Case Notes
Highlights of the latest product liability cases from around the country.
Inadvertent Disclosure of Privileged Material: Complex Ethical Issues for the Recipient
Courts typically do not treat an inadvertent disclosure of documents protected by the attorney-client privilege as a waiver. When, however, a lawyer receives documents from the opposition that appear privileged, the issues quickly become complex. Questions arise as to the appropriate response. Unlike challenging a claim of privilege asserted in a privilege log, when the full substance of the communication is revealed through an inadvertent production, there is often a powerful incentive to challenge the applicability or scope of the privilege.
Back to the Drawing Board for Asbestos Pre-Packs? The Third Circuit's Opinion in Combustion Engineering
The decision by the Third Circuit Court of Appeals overturning confirmation of a Chapter 11 plan in the Combustion Engineering ("CE") bankruptcy case has significant consequences for mass tort bankruptcies, and especially for asbestos "pre-packaged" or "pre-pack" cases. While courts have traditionally given mass tort debtors some leeway and flexibility in applying the provisions of the Bankruptcy Code, this court was clearly troubled by the particular design of the CE pre-pack, a model that has been subsequently used in other asbestos pre-pack cases. In a lengthy and far-reaching opinion issued in December 2004, the Third Circuit's ruling in the CE case may have fundamentally changed the strategy, negotiation dynamic, and structure of pre-pack asbestos bankruptcy cases.
Online: Vioxx Information from Merck Available on the Web
For information about Vioxx directly from Merck, visit <i>www.vioxx.com</i>. The site posts the announcement of the withdrawal on Sept. 30, 2004, explaining that the voluntary worldwide withdrawal of VIOXX' (rofecoxib) was based on 3-year data from a prospective, randomized, placebo-controlled clinical trial, called the APPROVe (Adenomatous Polyp Prevention on Vioxx) trial. The trial, which was stopped, was designed to evaluate the efficacy of Vioxx 25 mg in preventing recurrence of colorectal polyps in patients with a history of colorectal adenomas. The announcement explains that in the study, there was an increased relative risk for confirmed cardiovascular events, such as heart attack and stroke, beginning after 18 months of treatment in the patients taking Vioxx compared with those taking a placebo. According to Merck, the results for the first 18 months of the APPROVe study did not show any increased risk of confirmed cardiovascular events on Vioxx, and in this respect, are similar to the results of two placebo-controlled studies described in the current U.S. labeling for Vioxx.
Vioxx Multidistrict Litigation Judge Profile: A Closer Look at the Odds
Statistical analysis of federal litigation provides a unique insight into particular judges involved in a case, including information on the probable timing/outcomes of cases, and what significant motions are generally granted or denied before a federal judge. Answers are based on verifiable facts, rather than anecdotal assumptions, and provide interested parties with more accurate data.
Vioxx and the FDA Advisory Committees: Yesterday, Today, and the Search for Tomorrow
Amid a cacophony of wailing and gnashing of teeth decrying the Food and Drug Administration's ("FDA's") failure to protect the public from unsafe drugs, the FDA held an emergency advisory committee meeting, which included consultants, to address the safety issues associated with the use of COX-2 selective and non-selective non-steroidal anti-inflammatory drugs ("NAIDs"). The meeting was scheduled and held at warp speed. It provided a transparent dispassionate opportunity to address the safety issues for scientists, affected parties and the public. The decisions of the advisory committee were to some extent, unexpected. This accelerated review process differs from the current advisory committee process of reviewing limited data in a product pre-approval setting. However, this use is a natural extension of the FDA's historic use of advisory committees, <i>ie</i>, analysis of voluminous data on any active ingredient over a period of years and application of the analysis to specific drug products containing the active ingredient.
A Plaintiff's Perspective
Dr. David Graham, a courageous FDA expert, blew the whistle and started a cascade of events that ultimately led to Merck & Co., Inc.'s withdrawal of its blockbuster drug Vioxx. Recently, he testified in Congress that Vioxx could be "the single greatest drug catastrophe of this country." Various experts have postulated that Vioxx may be directly responsible for 20,000 to 160,000 heart attacks or strokes with perhaps as many as 40,000 deaths.
Merck's Strategy for Dealing with Vioxx: Why the Old Recipes for Success Won't Succeed
It seems that the same question is asked every time two pharmaceutical plaintiffs' lawyers get together these days: "Don't you think Merck can just pull a Baycol?" Referring to Bayer's strategy for resolving the recent litigation over Bayer's dangerous — and withdrawn — statin drug, these lawyers are concerned that Merck, like Bayer, can somehow escape compensating thousands of victims. No doubt due to the widely read article in The Wall Street Journal (May 3, 2004) that essentially gave Bayer an "academy award" for its handling of Baycol, reporters across the country, trying to analyze the emerging Merck debacle last fall, were asking the same question of their trial lawyer interviewees. What these inquiring minds are inquiring about is whether Merck, clearly faced with thousands of actions, can "lump and split" them. On the one side, Merck would place a very large pile of cases it deems non-compensable, and on the other, a much smaller pile comprised of those cases that Merck will agree to discuss and value. The answer to this question seems to be, at this relatively early date, that even if Merck wishes it could approach the problem this way, it cannot. Moreover, it cannot use the strategy it used in the phenylpropanolamine ("PPA"), Propulsid, or Rezulin litigation, either. In fact, any attempt to apply the strategies employed in those litigations may end in sheer disaster.
A Word from the Defense: Is Defending Vioxx a Recipe for Disaster? Take a Careful Look at Who Is Sounding the Alarm
The message from our plaintiffs' lawyer colleagues has been steady and direct: "Don't bother defending these cases — you're going to lose and you're going to lose big. Just pay us all lots of money now and save yourself a lot of pain and agony." And what other message would they send? Their goal is to reap the highest reward from the least amount of effort. Litigating every case on every level; financing and staffing hundreds of complex trials, and waiting for final appellate review of every verdict is no way to run a mass tort practice — at least not from the plaintiffs' perspective. Given this author's perspective, it makes sense to examine the options more carefully before deciding that the only way to avoid ruin is to wire massive sums into the trial bar's trust accounts.
New HSR Rules for Transactions Involving Partnerships and LLCs
Forget what you know about the Hart-Scott-Rodino Antitrust Improvements Act (HSR) and partnerships. Forget what you know about HSR and LLCs. The rules have changed ' again. The good news is that the rules make more sense, and certain exemptions to the filing requirements have been codified or expanded. The bad news is that a small number of deals that used to slide under the HSR radar may now be caught. More strategically speaking, the rules now provide more opportunities to "choose" whether your next joint venture will be subjected to substantive agency review under the HSR scheme, heightening the value of HSR counselors' advice on structure issues at early planning stages.
