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.
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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.Continue Reading Cajun Home Cooking?