Remember Bruesewitz v. Wyeth? That’s the case about the Vaccine Act and express preemption. It made our top ten list last year. Bruesewitz and it’s evil twin, Wyeth v. Ferrari, appeared for a while to be headed for the Supreme Court together – there being a direct conflict between the two.
One of the interesting things about blogging is that a lot of people seem to consider us part of the “press” – whether that’s the “health” press or the “legal” press. As a result, we get sent a lot of unsolicited press releases, maybe a couple of dozen a week. Most of them are from various small medical-related companies announcing this or that medical advance. Since we’re lawyers, not doctors, we’re not competent to evaluate such things, nor would product reviews be what our chosen audience wants to read. Those emails get the “delete” button, even though they’ve occasionally offered us money for reviews.
But part of the litigation dance these days also involves the press. One thing that the other side does is try to make itself as obnoxious as possible to our clients any way they can. There’s good reason for it. It’s part of the game; their rationale being that anything that annoys our clients increases the settlement value of their cases. Even if a case is lousy and has only a nuisance value – the bigger the nuisance, the bigger that value will be. Or so a lot of folks on the other side thinks.
Among other things, plaintiffs’ lawyers pursue this annoyance function by trying to generate negative buzz about our clients in the media. So they (or their PR flacks) send out press releases too. And they send them out to bloggers and other media types who aren’t really competent to make heads or tails of what they’re getting. In particular, the other side throws adjectives like “illegal” and “fraudulent” around as if they’re so much confetti – or, if (like us) you’re less inclined to be charitable, a smokescreen. Toss in a few vague but dark hints about safety risks, and the other side hopes it can generate negative press. We know all about this as lawyers; it’s part of the drill, especially in the major litigation that we get called upon to defend.
But sometimes the plaintiff side’s offerings to the press find their way to us – as bloggers.Continue Reading Qui Tam Action Looks Like A Ripoff
We read lots of cases. A few are flawless and a few have no redeeming features, but most have a little bad mixed with the good, or vice versa. We tend to be curmudgeonly, even though we are down a curmudgeon, and we will fuss about a flaw in a opinion that rules in favor
We’ve always thought that the FDA’s close regulation of SSRI’s (selective serotonin reuptake inhibitors) and the issue of suicide was among the best fact patterns for preemption. So did the FDA – it entered the preemption field to preserve its control over the labeling of these drugs.
If our side can’t win the preemption fight after
We’re feeling uncharacteristically magnanimous after last night’s USA Olympic hockey victory, so we’ll cheerfully report on a recent pharma innovator-liability case from the True North. In Goodridge v Pfizer Canada Inc., 2010 ONSC 1095 (Feb. 18, 2010), the plaintiffs claimed injuries from off-label use of Neurontin and its generic version. We tip the cyber
Back in April we posted about the “funky” non-manufacturer claims in Timberlake v. Synthes Spine Co., 2009 U.S. Dist. Lexis 29074 (S.D. Tex. Mar. 31, 2009). Those claims – trying to hold people who conducted clinical trials liable in a post-approval case for alleged misconduct in how the trials were conducted – were dismissed, but
In an (unfortunately) not-for-publication opinion, the 9th Circuit affirmed a defense summary judgment in Carson v. Depuy Spine, Inc., No. 08-56698, slip op. (9th Cir. Feb. 16, 2010). There’s nothing particularly interesting about the affirmance as to the manufacturing defect claim. But what the court had to say about plaintiff’s allegations concerning off-label promotion
This post is about un-preempted fraud on the FDA claims and how to approach them….
“Heresy!” We hear you shout. “There’s no such thing as an unpreempted fraud on the FDA claim – at least one not brought by DoJ on behalf of the FDA itself. You guys have said so yourselves, in your
Readers of this blog know that we have strong opinions about many issues. We like Twombly/Iqbal. We hate junk science. And we really, really like preemption.
On some issues, however, we don’t have strong views, such as most choice-of-law issues. There are some choice-of-law issues about which we care deeply – for example we
We have no intention of wading into the treacherous (and heated) debate about Citizens United v. Federal Election Com’n, ___ S. Ct. ___, 2010 WL 183856, slip op. (U.S. Jan. 21, 2010), an early frontrunner for hot-button Supreme Court decision of the year, especially after President Obama’s State of the Union speech. We leave it to the general constitutional law types to debate the pros and cons of the application of the First Amendment to campaign contributions.
But to our readers (some of whom are also clients): Pssst – we have elected judges here in Pennsylvania, and we could do with more good ones.
But here at Drug And Device law, we are interested – very interested – in specific aspects of First Amendment jurisprudence. Just click on the First Amendment topic tab over on the right hand side of your screen, and you’ll see what we mean.
Thus we’ve studied the lengthy opinion in Citizens United to divine whether there are any usable soundbites that we could employ in support of a First Amendment challenge to FDA’s ability to regulate off-label promotion (previously blogged about here, here, here, and here – and elsewhere).Continue Reading Weighing In On Citizens United