January 31, 2009
Erin Glenn Busby on Wyeth v. Levine
In a Federalist Society SCOTUScast, appellate lawyer Erin Glenn Busby discusses Wyeth v. Levine, the pending Supreme Court case involving whether state tort lawsuits are preempted by FDA approval of prescription-drug labeling.
January 29, 2009
American Pipe tolling in mass torts
Interesting post yesterday at the Drug & Device Law Blog arguing that the American Pipe tolling rule does not make sense in the mass tort context, and praising Beisner and Miller for their arguments along the same lines. In 1974, the Supreme Court held in American Pipe v. Utah that the pendency of a class action tolls the statute of limitations for the claims of the class members. The idea was that if a class action has been filed, even if not yet certified, we don't want each class member to feel the need to file a timely individual action (or to intervene in the class action) to preserve the claim. Rather, the individual class members should be allowed to wait and rely on the class action to protect their interests; if the class action is not certified, then the individuals can go ahead and file claims if they so choose.
Defense lawyers, seeking dismissal of potentially time-barred individual claims, have advanced a number of arguments against applying the tolling rule in mass torts:
(1) Class certification in most mass torts is a long shot, unlike some other types of class litigation.
(2) Individual claimants in mass torts rarely rely on class actions as a reason to postpone individual complaints because (a) class cert is a long shot, (b) claimants don't know whether a class action has been filed, (c) even if they know a class action has been filed, claimants with sizeable claims would file individual complaints anyway, and (d) claimants with very small (negative value) claims would not file individual complaints regardless of a class action.
(3) In mass torts, MDL and statewide centralization and consolidation procedures allow courts to handle an influx of individual claims, so a flood of individual complaints presents less of a downside than thought in 1974.
These arguments are neither new nor ready to disappear. My former colleagues Mitchell Lowenthal and Menachem Feder made similar arguments in a 1996 article, The Impropriety of Class Action Tolling for Mass Tort Statutes of Limitations, 64 Geo. Wash. L. Rev. 532 (1996). More recently, Judge Fallon in the Vioxx litigation acknowledged these arguments but nonetheless faithfully applied American Pipe in denying several of Merck's motions to dismiss on statute of limitations grounds.
January 28, 2009
Investigation into FDA's Medical Device Approval
The New York Times reports that several dissident FDA scientists may be under criminal investigation for their role in approving high-risk medical devices. In response, they wrote a letter to President Obama stating, "It is an outrage that our own agency would step up the retaliation to such a level because we have reported [the FDA's] wrongdoing to the United States Congress. Here's an excerpt of the Times piece:
The letter is the latest escalation in a highly unusual internal battle that has been simmering for nearly a year within the agency’s device division. The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective.
The scientists complained in May to Dr. Andrew C. von Eschenbach, who was then the F.D.A. commissioner, and the agency began an internal review that continues. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one, which also continues.
Three weeks ago, the scientists wrote a similar letter to the president-elect’s transition team. And on Monday, the scientists wrote another letter to President Obama.
Confidential agency documents, which include both e-mail messages and medical reviews detailing the internal dispute were provided to The Times.
It can be a crime for agency employees to reveal documents or information considered confidential by companies seeking agency approval for medical products.
Some of the scientists’ claims about the agency’s device approval process were echoed in a report released two weeks ago by the Government Accountability Office that was also critical of the agency’s device center.
January 27, 2009
WLF program on MDL for mass torts
The defense-oriented Washington Legal Foundation is sponsoring a live webcast entitled Litigate the Torts, not the Mass: Improving the Multi-District Litigation Process, featuring John Beisner and Jessica Davidson Miller of O'Melveny & Myers. The webcast will occur Friday, Jan. 30, 2009, at 10:00 a.m.
January 26, 2009
The Causation Problem in Chemical Exposure Cases
Whereas some toxic substances have signature diseases (asbestos and tobacco come to mind) in other cases causation is difficult for impossible to prove, creating serious legal problems for workers and others exposed to the substances seeking compensation through the tort system. A New York Times article by Felicity Barringer ("Exposed to Solvent, Worker Faces Hurdles") from this past Saturday (January 24, 2009) details the story of a worker trying to obtain compensation for workplace exposure that he believes caused his Parkinsons. While a 2008 study showed increased risk of disease from exposure to the chemical at issue, that does not necessary translate into legal causation for purposes of worker's compensation and/or tort suits.
The article demonstrates how difficult it is to bring tort claims arising out of exposure to various toxic chemicals. As one lawyer stated:
“Most workers who have an occupational disease don’t think they have an occupational disease,” Mr. Metzger said, adding that “the few who might think it are mostly not successful” in getting compensation “because there isn’t a robust body of literature to support the claim.”
This problem demonstrates the interrelationship between our tort system, worker's compensation system, environmental, insurance and healthcare systems. Because we have a weak insurance and healthcare regime and weak regulations, many turn to the tort and worker's compensation systems to support workers who are harmed. But these systems are not well structured or suited to address the problems they are being asked to solve. The currect state of causation doctrine is one reason why.
Pfizer to acquire Wyeth
The deal not only create a pharmaceutical behemoth but would be a rarity in the current financial tumult: a big acquisition that is not a desperate merger of two banks orchestrated by the government. It will also be the first big merger backed by Wall Street in months. While credit has been notoriously tight of late, five banks have agreed to lend Pfizer $22.5 billion to pay for the deal. Pfizer, which has roughly $26 billion in cash, would finance the remainder through a combination of cash and stock.
Every major pharmaceutical company has experienced mass tort litigation, and these two are no exceptions. Pfizer defended the Celebrex and Bextra litigation, and earlier the Bjork-Shiley heart valve litigation. Wyeth (formerly American Home Products) took a huge hit in the fen-phen litigation, and more recently has faced mass litigation over its Prempro and Premarin hormone replacement therapy products.
Last May, Amy Schulman joined Pfizer as its general counsel. Before going in-house at Pfizer, Schulman headed the mass tort practice at DLA/Piper and was lead counsel for Pfizer in the Celebrex-Bextra litigation. In December, Pfizer hired Bradley Lerman as its litigation chief. As a partner at Winston & Strawn, Lerman defended McDonald's in the fast food litigation and worked for Phillip Morris in the Engle tobacco class action.