There used to be a TV show called “That Was the Week That Was.”  It was a satirical look at the news of the prior week, but perhaps it’s most lasting accomplishment was to launch David Frost’s career.  Without an ounce of satire, however, we have to say that the business week of August 15 through 19, 2016 was a heck of a week for implied preemption utilizing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  We’ve already blogged about the Ninth Circuit’s decision in DeBons v. Globus Medical, Inc., ___ F. Appx. ___, 2016 WL 4363171 (9th Cir. Aug. 16, 2016), which invoked Buckman preemption to affirm dismissal of a consumer protection class action that was seeking to recover based on allegations that a medical device wasn’t properly “approved” (but rather cleared under §510(k)) by the FDA.

But DeBons was only one part of that week’s Buckman hat trick.

On the same day, the Fifth Circuit got into the act, affirming a preemption-based dismissal of another medical device product liability suit in Estes v. Lanx, Inc., ___ F. Appx. ___, 2016 WL 4375644 (5th Cir. Aug. 16, 2016).  We’ve already blogged about favorable district court results in the Estes case three times.  The Fifth Circuit affirmed all of them.  Estes involved a spinal fixation system anchored with bone screws, some of which broke under the intense pressures of holding the human body upright.  The screws were explanted and replaced, but “neither the hospital nor [defendant]  retained” them. Id. at *1.

Plaintiff first screamed “spoliation” – he lost.  Id. (“we find no basis for disturbing the district court’s finding of no bad faith”).


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This post is from the non-Reed Smith side of the blog.

We do have two opinions to talk about, they’re just from the same case.  They are the magistrate’s Report and Recommendation and the district court’s subsequent ruling in Lyles v. Medtronic, Inc.  This is the latest Infuse victory but it’s not all about preemption this time. There’s a little statute of limitations, a little statutory exclusivity, some judicial notice, and of course a bit of preemption.  We’ll break it down for you.

Plaintiff underwent spinal surgery on May 10, 2013.  On February 6, 2014 he began to suffer from complications that necessitated a revision surgery.  Plaintiff alleges that on February 13, 2014 he was told by his doctor that the plate used in his surgery had failed.  Lyles, 2015 U.S. Dist. LEXIS 175042 at *1-4 (W.D. La. Nov. 23, 2015) (Report and Recommendation (“R&R”).  Then plaintiff started filing complaints.  He first filed on February 10, 2015 alleging products liability claims against Medtronic, Inc.  He amended his complaint with additional knowledge gained on May 8, 2015.  He filed a second amended complaint substituting Medtronic Sofamor Danek USA, Inc. for Medtronic, Inc. on June 11, 2015.  At this point, Medtronic, Inc. is no longer a defendant.  Id. at *4.  Plaintiff still wasn’t done.  He filed a third amended complaint on July 17, 2015 asserting claims for fraud and violation of the Louisiana Unfair Trade Practices Act against both Medtronic Sofamor Danek USA, Inc. and Medtronic, Inc.  Id. at *5.  That’s four complaints and none of them were sufficient to survive a motion to dismiss.

As to Medtronic, Inc. plaintiff’s claims were time-barred.  The allegations in the third amended complaint didn’t related back to the original filing.  Medtronic, Inc. may not have been  an entirely new party, but the allegations against it are.  Fraud and consumer protection violations were not alleged in the original complaint – “they do not arise out of the same occurrence previously set forth as those were all products liability claims and cannot relate back.”  Id. at *7.  Plaintiffs also argued that the Medtronic defendants were solidary obligors and therefore the statute of limitations was stayed from the original filing date.  But without an allegation of conspiracy, this argument was without merit.  Id. at *6-7.


