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We hope at least some of our readers will recall the classic ad campaign where a tub of Parkay margarine would try to trick celebrities into thinking it was butter (this one stars Deacon Jones).  Clever and catchy?  Yes. Misleading?  No.  Now, you may be saying:  well, back then there were only two choices – butter or margarine.  Now the “butter” section of your local supermarket contains a panoply of choices — butter, unsalted butter, flavored butter, spreadable butter, margarine, low fat margarine, dairy spread – and on and on.  There is even a product called “I Can’t Believe It’s Not Butter.”  Really? I can.  But while more choices may cause the need to linger a bit longer in the dairy aisle, is anyone really being misled?  At least one California state court said no – Simpson v. The Kroger Corp., 2013 Cal. App. LEXIS 769 (Sept. 25, 2103).

Before we get to the decision, we have to emphasize the importance of a win at the state appellate level in California.  While food labeling litigation isn’t our primary focus on this blog, it is a close cousin to drugs and devices and almost always involves preemption, which is one of our core interests.  But, if you look back at our food-related posts, they are almost exclusively from federal court (almost always a California federal court too).  Ever since the California Supreme Court’s decision in Farm Raised Salmon, 175 P.3d 1170 (Ca. 2008) (see our discussion here) finding California’s Sherman Law (which incorporates the requirements of the FDCA) provides a basis for non-preempted state-law parallel violation claims, we haven’t held out much hope for California food labeling claims.  But, the Simpson court’s hard line on the “identical” requirement in its preemption analysis and its application of the “reasonable consumer” standard have perked us up a bit.

We’ll try not to get bogged down in the details, of which there are many.  But, as we’ve already implied, the case is about butter, or more accurately “spread.”  Plaintiff purchased a tub of Challenge Spreadable Butter with Canola Oil believing that it was simply butter.  2013 Cal. App. LEXIS 769 at *3.  Plaintiff alleged causes of action for unfair competition, false advertising, and violations of the Consumer Legal Remedies Act.  She based her claims on allegations that defendant’s product did not comply with the California Milk and Milk Products Act of 1947 (“MMPA”).

Id. at *5.  Plaintiff also sought to amend her complaint to add mislabeling claims under the Sherman Law.

Id. at *2.  The court held the first were preempted and the second would be futile.

Id. Just a quick reminder that food is governed by the Nutrition Labeling and Education Act (“NLEA”) and the NLEA has an express preemption provision:

no State or political subdivision
of a State may directly or indirectly establish under any authority or continue
in effect as to any food in interstate commerce– … (3) any requirement for
the labeling of food of the type required by section … 343(k) of this
title that is not identical to the requirement of such section …

Id. at *9 (quoting 21 U.S.C. § 343-1(a)).  So, the first question for the Simpson court was whether California’s MMPA requirements were different than FDCA requirements for butter, margarine, and spread.  And the decision contains a lengthy discussion of how all of those foods are defined and required to be labeled under both acts.  See id. at *10-15.  For example, the FDCA requires margarine to be labeled as such “in type or lettering at least as large as any other type or lettering on such label” whereas the MMPA “requires the word ‘margarine’ to be in type at least as large as any other type or lettering on the label in ‘a color in strong contrast to the color of the container.”  Id. at *27-28.  The FDCA also provides requirements for the height, prominence and boldness of each letter, not contained in the MMPA.

Id. Plaintiff’s sole argument against preemption was that the FDCA and MMPA requirements are “substantially identical.”

Id. at *27.  But “substantially identical” isn’t “identical”:

These provisions are not
identical, despite plaintiff’s efforts to characterize them as such. Nothing in
the preemption provision of the FDCA, or in the rationale of the [California] Supreme
Court in Farm Raised Salmon Cases, extends the exemption from preemption
to state laws which are “substantially identical” rather than
identical as plaintiff asserts. We conclude that plaintiff’s MMPA claims are
preempted under section 343-1 of the FDCA.

