We’ve made no secret of our dislike of the so called “heeding presumption.” We have a tag on this subject with multiple posts decrying this presumption — that juries may presume that if an alternative adequate warning had been given, it would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber). That is essentially a shift of the burden of proof on warning causation from plaintiffs to defendants without any justification. Warnings are ignored all the time.

Our posts note that it is a fairly even split between jurisdictions rejecting and those adopting the heeding presumption. But we’ve taken special note of New York law on the issue because it is a bit muddled. In a post a couple of years ago we explained how a bad Second Circuit decision on the issue (Liriano v. Hobart Corp., 170 F.3d 264 (2d Cir. 1999)) overreached and ignored New York state court precedent spawning a line of cases which purport to recognize a general heeding presumption. At that time we predicted it would require a decision from the New York Court of Appeals to clean up the mess the federal and lower courts had made. We came close to such a decision last year in In re New York City Asbestos Litigation, 59 N.E.3d 458 (N.Y. 2016) (“NYC Asbestos”). Unfortunately, the court determined that the defendant had waived the issue of whether the heeding presumption existed in New York. But, in dicta, went on to say:

[Defendant’s] current complaint about the court’s instructions on the presumption is unpreserved. Of course, our rejection of [defendant’s] claim on preservation grounds should not be taken as an acceptance or rejection of the trial court’s heeding instructions on the merits, and regardless of the propriety of those instructions, trial courts must continue to ensure that their jury instructions honor the principle that the burden of proving proximate causation, which in a case like this one includes the burden of demonstrating that the injured party would have heeded warnings, falls squarely on plaintiffs.

Id. at 482 (emphasis added).

We are happy to report today that that dicta has not gone unnoticed in the drug and device context. Last week, a New York federal court ignored the line of cases from Liriano and instead cited NYC Asbestos and basic New York causation law to hold that New York doesn’t recognize a heeding presumption. The case is Adeghe v. Janssen Pharmaceuticals, 2017 WL 3741310 (S.D.N.Y. Aug. 30, 2017) and involves allegations that plaintiff developed gynecomastia as a result of his use of Risperdal. Id. at *1.  In addition to NYC Asbestos, the court relied on other cases for the general proposition that plaintiff bears the burden of proof that the alleged failure to warn was a proximate cause of his injury and that plaintiff’s burden “includes adducing proof that the user of a product would have read and heeded a warning had one been given.” Id. at *6.

The court provided a strong rationale for why the heeding presumption is not justified in drug/device cases:

Particularly in a case involving failure to warn of the risks of a pharmaceutical product, depending on the plaintiff’s condition and treatment alternatives, one may not reasonably assume that a patient or his treating physician will forego a drug because of disclosed risks.

 Id.

This is an important reminder about just what it means to apply a heeding presumption in a pharmaceutical case. The warnings at issue for drugs and devices are warnings about potential risks. Risks that the prescriber, the learned intermediary, needs to weigh against his knowledge of his patient, his patient’s medical condition, other available alternative treatments (and their risks), and his general medical knowledge. All of that cannot be swept under the rug with a presumption that an alternative warning would have tipped the scales toward non-prescription. Doctors prescribe drugs/devices everyday despite any number of risks inherent in their use.   At best a heeding presumption in a pharmaceutical case, if applied at all, should only go so far as to assume that the alternative warning would have been read by the prescriber. But, it is simply too huge a leap to presume the effect that new warning would have had on the prescribing decision given all the other variables.

In Adeghe, the court found no evidence (no prescriber testimony) that plaintiff wouldn’t have been prescribed Risperdal if a different warning had been given. Id. at *7. Moreover, plaintiff did not adduce any evidence that when the risks of the drug were balanced against its benefits, it would not have been prescribed. Id. “Plaintiff cannot rely on mere speculation as to this medical determination to defeat summary judgment.” Id. Kudos to the court for distinguishing prescription drugs and devices from household consumer goods.

Summary judgment was granted on plaintiff’s failure to warn claim (and on express warranty for lack of any affirmation, id. at *5), but several other causes of action remain because summary judgment was denied on medical causation. The court found plaintiff’s expert had done enough, reviewed studies and considered and addressed alternative causes, to survive a Daubert challenge. Certainly not the worst expert we’ve seen and hardly as important as the heeding presumption decision both for its help in further clarifying New York law and in its acknowledgement of why the presumption has no place in prescription drug and device cases.

