July 2014

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This post is only from the Reed Smith (more properly, the non-Dechert) side of the blog.  It is updated whenever a relevant new decision is found.

One hundred what, you say?

Certainly not years; the awful Conte v. Wyeth, Inc., 85 Cal. Rptr.3d 299 (Cal. App. 2008), decision just turned six – this blog

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Here’s another guest post, this time by Vani Singhal and Jason McVicker of McAfee Taft.  It’s about tort reform, Sooner style.  As always, our guest correspondents get all the credit (or blame, as the case may be).

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Oklahoma has enacted a new law relating to evidence in product liability cases.  It is effective on November 1, 2014 (for new cases, its application to existing cases will probably be litigated).  The short version is as follows: In a formulation/labeling/design case, if a manufacturer or seller can prove compliance with federal safety standards, it triggers a rebuttable presumption the manufacturer or seller is not liable for injury arising out of the formulation/labeling/design.  The presumption can be rebutted only if the plaintiff demonstrates the federal regulations were inadequate or the manufacturer withheld or misrepresented facts relevant to the federal determination.

Alternatively, if a manufacturer or seller can prove “by a preponderance of the evidence” that the product was subject to premarket licensing or approval by the federal government, that it complied with the licensing or approval process, and that it was licensed or approved, it triggers a rebuttable presumption that the manufacturer or seller is not liable for any injury to a claimant arising out of the formulation/labeling/design.  The presumption can be rebutted only if the plaintiff demonstrates the standards were inadequate or that the manufacturer withheld or misrepresented facts relevant to the process if causally related to the plaintiff’s injuries.

Continue Reading Guest Post – Oklahoma’s Latest Tort Reform

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

We’ve all been through it.  We’ve spent painstaking hours drafting a brief or a memo.  We’ve combed through each page, paragraph, and sentence. We’ve cut, copied, and pasted.  Then, when we are satisfied with the result we hand it to someone else to review.  We move on to something else, almost forgetting about what we conceived of as masterful and persuasive prose.  Until . . . we get the redline.

While there are certainly times when you don’t agree with “suggested” edits that you are given, more often than not the person playing the role of the editor does what you previously believed to be impossible – he/she has improved your product.  Inconceivable? Not really.  That’s the job of an editor.  First, the editor is coming at the project with fresh eyes and more objectivity.  Second, a good editor will read the entire piece first giving him a different perspective than the author.   Third, think of your editor as your guinea pig.  If he didn’t “get it,” it’s unlikely anyone else will either.  Fourth, editors pay attention to detail that authors often overlook.  Finally, your editor is your partner.  Not in the law firm sense, but in the collaborative process sense.  You both want the same thing – a better brief.Continue Reading Court Takes A Red Pen to InFuse Complaint

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Birth defects are scary.  We suspect most parents among our readers can remember their relief upon hearing the pronouncement “normal” during a sonogram and when the post-birth count of fingers and toes came up as expected.  When there is a child born with birth defects, parents search for reasons.  On possible explanation may be a drug the mother took while pregnant.  For more than fifty years, the vast majority of people in this country who have hit or passed childbearing age have understood that some drugs are associated with (or, more conventionally, “cause”) birth defects.  The FDA’s familiar regulatory framework for drugs dates to 1962, when it was revamped because of concern over birth defects with a drug approved in other countries.  Patient information for drugs, prescription and over-the-counter, is read unevenly, but the risks of use by pregnant women tends to get more attention in the real world.  Not surprisingly, there has been quite a bit of litigation involving allegations of birth defects with drugs for many years, some of which has been detailed in various posts here (not to mention Daubert itself).  Plaintiffs and their contentions have inherent jury appeal.  The child (regardless of age at trial) is faultless and juries are disinclined to hold anything the mother (or father) did against the child.  Although birth defects occur in the general population without regard to drug usage, the tendency of jurors to put themselves in the shoes of the parents of the child with birth defects can impede rationality and shift burdens to defendant drug manufacturers—after all, every knows that some drugs can cause birth defects and women are supposed to avoid taking them while pregnant for a reason.