Id. at *28.  That language could certainly be helpful in a drug or device case in fighting off a parallel violation claim.  The standard there is whether the state law claim imposes a duty that is “different from or in addition to” federal regulations.  Isn’t that the same as saying the state law requirement must be identical to the federal requirement?  If so, Simpson is strong support for what exactly “identical” means.  And, the standard appears to be high. Moving on to plaintiff’s attempt to add Sherman Law violation claims.  First, under Farm Raised Salmon, such claims are not preempted.

Id. at *26.  But, the court didn’t end its inquiry there.  Plaintiff’s allegation here is that the word butter was overly prominent on the label (larger than the words “with Canola Oil” or “Spread”) and therefore misleads consumers into thinking the product is butter.

Id. at *29-30.  However, to state a false advertising claim, “plaintiff must establish that consumers were likely to be deceived by the product” – the reasonable consumer test.

Id. at *31.  And, this brings us back to where we started, is anyone really being misled?

The labels on the products here
clearly informed any reasonable consumer that the products contain both butter
and canola or olive oil. This was plain on both the top and side panels of the
tubs in which the products are sold. No reasonable person could purchase these
products believing that they had purchased a product containing only butter.

Id. at *33.  Hence, no need to add Sherman Law claims because, as a matter of law, plaintiff can’t prove them.

Id. at *2.   We like this finding as well because plaintiffs like to file false advertising claims against drug and device manufacturers too.  So, while the food industry should obviously be excited about this decision, its implications for drug and device litigation are positive also.  We hope you find the potential cross-over between food/beverage and drug/device litigation valuable.  We do, so we’ll keep writing about it.

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In the index to this blog, we list 39 posts about the Aredia-Zometa litigation.  After today it will be 40.  And counting.  That might actually be understating our coverage.  (We’re not always so punctilious at affixing topical labels to our posts.) Sometimes it seems as if one could understand all of recent drug and device law, from A to Z, just by looking at developments in the Aredia-Zometa litigation. Maybe that is so because so many of the Aredia-Zometa cases have gone so far through the litigation gristmill, including trials, and have thereby produced so many judicial opinions on so many different areas, such as design defect, warning causation, learned intermediary, bankruptcy estoppel, abatement, ghostwriting, loss of consortium, etc.

In fact, just one of the Aredia-Zometa cases, Dopson-Troutt, has been like a mini-industry churning out drug and device law rulings. We have blogged about that case on topics such as choice of law, punitive damages, comment k, warranty claims, and Daubert (including Parisian). Just a couple of days ago, Dopson-Troutt maintained its status as the A-Z gift that keeps on giving. In the pretrial order we discussed last week, the court went the right way in rejecting non-mutual, offensive collateral estoppel.

This week’s Dopson-Troutt ruling heaves in some lumps of coal amidst some shiny baubles.  The defendant filed an omnibus motion in limine.  The court’s opinion in Dopson-Troutt v. Novartis Pharmaceuticals Corp., 2013 U.S. Dist. LEXIS 135834 (Sept. 23, 2013), characteristically, covers a lot of ground.  (Maybe the “omnibus” term should have been a clue.)  Some of the terrain is lovely. Some of it is rocky.  First, the court correctly holds that Pennsylvania law does not recognize the heeding presumption in cases involving prescription products.  The court had little difficulty distinguishing the asbestos and OTC cases relied upon by the plaintiffs.  Dopson-Troutt, 2013 U.S. Dist. LEXIS 135834 at *10-11.  We like this ruling, but we are not exactly going to applaud when a court manages to  get something right that should be perfectly clear and obvious.  And we are definitely not going to applaud when the court proceeds to mangle the ruling by saying that testimony by nonprescribing doctors “could be relevant” to a jury’s determination of whether warnings would affect a “reasonable doctor.”  Id. at *12-13.   The court did not want to rule in a vacuum.  It wanted to see what testimony would be excluded.  Maybe the court will ultimately get this issue right and exclude a lot of speculative drivel.  But now we’re the ones who are speculating, aren’t we?

