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Clinical trial agreements can almost always be negotiated. Most part-time investigators, however, do not have the necessary legal expertise or time to interpret the agreement and conduct an effective negotiation. Proper legal representation at present requires an attorney who is expert in this very specialized field. Because sponsor negotiators often have huge backlogs of contracts in process, and over half of part-time investigators do not negotiate (or even read) the clinical trial agreement, an investigator who opens a negotiation may never emerge from the queue.
In recent years, during <i>voir dire</i>, plaintiffs in medical malpractice cases have sought to ask jurors about their attitudes regarding "tort reform" and the so-called "medical malpractice crisis." These efforts have increased as those issues have moved to the political front burner, receiving considerable media coverage. Only a few courts have considered the validity of such questions, but of those that have, plaintiffs generally have been permitted to inquire as to a potential juror's views on those issues, though some courts have limited the line of questioning.
In product liability, toxic tort, and even medical malpractice litigation, the science in the relevant field is often a crucial battleground, and expert witnesses will do battle over treatises, journal articles, and the like. As every law student knows, scientific publications are inadmissible hearsay. Under the learned treatise rule, an expert witness may testify about scientific publications that have been qualified as learned treatises, but they do not come into evidence and so may not be published to the jury.
Highlights of the latest product liability cases from around the country.
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The Web site <i>www.pharmacist.com</i> is the single-source site for the continuous professional development needs of pharmacists, pharmacy students, and pharmacy technicians. The site is a joint project of the American Pharmacists Association and the National Association of Boards of Pharmacy.
An interesting case in New Jersey might provide an answer to a significant question on employers' liability under workers' compensation statutes and, by association, manufacturers' liability under defective-design theories. The issue: How does a plaintiff prove "substantial certainty" of injury in order to proceed under common law standards against the employer, as opposed to recovering under workers' compensation?
Our previous article in the March issue reviewed punitive damages awards since the U.S. Supreme Court's decision in <i>State Farm Mutual Automobile Insurance Co. v. Campbell,</i> 538 U.S. 408 (2003). This month we will look at the way the Court's directives impact pretrial activities, evidentiary issues, and jury instructions in our cases.
By and large, the FDA has confined its participation to cases where it had specifically considered — and rejected — the plaintiffs' claims that a product's labeling or advertising should have included different language from that which was used. <i>See</i> Daniel E. Troy, <i>FDA Involvement in Product Liability Lawsuits,</i> Update: Food & Drug. L., Reg. & Educ. (Food & Drug Law Inst., Wash., D.C.), Jan./Feb. 2003, at 1. In 2004, however, the FDA submitted a brief in a state products liability action that signals the agency's willingness to be much more aggressive in protecting its jurisdiction from lay judge and jury determinations concerning a product's risk-benefit balance that conflict with the FDA's own determination of where that balance lies. <i>See Br. of Amicus Curiae U.S. Dep't of Justice, Horn v. Thoratec Corp.</i>, 376 F.3d 163 (3d Cir. 2004) (No. 02-4597) ("FDA Br.").
