• June 24, 2011
    Guest Post

    By Elizabeth B. Wydra, Chief Counsel, Constitutional Accountability Center. This analysis is cross posted at CAC’s Text & History blog.

    Two years ago in Wyeth v. Levine, the Supreme Court refused to allow federal food and drug law to displace state consumer-safety law.  Instead, the Court held that Diana Levine, a Vermont musician whose arm had to be amputated after Levine suffered adverse effects from Wyeth’s brand-name drug, Phenergan, could hold the drug manufacturer liable under state failure-to-warn laws—laws which hold drug and other manufacturers responsible for inadequate safety labels.  Yesterday, in a 5-4 ruling, the Supreme Court held in PLIVA, Inc. v. Mensing that generic drug manufacturers may not be sued under state failure-to-warn law because it would be “impossible” for the generic drug manufacturers to comply with both state failure-to-warn law and federal law.  Given the nearly identical storylines, how did the Supreme Court come up with a happy ending for consumers in Wyeth but a happy ending for big business in PLIVA?

    To be sure, there are important differences between the labeling laws for brand-name and generic drugs.  Federal law, for example, requires a generic drug to carry the same label as the brand-name drug it replicates.  But this “duty of sameness” for generic manufacturers is tempered by a duty under federal law to report problems with generic drugs.  So, while generic drug manufacturers cannot unilaterally change their labels, they can—and must—approach the FDA to seek to revise a drug’s label when they have reasonable evidence of a serious problem with the drug.  Such a label change would then go into effect for both brand-name and generic drugs. There is no guarantee, of course, that the FDA will act based on the information provided by the generic drug manufacturer, but the manufacturer’s attempt to achieve a safe and adequate warning label would nonetheless likely serve as a defense to state liability.  In other words, if the generic manufacturer did what it could under federal law, a state failure-to-warn claim should be preempted by federal law because it would be impossible for the manufacturer to comply with both federal and state law.

    But if a generic drug manufacturer doesn’t even try to comply with federal drug safety law and state failure-to-warn standards, it is difficult to see how it is “impossible” for the manufacturer to comply with both sets of laws.  As Justice Sotomayor explained in her PLIVA dissent, “because federal law affords generic manufacturers a mechanism for attempting to comply with their state-law duties to warn, . . . federal law does not categorically pre-empt state-law failure-to-warn claims against generic manufacturers.”  

    For the majority, led by Justice Thomas, to find impossibility preemption in this context is to twist the word “impossibility” beyond recognition.

  • June 22, 2011

    Several of the nation’s top constitutional experts engaged in a robust discussion on what the U.S. Constitution means and how to interpret it, during the opening plenary discussion at the American Constitution Society’s Tenth Anniversary National Convention.

    ACS Board Chair Geoffrey R. Stone, a law professor at the University of Chicago, kicked off the discussion by offering a new way of framing constitutional interpretation, as articulated in a recent article in Democracy: A Journal of Ideas he coauthored with University of North Carolina law professor William Marshall, entitled “The Framers’ Constitution.”

    In the article, Stone and Marshall lay out their vision for interpreting the Constitution as the Framers intended, recognizing that the Framers were “visionaries” and not “timid men” who would have viewed originalists’ vision that “any particular moment’s understanding of the meaning of the Constitution’s open-ended provisions should be locked into place” as wrongheaded.

    “As men of the Enlightenment, [the Framers] believed that just as reason, observation and experience would enable us to gain greater understanding over time into questions of biology, physics, economics and human nature, so, too, would they enable us to learn more over time about the content and meaning of the broad principles they had enshrined in our Constitution,” Stone explained in his remarks.

  • May 11, 2011
    Guest Post

    By Rochelle Bobroff, Directing Attorney, Herbert Semmel Federal Rights Project, National Senior Citizens Law Center

    What good is Medicaid insurance if doctors won’t provide preventive care and pharmacists won’t dispense medications?  When reimbursement rates are too low, doctors and pharmacies can decline to provide care.  Then without meaningful access to medical care and services, individuals are likely to experience dire health consequences that are much more expensive to treat in emergency rooms. 

    To lower their short term Medicaid costs, some states are slashing rates reimbursement for medical providers.  But lowering rates only for low-income Medicaid beneficiaries does not drive down the cost of health care.  Instead, providers just stop serving Medicaid patients and keep getting paid higher rates by everyone else.  And without preventive care, beneficiaries are prone to end up seeking emergency treatment, eliminating in the long term any short term fiscal savings.

    To address the issue of rates so low that treatment is refused, the Centers for Medicare and Medicaid Services (CMS) issued proposed regulations last week that explain the requirements of federal law when states seek to lower Medicaid rates.  The regulations “clarify that beneficiary access must be considered in setting and adjusting payment methodologies for Medicaid services.” 

  • April 14, 2011
    Guest Post

    By University of Arizona College of Law professors Gabriel “Jack” Chin and Marc L. Miller, coauthors with law professor Toni M. Massaro of the ACS Issue Brief, “The Constitutionality of Arizona SB 1070 and Other State Immigration Laws.”

    State efforts to regulate immigration have run into a rough stretch lately.

    In the 2010 and 2011 legislative sessions, legislators around the country introduced copycat versions of Arizona’s SB1070, designed to drive undocumented immigrants out of the state through a policy of “attrition through enforcement.” (The ACS Issue Brief on the topic is here). Only one of the dozens introduced has actually become law, in Utah. The Utah law’s radical difference from the Arizona statute is exemplified by inclusion of a state level guest worker program designed to allow some undocumented people to stay. 

    In September, 2010, the Third Circuit invalidated a local anti-immigrant ordinance. The Town of Hazelton imposed local restrictions on employment and housing designed to make it impossible for undocumented people and their families to live in the city.

    The latest bad news came on Monday, when a Ninth Circuit panel affirmed all aspects of a July, 2010 injunction against many provisions of SB 1070. The panel decision and partial dissent framed the issues with clarity and precision, making it easy for the Supreme Court to take the case and, in a way, perhaps inviting them to do so.  

  • March 7, 2011

    Those interested in monitoring how the Supreme Court will rule on challenges to the Affordable Care Act should mark their calendars now for the last week in June of 2012, former acting solicitor general Walter Dellinger, chair of the appellate practice at O'Melveny & Myers, said during an ACS discussion about challenges to implementation of the health care law.

    And on that June  day when the Supreme Court does issue a decision, Chief Justice John Roberts will join the majority to uphold the law, Dellinger predicted.

    "I think at the end of the day Chief Justice Roberts will be in the majority to uphold this," Dellinger said. "He is thinking of a very long philosophical position as a chief justice and he would not want to adopt a principle that said that 25 or 30 or 40 years from now, the only way Congress could deal with a social problem is by providing a monolithic, single, governmental bureaucratic approach, rather than creating incentives for people to utilize choices within the free market. Why would someone who has grown up with conservative principles want to adopt that?"

    The panel discussion featured a keynote address by former Senator Tom Daschle, who predicted that, even if all goes well in implementing the Affordable Care Act, it will take at least a generation before the law fulfills its potential. But, he continued, it's potential worth fighting for.

    "This is a fight for the equality and the liberty of all Americans and their moral right to health security at long last," he said.

    As the debate that followed his remarks got under way, news broke that U.S. District Court Roger Vinson had issued a seven-day stay of his decision in Florida federal court striking down the health care law, allowing the Department of Justice time to appeal.

    "I think what's most important is that we have the news that we've just had, which is that the Vinson decision has actually been stayed," Center for American Progress Chief Operating Officer Neera Tanden said in response to the news. She continued: