It’s a good day in suburban Philadelphia. The sun is shining, the snow is melting, Covid-19 cases are down nationwide, and we just got a text from the Drug and Device Law Rock Climber heralding a weekend visit (with the Irascible Rescue Pomeranian in tow). We are enjoying a welcome (if cautious) flash of optimism.
If you have read more than a few posts on this Blog, then there is a good chance that you realize we have strong views on preemption. You might have also picked up that we think the way an issue is analyzed, not just the ruling after the analysis, matters. We have talked about the…
Defense hacks. Homers. Biased. These are just a few of the labels we have applied to the authors of this Blog. While we recognize our leanings and strive to offer something more than just cheering a decision for the defense and jeering a decision for the plaintiff, we do see some cases as…
If you have been following along for a while, then you have surely run across our posts making some combination of the following points: 1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture). One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted. That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.
The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted. The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged. Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection. Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis. When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds. We will address only some of them.
Part of our point here is that the order can matter. We do not have the briefs, so all we can go off of here is the opinion. After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this: “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:
If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.
Id. at *8. This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary. Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.
Maybe you’ve noticed that many of our recent posts have reported good decisions out of Mississippi. Here, here, and here, for example. It’s as if there has been an outburst of judicial common sense in that fair state. But it has not really been such a sudden thing. Looking back over last year, sound reasoning and clear decision-making seem to be commonplace in Mississippi opinions. You just had to look for these things, and you didn’t have to look all that hard.
Consider Mealer v. 3M Co., 2015 WL 9692735 (Miss. March 28, 2015). That opinion came out ten months ago, and is now available on Westlaw. It isn’t a drug or device case, but its holding on the safer alternative requirement is important for any product liability design defect claim.
The product at issue was a one-use, disposable respirator mask. The plaintiff wore one while wielding a jackhammer in a demolition project. The claim was that the mask did not adequately filter out silica particulates, and that the plaintiff ultimately contracted a fatal lung disease as a result. The plaintiff’s experts opined that there was no design change that could make a disposable respirator mask adequate. Instead, the safer, feasible alternatives included such things as elastomeric respirators with cartridge filters and exhalation and inhalation filters with rubber seals. The court held that those weren’t safer alternatives but were, instead, different products altogether. The disposable mask used by the plaintiff was a simple fiber piece that costs about a dollar. By contrast, the elastomeric respirator costs about $25-30. As the court reasoned, “[t]hey are completely different and their utility is completely different, the variation in longevity of the two products is obvious.”
Last month, we discussed Estes v. Lanx, Inc., 2015 WL 9462964 (N.D. Miss. Dec. 23, 2015), and mentioned that the court had left a bit of unfinished business behind – having raised sua sponte the question of whether the plaintiff’s assertions that the device lacked proper FDA clearance was preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).
A lot of you were interested. That post has received over 1000 hits.
The other shoe has now dropped.
We spent the past weekend in Cleveland, visiting a dear law school friend of whom we see much too little. Cleveland deserves more press as a travel destination. It boasts beautiful architecture, (including spectacular bridges, like the Detroit-Superior Bridge over the Cuyahoga River), reasonable prices, and the Cleveland Clinic. It is also home to the world-class Cleveland Symphony and the renowned Cleveland Museum of Art. But (not surprisingly, for regular readers of our posts) our most memorable afternoon was spent in that mecca of popular culture, the Rock and Roll Hall of Fame. We had to be dragged away from the continuous loop of induction ceremony highlights. We gleefully donned headphones and entered a simulated recording booth, where we “laid down the harmony track” over a melody line sung by a popular artist. We stared at Elvis’s army uniform and the sheet of paper on which Neil Young first jotted the lyrics for “Heart of Gold.” But we were most captivated by a room-size exhibit devoted to one of our personal idols, Graham Nash, a two-time Hall inductee (with the Hollies and with Crosby, Stills and Nash), onetime Joni Mitchell cohabitant, and author of a song in serious contention to be our all-time favorite, the folk-y classic “Teach Your Children.” (In a minute, we will find a way to tie this, however tenuously, to something legal. We make no such attempt with this link to a lovely moment from the 2007 American Idol finale, on which Nash sat on a stool with an acoustic guitar and performed this song with an Idol finalist.)
