Upcoming WLF Web Program on Congressional Oversight and Investigations

The ability of the Unites States Senate and House of Representatives to conduct investigations and oversight activities in support of their legislative activities is nearly limitless.  The same can be said for their authority to seek information, require testimony, and orchestrate inquisitions where their targets have few of the protections afforded to litigants in the U.S. legal system.  Our speakers for the WLF Web Seminar described below have decades of highly relevant experience in the political, legal, and strategic advocacy realms.  They will provide their concise thoughts and take your questions during this hour-long program.  Sign up for free at www.wlf.org.

Last Week At WLF

New Publications:

From The Legal Pulse:

Finger on the Pulse: From Our Blogroll and Beyond

  • Litigation keeps kids off the best sledding hills in a New Jersey community (Professor Bainbridge)
  • Wisconsin governor signs law imposing limit on punitive damages; countdown to trial lawyers’ “constitutional” challenge of law begins (California Punitive Damages)
  • Interview with leading securities fraud class action plaintiffs’ lawyer on what to expect in 2011 (D&O Diary)
  • News on preemption of state suits vs. innovative medical device makers goes from bad (7th Circuit’s Bausch ruling) to worse (5th Circuit’s Hughes) (Drug & Device Law)
  • Here we go again: media misleadingly reports on breast implant risks, many lawsuits to follow (Drug Wonks)
  • Report on DOJ enforcement of Foreign Corrupt Practices Act in 2011: not a pretty picture for businesses (FCPA Professor)
  • New House of Representatives government oversight panel head asks, businesses respond on what regulations ail them (Shopfloor)
  • Will more businesses become “uncorporations” (i.e. LLCs and LLPs) to free themselves from Dodd-Frank law? (Ribstein @ Truth on the Market)
  • Dow Jones sues to get access to Medicare records (WSJ Law Blog)

FDA’s 510(k) Device Review Improvements: Right Steps But Many Open Questions

Guest Commentary

Neil F. O’Flaherty, Olsson Frank Weeda Terman Bode Matz PC

On January 19, 2011, the Food and Drug Administration (FDA) published its much-anticipated initial plan to revise and improve its pre-market notification (510(k)) review program.  The plan outlines 25 actions or tasks that the Center for Devices and Radiological Health (CDRH) intends to implement or undertake this year as part of its program changes.  Some of the more important action items are the anticipated guidance documents intended to clarify various aspects of the 510(k) review program, including how to appeal CDRH 510(k) decisions, when clinical data are necessary to support a 510(k) submission, when device modifications require a new 510(k) submission, when one can file a special 510(k) submission, and other topics.  Click here for the complete plan for 2011. 

Obviously, FDA’s plans to improve and streamline the 510(k) review process are welcome, and many of the action items have the potential to accomplish these goals.  However, as with many or most government initiatives, the success or failure of the action items will largely rest in how they are implemented by the agency.  Many of them have the potential to assist industry, but they also could create additional burdens for industry if their implementation is not carefully thought through and managed properly. Continue reading “FDA’s 510(k) Device Review Improvements: Right Steps But Many Open Questions”

Court Excludes Expert Who Contradicted His Own Testimony from Mass Tort Drug Case

Guest Commentary

Michael L. Junk, Hollingsworth LLP

On January 18, 2011, the United States District Court for the Western District of Arkansas (Volpe, M.J.) issued an order excluding the expert/opinion testimony offered by Dr. Donald F. Austin on behalf of the plaintiffs in the In re: Prempro Products Liability Litigation.

The court’s decision is remarkable first because it recognized that Dr. Austin’s opinions contradicted not only the plaintiffs’ longstanding medical- and scientific-causation case, but they also contradicted Dr. Austin’s prior testimony for the plaintiffs in the same litigation. 

