Increased Scrutiny of Pharmaceutical Company Clinical Trials: The Defense Perspective
August 01, 2006
In recent large-scale pharmaceutical litigation, plaintiffs' counsel have concentrated significant resources seeking the details of how individual patients in pre- and post-marketing company clinical trials were assessed, characterized, and reported to the Food and Drug Administration ('FDA'). The reason is clear: They are seeking to develop (in the author's opinion unfairly) a story that the pharmaceutical company hid risks and overstated benefits. The efficacy and safety data generated by industry-sponsored studies, and the manner in which the data are analyzed and reported, have therefore become the focus of large-scale pharmaceutical litigation.
Products Liability and the Illegal Acts Doctrine
August 01, 2006
In products liability cases in most states, a plaintiff's conduct that contributes to his or her harm does not bar a claim, but instead may be considered by the jury in weighing the comparative fault of the parties. But should a case even have to go to a jury when the very harm that the plaintiff is suing for resulted from the plaintiff's own criminal misconduct?
Coverage Disputes Involving Multiple Insureds or Claimants
July 31, 2006
Coverage disputes may become more complicated when multiple co-insureds or claimants assert rights to coverage under the same finite set of policy limits. For instance, some policyholders have argued that when co-insureds are seeking coverage under the same policy, the insurer must reserve a portion of the available policy limits for each insured so as to ratably distribute the available funds ' even while presently pending claims remain outstanding against one of those insureds. If this were correct, however, the insurer would be placed in an untenable position. If the insurer is required to forego the reasonable settlement of presently pending claims in order to preserve shared limits for co-insureds, the insured facing outstanding claims could argue that the insurer violated its good faith duty to settle on its behalf when the opportunity arose. On the other hand, other co-insureds might later argue that the insurer violated the duty of good faith by failing to preserve adequate limits for future claims ' leaving the insurer in what is essentially a no-win situation.
Occurrence Limits Under Multi-Year Policies: NJ Courts Are Changing Their Approach
July 31, 2006
In complex coverage cases involving 'long-tail' claims (such as asbestos bodily injury claims or property damage claims related to environmental pollution), decades of insurance policies can be put at issue. In many states, the policyholder's losses will be spread across the years in which the injury or property damage occurred on a proportionate basis, typically referred to as 'time on the risk' or pro rata allocation. <i>E.g., Security Ins. Co. of Hartford v. Lumbermens Mut. Cas. Co.</i>, 826 A.2d 107, 116 (Conn. 2003); <i>Sharon Steel Corp. v. Aetna Cas. & Sur. Co.</i>, 931 P.2d 127, 141 (Utah 1997); <i>Insurance Co. of N. Am. v. Forty-Eight Insulations, Inc.</i>, 633 F.2d 1212, 1224-25 (6th Cir. 1980).
Court Watch
July 31, 2006
Highlights of the latest franchising cases from around the country.
Compliance Programs for Private Companies
July 31, 2006
We all know that a proactive Securities Exchange Commission (SEC), combined with implementation of the Sarbanes-Oxley Act of 2002 (SOX), and activation of the Public Company Auditor Oversight Board (PCAOB), has triggered intense scrutiny on corporate ethics and accountability. One by-product of this is that the public company has come to serve as a mentor of sorts to the private company in the arena of corporate compliance programs, offering certain 'best practices' that may also be useful to the privately held company, its management, and its shareholders or owners.
<b>Product Review:</b> A Solution For Today's Data-Intensive Litigation Workflows
July 31, 2006
Bowman and Brooke LLP has 160 trial lawyers coast-to-coast in Minneapolis, Phoenix, Detroit, San Jose, CA, Los Angeles and Richmond, VA. Together, the firm defends corporations in products liability, toxic torts and other high-stakes litigation throughout all 50 states. <br>The nature of the firm's work ' and litigation in general ' is collaborative, and often dependent upon massive amounts of data. The explosion of documentary evidence brought on by compliance and electronic discovery obligations has made finding, organizing, analyzing and understanding case evidence more challenging than ever before.
Practice Tip: Toxic Cases ' Proceed with Caution
July 31, 2006
All product liability cases are difficult; however, toxic product cases that involve a substance that has caused injury during its use or application pose more of a problem than most others. For example, some spray paints may contain toxic substances that are part of the composition of the product. The warnings on such products are covered by the Federal Hazardous Substances Act ('FHSA'), which requires hazardous household products sold in interstate commerce to contain cautionary labeling, 15 USCA 1261. (A hazardous substance is toxic, an irritant, or a strong sensitizer if the substance may cause substantial personal injury or illness as a result of any reasonably foreseeable use.)
'Involuntary Dismissal' of the 'Innocent Seller': Continuing Choice of Law Issues in Products Liability MDL Proceedings
July 31, 2006
In multidistrict litigation ('MDL') proceedings involving product liability claims, the choice of what law to apply continues to be a thorny issue. For instance, in <i>In re Ephedra Products Liability Litigation</i>, No. 04-1598 (S.D.N.Y) (the 'Ephedra MDL'), Judge Jed S. Rakoff of the Southern District of New York raised the question of whether the Restatement of the Law Third of Torts could be applied as the universal law applicable to all claims in the proceeding. <i>See</i> Case Management Order ('CMO') No. 4 at '11, July 9, 2004. Judge Rakoff later concluded, at the Sept. 10, 2004 Status Conference, that application of such a 'universal law' would be inappropriate. Such choice-of-law issues, however, remain problematic. That is so not only with regard to substantive law, but with regard to procedural law as well.
