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Bexis is pretty pleased this morning.  Almost eighteen years ago, to the day, he filed his first brief with the Pennsylvania Supreme Court challenging the negligence/strict liability dichotomy adopted in Azzarello v. Black Brothers Co., 391 A.2d 1020 (Pa. 1978) (in a case called Spino).  Over twelve years ago, he filed his first outright “overrule Azzarello” brief (in a case called Phillips).  Well, yesterday the Pennsylvania Supreme Court did precisely that – it overruled Azzarello – unanimously in an opinion written by Chief Justice Castille.  In the end, even the most pro-plaintiff members of the Court (those remaining, anyway) could not stomach the travesty that Azzarello had become.  End of self-congratulatory gloat.

We learned of this development late yesterday afternoon and published a very brief “breaking news” post alerting our readership.  At that point we had not yet read the Court’s entire 137-page opinion, Tincher v. Omega Flex, Inc., No. 17 MAP, slip op. (Pa. Nov. 19, 2014).  Now we have.  While it’s clear that the most obnoxious aspects of the Azzarello regime − the bizarre pre-trial procedure for determining “unreasonably dangerous” as a matter of law, the absolutist negligence/strict liability dichotomy, and the “plaintiff wins” guarantor/any element jury instruction (for those of you not familiar with Pennsylvania law, this is what jurors are instructed: “The supplier of a product is the guarantor of its safety.  The product must, therefore, be provided with every element necessary to make it safe for its intended use, and without any condition that makes it unsafe for its intended use,” Azzarello, 391 A.2d at 559 n.12) – have been disapproved, what’s taken their place is less clear.

On the theory that you can’t beat something with nothing, ever since Phillips Bexis had been advocating the Third Restatement of Torts as an alternative, even though there were significant aspects of the Third Restatement that could hardly be called defense friendly.  Yes, Azzarello was that bad.  The Court, however, did not adopt the Third Restatement in Tincher.  Instead, it has adopted a more mainstream (compared to Azzarello) approach to Restatement Second §402A, that in places is also informed by Third Restatement principles.  We’ll be discussing that in more detail.

Continue Reading Pennsylvania Product Liability – Azzarello Is Dead, Long Live…?

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This is as short as the Tincher majority opinion (137 pp.) is long.  Azzarello is overruled.  The preliminary judicial evaluation of “unreasonable danger” is abolished.  The jury considers it under a dual standard.  The negligence/strict liability dichotomy originating in Azzarello is gone.  The Third Restatement is not adopted.  Haven’t finished reading.  There will be more tomorrow about this.

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This is short – but very sweet.  Regular readers will recall the California appellate decision that we criticized in our “Hotel California” post back in August.  In that case, the court avoided the restrictions that Daimler AG v. Bauman, 134 S. Ct. 746 (2014), had imposed on “general” personal jurisdiction by transferring wholesale the prior “continuous and substantial” rationale to “specific” personal jurisdiction.  See Bristol-Myers Squibb Co. v. Superior Court, 175 Cal.Rptr.3d 412 (Cal. App. 2014).

Well, today the California Supreme Court granted review in the case.  Here’s a link to the docket entry reflecting the grant. Because the grant of review automatically depublishes the Court of Appeal’s opinion under California procedure, the Court of Appeal’s overreaching opinion is no longer—which is a welcome development, albeit not entirely surprising.

You see, this case was Bauman to a T – the claims were brought against non-resident defendants by non-resident plaintiffs alleging injuries that occurred outside California and involving products designed, manufactured, and sold outside California.  In other words, neither the parties nor the particular products consumed by these plaintiffs ever reached California, yet the Court of Appeal held the manufacturer defendants to answer.  We viewed it as an end run on Bauman, with the Court of Appeal finding “specific jurisdiction” based on “substantial, continuous economic activity” that sounded an awful lot like the “systematic and continuous” forum contacts that characterized general jurisdiction before Bauman recalibrated the scales.