So, it takes a brave judge and strong record to get rid of the general causation opinions of a well-qualified epidemiologist across all cases in an MDL about birth defects with a drug.  That is what came together in In re Zoloft (Sertraline Hydrochloride) Prods. Liab. Litig., MDL No. 2342, 2014 WL 2921648, __ F. Supp. 2d __ (E.D. Pa. June 27, 2014).  The expert, Dr. Berard, holds a Ph.D. and is a professor in a relevant discipline—Canadian schools count here—and actually had done research outside of litigation on birth defects with this the relevant class of drugs, SSRI antidepressants.  The lack of research outside of litigation can be a major Daubert attack on an expert, but Dr. Berard’s non-litigation work was inconsistent with her opinions here.  In addition, her work for plaintiffs suing over birth defects with another SSRI produced inconsistent opinions, which leads to the whole petard hoisting thing.  (We are not suggesting Dr. Berard actually injured herself with an explosive device.  A petard, given the context of the expression, sounds to us like an article of French clothing or perhaps an uncomfortable chair.)Continue Reading Hoisted By Her Own Petard: A Qualified Epidemiologist’s Causation Opinions Get Tossed Across An MDL

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Our first reaction to Zeman v. Williams, 2014 U.S. Dist. LEXIS 91501 (D. Mass. July 7, 2014), wasn’t related to the fact that it involved a federal court recognizing a cause of action previously unrecognized by Massachusetts state courts.  Our first reaction was that the case shouldn’t be complicated.  The plaintiff participated in a clinical trial involving a bilateral gene transfer, which is a new procedure intended to treat Young-Onset Parkinson’s Disease.  Id. at *3.  As the “bilateral” in its name implies, a bilateral gene transfer consists of two injections of genes into the brain, one into the right side and one into the left.  Id. at *3-4.  But (plaintiff alleged) the surgeon gave both injections to the left side.  Id. at *4.

It seems fairly easy to identify the problem here.  If an engineer designs a twin-engine plane, and the mechanics put both engines on the left side, you’ve got a good idea who made the mistake.  If the Doublemint gum company told its casting director to hire blond twins for its commercial, and the casting director hired some guy named Roy, you can be pretty sure who made that mistake too.  So whom did the Zeman plaintiffs sue over the improper procedure?  The manufacturer and the Institutional Review Board (“IRB”), of course.Continue Reading Federal Court Finds a Duty With Regard to Consent Forms in Clinical Trials That the State Court Had Not Previously Recognized

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Taking a sad song and making it better, St. Jude Medical recently scored double-barreled preemption victories in implantable cardioverter defibrillator (“ICD”) lead litigation.  On consecutive days, federal courts in Minnesota, Pinsonneault v. St. Jude Medical, Inc., 2014 WL 2879754 (D. Minn. June 24, 2014) (Riata), and New York, Franzese v. St. Jude Medical, Inc., 2014 WL 2863087 (E.D.N.Y. June 23, 2014) (Durata) issued favorable decisions.  In the post-Daimler AG v. Bauman, 134 S.Ct. 746 (2014), personal jurisdiction landscape, the Pinsonneault decision is particularly sweet, because St. Jude Medical is based in Minnesota.

Briefly, the company produces implantable cardioverter defibrillator (“ICD”) systems, which the FDA-approved labeling indicates are for certain heart arrhythmias.  Critically for preemption purposes, these devices and their leads (the part that transmits current to the heart), are pre-market approved.  Franzese involved a Durata lead, and Pinsonneault (brought by five plaintiffs) involved Riata leads.  In both cases, plaintiffs alleged that their leads had to be explanted and replaced.

Continue Reading Hey, Jude! Making It Good on Preemption

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The Northern District of California has just given us a great example of the use of Daubert in connection with summary judgment to get rid of cases that never should have been filed.  You know the type.  These are the cases where the plaintiffs plead a good game in connection with some prescription drug, but then cannot come up with reliable expert opinions that the drug actually could have caused their alleged injuries, which should lead to judgment in favor of the drug manufacturer.

That is what happened in Wendell v. Johnson & Johnson, No. C 09-4124 CW, 2014 U.S. Dist. LEXIS 89576 (N.D. Cal. June 30 2014), although it took far too long for the case to reach that result.  Wendell was a wrongful death case where the decedent started treatment for inflammatory bowel disease at age 12, including a six-mercaptopurine (“6MP”) drug called Purinethol, initially on its own and later in combination with two different anti-tumor necrosis factor (“anti-TNF”) drugs.  After eight years of drug therapy for his IBD, this unfortunate young man developed a rare and aggressive form of cancer known as hepatosplenic T-cell lymphoma (“HSTCL”), which led to his rapid and untimely demise.
Two years later – in July 2009 – his parents sued the manufacturers of the drugs he used, eventually alleging in a Fourth Amended Complaint in April 2011 that he had developed HSTCL as a result of taking his combination of drugs and that the drug manufacturers failed to warn adequately about the risks of taking 6MP drugs with anti-TNF drugs.

