Aredia/Zometa

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Sometimes we take routine things for granted. We don’t appreciate the taste of our morning coffee, it’s just always there. We don’t appreciate the softness of our favorite college sweatshirt, it’s just always been that way. We don’t appreciate that while watching an episode of The Walking Dead and seeing a familiar face we can IMDB and find out we recognize the actor from a 3-episode storyline on Law & Order from the late 1990s. That last one hasn’t always been available, but it’s getting harder to recall what it was like to not have that answer until it woke you from a sound sleep at three in the morning.

In the legal world we take things for granted too. We talk about things like breach, duty, causation, and on this blog, preemption, so routinely, we do start to gloss over them a bit. TwIqbal, Daubert, Buckman. Routine, routine, routine. And for sure, learned intermediary fits into this category of things we know about, we like, but maybe take a bit for granted. For many of us, it’s been part of drug and device law our whole careers given that the term was first coined in 1966 by the Eighth Circuit in Sterling Drug Inc. v. Cornish, 370 F.2d 82, 85 (8th Cir. 1966). So sometimes, it’s good to be reminded just how important it is.

That is what today’s case is all about. In Bock v. Novartis Pharmaceuticals Corp., 2016 U.S. App. LEXIS 18042 at *1 (3d Cir. Oct. 5, 2016), decedent’s family alleged that the defendant failed to adequately warn decedent’s doctors that its drugs Aredia and Zometa contribute to the risk of developing osteonecrosis of the jaw (“ONJ”), which decedent developed following multiple tooth extractions and other dental procedures. The court’s decision starts out with a recitation of the warnings that accompanied the drugs as well as additional warnings distributed by the defendant via “Dear Doctor” letters. Those warnings, which pre-dated decedent’s prescription and use of the drugs, included information such as that ONJ had been reported in patients using the drugs, mostly associated with dental procedures like tooth extractions and that invasive dental procedures should be avoided. Id. at *2-3. We know we come at this from the skewed perspective of drug and device defense counsel, but the warning seems fairly clear to us.Continue Reading Aredia/Zometa Plaintiff Can’t Avoid Learned Intermediaries

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We were surprised by the article in the New York Times this weekend about how the Supreme Court revises some of its opinions years later.  Those changes are picked up in some reporters, but not others.  Some of those changes are relatively minor (e.g., Justice Scalia correcting his statement of what the EPA’s position was on a particular issue) but others are not. The article sent us into a reverie of wishful thinking about ‘correcting’ the Wyeth v. Levine opinion to take into account the non-automatic nature of Changes Being Effected, or to excise Riegel’s frolic and detour on parallel claim exceptions, or to foreclose the Solicitor General’s new, crabbed interpretation of FDA preemption applying only to device-specific actions.  But why stop at Supreme Court opinions?  Looking back over the years, we can think of many things we said and wrote that we’d now like to edit.  That wedding toast where the ex-girlfriend, rather than the bride, was saluted would be fixed.  And now in our dotage we finally realized the correct answer to the question of whether “this makes me look fat.”  It reminds us of the classic definition of a gaffe: telling the truth at the wrong place and time.

Many of the cases we post about here could use a bit of editing.  When the blogging team goes over the cases on offer for any given week, the phrase “mixed bag” comes up more often than any other.  That shouldn’t be surprising.  For every wonderful one-two punch Mensing/anti-Conte case, or every Bausch/Perez train wreck, we get ten cases that are more like what we see regularly in real-life – cases that have a little good and a little bad.  We cannot exactly edit those cases, but we can accentuate the positive in our humble reviews.  That’s what we will do with Kruszka v. Novartis Pharms. Corp., 2014 U.S. Dist. LEXIS 68439 (D. Minn. May 19, 2014).  Kruszka is yet another Aredia-Zometa case where a cancer survivor alleges that the drugs that helped her survive cancer caused osteonecrosis of the jaw (ONJ).  Some of the rulings we like better than others.  While we cannot edit the opinion, we can certainly highlight the good stuff while mumbling sotto voce about the bad. With the glow of the long holiday weekend not yet worn off, we are reluctant to be the deliverer of evil.

