March 2011

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We had Pitt and Louisville in our Final Four. Plus our favorite hoops coach, Bruce Pearl, was just axed. No man ever looked finer in an orange sport coat. All of Rocky-top, and fans of wacky YouTube videos, will miss him desperately. Put plainly, we are broken-hearted and broken-bracketed. And paralyzed. Therefore, no Monday post.
At moments like this, we think of our favorite character from Entourage, Bob Ryan. He is a has-been — or maybe, never-was — agent whose stilted pitch is always the same: “If I had x, do you think that’s something you’d be interested in?” You know, like “If I had a script and songbook for a musical version of Franz Kafka’s Metamorphosis — Roach! – is that something you might be interested in?” Martin Landau plays Bob Ryan like the Willy Loman to Jeremy Piven’s profane Super-Agent Ari. Bob Ryan is way more likeable than Bela Lugosi in the film Ed Wood, or the guy on the old Mission Impossible television show, or the creepy villain in North by Northwest — all brilliant creations of Landau’s. We can imagine Bob Ryan catching us in a down-mood today and saying, “If I had a case where a product could have a statement that was factually wrong on its label, and even falsely said it was ‘healthy,’ but the court said the plaintiff was out of luck because the FDA had approved such language, would that be something you might be interested in?” Golly, yeah. Where do we go for such enlightened jurisprudence?
Turns out it’s not a place. It’s another area of litigation: food, glorious food. In Yumul v. Smart Balance, Inc., CV 10-00927 (C.D. Cal. March 14, 2011), the plaintiff filed a putative class action alleging violations of California consumer fraud laws because the margarine product in question had a few iffy statements on its label. For example, the label said “cholesterol free” while also disclosing that it contained partially hydrogenated soybean oil and that each serving contained 1.5g of trans fat. The label also contained the word “healthy.” The plaintiff said the label lied because the margarine raised LDL (“L” for lousy) cholesterol, and there is nothing “healthy” about trans fat.Continue Reading Like Butter

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Could the FDA prosecute a drug manufacturer for sending a copy of a judicial opinion to its customers?  Maybe, if the decision described off-label use as favorably as Layzer v. Leavitt, 2011 WL 813822 (S.D.N.Y. Mar. 7, 2011).  Here’s what happened.

The Medicare Act obligates the government to pay for “qualified” prescription drugs used by eligible persons.  Medicare covers all drugs prescribed for “medically accepted indications,” not just drugs prescribed for uses the FDA has approved.  Id. at *1.

Plaintiff #1 had a rare disease, a “granulose cell tumor,” that probably had no on-label treatment.  In any event, her oncologists prescribed a drug called Cetrotide, which they determined was the best possible treatment:

According to [the prescriber], Cetrotide retards the growth of [Plaintiff 1’s] cancer and prevents her tumors from hemorrhaging.  He has warned that the medicine “is essential for my patient.  There is no substitute at this time.  Furthermore, if the medicine is stopped, even temporarily, it is likely that the remaining tumors will grow quickly and she will suffer grave consequences.  Other physicians have echoed the conclusion that Cetrotide is critical to [Plaintiff 1’s]treatment.  Peer-reviewed medical literature has also recognized the unique and effective capacity of Cetrotide to treat ovarian cancer.

2011 WL 813822, at *1 (quotation marks and record citations omitted).  But Medicaid said no, to them it was a “fertility agent.”  Id.Continue Reading Off-Label Uses Held “Medically Accepted” As A Matter Of Law

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We’ve heard about a new plaintiffs’ informed consent theory that’s making the rounds.  It’s similar to, if even goofier than, the FDA regulatory status (that is, off-label use) theory that the plaintiffs tried with notable lack of success in the Bone Screw litigation (which we’ve discussed here and here).

