Following the Supreme Court’s decision in Mississippi ex rel. Hood v. AU Optronics, state attorneys-general and their trial bar friends have been able to avoid federal court altogether by simply bringing their class and mass actions through the AG’s office as a parens patriae suit. Not only does this clever maneuver treat courtrooms as cash registers and corrode the integrity of the judicial process, but it also constitutes a staggering conflict of interest, as WLF has long argued. Continue reading
Fair notice of the law is a basic principle that separates liberal democracies like the United States from more authoritarian governments. Fair notice is an especially critical due-process check against government’s power to criminally prosecute. Government must not only prove that a person did the unlawful act, but also that he intentionally engaged in wrongful conduct or knew the conduct was illegal—that it, that he had a guilty mind. So why, then, is the Obama Administration and other elected representatives opposing reforms to ensure that federal criminal laws include a clear criminal-intent standard?
The idea being advanced seems far from revolutionary or controversial, which may explain why politicians and interest groups of every ideological stripe support it: Federal laws with criminal provisions must require prosecutors to prove that the accused possessed the mens rea, or culpable mental state, to commit a crime. If a law lacks such language, then a default intent provision will apply, such as showing that the defendant acted “willfully” or “recklessly.” Continue reading
In a recent post, we lampooned the “high trans fat intake consumer” the Food and Drug Administration (FDA) invented to advance its de facto ban of partially hydrogenated oils (PHOs) as being a cross between Augustus Gloop and Homer Simpson. The ramifications of such a PHO ban for many processed food makers and their customers, however, are no laughing matter. Among other things, FDA’s final determination could expose the food industry to an avalanche of lawsuits and potentially billions of dollars in liability costs.
The Current Litigation Environment. Plaintiffs’ lawyers have been working feverishly for the past decade to turn lawsuits against “Big Food” into the next big payday. As chronicled on this blog since its inception in 2011, a small but persistent segment of the Litigation Industry has filed hundreds of class-action lawsuits alleging that everything from a perceived excess of empty space in a bag of chips to the printing of “evaporated cane juice” on a label violates state consumer protection laws.
By Litigation Industry standards, this lawsuit product line has not yet met profit expectations. But the lawsuits have successfully established, especially in California, that private litigants can enforce federal food laws and regulations. Continue reading
On June 16, the Pennsylvania Supreme Court rejected the Commonwealth’s arguments that Bristol Myers Squibb (BMS) was liable for fraudulently overcharging state health agencies. The state had sued BMS and 13 other pharmaceutical companies and won a $27 million damage award. In the unanimous ruling, the Court dropped a noteworthy footnote in which it questioned Pennsylvania’s reliance on private contingent-fee lawyers to prosecute the case. The decision is just the latest in a string of costly failures by deputized plaintiffs’ lawyers in state actions against drug companies.
The Court’s unanimous Commonwealth v. TAP Pharmaceutical Products decision turned on whether the Pennsylvania agencies suffered any financial loss when taking into account the value of rebates that BMS provided the state for drug purchases. The state claimed that BMS took advantage of the complex “average wholesale price” (AWP) formula to artificially increase its profits from sales to health agencies. BMS denied those charges, and argued that even if the agencies were overcharged, the rebates offset the alleged financial harm. Despite testimony from state officials that they did take rebates into consideration when assessing drug payments, Pennsylvania excluded rebates when formulating its damages claim. The trial court bought the state’s justification for this contradictory stance, as did the Commonwealth Court on appeal.
The justices seemed shocked by the lower courts’ unquestioned acceptance of Pennsylvania’s stance on rebates. Justice Saylor wrote, “[T]his Court is not in need of a body of evidence to apprehend that a rebate operates to reduce the net price of a commodity.” The Supreme Court found it “astonishing” that the Commonwealth Court would allow the state to collect “a billion dollars in rebates relative to social welfare reimbursements while giving no credit to the payers.” Continue reading
The Obama Administration has been a faithful friend of the plaintiffs’ bar, particularly regarding federal preemption of State-law tort claim against product manufacturers. The Food and Drug Administration has, for example, proposed a regulation (with direct input from plaintiffs’ lawyers) on labeling of generic drugs that would sweep away a federal preemption defense upheld twice by the U.S. Supreme Court.
A Supreme Court brief filed on May 20 by the Solicitor General of the United States provides another example of just how committed the Administration is to this mutually beneficial friendship. In urging the Court to deny review in a medical device preemption case, the brief urges the Court to ignore an express preemption statute and to effectively overrule its 2008 pro-preemption decision in Riegel v. Medtronic.
The Supreme Court has steered a middle course when previously considering claims that the federal statute at issue, 21 U.S.C. § 360k(a), preempts product liability suits against medical device manufacturers. It held in a 1996 case that federal law does not preempt claims involving the vast majority of medical devices: those devices being marketed based on a determination that they are “substantially equivalent” to devices already on the market as of 1976 (so-called § 510(k) devices). The Court explained that FDA never undertook a formal review of the safety and effectiveness of such devices, and thus there was no reason to believe that Congress intended to prevent States from imposing their own safety and effectiveness requirements. The Court later held in Riegel that § 360k(a) generally does preempt design defect and failure-to-warn claims involving the small number of Class III devices that FDA has approved for marketing following a safety and effectiveness review undertaken in accordance with the agency’s rigorous pre-market approval (PMA) process.