We love preemption.  We wish we could sprinkle a little preemption in our coffee in the morning and on our ice cream at night.  We try to sprinkle preemption in just about every case we have.  Sadly, not all courts share our taste for preemption.  In fact, we are starting to get the idea that some courts don’t like it at all. They make a face and spit it out whenever possible.  For some judges, preemption is ipecac. (And we are emetophobes.)  In Dopson-Troutt, the defendant mounted a fairly aggressive preemption defense against the failure to warn claim. The defendant argued that “a label change requiring prior FDA approval is preempted.”  Id. at *19.  Not surprisingly, the plaintiffs relied upon Levine.  The defendant tried to read Bartlett and Mensing as opening up new preemption ground, even for brand manufacturers.  We agree that Bartlett and Mensing have implications for brand preemption, and we have said as much before.  But it will take some guts for a court to reread Levine in light of Mensing/Bartlett.  Frankly, it would amount to a pleasant surprise.  A court that treats preemption as a red-headed stepchild simply isn’t going to go our way.  Let’s just say that the Dopson-Troutt court did not surprise us.  It discounted Bartlett and Mensing, saw the Levine decision as the colossus still bestriding brand manufacturer preemption law, and denied the defendant’s effort to cabin Levine.

The defendant sought to prevent the plaintiffs from arguing that the Zometa label should have disclosed that Aredia was safer.  The FDA requires certain types of evidence to justify comparative claims. The Dopson-Troutt court denied the defense motion but it seemed to be animated more by caution than logic.  The denial of the defense motion was without prejudice:  “Without knowing what comparisons and supporting studies are at issue, the Court lacks sufficient information to make a determination.”  Id. at **23-24. Maybe we are cockeyed optimists, but we bet that when the plaintiffs are forced to put up or shut up as to whether studies would have proved the claimed comparison, they will be forced to shut up.

The defendant fared much better on the plaintiffs’ claim that there should have been a black box warning.  FDA regulations clearly prohibit manufacturers from unilaterally adding a black box warning.  See, e.g., 21 CFR section 201.57(3); 44 Fed. Reg. 37434, 37448 (June 26, 1979).  The plaintiffs had no response save a rather silly one – that there is no instance of the FDA striking a black box warning used by a pharmaceutical company.  Id. at *25.  Yeah, but still.  And by “still,” we mean that the regulations still say what they say.  That, at least, is how the Dopson-Troutt court saw the issue, and it granted the defense motion to exclude the black box argument.

The plaintiffs challenged the form, as well as the content, of the Zometa label.  The quarrels over form included placement, bolding, and font size.  It is hard to believe that this sort of thing is not wholly entrusted to the judgment of the regulatory body.  The defendant cited the Pom Wonderful case in arguing that the plaintiffs’ desire to fly-speck the format of the label threatened the FDA’s primary jurisdiction.   Wonderful or not, the Dopson-Troutt court concluded that Pom Wonderful was inapplicable because it was a food, not drug, label case. The court denied most of the defendant’s motion, which strikes us as an invitation to plaintiffs to come forward and propose all sorts of dopey format changes.   Nevertheless, to the extent the plaintiffs insisted that the label use an FDA disapproved font, that claim was deleted.  Id. at **27-28.  Perhaps one should be grateful for small favors.

Finally, the defendant sought to exclude evidence of any corporate conduct post-dating the plaintiff’s tooth extraction (which plays a major role in determining onset of an A-Z plaintiff’s injury).  The court would not at this point agree to that exclusion ex ante, because there was the possibility that after-the-fact documents or actions might be somehow relevant, such as for showing prior knowledge.  Id. at *28.  This is a court that views in limine motions with almost as much trepidation and suspicion as preemption.  Even so, reserving judgment is better than indulging in bad judgment.  If the court wants to hold off on categorical rulings, so be it.  It’s all good so long as the court ends up making the right ruling, and does so before the plaintiffs manage to poison the jury well.

In other words, there is every reason to believe there will more rulings in the future.  We will hear from Dopson-Troutt again.