Devoted as we are to the defense of manufacturers of prescription drugs and medical devices, we have often advocated for the full implication of the fundamental—to us, at least—requirements that warnings claims focus on the decision making of the learned intermediary and that proximate cause matters.  One implication is that heeding presumptions typically make little sense for claims about these products.  It is one thing to say that a plaintiff should be allowed to proceed with a warnings claim when a prescriber is truly unavailable to provide testimony—like by dying before the plaintiff knew he had a claim—and the alleged missing warning would have clearly contraindicated the plaintiff from receiving the prescription product.  In such a case, it might make sense to presume, absent contrary evidence, that the physician would have heeded the warning and not prescribed the product to the plaintiff.  In just about every other prescription drug and device case we can imagine, the heeding presumption does not make sense.

We feel the same way about a post-sale duty to warn.  Not only do such duties run contrary to the typical focus in warnings cases on the notice to the manufacturer of potential risks before the product leaves its control (or is prescribed to plaintiff), but the proximate cause inquiry can quickly become an exercise in layered speculation.  Cases acknowledging such a post-sale duty have typically involved situations where the seller had a continuing relationship with the purchaser, with an obvious route for relaying additional information about the product in a way that allows a jury to evaluate whether injury would have been avoided.  In prescription drug and device cases, there tends not to be any direct relationship at any time and the manufacturer does not know the names or addresses of patients using its products.  Over time, patients move, change their physicians, and even see physicians for reasons unrelated to the reason they were prescribed a drug or device in the past.  Over time, manufacturers also stop selling specific products or product lines and may even go out of business.  When it comes to drugs with alleged remote effects or devices that are implanted for many years, these real world considerations make potentially unlimited post-sale duties to warn a folly.  We could go on, but we will not.

Continue Reading Heeding Presumption Only Goes So Far In Post-Sale Warning Case

The recent decision of the New York Court of Appeals in In re New York City Asbestos Litigation, ___ N.E.3d ___, 2016 WL 3495191 (N.Y. June 28, 2016) (“NYCAL”), was not too good for asbestos defendants – as it permitted, under certain circumstances, non-manufacturers to be sued for failure to warn of a risk that the product they manufactured didn’t have (exposure to asbestos), where they “encourage[ed]” the use of products containing that risk with their products and thereby benefitted economically:

[A] manufacturer’s duty to warn of combined use of its product with another product depends in part on whether the manufacturer’s product can function without the other product, as it would be unfair to allow a manufacturer to avoid the minimal cost of including a warning about the perils of the joint use of the products when the manufacturer knows that the combined use is both necessary and dangerous. And, the justification for a duty to warn becomes particularly strong if the manufacturer intends that customers engage in the hazardous combined use of the products at issue.

*          *          *          *

[W]here a manufacturer creates a product that cannot be used without another product as a result of the design of the product, the mechanics of the product or the absence of economically feasible alternative means of enabling the product to function as intended, the manufacturer has a substantial, albeit indirect, role in placing the third-party product in the stream of commerce. . . .  Specifically, when the manufacturer produces a product that requires another product to function, the manufacturer naturally opens up a profitable market for that essential component, thereby encouraging the other company to make that related product and place it in the stream of commerce.

NYCAL, 2016 WL 3495191, at *__ (for some reason there is no Westlaw star paging at the moment).  This opinion is very bad news for the affected companies, who are now sucked into the maw of interminable asbestos litigation on the basis of products they didn’t even make, but it should not open the door to innovator liability type claims against our medical product manufacturer clients, and it’s good on causation, too.

Here’s why.

Continue Reading New York Decision Not Good For Asbestos, But Not Bad For Drug/Device

Ever since this blog started, we’ve made plain that we have no use for the so-called “heeding presumption.”  This presumption posits that, because under Restatement §402A, comment j, a defendant providing an adequate warning can presume it will be heeded, a plaintiff should also be able to presume that an adequate warning, had it been granted, would have been heeded.  That’s false equivalence if we’ve ever seen it.  A defendant to such a warning claim needs no heeding presumption, since it wins on adequacy without ever getting to causation.  The comment j discussion really involves design defects (about which more below).  Plaintiffs, on the other hand, are getting a burden of proof shift on warning causation that simply has no basis in reality.  People disregard adequate warnings all the time.