As with all informed consent…

We have reported periodically on rulings in the Aredia/Zometa litigation, including Daubert and summary judgment rulings by the MDL judge and choice of law rulings by Judge Arthur Spatt of the E.D.N.Y. in Deutsch v. Novartis Pharmaceuticals Corp., a case remanded for trial from the MDL. Judge Spatt has now decided Daubert motions in Deutsch and another remanded case, and his very long opinion is a bit like yesterday’s list of silly law songs : there is something in there for everyone. Deutsch v. Novartis Pharmaceuticals Corp., 2011 U.S. Dist. LEXIS 22755 (E.D.N.Y. March 8, 2011).
MDL rulings are law of the case. The MDL judge ruled on Daubert challenges to several plaintiffs’ experts. Novartis challenged those experts based both on arguments made to the MDL judge and on new arguments. Judge Spatt generally refused to consider the arguments previously decided by the MDL judge based on the law of the case doctrine, finding the doctrine particularly applicable when cases are transferred from an MDL. 2011 U.S. Dist. LEXIS 22755 at *18-21. “Reversing or otherwise undermining the decisions by the MDL court could lead to the type of inconsistent pretrial rulings that Congress sought to avoid [in the Multi-District Litigation Act], and therefore frustrate the very purpose of consolidation.” Id. at *21.
As a general matter, we agree that issues decided by the MDL judge should not be relitigated on remand. In Deutsch, however, the MDL rulings became the third rail, and anyone raising an argument that came within a few yards of an issue decided by the MDL court got zapped.Continue Reading A Grab Bag Of Rule 702 Rulings In A Remanded Aredia/Zometa Case

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We’ve more than once voiced our admiration for the bloggers over at Abnormal Use. They’re smart and funny. They know a lot about the law. They may even know more about comic books. And they know a lot about popular music. How do we know this? Because every time we whisper a word about popular music in one of our posts we receive a prompt corrective from those guys — usually Jim Dedman. In side conversations with Jim, we’ve learned of his deep affection for rock music. Sometimes his taste seems right on, sometimes it’s appalling (DEVO? Really?!), but it’s always impressive in some way.

Recently, we were chatting with Jim about law-related songs, and agreed that we would simultaneously each put up a post (here’s theirs) discussing our favorite law songs. Whether we produce harmony or cacophony is for you to decide.

There are already several websites that cover similar ground, though none really does the subject justice. It turns out that there are a lot of songs about the law, both famous and obscure. Here are some examples of the latter:

“Better Get a Lawyer” – Cruel Sea
“Philadelphia Lawyer” – Woody Guthrie
“Me and You (I’m Like a Lawyer With The Way I’m Always Trying To Get You Off)” – Fall Out Boy
“Our Lawyer Made Us Change The Name Of This Song” – Fall Out Boy
“Annie the Imaginary Lawyer” – The World/Inferno Friendship Society
“Why A Lawyer” – Steve Hefter And Friends Of Friends
“Courthouse” – NAS
“Beautiful Lawyers” – The Zincs
“Lady Lawyers” – Oxford Collapse
“We Love Our Lawyers” – Cibo Matto
“Lovers Need Lawyers” – The Good LifeContinue Reading Silly Law Songs

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This just in:  In Ironworkers Local 68 & Participating Employers Health & Welfare Funds v. AstraZeneca Pharmaceuticals LP, 2011 WL 833222, slip op. (11th Cir. March 11, 2011), the court affirmed dismissal under Rule 12(b)(6) (failure to state a claim) of one of these third-party payer economic loss class action strike suits.  Because of…

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If it’s not Rule #1 in elementary appellate procedure, probably it should be – don’t lie on your certificate that your brief complies with applicable length limitations – at least where it flagrantly violates those limits.  Chances are your opponent can count, since s/he did graduate from law school, and going to law school does…

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Our post the other day on Wolicki-Gables v. Arrow International, Inc., 2011 WL 780684, slip op. (11th Cir. March 8, 2011) (“W-G”), generated a fair amount of attention from some of the more sophisticated reporters who cover our field, because we discussed how the decision contributed to a growing circuit split concerning…

Drug & Device Resources

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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