In a pair of precedential opinions, the Third Circuit affirmed today the dismissal – for lack of standing- of the Intron off-label promotion RICO class action.
See: In Re: Schering Plough Corp. Intron/Temodar Consumer Class Action, No. 10-3046, 3047, slip op. (3d Cir. May 16, 2012), and In Re: Schering Plough Corp. Intron/Temodar Consumer
First, Bexis wishes to welcome the Blog’s readership from his new office at Reed Smith. A fair amount of PR occurs with significant lateral hires in the law biz, but Bexis promises that it won’t go to his head, even though the folks at 360 decided he deserved a promotion to “guru” status.
Yesterday, we blogged about a case where plaintiff failed to do even the most basic investigation to identify the product at issue before filing suit. She was hoping her case would survive with some vague pleadings in the alternative and a request for discovery. Unfortunately, for now it is. So, since that case left us feeling a little down, we decided to focus today on a case that similarly suffered from a lack of facts — but this one got tossed out. Happy faces back in place.
As this blogging team is made up of parents with children of varying ages, we are all too familiar with homework. So, we are also familiar with phrases such as: “Take your time;” “show all your work;” “follow the directions;” and most importantly – “do your best!” We tell our children that we understand they want to go to the park, text their friends, or drive to the mall — but they have to do their homework. Why? Not just because it is required, but because they will learn something. That’s the point of homework, isn’t it? Not just to torture kids (and parents), but to teach them something. Well, the same is true for lawyers – we need to do our homework. For plaintiffs’ lawyers that means learning the basic facts that support their clients’ claims before they file their lawsuits. And, just like kids who don’t do their homework get zeros – so should plaintiffs.
That is precisely what recently happened in the Darvocet MDL in the context of personal jurisdiction – or lack thereof. The Darvocet litigation involves injuries alleged to have been caused by the prescription pain medication propoxyphene, which is manufactured by several pharmaceutical companies (brand and generic). Shortly after propoxyphene was withdrawn from the market, Endo Pharmaceuticals purchased three companies that had previously manufactured or distributed the drug. In re: Darvocet, Darvon and Propoxyphene Products Liability Litigation, MDL Docket No. 2226 (E.D. Ky. Apr. 18, 2012), slip op. at 2. Plaintiffs filed suit against both Endo and its newly purchased subsidiaries. Id.
As one of several reasons why these cases should be dismissed (including our new one-two preemption punch, see prior post re: Darvocet MDL), Endo asserted lack of personal jurisdiction. While plaintiffs bear the burden of proving personal jurisdiction, as this court recognized, the burden is “relatively slight.” Slip op. at 4. But slight is at least one degree up from nothing, which is what plaintiffs had.Continue Reading Another Homework Failure By Plaintiffs
The more they stay the same.
Things are about to change at the DDLaw blog, but they will also remain the same. First, after more than nine years, Bexis is changing law firms. He’ll be leaving Dechert and joining Reed Smith (still in Philly) on May 14, 2012. The reasons for the change are
We’ve blogged before, occasionally, about drug/device developments north of the border. Most of these developments have involved class action practice, where Canadian law is considerably more liberal than the corresponding rules here in the USA.
But there’s a point at which class actions fail even under Canadian law. That point was recently reached in the parallel Seroquel litigation pending in Ontario. We’re pleased to report that, in Martin v. AstraZeneca Pharmaceuticals PLC, No. 06-CV-314632CP, slip op. (Ont. Super. May 7, 2012), the court flatly rejected class certification.
Unlike the Canadian judiciary (the opinion is 78 pages long, single spaced), we’ll try to keep this report brief.
The class was huge and undifferentiated – “all persons” in Canada who “ever used Seroquel.” Slip op. at ¶5. Likewise, the alleged injuries were everything under the sun. Id. ¶¶7-9. The claims are the same that we typically see in the USA, a hodgepodge of inadequate warning, off-label promotion, and fraud on regulatory agency allegations. Id. ¶¶11-13. Their experts were also eye-rollingly familiar to US litigators, Laura Plunkett and William Wirsching. Id. ¶¶26-28. As often happens in the US, Plunkett was ruled incompetent to offer any medical opinions. Id. ¶¶50. More interestingly, since it’s part of her schtick, Plunket was also held incompetent to testify about Canadian regulations, since her only background involved the American FDA. Id. ¶¶65-66. Contrary to the plaintiffs’ apparent position, Canada is not simply an appendage of the US.
