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Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards.  As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).

The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a).  Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.”  361 P.3d at 871 (citations omitted).  See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).

So why are we telling you this?  We’re not the food blog, after all.  Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.Continue Reading California Supreme Court – Presumption Against Preemption Still Around

Multidistrict Litigation – the name says it all.  It is an amalgamation of related cases from multiple federal district courts across the country.  Think about the journey a single case in an MDL may take.  Plaintiff files in state court.  Defendants remove the case to federal court based on diversity.  But as soon as the…

It was big news that there will be a six hour return of The X-Files, a show that dazzled us from 1993 to 2002.  The “myth-arc” episodes about an alien invasion, black oil, and the disappearance of Special Agent Mulder’s sister were overwrought and confusing, but the standalone entries were television at its creepy best.  The bullpen of X-Files writers was stellar, including, among others, Darin Morgan and Vince Gilligan.  You probably have heard of Gilligan, since he later went on to helm a program now carved on the medium’s Mt. Rushmore, Breaking Bad.  (Gilligan’s current show, Better Call Saul, is also quite good.  And the ‘hero’ is a lawyer!)  Morgan is less well-known, but he penned some of the most admired X-Files episodes, which married humor to mystery in ways not matched since.  If you want to treat yourself to three hours of splendid viewing, fire up Netflix and take in these four all-time great X-Files episodes, the first two by Morgan and the latter two by Gilligan:
Continue Reading Illinois Appellate Court Misapplication of Bartlett Preemption: The Monster Case of the Week

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.

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

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

Continue Reading Quirky Facts About Tennessee and Choice of Law

Certain carbon products are supposed to last forever.  Houses should last more than 14 years, but they will need significant upkeep along the way.  Well maintained cars can last more than 14 years, but we think most do not.  We have a hard time thinking of many electrical products that last more than 14 years…

Every now and then we come across something new and interesting that, frankly, we hadn’t thought of ourselves.  That’s how we felt when we read the recent opinion in Boudreaux v. Corium International, Inc., C.A. No. :12-cv-2644-M, slip op. (N.D. Tex. May 7, 2013).   We mentioned the same sort of thing a few years…

For some reason, just as pharmaceutical manufacturing is concentrated in New Jersey and Southeastern Pennsylvania, and just as there are an abnormal number of Class II implant manufacturers in Indiana, the epicenter of American pre-market approved medical device manufacturing seems to be in Minnesota.

Similarly, preemption is at the epicenter of medical device product liability litigation involving PMA devices.

Since plaintiffs are able to avoid federal court through the simple stratagem of suing defendants (all defendants, not just medical device manufacturers) in their “home” courts, we have been wondering how PMA preemption would fare in Minnesota state court.  Minnesota already has a relatively expansive consumer protection statute and (until recently) an extremely long (six-year) statute of limitations for personal injury cases.  If there were also an indication that Minnesota courts would view PMA preemption in a pro-plaintiff fashion, we could see Philadelphia-style influx of litigation tourism.

Fortunately that doesn’t appear to be in the offing.  A couple of years ago, Medtronic scored big with In re Medtronic Sprint Fidelis Leads State Court Litigation, 2009 WL 3417867 (Minn. Dist. Hennepin Co. Oct. 20, 2009), which as we discussed at the time, adopted just about all the pro-preemption holdings in In re Medtronic Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. Oct 15, 2010).  There were a lot of good holdings, which we gloated over here.

Still, Sprint Fidelis was just a county-level trial court.  The Sprint Fidelis plaintiffs chose not to take their chances on appeal.  One bad decision from the Court of Appeals of Minnesota could wipe everything out.

Or, conversely, one good appellate decision could cement everything in place and send the litigation tourists scurrying elsewhere.

Fortunately, the latter happened the other day.  See Lamere v. St. Jude Medical, Inc., ___ N.W.2d ___, 2013 WL 599178, slip op. (Minn. App. Feb 19, 2013).  Lamere involved a Class III PMA approved mechanical heart valve, and the court affirmed summary judgment on the basis of preemption.  Not even the Public Citizen Litigation Group (probably the other side’s biggest guns on preemption) could sway the result in Lamere.Continue Reading Preemption in the Land of 10,000 Medical Devices

This post is by the Reed Smith part of the blog only.  The Decherts are too involved in this litigation to comment publicly.

There aren’t many research-oriented pharmaceutical companies based in Alabama, and after last week’s execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2013 WL 135753, slip op. (Ala. Jan. 11, 2013), that’s not likely to change any time soon.  We don’t know why that started; Huntsville, at least, has a distinguished scientific background (and there’s a statue of a Vulcan in Birmingham – wait a minute, the ears don’t match Spock’s), but it’s certainly true now.  Unfortunately it appears that, instead of (or perhaps in addition to, given the recent election results) the Ten Commandments, there’s another commandment that the Alabama Supreme Court is following:  Thou Shalt (if you’re an Alabamian) Recover From An Out-Of-State Drug Company.

While the Alabama Supreme Court certainly has the power to abandon the notion of manufacturer liability for defects in its products (unlike a federal court sitting in diversity), having the power to do something doesn’t make it right.  And if there’s one thing that’s not right, it’s having the liability of a defendant non-manufacturer turn on what its competitors did (or didn’t do).  And if there’s another thing that’s not right, it’s imposing liability on a product manufacturer that didn’t make a cent (and probably was driven out of the market by) from the product that actually caused the injury in question.

Nor is it very likely that this novel theory of “fraud/misrepresentation” liability can be limited to prescription drugs, whatever its intended scope.  There are lots of situations in which products bear similar warnings.

Sometimes, as with prescription drugs, such similarity is mandated by the government (cars, for example, or chemicals); sometimes similarity is simply a function of similar products having similar risks, and thus requiring similar warnings.  One such example could be asbestos.  There were lots of different asbestos products, and the same kinds of asbestos products do (or, at least, plaintiffs allege they do) have similar risks.  We have to think that asbestos plaintiffs are going to have a field day with Weeks – more, perhaps, than even generic plaintiffs, since the learned intermediary rule still applies to prescription drug cases.

Anyway, we could go through each of these policy considerations at length, but we’re not going to.  We already did that in connection with the original decision in Conte v. Wyeth, 168 Cal. App. 4th 89 (Cal. Ct. App. 2008).  So we’ll rely on our discussions there:

First, this kind of liability is contrary to the fundamental legal tenet that manufacturers’ are supposed to be liable because they made money putting the injurious product on the market:

Well, [branded liability] is an end run around the heart of modern product liability, which was created . . . some fifty years ago.  [Courts] recognized a core principle of social responsibility that justified what was then a new form of liability:  The purpose of this [product] liability is to ensure that the costs of injuries resulting from defective products are borne by the manufacturers that put such products on the market.  In other words, because manufacturers profit from the sale of their products, it is appropriate for them to answer for injuries caused by defects in those products.  Time after time, . . . liability for injuries caused by allegedly defective products has been justified by reference to this paramount policy.

DDLaw, Closing The Arguments On Conte (1/22/2009) (citations and quotation marks omitted).Continue Reading Weeks Reasoning – No Sweet Home In Alabama For Research Pharma

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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