When this blogger hears “negligent undertaking,” my mind does not automatically turn to products liability – but rather to pre-teen children. Pre-teen children are at the age where they are asked (actually required) to “undertake” more and more duties and responsibilities. But often these duties are undertaken in a rather haphazard or lackadaisical way that some might say rise to the level of negligence. Dishes with food left on them put back in the cabinet. Wet laundry left in the dryer for more than a day. And as for cleaning up after the dog, well enough said. And as one of the two arbiters of whether such pre-teens have failed to act in good faith, I admit to guilt in an expanding definition of what constitutes negligent undertaking. The New Jersey courts fortunately have stricter and more precise guidelines than mood and level of tolerance on any given day to guide them and those rules led them to dismiss plaintiff’s negligent undertaking claim in Nelson v. Biogen Inc., 2017 WL 1382910 (D.N.J. Apr. 17, 2017).

The product at issue is Tysabri, a drug used to treat multiple sclerosis. Patients who test positive for anti-JC Virus antibodies were shown to be at an increased for developing a certain brain infection with use of the drug. Id. at *1. Plaintiff contracted the infection after being treated with the drug for three years.

It is worth pointing out some of the procedural history here to understand that his was a bit of a hail-Mary by the plaintiffs. Plaintiff’s initial and first amended complaints contained a claim for negligence that was dismissed because in New Jersey the sole remedy for products liability is the New Jersey Product Liability Act (NJPLA). Id. at *2. All products liability claims, except express warranty, are subsumed by the Act. So plaintiff’s second amended complaint alleged design defect and failure to warn under the NJPLA. Defendants moved to dismiss the design defect claim as preempted and plaintiff withdrew the claim before the court could rule on the motion. Id.   Which left plaintiff with only a failure to warn claim in his third amended complaint. After two years of discovery, plaintiff moved to amend his complaint for a fourth time, this time to add a negligent undertaking claim.

The basis for the claim, argued plaintiff, was that defendants had entered into a licensing agreement with the NIH to allow defendants to use the NIH’s JC virus antibody assay to develop the assay for commercial use. The assay would allow doctors to test for the antibodies to determine if their patients were at an increased risk for the brain infection. Id. The licensing agreement was entered into in 2006 and defendants released their JC virus antibody assay in 2012. Plaintiff alleges that when defendants entered into the licensing agreement, they were voluntarily undertaking the duty to develop the assay and that they failed to do so in a reasonable and timely manner. Id. at *3.

First, the court held that this negligent claim, like the negligence claim in plaintiff’s original complaint, was preempted by the exclusivity of the NJPLA. Plaintiff argued that negligent undertaking was different than other negligence claims because it is not based on a pre-existing duty. Not only did plaintiff have no New Jersey or other authority for this argument, it is a distinction without merit. As the court pointed out, “the application of the NJPLA is not premised on the timing of the duties incurred.” Id. at *4. Further, most duties (unlike those in my household) are at some point voluntarily assumed. “For example, before Defendants decided to develop, market, and sell Tysabri, they had no duty to do so. Once Defendants voluntarily decided to produce Tysabri, they then had a duty to act with reasonable care in doing so.” Id. Negligent undertaking is precluded by the NJPLA.

Second, the court found it would be an unprecedented expansion of liability to use negligent undertaking to create third-party negligence obligations to non-parties to the license, or indeed to any contract.  Plaintiff cited no cases in which a party who agreed to a license was held liable for negligent undertaking. Id. at *5. Acknowledging significant policy concerns, the court suggested that the more appropriate way to address issues of the type raised by plaintiff would be to deal with them specifically in the contract. The NIH could have included a time limit by when defendants should have developed the assay or the license would be revoked. Id.

Further, plaintiff failed to allege an essential element of negligent undertaking – reliance. Id. at *6. Plaintiff alleged that his status as a third-party beneficiary to the license agreement satisfied the reliance requirement, but he cited no authority for that proposition. So, closely adhering to the Erie doctrine, the court concluded that “If the courts of New Jersey believe that such an extension is appropriate, then they are in a better position to expand their own common law in the first instance.” Id.

