Third Circuit Holds That MDL Judges Can't Reverse Pre-Transfer Orders Absent Extraordinary Circumstances

This post written by Eric Buhr.

In a precedential decision issued Thursday, In Re: Pharmacy Benefit Managers Antitrust Litigation (MDL 1782), the U.S. Court of Appeals for the Third Circuit reinstated a district court order compelling arbitration of antitrust claims, an order which another district court judge vacated after the case was transferred to a federal Multi-District Litigation (MDL)s. Based on the law of the case doctrine, the Court of Appeals held that MDL judges may not overturn an order of the transferor court absent a finding of extraordinary circumstances - a conclusion that has broad ramifications for MDL proceedings in general.

The In Re Pharmacy Benefit Managers Antitrust Litigation case began in 2003, when Bellevue Drug Co. and several other pharmacies and associations sued AdvancePCS, a pharmacy benefits manager now known as CaremarkPCS, Inc for antitrust violations. In 2004, AdvancePCS moved to compel arbitration of all of the Plaintiffs' claims based on a contractual arbitration clause, and the district judge, Judge Eduardo Robreno of the U.S. District Court for the Eastern District of Pennsylvania, granted the motion to compel arbitration and stayed the district court action. 

Two years later, though, the case was transferred to an MDL pending in the Eastern District of Pennsylvania before Judge John P. Fullam. There, Judge Fullam lifted the stay and vacated the order for arbitration. Although Judge Fullam admitted the orders compelling arbitration were "clearly appropriate under the Federal Arbitration Act," he felt that an order vacating the arbitration order would help expedite the case. In support of his ruling, he explained his belief that a transferee judge under the multidistrict litigation statute had the power to vacate or modify any order of a transferor court bearing on pretrial matters.

The Court of Appeals clearly disagreed, stating that "there is nothing in the rules adopted by the Joint Panel on Multidistrict Litigation that authorized a transferee judge to vacate or modify the order of a transferor judge."   Although Judge Fullam relied, in part, on portions of the Manual for Complex Litigation suggesting that a transferee judge may vacate or modify orders of the transferor court, the Third Circuit dismissed that argument. The Court explained that "if Judge Fullam's interpretation of the statute were accurate, litigation could begin anew with each MDL transfer…Moreover, we do not believe that Congress intended that a 'Return to Go' card would be dealt to parties involved in MDL transfers." 

Ultimately, the Third Circuit agreed that the transfer of a case to an MDL does not confer more power on a transferee court; its powers are commensurate with those the transferor court has absent the transfer. Therefore, under ordinary application of the law of the case doctrine, an MDL court may only revisit past orders upon a finding of "extraordinary circumstances". Some recognized examples justifying exceptions and revisiting old orders anew include: (1) when new evidence becomes available; (2) when a supervening new law has been announced; (3) when there is a need to clarify or correct an earlier ambiguous ruling; and (4) when the order might lead to an unjust result. Since the MDL judge had not relied on on any such exception to the law of the case doctrine, the Third Circuit reinstated the original order by the transferor court.  

New HHS Regulations Impose Federal Security Breach Notification Requirements

The recently enacted Health Information Technology for Economic and Clinical Health (“HITECH”) Act, which amends various aspects of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), including the associated Privacy and Security Rules, marks a significant change in how covered entities and their business associates must respond to security breaches under HIPAA.

On August 24, 2009, the U.S. Department of Health and Human Services (“HHS”) issued its interim final rule (“the Rule”) regarding a covered entity’s obligation to notify individuals when their unsecured protected health information (“PHI”) is breached. Furthermore, and depending on the nature of the security breach, the Rule also requires a more global notification whereby covered entities must post information regarding certain breaches in newspapers and on the HHS website.

The HHS Rule is effective on September 23, 2009, however, HHS will not impose sanctions for failure to provide the required notices for breaches that are discoverable before February 22, 2010.

For additional details, read the full alert

U.S. Department of Homeland Security Mandates Use of E-Verify for All Employees Performing Work on Government Contracts

This post was written by Irene M. Recio and Lorraine M. Campos.

E-Verify is a free internet-based program operated by the U.S. Department of Homeland Security, U.S. Citizenship and Immigration Services ("CIS") to allow employers to verify the employment eligibility of new hires. Until recently this had been a voluntary program. However, a new regulation went into effect on September 8th, which now requires that all Federal contracts awarded and solicitations issued after that date must include a clause mandating use of E-Verify for all employees hired during the contract period, and those employees who will perform work under the given contract. Employers are not required to use E-Verify with employees who perform support work on the contract, such as indirect or overhead functions. Institutions of higher education, state and local governments, and governments of federally recognized Native American tribes need only verify employees assigned to a covered federal contract (and not all newly hired employees, as is the case for all other Federal contractors).

