[Drug and Device Law] Maryland, My Maryland: Aldara Case Dismissed for Multiple Reasons
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?
It is also possible that today is Shakespeare’s birthday, though that is unclear. (Shakespeare would be 451 years old - which places him squarely within the core demographic for CBS's lineup of law enforcement procedural dramas.) Shakespeare’s birth was not officially recorded, but we know that he was baptized on 26 April. The conventional deduction is that baptisms took place three days after birth, so that would place Shakespeare’s birthday tomorrow, on the 23rd. But Nabokov liked to think that he shared a birthday with the Bard, and that is good enough for us. Nobody writes like Nabokov, though many try. It has been a long time since anyone tried to write like Fielding. The last example we can think of was John Barth’s magnum opus, The Sot Weed Factor, written in 1960. Sot Weed refers to tobacco. The book is about a poet laureate of Maryland. He was charged with writing an epic called Marylandiad. Barth's novel recounts the poet’s journey to and through Maryland, where he gathers experiences and cobbles literature, all whilst doing his best to preserve his “innocence” (virginity). There are so many great things about Maryland: crab-hammering, a state song sharing the tune of “O Tannenbaum” [though it is a bit awkward that the song is a pro-Confederate ditty decrying “Northern Scum”], Frederick Douglass, Babe Ruth, Thurgood Marshall, Cal Ripken, The Wire, and a robust contributory negligence defense. There is also H.L. Mencken, who defined a judge as "a law student who marks his own examination papers."
Now we can add today’s decision, Morris v. Minnesota Mining and Manufacturing Co., No. BPG-13-1107 (D. Md. April 16, 2015), to that list of Maryland marvels. Everything went right for the defendants in that case and everything went wrong for the plaintiff. It is sort of epic. You can find a link to the Morris decision here.
Let’s start with the facts. In October 2007, the plaintiff was prescribed Aldara cream for treatment of Bowen’s disease, a form of skin cancer. Shortly after the plaintiff began applying Aldara to her nose, she developed burning lesions on her entire body. The plaintiff was diagnosed with cutaneous Lupus, which she alleged was caused by the Aldara. She was also diagnosed with Posterior Reversible Encephalopathy Syndrome, which she also alleged was caused by Aldara. Aldara is indicated for several things, but Bowen’s disease is not one of them. Thus, the use of the Aldara for the plaintiff’s Bowen’s disease was an off-label use.
Whether or not the Aldara actually caused the alleged injury, it certainly caused a lot of litigation here, to wit:
• In November 2010, the plaintiff sued her dermatologist in federal court for medical malpractice by prescribing Aldara off-label. That case was dismissed for lack of subject matter jurisdiction.
• In December 2010, the plaintiff filed suit against her dermatologist in state court. That case was dismissed for failure to comply with the Maryland Health Claims Malpractice Act.
• In October 2011, the plaintiff once again filed suit against her dermatologist in state court. The Amended Complaint not only asserted that the defendant prescribed Aldara for an off-label use due to the potential for severe side effects. The state court dismissed the plaintiff’s case in February 2012.
• In April 2013, the plaintiff filed a case in federal court (this case) against the 3M defendants, asserting claims for negligence, negligence per se, product liability, breach of warranty, “conscious indifference,” and malice. The central claim was that the defendants failed to provide adequate warnings concerning the risks, consequences, and side effects associated with the use of Aldara.
Usually, plaintiffs exploit off-label use by arguing that it calls off certain defenses (such as preemption) and makes the defendants’ conduct worse in various ways. But Maryland is a bad place to try that tactic, because Maryland law is clear that a manufacturer is under no obligation to warn the patient of risks associated with an off-label use of a drug and, therefore, cannot be held liable in the event the physician prescribed a drug for such use. The controlling case is Robak v. Abbott Labs., 797 F. Supp. 475, 476 (D. Md. 1992), and it is one you should keep in your hip pocket anytime you have a case in Maryland. Under Roback, off label use pretty much walls off a manufacturer from any product liability theory.
Naturally, the plaintiff attempted to distinguish Robak, arguing that the plaintiff’s injuries were not attributable to her dermatologist’s off-label prescription of Aldara, but rather the inherently dangerous design of Aldara itself. That is, the plaintiff was saying that even an on-label prescription of Aldara would have caused her alleged injuries. Well, then. So what exactly is this case about? In any event, the court ruled that the fact that an on-label use of Aldara might have caused injuries similar to the plaintiff’s alleged injuries did not negate the application of Robak to the facts presented here. Because of Roback, the plaintiff’s case against the manufacturer was going nowhere. End of story.
