A couple of weeks ago, the Drug and Device Law Dog Walker texted us midday to report that a coyote had been spotted in our suburban neighborhood and that we should be vigilant when the Drug and Device Law Little Rescue Dogs were out in the yard. We scoffed, insisting that it must have been
The Supreme Court’s opinion on personal jurisdiction in BMS v. Superior Court has already made a substantial impact, despite being on the books for a mere three weeks. That’s probably because it’s the Supreme Court and also because personal jurisdiction is an issue in every lawsuit filed, whether in state or federal court. Another reason
Today’s date is rich in literary history. It is the birthday of Vladimir Nabokov, one of two writers whose prose style makes us want to snap our Pilot Varsity pens in despair, so great is the gap between those authors’ mastery and our pedestrian scribblings. Perhaps the biggest laugh-out-loud moment a book ever gave us was from Lolita, when the Humbert character travels a long way to visit a family that has at least one member he is especially, um, interested in, only to be greeted at the train station by the patriarch, who shared “the news that his house had just burned down – possibly, owing to the synchronous conflagration that had been raging all night in my veins.”
Today is also the birthday of Henry Fielding, the great British novelist of the 18th century. In high school we were forced to read Joseph Andrews and Tom Jones, and we grumbled about it, especially upon getting a peek at the girth of Tom Jones (we mean the book). But the joy, wisdom, and energy of Fielding’s words, often propelling the most ribald adventures, converted our dread into a wholly unforced pleasure, indeed. There is a sentence in Tom Jones that stopped us abruptly in our tracks. Fielding on many occasions spoke directly to the reader, and at one point he explained his intention to “fill my pages with humour till mankind learn the good nature to laugh only at the follies of others and the humility to grieve at their own.” Has any writer ever articulated a more noble goal?
This post is from the non-Reed Smith side of the blog only.
It’s been a while since we’ve seen a legal reference to Scylla and Charybdis, the sea monsters of Greek myth who posed an intractable dilemma to all sailors who attempted to navigate between the two. It is a tried and true metaphor, like its modern English counterpart — between a rock and a hard place. But it is particularly fitting in products cases dealing with pre-market approved medical devices. So, even though it is another favorable InFuse decision and we probably would have blogged about it anyway, the court’s clever turn of phrase was enough to reel us in:
We’ve blogged several times about the nearly unanimously accepted proposition that FDA regulatory status – that is, the bare fact that a drug or medical device is used off-label – is not a medical risk, benefit, or alternative about which physicians must tell patients under the law of informed consent. Bexis in particular is emphatic
This post is not from the Dechert side of our tripartite blog.
We are particularly pleased with the result in Drager v. PLIVA USA, Inc., ___ F.3d ___, 2014 WL 292700 (4th Cir. Jan. 28, 2014), a generic preemption case that – like so many – involves metoclopramide/Reglan. Drager is the first appellate court
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.
Having been in this business (defending pharmaceutical product liability) for a long time now, we’ve learned that what happens to prescribing doctors often comes back to haunt our clients. Nowhere is that better illustrated than with the thankfully discredited theory of regulatory informed consent, which since we’ve already discussed it, here, we won’t go