The plaintiff in Kruszka was diagnosed with blood cancer in the form of multiple myeloma in 2000.  That cancer resulted in hypercalcemia, a compression fracture in her spine, and lytic lesions in her skull, spine, and bones.  Multiple myeloma patients’ survival rate is approximately six months where no treatment is received.  Doctors told the plaintiff she could expect to live six weeks without treatment.  But she did receive treatment.  Her doctor prescribed Aredia to protect against bone damage and treated the plaintiff with chemotherapy.  She received both branded and generic bisphosphonates.  The good news is that she lived.  The bad news is that a couple of years later she was diagnosed with chronic osteomyelitis (infection in the bone).  The plaintiff was prescribed a prolonged course of four different antibiotics after her prior treatments were determined to be ”suboptimal.”  Dead bone was removed from the jaw area in 2003.  A year later, the plaintiff complained of numbness in her jaw, chin, and lip resulting in difficulty swallowing and chewing, a “deformed face” and other issues.  The plaintiff alleged that the damage to her face and jaw changed her life dramatically, including her speech, eating, social interactions.  She had to give up her church choir.  There is no doubt that the plaintiff earned sympathy.  She was also, as of November 2013, still alive.Continue Reading Rule 702 and Summary Judgment Rulings in Minnesota Aredia-Zometa Case

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We watched some of the recently concluded Winter Olympics.  When the temperature at the Black Sea-side resort exceeded the temperature of Washington, D.C., by 20° Fahrenheit (or 11.1° Celsius), we questioned the “Winter” part of the event’s title in a way we never expected.  Of course, we watched some action from familiar sports, like the hockey showdowns with our once-archrival and our northern neighbor.  We also watched some of the biathlon, a fascinating sport that involves cross country skiing with a rifle on your back and stopping periodically to shoot at targets.  Our initial thoughts on that sport ran like this:  “This is not a sport that people do casually.  Maybe this is to echo the Winter War.  Maybe they could make it a more militaristic triathlon by adding a phase where an edged weapon is used to decapitate a snowman while skiing.  These tortilla chips are making me thirsty.”  This being a blog on drug and device law—as its title hints—and our thirst having been quenched, it occurs to us that our experience with the cases we write about is like watching the biathlon.  (We may have quenched our thirst with a nice winter ale and/or a little Russian water, but we are sober as we write.)  We do not hear much about the exhausting cross-country grind of discovery.  We do not follow all the ups and downs of trial argument and evidence.  We check in, periodically, when the litigants have paused long enough to shoot (at each other, unlike in the Olympic version of the biathlon) and the court issues some ruling explaining the targets, hits, and misses.  Even then, we typically pay attention to the results of the shooting only when the decision is published (or sent to us by a participant) and it seems interesting.  Occasionally, we notice multiple decisions from a single case as it proceeds past discovery, dispositive motions, and pretrial motions, and through trial.  These may not be the highest stakes or most groundbreaking cases, though.  This is somewhat like watching NBC focus on the battle for 15th place in the Men’s Relay, just because the U.S. team was battling.  (Bulgaria, you are the ancestral homeland of the mighty Spartacus.  Need you grab more glory by 0.7 seconds?)

The Guenther case is one of many Aredia/Zometa cases involving allegations about osteonecrosis of the jaw (ONJ) whose decisions have been discussed in our posts.  Guenther, however, has achieved special puffy coat status due to its recurring role in six prior posts.  Over the last year, we have posted on decisions on case consolidation, summary judgment, punitive damages, limiting Dr. Parisian (as part of a compilation), motions in limine, and more motions in limine.  Yet, we know that there were other decisions and developments in the case that shaped its course.  We know from Guenther v. Novartis Pharm. Corp., No. 6:08-cv-456, 2014 U.S. Dist. LEXIS 21182 (Feb. 20, 2014), that its course took the case all the way to trial, where the plaintiff won on strict liability and negligent warnings causes of action and was awarded $1.3 million in compensatory damages, leading defendant to move for judgment notwithstanding the verdict, a new trial, and/or remittitur.  All we know about the trial evidence from the plaintiff, prescribing physicians, other treating physicians, and the experts comes from the decision itself, as the court identifies and characterizes the evidence it wants as it explains its particular findings.  See, this is just like watching biathlon.  No need to analyze the parallels any further.Continue Reading Understanding the “Intermediary” Part of The Learned Intermediary Doctrine

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As we descend toward dotage, we find ourselves more and more often telling jolly stories that we realize, halfway-through and courtesy of the strained expressions on the poor listener’s face, we have told before. When the Drug and Device Law toddlers were underfoot, that wasn’t much of a problem; they loved hearing the same stuff…

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Happy thanksgiving to all.  We all have plenty of things to be thankful for.  We also have some things we’re not thankful for.  This post discusses one of those.