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The Philadelphia diaspora has begun.  A confluence of factors is responsible, such as the “under New management” (pun intended) sign on the Complex Litigation Center, the changed, less plaintiff-friendly procedures that have been put in place (discussed here), and a couple of hard-fought diversity of citizenship wins taking major defendants out of the Philadelphia mix, Johnson v. Smithkline Beecham Corp., 724 F.3d 337 (3d Cir. 2013) (lauded here), and Moore v. Johnson & Johnson, 2013 WL 5298573 (E.D. Pa. Sept. 20, 2013).  The new precedent has led to a spate of removals (58 “trial documents” on Westlaw citing Johnson), a phenomenon we’ve both anticipated and discussed .  Put together, all these factors have prompted tactical decisions by a growing number of litigation tourist plaintiffs to voluntarily dismiss/discontinue their Philadelphia actions altogether.  Sometimes these voluntary dismissals precede any attempt at removal.  See Benge v. SmithKline Beecham Corp., 2013 WL 5278220, at *1 (E.D. Pa. Sept. 19, 2013) (mentioning nine cases).  Sometimes these discontinuances occur in federal court after removal has occurred.  See Yazzie v. GlaxoSmithKline LLC, 2013 WL 3993455, at *1-2 (E.D. Pa. Aug. 5, 2013).

We suspect that these tourist plaintiffs, once rousted from Philadelphia, are not simply going to go away.  Rather, they will probably try to file their suits again, somewhere else, possibly a defendant’s true home state, perhaps some other perceived beneficial jurisdiction or – heaven forbid! – in a plaintiff’s own home state.  Should any new filings occur, some of our readers may encounter these refugee lawsuits.  So we’re pointing out what we think defense counsel in other jurisdictions need to know about Pennsylvania law and voluntary dismissals (also called “nonsuits”).

A lawsuit once filed in Pennsylvania state court, but then voluntarily discontinued, does not toll the statute of limitations (two years for personal injury).  Not only that, Pennsylvania’s saving statute, which otherwise tolls the statute of limitations for actions dismissed for reasons other than on the merits, is expressly inapplicable to “[a]n action or proceeding terminated by a voluntary nonsuit, [or] discontinuance.”  42 Pa. C.S.A. §5535(a)(2).  So the legislature has weighed in as well.  What this means is that the litigation tourists, in voluntarily discontinuing their Pennsylvania actions (without prejudice, of course), may well end up outsmarting themselves.

Here’s the primary case that says so.  Williams Studio Division v. Nationwide Mutual Fire Insurance Co., 550 A.2d 1333 (Pa. Super. 1988).  In Williams the plaintiff sought a voluntary nonsuit of its first-filed action, for unstated reasons, and then refiled and sought to prosecute a second lawsuit.  Not so fast, said our Superior Court (back when this statewide intermediate appellate court wasn’t as plaintiff friendly as today), your voluntary discontinuance of the first action effectively nullified that case.  For statute of limitations purposes, it is as if the voluntarily nonsuited case “never existed”:

[W]e conclude that, when a plaintiff takes a voluntary nonsuit, it is as if the original suit was never initiated.  Logically, since the original complaint is treated as if it never existed, the statute of limitations is not tolled by the filing of a complaint subsequently dismissed without prejudice.

Id. at 1335 (citation and quotation marks omitted).  Thus, if a case from the Philadelphia diaspora was sitting around for years here in our Court of Common Pleas (a not uncommon occurrence), the voluntary dismissal means that there’s no tolling of the statute of limitations for that period.

Interestingly, the court in Williams found support for its holding in analogous decisions interpreting federal rules:

To determine what effect, if any, a voluntary nonsuit has upon the running of a statute of limitation, we must first determine the result of a voluntary nonsuit. Although this is a case of first impression under Pennsylvania law, Federal law is well settled, and numerous Federal cases hold that dismissal without prejudice operates to leave the parties as if no action had been brought at all.  While not expressly stating that a voluntary nonsuit or discontinuance operates to leave the parties as if no action had been filed, Pennsylvania case law reflects a similar result.

