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.

Continue Reading Time and Preemption

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).

Continue Reading One Mississippi, Two Mississippi: Dismissal of Claims against Brand Name Reglan and Generic Metoclopramide Manufacturers

If anyone gave out prizes for the most incomprehensibly named multi-district litigation, the one currently proceeding as “In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation” would be right up there.  Rarely have we encountered a case name with four words in a row that, without a dictionary, we didn’t know what they meant.  Basically, this is product liability litigation about two dialysis solutions (Granuflo and Naturalyte) over alleged serious adverse reactions related to effects on blood chemistry.

This MDL is currently pending in the District of Massachusetts.  Just after the new year the Fresenius MDL (that’s all the designation really needed) made some news with a quartet of decisions.  We’ll describe them for you briefly.

First Decision

In In re Fresenius Granuflo/Naturalyte Dialysate Products Liability Litigation, ___ F. Supp.3d ___, 2015 WL 44589, at *1 (D. Mass. Jan. 2, 2015), the court denied remand to a batch of California plaintiffs.  As is so often the case in removal/remand, there was a lot of gamesmanship going on.  The defendant proved, to the court’s satisfaction, that the principal place of business of the target defendant, Fresenius, USA, had been its Massachusetts for almost a decade, since a merger.  Id. at *2.  It satisfied the relevant “nerve center” test (see here for more on that) for personal jurisdiction.

Continue Reading Fresenius Potpourri

It is a pity that the case discussed in today’s post did not come out around Halloween.  That is not to say that there is anything ghoulish about the invaluable service (keep that word “service” in mind) of making blood and body tissues available to patients in need.  We are more likely to perceive certain tactics of predatory plaintiff lawyers as ghoulish.  We are not saying that our opponents often resemble vampires or werewolves.  No.  We are not saying that.  Not out loud.

It has been a while since we have seen a case about a blood shield law – that is, a state law that immunizes providers of blood (and other body tissues) from strict liability.  In Palermo v. Lifelink Foundation, Inc., 2014 WL 6480524 (Mississippi Nov. 20, 2014), the Mississippi Supreme Court for the first time addressed the interplay between the state’s blood shield law and the strict liability provisions in the Mississippi Products Liability Act (MPLA).  The plaintiff alleged that he was injured by infected tissue surgically placed into this knee.  He argued that the strict liability and breach of warranty provisions of the MPLA trumped the blood shield law.  He lost.

The Mississippi Supreme Court’s opinion is extensive, but the reasoning is straightforward.  First, we are treated to a little history.  In May of 1966, the Mississippi Legislature passed the blood banking statute.   Here is the meat of it:

“[t]he procurement, processing, storage, distribution and or/use of whole blood, plasma, blood products, and blood derivatives for the purpose of injecting or transfusing, transplanting the same or any of them into the human body for all purposes whatsoever is  the rendering of a service by every person participating therein, … and does not constitute a sale.”

Continue Reading There Will be Blood (Shield Laws)

Even a casual reader of the blog would know that we like it when drug or device manufacturers defeat dubious claims.  It is also no secret that we are enamored of the learned intermediary doctrine and challenging the link of proximate cause for failure to warn.  We also value decisions that use common sense, at least what our biased perspective allows us to see as common and sensical.  When these things come together, we are as pleased as a robin finding juicy, wriggling worms after the spring thaw.

The decisions in Averhart v. Ortho-McNeil Pharm., Inc., No. 3:09 oe 40028, 2014 U.S. Dist. LEXIS 38446 (N.D. Ohio Mar. 24, 2014), and Casso v. Ortho-McNeil Pharm., Inc., No. 1:11 oe 40006, 2014 U.S. Dist. LEXIS 38443 (N.D. Ohio Mar. 24, 2014), largely satisfy our annelid cravings.  First, the defense won summary judgment on the warnings claims they moved on in each case.  (The defense moved for judgment on the pleadings on some other claims and apparently raised some new arguments for summary judgment in reply briefs. Defendants were rebuffed in almost all of those attempts.  We cannot tell from the decisions why summary judgment was not sought across the board or if the plaintiffs had any evidence for their non-warnings claims, so we will focus of the warnings part of the decisions.)  Second, the warnings claims fell because the prescribers testified to their understanding of the risk at issue and the plaintiffs had nothing else suggesting that the warnings were inadequate in any material way.  Third, the warnings analysis, despite some quirks of the phrasing of the applicable Mississippi and Minnesota law, was pretty straightforward, focusing on the actual testimony of the prescribers and some of the basics of how drugs are prescribed to patients.

