In what’s a bit of a mixed bag decision, the ultimate takeaway from Bird v. Globus Medical, Inc., 2020 WL 5366300 (E.D. Calif. Sep. 8, 2020) is that the complaint was generally lacking. So, plaintiff is going to get a second chance. Meanwhile, we can take a look at just what wasn’t up to
The plaintiffs’ allegations in In re MDL 2700 Genentech Herceptin (Trastuzumab) Marketing & Sales Practice Litigation, ___ F.3d ___, 2020 WL 2781287 (10th Cir. May 29, 2020), weren’t safety related. Rather, they sought damages for purely economic loss because the way the vials of Herceptin (a prescription biologic) were filled allegedly resulted in most…
Every day our inbox overflows with legal news aggregation emails. Some of the items are useful. Some must have been authored by Captain Obvious. Some are irrelevant to our practice. We would have thought that comfortably residing in that last category are discussions of the burgeoning marijuana field. The “Week in Weed” and other such…
Before Bryan Cranston was Walter White, terminally ill chemistry teacher turned murderous meth manufacturer; before he was Hal, the clumsy and loving husband on Malcolm in the Middle – he was Tim Whatley. Jerry Seinfeld’s re-gifting dentist who converted to Judaism just “for the jokes.” So affronted is Jerry for his profession, that Kramer –…
Today we have this guest post from Reed Smith‘s Andrew Stillufsen about a recent defense win in a third party payer (or is it”payor”?) case here in the Eastern District of Pennsylvania. We hope you find it as interesting as we did. As usual all credit and/or blame belong to the guest poster.
Travelers Indemnity Co. v. Cephalon, Inc., is a third party payor case where plaintiffs – workers compensation insurers – claimed that they were injured by paying for prescriptions for defendant drug company’s pain medications which were written as a result of its alleged off-label marketing of the drug. 2014 U.S. Dist. Lexis 95075 (E.D. Pa. July 14, 2014). SPOILER ALERT: as with similar cases, even after extensive discovery and an amended complaint, plaintiffs still failed to allege facts sufficient to establish standing or to support any of their fraud claims. Motion to dismiss granted.
Before the court could address plaintiffs’ substantive claims, it first had to determine whether the allegations were sufficient to establish standing. To establish standing, the plaintiff must show that they suffered a cognizable injury. Id. at *16-18. “The contours of the injury-in-fact requirement, while not precisely defined, are very generous, requiring only that the claimant allege some specific, identifiable trifle of injury.” Id. at *17. (citations and internal quotations omitted). Under the now-familiar TwIqbal analysis, plaintiffs failed to allege sufficient facts to show even a mere “trifle.”
In this case, plaintiffs essentially alleged two theories of injury. First, they claimed they were injured because “they did not get what they paid for,” as plaintiffs paid for drugs that were not safe or effective due to defendant’s alleged fraudulent off-label marketing. Second, but for the alleged off-label marketing, plaintiffs claimed they were injured when they paid for more expensive drugs when less-expensive drugs were available. Id. at *18-19.
This post is not from the Dechert side of the blog, as Dechert handled the successful appeal of the case being discussed.
We haven’t really covered “Average Wholesale Price” (“AWP”) litigation very much because, while it is typically brought against pharmaceutical defendants, it’s about as far from product liability litigation as, say anti-trust or securities law. But it’s hard to ignore when a state supreme court blows out such claims (as here). It’s even harder to ignore when the state supreme court in question is ours. So here’s what the Pennsylvania Supreme Court recently did to an AWP
Briefly, and at the risk of oversimplification, “average wholesale price” is a term used to describe a much-tinkered-with basis for determining how much manufacturers may charge governmental purchasers of drugs used in public programs. Governmental plaintiffs claim that drug manufacturers manipulated the AWP to overcharge them. Manufacturer defendants counter that AWP is a misnomer, and was not intended or calculated to be as limited as the governmental plaintiffs claim. Manufacturers also point out, with lots of evidence to back them up, that governmental units were at all times well aware of
what the drawbacks and complexities of what AWP quotation did (or did not) mean. There are many other issues in AWP litigation, but these are the biggies.
First of all, we wish to point out that the trial result in Pennsylvania was not really a verdict. In Commonwealth v. TAP Pharmaceuticals (Bristol Myers Squibb Appeal), No. 85 MAP 2011, slip op. (Pa. June 16, 2014), the jury had the good sense to enter a defense verdict on all the claims submitted to it. Id. at 16. However, Pennsylvania’s consumer protection statute is quirky, and does not provide for a jury trial. So the trial judge got snookered.