The recent opinion in Rowland v. Novartis Pharmaceuticals Corp., ___ F. Supp.2d ___, 2013 WL 6145119 (W.D. Pa. Nov 22, 2013), has us shaking our heads.  That’s not so much because of the legal issue being fought over, but rather because of the machinations that led to a most peculiar result.

Basically, forum-shopping paid off.

Rowland involved three plaintiffs, Rowland, Machin, and Orr, all of whom are (or were) Pennsylvania residents.  Rowland, 2013 WL 6145119, at *1.  However, none of them filed suit in Pennsylvania.  Rowland and Machin brought suit in D.C. and Orr in New York.

Id. at *2.

Rowland is yet another Aredia/Zometa case.  We’ve discussed the underlying issue − whether availability of punitive damages should be determined under:  (1) the law of a corporate defendant’s principal place of business, or (2) the law of the place of the plaintiff’s injury – before.  See here and here.Continue Reading Making Forum-Shopping Pay

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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…

Photo of Stephen McConnell

Many of our posts are inspired by attorneys who relay their latest wins to us.  Since we make no bones about our intention of aiding and abetting the defense cause, it is no surprise that it is usually fellow defense hacks who do the relaying.  Sometimes there is a whiff of self-promotion, sometimes not.  We frankly do not care.  If it constitutes news-defendants-can-use, we are grateful to get it. Call it legal capitalism at its finest.

Believe it or not, occasionally plaintiff lawyers send us case results.  Whether such efforts represent promotion, correction, or sadism, we cannot help but admire the enterprise and temerity.  We have no desire to publicize bad results if there is any decent chance that such publicity could cause proliferation, but most of the time it is better to know about traps for the unwary (or the wary; or the unlucky; or anyone in Madison County).  In The Godfather, Tom Hagen says that Mr. Corleone insists on getting bad news quickly.  We agree.  We’re just sorry we cannot deposit a horsehead in the malefactors’ beds.

Strangest of all is when we get case reports from both defense and plaintiff lawyers.  Is there self-delusion going on?  Or, as is more likely, does the case contain goodies for both sides?  Last week’s rulings on pretrial motions in Earp v. Novartis Pharmaceuticals Corp., 2013 WL 4854488 (E.D.N.C. Sept. 11, 2013), gave a little bit to each litigant.  We will emphasize the parts we like best.  Rather than curse the darkness, we will paint a one-sided view of the candle.

No Leave to Amend the Complaint

Earp is another case where plaintiffs claimed osteonecrosis of the jaw (ONJ) from taking Aredia-Zometa. The plaintiffs wanted to amend their complaint to add a claim under North Carolina’s Unfair and Deceptive Trade Practices.  The court ruled that the plaintiffs failed to show good cause under rule 16.  Amendment denied.  Earp, 2013 WL 4854488 at *2.

We are off to a good start.Continue Reading Earp Rulings are OK with Us

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The Drug and Device Law Son is attending a college with a curriculum that is both catholic and Catholic. Thus, in addition to his courses in Business Dynamics, Calculus, and Russian, he is required to take a course in Religion. His first assignment was to write out an argument that religion and science are similar and fundamentally compatible. That topic is one that might get a lot of people excited, maybe even exercised.  (We wanted to say “exorcised,” if only for the fun of it, but the grammar police here pointed out that such usage had the drawback of being utterly wrong.  It would be almost as bad as abusing the word “fulsome,” which happens within our earshot at least twice a day.) The religion-science contest has, in fact, been the subject of some dramatic courtroom battles. The Scopes trial in Tennessee is perhaps the most famous, but only a couple of years ago a federal judge in Harrisburg, PA had to wrestle with a case challenging the place of creationism in the science classroom.

The likes of Hawkins and Hitchens have suggested that what distinguishes science from religion is the concept of falsifiability. A theory is scientific if one can conceive of facts that would disprove it. But if any set of facts can coexist with a belief because one can always point to mystery, miracles, or faith, then that belief looks not so scientific and more like religion. That is not necessarily to say one is right or wrong, but it is to say that there is a difference. Maybe you can take shots at that difference (more on that in a minute), but it is at the very least a difference of degree. As the brilliant and opaque Hegel was fond of saying, quantitative differences after a point become qualitative.  The almost as brilliant and never opaque Bexis pointed out to us that one of our heroes, the Harvard sociobiologist E.O. Wilson, is adamant that religion and science are fundamentally incompatible.  Wilson has spent a lot of time writing about ants.  It is certainly true that ants are incompatible with a church picnic.  If he is saying anything beyond that, we confess to being too frightened to comment.

