Photo of Steven Boranian

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

Photo of Michelle Yeary

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

Photo of John Sullivan

Four bellwether cases have been prepared for trial in the pelvic mesh MDL, and so the court has begun issuing pre-trial rulings.  Over the coming days (and later if further decisions come out), we’ll discuss a number of those rulings.  All of these posts, however, come solely from the Dechert side of the blog.

Today, we have the court’s summary judgment decision in a bellwether case that originated in Mississippi. In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 78059 (S.D.W.V. June 4, 2013).  The plaintiff’s doctor had implanted the defendant’s Avaulta Plus Biosynthetic Support System into plaintiff during her pelvic organ prolapse surgery.  The court’s summary judgment decision addressed all, or almost all, of plaintiff’s claims and five of defendants’ affirmative defenses.

By far, the most interesting issue, and the main reason that the opinion merits discussion, is the court’s decision on plaintiff’s failure to warn claim.  The defendant’s first argument was that Avaulta’s label, called the Instructions for Use (“IFU”), warned of the precise risks that the plaintiff was suing about.  Id. at *15.  But, while plaintiff conceded that the IFU warned about a list of possible complications, she claimed that the defendant failed to warn doctors about a particular resin used in the Avaulta product.  Id.  The material safety data sheet for the polypropylene resin, she claims, disclosed that the resin was not proper for permanent implantation in humans, and the defendant didn’t disclose that to doctors.  Id. The court accepted this argument. It held that, while defendant disclosed potential adverse events, it was a fact issue for the jury to decide whether its warnings were adequate overall.  Id. at *16-17.Continue Reading The MDL Court Has Begun Issuing Pre-Trial Decisions on Bellwether Cases in the Pelvic Mesh Litigation

Photo of Stephen McConnell

The scope of Mensing is one of the hotter issues in drug and device law these days. (The Bartlett appeal is one example.) To our defense-hack eyes, Mensing seems perfectly straightforward: a claim is preempted to the extent it alleges that the risks of a generic drug were not adequately disclosed. But the doctrinal landscape

Photo of Bexis

We tried to think of a great issue to explore today – and struck out. So instead we’ll discuss this and that – various things that we’re aware of, but that we haven’t gotten around to mentioning.

Pigs Get Fat, Mississippi Got Slaughtered

The top of the agenda, of course, is a review of Judge

Photo of Bexis

This just in – Eli Lilly has received summary judgment against the Mississippi Attorney General’s consumer fraud lawsuit in all respects – except one. The court left the state’s claim based on the difference between the price paid for Zyprexa and the value received by the State alive, but largely because that issue is currently

Photo of Bexis

Good things can come in small packages.

In Greer v. Medtronic, No. 4;08CV042-P-B, slip op. (N.D. Miss. Apr. 25, 2008), plaintiff pleaded a host of product liability claims against Medtronic relating to an implantable cardiac defibrillator. But the decedent had died on January 22, 2005, and plaintiff didn’t file her complaint until February 20,