REMS, Risk and Reward
REMS, or Risk Evaluation and Mitigation Strategy, is a new tool that Congress provided the FDA to ensure the safe use of certain types of prescription drug products. The FDA may require a drug manufacturer to include a REMS in its new drug application when the agency concludes this is necessary to ensure that the benefits of the drug outweigh its risks.
Is Europe Ready for Class Actions?
Several recent developments suggest that the European Union (EU) and some of its individual Member States are preparing to embrace the idea of collective redress mechanisms for consumer claims. Although an effective European collective redress mechanism has yet to materialize, the process toward crafting one is certainly underway.
Practice Tip: Products Class Action Incentive Awards
This article discusses the Ninth Circuit's recent decision in <i>Rodriguez v. West Publishing Co.</i>, 563 F.3d 948 (9th Cir. 2009), that specifically considered the viability of incentive awards and their impact on the adequacy of class representatives.
The 'On-Sale' Bar After Pfaff
<i>Pfaff v. Wells Elecs., Inc.</i> is widely recognized as a milestone in the annals of patent law for providing direction as to how courts are to analyze and apply the statutory "on-sale" bar to the granting of patents. This article explores how the Federal Circuit has applied <i>Pfaff</i> in more recent cases.
FJC's Study of Diversity Jurisdiction Class Actions
In November 2008, as part of its ongoing study of the impact of the Class Action Fairness Act of 2005 ("CAFA") upon federal courts, the Federal Judicial Center ("FJC") published Preliminary Findings from Phase Two's Pre-CAFA Sample of Diversity Class Actions. That report studied 231 diversity jurisdiction class actions filed in or removed to federal court in the two years prior to Feb. 18, 2005, CAFA's effective date.
The Recovery Act's Daunting Whistleblower Provisions
This article describes the type of activity Section 1553 protects and the competing burdens parties must bear in pursuing and defending retaliation claims under this statute. It also provides a framework for assessing the risks Section 1553 poses to employers, identifies questions Section 1553 leaves unanswered, and presents the question of whether a few of Section 1553's provisions pass constitutional muster.
Statistical Lessons of Ricci v. De Stefano
The first part of this article about the Supreme Court's ruling <i>Ricci v. De Stefano</i> discussed what statisticians really have to say about disparate impact. The conclusion herein addresses the results of, and lessons to be learned from, the <i>Ricci</i> case.
Update on Retaliation Claims
If an employee orally complains to a supervisor about the employer's wage practices, which he believes violate the Fair Labor Standards Act ("FLSA"), has the employee engaged in protected activity that may form the predicate to a claim of retaliation under the FLSA?
Changes to Form I-9: Administrative on Their Face; Substantive in Effect
As of April 3, 2009, employers were required to use the new Form I-9 for employment eligibility verification for new employees and applicable re-hires. The new form is the latest step in what has been an unsystematic effort by the United States government to create and enforce immigration laws in the workplace.
