Maybe it’s the word. It sounds so positive and promising: “Discovery.” Discovery leads to good and helpful things: “Einstein discovered relativity.” “Ben Franklin discovered electricity” (well, not really, but he was big in electricity). When we discover something, it’s good, never bad. You never read, “Edward Smith discovered an iceberg.” Or, “Amelia Earhart discovered vanishing.”
In a pair of cases, the Maryland Court of Appeals (the state’s highest court) rumbled through more than $1 billion in verdicts in a gasoline spill case, reducing them to nothing (although one plaintiff managed a new trial on one issue unrelated to this post). See Exxon Mobil Corp. v. Albright, ___ A.3d ___, 2013 WL 673738 (Md. Feb. 26, 2013); Exxon Mobil Corp. v. Ford, ___ A.3d ___, 2013 WL 673710 (Md. Feb. 26, 2013). While a lot of the analysis in these opinions is devoted to property damage issues (purportedly from groundwater contamination) that we don’t see much in our drug/device sandbox, they also dealt with a couple of issues that are near and dear to our hearts – medical monitoring and fraud on the FDA.
A Tough Medical Monitoring Standard
First, we’re sorry to report, Albright (the lead opinion) did recognize a cause of action for medical monitoring by presently uninjured plaintiffs. 2013 WL
673738, at *26, 31. That being said, we’re pleased to report that the court attached rigorous requirements to the monitoring cause of action – a “proven necessary medical costs” requirement as tough as any state we’ve seen.
What do we mean? Well, first, medical monitoring is a “remedy”; thus plaintiffs must first prove some underlying cause of action. Albright, 2013 WL 673738, at *26-27. Second, medical monitoring costs must be both “necessary and reasonable.” Id. at *27 (emphasis original). “Necessity for medical monitoring . . . must be reasonably certain, rather than merely possible.” Id. Third, a plaintiff must “experience[] direct and hence discrete exposure.” Id. at *28 (emphasis original). Fourth, the condition for which monitoring is allegedly needed must be “related specifically and tangibly to that exposure.” Id. Fifth and finally, the risk must be “a direct and proximate result of th[at] exposure.” Id. (emphasis original).
The court in Albright was determined that medical monitoring not become an excuse for crappy, unsupported claims:
[W]e are wary of damages for speculative claims resting on tenuous proof of risk of disease attributable to the type of exposure. . . . [W]e believe that . . . recovery for a latent disease due to toxic exposure involves necessarily somewhat nebulous forecasts of a potential risk to develop a disease in the future. . . . Requiring quantifiable and reliable proof, however, will assist courts in determining whether causation and significant risk are present in a plaintiff’s prima facie case.
Id. at *28 (emphasis original). The medical monitoring standards that the court adopted are expressly intended to “inhibit[] damages awards for speculative, and thus unreliable, opinions as to a plaintiff’s potential risk of developing a future disease.” Id. at *29.Continue Reading Maryland Allows Medical Monitoring (Sort Of); Rejects Fraud On The FDA
…You know somebody’s getting hammered. You just hope it’s the other side.
In Wilson v. Novartis Pharmaceuticals Corp., 2013 WL 593895 (N.D. Tex. Feb. 15, 2013), thankfully it was. The first line was a quote from Marmion: “Oh, what a tangled web we weave when first we practice to deceive!” We first heard that line in middle school, from a teacher who caught a miscreant classmate lying about failure to turn in a homework assignment.
It’s much worse when uttered by a federal judge.
Wilson was an Aredia/Zometa case – and, yes, it was pitched to us by defense counsel (Hollingsworth). But the opinion is such a stark cautionary tale that we would have blogged about it anyway (assuming we otherwise found out).
Here’s what happened.
The plaintiff died.
That’s of course tragic for all immediately concerned, but it is hardly something to dismiss a case over. Death is a fact of life, and the court system has evolved standard procedures for dealing with the mid-stream death of a party to litigation.Continue Reading When An Opinion Starts Out This Way….