So we fight the heeding presumption whenever it comes up.  Some states have good law on the issue.  N.C. G.S.A. §99B-5(a); Wis. Stat. §895.047(1)(e); Ford Motor Co. v. Boomer, 736 S.E.2d 724, 733 (Va. 2013); Rivera v. Philip Morris, Inc., 209 P.3d 271, 274 (Nev. 2009); Leaf v. Goodyear Tire & Rubber Co., 590 N.W.2d 525, 528-29 (Iowa 1999); Riley v. American Honda Motor Co., 856 P.2d 196, 199-200 (Mont. 1993); Deere & Co. v. Grose, 586 So. 2d 196, 198 (Ala. 1991); Huitt v. Southern California Gas Co., 116 Cal. Rptr.3d 453, 467-68 (Cal. App. 2010); Harris v. International Truck & Engine Corp., 912 So. 2d 1101, 1109 (Miss. App. 2005); McPike v. Enciso’s Cocina Mejicana, Inc., 762 P.2d 315, 319 (Or. App. 1988); DeJesus v. Craftsman Machinery Co., 548 A.2d 736 (Conn. App. 1988); Muilenberg v. Upjohn Co., 320 N.W.2d 358, 366 (Mich. App. 1982); Potthoff v. Alms, 583 P.2d 309, 311 (Colo. App. 1978); Payne v. Novartis Pharmaceuticals Corp., 767 F.3d 526 (6th Cir. 2014) (applying Tennessee law); Tuttle v. Lorillard Tobacco Co., 377 F.3d 917, 925 (8th Cir. 2004) (applying Minnesota law); Wilson v. Bradlees of New England, Inc., 250 F.3d 10 (1st Cir. 2001) (applying New Hampshire law); Christopher v. Cutter Laboratories, 53 F.3d 1184, 1192-93 (11th Cir. 1995) (applying Florida law); Odom v. G.D. Searle & Co., 979 F.2d 1001, 1003 (4th Cir. 1992) (applying South Carolina law); Muzichuck v. Forest Laboratories, Inc., 2015 WL 235226, at *13 (N.D.W. Va. Jan. 16, 2015); Luttrell v. Novartis Pharmaceuticals Corp., 894 F. Supp.2d 1324, 1345 n.16 (E.D. Wash. 2012).

Almost as many states are adverse.  House v. Armour, Inc., 929 P.2d 340, 347 (Utah 1996); Coffman v. Keene Corp., 628 A.2d 710, 717-19 (N.J. 1993); Eagle-Picher Industries, Inc. v. Balbos, 604 A.2d 445, 468-69 (Md. 1992); Bushong v. Garman Co., 843 S.W.2d 807, 811 (Ark. 1992); Arnold v. Ingersoll-Rand Co., 834 S.W.2d 192, 194 (Mo. 1992); Butz v. Werner, 438 N.W.2d 509, 517 (N.D. 1989); Harlow v. Chin, 545 N.E.2d 602, 606 (Mass. 1989); Bloxom v. Bloxom, 512 So.2d 839, 850 (La. 1987); Payne v. Soft Sheen Products, Inc., 486 A.2d 712, 725 (D.C. 1985); Wooderson v. Ortho Pharmaceutical Corp., 681 P.2d 1038, 1057-58 (Kan. 1984); Seley v. G.D. Searle Co., 423 N.E.2d 831, 838 (Ohio 1981); Menard v. Newhall, 373 A.2d 505, 506 (Vt. 1977); Cunningham v. Charles Pfizer & Co., 532 P.2d 1377, 1382 (Okla. 1974); Dole Food Co. v. North Carolina Foam Industries, Inc., 935 P.2d 876, 883 (Ariz. App. 1996); Ortho Pharmaceutical Corp. v. Chapman, 388 N.E.2d 541, 555 (Ind. App. 1979).

Continue Reading Heedless Heeding Presumptions – How New York Law Became a Morass

We are pleased to have left the bullpen and joined the starting rotation of contributors to this blog. We will strive for the relevance and style our colleagues’ posts consistently display.

