6/9/2015 The FDA backtracks on labels, Big Tobacco drops its suit. America’s three largest tobacco giants, Phillip Morris USA (owned by Altria Group, Inc.), RJ Reynolds (owned by Reynolds American) and Marlboro, Camel & Newport (owned by Lorillard Tobacco) sued the FDA for overstepping its bounds by considering requiring approval for label changes such as
6/9/2015 Pfizer may have lied about Zoloft birth defects. According to research reports recently uncovered in one of the many suits claiming Zoloft causes birth defects, there may actually be a true causal link. This is despite Pfizer denying such a link. The Big Pharma giant successfully defended one such suit in April; however, the
6/9/2015 Onglyza could lead to heart failure, according to a recently-issued FDA warning. The agency also asked AstraZeneca and Bristol-Myers Squibb, manufacturers of Onglyza, to turn over all of their clinical trial data for review. In addition, the FDA asked that all medical professionals report occurrences of Onglyza side effects, heart-related or not, to the
6/9/2015 Johnson and Johnson settles Arkansas Risperdal suit for $7.8B. The suit has been ongoing for eight years and the state’s AG alleges that J&J’s marketing of the psychiatric drug was flawed. The AG claims J&J misrepresented the drug’s safety and effectiveness, especially concerning diabetes risks. The state will take $2M of the settlement to
6/9/2015 A new class of cholesterol drugs will undergo a preliminary review this week from a Food and Drug Administration (FDA) advisory panel. The drugs, Amgen’s Evolocumab and Alirocumab from Sanofi SA and partner, Regeneron Pharmaceuticals, block a protein called PCSK9, which can prevent the liver from eliminating bad cholesterol. Early studies show the drugs
06/8/2015 Whitening teeth in Alabama is a crime… Unless you’re a licensed dentist. The State Supreme Court handed down a decision upholding a lower court’s ruling that only licensed dentists can provide teeth bleaching services. One wonders, if it’s a violation of public health and safety to bleach teeth as a non-dentist, can non-dermatologists do
6/8/2015 Viagra may increase melanoma risk by 84%. This is hard news to report, but something every man must understand: your “little blue pills” may end up giving you “little brown spots,” according to recent studies showing a correlation between Viagra use and incidence of melanoma skin cancer. At present, only one federal suit has
Statutory law in Texas differs on what fiduciary duties are owed based on the various entities recognized by the BOC. A corporation has extensive statutes directly addressing fiduciary duties of directors while LLC statutes are less clear on what exactly are the default fiduciary duties of managers. Corporations Generally, directors have fiduciary duties owed
When forming an LLC there are certain precautions that owners must take in order to avoid incurring personal liability in connection with your business. The general rule in LLCs is that a member or manager is not personally liable for a debt, obligation, or liability of a limited liability company, including a debt, obligation, or
Inherently Dangerous Products Washington has adopted comment k of the Restatement (Second) of Torts Section 402A, which precludes liability for certain “unavoidably unsafe products.” Moreover, a defendant will not be held strictly liable merely because a product is potentially unsafe, unless it also fails to provide adequate warnings. The Washington Supreme Court has explained that