We are honored to announce that the ABA Journal has once again recognized the Drug and Device Blog (that’s us) as one of the top 100 legal blogs of the year. Here’s the announcement.

If we’re judged by the company we keep, we must be doing pretty well, as once again the ABA Journal

A couple weeks ago, we took a look at the brief submitted by the Solicitor General in the Mensing generic preemption case. If you didn’t have time to read that brief, or our slightly shorter post summarizing that brief, here’s an even shorter recap of the government’s position: the 8th Circuit was right to reject

For those of you who don’t know, Twinkie the Kid is the mascot for that classic American dessert cake, Twinkies. You may also be surprised to learn that Twinkies originally contained banana cream, until bananas were rationed during World War II (interesting), that a nutrition professor recently lost 27 pounds on a “Twinkie diet” (take that, Jared), or that, sadly, Twinkies do not keep forever (goodbye to the urban legend). These are some of the fascinating facts you learn when you look up Twinkies on Wikipedia.

Plaintiffs’ lawyers, though, seem more inclined to sue Hostess rather than revel in the cultural history of the Twinkie. Last week, a federal court in California shot down a putative class action complaining about Hostess’s “100 calorie packs” – not because you don’t get very many mini-Twinkies in those packs, but rather because they contain the following claim: “0 Grams of Trans Fat.” The putative class claimed this trans fat claim was misleading because the baked-goods products contained partially hydrogenated oils, which allegedly are linked to a parade of horribles – “heart disease, diabetes, cancer, obesity, liver dysfunction, Alzheimer’s disease, and female infertility.” Peviani v. Hostess Brands, Inc., Case No. 2:10-cv-02303-CBM-VBK (C.D. Cal. Nov. 3, 2010), slip op. at 2. The putative class brought claims under California and Missouri consumer protection laws, as well as a Lanham Act claim that was doomed from the get-go because consumers lack standing under the “false advertising” prong of that Act. Slip op. at 3, 12.

The consumer protection claims fared no better – they were preempted by the Food, Drug, and Cosmetic Act (FDCA) and its 1990 amendment, the Nutrition Labeling and Education Act (NLEA). When you flip over a package of food to check out the nutritional contents, all the information you see in that Nutrition Facts Panel is heavily regulated by the FDA through the NLEA. And the FDA will consider foods misbranded if the labeling is “false or misleading in any particular.” Slip op. at 7 (quoting 21 U.S.C. § 343 (a)(1)).


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OK, not really. But we have had a chance to review yesterday afternoon’s oral argument transcript in Bruesewitz v. Wyeth, and here’s what went down (for a lot of Bruesewitz backstory, click here for our prior posts).

David Frederick argued on behalf of the petitioners. Adhering to the rule of three, Frederick said the Third Circuit was wrong for three reasons when it ruled that the Vaccine Act expressly preempts state-law design defect claims. First, argued Frederick, the language of the Act itself does not explicitly preempt design defect claims. Second, the question of whether or not an injury was “unavoidable” should be determined on a case-by-case basis, rather than triggering a broad express preemption of all design defect claims (Section 22(b)(1) of the Vaccine Act, which lies at the heart of this dispute, states that manufacturers are not liable if the side effects were “unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.”). Finally, Frederick advanced the “think about the children” policy argument – i.e., preemption of design defect claims exposes kids to unnecessary safety risks. He also suggested that it will be very rare to see a design defect case get out of vaccine court and go to a state court jury, because proving causation and the availability of an alternative design is not easy. In other words, don’t worry about disincentivizing manufacturers with the specter of massive liability, because it is unlikely to happen.

Kathleen Sullivan argued on behalf of Wyeth. Although she was immediately beset by questions, primarily from Justice Sotomayor and Justice Ginsburg, Sullivan was able to argue (persuasively, in our opinion) that the petitioners’ reading of the statute ignores its plain language and meaning. In essence, there are three types of products claims one could bring against a manufacturer: manufacturing defect, design defect, and warning defect. Section 22(b)(1), read as a whole, makes clear that only manufacturing and warning defect claims survive; manufacturers are not liable for unavoidable risks where the vaccine was “properly prepared” and accompanied by proper…warnings.” In other words, if the vaccine wasn’t made right, you lose the protection of 22(b)(1). If you didn’t slap an appropriate warning on the vaccine, you lose the protection of 22(b)(1). Otherwise, you’re protected, since the statute did not include any clauses recognizing design defect claims. Sullivan also hit hard on the policy arguments supporting preemption of design defect claims, highlighting that the legislative history shows Congress was concerned about a vaccine “crisis,” where “manufacturers were being driven out of the vaccine business, imperiling the nation’s…vaccine supply by design defect claims that did survive summary judgment.”

