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For some reason, we recently found ourselves comparing our favorite defenses to our favorite rock bands.  Preemption, of course, would be The Beatles, and Daubert/Frye the Rolling Stones.  The learned intermediary rule could be Bob Dylan (I know, we’re showing our age, here).  Comment k could correspond to Led Zeppelin, and state of the art might be The Who.

And it seems that, for each of these bands, there’s a song we really like that gets slighted (in our opinion) when it comes to air time on classic rock stations.  For The Beatles that would be It’s All Too Much.  For the Rolling Stones, when you discount those songs generally considered too raunchy for mainstream radio (one from Beggars Banquet, one from Let It Bleed and one from Goats Head Soup, you can guess which ones), we’d say the disrespected Stones song we like most is Child of the Moon.  For Bob Dylan, we almost never hear Desolation Row on the radio (and thanks to Zimmerman’s late-in-life conversion to copyright trolldom, you won’t find a decent studio version on YouTube, either).  For Zep, we’d award the buried treasure award to Immigrant Song.  And finally, for The Who, we’ve always been peculiarly partial to the Punk and the Godfather.

Somewhat similarly disrespected as a defense to warning causation has been the prescriber’s failure to read the relevant warnings.  One of the benefits of the learned intermediary rule is that it replaces self-interested plaintiffs with highly trained medical professionals when it comes to warnings, and in particular with respect to warning causation.  While a plaintiff with dollar signs in his/her eyes will typically testify to whatever is necessary to establish warning causation (“Oh, yes, if I had only known about that risk, I would have rejected my oncologist’s recommendation and never taken the drug.”), medical doctors are most interested in the effective treatment of their patients, and thus typically tell it like it is.  The truth often is that, for one reason or another, the prescribing physician did not rely on the particular warning in question, and thus a different one wouldn’t have made any difference.

There are a number of fact patterns that lead to physician non-reliance, the golden boy of the bunch being when a doctor (a trained professional, after all) already knew about the risk in question and thus did not need to be warned about it.  Another commonly seen warning causation defense is when the doctor testifies that none of the plaintiff’s warning sophistry matters, s/he would still treat the plaintiff the same way today.Continue Reading Don’t Forget About A Prescribing Physician’s Failure To Read Warnings

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

A few weeks ago we brought you up to speed on the goings on around the country in the Infuse litigation.    We’ve decided not to let the cases pile up again and so, today’s post is on the latest Infuse decision – Eidson v. Medtronic, Inc., 2013 U.S. Dist. LEXIS 144179 (N.D. Cal. Oct. 3, 2013).  Like most of the decisions this summer, this one is strong on preemption and ultimately, it dismisses most of plaintiffs’ claims.

Eidson actually involves two related cases – claims by Mr. Eidson and claims by Mr. and Mrs. Bell.  The allegations are more or less the same.  The Infuse bone graft system is a Class III medical device approved by the FDA through the Premarket Approval (“PMA”) process.  The system was approved as a medical device consisting of three parts (a spinal fusion cage, a bone graft substitute, and a spongy carrier) for use in anterior (through the abdomen) lumbar surgery.  Both plaintiffs allege that the device was used off-label in their surgeries because it was implanted posteriorly (through the back) and without the spinal fusion cage.  Eidson, 2013 U.S. Dist. LEXIS 144179, at *6-7.  At the outset, both plaintiffs also abandoned their strict liability design defect claims as barred by California law.  Id. at *57-58.

Continue Reading An Infuse Update

“The best lack all conviction, while the worst are full of passionate intensity.”

