Friday, March 20, 2009

Albany Law School Symposium on Off-Label Prescription of Drugs

As I previously briefly noted, Albany Law School is hosting on Friday, March 27 a symposium entitled, Regulating the Cure: Topics Arising Out of the Prescription of Drugs Off-LabelI will be speaking about liability from off-label promotion of drugs.  Other participants include Dean Thomas Guernsey (Albany Law); Professors Beverly Cohen (Albany Law), Michael Kane (Albany College of Pharmacy & Health Sciences), Alicia Ouellette (Albany Law), Sarah Scarpace (Albany College of Pharmacy & Health Sciences), and Dan Thompson (Alden March Bioethics Institute); Mollie Hertel (U.S. Government Accountability Office); and practitioners Eric Chaffin (Bernstein Liebhard), Arnold Friede (McDermott, Will & Emery), Patrick Igoe (Registered Patent Attorney), and Raul Tabora (Ruffo, Tabora).  Here's a link to the brochure.


March 20, 2009 in Conferences, FDA, Mass Tort Scholarship, Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Higbee Denies Class Cert for N.J. Vioxx Users

Superior Court Judge Carol Higbee of New Jersey denied class certification to Vioxx users in Kleinman v. Merck & Co., Inc.  Plaintiffs alleged that Merck violated New Jersey's Consumer Fraud Act by deceptive marketing practices.  The proposed class definition included users from every state but California, where a similar action is pending.  Here's an excerpt of an article about the decision in the New Jersey Law Journal:

But Higbee found the plaintiffs failed to meet the class-action requirement of predominance, because questions affecting individual members outnumbered issues of law or fact common to the class.

To prove a consumer fraud claim, the plaintiffs would have to show that Merck acted unlawfully, that each class member sustained an ascertainable loss and that the unlawful conduct and ascertainable loss had a causal nexus. The first two issues could be put to a jury, but the third is "an insurmountable barrier," Higbee wrote.

A determination of whether Merck's concealment of risks had a causal relationship to each individual's decision to purchase Vioxx would require an "individualized determination" of the factors that led each class member to buy the drug, such as the person's medical history, current condition and use of other pain-relieving drugs.

The plaintiffs also failed to show that the claims of their class representatives are typical of the claims or defenses of the class. Plaintiff Elaine Kleinman's doctor testified that he would continue to prescribe Vioxx if it were still available and said he took it himself, even after it was pulled off the market. Since other plaintiffs' doctors are likely to feel Merck deceived them, the views of Kleinman's doctor go against the typicality requirement, Higbee wrote.

Finally, Higbee found the plaintiffs failed to show that a class action was a superior way of settling the matter. While recognizing that individual consumers may have no other means of resolving their claims, she said the lack of predominance would make the case unmanageable, even if the class were restricted to New Jersey.

David Cohen, one of the eight plaintiffs' lawyers in the case, agrees that litigation of claims of this size is impracticable without class certification. The two named plaintiffs, Kleinman and Ronald Martin, claim damages of less than $1,000 each. No decision has been made on whether to appeal, says Cohen, of Philadelphia's Saltz, Mongeluzzi, Barrett & Bendesky.


March 20, 2009 | Permalink | Comments (0) | TrackBack (0)

Wednesday, March 18, 2009

Managing Mass Tort MDLs

A new article on managing mass tort multidistrict litigations -- Charles Silver and Geoffrey Miller, The Quasi-Class Action Method of Managing Multidistrict Litigation -- has just been posted on SSRN.  If any mass tort lawyers reading this blog have a chance to look at the article, I'd be very interested in your responses to the proposals therein.  Is their diagnosis of the problem correct?  What do you think of their proposal to solve it?  What are the unforseen results this proposal might cause? 

Here is the abstract:

This article uses three recent multi-district litigations (MDLs) that produced massive settlements -- Guidant ($240 million), Vioxx ($4.85 billion), and Zyprexa ($700 million) -- to study the emerging quasi-class action approach to MDL management. The approach has four components: (1) judicial selection of lead attorneys; (2) judicial control of lead attorneys' compensation; (3) forced fee transfers from non-lead lawyers to cover lead attorneys' fees; and (4) judicial reduction of non-lead lawyers' fees to save claimants money. These widely used procedures have serious downsides. They make lawyers financially dependent on judges and, therefore, loyal to judges rather than clients. They compromise judges' independence by involving them heavily on the plaintiffs' side and making them responsible for plaintiffs' success. They allocate monies in ways that likely over-compensate some attorneys and under-pay others, with predictable impacts on service levels. They also lack needed grounding in substantive law because the common fund doctrine, which supports fee awards in class actions, does not apply in MDLs. Academics have not previously noted these shortcomings; this is the first scholarly assessment of the quasi-class action approach.

This article also proposes an alternative method of MDL management. It recommends the creation a plaintiffs' management committee (PMC) composed of the attorney or attorney-group with the most valuable client inventory, as determined objectively by the trial judge. The PMC, which would have a large interest in the success of an MDL, would then select and retain other lawyers to perform common benefit work (CBW) for all claimants and monitor the lawyers' performance. The new approach would thus use micro-incentives to organize the production of CBW in MDLs rather than judicial control and oversight. The court would stand back from the process, exercising only a limited backup authority to prevent abuses. If enacted as a statute, the proposal would restore judges' independence, preserve lawyers' loyalties, provide the requisite legal foundation for fee awards, and encourage the fairer, more efficient, and more appropriate representation of claimants in MDLs.


March 18, 2009 | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 17, 2009

Margaret Hamburg Picked to Head FDA

Article in the Wall Street Journal -- Hamburg, Pick for FDA, Faces an Agency in Crisis, by Alicia Mundy.  Here's an excerpt:

President Barack Obama's choice to lead the Food and Drug Administration faces several crises at the beginning of her term.

If confirmed by the Senate, Margaret "Peggy" Hamburg will take the helm of an agency under investigation on multiple fronts on Capitol Hill. It has struggled to address problems involving imported drugs such as heparin from China. There have been high-profile outbreaks of illness from peanut butter and tomatoes. And a seemingly endless line of FDA scientists have complained to Congress about agency decisions.


March 17, 2009 in FDA | Permalink | Comments (0) | TrackBack (0)

Sunday, March 15, 2009

William Rubenstein Joins Mass Tort Litigation Blog as Co-Editor

Rubenstein_07Welcome to Professor William Rubenstein (picture, left) of Harvard Law School, who joins the Mass Tort Litigation Blog as co-editor!  We're delighted he's joined us -- welcome aboard!


March 15, 2009 | Permalink | Comments (0) | TrackBack (0)