<i>'Men occasionally stumble over the truth, but most of them pick themselves up and hurry off as if nothing ever happened.'</i> In this author's opinion, Winston Churchill's keen observation of human nature is an apt description for how the pharmaceutical industry deals with dangers revealed or at least signaled in clinical trials. For years, plaintiffs' lawyers have honed in on clinical trials conducted by pharmaceutical companies when preparing for and trying cases. These studies, often the banner touted by defendants as evidence of their innocence, are a natural place to begin the search for what went wrong when a drug is subsequently pulled from the market despite the supposed 'rigors' of clinical testing. While there is nothing new about plaintiffs' lawyers reviewing clinical trials with a fine-toothed comb, there has been a radical and bold step taken in the world of medical/science academia. Specifically, major publications such as the New England Journal of Medicine ('NEJM') and the Journal of the American Medical Association ('JAMA') are ensuring that industry-sponsored studies do not merely contain partial truths.
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.
Whatever happened to the title agents licensing bill? At one point, it 'had to happen.' Innumerable meetings were held. Forests were felled to provide the paper to print and distribute various drafts of proposed bills. Lincolnesque letters and articles were written and published. E-mails clogged up thousands of mailboxes. And now silence. There may very well be a bill on the Governor's desk in the near future. This article represents an attempt to explain why the agent-licensing bill is not there yet. The opinions expressed are the author's own, have no official sanctions and do not advocate any particular version of the bill.
The Article 8 opt-in election adds an additional layer of complexity to the already labyrinthine rules governing perfection of security interests under the UCC. A lender that is unaware of the nuances created by the opt in (may find its security interest vulnerable to being primed by another party that has taken steps to perfect in a superior manner under the circumstances.
With each successive large-scale cyber attack, it is slowly becoming clear that ransomware attacks are targeting the critical infrastructure of the most powerful country on the planet. Understanding the strategy, and tactics of our opponents, as well as the strategy and the tactics we implement as a response are vital to victory.
The owner of a commercially successful patent may have competing desires. On one hand, the patent owner wants to protect the patent and secure its maximum benefit; on the other hand, the patent owner wants to avoid enforcement litigation with competitors because it is expensive and puts the patent at risk.
The doctrine of equivalents is a rule of equity adopted more than 150 years ago by the U.S. Supreme Court. Prosecution history estoppel is a rule of equity that controls access to the doctrine. In May 2002, the Court was called upon to revisit the doctrine and the estoppel rule in <i>Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushiki Co. Ltd.</i> Ultimately the Court reaffirmed the doctrine and expanded the estoppel rule, but not without inciting heated debate over the Court's rationale — especially since it included a new and controversial foreseeability test in its analysis for estoppel.
In 1987, a unanimous Court of Appeals reaffirmed the vitality of the "stranger to the deed" rule, which holds that if a grantor executes a deed to a grantee purporting to create an easement in a third party, the easement is invalid. Daniello v. Wagner, decided by the Second Department on November 29th, makes it clear that not all grantors (or their lawyers) have received the Court of Appeals' message, suggesting that the rule needs re-examination.