– Yeats, The Second Coming

We remember the early days of ESPN’s Sportscenter when Stuart Scott constantly complained about how he always had to do the summaries of the week’s crappiest football games (the bad teams back then were Tampa Bay, Green…

While waiting for next month’s Bartlett oral argument and then the Supreme Court’s decision, and as plaintiffs continue to prod and poke to find ways around Mensing, the Fifth Circuit gave us a nice (though unpublished) Valentine’s Day present in Morris v. Pliva USA, Inc., No. 12-30319, 2013 U.S. App. LEXIS 3167 (5th…

The case of Murthy v. Abbott Laboratories, first came to our attention last year when it took the #8 spot on our list of the top ten worst drug and devices decisions for 2011.  That decision, 2011 U.S. Dist. LEXIS 129102 (S.D. Tex. Nov. 7, 2011), without citing any law – and contrary to a lot of law it didn’t cite – announced what amounted to a blanket exception to the learned intermediary rule for all investigational drug cases and carved out a second exception for DTC advertised drugs.  You can see our full discussion of this “ugly” decision here.  Fortunately, this year’s Texas Supreme Court decision in Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012) fully embracing the learned intermediary doctrine and rejecting a DTC exception (see our post on Centocor here) undercuts much of the 2011 Murthy decision making it more like a nightmare – we’ve woken up and it found out it wasn’t real (or at least easily discounted).
A few months before the Centocor decision, the Murthy court was at it again in Murthy v. Abbott Labs., 847 F. Supp. 2d 958 (S.D. Tex. 2012).  Here they incorrectly predicted that the Texas Supreme Court would recognize a DTC learned intermediary exception and based on that again refused to dismiss plaintiff’s claims based on the learned intermediary doctrine.  Id. at 967-973.  Since Texas has gone the way of every other state except New Jersey and rejected the DTC exception, that portion of the March 2012 Murthy decision is likewise just part of history.
The remainder of that decision, however, gave us some better news.  The court dismissed all of plaintiff’s claims except breach of contract based on Texas’s immunity statute.  The statute provides that in a pharmaceutical products liability action “there is a rebuttable presumption that the defendant . . . [is] not liable with respect to the allegations involving failure to provide adequate warnings . . . if  the warnings or information that accompanied the product . . . were those approved by the [FDA].”  § 82.007 of the Texas Civil Practices and Remedies Code.   Since the presumption is rebuttable, the statute also provides certain exceptions to the rule and for a failure to warn claim to survive, plaintiff must adequately plead at least one of those exceptions.  In March, the Murthy court found that plaintiff had not sufficiently pleaded any of the exceptions and dismissed her failure to warn, breach of warranty, strict liability and negligence claims accordingly.  Id. at 973-77.Continue Reading Murthy Update – The Case That Wouldn’t Go Away

Updates are not necessarily a good thing, but we
suppose they can be necessary.  So here
are a couple.
First, some time ago we blogged about
Degelmann v. Advanced Medical Optics, 659 F.3d 835 (9th Cir. 2011).  The case even made last year’s honorable
mention list on our best of the year post

…

Here are a few updates to some of our previous posts.
First, we posted about In re Aspartame Antitrust Litigation, ___ F. Supp.2d ___, 2011 WL 4793239 (E.D. Pa. Oct. 5, 2011), as we considered the case a promising development insofar as taxation of costs of production could exercise a restraining influence on…

Back in April, we put up a post complaining about Weeks v. Wyeth, 2011 WL 1216501 (M.D. Ala. March 31, 2011), one of the few courts anywhere not to dismiss a Conte-type non-manufacturer liability claim for failure to state a claim.  Instead, contrary to five prior Alabama decisions (and literally scores of cases…

This, that, and the other thing.
Potpourri.
Odds and sods.
Whatever. This post is about stuff that we learned about recently that relate to our prior posts. Other than that, they have nothing in common with each other.
Together, they add up to enough material for a decent post.

Rebel Flag Still Flies In Georgia

…

We’ve had a couple of complaints that it’s hard to locate on this blog old posts that contain information of interest. (One of those complaints was Beck complaining to Herrmann; the other was Herrmann complaining to Beck.)
To make things easier, here’s an index of all of our posts to date, with hyperlinks to the…

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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