Search We the Jury

We have not posted for a while—that day job can really get in the way sometimes—so we agreed to tackle the ridiculously long decision in Christiansen v. Wright Med. Tech. Inc., MDL No. 2329, 1:13-cv-297-WSD, 2015 U.S. Dist. LEXIS 115601 (N.D. Ga. Aug. 31, 2015), as a bit of penance.  This act may be appropriate given the recent Day of Atonement and, much like long Yom Kippur services during a fast, the decision drags on, repeats itself, has some highs and lows, and maybe induces some confusion and a touch of a headache.  While we are not looking for a scapegoat, some of the reasoning for why the issues were presented how they were presented and why they were decided is lost on the reader, at least this reader.  (Much like the original meaning of Azazel, to where/whom the original scapegoat was to be sent by Aaron.  Or maybe not at all like that.)  As a combination Daubert and summary judgment order on a bellwether case from an MDL for a product, a metal-on-metal hip implant, for which there is considerable litigation on similar products made by other manufacturers, there will likely to attempts to extend various parts of this decision to other cases.  So, we will resort to the dreaded use of subheadings in discussing it.

Background

Plaintiff had a left hip replacement in 1995 with a device that used a ceramic femoral ball, a polyethylene liner, and a metal acetabular shell.  In 2006, plaintiff had her right hip replaced with the defendant’s product, which utilized a ball and cup each made of cobalt-chromium with no liner.  In 2012, plaintiff started experiencing pain in her right hip and, within a week, had a revision surgery where the defendant’s product was explanted (and presumably something else was implanted).  All three surgeries were done by Dr. Lynn Rasmussen, who happened to have been consulting with defendant on designing hip implants in between the second and third surgeries.  In doing the third surgery, Dr. Rasmussen observed what he called “metallosis” (sometimes “metalosis” in the records and briefs), but did not send any explanted tissue or material for pathological evaluation.  Plaintiff sued under a range of product liability theories based on the risk of “metallosis.”  Thereafter, plaintiff named at least ten experts to weigh in on causation and defect in some form or other, most of whom relied to some degree on Dr. Rasmussen’s characterization of what he saw—and defendant filed a bunch of Daubert motions.  Plaintiff filed a “motion for partial summary judgment” that preemption and the learned intermediary doctrine did not apply to her claims and, at the court’s request, the defendant filed a motion for summary judgment on all the claims that plaintiff did not drop.  An affiliated defendant also filed for summary judgment on different grounds.  There were some other motions we are ignoring, but everything was addressed in one big decision.Continue Reading Making Sense of the Rule 702 and Summary Judgment Orders in A Metal-on-Metal Hip Implant Bellwether Case

Today we have a guest post (her second – she’s a glutton for punishment) from fellow Reed Smith associate Danielle Devens.  This one brings together recent precedent recognizing post-Levine preemption in cases involving non-generic prescription drugs (there are a couple our readers may not have seen before).  As always with our guest posts, the author gets all the credit, and any blame, for the contents of his/her work.

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As this blog has been explaining for a while, the rationale in Mensing – that “[t]he question for ‘impossibility’ is whether the private party could independently do under federal law what state law requires of it” –  could apply to innovator (brand-name) pharmaceutical manufacturers and not just to generics.  131 S. Ct. 2567, 2579 (2013).  About a year ago, this blog reported on cases in which defendants argued for the application of the impossibility preemption doctrine outside of the context of generic drugs.  Since that time, there have been several new decisions involving innovator pharmaceutical manufacturers arguing for the application of impossibility preemption principles.  It makes sense at this point to condense the available information into one post and assess the question “where are we now?”

First, the relevant statutes in a nutshell:  to obtain FDA approval for a new drug, an innovator manufacturer must prove the safety and efficacy of its product through lengthy clinical testing, while generic drugs can gain FDA approval by showing that the product is equivalent to a brand-name drug that has already been approved by the FDA.  21 U.S.C. §355(j)(2)(A).  (One caveat – there may be drugs legally marketed today that were not subject to these requirements, such as drugs evaluated prior to 1962 which were instead subject to the FDA’s Drug Efficacy Study Implementation program). This, of course, is not a complete description of the requirements, but you get the gist.  The generic drug application must also show that the safety and efficacy labeling proposed is the same as the labeling approved for the innovator drug.  21 U.S.C. §355(j)(2)(A)(v).Continue Reading Guest Post – Impossibility Preemption for Innovator Drug Manufacturers: Where Are We Now?