This means plaintiff is back to his third amended complaint – failure to warn only. And as we just reported last week, there is good precedent on the adequacy of the Tysabri warnings and on Wyeth v. Levine preemption. And precedent has much more bearing in the courtroom than in the laundry room – where when prior rulings are cited to the judges they can be summarily ignored with a simple – “that was then, and I’ve changed my mind.”

 

We aren’t going to mince words today. We don’t like Christiansen v. Wright Medical Technology Inc., MDL 2329, 2016 U.S. Dist. LEXIS 46409 (N.D. Ga. Apr. 5, 2016). It is an opinion on post-trial motions in a case that went to trial in the Conserve Hip Implant Products Liability Litigation. It’s a beautiful spring day here in the Mid-Atlantic and we hope that’s true where you are. If it is, and if anything in this post makes you interested in the greater details and nuances of the decision, we recommend taking it outside, sitting under a tree, and enjoying some fresh air. You should at least have pleasant surroundings while you try to get through it. It’s long, and tedious, and frankly, muddled. So, we are going to try to focus in on the key parts – so that we might also try to get out and enjoy some of this fine weather.

Christiansen is a hip implant case. It went to trial on 5 theories of liability: strict liability design defect, negligent design defect, fraudulent misrepresentation, fraudulent concealment, and negligent misrepresentation. Id. at *2-3. Apparently the court had dismissed plaintiff’s failure to warn claim on summary judgment. Id. at *69 n.18. The jury ultimately returned a verdict finding the hip implant was defectively designed and caused plaintiff’s injuries and awarded $550,000 in compensatory damages. The jury also found in favor of the defendant on the fraudulent misrepresentation and concealment claims, but awarded another $450,000 to plaintiff on his negligent misrepresentation claim and $10 million in punitives. Id. at *18.

But that wasn’t the jury’s first verdict. It’s first verdict, delivered days earlier, answered the first question on the Verdict Form – do you find the hip implant was defectively designed – in the negative. Id. at *6. While that should have been the end of the inquiry, the jury didn’t understand the instruction to not go any further and they kept answering the verdict form. So, they went on to find that defendant had made negligent misrepresentations and awarded plaintiff $662,500 in compensatory damages and $2.5 million in punitives. Id. at *7.

Continue Reading Georgia MDL Court Muddles Utah Law

Once upon a time there was a federal judge . . . . When we were little, we liked it when our mom spun free-form fairy tales for us.  We would contribute the object of the “was” (“Once upon a time there was a . . . bullfrog”), and she would make up the rest as she went along.  Which is fine for mommies, but less so for federal judges, as today’s (very short) case illustrates.

In Fay v. Depuy Orthopedics, Inc., et al, 2015 U.S. Dist. LEXIS 175344 (D.N.D. June 11, 2015), plaintiff’s hip was replaced with a metal-on-metal hip system.  The system consisted of various components, two of which were at issue:  the femoral head and the acetabular cup.  Both components come in various sizes, but, for the system to work correctly, matched sizes of the two components must be implanted in the patient.

In Fay, it was undisputed that Plaintiff received mismatched components and had to undergo revision surgery.  One of the defendants was a distributor that marketed and sold the system. Plaintiff’s surgeon testified that two specific sales reps employed by the distributor were always in the operating room when he implanted that particular hip system.  According to the surgeon (who was not sued), the reps were responsible, based on a process called “templating” of the patient’s x-rays, for placing an appropriate range of sizes of the two components on a table in the operating room before the surgeon arrived.  From the prepared template, the surgeon would determine what size acetabular cup would be implanted, and would ask for that size cup and the correspondingly-sized femoral head.   The sales reps were allegedly responsible for selecting the components from the implant table, verifying for both that they had pulled the size the surgeon requested, and handing the packaged components to the circulating nurse, who unpacked them and placed them in the sterile field.  In the absence of sales reps, the circulating nurse would be responsible for selecting the correct sizes of components.