Occasionally we will encounter plaintiff experts who pretend to be engaging in science, but it drearily becomes clear that something else is afoot. Again, it comes down to the concept of falsifiability. When you encounter these experts and dangle in front of them possible facts and ask if such facts would undermine their bought-and-paid-for conclusions, these experts find ways to wriggle out of admitting that anything would cause them to change their minds and thereby disappoint their clients. These experts are no longer practicing science; they are worshipping at the altar of Mammon.

But back to the alleged convergence of religion and science. The DDLS wrote his paper without any help from us. He received a good grade. For that, our eyes turned toward the Heavens, and definitely not in a scientific sense.  We might posit that there is a cause and effect relationship between our nonparticipation and the good grade.   But if we had been given the opportunity to contribute our thoughts to the paper, we probably would have said something about how science is ineluctably based on certain articles of faith. One of those articles of faith would be the concept of cause and effect. Even the Bradford-Hill criteria arguably announce a creed as much as a scientific concept.Continue Reading New Aredia-Zometa Dismissal is Cause for an ‘Amen’

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Our recent post on the outcome of the plaintiffs’ in limine motions in the Guenther Aredia/Zometa case prompted a volcanic retort from one of the plaintiffs’ counsel (who will remain anonymous) that “all was not beer and skittles” (yech – not an appetizing combination) for the defense, specifically listing the court’s rejection of a defense “paper storm” and “preemption based in limines.” Attached to counsel’s emails were an order striking an original set of defense in limines as too darn long and a second order resolving a choice of law dispute in favor of Florida, rather than Georgia, law.  Why a plaintiff would prefer Florida law in prescription drug product liability litigation case escapes us; some of us remember the excellent Florida law on causation and the learned intermediary rule that led to huge defense wins in the Seroquel litigation.

At about the same time as that email, one of our automatic searches pulled up the opinion on the Guenther defense in limines, which counsel had referenced but did not attach.  See Guenther v. Novartis Pharmaceutical Corp., 2013 WL 4648449 (M.D. Fla. Aug. 29, 2013).  Because (as counsel noted) we are interested in preemption issues – even hard ones for our side, which certainly includes preemption in innovator drug cases post-Wyeth v. Levine, 555 U.S. 555 (2009) – we took a look. Hmmmm.

For a post-Levine decision, we actually don’t think the rulings are all that bad.  In fact, since the opinion provides a road map for possible future preemption inroads, we think this Guenther decision is worthy of comment.Continue Reading More On Aredia/Zometa – Innovator Drug Preemption

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In tracking the progress of a case that produces multiple decisions, we sometimes feel like a distant relative getting intermittent updates of a child’s milestones.  As with a child, the milestones do not necessarily become more important and interesting. (Elementary school “graduation” does not eclipse starting school and not just because caps and gowns are absent.)  With Guenther v. Novartis Pharm. Corp., No. 6:08-cv-456-Orl-31DAB (M.D. Fla.), a case on remand from the Aredia/Zometa MDL, we have already posted three times this year on four separate decisions in the case.

Plaintiffs were not consolidated for trial, punitive damages were not available under New Jersey law, Dr. Parisian was limited in trying to make up new duties for drug companies, and the plaintiff was allowed to duck summary judgment on her warnings claims even though she lacked proximate cause evidence from her prescribing physician.  Some important and interesting issues, mostly decided correctly, with a notable exception. Now, as the case heads toward trial—which is undoubtedly an important and interesting event, but one unlikely to produce written decisions on which we would post—we return to Guenther for some rulings on motions in limine.  As we noted recently, pre-trial evidentiary rulings can seem, even at a quick glance, to be significant to the course of the coming trial and to involve recurring issues.  Others, like some photos of someone else’s kid that are sent with expectation of a positive response, clearly matter to the parties but are too fact-specific to matter to other cases.  The Guenther rulings are probably in the middle, yet unusual enough to draw our comment.

The plaintiff sought to preclude the defendant from offering two categories of evidence and argument relating to the drug’s benefit.  As with most in limine motions, the denial does not actually mean any evidence will end up being admitted at trial.  The proponent of the evidence will still need to weather potential form and foundation challenges, but may be most interested in getting to use the verbiage or make the arguments it wants during opening statement even if the actual evidence does not come in as hoped.Continue Reading For Whom The Benefit Rolls (Into Evidence)

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