Id. (quotation marks and citations to numerous federal cases omitted).  Given that federal and Pennsylvania law both hold that voluntary dismissals nullify prior actions for statute of limitations purposes, it shouldn’t matter whether the plaintiff dismissed in state court prior to removal (as in Benge) or in federal court after removal (as in Yazzie).  In either case, if the period of time the case was pending in Philadelphia puts the action beyond the relevant statute of limitations (don’t forget borrowing statutes, either), the action is time-barred and should be dismissed, as in Williams.  550 A.2d at 1336 (affirming judgment on the pleadings against second action).  See Marra v. Smithkline Beecham Corp., 789 A.2d 704, 706 (Pa. Super. 2001) (“[o]nce a case has been discontinued, the plaintiff may commence a second action . . . so long as the statute of limitations on the second action has not expired”) (following Williams).

Subsequent Pennsylvania cases dismissing voluntarily discontinued cases on the statute of limitations under Williams include:  Atlantic Pier Associates, LLC v. Boardakan Restaurant Partners, L.P., 2011 WL 3268129, at *7 (E.D. Pa. July 29, 2011) (“the filing of a prior [Pennsylvania] action will not toll the limitations period for a subsequently filed state action where the first action was terminated by a discontinuance”); Stout v. Selective Way Insurance Co., 2010 WL 2034637 (Pa. C.P. Philadelphia Co. May 3, 2010) (no pagination), aff’d, 23 A.3d 598 (Pa. Super. 2010); American Continental Properties, Inc. v. Lynn, 2003 WL 2152487, at *9-10 (Pa. C.P. Philadelphia Co. April 16, 2003) (plaintiff’s first, voluntarily dismissed action was in New York), aff’d, 855 A.2d 125 (Pa. Super. 2004); Grove v. Scott, 17 Pa. D. & C.4th 212, 216 (Pa. C.P. York Co. 1992) (prior voluntary dismissal of third-party claim).

In our view these out-of-state, litigation tourist plaintiffs chose voluntarily to file in the Pennsylvania forum.  In pursuit of litigation advantages to which they were not entitled, they willingly submitted themselves to Pennsylvania rules and procedures.  If in further pursuit of litigation advantage, they voluntarily dismiss those actions and they later turn out to be time barred, well, they made their jurisprudential beds, so let them sleep in them.

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Thompson v. Zimmer Inc., 2013 U.S. Dist. LEXIS 137391 (D. Minn. Sept. 25, 2013), is one of the good ones.  It stands for the notion that, when the evidence isn’t there, the defense wins.  It was a hip implant case, and the defense won because the court placed the evidentiary burden where it belonged, on the plaintiff, and because the court didn’t accept what often amounted to speculation from the plaintiff’s expert.

The defense’s first victory was on plaintiff’s failure to warn claim.  If you read our blog with even mild regularity, you know that
we stress the principle that the burden lies with the plaintiff to show that a prescribing doctor would’ve acted differently under an allegedly adequate warning.  And so, in a device case, a plaintiff who presents absolutely no testimony from the doctor who implanted the device simply can’t meet that burden.  And the defendant is entitled to summary judgment.  That’s what the Thompson court did:

In this case, no reasonable jury could find that Zimmer’s failure to warn caused Thompson’s damages. Thompson chose not to depose Dr. Kavanaugh, the surgeon who implanted the allegedly defective liner, and who would have been the recipient of the warnings that Thompson contends should have been given.  Consequently, there is no evidence that Dr. Kavanaugh would have implanted the acetabular shell at a different angle, or that he would have chosen a different liner, if he had been given those warnings.

Id. at 9-10.  The opinion has additional helpful language that elaborates on the complexity of a treating doctor’s implant decision and, therefore, why plaintiffs need evidence from that doctor:

An artificial hip is not a single, integrated device; instead, implanting surgeons choose a combination of modular components based on the risks and benefits to the individual patient.  Without Dr. Kavanaugh’s testimony, there is no way for the jury to know why he chose the particular configuration of components that he implanted or why he implanted
them at a 60 to 65 degree angle of abduction. It may well be that Dr. Kavanaugh was fully aware of the risks that Thompson says he should have been warned of, and that Dr. Kavanaugh concluded that the benefits of implanting the liner at that particular angle (in conjunction with the other components he chose) outweighed those risks.

Id. at *10-11. In short, plaintiff’s failure to depose the implanting doctor meant that there was “no evidence from which a jury could conclude that a warning would have caused Dr. Kavanaugh to do anything differently.”  Id. at *11.