Despite having sophisticated class action counsel, plaintiffs were really lousy pleaders. “It is plain and obvious that the causes of action as pleaded will fail.” Id. ¶108. Among other things, they “lump” differently situated defendants “together as a group” and allege that everybody’s liable for everything. Id. ¶109. Maybe we should call these pleading rulings “Canadian TwIqbal” or “CwIqbal” for short. Whatever it’s called, the plaintiffs couldn’t meet the standard and the entire complaint was pitched.
How can counsel who can’t or won’t satisfy the most basic pleading requirements possibly be considered “adequate” for class action purposes?
Just a thought.
Another interesting holding in Martin – at least to us, since we don’t know much Canadian substantive law – is that it’s essential in design defect cases to plead “a safer and economical alternative design.” Id. ¶¶136-37. That’s also the law in many US jurisdictions. Of course plaintiffs can’t plead an actual alternative design in most drug cases, so they just plead that somehow some other drug is safer. That didn’t cut it in Martin. Id. ¶136.Continue Reading Oh, Canada!
We can’t say much about it because of Dechert’s involvement in the Reglan/metoclopramide litigation, but Judge Higbee has ruled on on generic preemption under Mensing. There are two opinions. The first, In re Reglan Litigation, No. 289, slip op. (N.J. Super. Law Div. May 4, 2012), deals with generic preemption generally. This decision
Plaintiffs try all sorts of funny business to defeat federal jurisdiction – fraudulent joinder, fraudulent misjoinder, jurisdictional amount – you name it, they’ll tinker with it. Defendants for their part, do what they can to match the plaintiffs stratagem for stratagem. Can you say “removal before service?”
In any removal/remand situation, a
Our initial post about Bartlett v. Mutual Pharmaceutical Co., ___ F.3d ___, 2012 WL 1522004 (1st Cir. May 2, 2012), was more or less a crie de coeur over what we saw as an essentially absurd result: that while a simple warning claim involving a generic drug is indisputably preempted under PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), a claim much more fundamentally in conflict with FDA approval of generic drugs – that state tort law can impose liability for not removing an FDA-approved product off the market entirely – supposedly is not.
Plain and simple, the preemption result in Bartlett makes no sense.
Today we take a closer look at the Bartlett opinion and the reasoning, if it can be called that, that brought the court to its highly questionable result.
Two fundamental facts underlie Bartlett: First, the plaintiff had (at least in theory) lost her warning-based claim for lack of causation – the prescribing physician did not read or otherwise rely on the allegedly inadequate warning, rendering the warning non-causal. Second, for whatever reason, the defendant at trial made the strategic decision (which with the benefit of 20-20 hindsight now seems disastrous) not to offer any affirmative defense at all.
The plaintiff’s lack of a warning claim itself had two effects. One, plaintiff was damn lucky, because warning claims against generic drugs were precisely what the Supreme Court held to be preempted in Mensing. A verdict in Bartlett based upon a warning claim – the most common theory – would undoubtedly have been overturned before the First Circuit ever saw the case. Two, since both Mensing and Wyeth v. Levine, 555 U.S. 555 (2009), involved warning claims (again, they’re the most common), neither case was 100% on point.
Bartlett initially demonstrates why “design defect” simply doesn’t fit prescription drugs (some medical devices are different). As the First Circuit mentioned, you can’t change the “design” of something that “is a one-molecule drug; and the variations in [it] as sold consist of inactive ingredients that ordinarily do not have significant pharmacological effects.” 2012 WL 1522004, at *2. The ordinary constraint on design defect claims – that there be an alternative design – does not exist where the product is a chemical molecule, let alone one that would require FDA re-approval if it were changed in any way that affected its safety or efficacy.Continue Reading More Thoughts On Bartlett