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Several months ago we responded with some disdain to recent plaintiff-side arguments we had seen claiming that the strict liability decision in Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), somehow altered Pennsylvania’s negligence-only standard for prescription medical product litigation that has been unquestioned since Hahn v. Richter, 673 A.2d 888 (Pa. 1996).  Hahn, of course, expressly applied comment to all prescription medical product cases, with the effect of eliminating strict liability in such litigation.  673 A.2d at 890-91.  We thought the other side’s Tincher arguments were disingenuous, to say the least, since Tincher expressly recognized Hahn’s exception to the general rule of strict liability in Pennsylvania.  104 A.3d at 382 (listing Tincher as a “but see” exception to proposition that “no product” is exempt from strict liability.

Well, now returns are starting to come in, and courts agree with us.  Most notably, the issue received a thorough airing before an MDL judge in In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2015 WL 3669933 (N.D. Ill. June 12, 2015).  The same result was also reached (albeit without citing Tincher) in Runner v. C.R. Bard, ___ F. Supp.3d ___, 2015 WL 3513424, at *3-4 (E.D. Pa. June 3, 2015).  Of the two, the Nexgen decision was dicier, because a court in Illinois can’t be expected to be as intimately familiar with Pennsylvania law as a Pennsylvania judge, so there’s always a chance….

Didn’t happen.

The MDL court saw through plaintiffs’ sophistry and recognized that Tincher didn’t do anything that dislodged comment k from its existing position under Pennsylvania §402A jurisprudence.  For purposes of this discussion, we’ll skip the first three-quarters of the Nexgen decision, which dealt with (very thoroughly) a host of litigation-specific Daubert points.  If issues such as “posterior edge loading,” “two-millimeter bone cut,” “tibial loosening,” and “polyethylene lift-off” are your thing, you probably can skip this post anyway, since you know already more about this litigation than we do.  Since several of us practice in the Keystone State (technically it’s a commonwealth), it’s the Pennsylvania law rulings that interest us here.Continue Reading MDL Court Agrees – Tincher Doesn’t Change Pennsylvania Drug/Device Law

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In our initial post about Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), we stated up front that we didn’t think that Tincher changed Pennsylvania law applicable to prescription medical products much, if at all.

We wrote:

For prescription products, the short answer is “not much..” . . . Largely as a result of concerns over liability for scientifically undiscovered risks . . . in Hahn v. Richter, 673 A.2d 888 (Pa. 1996) (another case Bexis briefed) the Court excluded prescription medical products entirely from Azzarello strict liability using Restatement §402A, comment k . . . .  Thus Tincher’s reworking of strict liability doesn’t affect prescription medical products because that theory wasn’t applicable in the first place.  Indeed, one of Bexis’ worries about the Third Restatement was that eventually it might call the Hahn strict liability exemption into question.  Without the Third Restatement, that doesn’t happen.

Just because we said so, however, doesn’t make it so.  We’ve learned recently that at least one plaintiff’s lawyer has created an argument for the opposite position – that Tincher supposedly opens up wide vistas of strict liability in prescription medical product cases – and has asserted it in certain medical device litigation in which none of your bloggers are participants.  One of our readers sent us that brief (a publicly filed document) and asked us to comment.

So we will, but we’re not identifying either the case or the plaintiff’s lawyer – if you’re reading, you know who you are.

To us, the plaintiff’s proposition is, in one word, absurd.  It makes no sense that Tincher, which was primarily devoted to moving strict liability design defect cases closer to negligence, would somehow expand strict liability sub silentio (that’s legal Latin for “without explicitly saying so”) in the prescription medical product area, while simultaneously reining it in everywhere else.  There are three fundamental reasons why Tincher cannot be read in that fashion.Continue Reading Don’t Mix Apples & Bricks – Tincher Didn’t Change Pa. Drug/Device Law