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Imagine our surprise at learning that people are still filing cases alleging rhabdomyolysis resulting from Lipitor use.  Lipitor is the best known prescription drug ever (except maybe for Viagra), and the association between rhabdomyolysis and statins is one of the most warned-of drug risks in history.  Every doctor knows about it, and litigation involving another

Some states have statutes that we find very helpful.  Louisiana has the Louisiana Product Liability Act, with its strong exclusivity clause; New Jersey’s PLA provides some very helpful presumptions, including a presumption of adequacy for FDA-compliant drug labeling.  We have often cited the Texas statute that creates a presumption that pharmaceutical manufacturers and sellers are

Poll v. Stryker Sustainability Solutions, Inc., 2014 U.S. Dist. LEXIS 6309 (D. Az. Jan. 17, 2014), is a pretty good preemption decision but, more important, another decision holding that courts may take judicial notice of documents on the FDA website as part of a motion to dismiss.  The case involved a hip resurfacing system,

So, in case you’ve missed every national news report over the last 24 hours – it’s cold outside.  Really cold.  The media is calling it Polar Vortex 2014 – because it’s nothing without a catchy name and graphic.  Weather reporters are demonstrating how long it takes anything from a wet t-shirt to a hamburger to freeze outside.  To the reporter who was stunned that her water froze this morning, I suggest you re-acquaint yourself with what happens in your freezer every day.  Social media sites were over loaded with Canadians sending tips to their southern neighbors on how to beat the cold.    All this hype over cold weather also prompts anyone over the age of 40 (which means us too) to seem to recall whole winters where the temperature never went above 20 degrees.

The bottom line – it’s winter.  Those of us above the Mason-Dixon Line should have the necessary gear to make it through a few days of real cold.  For those of you who aren’t used to it dipping below 65 – gloves, scarves, extra socks and let your car warm up for at least 10 minutes before heading out.  That about covers it.  Cold weather in January just doesn’t seem like something that warrants this much excitement.  After all, it’s not like a blogworthy pharmaceutical case out of Idaho.  Now that’s news.

The case is Wilson v. Amneal Pharmaceuticals, L.L.C., 2013 U.S. Dist. LEXIS 181953 (D. Idaho Dec. 31, 2013).  Plaintiff alleged he developed Stevens-Johnson Syndrome (a severe skin condition) as a result of taking the generic version of the prescription antibiotic Bactrim, manufactured by the defendant.  Attached to its answer to the complaint, Defendant included the first FDA approval of Generic Bactrim, the FDA’s acknowledgement of transfer of ownership of the ANDA to the defendant, and three versions of the label for Generic Bactrim.  Id. at *4-5.  When the defendant moved to dismiss the complaint, it asked the court to take judicial notice of those documents as well as the FDA approval letter for brand name Bactrim and two FDA approvals of label changes for the brand name drug.  Id. at *6.  Plaintiff objected to the judicial notice request, arguing that defendant’s motion should be converted to a motion for summary judgment and that in turn plaintiff be afforded an opportunity to conduct discovery before the motion was ruled on.


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Bexis was away on vacation last week.  When he returned, he found four more reasons why we (on the defense side) should love TwIqbal. These four opinions have been duly added to our TwIqbal Cheat Sheet, but they deserve more mention than that:

Maybe An Advisory Opinion – But A Good One

In

Most of the opinion in Riley v. Medtronics [sic], Inc., C.A. No. 2:10-01071, slip op. (W.D. Pa. Aug. 8, 2011), is a fact-specific statute of limitations discussion – oddly occurring in the context of a motion to dismiss – about a less-than-diligent plaintiff who did next to nothing until the statute had almost expired

This post is largely about drug and medical device litigation “inside baseball.” Some of it’s going to be really technical. So if you’re looking for philosophical musings, or just a chuckle or two over the latest bizarre goings on in our neck of the woods, come back later.

But if you’ve ever had to worry

We’ve previously offered our collective four cents worth about tactical considerations that pharmaceutical defendants need to think about in deciding whether or not to bring preemption motions in particular cases. Given the importance of the issue, and (until 2008) the relative equipoise in the opposing positions, we strongly recommended the Hippocratic Oath – “First, do