Continue Reading Rule 702 and Summary Judgment: Together Again

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It’s about time we got a Summer movie worthy of adult eyes.  Roger Ebert called the cinema a “machine for generating empathy.”  (The Life Itself biopic of Ebert is out now in theaters and available at home on demand.)  Not much empathy washes over us as we turn our eyes to Transformers or superheroes. All those explosions and flattened cities leave us feeling tired and hopeless, or feeling nothing at all.  Those films are about nothing.  The celluloid – or, more likely, the digital 0’s and 1’s – are full of sound and fury, signifying … well, you know.  It is life itself that offers thrills, mystery, and passion.  Where is that in the midst of the inevitable June-July CGI orgy?

It’s about time we got something to look at that said something about life itself.  And with Richard Linklater’s Boyhood, we’ve got it.  It’s about time.  Literally.  Linklater filmed a kid and his family over a 12 year period.  We see the actors age, which might sound like grim stuff, like watching our friends and, therefore, ourselves, slouch toward mortality.  But there is nothing grim about seeing a six year old emerge into adulthood.  That is life.  Dreams, experience, and memories collide and conspire to produce some luminescent thing that seems simultaneously transient and immortal.  It is more arresting and miraculous than cosmic warfare among the exoskeletons.  It stays with us long after the hobbits and avatars exit stage right.  As with Michael Apted’s Up series, or Linklater’s own Before series, Boyhood reminds us what life is about and what movies can do.  The film theorist Siegfried Kracauer said that the function of film is to do what no other art form can do – show light and movement.  We can see the leaves blowing in the wind, flaunting different shades of green as they flutter in sunlight.  We see things live and change in time.  Perhaps everything takes place under the eyes of eternity, but those are not our eyes.  Ours blink.  Ours close.

Time is the big subject today.   It always is.  The most important philosophical work of the 20th Century is not A Theory of Justice by that very nice Rawls fellow, but Being and Time by that not very nice Heidegger fellow.  Our favorite poem of the 20th Century, Auden’s “As I Walked Out One Evening,” is about time.  “Oh let not time deceive you/you cannot conquer time.”  Our favorite beach-reading book that we could not finish was A Brief History of Time.  Our favorite rock song is “A Day in the Life.”  Our favorite baseball team stinks because the star players all got old at once.  Father Time is undefeated.  Time marks victories and defeats.  Time marks births and deaths.  Time marks us.  Time also marks lawsuits.

We do not too often write about statute of limitations decisions.  They are fact-bound.  The people behind Seinfeld (which premiered 25(!)  years ago) vowed that their show would have no learning and no hugging.  Maybe we here at DDL won’t force a hug on you, but we do hope for some learning.  With statute of limitation decisions, we are usually unsure as to what we can learn from any particular case.   Not so with today’s case, Truitt v. Bayer, No. 13-CV-7811, (SDNY July 2, 2014).  A copy of the opinion can be found here.Continue Reading Knowledge of Injury is Enough to Start the Statute of Limitations

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For so many reasons, we don’t usually blog about insurance coverage issues.  First, it’s not really our area of expertise.  Second, because of point number 1 we tend to find the issue a little dull.  Third, most tort litigators – on both sides of the v. – aren’t all that fond of insurance companies.  On the defense side, it is our clients who are often pitted against insurers who deny coverage.  And as our client’s advocates, from time to time we have concerns with insurance company’s micromanagement which can lead to conflicts regarding the best way to defend cases.  This is certainly an over-generalization and we don’t mean to lump all insurers in the same boat.  But, the disputes are what make it to the courtroom.

Disputes such as an insurer who declines to cover, under a “wrongful employment acts” policy, a qui tam False Claims Act action alleging off-label promotion.  If you’re thinking we couldn’t have just plucked that example out of thin air, you are correct.  It was the disputed issue in Eisai, Inc. v. Zurich American Insurance Co., 2014 U.S. Dist. LEXIS 90305 (D.N.J. Jul. 1, 2014).  And, with a favorable result for the insured pharmaceutical manufacturer from a fairly significant jurisdiction, we decided to make an exception today and talk insurance.Continue Reading And Now for Something a Little Different – Insurance