Continue Reading Sales Reps Denied Summary Judgment in Artificial Hip Case Despite Absence of Legal Duty to the Plaintiff

Way back when – before Restatement (Second) of Torts §402A (1965) crystallized the concept of strict liability – courts around the country were poking around, trying to come up with viable theories of what we would now call “product liability.”  One method that gained some traction, prior to the advent of strict liability, was to strip contractual implied warranty of its historical requirement that the buyer and seller have been in “privity” (that is, that they dealt directly with each other).  New York was one of the states that started down that road.  In Goldberg v Kollsman Instrument Corp., 191 N.E.2d 81 (N.Y. 1963), the court held 4-3 that the manufacturer of a “thing of danger” (not otherwise defined, but in Goldberg, an airplane part that allegedly caused a crash) could be liable for breach of implied warranty without being in contractual privity with the plaintiff.  Id. at 83 (“at least where an article is of such a character that when used for the purpose for which it is made it is likely to be a source of danger to several or many people if not properly designed and fashioned, the manufacturer as well as the vendor is liable, for breach of law-implied warranties, to the persons  whose use is contemplated”).  This was problematic, because until §2-318 was amended in 1975, New York’s UCC hadn’t done away with privity in all personal injury cases.

But along came strict liability, and New York’s tentative steps down the road of privity-less implied warranty were largely forgotten.  Nobody paid much attention to warranty in the Empire State until the Court of Appeals held that strict liability and implied warranty were “not identical” in Denny v. Ford Motor Co., 662 N.E.2d 730, 739 (N.Y. 1995), in that strict liability utilized a risk/utility approach whereas implied warranty focused on consumer expectations.  Id. at 736.  While this distinction “may have little or no effect in most cases,” it can in some.  Id. at 738.

Continue Reading The Citadel Revisited – New York’s “Thing of Danger” Privity Exception Is Obsolete (and Another New York Note)

The Judge in the ObTape device litigation has allowed another manufacturing defect claim to go to trial with no direct evidence that the device implanted in the plaintiff had a manufacturing defect.  See In re Mentor Corp. ObTape Transobturator Sling Prods. Liability Litig., 2015 U.S. Dist. LEXIS 140263 (M.D. Ga. Oct. 15, 2015).  In denying the manufacturer’s motion for summary judgment, the court relied solely on a review conducted by plaintiff’s experts of sample ObTape devices—that is, devices other than the one implanted in the plaintiff.  The experts found that the pore sizes of those other samples were at times outside of the alleged manufacturing requirement of 40 to 100 microns.  Relying solely on this, the court rejected the manufacturer’s argument that plaintiff had not shown a manufacturing defect in the device implanted in her.  The court explained its reasoning, which from our point of view is less than convincing:

One way to prove a manufacturing defect is to test the specific subject product against manufacturing standards.  For example, in BIC Pen Corp., the parties tested the cigarette lighter that caused the plaintiff’s injuries.  346 S.W.3d at 540-41.  But Mentor [the manufacturer of ObTape] did not point the Court to any authority that such testing is the only way to establish a manufacturing defect under Texas law.  Here, Mrs. Sanborn relies on the same evidence as the Phase I Georgia Plaintiffs, whose specific ObTape was not tested, either.  Rather, their experts tested a number of ObTape samples and concluded that a substantial portion of each ObTape tested had pores smaller than 40 microns.  In re Mentor, 711 F. Supp. at 1376.  At this time, the Court remains satisfied that this evidence is sufficient to create a genuine fact dispute on Mrs. Sanborn’s manufacturing defect claim.  Mentor’s summary judgment motion on the manufacturing defect claim is thus denied.  The Court may reconsider this issue when ruling on any motion for judgment as a matter of law that may be presented at trial.

Id. at *8-9.

Continue Reading MDL Judge Allows Manufacturing Defect Claim to Go to Trial with No Direct Evidence of a Defect in the Device Actually Implanted in Plaintiff

It wasn’t a complete win, but the summary judgment outcome in Rheinfrank v. Abbott Laboratories, Inc., ___ F. Supp.3d ___, 2015 WL 4743056 (S.D. Ohio Aug. 10, 2015), has to put a spring in the step of the defendants as they approach trial.  What’s left doesn’t strike us as a very good warnings case.  Rheinfrank involved claims that the antiepileptic drug Depakote caused the minor plaintiff’s birth defects.  Make no mistake about it, Depakote has a known association with such injuries.  First approved in 1983, it’s been a Pregnancy Category D drug since 1988, meaning, according to FDA regulations, that:

there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but the potential benefits from the use of the drug in pregnant women may be acceptable despite its potential risks.