We have only skimmed the defendant’s petition for review, but they have compelling arguments, including that general and specific jurisdiction are distinct concepts that should be kept within their respective spheres. We agree, and let’s hope the California Supreme Court agrees, too.  We like the defendant’s chances.  The case made its way to the Court of Appeal in the first place on an order from the Supreme Court to consider and apply Bauman, which the Court of Appeal purported to do, but incorrectly and to the wrong result.  This is the second time then that the California Supreme Court has voted to take up the case.  Will the Supreme Court reel in the Court of Appeal’s expansion of specific jurisdiction and toe the Bauman line?  Again, we hope so, but either way, we can foresee a petition for certiorari to the U.S. Supreme Court coming down the road.

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This is the time of year when our thoughts start migrating southward.  We can see all those birds’ nests in our suddenly denuded poplar trees.  The driveway is a skating rink of damp leaves.  The baseboards in our home now gurgle from the operation of an ancient oil heating system.

Over the last two weeks our posts leaned against a pair of intemperate blasts from a Vermont federal court.  The results were dreary and/or indecipherable.  Thus, it is with some relief that we bask in the warm glow of a nice, straightforward decision from the happiest place on Earth, the federal court in Orlando.  In Stanifer v. Corin USA Ltd, Inc., 2014 U.S. Dist. LEXIS 158587 (M.D. Fla. Nov. 10, 2014), a hip resurfacing system was implanted into the body of the plaintiff during a right hip arthroplasty procedure.  Subsequent failure of the system allegedly caused the plaintiff to suffer a revision left total hip arthroplasty and surgical removal of the system.  The plaintiff filed a lawsuit in state court seeking to recover “damages and losses” from the defendants based on state law strict liability claims for breach of warranty, manufacturing defect,  and design defect.  After removal of the action to federal court, the defendants moved to dismiss the claims based on federal preemption.

The hip system was a class III device, and therefore subject to the PMA process and the attendant federal preemption.  After the Supreme Court’s decision in Reigel, a plaintiff injured due to use of a Class III PMA device can escape preemption only by asserting a “parallel” state law claim.   As readers of this blog likely know, we think of the parallel claim exception as something crazy and made-up, like a fairy tale or a Johnny Depp movie.  Luckily, the Stanifer case is governed by the law of the Eleventh Circuit, a place that knows how to deal with such things. The Stanifer court embraced Eleventh Circuit precedent to the effect that plaintiffs cannot effectively state a “parallel claim” absent allegations that the defendant violated a “particular federal specification.”  Ah – we are far from the windy incoherence of Vermont (or Chicago – the Bausch case still stands as the babbling zenith of parallel claim doofus-prudence).

Continue Reading Far from Dumbo: M.D. Fla. Gets “Parallel Claim” Case Right

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Today’s post is really three different posts on three unrelated subjects.  None of them very long (at least by DDLaw Blog standards), but we think that each will be of interest to at least some our readers.

On Generic Plaintiffs’ Preemption “Win” in New Jersey

This piece is from the non-Dechert side of the blog.

Plaintiffs alleging failure to warn of the risks of a generic drug scored a “win” of sorts in In re Reglan Litigation, 2014 WL 5840281 (N.J. Super. App. Div. Nov. 12, 2014).  The court held, in an unpublished decision, that “failure-to-update” claims survived the otherwise comprehensive impossibility preemption that applies to generic drugs:

[T]he trial court correctly determined that plaintiffs’ claims based on the Generic Defendants’ failure to update their warnings to conform to changes made to the brand-name warnings are not preempted by federal law.  The court correctly found that allowing plaintiffs to assert these claims would not frustrate any of the purposes or objectives that Congress sought to achieve . . . .  Moreover, plaintiffs are not pursuing state-law claims based on an alleged violation of federal law.

Id. at *4. As the Appellate Division points out, non-preemption of “duty to update” is the majority view.

We may not like it, but we’re not losing much sleep about it.

Why?

Continue Reading Short Subjects

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Here’s another guest post by Reed Smith’s own Kevin Hara, this time about a recent Texas case holding that health care providers involved in clinical trials are still protected by a state medical malpractice statute, and thus were fraudulently joined.  While we are of two minds about such statutes (making it harder to sue HCPs increases litigation against our clients), since HCPs are our clients’ clients, and thus the heart of their businesses – and we’re defense lawyers by temperament – in the end we come out in favor of less liability generally.  This is an interesting use of fraudulent joinder that could well apply to the definition of “health care provider” under similar statutes in other states.

As always, our guest posters deserve all the credit and any blame for the contents of their posts.

