July 2013

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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

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If somebody were to ask us whether as a general proposition it’s relevant to the presentation of a product liability case about a prescription medical product that the FDA had approved/cleared the product and the defendant had complied with FDA regulations, our immediate reaction would be “Duh, of course, it’s relevant.”  We may have an overriding preemption or standing argument under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), but relevance?  Particular aspects of FDA approval or compliance might not pertain to the particular defect allegations in a given case, but in general, the relevance of the fact the FDA has allowed the product on the market, and that the manufacturer complied with pertinent FDA regulations, seems unassailable.

Ask that to the other side, however, and the answer will be “only if it helps me win.”  Plaintiffs are more than happy to offer evidence of FDA approval/compliance evidence – but only if it’s about non-approval/noncompliance.  If the FDA pedigree of a particular product doesn’t include any sort of FDCA violation, then the same counsel who so zealously advocated the relevance of the FDA last week is quite happy the next week to disavow every word of it.  That happened to us recently, hence this post.

When an application is required to sell an FDA-regulated product (including almost all such products likely to be involved in litigation), the manufacturer cannot sell it in the U.S. until and unless the FDA says ‘yes.’  Indeed, over a dozen states have statutes that, to one extent or another, presume that products passing FDA muster aren’t defective.  For reasons such as these, the overwhelming majority of the caselaw recognizes the relevance of the FDA’s decisions.

Putting aside preemption (which is predicated on federal, not state, legal principles) the general state-law rule is that a product’s compliance with FDA regulations – whether they’re characterized as “minimum” or otherwise, is relevant, albeit not controlling, in product liability litigation.

[A] product’s compliance with an applicable product safety statute or administrative regulation is properly considered in determining whether the product is defective.

Restatement (Third) of Torts, Products Liability §4(b) (1998).  The supporting Reporters’ Note to §4(b) confirms:

The overwhelming majority of jurisdictions hold that compliance with product safety regulation is relevant and admissible on the question of defectiveness, but is not necessarily controlling.Continue Reading FDA Device Clearance – Clearly Relevant

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The Fourth of July is the time to celebrate everything American – baseball, apple pie, almost anything that’s red, white and blue (ironically so are the Russian, French, and British flags), the Declaration of Independence, the Constitution, and the Supreme Court making decisions that infuriate us one day and exhilarate us the next.  And regardless what decisions we love or we hate, we can get up on our soap box (literal or cyber) and disclaim our reasons.

That’s free speech.

And free speech is one of the linchpins of preserving everything else that makes America what we hope America can be.

So we thought we’d devote today’s post about an interesting free speech case, ONY Corp. v. Cornerstone Therapeutics, Inc., 2013 WL 3198153 (2d Cir. June 26, 2013) (also available here in slip).  No, this is not another screed about off-label use, although it’s related. ONY has nothing to do with the FDA, or even the federal government.  It’s a Lanham Act (and related state-law torts) case in which the plaintiff manufacturer accused a competing manufacturer of making inaccurate statements about the comparative effectiveness of their respective products.Continue Reading Celebrating Free Speech on the Forth of July

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This is more of a think piece, we won’t be citing many cases (by our standards) today.

There are two preemption principles at work in the Supreme Court’s recent Bartlett decision.  The first of these, which we’ll call “independence,” was articulated first in PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  “[W]hen a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.”  Id. at 2581.  That was reiterated in Bartlett in the design defect context, holding that “redesign was not possible” in part because that would require intervening FDA action.  Any redesign “would be a new drug that would require its own NDA to be marketed.”  Mutual Pharmaceutical Co. v. Bartlett, 2013 WL 3155230, at *8 (U.S. June 24, 2013).  And, as in Mensing, to the extent that the “design” claim in Bartlett devolved into a warning claim (because redesign was impossible), FDA regulations “prevented [defendant] from independently changing” its label.  Id. at *10 (quoting Mensing).