The Solicitor General’s office submitted its brief in connection with a petition (Medtronic v. Stengel) seeking review of a U.S. Court of Appeals for the Ninth Circuit decision that claims involving a PMA device for delivering pain medication were not preemped. (WLF filed an amicus brief in support of certiorari). Riegel left open the possibility that some State law claims might escape § 360k(a) preemption if they were “parallel” to federal law; i.e., if the State were simply imposing the very same requirements on a device that FDA regulations specific to the device already imposed. Lower courts have struggled in the ensuing years to craft a workable definition of a “parallel claim,” and the Stengel petition asks the Supreme Court to resolve a well-entrenched conflict among the federal appeals courts regarding the meaning of the parallel-claims exception. Last October, the Supreme Court invited the Solicitor General to comment on the petition. Continue reading
Cross-posted at WLF’s Forbes.com contributor page
In its unanimous Mississippi ex rel. Hood v. AU Optronics ruling, the Supreme Court on Tuesday refused to interpret the Class Action Fairness Act (CAFA) so as to allow the “mass action” removal of a parens patriae suit in which the State of Mississippi was the only named plaintiff. The decision marks only the second time that the high court has considered the 2005 statute, which Congress enacted to expand a defendant’s ability to remove to federal court a class action that did not satisfy the traditional requirements of diversity jurisdiction. (Last term, a unanimous Court in Standard Fire Insurance Co. v. Knowles ruled in favor of removal in a case where the class representative attempted to avoid CAFA jurisdiction by stipulating to damages below the threshold amount in controversy).
Utilizing a “real-parties-in-interest” analysis, the U.S. Court of Appeals for the Fifth Circuit had agreed with the district court that the case constituted a “mass action” under CAFA. But on the question of the applicability of CAFA’s “general public” exception, the appeals court reversed the district court, which had remanded the case back to state court on the basis that it was “asserted on behalf of the general public (and not on behalf of individual claimants or members of a purported class)” under 28 U.S.C §1332(d)(11)(B)(ii)(III). Oddly, the Supreme Court didn’t bother weighing in on CAFA’s “general public” exception, holding instead that the suit failed even to meet the basic definition of a “mass action” because it did not involve 100 or more named plaintiffs. The Court rejected the lower courts’ “real-parties-in-interest” approach in favor of a narrow reading of the statutory language.
As a result, state attorneys-general and their trial bar friends are now free to avoid federal court altogether by simply running their class and mass actions through an AG’s office as a parens patriae suit. The trial lawyers will still receive their big contingent-fee awards, and they can continue to send AGs their out-of-state campaign contributions. According to a recent report, for example, the Mississippi AG’s “plaintiffs’ firm contributors were all out of state, and they made no contributions to any other candidates for statewide office in Mississippi.” In only two instances where contingent-fee law firms represented Mississippi in securities fraud class actions did the firms not make a previous contribution to the AG’s campaign. They did so subsequently, however, according to the report.
If this staggering conflict of interest is ever to be reined in, the Court has left it up to Congress to do so. That’s a shame, inasmuch as the Supreme Court should take a greater interest in cleaning up practices that treat courtrooms like cash registers and corrode the integrity of the judicial process.
Cross-posted by Forbes.com at WLF’s contributor site
A little over a decade ago, federal regulators and state attorneys general initiated a litigation campaign to alter how government health care programs reimbursed doctors for prescription drugs. Like most “regulation by litigation” efforts, this campaign seized upon laws of broad application such as the False Claims Act (FCA) and encouraged private lawsuits of questionable merit. Government enforcers have long since moved on to other crusades, but as a federal court decision last month reflects, some private suits still drag on, burdening American businesses with needless legal expenses.
AWP. In the early 2000s, the federal government reimbursed health care providers based in part on a drug’s average wholesale price, or “AWP.” Some likened AWP to the sticker price, or MSRP, of a new car: an inflated number which almost no one actually paid. Everyone involved in health care was aware of the illusory nature of AWP, and federal and state regulators urged legislative change, but Congress resisted reform. So unelected officials and their brethren in the plaintiffs’ bar sought to impose change. As this 2002 WLF Working Paper explains, they devised legal theories which branded AWP as an overcharging scheme, and accused drug makers, price publishers, and other entities such as pharmacy benefit managers (PBMs) of perpetrating a fraud. State attorneys general filed billion-dollar fraud actions and plaintiffs’ lawyers teamed up with “whistleblowers” to file qui tam suits under the FCA.
The ensuing litigation crusade provided moderate returns at best to the plaintiffs’ lawyers and state AGs who jumped on board. For instance, in 2009, the Alabama Supreme Court dashed the state’s (and its contingent-fee lawyers’) dreams of a huge payday, dismissing two AWP cases, finding no fraud existed. Continue reading