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When it comes to Texas, one might never know based on its jurisprudence that the state motto, and indeed the state’s moniker, is derived from “Tejas,” a Native American term for Friendship.  At least from a defense perspective, the Lone Star State at times seemed mighty inhospitable; after all, Texas invented that awful “heeding presumption” back in 1972, touching off a Reign of Fire, as states followed suit, adopting a variety of feeding presumptions.  It also allowed personal injury recovery under its consumer protection statute, made a big deal of Restatement Second §402B, and was the last of the large states to adopt the learned intermediary rule.  While we’re at it, let’s not forget the decision that would never die, the Murthy case, making the worst decisions list in consecutive years in 2011 and 2012, giving us not just one opinion to lament, but Two for the Money.

But we’re forgiving, and won’t “mess with Texas” too much.  Although it took until 2012, with some help from Bexis, for the Texas Supreme Court to finally adopt the learned intermediary doctrine, deciding that it was A Time to Kill an awful decision from 2010 whose name should have been Mud.  Texas adopted the Third Restatement, which should kill the heeding presumption, and even if it doesn’t, that presumption now excludes prescription drugs and medical devices, at least forcing it into Submission.  The Legislature amended the DTPA to eliminate personal injury damages, and we haven’t heard a peep from §402B in a while, and this section’s Failure To Launch into widespread acceptance is a good thing.  Texas Daubert decisions have been outstanding.  Not only that, a lot of excellent Reed Smith practitioners are based in our Houston office.

Texas has other positive attributes as well, including being the birthplace and home of Matthew McConaughey, and of baseball standout Nolan Ryan, who we believe, despite numerous accolades, remains underrated because of his somewhat pedestrian won loss record (which for pitchers reveals more about the team and much less about the individual).  Seriously, seven no-hitters?  Ryan pitched in an era where starters routinely went the distance, and they were their own closers; we urge you to check out his career innings pitched, hits allowed, complete games, and well, the strikeouts speak for themselves. No disrespect to Madison Bumgarner, who was otherworldly in the 2014 World Series, but who has 6 complete games in his career.  Ryan had an incredible 222, including several years where he had more than 20.  We realize that people smarter and more knowledgeable than we are will correctly we might add, mention that Ryan also walked many hitters and never won the Cy Young. That’s the beauty of sports.

And then there’s ZZ Top and Janis Joplin and Beyonce.

But we digress.  Back to the legal issues.  It would be remiss not to note that Texas also has some very favorable statutes, including Civil Practice and Remedies Code 82.007, which provides a rebuttable presumption of nonliability for manufacturers and prescribers in pharmaceutical product liability actions involving failure to warn for FDA approved warnings, and 82.008, which provides a presumption of nonliability for compliance with government standards.  See Tex. Civ. Prac. & Rem. Code §§ 82.007(a)(1) and 82.008.  We were concerned that a recent Southern District of Texas decision would a la Murthy, run roughshod over state law like the TCU Horned Frogs in an 82-27 rout of Texas Tech this year or UCLA in a 66-3 drubbing of Texas in 1997 (the Longhorns’ worst loss ever).  Fortunately, we were pleasantly surprised.

Continue Reading Guest Post – When It Comes To Fraudulent Joinder In Texas, Let’s Hail The Glory Daze And Just Keep Winning

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There is no express federal preemption for drugs, right?

Wrong!  Today we expound on a flavor of preemption that we don’t often get around to—express preemption for claims related to non-prescription, over-the-counter drugs.  Under section 379r of the FDCA, no state may establish any requirement that relates to a non-prescription drug and “that is different from or in addition to, or that is otherwise not identical with” a federal requirement.  28 U.S.C. § 379r(a).  The “different from or in addition to” language rings familiar from medical device express preemption that we write on multiple times each month (such as here), and as if that were not clear enough, Congress drove the point home with the “otherwise not identical with” language.

So there you have it.  Express preemption in connection with drugs, albeit not the prescription drugs that usually occupy us, and not without significant exceptions.  The FDA can grant exemptions to the preemption rule under certain circumstances, and the provision does not preempt (1) state regulation of pharmacies or (2) any state requirement that a drug be dispensed only upon by an authorized prescription.  Id. § 379r(b), (c).  The really big exception is that the provision does not preempt product liability claims, Id. § 379r(e), so if we’re faced with claims alleging personal injury attributed to use of an allegedly defective non-prescription drug, express preemption will probably not come into play.