The drug at issue in these cases was Ortho-Evra, a combination hormonal contraceptive patch; “combination” means that there is estrogen with the progestin.  It has long been common knowledge in the medical community, and, we think, the population of patients who use hormonal contraceptives, that this class of products has a risk of blood clots.  Patient package inserts started forty years ago because of this risk with these products. Advertisements for these products on television and in popular magazines have identified this risk since the 1990s. There has been litigation for decades over various hormonal contraceptives and their risk of blood clots (among other things).  Because of this, to say nothing of medical journals, medical schools, and medical education, it is hard to imagine healthcare providers making decisions on prescribing hormonal contraceptives without being aware of the risk of blood clots and at least thinking about what to tell the patient about the risk with the product or products that might be prescribed.  Because of the nature of hormonal contraception, it is particularly important that the prescriber and patient work together to identify the particular medication that the patient will actually use as directed.  The risk of blood clots present in all marketed prescription combination hormonal contraceptives goes up with pregnancy–that is, when contraception fails—so the risk-benefit decision for prescribing a particular contraceptive is very much tied up patient-specific considerations. Thus, for warnings claims on blood clots, there are some obvious challenges for plaintiffs:  (1) that the claims are for inadequate warnings rather than failure to warn completely, (2) that prescribers will typically be well-versed in the risks regardless of the label, and (3) decisions to prescribe one combination hormonal contraceptive instead of another will usually not be based on a comparison of their blood clot risk.  This means the manufacturers of these products should have a good chance of getting summary judgment on inadequate warnings claims for the risk of blood clots.

Continue Reading Common Sense Contraceptive Warnings Cases

Isn’t it strange how, once you focus on a particular topic or item, you start espying it everywhere?  If you are in the market for an SUV, for example, they start showing up at every intersection, parking lot, and billboard.  Lately, we keep bumping up against body parts.  Bear with us; this is not a descent into ghoulishness.  Well, maybe it is, a little.  Advertisements for I, Frankenstein have taken over our television.  The weekend Wall Street Journal had an article co-authored by Nobel prize winner Gary Becker advocating creation of a market for sale of transplant organs.

And then there’s the case of Palermo v. LifeLink Foundation, 2014 WL 114531 (Mississippi Ct. of Appeals January 14, 2014).  The plaintiff sued LifeLink Foundation for strict products liability, products-liability negligence, and breach of warranty, alleging that LifeLink supplied a contaminated infected allograft (body part/tissue) for his surgery.

The facts sound pretty favorable for the defendant.  There was testimony that prior to shipment of the allograft there were no findings of sepsis or medical infection in the medical history or autopsy of the allograft donor.  After the allograft was removed from the plaintiff’s knee, it was tested and no bacteria was present. LifeLink, as a tissue bank, was required to follow certain guidelines with regard to testing, packaging, and distributing human tissue set by the FDA and the American Association of Tissue Banks (AATB).   In packaging the allograft for shipment, LifeLink followed the AATB’s standards for tissue banking, which require processed frozen or cryopreserved muscular-skeletal tissue to be stored at negative 40 degrees Celsius or colder.  The record showed that the allograft was shipped on dry ice and stored at the required temperature during delivery.  There was no evidence or expert testimony to show that LifeLink did not comply with the requirements issued by the FDA and AATB.

The more fundamental issue was whether body parts could be the subject of a product liability suit under Mississippi law.  The trial court said no, granted summary judgment for the defendant, and the Court of Appeals affirmed.  The reasoning was rigorous and inescapable.  Mississippi law specifically provides protection for those persons or entities who use “human tissue” for medical purposes. The Mississippi court reviewed case law from all over the country and saw “a nationwide antipathy over applying products-liability or strict-liability concepts to body parts such as blood and tissue.”  Finally, the court looked to the Restatement (Third) of Torts, section 19, which provides that “human blood and human tissue[,] even when provided commercially, are not subject to the rules of this Restatement.”  Accordingly, the court concluded that, “like blood made available for transfer to others, human tissue provided to others in medical procedures is not a ‘product’ subject to products-liability law, and the distribution of human tissue, including reasonable payments for related services, does not constitute a ‘sale’ for purposes of strict liability.”

Continue Reading A Worthy Addition to the Body of Law

California and Mississippi have little in common, but they  both apply the learned intermediary doctrine in prescription drug cases.  Prescription drug manufacturers have a duty to provide adequate warnings in connection with their products, but only to prescribing physicians – the learned intermediaries – and not directly to patients.  We write on the learned intermediary doctrine a lot because it comes up in so many of our cases, and also because it is a sound legal rule that should apply, and should apply consistently.  Toward that end, the Northern District of Ohio recently gave us twin opinions applying the learned intermediary doctrine under the laws of California and Mississippi, and the district court found that the defendants in both cases were entitled to summary judgment.