Second, before we get accused of affording this decision too much significance, yes we know that it’s styled as an “opinion in support of reversal” by an evenly divided (3-3) court. However, all six sitting justices agreed entirely with the rationale reversing the lower courts. The only disagreement was that the OAJC would have dismissed the case outright and entered judgment n.o.v., whereas the concurring opinion – not an opinion in support of affirmance – wanted a remand. So as not to have the bizarre result of a 3-3 split resulting in an affirmance by operation of law of a decision that nobody thought should stand, the OAJC gave in as to that outcome. OAJC at 23.
You may already know this, but we had to comment on the Supreme Court’s November 15 grant of certiorari in Halliburton Co. v. Erica P. John Fund, Inc., No. 13-317 on the question of: “(1) Whether this Court should overrule or substantially modify the holding of Basic, Inc. v. Levinson, 485 U.S. 224…
This is our initial blog post from Eric Alexander, a partner here at Reed Smith. We hope we can corral him into more regular contributions, but we have to keep from him just how much of a hassle regular blogging can be until we have him lassoed in. So don’t you go telling him.
As a first time blogger, a brief introduction is in order. I have neither a nickname that borders on copyright infringement – BeckstLaw or something like that – nor did I devote enough attention to television dramas and literature assigned to college sophomores to turn every legal analysis into biting social commentary. I also do not have the habit of referring to myself with plural pronouns. However, I have been representing drug companies in product liability cases for more than fifteen years and device companies for about half as long. Over the years, I have formed some strong views about the laws – as written and as applied- governing such cases. So, when we were asked – see, attempting the plural thing – to author a guest blog entry, we used our fingers on our keyboard to type this up for our readers.
We find Caldwell v. Janssen Pharmaceutical, Inc., 2012 La. App. Lexis 1099 (La. App. Aug. 31, 2012), strangely lacking in detail and analysis, particularly for an appeal of a $330 million judgment. The case is one of many actions by or on behalf of various states against the makers of Risperdal, a prescription medication indicated primarily for the treatment of schizophrenia. Indeed, a similar case in Pennsylvania resulted in a non-suit at trial (no causation as a matter of law) that was affirmed on appeal. But in the Caldwell opinion, you will not find what that drug is used for in the opinion. You actually will not find the word “Risperdal” in the text of the opinion – it is the last word in an earlier footnote explaining what DDMAC stands for – until the 11th page of the slip opinion (*16 on Lexis). More about that later, but the case is about allegedly misleading statements in the marketing of the drug and false claims to the Louisiana medical assistance program funds. After the court had already determined that there was sufficient evidence presented at trial to support the verdict, the reader learns for the first time that the alleged misleading statements concerned drug “safety” (as opposed to its efficacy, price, color, smell, etc.); this comes up when the court is affirming that exclusion of expert testimony that the defendant “did not misrepresent Risperdal’s safety and that Louisiana doctors were not misled by the ‘dear doctor’ letters.” What was the safety issue? The opinion never says. What did the defendant actually say about that unknown issue and why was that representation misleading in light of the information known at the time about the issue? The opinion never says. It does quote the trial court’s oblique reference to “subsequent scientific developments” in affirming exclusion of certain “scientific evidence.” It does not quote any portion of any communication by the defendant about the drug at all.
How can there be an opinion affirming a $330 million award – $257 million penalty, $70 million attorney fees, and $3 million costs, exclusive of interest – about how a manufacturer marketed a prescription drug without such basic information presented right up front, or anywhere? When the Louisiana AG, who is the plaintiff here, issued a press release about the opinion, he had no trouble saying the suit was for “serious misrepresentations regarding Risperdal’s link to diabetes in order to obtain funds from Louisiana’s Medicaid program.” Diabetes is not mentioned in the opinion, though. When you look at the current drug label, in PLR format, you see that information on the risk of diabetes is about half-way through the Warnings and Precautions section. When you run a search on PubMed for “risperidone diabetes,” you get 231 hits for articles over the last 14 years. So, there surely there was plenty of possible evidence about what was known about the risk of diabetes with Risperdal at the relevant time from which to judge whether what the defendant said about it was misleading. The opinion says “a plethora of evidence” was presented to the jury over the course of what it described as a five day trial. Setting aside how you fit a plethora of evidence into a five trial days (especially if openings and closings were included in those days) and whether the court meant to say there was too much evidence presented – which is what plethora really means – the absence of any discussion of what seems like the most relevant evidence makes us suspicious. While the court says “[t]he resolutions of the myriad issues in this case are primarily fact driven,” the opinion is devoid of fact, notwithstanding the repeated incantation of the phrase “[a]fter carefully reviewing the record” before overruling each assignment of error. The determination that the plaintiff’s closing argument did not violate due process by “appeal[ing] to prejudices against out of state corporations” without quoting any portion of the closing itself is particularly mind-numbing.
First the Digitek MDL gave us a new weapon – the “Digitek Order” – to ensure plaintiffs’ counsel comply with their Rule 11 obligations to actually investigate their clients’ claims before filing thousands of cases. Novel concept, right? And now we have another helpful opinion – a new decision out of the MDL…