But that does not mean that OTC express preemption does not have teeth.  In Bowling v. Johnson & Johnson, No. 14-cv-3727, 2014 U.S. Dist. LEXIS 155899 (S.D.N.Y. Nov. 4, 2014), the plaintiffs alleged that the label on a popular brand of mouthwash falsely claimed that use would “Restore Enamel.”  Id. at *2.  According to the plaintiffs, loss of tooth enamel is permanent, making it “physically impossible” to restore enamel.  Id.  Based on this allegation, the plaintiffs alleged violations of multiple state statutes (the order does not say which statutes, but we presume they were statutes of the consumer fraud type) and the federal Magnuson-Moss Warranty Act, which governs warranties on consumer products.  Id. at *1.

Continue Reading Express Preemption OTC

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Courtesy of Mike Imbroscio of Covington (who was on the winning team) today’s post is about a very satisfying Cymbalta win – not only did warning causation fail under the learned intermediary rule, but the warning for the drug was held adequate as a matter of law.  The case is McDowell v. Eli Lilly & Co., ___ F. Supp.3d ___, 2014 WL 5801604 (S.D.N.Y. Nov. 7, 2014).  It involved injuries (such as “brain zaps,” whatever those might be) allegedly suffered by the plaintiff when she was weaned from the drug too quickly.

We’ll briefly touch on the causation part first.  Under New York’s learned intermediary rule, a prescriber’s “independent knowledge” of a supposedly unwarned-of risk breaks any causal connection between the warning’s inadequacy and the plaintiff’s injuries.  2014 WL 5801604, at *15.  The prescriber (a nurse practitioner – we think McDowell is the first nurse-as-learned-intermediary decision under New York law) “testified that, based on her clinical experience and training, she was aware of the risk of discontinuation symptoms with abrupt cessation of [drug] treatment.”  Id. (there’s a lot more than just that statement).  Because the alleged understatement of the risk wouldn’t have changed the prescribing decision, plaintiff lost.  Id. at *17-18.  Plaintiff’s attempt to mislead the prescriber at her deposition with statements about the drug that had no basis in fact couldn’t create a disputed issue of fact.  Id. at *18 (pointing out “the absence in the record of any support for the claim”).  We also like the causation standard employed in McDowell:

[U]nder New York’s proximate cause standard, a plaintiff must demonstrate that had a different, more accurate warning been given, his physician would not have prescribed the drug in the same manner.  Summary judgment is appropriate where a plaintiff fails to establish that a prescribing physician’s decision to prescribe a particular medication would have changed had a different warning been given

Id. at *16 (citations and quotation marks omitted).  We’ve discussed as some length recently the muddle in New York law concerning the heeding presumption, with some federal courts ignoring state-court precedent that there’s no such animal.  No such laxity appears in McDowell.

Continue Reading Statistics Not Necessary For Adequacy as a Matter Of Law

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A week or so ago Grantland tv critic Andy Greenwald penned a “can we talk” letter to Sunday night, asking how it managed to fall so far from greatness.  Just last Spring we could plop down on our couch at the end of the weekend to watch Game of Thrones, Mad Men, Veep, and Silicon Valley. Even if some time-shifting was required, it was worth it.  Now with the departure of the criminally underrated Boardwalk Empire, Sunday evening has morphed into a drama wasteland.  (Sunday Night Football certainly has not supplied any drama.  Did you see the dumpster fire that calls itself the Chicago Bears?) The sheer craziness of Homeland has driven us away, with a lead character who calls in drone strikes as she boinks her way into fresh intel.  And then we get the competing stories of The Affair, a show that hasn’t attained Rashomon heights of greatness (“Look, the guy from The Wire and the girl from Luther are remembering different wallpaper designs!” “Why is the cop telling them completely different stories about his home life?”).