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

Is anyone else watching the CW’s “Penn & Teller: Fool Us”?  It is perfect summer TV – easy, funny and interesting.  Each week aspiring, talented magicians perform to try to fool Penn & Teller.  If at the end of the trick, the comedy-magic duo can’t figure out how the trick was performed, the magician gets to appear on Penn & Teller’s enormously popular Las Vegas show.  Recorded on your DVR so you can skip commercials, it’s 45 minutes of stage performances, most of which are quite good and entertaining.  And that’s where we like to see magic – on the stage.  Who isn’t intrigued when a torn up playing card turns up tucked into a magician’s wallet whole again?  Or when a dove appears where only an egg was before? Slight of hand, hidden compartments, mirrors, trap doors – all things designed to make an audience think they are seeing something more than they really are.

When magic is at work in legal opinions, we aren’t as enthusiastic.  Especially, where the result is the conjuring of a case out of thin air.  That is precisely what happened in Fields v. Eli Lilly and Co., slip op., Case No. 2:13-CV-35-WKW (M.D. Ala. Jul. 20, 2015).  Plaintiff alleged that because she ingested Prozac in 1996 during the first 8 months of pregnancy, her son was born with a congenital heart defect.  But she has NO proof of two of the most fundamental aspects of any prescription drug case – that she ingested the drug and that an alleged inadequate warning caused the injury.  We would have thought that a complete lack of evidence on two key elements is enough for summary judgment, but plaintiffs managed to pull a rabbit out of a hat.

Let’s sum up all of the missing evidence. Plaintiff has no pharmacy records showing that a Prozac prescription was ever filled.  She alleges her pharmacy no longer has those records.  She has no financial records (bank statements, receipts, credit card statements) showing a purchase of Prozac. Id. at 9.  Presumably she also doesn’t have insurance records reflecting a Prozac prescription. She has no medical records that Prozac was ever prescribed.  Id. at 8.  There isn’t a single reference in any of her medical records that confirms that Prozac was ever prescribed to plaintiff.Continue Reading Plaintiffs Allowed To Make a Case Out of Thin Air

We wrote recently on Lone Pine orders and the role they might play in today’s world of inventory litigation.  You know what we are referring to – the mass litigation that occupies much of our time, where some people would say that the number of cases involving similar products is more important than whether any particular case has arguable merit.  We are not among the people who subscribe to that view, but it got us to thinking about resolution, and particularly about trials, and particularly about bellwether trials, which have become common in multidistrict litigation and other coordinated pretrial proceedings.  Bellwether trials are supposed to result in bellwether verdicts, which are intended to provide benchmarks against which to measure the resolution value of similar cases.

It is an imperfect concept, which we have noted multiple times (including here and here ).  But it is the system that we have, and it has gained both legitimacy and traction. Following a number of trials in the Vioxx MDL – an MDL that saw the resolution of a great many cases – Judge Fallon and his clerks published an article in the Tulane Law Review (available here) providing very thoughtful commentary on the entire process.  For our part, we have participated in the selection and trial of bellwether cases, and sometimes multiple claims get resolved in the aftermath, and sometimes they do not.

Which leads to our question for today:  Has the bellwether trial process lost its luster?  We have not yet formed a strong opinion one way or another, but we raise the issue now because of an order entered earlier this month in the Cook Medical pelvic repair system MDL in the Southern District of West Virginia.  See Pretrial Order #59, In re Cook Medical, Inc. Pelvic Repair System Prods. Liab. Litig., MDL No. 2440, 2015 WL 3385719 (S.D. W. Va. May 19, 2015).  There, the district court set up a bellwether trial process that largely followed the approach that Judge Fallon and his co-authors set forth in their article. The court first selected a pool of 30 cases to be worked up in discovery, with each side selecting 15 cases. That was about 20 percent of the then-pending cases, which is a significant number, and from that group the district court selected four “bellwether cases” that would be tried to verdict and provide the benchmarks that the bellwether process aims to provide. (Id. at pp. 1-2)Continue Reading Is This A Crack In The Bellwether?

