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The key to appreciating the latest order granting summary judgment for the defense in the Ortho-Evra birth control patch MDL is to start with the order’s last paragraph:

The Court has found that the Defendants provided adequate warnings sufficient to discharge their duty to warn.  Because the Defendants exercised reasonable care by communicating the risks involved with the Ortho Evra® patch to [the plaintiff’s] physician, and those warnings were not faulty, [the plaintiff] has not established a claim of negligent misrepresentation under Tennessee law.

Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 145415 (N.D. Ohio Oct. 10, 2014).  Ah, the familiar ring of the learned intermediary doctrine, the beat to which the Drug and Device Law Blog most often marches.  But what’s this?  The doctrine applied to negligent misrepresentation?  Some background is in order:  The plaintiff in Brown alleged that her use of hormonal contraceptives caused blood clots, which is one of the most widely known drug risks ever known to medical science.  As we said when we first reported on this case, every doctor and medical student knows about the risk—so do most women—and the labeling for hormonal contraceptives has fully disclosed the risk of clots for decades.

The defendants therefore moved for judgment on the pleadings, which the district court granted on the failure-to-warn claims back in April 2014.  See Brown v. Janssen Pharmaceuticals, Inc., No. 3:12-oe-40003, 2014 U.S. Dist. LEXIS 57319 (N.D. Ohio Apr. 24, 2014).  This was absolutely the correct result as far as it went, but there were still several claims left over—manufacturing defect, negligence, and fraud.

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Continue Reading Without Failure To Warn, Other Claims Collapse

Would you have bet on the Red Sox to win the 1986 World Series?  Would you have booked passage on the Titanic?  Would you have bought a ticket to see the movie Ishtar?  If someone asked us these questions today, we all would answer in the negative because we already know the outcomes.  The…

This post is written by our Reed Smith colleague, Adam Masin, who is solely responsible for its content.  He gets all the credit and all the blame.

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This blog has previously written about Tennessee’s unusual statute of repose, here, here, and here, which bars claims “within one (1) year after the expiration date of the anticipated life of the product.”  Tenn. Code Ann. Sec. 29-28-103.  “Anticipated life” is a curious term.  For example, the season finale of Homeland had many of its main characters wondering what their own “anticipated life” might be like given their circumstances.  But we are not here to discuss the rather unrealistic-yet-compelling Homeland universe in which a bipolar CIA agent who never follows orders and is carrying the baby of the brainwashed former almost-terrorist who may not have bombed the CIA but still pretty much murdered the Vice-President can somehow find herself sent to Iran on purpose to oversee an impossible mission that involves trying to save her magically detoxed boyfriend (no spoilers here!).  That’s a different blog post we’d like to write.  We are here now to talk about “anticipated life” as it refers to products in Tennessee, the state that shares a border with the state where Homeland is filmed.

In Tennessee, “anticipated life of the product” is the “expiration date placed on the product by the manufacturer when required by law but shall not commence until the date the product was first purchased for use or consumption.” Id. at Sec. 29-28-102.  In Wahl v. General Electric Company, 2013 U.S. Dist. LEXIS 162320 at *19 (M.D. Tenn. Nov. 14, 2013), that meant that the plaintiff’s claims were barred by the statue of repose well before the plaintiff knew she had developed the condition she based her lawsuit on.  The same was true in Montgomery v. Wyeth, and Spence v. Miles Lab.  Other states have carved out latency or similar exceptions to their statues of repose that might apply to prescription medical products for various reasons, but Tennessee has not chosen that path.

Perhaps the only thing more unusual than Tennessee’s “anticipated life” statute of repose, however, is how courts have reacted to it.  In Montgomery, the trial court began its opinion by questioning the propriety of the law:

Rarely does this Court suggest that a legislative body reconsider one of its enactments. The Court believes its role is simply to apply the law applicable to the case before it and not concern itself with the merits of the case. However, because of the result in this case, this is one of those rare cases where the Court believes it is appropriate to urge the Tennessee legislature to look closely at the law governing this case.

The court in Wahl ended its own opinion doing the same thing:

the court views the result in this case as manifestly unjust. Through no fault of her own, Wahl is left with an essentially incurable degenerative condition for which she has no recourse, because Tennessee extinguished her claims against GE before she could have discovered them. The time period here between the procedures at issue and Wahl’s NSF diagnosis was only about four years, which is not a time period that shocks the conscience. This court, as did Judge Collier in Montgomery, 540 F. Supp. 2d at 936 and 945, urges the Tennessee General Assembly to revisit the TPLA and its effect on Tennessee citizens injured by pharmaceutical products.

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Continue Reading Guest Post – Homeland and Anticipated Life (under Tennessee law): Being On the Wrong Side of Policy Isn’t Always Unjust

This post is not from the Dechert side of the blog, since they are involved in Reglan litigation.

