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24 Jan 2011, 3:15 pm by FDABlog HPM
” The Ninth Circuit’s decision that there is no impossibility of compliance in this case (as in Demahy and Mensing) is based on the Court’s determination that the FDC Act provides generic drug manufacturers “with at least three separate mechanisms by which they can discharge their state-law duty to warn of additional risks associated with their products: (a) the CBE process approved by the Supreme Court in Levine; (b) the ‘prior approval’… [read post]
7 Jan 2011, 12:09 pm by Bexis
Ohio, like most states doesn't impose any duty to warn of scientifically unknown information:There is no duty to warn of unknown and unknowable hazards. [read post]
5 Jan 2011, 9:37 am by Will
The court thus had to decide whether any such “duty to test” arises under Virginia law.Relying on prior Virginia Supreme Court precedent, the court concluded that a “manufacturer’s duty to warn of a product’s dangers imposes no underlying duty to conduct additional studies or tests because a failure to warn claim rests on a reason to know standard rather than the broader should have known standard. [read post]
3 Jan 2011, 5:49 am by Steve McConnell
Novartis argued that controlling Montana learned intermediary precedent extended the duty to warn only to the prescriber. [read post]
31 Dec 2010, 11:31 am by Bexis
  Two things:Yesterday the Montana Supreme Court, reaffirmed the learned intermediary rule, although holding that the duty to warn extended to all of the medical personnel - including nurses - who treated the plaintiff. [read post]
29 Dec 2010, 9:30 am by Brian A. Comer
This exception to the duty to warn includes dangers that are open, obvious, or matters that should be “common sense” to the user. [read post]
24 Dec 2010, 8:06 pm by lawmrh
The appeals court said the duty to warn only arises “to other persons within the foreseeable ambit of danger. [read post]
22 Dec 2010, 12:39 pm by Bexis
  It’s not quite as bad as Wimbush because at least Mason involved a warning claim. [read post]
10 Dec 2010, 5:49 am
To make matters worse, Align has known since at least 2007 that its product can cause life-threatening allergic reactions, but failed in its duty to warn customers and the FDA. [read post]
9 Dec 2010, 6:57 am by Brian A. Comer
A seller has no duty to warn about the risks associated with such products from extended or excessive consumption. [read post]
8 Dec 2010, 7:44 am by Sean Wajert
Meade; (3) PLIVA satisfied any alleged duty to warn by providing a package insert explaining potential side effects of metoclopramide. [read post]
7 Dec 2010, 4:30 am by Mary Giorgi
The defendants asserted that "this court committed clear error in holding that [defendant], as a matter of law, had a duty to warn of the risk of heat exhaustion and heat stroke, and in extending the duty to non-injured, non-users of the products, i.e. the Vikings' trainers and coaches. [read post]
1 Dec 2010, 11:34 am by David Walk
PLIVA then moved for summary judgment based on lack of proximate cause.The court first noted that the West Virginia Supreme Court of Appeals had held that drug manufacturers had a duty to warn consumers but had not clarified whether they also had a duty to warn the physician. [read post]
18 Nov 2010, 1:56 pm by Pamela Pengelley
Similarly, it may be argued that distributors and retailers of brass plumbing fixtures have a duty to warn customers of the well known risks posed by the use of plumbing fixtures comprised of uninhibited brass containing greater than 15% zinc. [read post]
15 Nov 2010, 9:39 am
Duty to Warn Maritime law imposes the duty upon cruise lines to warn of dangerous conditions. [read post]
20 Oct 2010, 7:00 am by Jacksonville Personal Injury Attorney
If parents have a trampoline in their yard, they have a duty to warn other children of the dangers otherwise, the injured person may have a claim against the homeowner. [read post]
14 Oct 2010, 4:45 pm by Colin O'Keefe
Distracted Driving Lawsuits: Who Can You Sue for Loved One's Injury or Death in Distracted Driving Car Crash - Is There a Doctor's Duty to Warn? [read post]
13 Oct 2010, 5:00 am by Brian A. Comer
From doing research on warnings and from my experience in litigation, a frequent question that comes up is whether a manufacturer has a post-sale duty to warn, i.e., after the product is sold in the marketplace.South Carolina does not recognize a post-sale duty to warn. [read post]
7 Oct 2010, 1:33 pm
"Plaintiffs argued the Gas Company had a duty to warn them that new steel gas pipes adsorb the odorant in the natural gas and, had they known of this fact, they would not have bled the gas pipe into a confined closet. [read post]