We adopted a Drug and Device Rescue Cat this week.  Her housemates, two Drug and Device Rescue Dogs, are poodle mixes, so we haven’t dealt with the issue of shedding since we last had cats, years ago.   We have discovered a nifty tool that claims to dramatically reduce the hair deposited on furniture and clothing, reminding us of our fondness for anything that strips away the clutter of useless underbrush and leaves only what is neat and firmly rooted.   And that is the (admittedly tenuous) segue to today’s case, in which the United States District Court for the Northern District of West Virginia bushwhacks through plaintiff’s detritus to arrive at a solid holding and a (mostly) tidy opinion.

In Muzichuck v. Forest Laboratories, Inc., No. 1:07-CV-16, 2015 U.S. Dist. LEXIS 5440 (N.D.W.Va. Jan. 16, 2015), the Court considered defendant’s Motion for Summary Judgment in a Lexapro suicide case.   Plaintiff, who opted out of the global Lexapro settlement, alleged that defendants, Forest Laboratories, Inc. and Forest Pharmaceuticals, Inc. (“Forest”) failed to warn her decedent-husband and his prescribing physicians of the risk of suicide associated with the antidepressant Lexapro.

Continue Reading Opt-out Out of Court: Northern District of West Virginia Dispatches Lexapro Warnings Case

We’ve made no secret of our distaste for the so called “heeding presumption” – that juries may presume that any alternative “adequate” warning would have been heeded by the plaintiff (or, in prescription medical product cases, the prescriber).  We have a topic header on this subject with multiple posts decrying such presumptions, both generally and in the particular context of prescription medical products.

The biggest conceptual problem is that there are two fundamentally different kinds of warnings.  Most warnings concern a product’s use – that if you use (or don’t use) the product in a certain way, you are likely to get hurt; and if you follow the warning, you won’t.  Examples are not driving a riding lawnmower parallel to a slope (because you’ll tip over) or only handling asbestos while using a respirator (because breathing asbestos can do nasty things to you).  Most step-by-step directions also fall in this category.

While so-called “use” warnings occasionally arise as to prescription medical products – overdose instructions come to mind – that type of warning is not what most litigation involving these products is about.  Rather, with prescription-only products, most of the relevant risks arise whenever the product is used.  A warning about an inherent risk – a so-called “risk warning” – serves an entirely different purpose.

With inherent risks, people are warned so they can decide whether that risk outweighs the benefits that might be gained from using the product.  The only way to avoid the risk is not to use the product at all.  All prescription medical products have inherent risks – which is why the FDA requires a physician’s prescription in the first place.  For a case discussing the distinctions between these two types of warnings in detail, read Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 814 (5th Cir. 1992) (applying Mississippi law), which you can find later in this post.

Continue Reading Who Heeds The Heeding Presumption?

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.

We like juries. Jurors give us their time and attention, sometimes for weeks or months at a time, and they receive little or nothing in terms of tangible benefit in return. The vast majority take the task seriously and give us their best on topics that are at once human and very complex. We sometimes embrace their results, and sometimes we appeal from them or move to set them aside, but either way we respect the process without reservation.

Not every issue, however, is best left to juror discretion, and juries require guidance, mainly in the form of instructions on the law and rulings on the evidence. The former provides a proper legal referent against which to render a verdict. The latter regulates the information they receive so they consider material that is relevant and helpful, and not information that is misleading, improper, or tends to show nothing of consequence to the issues in the case. And the court should provide a necessary check against jury discretion with its power to decide issues as a matter of law and grant new trials.

Juries operating outside these parameters might not come to fair results, through no fault of their own, and we think that is what went wrong in Cox v. KLS Martin, L.P., 2013 U.S. Dist. LEXIS 114708 (W.D. Mo. Aug. 14, 2013). As with many bloggable cases, the facts provoke sympathy. Cox involved an implanted medical device known as a mechanical intraoral distracter, which was used as intended to treat Pierre Robins Sequence, a rare disorder in which an infant’s lower jaw is underdeveloped. As the court described it, mandibular distraction involves cutting through bones on both sides of the patient’s mandible behind the molars and securing a mechanical intraoral distraction device to both sides of each cut. By then turning an activation mechanism, each distractor slowly separates the bone sections, allowing the formation of new bone. Id. at *1-*2.