The Supreme Court has now enunciated and applied this “independence” principle twice.  Nor has it limited that principle to the FDCA.  See Id. at *10 n.3 (invoking Florida Lime & Avocado Growers, Inc. v. Paul, 373 U.S. 132 (1963) (a non-FDA case involving agricultural pricing)).  Moreover, since Bartlett (and Mensing) involved solely implied preemption, their principles apply regardless of the statutory scheme.  E.g., Bartlett, 2013 WL 3155230, at *6 (impossibility preemption applies “in the absence of an express preemption provision”).
Continue Reading Ruminations on Independence and Inaction: Further Implications of Bartlett

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This discussion of an opinion in the Pelvic Mesh litigation once again comes only from the Dechert side of the blog. The MDL court in the pelvic mesh litigation issued rulings on motions in limine last week.  In re: Bard, Inc. Pelvic Repair Sys. Prods. Liab. Litig., MDL No. 2187, 2:11-cv-00195, 2:11-cv-00012, 2:10-cv-01224, 2:11-cv-00114, 2013 U.S. Dist. LEXIS 90210 (S.D.W.V. June 27, 2013).  In previous pretrial rulings, the defense made out well, winning summary judgment on a number of plaintiffs’ claims, including a failure to warn claim in one case (see here and here), and winning a number of key Daubert motions (here).  Things didn’t go as well with the in limine motions.  It was more of a mixed bag.  Here are a few of the issues addressed by the court.

FDA 510(k) Clearance 

This was plaintiffs’ motion.  They wanted to exclude evidence related to the FDA’s clearance of the Avaulta products through its 510(k) process.  Id. at *4-6.  Seems pretty relevant, doesn’t it?  It’s the process established by the industry’s primary regulator as to what the industry must do and how it must do it in order to be able to bring its product to market.  Yet the court granted plaintiffs’ motion.Continue Reading Pelvic Mesh Litigation: In Limine Rulings

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We stand at the midpoint of our journey around the Sun.  182 days precede us this year, and 182 remain before 2013 concludes.  July 2 is a big day historically, and not just because it is the day when Larry David and Lindsay Lohan entered this world and Vladimir Nabokov left it.  Exactly 237 years ago in Philly our Founders approved the Declaration of Independence. There is a good argument that we should celebrate the Second of July rather than the Fourth, when the Declaration was publicized. Zounds, why not celebrate both? Who can get enough barbecues and fireworks?

150 years ago on this date Joshua Chamberlain and his Maine boys held Little Roundtop and prevented day 2 of the Battle of Gettysburg from turning into a very bad day for the Union.  (Bexis is vacationing Down East and reports that the weather is miserable there and that it is no wonder the Maine contingent took their chances at Gettysburg.)  As we sweat in this soupy weather, barely able to rouse ourselves from terminal torpor, it seems a good time to reassess where we are, to count our blessings, to acknowledge the bravery and sacrifice of our predecessors, to laugh at the faults of others and grieve at our own … and to talk once again about the Aredia-Zometa litigation.

Last week was eventful in the Aredia-Zometa litigation.  After a two-week trial, a jury in the Eastern District of California returned a defense verdict in Hill v. Novartis Pharmaceuticals Corp., No. 1:06-cv-00939-JSR-SAB (E.D. Cal. June 26, 2013). Any drug and device trial is likely to catch our attention, but this one was especially interesting because it was presided over by Judge Rakoff, who hails from the Southern District of New York and was sitting by special designation.  For those of you who follow securities and other financial litigation, you know that Judge Rakoff is brilliant, opinionated, and strong-willed.  If he does not like a proposed settlement, he will not approve it.   We remember going to a RICO conference over 20 years ago where Rakoff was one of the two MCs. He was then at the Mudge Rose firm, where Richard Nixon practiced law once upon a time.  It was clear that Rakoff was lightning smart.  After one session, we went up and chatted with him about some of the intricacies of the much-overused RICO statute.  Rakoff was helpful.  He was nice.Continue Reading Mid-Summer Aredia-Zometa Doings

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Guest Post – Tale of Two Districts: How Does Fennell Apply to Illinois Resident Plaintiffs?

Here’s another guest post about recent forum non conveniens developments in Illinois by Brendan Kenny of Blackwell Burke.  This is important because forum non constrains the appetite of the black hole counties of that state.  As always our guest posters get all the credit and take all the blame.

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In Fennell, the Illinois Supreme Court made clear that Illinois trial courts must grant a defendant’s forum non conveniens motion if the plaintiff has no significant connection to the forum. Readers will recall that Fennell was one of the thousands of out-of-state residents who have filed cases in Illinois plaintiff-friendly forums. So much for foreign plaintiffs—but what about Illinois residents who file in Cook, Saint Clair, or Madison County instead of the county where they live? Does Fennell prevent Illinoisans from forum-shopping within their state’s borders? Two recent appellate court decisions suggest that it does.Continue Reading Forum non Conveniens

Drug & Device Resources

Bexis’ Book

FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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