That didn’t take long.  Yesterday the Alabama House of Representatives passed SB-80, which abolishes the innovator liability theory created in the execrable decision in Wyeth, Inc. v. Weeks, ___ So.3d___, 2014 WL 4055813 (Ala. Aug. 15, 2014 (discussed here and here, and named #1 worst decision of 2014 here).  Here is a copy of the enrolled bill.  The online legislative history indicates that SB-80 passed the Alabama Senate 32-0 and the House 86-14.

The relevant statutory language, imposing a product identification requirement in all cases seeking damages caused by a product, states:

Section 1. In any civil action for personal injury, death, or property damage caused by a product, regardless of the type of claims alleged or the theory of liability asserted, the plaintiff must prove, among other elements, that the defendant designed, manufactured, sold, or leased the particular product the use of which is alleged to have caused the injury on which the claim is based, and not a similar or equivalent product.  Designers, manufacturers, sellers, or lessors of products not identified as having been used, ingested, or encountered by an allegedly injured party may not be held liable for any alleged injury.  A person, firm, corporation, association, partnership, or other legal or business entity whose design is copied or otherwise used by a manufacturer without the designer’s express authorization is not subject to liability for personal injury, death, or property damage caused by the manufacturer’s product, even if use of the design is foreseeable.Continue Reading Alabama Legislature Abolishes Weeks Innovator Liability Theory

We knew that the Supreme Court’s opinion in Daimler AG v. Bauman, 134 S. Ct. 746 (2014), was a game changer the first time we read it. Gone is the concept of general personal jurisdiction that we learned in law school, where a defendant’s “continuous and systematic” contacts with a forum could allow a plaintiff to bring any and all causes of action against that defendant in that forum. Personal injury claims, business disputes, consumer claims, claims that the day is too long, that the night is too dark, or that Zane should never have left One Direction. Whatever. General jurisdiction means that a defendant can be held to respond without regard to the subject matter of the lawsuit.

In its place we have the properly recalibrated principle that a defendant can be subject to general personal jurisdiction only in forums where it is “at home”—which for a corporation means the place of incorporation and the principal place of business. This rule places no undue burden on plaintiffs: A plaintiff can still proceed in the defendant’s home forum, and we still have specific personal jurisdiction, under which a plaintiff can proceed against a defendant in a forum where the dispute arises from the defendant’s forum contacts. The Supreme Court merely reestablished that the Constitution will not permit importing disputes into forums where they absolutely do not belong. We are on board with that.

Our fear when Bauman came out in 2014 was that it would take an entire generation for the rule to catch on. But to our modest surprise, the Bauman track record is shaping up nicely. We reported to you last August on Bristol-Myers Squibb Co. v. Superior Court, 175 Cal.Rptr.3d 412 (Cal. Ct. App. 2014), a wrongly decided case in the California Court of Appeal, where the court paid lip service to Bauman and rejected general personal jurisdiction. But then it reached out to find specific personal jurisdiction based on “substantial, continuous economic activity” within the state, which sounds a lot like the old test for general jurisdiction. This wolf in sheep’s clothing lasted less than four months on the books before the California Supreme Court wiped it away.Continue Reading We’re Not in Kansas: No General Jurisdiction After Bauman

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

The George and Ira Gershwin classic, first introduced to the world through the talented voices and feet – on roller skates no less — of Fred Astaire and Ginger Rogers.  While the difference between pronouncing it to-may-to versus to-mah-to (or if you’re Larry the Cable Guy in Pixar’s Cars – tow-mater) doesn’t seem like enough to call off a marriage – the difference between Riata and Durata defibrillator leads should have been enough to end the case of Teixeria v. St. Jude Medical S.C., Inc., 2015 U.S. Dist. LEXIS 25657 (W.D.N.Y. Mar. 3, 2015).