Last evening, just before quitting time on the East Coast, we found the Sixth Circuit’s affirmance of the Rule 12 dismissal (that means no expensive discovery necessary) of seven Reglan cases under Tennessee Law.  See Strayhorn v. Wyeth Pharmaceuticals, Nos. 12-6195, et al., slip op. (6th Cir. Dec. 2, 2013).  The court also affirmed summary judgment against another set of defendants – affiliated with the original innovator manufacturer.

Because of that, we call this type of result a “one–two punch” case.  That means that the plaintiffs – who took the generic version of the drug only – are:  (1) knocked out of the box against the generic manufacturer by preemption under PLIVA v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013); and (2) barred from suing the original innovator manufacturer of the drug by the very simple and basic fact that the plaintiff never used that defendant’s product.

First, the generic side:

Plaintiffs had filed the usual kitchen-sink type complaint alleging everything from design defect to consumer fraud.  Plaintiffs abandoned consumer and unjust enrichment claims, but appealed dismissal of everything else.  Strayhorn, slip op. at 7.

They lost.

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Continue Reading Lucky Seven − Strayhorn Affirmed

It’s late and we want to go home, but we just learned that the “one-two punch” dismissal of the plaintiffs’ claims in Strayhorn v. Wyeth (that is, generic preemption plus no innovator liability in a generic case) has been affirmed by the Sixth Circuit applying Tennessee law.  More about it tomorrow, when we’ve had more…

Every state has its peculiarities, oddities, firsts, and little known facts. For instance, did you know that New Jersey (this blogger’s home state) has the tallest water tower in the world or that it was the site of the first baseball game? Well, our case for today is from Tennessee.  So, did you know?

The world’s largest artificial skiing surface is located in Gatlinburg

Tennessee was the last state to secede from the Union during the Civil War and the first state to be readmitted after the war.
  • Bristol is known as the Birthplace of Country Music
  • Oak Ridge is known as the Energy Capital of the World
  • Tennessee has more than 3,800 documented caves
  • Nashville’s Grand Ole Opry is the longest continuously running live radio program in the world. It has broadcast every Friday and Saturday night since 1925
  • Coca-Cola was first bottle in 1899 at a plant in downtown Chattanooga after two local attorneys purchased the bottling rights to the drink for $l.00

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Continue Reading Quirky Facts About Tennessee and Choice of Law

Remember right after Mensing when the refrain from the other side of the “v.” was that the “immunity” conferred upon generics meant that branded drugs were “safer”?  But once the other side realized that generic preemption was for real, that line was quickly airbrushed from their playbook (ATLA pulled down that press release within a…

Since we haven’t heard any of the services mention it, we thought we’d point out that the learned intermediary rule recently got a lengthy endorsement in prescription medical product cases from the Tennessee Supreme Court:

[T]he learned intermediary doctrine. . ., which allows a seller in a failure to warn case to rely on an

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We wish everyone a nice Martin Luther King Day. Today not only honors a great American, it has also evolved into a day of service. That says something profound and wonderful about the honoree. We’ll do our best to observe the spirit of the day. There are all sorts of service. A friend in SoCal is helping to paint a lifeguard station. That makes us wildly jealous, given that we are staring outside at sheets of ice and awaiting the next visit of “Wintery Mix.”

Frankly, we were a little worried about whether this blog could render any real service today. There’s been a Monday curse of late, as we’ve opened the last couple of weeks with kvetch-fests on truly dreadful opinions (Bausch, Stevens, and Bartlett). But recently the Middle District of Tennessee rode to the rescue and delivered a useful opinion in a pain pump case, Rodriguez v. Stryker Corp., 2011 U.S. Dist. LEXIS 1252 (Jan. 5, 2011). It grants summary judgment to the defendants and supports its ruling with common sense and clear thinking.

The plaintiff in Rodriguez underwent shoulder surgery in 2004, including installation of a pain pump. A follow-up procedure in 2008 showed that the cartilage in the plaintiff’s shoulder had been destroyed. The plaintiff filed a lawsuit claiming that the pain pump had caused chondrolysis (a condition marked by destruction of the articular cartilage). The plaintiff alleged causes of action for strict liability, negligence, and breach of implied warranty.

The court applied Comment K to the strict liability claim, concluding that with “unavoidably unsafe products” such as a prescription medical device, the only issue was whether the manufacturer had failed to supply appropriate warnings. Rodriguez, 2011 U.S. Dist. LEXIS 1252, * 19. See how straightforward that was? Unlike the Bartlett case, the court didn’t conflate design defect and failure-to-warn theories.

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Continue Reading Helpful Pain Pump Case on Comment K and Warning Causation