Continue Reading Shared Too Much: Missouri Court Gives Jury Too Much Leeway

Another remanded Aredia/Zometa case has apparently bitten the dust.  See Ingram v. Novartis Pharmaceuticals Corp., No Civ-05-913-L, slip op. (W.D. Okla. July 18, 2012).  Ingram threw out all of the plaintiff’s on warning causation grounds, a strong defense in this litigation, which involves a drug used to treat cancer.  A basic problem that plaintiffs face in such situations is that, when the alternative is likely death by cancer, most prescribing oncologists aren’t going to be swayed by the possibility of a much lesser injury (with bisphosphonates, osteonecrosis of the jaw).  So an allegedly defective warning about the lesser injury won’t deter anything.

The law, in Oklahoma as elsewhere, requires warning causation – some material change in prescriber conduct:
Slip op. at 6.

Even if the plaintiff establishes a duty to warn and a breach of that duty, she must further establish proximate causation by showing that had defendant issued a proper warning to the learned intermediary, he would have altered his behavior and the injury would have been avoided.

Slip op. at 4. Oklahoma is one of those unfortunate jurisdictions that applies a heeding presumption even in pharmaceutical cases, but for the reasons we discussed above, it was easily rebutted in Ingram.

[The prescriber] testified that had he known of [the drug’s] potential complication of osteonecrosis of the jaw, he would have prescribed it for [plaintiff’s decedent] anyway.  This testimony establishes that although the prescribing physician . . . would have read and heeded the warnings regarding [the drug] and ONJ, this would not have changed [the prescriber’s] decision to prescribe it to [the decedent].

As is also common in these cases, plaintiff tried to salvage the case with lesser causation evidence – that the prescriber, while still using the drug, now gives various advice about dental issues.  Slip op. at 6-7.  That didn’t work in Ingram because even the plaintiff’s own expert (a Dr. Marx – is that Harpo, Groucho, Chico, or Zeppo?) admitted that the decedent already had ONJ. Slip op. at 8:

When this finding [pre-existing ONJ] is kept in mind, it is clear that plaintiff’s arguments regarding [the prescriber’s] changed prescribing practices are insufficient to discharge her burden of proof on proximate causation.  As demonstrated above, [the prescriber] has unequivocally testified that had he known in January of 1999 that [the drug] had the potential complication of ONJ, he would have prescribed it for [the decedent] anyway.

Slip op. at 8.

The court also throws out plaintiff’s wrongful death claim, because it wasn’t supported by any expert testimony.  We’ve commented previously about the weakness of many of the cases we’re seeing after remand from the A/Z MDL, and judging by the expert testimony here, Ingram looks like another.

In any event put another one in the “W” column for the Hollingsworth Aredia team.

Every now and then there’s a piece of litigation that boldly goes where no court has gone before and opens up a host of new legal issues.  Bone Screw was like that, with plaintiffs inventing new causes of action (fraud on the FDA and regulatory informed consent) and our side having to invent new defenses.  We also felt that way while we were involved in the Fagan v. AmerisourceBergen litigation involving the then novel concept of liability of non-counterfeiters for injuries caused by counterfeit drugs.

We’ve just seen another opinion, Kapps v. Biosense Webster, Inc., ___ F. Supp.2d ___, 2011 WL 4470701, slip op. (D. Minn. Sept. 27, 2011), that makes us feel the same way.  We can’t recall ever seeing an opinion previously that addressing liability issues in the context of a reprocessed medical device that allegedly failed due to defects introduced by the reprocessing.

Kapps involves something analogous to the aftermarket for automobile parts, only in the medical device field.  The product, a heart catheter, was originally manufactured as a single-use product – expressly stated in the product’s original labeling.  2011 WL 4470701, at *3.  Apparently the FDA has chosen not only to tolerate, but to affirmatively allow the particular type of off-label use:  the reprocessing and reuse of products whose labeling is limited to single use.  Id. at *5-6 (describing FDA regulation of reprocessing/reuse of single-use devices).  After being completely relabeled and refurbished according to relevant FDA regulations, the heart catheter was reused and broke inside the plaintiff’s heart.  Id. (refurbishing changed the device’s serial number, and replaced its labeling with its own).  Plaintiff sued both the aftermarket and original equipment manufacturers.

The 68-page Kapps opinion raises, and in some cases decides for the first time, many fascinating issues.

Continue Reading Twice Nice?