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Amicus Briefs

Amicus curiae ("Friend of the Court") briefs are filed in connection with lawsuits by organizations and individuals who are not parties to those lawsuits but who have information or arguments that can be useful to the Court hearing the case.  PAL and its parent organization, Community Catalyst, frequently join amicus briefs in cases on pharmaceutical matters. The cases below are a cross-section of those amicus briefs:

 
Wyeth v. Levine
  • Amicus Brief of AARP, PAL, National Women's Health Network, before the Supreme Court (PDF)
Diana Levine, a professional musician in Vermont was given a Wyeth [NYSE:WYE] nausea medication called Phenergan in a visit to the emergency room. The drug was given incorrectly, causing her to lose her right arm below the elbow. She sued Wyeth, arguing that Wyeth’s warning in its FDA-approved labelling for the drug was insufficient.

A Vermont state court jury awarded her $6 million, and Wyeth appealed, all the way to the Vermont State Supreme Court, which sided with Levine. Wyeth argued that Levine’s state law personal injury and failure-to-warn claims should be “preempted” by the FDA’s authority to regulate the labels of prescription drugs. Wyeth appealed to the U.S. Supreme Court, which will hear the case on November 3, 2008.

PAL, AARP and the National Women's Health Network submitted a friend of the Court brief arguing against preemption of state law claims such as Ms. Levine's. The brief argues that the FDA lacks the resources and political will to propertly monitor drug safety and ensure that prescription drug labels adequately warn patients and prescribers of known risks. The brief further argues that the FDA lacks effective regulatory authority to require drug makers to strengthen warnings contained in drug labels to reflect newly-discovered risks. For all these reasons, the brief argues, state law claims that a drug maker failed to warn patients of known risks should not be preempted.

Tafas/GSK v. Dudas et. al.
The U.S. Patent and Trademark Office (USPTO) created new rules that were supposed to go into effect on Nov. 1, 2007, regarding "patent continuations." However, the rules were blocked by lawsuits brought by drug maker GlaxoSmithKline and inventor Triantafyllos Tafas. The proposed new regulations ask patent applicants to justify the need for more than two continuations per application and to assist the USPTO in performing initial technological research on applications that contain an excessive number of claims.
Under current rules which allow unlimited continuations, USPTO examiners who have repeatedly rejected an application often face an endless stream of continuation applications that “may well succeed in ‘wearing down the examiner’, so that the applicant obtains a broad patent not because he deserves one, but because the examiner has neither the incentive nor will to hold out any longer,” according to professor Mark A. Lemley of Stanford Law School and Kimberly A. Moore, now a Circuit Judge on the U.S. Court of Appeals for the Federal Circuit.

Pharmaceutical companies are most likely to use continuations in order to help them keep monopolies over their drugs. According to the publication Nature Biotechnology, from 1995 to 1999, 41% of drug patents issued were based on continuations. In contrast only 22% of the patents issued in mechanical engineering were based on continuations.

PAL joined an amicus brief prepared by the Public Patent Foundation and submitted to the U.S. District Court for Eastern Virginia, the Court hearing the case.

The Court issued a decision siding with Tafas and GSK, and blocked the proposed rules. The PTO appealed to the Court of Appeals for the Federal Circuit, and PAL joined a Public Patent Foundation amicus brief submitted to that Appeals Court. A press release about that amicus can be found here. 

 
Pharmaceutical Care Management Assocation (PCMA) v. District of Columbia
In 2004, the District of Columbia City Council passed "AccessRx," a law to provide low-income seniors and uninsured people in DC access to affordable prescription drugs through a discount program. The law also contained a provision that required Pharmacy Benefit Managers (PBMs) to be more transparent. PBMs are companies that contract with health plans and insurance companies to administer their prescription drug benefits, negotiate with drug companies, manage their lists of covered drugs (formularies), and the like. 
Unfortunately, PBMs have been accused of failing to protect the interests of their clients, and of instead protecting their own bottom lines. For instance, PBMs negotiate with drug companies for rebates based on the volume of drugs that the PBM's client health plans purchase, but often fail to pass on these rebates to the health plans.  PBMs have also been accused of switching patients' prescriptions when the PBM has a financial incentive to do so (such as higher rebates from a drug company) but without the patient's or physician's permission. 
Because of practices like these, DC included in the AccessRx law a provision stating that PBMs would be "fiduciaries" of their client health plans. This means that a PBM would have a legal duty to "perform its duties with care, skill, prudence and diligence,"  notify its clients of any conflicts of interest, and pass on rebates received from manufacturers. 
The PBM industry's trade association, the Pharmaceutical Care Management Association (PCMA) immediately sued DC in Federal Court to block the law. The PCMA claimed that the law was "preempted" by ERISA, the Employee Retirement Income Security Act. A state law can be "preempted" by a federal law when the state law conflicts with the federal law. When a state law is preempted, it is not permitted to go into effect.
PAL joined an amicus brief written by AARP at the trial court level, defending the measure and arguing that it is not preempted by ERISA.  The PCMA initially succeeed in convincing the trial court to issue a preliminary injunction blocking the PBM portion of AccessRx. After that decision, a similar law passed in Maine was challenged, and the state of Maine prevailed in defending its law. The U.S. Court of Appeals for the DC Circuit ordered the trial court to reconsider its earlier ruling in light of the Maine case. The trial court did, and vacated its earlier preliminary injunction, allowing the law go into effect. The PCMA again appealed to the Appeals Court.  PAL again joined an amicus brief prepared by AARP, this time submitted to the Appeals Court, expanding on the arguments previously made, that the law is not preempted by ERISA. 
On April 18, 2008, the U.S. Court of Appeals for the DC Circuit issued an opinion, finding that the First Circuit Court of Appeal's decision in Pharmaceutical Care Management Association v. Rowe, which upheld Maine's PBM law, did not preclude the PCMA from litigating against D.C.'s law. Specifically, the Appeals Court found that the doctrine of "collateral estoppel" does not apply in this case, and thus that the PCMA is not prevented from challenging the DC law. The Appeals Court remanded the case back to the District Court. 
   
Reigel v. Medtronic (.pdf)

The U.S. Supreme Court recently agreed to hear a preemption case (Reigel v. Medtronic), which involves consumer claims against medical device manufacturing companies.  While medical devices are obviously distinct from prescription drugs, the issues contained in this case may well affect how preemption defenses are treated in drug cases as well.

With so much as stake, PAL has joined an amicus brief written by Community Rights Counsel. The brief argues against the application of preemption where Congress has made no "clear statement" that it intends to override state law.  

 

IMS Health et. al. v. G. Steven Rowe (pdf)

The state of Maine enacted a law restricting the sale of data showing what drugs physicians write prescriptions for.  Pharmacies collect and sell information on what drugs individual doctors write prescriptions for, and sell it to companies like IMS Health and Verispan. Those companies then sell that data to drug companies. Drug company salespeople use that information to tailor the sales pitch that they make to doctors during visits to doctors' offices. Three states (ME, NH and VT) have now passed laws making the sale of such physician data for commercial purposes illegal.  "Datamining" companies that sell such data sued Maine to block the law, arguing that it violated their "commercial free speech" rights.  Community Catalyst (PAL's parent organization), AARP and others filed this amicus brief, arguing that the sale of such data is not "speech" that is entitled to protection, and that even if it is, the state of Maine has a "compelling interest" that makes regulating permissible.