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On the Drug and Device Law Son’s 13th birthday, back in 2008, we reflected on the contrast between his experience as a Philly sports fan versus that of a 13 year old in Boston.  Our son had no idea what a sports championship looked like.  Philly had not hoisted a banner since Moses Malone led the Sixers to the “Fo Five Fo” payoff run in 1983.  But a 13 year old New Englander probably had come to assume championships as a birthright.  The Celtics had a parade that Spring, the Patriots had won three Super Bowls (one against the Eagles), and even the Sawcks, who had dashed the hopes of the region for four score and six years, had managed to break the curse of the Babe and win the World Series in 2004 and 2007.  (In the 1915 World Series, the Red Sox demolished … Philadelphia.)  The Bruins had not won a championship in that 13 year period, but they would soon.

The Boston-Philly rivalry is an old one, and more one-sided than makes sense.  Even a Penn professor, Digby Baltzell, acknowledged that Boston seemed to overachieve while Philly persistently underachieved.  He thought that the historical Puritanism of Boston pointed the way toward public proofs of accomplishment and virtue, while the Quaker roots of Philly prompted people to tend to their own gardens and steer clear of the public sphere. The theory explained why Bostonians were braggarts and Philadelphians tended toward self-disparagement.  The Puritans hanged the Quakers, and both were happy.  Of course, it is hard to imagine how these old religious differences could say much about current mores.  We know some Quakers here, but not that many. In our four years in the Boston-area, we never encountered a Puritan.  Still, there are some odd points supporting Baltzell. Boston leaders are usually home-grown, but Philly has often chased away local high-achievers (Harvard’s main library came from a Philly-area fortune) and has frequently brought in outsiders to run things.  The most consequential Philly mayor in recent times hails from NYC.  We’re not sure how this fact fits in with Baltzell’s theory, but Ben Franklin fled Beantown and ended up doing fairly well in Philly.

We have no problem liking both cities a lot.  Both have great history, great schools, great museums, and great bars.  For many key criteria, Philly comes out ahead. Philly’s citizens get abused for their supposed hostility (throwing snowballs at Santa Claus, blah-blah-blah), but have you ever tried sharing a street with Boston drivers?  Philly is much better for bike riders.  Philly’s weather is okay; Boston’s is horrible.Continue Reading Massachusetts Federal Court Applies Comment K; Rejects Pennsylvania Lance Folly

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We can’t decide whether Anastasi v. Wright Medical Tech., 2014 U.S. Dist. LEXIS 58467 (E.D. Mo. Apr. 28, 2014), is bad or just frustrating.  It might just feel bad.  The fact section takes you through a soul-crushing, “accepted as true” recitation of plaintiff’s allegations that seems a bit over the top. It goes on…

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This post is not from the Dechert side of the blog, because of that firm’s involvement in this matter.

We mentioned, in the “here’s what’s out there” portion of our 2013 Top Ten post that “The long-pending Lance case (2010 #-6) remains undecided by the Pennsylvania Supreme Court, some three years after oral argument.”  Full disclosure:  Some of us worked on the Lance case in the past, but none of us currently represents anybody in that litigation.  So, while we are quite familiar with Lance, the post here does not address anything outside of the Supreme Court’s opinions and official record.

Lance pends no longer.  And if Lance in the Pennsylvania Superior Court warranted #6 on 2010’s worst ten list, the Pennsylvania Supreme Court’s equally unpalatable effort is likely to rank significantly higher on the still-young 2014’s eventual list.  For background (since it has been a long time), here is our description of Lance in the Superior Court from back in 2010:

6. Lance v. Wyeth, 4 A.3d 160 (Pa. Super. 2010).  . . . Lance is another example of the disturbing trend in post-Levine cases for plaintiffs to push for – and, worse, for courts to allow – “design” related claims against prescription drugs that are really frontal assaults on FDA drug approval decisions.  Here, the claim was “negligent design,” which had never before been recognized in a prescription drug product liability case in Pennsylvania. 4 A.3d at 165-66.  Disturbingly, the opinion does not discuss the requirement, imposed in negligent design cases involving other products, that the plaintiff must prove the existence of a safer alternative design.  Compounding matters, Lance also included gratuitous dictum suggesting that a post-sale duty to warn may exist in prescription drug cases, id. at 167-68 – despite that theory being a form of strict liability, which Pennsylvania doesn’t recognize at all in prescription medical product litigation.  If not for other, favorable, aspects of Lance (rejecting the “unreasonably dangerous product theory allowed in Wimbush and also failure to test or to recall), Lance might rank even higher/lower.  We discussed Lance here.  An appeal to the Pennsylvania Supreme
Court is pending.