This new requirement is of specific interest to health care providers and pharmaceutical and medical device manufacturers who have a Federal government contract containing the E-Verify clause, which requires the usage E-Verify with employees working on the Federal contract. Those providers will be required to use E-Verify with all new employees and with any employees assigned to work on the Federal contract. An important exception exists for health care providers only having an agreement with Medicare to provide patient services. In those situations the usage of E-Verify is not required. A provider will only be required to use E-Verify with employees assigned to a Federal contract when there is a separate contract with a Federal agency to provide specific health care items (i.e. pharmaceuticals or devices) or specific services delivered through a Government-sponsored health plan. In addition, Medicare administrative contractors and fiscal intermediaries will also be required to use the E-Verify System.

White House Announces Funding for Medical Tort Reform Demonstration Projects

On September 17, 2009, the White House released a “Patient Safety and Medical Liability Reform Demonstration” Fact Sheet, which outlines a new $25 million Department of Health and Human Services initiative designed to help states and health care systems identify new models for managing medical liability claims. The three-pronged initiative will support competitive grants to states and health systems with a focus on the development, implementation and evaluation of alternatives to improve health care quality and patient safety while reducing medical liability.

The Funding Opportunity Announcement will be available within 30 days. The Agency for Healthcare Research and Quality will review applications and make award decisions in early 2010.

The evaluation of the initiative will be released publicly within 18 months of the end of the initiative. The evaluation will focus on short-term improvements in both patient safety and medical liability systems with an allowance for long-term assessment of improvements as well.

China Launching National Essential Drug System

This post was written by Hugh T. Scogin, Gordon B. Schatz, Amanda Tao and Amanda Yang .

The Chinese government officially launched the National Essential Drug System (NEDS) Aug. 18, 2009 at a press conference held by the State Council, during which it explained the concentration of specific drug purchases in urban and county grass-roots health institutions as the first step in the implementation of NEDS. By 2009, NEDS will be implemented in 30 percent of government-run urban and county health care institutions in each province, region, or municipality. NEDS could have significant implications for the marketing, sale, distribution, and pricing of drugs by multinational and Chinese pharmaceutical companies in China.

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New Developments in Nanotechnology

A recent study suggests that exposure to nanoparticles may have caused the death of two female workers and the illnesses of five others in China. Life science health industry companies that manufacture, integrate, sell or buy products that contain nanomaterials may want to monitor reaction to this report, which may garner attention from media outlets, scientists, regulators and the plaintiffs' bar. For a full discussion of these issues, review the full Client Alert written by Reed Smith attorneys Antony Klapper, Jesse Ash and David Wagner.

Reed Smith Global Regulatory Enforcement Alert, "Significant Regulatory Changes to U.S./Cuba Sanctions to Benefit U.S. Telecommunications, Health Care, and Agriculture Companies"

Health care companies interested in doing business in Cuba may want to learn more about recent regulatory changes to U.S. economic sanctions promulgated by the U.S. government. Due to the difficult political situation on the island, doing business in Cuba remains challenging; however, U.S. sanctions have traditionally allowed for food, medicine, and other forms of humanitarian travel. The new regulations, in part, allow U.S. persons to travel to the island for "transactions that are directly incident to the commercial marketing, sales negotiation, accompanied delivery, or servicing in Cuba" of medicine and medical devices. Finally, U.S. companies interested in engaging the Cuba market should also assess the U.S. domestic political considerations that may come with Cuba sales.

To read the full Client Alert, written by Reed Smith attorneys Leigh T. Hansson and Jason I. Poblete, please click here.

FTC Issues Final Rule on Notifying Consumers About Breaches of Electronic Health Records

This post was written by Mark S. MelodiaMichael K. BrownJ. Ferd Convery, IIISteven J. Boranian, Brad M. Rostolsky, Shana R. Fried and Paul Bond.

Until now, the loss or theft of protected health information rarely resulted in notice to consumers. Very few state data security breach notification laws encompass medical information. The Health Insurance Portability and Accountability Act ("HIPAA") merely required an "accounting" of such events to a patient upon the patient's request.

All that has changed. Congress, in enacting the Health Information Technology for Economic and Clinical Health Act ("HITECH"), imposed breach notification obligations on many of the individuals and business entities that receive, create, or maintain patients' individually identifiable health information. Pursuant to HITECH, on Aug. 17, the Federal Trade Commission ("FTC") issued its Health Breach Notification Rule, governing the breach notification obligations of three new categories of entity: "vendors of personal health records," "PHR related entities" and "third party service providers."

To read the full alert, click here.