Except it wasn’t. The court decided a couple of other issues against the plaintiff as well. Perhaps it was a message that an appeal would be pointless. At this point, we should mention that the decision in Morris was rendered by the magistrate judge. The parties agreed that the magistrate judge could make the summary judgment ruling. This case reminds us that there are many excellent magistrate judges in federal courts around the country. They are often stuck with drudgery, such as ESL issues or privilege-log battles, but when given the opportunity to oversee larger issues they can really shine. To this day, the best trial experience we have ever had in our home E.D. Pa. jurisdiction was in front of a magistrate judge who was smart, diligent, and patient, and who dealt with lawyers, witnesses, and jurors with efficiency, fairness, and grace.
The defendants in Morris also argued that the claims against them were time-barred by the Maryland three-year statute of limitations. This three-year limitations period begins when the plaintiff “knew or reasonably should have known” of the alleged wrong. According to the defendants, the plaintiff’s claims were barred by limitations because the plaintiff had sufficient knowledge in October 2007 to suggest that she had a potential cause of action against the defendants. And yet she waited until April 2013, nearly five and a half years later, to file this lawsuit. According to the court, the defendants were right and the case was time-barred. And once again, just as with the off-label issue, something that plaintiffs typically try to use against defendants ended up biting them in the posterior here. In so many cases we see, the plaintiffs’ specific causation theory rests solely on temporal proximity. Stop us if you’ve heard this one before: there was no injury until after usage, so the product must have caused the injury. But the Morris court interpreted Maryland law to mean that the temporal proximity between the use of a drug and the manifestation of injuries was sufficient to prompt a reasonable plaintiff to investigate. Here, given the temporal proximity between the plaintiff’s use of Aldara and the appearance of the lesions, the plaintiff had sufficient knowledge in 2007 to be prompted to investigate whether Aldara was responsible for her injuries. Indeed, she did investigate, by seeking medical treatment immediately after her symptoms appeared. But the plaintiff argued that she was not properly diagnosed with severe cutaneous Lupus until 2011 and that her neurological symptoms were “never investigated” or “properly evaluated” until she was examined by her medical expert in 2014. The court did not buy that argument: “The fact that plaintiff’s symptoms, neurological or otherwise, were not properly evaluated or diagnosed from the outset does not form a basis for tolling the limitations period.”
There was a third reason why the plaintiff’s case had to be dismissed. The named defendants sold their pharmaceutical operations in 2006 – one year before the plaintiff used Aldara. In product liability cases the defendant must be a manufacturer or seller of the product. The 3M defendants were neither. Did the plaintiff yield to this unassailable logic? She did not. She argued that because Aldara was defectively designed, the 3M defendants remained liable to the plaintiff as the original manufacturer pursuant to the Hatch-Waxman Amendments of the Food, Drug and Cosmetics Act. We do not think that argument should work as a matter of law, whether the analysis is grounded in precedent, text, logic, or policy. But the Morris court grounded its dismissal on something even simpler: the plaintiff had simply failed to offer any evidence to support the proposition that Aldara was defectively designed. The plaintiff relied upon an expert affidavit that recited all the right conclusions. Again, stop us if you’ve heard this one before: the plaintiff pays some expert to spout all the elements of the cause of action and, presto, a factual dispute emerges that sends the summary judgment motion down the drain and sends the case to a jury. But not so here. The court actually read the expert affidavit carefully and spotted it for the litigation-driven drivel that such things usually are. The expert report contained no specific evidence that Aldara is defective, or that Aldara caused the plaintiff’s alleged injuries. Rather, the report merely contained the conclusory assertions, without evidentiary support, that the plaintiff’s neurological symptoms were “never investigated,” “never properly evaluated,” and “show direct causation to the drug Aldara.” The court held that “[s]uch conclusory affidavits must be rejected by the Court when they represent nothing more than ‘an effort on the part of the plaintiff to create an issue of fact.’”
Finally, the plaintiff argued that to respond to the defendants’ summary judgment motion, she required additional time to conduct discovery regarding her recently diagnosed neurological and neuropsychological conditions, as well as Aldara’s allegedly dangerous design. Pursuant to Federal Rule of Civil Procedure 56(d), the Court may allow time to take discovery “[i]f a nonmovant shows by affidavit or declaration” that she cannot present facts to justify her opposition to a summary judgment motion and that discovery might remedy that deficit. Fed. R. Civ. P. 56(d). But a hope is not the same thing as a showing. The plaintiff failed to identify specifically what further discovery she required, or what evidence that discovery would unveil.
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In addition to being a great satirist and one of the inventors of the novel, Henry Fielding had a career in the law. He was described by a historian as one of the two best magistrates in London. Based on the Morris decision, we think the magistrate who authored it also merits praise. The opinion is clearly reasoned and concisely expressed. Nabokov, Fielding, and Barth could hardly improve upon it.
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Posted By Steve McConnell to Drug and Device Law at 4/22/2015 07:30:00 AM --
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