Continue Reading Summary Judgment and Rule 702 Wins in Hip Implant Litigation

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We came to you a few weeks ago on the topic of collateral estoppel.  Not the most exciting doctrine as far as equitable doctrines go, but collateral estoppel has gained greater currency in drug and medical device litigation because of the nature of the mass proceedings in which we often find ourselves.

Whether at the state or federal level, litigation begets more litigation, and where there are significant inventories of cases involving similar products, there will be one case after another.  Throw into the mix the trend of selecting test cases and setting “bellwether” trials, and plaintiffs inevitably will argue that a result in their favor in one case should legally bind the defendant in the next.  Never mind that
neither plaintiffs nor courts would ever tolerate the reverse – a defendant binding future plaintiffs to defense wins and precluding them from presenting their cases.  Due process would not permit that so-called “non-mutual” collateral estoppel against plaintiffs who were not parties to the first proceeding, yet when unrelated plaintiffs assert collateral estoppel against defendants, they seem to get a hearing.  Before we said this reminds us of “head I win, tails you lose.”  Perhaps more precisely we should say “heads you lose, tails I get to try again.”

Fortunately for the sake of justice, plaintiffs almost never win at this tactic, and defendants almost always have a fair opportunity to defend their products.
Continue Reading Offensive Collateral Estoppel Foiled Again

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It’s not often – like once every quarter century – that the Advisory Committee on Civil Rules (the folks who decide when the Federal Rules of Civil Procedure need to be amended, and how) decide to take on Rule 26(a) (concerning scope of discovery) and Rule 37(e) (concerning sanctions) essentially from the ground up.  That’s what’s happening now, and it’s high time that our defense-side readers put their two cents (or more) into this process.  Some very helpful changes to reduce the outrageous costs of discovery and to do away with the “gotcha game” of discovery sanctions (primarily, but not totally, concerning ediscovery) have been proposed.  You can bet your bottom dollar that when anything is proposed that is useful to us and our clients as producing parties, the other side will be out in force (see here, for example) to try to stop it in its tracks.

We need to get off our collective duffs and do something about this.  Discovery, especially ediscovery, is the biggest single cost issue in litigation, both in pharmaceutical mass torts and elsewhere.

Specifically, the committee has asked for public comment on two proposals to amend the Federal Rules, both of which are designed to reduce the costs and burdens of discovery that we as defendants and defense counsel routinely face as producers of large quantities of information, both electronically stored and otherwise.  The broadest rules change is a revision to Rule 26(b)(1), which re-defines the scope of discovery.  It would get rid of the current, and often misused (as we discussed last week) standard by which discovery is measured:  “reasonably calculated to lead to the discovery of admissible evidence.”  Instead, discovery would be permissible of “any nonprivileged matter that is relevant to any party’s claim or defense and proportional to the needs of the case.”  Currently the proportionality concept is buried in Rule 26(b)(2)(C)(iii), where it looks more like an affirmative defense.  If the amendment is adopted, proportionality becomes part of the basic definition of scope.  Think of the difference that could make in encouraging both judges and the parties to take a pragmatic perspective on what discovery is appropriate to each particular case.

Continue Reading Everybody Bitches About Ediscovery, But Nobody Does Anything – NOT!

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Eight times out of ten, the advice of “save it for trial” is flat-out wrong.  Nine times out of ten, the person offering that advice has not done as many as ten trials.  It is laziness masquerading as sophistication.  Nine times out of ten there won’t be any trial.  But there will certainly be motions.  Or settlement talks.  Isn’t it better to have something valuable on the record for those festive occasions?  An after-the-depo, self-serving affidavit packs a puny punch.  If there is a trial, that thing you were saving might not really be available, or might not be what you thought it was.  When you spring that gotcha point during cross-examination of the expert, you might be the one who gets got.