In Miller v. Ortho-McNeil Pharmaceutical, Inc., 2013 U.S. Dist. LEXIS 158302 (N.D. Ohio Nov. 5, 2013), the plaintiff used a prescription contraceptive patch and experienced a pulmonary embolism, which she attributed to her contraceptive use.  Every physician in the world knows that hormonal contraceptives of this type increase the risk of blood clots, and so did the nurse practitioner who first prescribed the plaintiff’s contraceptive patch.  In fact, the nurse practitioner knew that the product’s warnings “included the elevated risks of blood clot[s].”  Id. at *3.  A second nurse practitioner who prescribed to the plaintiff likewise “was aware that [the contraceptive product] exposed patients to a higher concentration of hormones than typical birth control pills, increasing the risk of thrombotic disease and pulmonary embolism.”  Id. at **3-4.  Even with this knowledge, both nurse practitioners believed the benefits of prescribing the product to the plaintiff outweighed the risks.  Id.

On these facts, the court had little difficulty granting summary judgment on a familiar two-prong basis.  First, the product warnings were adequate under Mississippi law because “Defendants specifically warned of the risk of blood clots.”  Id. at **10-11.  We are sometimes surprised when courts allow failure-to-warn claims to proceed even where the package inserts warn about the exact risk that allegedly befell the plaintiff.  But this court was on the ball and, in our view, came to the right conclusion on these facts.  Second, the court ruled that the plaintiff could not prove causation because “she has not shown that a different warning would have changed the prescribing decision.”  Id. at *12.  This is another refreshingly straightforward holding, and it follows Mississippi’s learned intermediary doctrine to a tee:  The manufacturer owes a duty to warn only the prescribing physician, so if an alleged inadequacy in the warnings had no impact on the prescribing decision, then proof on the essential element of warnings causation fails.  In Miller, both prescribing nurse practitioners knew about the clotting risk, and they prescribed the product anyway.  For her part, the plaintiff had no evidence that a different warning would have made any difference.  Summary judgment granted.

Continue Reading Learned Intermediary Rule Applies, with No Exception for Contraception

A few months ago, we told you that the Supreme Court granted certiorari in a case to decide whether a state’s parens patriae action is removable as a “mass action” under the Class Action Fairness Act (“CAFA”) when the state is the sole plaintiff and the claims arise under state law.  The decision on appeal is the Fifth Circuit’s Mississippi v. AU Optronics Corp., 701 F.3d 796, 800 (5th Cir. 2012).   The Fifth Circuit answered the question in the affirmative and as that remains the controlling law for the circuit, the Northern District of Mississippi recently followed suit in Hood v. Bristol-Myers Squibb Co., 2013 U.S. Dist. LEXIS 90540 (N.D. Miss. Jun. 27, 2013).  Since  Hood is a pharmaceutical case, we thought we’d use it as an opportunity to explore the issue a little more, and there is a also a good diversity ruling.

This AG action was brought in state court solely under the Mississippi Consumer Protection Act (“MCPA”) seeking civil penalties, disgorgement and injunctive relief.  Id. at *3.  Defendants removed the case to federal court.  In opposing plaintiff’s motion to remand, defendants asserted diversity jurisdiction, federal question jurisdiction and jurisdiction under CAFA.  The court agreed with defendants on both diversity and CAFA.

As a quick but important side note, plaintiffs filed an amended complaint on the same day they filed their motion to remand – presumably attempting to address the jurisdictional issues.  The court, however, found that the question of removal should be determined based on the original complaint that was in effect at the time of the removal.  Id. at *6-7.  Good practical reminder if you are faced with amended pleadings in the midst of a motion to remand.

On to diversity.  Here the question is who are the real parties in interest?  If the State of Mississippi is the sole party in interest, there cannot be complete diversity because a State is not considered a “citizen” for purposes of diversity.  Id. at *9-10.  That is precisely what the Mississippi AG argued – that he was bringing a parens patriae suit on behalf of the State of Mississippi under the MCPA, not a suit on behalf of the individual users of [defendant’s product].”  Id. at *9.  In opposition, defendants argued that the real parties in interest were the citizens of Mississippi who are completely diverse from the defendants.  Id.

Continue Reading Diversity and CAFA Jurisdiction in Mississippi AG Action