So how did the Justices react to these core arguments? Of course, we have to offer the caveat that it is often a Talmudic exercise to guess at the meaning behind a particular Justice’s question, but the following patterns seem to have emerged:

Statutory Construction:

Chief Justice Roberts, Justice Alito, and Justice Scalia appeared to be most concerned about the plain language of the statute, and the extent to which the Court may go beyond that language to infer (or not infer) that Section 22(b)(1) has preemptive effect. For example:

Chief Justice Roberts asked whether the compensation scheme set up in the Vaccine Act evidenced a Congressional intent to preclude state law claims. Justice Sotomayor, on the other hand, asked Sullivan why Congress did not simply make vaccine court the exclusive forum for recovery, thereby foreclosing state lawsuits.


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Whenever the New Jersey Supreme Court gets its hands on a class certification decision, you never know what to expect. Sometimes, it’s great news (no class action for Vioxx TPPs!). Some times, it’s downright scary. Take, for example, the recent Relacore decision, issued just in time to kick off Halloween season. In Lee v. Carter-Reed Co., LLC, __A.3d __, 2010 WL 3781595 (N.J. Sept. 30, 2010) (no page numbers available yet), the court lauded the class action as a mechanism to “balance the scales of power between the putative class members and a corporate entity” (uh-oh…), and found that class certification was appropriate for a putative class of New Jersey consumers who purchased Relacore, a dietary supplement pill.

The trial court had denied class certification, seizing on a number of “individualized factors” that would render the class action unmanageable. The Appellate Division affirmed the trial court, finding that individual issues predominated over common issues. The supreme court reversed, ruling that both lower courts “failed to accept as true the allegations asserted in plaintiff’s complaint or to view the pleadings in a light favorable to plaintiff, as required by our jurisprudence. Had those courts…accepted plaintiff’s representations that [the defendant’s] advertising of Relacore was no more than a passel of lies, then they should have concluded that the common issues of fact and law predominated over individual ones and that the case was not beyond the management skills of our capable Superior Court judges.” (We do have to tip our hat to the turn of phrase, ” a passel of lies.” Great name for an up-and-coming indie band, a hardboiled detective novel, or a mediocre thriller starring Russell Crowe, Clive Owen, or Leo DiCaprio chasing after the truth in some exotic locale. But we digress…)


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Any time a sales rep’s conduct and statements are the centerpiece of a trial, our natural inclination as defense lawyers is to cringe. We know we will be fighting tooth and nail to explain to the judge and jury why the evidence should be excluded or ignored. Because let’s face it – the plaintiffs’ lawyer’s

Last Friday, we promised you more on the Second Circuit’s reversal of Judge Weinstein’s Zyprexa class certification decision. Well, here’s more (and the Westlaw cite to boot).

First, the background: A bunch of third-party payors (“TPP”) sued Eli Lilly and Company, claiming that Lilly had misrepresented Zyprexa’s efficacy and side effects. UFCW Local 1776 and

We’ve written about the Actimmune off-label marketing litigation before (here and here). Hey, we even named a prior Actimmune decision Honorable Mention in our Top Cases of 2009 post. And now, it seems the Actimmune litigation has finally met its demise. You can get more detail about the backstory from our prior posts, but here’s the quick synopsis: the plaintiffs filed consumer and third-party payor (TPP) class actions against InterMune and others, alleging that the defendants illegally marketed the drug Actimmune off-label for treatment of idiopathic pulmonary fibrosis (IPF), a nasty lung disease, when Actimmune was ineffective to treat IPF. Originally, the plaintiffs raised a host of fraud-based claims, which the court blew out for failure to plead with particularity. In a bit of deja vu, the plaintiffs took another hack at stating a viable claim, but the court dismissed all fraud-based claims with prejudice.

Which brings us to take three. This time, the plaintiffs tried to state a claim under California’s Unfair Competition Law (UCL), and the TPP plaintiffs also tried to assert a claim under Missouri’s Merchandising Practices Act (MMPA). Again, the court dismissed all claims. With prejudice. See In re: Actimmune Marketing Litig., 2010 U.S. Dist. LEXIS 90480 (N.D. Cal. Sept. 1, 2010). See ya, Actimmune litigation.

Taking apart the UCL claim, the court noted that the plaintiffs had one more shot to plead a non-fraud UCL claim, under the UCL’s “unlawful” and “unfair” prongs. Id. at *16. But the plaintiffs failed to plead such a claim consistent with their TwIqbal obligations. The plaintiffs pointed to alleged off-label marketing as “evidence” that the defendants’ conduct was “unlawful” under the UCL. Id. at *17. Unfortunately for the plaintiffs, they forgot that it is not enough to allege unlawful conduct “in the air” – you also have to establish that the alleged violation caused harm. Id. at *18 (statute requires showing of injury “as a result of” the alleged violation). And here’s the best part: the UCL’s causation element requires proof of “actual reliance.” Id. at *24-25. In other words, “the ‘as a result of’ language places the burden on plaintiffs to establish that they actually relied upon the representations delivered through defendants’ off-label marketing.” Id. at *23.


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