Let’s pour out some hooch in honor of Boardwalk Empire and remember its well-drawn characters, some of them plucked from the pages of history, and their poetic recitations of despair.  The show has one of those historical characters, the gambler/gangster Arnold Rothstein (some say he fixed the 1919 World Series), sharing this bit of wisdom:  “All of man’s troubles come from his inability to sit in a quiet room by himself.”  As we plunge toward dotage, that sentiment seems very true.  Ex-federal agent Van Alden (played by the great Michael Shannon, the same actor who declaimed the insane sorority letter) realized, on the doorstep of his personal doom, that “[w]e haven’t thought this through.”

We are feeling a bit of despair this week  after reading an opinion that we do not think was thought through.  Last week we identified some things we liked and some things we did not like so much in the Daubert rulings in the Drake case pending in Vermont federal court, where the plaintiff claimed injuries from Botox injections.   This week we will look at the summary judgment rulings in that same case.  We harbor no mixed feelings at all about the opinion;  it is a complete stinker. Drake v. Allergan, Inc., 2014 U.S. Dist. LEXIS 154979 (D. Vermont October 31, 2014).  The opinion was appropriately issued on Halloween.  It is scary bad.  It mucks up the learned intermediary rule, whilst pretending to steer clear of saying anything about it.

In one courtroom scene in Boardwalk Empire, a judge says this to a prosecutor:  “I sympathize with your desire to bring purpose to your life, however this courtroom is not the place to do it.”  That is a hard-headed judge.  We like that judge.

But now let’s go to Vermont.  In Drake, the plaintiffs brought an action on behalf of their son, J.D., alleging that he was injured after receiving an “overdose” Botox injection for treatment of lower-limb spasticity.  They brought claims of strict liability/failure to warn, negligence, and violations of the Vermont Consumer Fraud Act, all premised on an alleged failure to warn about proper dosages.  Here is an additional wrinkle in this Botox case:  because the FDA has not approved Botox as a treatment for pediatric spasticity, the administration at issue was off-label.  Off label or not, the treating doctor testified that Botox has been one of the standards of care for treating pediatric spasticity for over 20 years.

Continue Reading Hard Cheese: D. Vermont Avoids/Dilutes Learned Intermediary Rule

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This just happened yesterday down in Texas.  The defendant in this 77-plaintiff action raised fraudulent joinder/misjoinder and lack of personal jurisdiction in removing the case. Locke v. Ethicon, C.A. No. 4:14-CV-2648, slip op. (S.D. Tex. Nov. 10, 2014).  The defendant won, as the out-of-state (and non-diverse) plaintiffs were dismissed due to lack of personal jurisdiction under Daimler AG v. Bauman, 134 S. Ct. 746 (2014).  No other remand-related grounds (such as fraudulent (mis)joinder) had to be reached.

Of even greater importance is the “how to” aspect of Locke.  Can a court determining a remand petition decide a question of personal jurisdiction (the Bauman issue) prior to a question of subject matter jurisdiction (fraudulent (mis)joinder)?  The Locke court said “yes,” relying on Ruhrgas AG v. Marathon Oil Co., 526 U.S. 574, 586-87 (1999).  Slip op. at 3-4 & n.3.  That’s critical, because unless a court can reach the Bauman issue first, it would have to find some basis to dismiss the non-diverse plaintiffs under fraudulent (mis)joinder standards – and those standards are much more difficult to satisfy.  The Supreme Court, however, had resolved this issue in Ruhrgas.

[T]he Court notes that the two motions present the Court with a procedural dilemma.  If the Court addresses the question of subject matter jurisdiction first, then [one of the plaintiffs’] New Jersey citizenship destroys diversity, thereby justifying remand for the Texas state court to resolve the personal jurisdiction issue.  Alternatively, if the Court addresses the question of personal jurisdiction first and finds for the defendants, dismissal would simultaneously reduce the number of plaintiffs to one and permit the Court to retain jurisdiction over the case.  It is well settled that a district court has discretion to dispose of jurisdictional questions in a manner that promotes judicial economy.

Locke, slip op. at 3 (citing Ruhrgas and other cases following it).  This is the first time (we ran a search) that Ruhrgas has been invoked in a fraudulent (mis)joinder remand where the basis for fraudulent joinder is inability of nondiverse plaintiffs to obtain personal jurisdiction over the defendant under Bauman.

Continue Reading Breaking News: Win On Post-Bauman Personal Jurisdiction Avoids Fraudulent (Mis)Joinder Pitfalls

Drug & Device Resources

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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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