Nash is an intelligent, socially-conscious man of diverse talents that include painting and photography. Among the tidbits revealed in the headphone-accessible interview clips interspersed throughout the exhibit was the fact that he is also a serious collector of memorabilia. He seeks to acquire items that capture the seminal moments of significant political and musical events. (For example, his collection includes a piece of the fence that rings the grassy knoll in Dallas.) In today’s case (see – we told you!), a minor cautionary tale from the Mississippi Supreme Court, the seminal moment in the demise of the plaintiff’s case occurred 120 days after she filed her First Amended Complaint. While rock-and-rollers can often flout the rules, it’s always a good idea for lawyers to follow them, as this case demonstrates.
In Meeks v. Hologic, Inc., 2015 Miss. LEXIS 610 (Dec. 17, 2015), plaintiff initially sued a physician and a medical center for injuries she had allegedly sustained two years earlier during outpatient gynecologic surgery. Both defendants answered the Complaint. Two years and 363 days after she discovered her injuries (this becomes important, because Mississippi has a three-year statute of limitations), with leave of court pursuant to the Mississippi rules, plaintiff filed her First Amended Complaint (“FAC”) adding Hologic, manufacturer of a device used in her surgery, as a defendant, and adding warranty claims against all defendants. Plaintiff served the doctor and the medical center with the FAC, but never served the FAC upon Hologic. Neither the doctor nor the medical center answered the FAC. (This was also important in the plaintiff’s mind, but it wasn’t really.)
We are determined not to end 2015 on a bad note. Thus, we turn, as we do with surprising frequency (and as we did last week), to a federal court decision out of Mississippi for a heaping helping of solid legal reasoning. The case is Estes v. Lanx, Inc., 2015 U.S. Dist. LEXIS 171184 (N.D. Miss. Dec. 23, 2015), and the court got everything right. The case involves the usual panoply of product liability claims against a spinal fixation system. After a surgery on the plaintiff in 2011, two pedicle screws fractured. A revision surgery was performed in 2012. The plaintiff then sued, claiming that the pedicle screws were negligently designed or manufactured, that the defendant breached warranties as to the pedicle screws, and that the defendant had failed to obtain FDA clearance for the
spinal fixation system.
Mississippi has a Products Liability Act (the MPLA) that supplants common law claims, such as negligence or negligent misrepresentation. We wish every state enacted a product liability act. In fact, we wish every state enacted the MPLA. The MPLA requires a design defect claim to suggest a feasible alternative design. The plaintiff offered no such alternative design, so that theory was dismissed. The manufacturing defect and failure to warn claims also foundered, though there were wrinkles to those claims, and the court’s ruling on those wrinkles made the decision even better.
The time for Mad Men is almost over. Next Sunday is the finale, and we can hardly stand the thought that our tv screens will no longer harbor Don Draper, his predatory, boozing advertising colleagues, his aggrieved family, and all those random acquaintances who either wanted to love Don or beat him about the head with a telephone book. There has been a lot of speculation about how the show will end. Chief among the theories is that, consistent with the opening titles imagery of a man falling, Don will exit through a skyscraper window. A crazier notion is that Don will end his latest On the Road odyssey by becoming the notorious 1971 hijacker DB Cooper. But as the great tv critic Alan Sepinwall pointed out, when the last notes of the title song fade, Don ends up safely in a chair, with the inevitable cigarette tucked in his right hand.
A couple of weeks ago the episode was called “Time and Life.” The ad agency had been gobbled up by a much bigger agency, and was being forced to move out of its offices in the Time/Life building. “Time and Life” sounded suspiciously to our ears like Martin Heidegger’s Sein und Zeit (Being and Time), a big, forbidding book that birthed existentialism. When Heidegger wasn’t busy canoodling with Hannah Arendt or cheerleading for the Nazi party, he wrote perhaps the preeminent work of 20th Century philosophy. He said that we are thrown into the world, are baffled by our existence and its impending end, and struggle for authenticity under the vast indifference of the skies. If there is anything about Sartre that you thought was insightful or cool, odds are that he cribbed it from Heidegger. Anyway, Heidegger had a phrase for people who departed from authenticity. The English translation for the original German word is “falling.”