According to the court, “[s]ince the inception of the litigation” (Slip Op. at 5) the plaintiffs had trumpeted the results of a certain study which showed an association between long-term use of Prempro and an increased risk of breast cancer.  Among numerous other experts, Dr. Austin had himself endorsed the findings and methodology of this study.  “Accordingly, th[e] Court ha[d] consistently found that the . . . study is the most significant and reliable study for considering the risk of breast cancer from Prempro.”  (Slip Op. at 6.)  Importantly, the study found no increased risk of breast cancer associated with short-term Prempro use (i.e., 3 years or less). Continue reading “Court Excludes Expert Who Contradicted His Own Testimony from Mass Tort Drug Case”

Donald Verrilli to be the Next “10th Justice”?

The position of Solicitor General of the United States was created in 1870 by Congress in the Act to Establish the Department of Justice.  The law provides for “an officer learned in the law, to assist the Attorney-General in the performance of his duties, to be called the solicitor-general.” The Department of Justice’s short history of the position notes that the Solicitor General was originally second-in-command to the Attorney General.  While the Solicitor General no longer holds that distinction, he or she wields enormous authority and influence in the development of legal policy in America’s courts, which is why the Solicitor General is often referred to as the “Tenth Justice.”

Yesterday, President Obama nominated White House Deputy Counsel Donald Verrilli Jr. to replace Justice Elena Kagan as Solicitor General.  Don without question meets the requirement of an individual “learned in the law.”   His law practice at Jenner & Block was focused on appellate advocacy and, as Marcia Coyle writes at the Blog of Legal Times, “His cases have ranged from the intricacies of intellectual property, such as his defense of music industry copyrights in 2005, to the complexities of the death penalty, such as his pro bono work in Wiggins v. Smith.”

WLF is proud to have benefited from Don’s generous donation of his time and expertise.  He appeared on several occasions as a featured speaker at our Media Nosh events on the U.S. Supreme Court and its free enterprise cases; spoke at a Web Seminar program on securities fraud litigation; represented WLF on a pro bono basis on an amicus brief we filed supporting a cert petition in a Commerce Clause case; and authored two instructive WLF Legal Backgrounders on Supreme Court decisions.

Wall St. Journal Editorial Sees Environmental Justice as “Case Study” of Loophole in President’s Reg Reform

In its lead editorial today (here, subscription required), “Obama’s Rulemaking Loophole,” the Wall Street Journal added its respected voice to the case  which WLF has been making the past few weeks here at The Legal Pulse and in op-eds (see our post today) that President Obama’s “Improving Regulation” executive order is ineffectively narrow and easily circumvented.  The Journal notes that language in the order creates a possible exception that could swallow the entire guidance:

When the agencies weigh costs and benefits, the order says, they should always consider ‘values that are difficult or impossible to quantify, including equity, human dignity, fairness, and distributive impacts.’

A similar point was made last week by a January 19 post at Point of Law, as well as in a post at the NAM Shopfloor blog, which, we were happy to see, incorporated a passage from a Legal Pulse commentary on environmental justice.

The Journal op-ed also invokes the off-the-radar development of EPA’s environmental justice policies, and these policies’ inherently amorphous nature, in making their convincing case for the loophole in President Obama’s order:

The current EPA is a perfect case study. One of Administrator Lisa Jackson’s top priorities is “explicitly integrating environmental justice considerations into the fabric of the EPA’s process,” as a July 2010 memo to all senior regulators put it. ‘Environmental justice’ is the left-wing grievance movement that claims pollution has a disproportionate effect on minorities and the poor. Ms. Jackson’s memo introduced new regulatory guidance—that is, rules about how to make rules—so every EPA action has ‘a particular focus on disadvantaged or vulnerable groups.’

Ms. Jackson wrote that a new goal for rulemaking, enforcement and permitting is to have ‘a measurable effect on environmental justice challenges.’ But these amorphous concepts are not measurable at all. According to this guidance, EPA must nonetheless consider them when estimating the ‘economic impacts of regulations,’ and even its scientific analysis should ‘encompass topics beyond just biology and chemistry.’ So put on your lab coat and complete a randomized controlled experiment in politics.