtle or only become clear over time. In other instances like the outcome we write about here, the consequences are immediately obvious. On January 29, Royal Dutch Shell PLC, citing a January 22 U.S. Court of Appeals for the Ninth Circuit decision as a last straw, announced it would indefinitely put on hold plans to drill for oil beneath Alaska’s Chukchi Sea.

Shell has reportedly invested over $6 billion in its quest to become the first company to extract some of the possibly 27 billion barrels of oil from that offshore location. The leases it obtained from the federal government cost $2.6 billion alone. Over the last eight years, Shell has had to endure delay after delay as a cadre of activist groups—let’s call them collectively Environmentalists for Foreign Energy Dependence—filed lawsuit after lawsuit to slow final approval. A Legal Pulse post from July 2012 details several of these actions, which attacked, among other things, EPA’s emissions permits, Shell’s oil spill plan, and the Bureau of Ocean Energy Management’s (BOEM) environmental impact assessment supporting the lease sale. Continue reading

CVS Action Brings Call for a Food Fight

CVS aisle, CVS/Pharmacy, Bethesda, MD

CVS aisle, CVS/Pharmacy, Bethesda, MD
Photo by Glenn G. Lammi

Well, that didn’t take long.

Just hours after CVS announced last Wednesday that it would halt sales of tobacco, public health activists and their media allies seized the opportunity to advance a notion championed by such anti-“Big Food” luminaries as The New York Times’ Mark Bittman and the Dean of Duke University’s Sanford School of Public Health, Kelly Brownell: food is the next tobacco.

For instance, the Texas Medical Association sent out the following tweet:

The commentary referenced in the tweet stated baldly, “Wander the aisles of CVS and see how their nutritional offerings fit within the framework of an organization pitching health.”

Next, this from Slate business and economics correspondent Matthew Yglesias:

But the cigarettes issue seems to me to mostly raise the question of how far CVS can really go down this road. After all, I was in CVS just yesterday to buy myself some Diet Coke. The Diet Coke sits next to the sugary sodas. And they’re across the aisle from the potato chips. Up front where you cash out there are lots of M&M’s and Snickers bars.

A Saturday op-ed in The Boston Globe called on CVS to put soda, energy drinks, and other “sugary beverages” behind the counter. In support of its absurd viewpoint, the piece quoted health researcher Deborah Cohen from the (normally cerebral) think tank RAND Corporation, who proclaimed, “The food industry is just shoving food in to us.” Nice imagery.

Speaking of imagery, the food=tobacco messaging wouldn’t be complete without a political cartoon.  One by nationally syndicated cartoonist Jimmy Margulies appeared Saturday on the Washington Post op-ed page.

Food companies obviously chafe at the comparison of these two highly dissimilar product categories, as should any person who doesn’t have an axe to grind. But now that opportunities for paternalistic power and money through tobacco control are waning, anti-Big Food activists and their erstwhile allies in the plaintiffs’ bar see food as a logical and vulnerable next target. And they have at the ready an effective strategic activism plan, battle-tested from the “tobacco wars.” Continue reading

Proxy Advisory Services: Making Glass (Lewis) Transparent—and ISS Too

nasdaqCross-posted at WLF’s Forbes.com contributor page

With 2014 and many corporations’ annual meetings just around the corner, more and more publicly-traded companies find themselves girding for costly proxy fights over corporate governance issues.  The small cadre of firms that provide proxy advisory services increasingly hamper management’s ability to prevent proxy battles, and to win those it can’t forestall.  Entities like Glass Lewis & Co. and Institutional Shareholder Services (ISS) provide advice to their institutional money manager and investment adviser clients that increase the percentage of shareholders voting against management’s recommendations.

But it is not at all clear that this proxy voting trend serves shareholder interests.  The Securities and Exchange Commission (SEC) has been studying these firms (which together control some 97% of the proxy services market )and their grip over proxies.  As Edward Knight, General Counsel of NASDAQ OMX (the public company that owns NASDAQ) points out: “[T]here is evidence that the Firms not only increase the costs of being a public company, but also create disincentives for companies to become public in the first place.”  Perhaps, as an October petition filed with SEC by NASDAQ OMX urges, it’s time the SEC stopped studying and started acting to make the methodology behind such influential proxy voting advice more transparent.

A Creature of Regulation.  The current problem began when, in an effort to curtail potential conflicts of interest, SEC imposed a new rule in 2003—the “Proxy Voting by Investment Advisers” rule—that required entities such as institutional investors and investment advisers to disclose “the policies and procedures that [they use] to determine how to vote proxies.”  To satisfy this new requirement, investment advisers began turning to third-party firms that offer advice on proxy voting.  When a 2004 SEC no-action letter clarified that relying on such firms creates a veritable safe harbor, the reliance on these firms grew and their impact blossomed.

Thanks to a second 2004 no-action letter, SEC has also instructed proxy advisory firms that they can provide advice to public companies on corporate governance issues—including how to win proxy votes—at the same time that they make proxy voting recommendations to investment advisers.  As James Glassman and J.W. Verret wrote in a Mercatus Center analysis last April, “Instead of eliminating conflicts of interest, the rule simply shifted their source.  Instead of encouraging funds to assume more responsibility for their proxy votes, the rule pushes them to assume less.”  Such concerns, voiced both by public companies and SEC Commissioners, led SEC to publish a “Concept Release on the U.S. Proxy System” that elicited over 300 comments. Continue reading