Quite frankly, nothing in Lance improved in the 2+ year wait for it to be decided.  After all this time we had frankly thought the Court to be irretrievably split 3-3, with the newly appointed interim justice, Stevens, recused due to his participation at the Superior Court level. Thus, we had been speculating that the
most likely outcome would be a to vacate and remand after the court decides Tincher v. OmegaFlex (discussed here, here, and here) and clarifies Pennsylvania product liability law generally.

No such luck, although Lance does allow for some interesting speculation about what might ultimately happen in Tincher (see below). That’s particularly true because Justice Thomas Saylor, ordinarily the court’s most conservative member on product liability matters (and thus our favorite), wrote the majority opinion in Lance, aligning himself in this instance with justices with whom he frequently disagrees with on tort issues. The vote was 4-2, with Chief Justice Castille and Justice Eakin dissenting.

So what happened?

The first half of the majority opinion describes the proceedings below and the arguments of the parties in considerable detail.  To us, the most interesting aspects of the first 24 pages of that opinion are footnotes and other asides.  Thus, we have footnote 6, reaffirming the learned intermediary rule: “Per the learned intermediary doctrine, the manufacturer’s duty to warn is directed to physicians.”  Maj. Op. at 5.  We have footnote 8 (discussed more later), chastising the lower court for equating “strict liability” with “product liability.”  Id. at 8-9.  We also have footnote 11 reaffirming the essential holding of Hahn v. Richter, 673 A.2d 888 (Pa. 1996), that Pennsylvania law has adopted, and applies, Restatement §402A, comment k across the board:  “Other [jurisdictions], including Pennsylvania, have taken a blanket approach applying comment k to preclude strict-liability design-defect claims for all prescription drugs.”  Maj. Op. at 13.Continue Reading Lance – If This Is Negligence, Who Needs Strict Liability?

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We expect that most of our readers enjoyed yesterday with the American rituals of gluttony, football, and traffic.  For some, today is an opportunity to see if doing nothing is the best way to combat lingering indigestion. For others, it may be that the lure of transforming scattered leaves into tidy piles of leaves—tidy, that is, until wind or youthful leaps disturb them—is enough to separate butts from sofas. For yet others, there will be an urge to shop for presents for upcoming—or, in an incredibly rare calendar quirk, on-going—holidays (Yes, celebration of the festival of lights has been known to include the giving of socks, something probably not common with Saturnalia or its cultural descendants.)  To encourage shopping, the marketers have dubbed this day Black Friday.  Although we have heard it for a while, we have not really understood why this moniker would encourage people to spend money.  The same name has been given to a number of deadly historical events.  The Black Tuesday stock market crash of 1929 was hardly a spur to reckless spending.  Other days of the week have been dubbed “Black” to commemorate a range of bad happenings.  We are not marketers or shoppers by profession, so, to us, the term Black Friday bespeaks of something bad happening on a Friday.

What is bad, of course, depends on viewpoint.  The three NFL games yesterday were each good or bad depending on which team’s fans are asked.  That extra slice of chocolate pecan pumpkin cream pie last night may have been really good as you were eating it, but really bad as you realized that the practice of unbuckling your belt after a meal was not just something only other people did.  The decision from two weeks ago—a Friday—in LaBarre v. Bristol-Myers Squibb Co., No. 13-1405, 2013 U.S. Dist. LEXIS 23215 (3d Cir. Nov. 15, 2013), was good for the defendant drug manufacturers and for product liability defendants in the affected jurisdictions, but bad for the two plaintiffs on appeal and the other Plavix plaintiffs in the pipeline.  One of our first posts was on the district court’s grant of summary judgment against the two plaintiffs in LaBarre, one of several posts that have appeared here on good results from the Plavix litigation.  While we marvel at the speed of an appeal that produced an affirmance a little more than ten months after summary judgment, we are equally satisfied with the logic of the decision.Continue Reading A Black Friday for Plavix Plaintiffs