Plaintiff was implanted with a cardiac defibrillator but one of the wires (or leads) had to be replaced only 14 days after implantation.   Id. at *3.  The lead at issue is a Durata lead.  The Durata lead is a later version of the Riata lead in which the insulation material was changed.  Id. at *4.  Plaintiff alleges that the insulation on Durata wires/leads erodes, exposing the wire and causing it to malfunction.  Id. at *8.  Plaintiff appears to base this theory of defect on allegations almost exclusively focused on a different lead – the Riata lead – which has a different insulating material.  Po-tay-to/Po-tah-to.  So the defendant moved to strike all of the unrelated allegations – which would have essentially stripped the complaint of the facts needed to sustain a claim:

St. Jude is simply requesting the Court to not accept as true, or to strike, these made up allegations that St. Jude violated non-existent PMA requirements related to the manufacture of Riata leads–which allegations Plaintiff has copied from another case to challenge the Durata lead at issue in this case.  St. Jude asserts that the Riata and Durata leads for the defibrillator are different products approved separately by the FDA and containing different materials. St. Jude asserts further that “there is no evidentiary basis for Plaintiff’s allegation that his Durata lead suffered from the alleged product defect. Plaintiff neither includes nor attaches any medical report, device inspection or testimony from a physician or other expert. Plaintiff has no evidentiary support that his Durata lead suffered a Riata-like externalization lead failure.

Id. at *36-37.  The case from which plaintiff allegedly copied his allegations is Pinsonneault v. St. Jude Medical, Inc., 2014 WL 2879754 (D. Minn. June 24, 2014) – a great win for defendants that we posted about here in which plaintiff couldn’t prove his manufacturing allegations against the Riata lead.  Begging the question – if plaintiff’s allegations had no evidentiary support to sustain a claim against Riata, how can those same allegations sustain a claim about Durata.  Ee-ther/Igh-ther?Continue Reading You Say Durata, We Say Riata . . . Let’s Call the Whole Thing Off

Today’s case, blogger fanatics, is a good illustration of grinding out a victory.  It’s the story of a defendant calmly and effectively pressing its legal and factual arguments, winning a partial victory before trial, continuing to press its position on the law and facts at trial until it won a directed verdict, and then successfully…

It feels like we have been talking about Weeks for years.  Two slightly different versions of the same decision have allowed the “innovator liability” theory of recovery to survive in Alabama against manufacturers of drugs that the plaintiff did not take.  Each appeared on our bottom ten list over the last two years.

Too many posts to link have discussed how Weeks is on the wrong side of the weight of authority on what started with Conte years ago.  In the first five months after its feeble re-do, we did not see cases considering whether to extend Weeks. We now have, with Allain v. Wyeth Pharms., Inc., No. 2:14-cv-00280-KOB, 2015 U.S. Dist. LEXIS 4073 (N.D. Ala. Jan. 14, 2015).  And that led us to find an older Weeks case that took a while to appear in “print,” Stephens v. Teva Pharms., USA, Inc., No. CV-13-J-1357-NE, 2014 U.S. Dist. LEXIS 180568 (N.D. Ala. Oct. 1, 2014).  So, we present an end-of-the-week two-fer on Weeks from the federal judges in the northern part of this southern state.

Both cases involve plaintiffs who died sometime after taking generic amiodarone, a prescription anti-arrhythmia drug, and who sued various manufacturers, including the company that brought the branded drug to market long before the plaintiff got the generic.  Both cases also involve other issues we often discuss, like TwIqbal, preemption, and the learned intermediary doctrine, but we are not discussing those issues here.  Instead, we are limiting ourselves to how these cases limit Weeks and do not allow the plaintiffs to proceed against the branded manufacturer on the allegation that it owed a duty to each plaintiff to provide him with the Medication Guide that would have made clear that his physician was prescribing the drug off-label and that it had various risks.  (If we were talking about the risk of these cases, we might talk about how little apparent connection there seems to be between the information gap alleged with each brief prescription and the remote injuries.)  Amiodarone was originally approved as a “special needs” drug to be used as “a last resort,” and has a regulatory history with a fair amount of back-and-forth on discouraging (and not encouraging) physicians from prescribing it as first or second line therapy.  Plaintiffs apparently did not contend that the Medication Guide hid the ball on the drug’s indication or risks.Continue Reading Not The End Of Weeks But A Start

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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