But any connection with our junior year class on The Political Philosophy of Marx, Nietzsche, and Heidegger (the class was taught by
Harvey C. Mansfield, and he ended up concluding that those three German philosophers were brilliant but wrong and, worse, irresponsible, because their writings supported the most murderous regimes of our time) is not why Mad Men matters so much to us. More than any other of the ‘difficult men’ shows of the current Golden Age of TV, Mad Men is relevant to more than our jiggling neurons. We don’t kill people or cook meth, so The Sopranos and Breaking Bad seem diversionary by comparison. Mad Men is about things we do do: persuade people, muck up personal relationships, and drink whisky on school nights. Moreover, because of its 1959-70 setting, Mad Men feels like a conversation with our parents that we were never able to have. They had lived through the depression and then found themselves in the midst of a nutty American hegemony that could be easy, cruel, fun, and wildly unfair all at the same time. There was a lot to admire about that generation and a lot to make you shake your head in fury. But one way or another, they were ours. Maybe Mad Men will end by taking a stab at the same questions that drove so much of the action in The Sopranos and Breaking Bad: Can people learn? Can they change? In The Sopranos, it seemed that Tony Soprano never really could change, no matter how much he could goofily appropriate the language of psychology. In Breaking Bad, Walter White certainly did change. The creator of Breaking Bad, Vince Gilligan, famously described the arc of the show as taking Mr. Chips and turning him into Scarface. People can get worse. Perhaps on Sunday Don Draper will emulate the original Odyssey by finally going home and doing right by his family. That would be something of a surprise, since the creator of Mad Men, and the writer and director of the finale, Matt Weiner, wrote some of the darker episodes of The Sopranos.
But even writers learn and change. The title of the Mad Men finale is “Person to Person.” That title incites optimism in our scurvy soul. We bet Weiner and Don stick the landing.
Today’s case is a straightforward one with a good result, and there is some learning to be had from it. It is about one issue that we love to discuss, preemption, and one that we do not say so much about, statute of limitations, because that issue is usually so fact-specific. The case is called Williams v. Ciba Vision Corp., 2015 WL 1903429 (S.D. Mississippi April 27, 2015). The plaintiff received a replacement lens during cataract surgery in 1999. Over the next couple of years, the plaintiff experienced problems with the lens, including infections, pain, and an inability to see. But it was not until 2012 that the pain became so severe that the plaintiff underwent an extraction of the lens. Testing on the lens confirmed the existence of a foreign substance. The plaintiff filed suit in 2013 and alleged that the defendant deviated from an FDA-approved manufacturing process and thereby permitted biofilm formation on a majority of lenses.
We normally prefer to trumpet birthday wishes rather than deathday anniversaries. But the guillotining of King Louis XVI was such a huge moment in Western history, not just French history, that we cannot let the event of January 21, 1793, go unremarked. It is only a series of tiny conceptual steps to go from the French Revolution to nationalism, to total war, to the Napoleonic Code, to the metric system, and then to a weird overestimation of the films of Jerry Lewis.
Today is also National Hug Day in the United States. Surely, Louis and Marie Antoinette could have used a hug as they rode toward the Place de la Revolution, which is now called the Place de la Concorde. (In the Star Trek universe, the President of the United Federation of Planets is officed in the Place de la Concorde. What other legal blog supplies that sort of crucial context?) If we were discussing an especially lousy case today, we might say that we could use a hug, too. But that turns out not to be necessary, because we are today reporting on a perfectly sensible case that rejected the Conte infamy. It comes from the land of magnolias and Faulkner, of Robert Johnson and the International Ballet Competition, of Blind Melon and Viking Ranges. It comes from Mississippi.
The case is Truddle v. Wyeth,LLC, 2015 U.S. Dist. Lexis 4563 (N.D. Miss. Jan. 12, 2015). Being long-time blues lovers, we cannot resist mentioning that the Truddle case resided in the Delta Division of N.D. Mississippi. None of the courts in our burg has a title nearly so colorful. (We could see Philly courts conducting proceedings in a Schuylkill Division, Hoagie Division, Mummers Division, and, in honor of the Sixers basketball team, Tankers Division.) Truddle was a pro se case and, as with so many of the cases we discuss, it arose from very sad circumstances. A young man suffering from gastritis and related conditions was prescribed Reglan/metoclopramide. He subsequently committed suicide. That is not the typical injury alleged in Reglan/metoclopramide cases. His relatives sued both the manufacturers of brand name Reglan as well as the manufacturers of generic metoclopramide. Earlier in the proceedings, the court had dismissed the claims against the generic manufacturers based on Mensing preemption. Then the brand name manufacturers moved for summary judgment on the ground that there was no evidence that the decedent had ever taken brand name Reglan. Thus we have the ‘one-two punch’ we have written about several times before, including here and here and here, among others. The Truddle court followed the analysis of almost every other court in deciding that a brand name manufacturer cannot be held liable for injuries suffered by someone who never ingested the brand name product. Put another way, the Truddle court rejected the Conte craziness that came out of California and that has been rejected by every right-thinking court (though, sadly, incoherently, maddeningly, it has been embraced by Mississippi’s neighbor to the immediate east).