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We have all heard that bad facts make bad law.  We have also heard that discretion is the better part of valor.  Sometimes, faced with bad alleged facts, a bad decision may be the predictable result of a motion to dismiss.  We are all for knocking out non-existent claims and making plaintiffs plead properly, but it is important when deciding to file 12(b)(6) to keep an eye on the relief being sought and how that relief would affect the case.  Although we do not have any knowledge of the considerations that went into the filing of this motion to dismiss, sitting here with our retrospectoscope, we see Williamson v. Stryker Corp., No. 12 Civ. 7083 (CM), 2013 U.S. Dist. LEXIS 104445 (S.D.N.Y. July 23, 2013), as a predictably bad decision.  We also feel a little like the venerable plaintiffs’ expert from whom we first heard the term “retrospectoscope,” smug, in our office, blathering on about something with which we were not involved.  Unlike him, however, we will resist the temptation to ascribe motive to why the court ruled as it did, as we believe motive is a subject for juries/readers to decide not for experts/blawgers to opine.

When testing the adequacy of a complaint, the “facts” at issue are those plaintiff chooses to include in the complaint, how she chooses to include them.  As such, it is not surprising that the facts analyzed in Williamson seem incomplete to anyone who knows medical device product liability cases.  It seems likely that a knee replacement plaintiff with at least four prior failed replacement surgeries, who was told her only treatment options were amputation or surgery with defendants’ product, had something else going on besides her basic allegation that:  1) the product broke not long after an uneventful implant, 2) then she was assured by defendants’ representative that there had been no prior reports of such breaks, 3) then she proceeded to have the broken product explanted and replaced with another of the same product, and 4) then the second implant also broke.  The court cannot assume additional facts to help direct its analysis to a different result, though.  (Hint, hint.)  So, the court analyzed a motion to dismiss every count other than failure to warn and loss of consortium.  The central allegations were of “manufacturing defect and/or design defect”:

(1) it relies exclusively on “the fixation in place of the femur and tibia bones”; (2) the knee revision system “is not properly designed or constructed to constrain motion between the femur and tibia bones so as to promote fusion by compression of the bones”; and (3) motion by the bones causes excess force on the device, leading to breakage and injury.

Id. at **6-7.  Plus, plaintiff’s review of defendants’ website before the first surgery and discussions with their representatives before the second allegedly created liability under theories of fraud, warranty, negligent misrepresentation, and deceptive business practice.  As you might expect from this lead in, defendants’ motion was denied across the board, although the court directed plaintiff to flesh out her fraud and negligent misrepresentation counts.Continue Reading Pleading Defect

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The Aredia/Zometa case of Guenther v. Novartis Pharmaceuticals Inc., 2013 U.S. Dist. LEXIS 50945 (M.D. Fl. Apr. 9, 2013), produced another interesting decision last week.  Not necessarily good, but interesting.  The defense moved for summary judgment on plaintiffs’ failure-to-warn-based claims for failure to satisfy the proximate causation element of the learned intermediary doctrine.  Id…

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This post is really the work of co-blogger Eric Alexander, but technical problems meant that Bexis had to post it.

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On this week of Martin Luther King Day and the Presidential Inauguration, we start this post with some regrets. We regret that we lack the eloquence to offer a sufficiently meaningful link between…

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Today’s post is of the “this and that” variety − dealing with things we’ve come across that we haven’t yet blogged about this week.
 

Medical Device Preemption − The Greatest

As defense counsel appreciate, PMA preemption post-Riegel floats like a butterfly and stings like a bee.  Anybody representing PMA medical device clients will…

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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