Earlier this week, blogger emeritus Mark Herrmann wrote a column entitled, “The Need for Direct Exams of Your Own Witnesses at Depositions.”  It is on the Above the Law blog and can be found here. Read it.  Learn it. Live it.  We admit that we are completely in the bag for Herrmann, and not only because he is a cofounder of the DDL blog.  He is relentlessly insightful.  He has a way of making points that are clear and stick to the mind – even if, like ours, that mind is made up of Teflon, the fake butter that greases movie popcorn, and the collected works of Sid and Marty Krofft.  If we had to fling one book at a first year lawyer who handed in an especially dismal scrap of work product, it would be Herrmann’s The Curmudgeon’s Guide to Practicing Law.  That book is full of useful, concrete advice.   (Ask short questions, do not hand in incomprehensible memoranda, treat your secretary with respect, etc.)  Plus, now Herrmann is in-house counsel, which confers on him an undeniable aura of infallibility.

We cannot improve on Herrmann’s pellucid prose, and he does a fine job of demolishing the conventional wisdom of reserving all questioning of one’s own witnesses for trial.  Even if the witness is young and healthy and apparently cooperative, a lot of things can happen that will make that witness unavailable for trial.  There is a whirlwind of employee turnover out there and our clients are not immune from it.  Attitudes change.  Judicial caprice or cruel logistics might make it not so easy to haul company witnesses to a jurisdiction that exists far away (and maybe back in time).  Moreover, wouldn’t you like to have a few good things on the depo videotape?  All it takes is a couple of minutes of innocuous praise of company policies, procedures, and culture to create context and blunt the awfulness of a series of damaging admissions.

Continue Reading Herrmann is Right (as usual): Do Direct Exams When You Defend Depo Witnesses

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This is from the Dechert side of the blog only.

Last week we gave you a lot of Medtronic decisions to mull over and to mostly be happy about.  And, like we mentioned, Medtronic is no stranger to preemption issues.  So, when we found yet another new Medtronic favorable device preemption case, at first we thought we might add it to one of our scorecards or cheat sheets and call it a day.  But, this is a win in a Ninth Circuit court and after Stengel, that can’t go overlooked. But, we’ll keep it short and simple nonetheless.

The case is Suckow v. Medtronic, Inc., No. 2:12-cv-01870-GMN-CWH, slip op. (D. Nev. Sept. 20, 2013) and it involves a pacemaker manufactured by Medtronic that was implanted in plaintiff in 2006.  Plaintiff had to have the device removed on an emergent basis in December 2010 and alleges she suffered injuries as a result of the removal surgery.  In addition to strict liability and breach of express warranty claims against Medtronic, plaintiff also brought negligence and misrepresentation claims against a Medtronic sales representative alleging that a few months before the removal, he evaluated the device and found it was operating normally and was fit and safe for continued use.  Slip op. at 2.Medtronic removed the case to federal court and argued that the sales representative was improperly joined.

Medtronic challenged the plaintiff’s claims against the sales representative on two grounds.  First, the sales rep had no contact with the plaintiff before December 2010.  Second, if the sales rep evaluated the device, it was at the request of the physician and it is the physician who “interprets any data and makes decisions.”  Id.  at 6.  While plaintiff argued that her claims against the sales rep weren’t preempted, she apparently neglected to address any of the arguments on fraudulent joinder.  Id.  So, it really was a no-brainer for the court to uphold removal and move on to decide Medtronic’s preemption motion.

But, we just want to take a minute to remind our readers that there are more substantive decisions out there about the risks of liability from the involvement of sales reps in the care and treatment of patients.  See our post here.  In Suckow, while the court didn’t have to reach it, it looks like defendants had a strong learned intermediary defense because the sales rep’s role was limited to the evaluation of the performance of the device, not in rendering advice, opinions, or direct care to the plaintiff.
Continue Reading Another Notch on Medtronic’s Preemption Belt

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We use the phrase so much, particularly on this blog, that you hardly notice.  Try our blog’s search box, and you’ll see that just about every author on the blog, current or past, has used the phrase.  It’s useful, we guess, in introducing the reader to what’s coming: that is, some good, some bad.  And, for whatever reason, lawyers seem to like to use it more than most.  We encounter one every so often in real life. A filled stocking on Christmas morning is like one.  A variety of nuts or candies often comes in one.  Maybe donuts, but those are almost always in boxes.