“The best lack all conviction, while the worst are full of passionate intensity.”
– Yeats, The Second Coming
We remember the early days of ESPN’s Sportscenter when Stuart Scott constantly complained about how he always had to do the summaries of the week’s crappiest football games (the bad teams back then were Tampa Bay, Green
“Don’t leave home without it.” “Takes a licking and keeps on ticking.” “Just do it.” “Tastes great, less filling.” Iconic ad campaigns so recognizable that we don’t even need to tell you the product being advertised. Here’s another one: “The nighttime sniffling, sneezing, coughing, aching, stuffy head, fever, so you can rest medicine.” For over
You may have read in the last few days that the FDA issued a Warning Letter to a nutrition supplement manufacturer for allegedly promoting its product as a drug by, among other things, using social media. The Warning Letter, seemingly for the first time, signaled the FDA’s view that “liking” a post on Facebook can constitute promotion. While this may be a new signal, more important is that we are still without a broad guidance document from the FDA on promotion over the internet or social media.
We’ve followed this issue for some time, posting on it here and here. That’s because FDA guidance is needed. For practical reasons, the industry’s use of the internet and social media to provide information to the users of its products will be limited until the FDA speaks with broad guidance. We saw this with print and broadcast promotion, which only increased substantially once the FDA issued its guidance. And we’re seeing it here.
Now, the FDA has issued intermittent signals as to promotion over the internet and social media. In late 2009, it held a “Public Hearing on Promotion of FDA-Regulated Medical Products Using the Internet and Social Media Tools.” It has also engaged in ad hoc regulation through Untitled Letters and Warning Letters that address promotion through product websites, sponsored internet links, online banners, and Facebook widgets. And the FDA did issue one draft guidance document, but it was limited, not broad, addressing only how the FDA believes that manufacturers should respond to off-label questions that come from, among other sources, the internet and social media. After all this time, however, the FDA has not issued a broad guidance document.Continue Reading 491 days, 490, 489 . . . . The Social Media Guidance Countdown Is Still Going
We’ve been pondering what to do with the latest 70+ page whopper from the Philadelphia Court of Common Pleas for a couple of weeks. All the while Maya v. Benefit Risk Management, 2012 Phila. Ct. Com. Pl. Lexis 449 (Pa. C.P. Philadelphia Co. Dec. 31, 2012) (also at 2013 WL 663158 – but essentially useless due to lack of internal pagination), has been sitting around, begging for us to take it on.
What would it take to make Maya better?
Well, just about everything would have to be substituted. If that happened the $10 million plaintiff’s verdict in Maya would be toast…. Which reminds of the classic substitution scene from the movie Five Easy Pieces (hence the title of the post). That was pretty brutal, but so is the opinion in Maya. We’ll try to be less brutal in our analysis than Jack Nicholson was before he became a Lakers fan. But without any substitutions – well, ATRA might want to think again before letting the Philadelphia court system off the hook.
A lot of things could be said about the Maya decision – since it touches on so many issues. But we’ll limit ourselves to five – the five theses in Maya that are just plain wrong.
Waiver for Preserving Too Many Issues
Maya was another high-stakes SJS/TENS case. This medical condition is terrible, but it is an example of what used to be called an “idiosyncratic reaction.” Most doctors – at least those not serving as plaintiffs’ experts – admit that they don’t know what triggers the disease. It’s been blamed on just about every drug (prescription or non-prescription) imaginable, but it could just as well be a reaction to something else in the environment, something that’s ordinarily non-bioreactive, such as plastic. But plastic manufacturers don’t have to keep records of adverse reactions. Drug companies do, and those reactions duly get listed on product labeling – whether there’s causation or not.Continue Reading Five Uneasy Theses
We sometimes tire of reading cases, ours or others, base on the same old allegations about what the drug or device manufacturer allegedly did wrong. It often seems that the plaintiff lawyers work from the same playbook, written, we suspect, by Velvet Jones. So, we perk up somewhat when we see atypical allegations of liability.