But we see it way more in writing.  And here it comes again:  the Daubert and summary judgment decisions in the Zometa opinion in Sheffer v. Novartis Pharma. Corp., 2013 U.S. Dist. LEXIS 133760 (S.D. Oh. Sept. 18, 2013), are . . . . ready, here it comes  . . . a mixed bag.  And it truly is.  Well, not truly.  It isn’t a bag. It’s a legal decision.  But it’s mixed.  Well, that’s probably not right either.  It’s not mixed.  We’re not sure how you’d do that.  But it’s got . . . well, good stuff and bad stuff.

The Daubert portion has both.  As for the bad, the court acknowledged that a causation expert can use a differential diagnosis to reach a specific causation opinion.  Id. at *12-16.  We’ve discussed many times the shortcomings of differential diagnosis opinions, but regardless of their shortcomings acceptance of these opinions has become more and more common.  The court even called it “differential etiology,” which is more accurate.  But we still haven’t seen, in this opinion or elsewhere, much discussion of differential etiology being an established and regularly practiced scientific process used by doctors outside the court room to establish causation. 

Nonetheless, the court allowed plaintiff’s expert to use it as the basis for his opinion that Zometa caused plaintiff’s osteonecrosis of the jaw (ONJ).  Worse, though, the court allowed the expert to give this opinion despite his deposition testimony that he couldn’t rule out other potential causes, such as plaintiff’s use of another drug, Avastin, metastasis from her breast cancer, or her having had a bone infection before being diagnosed with ONJ.  Id. at *14.  The court pointed, instead, to the expert’s report, presumably served before his testimony, in which he wrote without explanation that he had ruled out these causes. Id. at *15.

The court also noted that the expert didn’t need to exclude all other potential causes, though you’d think that these three were important enough to merit an expert’s explanation.  Id. You can be sure that this type of opinion won’t do anything to lessen the uptick in differential diagnoses opinions that we’ve seen in recent years.  As for the good, the court excluded specific causation opinions from plaintiff’s treating physicians.  Id. at *9-12.  Plaintiff’s treaters admitted that they weren’t causation experts and, when addressing whether Zometa caused plaintiff’s ONJ, they used words such as “possibly,” “may” and “some idea.”  Id. That’s not good enough, and the court excluded any causation opinions from them.

Continue Reading An Aredia/Zometa Remand Court Addresses Rule 702 and Summary Judgment Motions

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It is common to characterize an opponent’s discovery request as a “fishing expedition.”  Of course, all discovery seeks something it may not find—much like our own experience with actual fishing for, you know, fish.  However, Federal Rule of Civil Procedure 26 (like various state court equivalents) requires that “the discovery appears reasonably calculated to lead to the discovery of admissible evidence,” focusing on the level of expectation that the discovery will turn up something relevant to the issues in the case.

Throwing a line in a dirty pond in Nebraska may be reasonably calculated to find you some fish, but not salmon.  In prescription drug product liability cases, it is the prescribing physician whose actions and testimony help define what marketing evidence is admissible.  (OK, so we got tired of talking about fish.)  When the prescriber has already testified what she did and did not rely on in making her decision to prescribe to the plaintiff, there is a good indication of what discovery on marketing practices will or will not be reasonably calculated to lead to the discovery of admissible evidence.  Like a big sign that says “there are fish here” or “there are no fish here.”  (We gave the fish thing another shot.)

Peetz v. Genentech, Inc., No. 8:10-CV-297, 2013 U.S. Dist. LEXIS 126803 (D. Neb. Sept. 5, 2013), is a case where the court ignored such a sign in the context of a motion for protective order on 30(b)(6) depositions on general marketing practices.  The plaintiff used defendants’ immunosuppressant drug for something called thrombotic thrombocytopenic purpura (TTP), an off-label autoimmune disorder—the drug was approved only for lymphoma—and claimed to have developed a paralyzing viral infection.  He claimed that defendants had not adequately warned in their marketing materials, and, presumably, label, that the immunosuppressant drug “carried a risk of severe immunosuppression.”  Id. at *6.
Continue Reading Marketing Omission Fishing Expedition

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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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