21 C.F.R. §201.57(c)(9)(i)(A)(4).  Not only that, since 2003, this drug has carried a black box “teratogenicity” warning, as well as other quite explicit, and all-caps, language to the same effect.  For details, see 2015 WL 4743056, at *2-3.

Plaintiff-mother had used Depakote for years, through four previous uneventful pregnancies.  Id. at *1.  On her fifth pregnancy, even though Depakote came with all these warnings, she continued to take it.  Id.  Her allegations did try to change the subject, however.  In addition to claiming that the black box warning (more about that later) and all the other teratogenicity language were inadequate, she asserted that the defendants failed to warn altogether about “developmental delay.”  Id. at *5.

Continue Reading Preemption (and Other Things) Defanging Depakote Claims

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

In the latest decision from the Pelvic Mesh MDL, the court ordered a consolidated trial of no fewer than thirty-seven plaintiffs with nothing in common save claiming injury from the same product.  See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op.  (S.D.W. Va. Aug. 4, 2015).  The consolidation is an attempt at a Rule 23(c)(4) single-issue class certification without the class action – since class actions are never certified anymore in personal injury prescription medical product litigation (as demonstrated here).  To reach the same procedural result, Mullins limits consolidation to defect/breach of duty and “general causation”:

[T]he consolidated trial will only involve . . . issues concerning the design of the [defendant’s mesh]  and whether that design was reasonably safe.  Determining reasonable safeness necessarily involves consideration of the [product’s] capability to cause injury.  As a result, causation will be relevant to the consolidated trial but only in the general sense. In other words, the pertinent issue will be whether the [product] can cause injury (general causation), not whether it did in fact cause injury to a particular plaintiff (specific causation).

Mullins, slip op. at 5 (citation omitted).

Continue Reading Further Deconstruction of the Law in Pelvic Mesh

Yes, we’re well aware of the latest development in the Pelvic Mesh MDL.  See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op. (S.D.W. Va. Aug. 4, 2015).  However, due to Reed Smith’s Pelvic Mesh representations, we’re constrained in what we can say.  We’ll just have to let prior, non-Mesh posts speak for us on Mullins.  We’ve already blogged on consolidation.  We’ve already blogged about Restatement (Second) of Torts §402A, comment k (1965).  We’ve also blogged about the appropriate application of Erie principlesMullins implicates all of these issues.  We’d like to say more, but our obligations to our clients must take precedence.

Since the inception of the blog we’ve taken interest in “flip side” lawsuits in which a plaintiff sues one of our manufacturer clients making allegations diametrically opposed to what we  usually see in product liability litigation – that, far from being injurious or “defective” − our client’s product is so valuable that the plaintiff can’t do without it, and is suing because of some threat to his/her supply of that product.

The first time we commented on such suits, the plaintiffs were suing the government, claiming a constitutional right to try investigational drugs.  We opposed that, knowing that, were such a right recognized, our clients would be the next targets of such constitutionally empowered plaintiffs, because our clients, not  the government, had the drugs in question.  The courts ultimately said “no,” see Abigail Alliance v. von Eschenbach, 495 F.3d 695 (D.C. Cir. 2007), but the lawsuits followed anyway.  Most of these cases involved desperately ill people grasping at investigational straws because there was no cure (or even reliable treatment) for their conditions (muscular dystrophy, multiple sclerosis, and similarly devastating and fatal conditions).  We summed this kind of litigation up recently in reviewing the first comprehensive law review article on the subject.

Continue Reading Still No Duty To Supply Drugs – In 22 States

While we are often critical of federal courts that reach out to make new state law, today we commend a far-away judge for bringing California’s learned intermediary doctrine law back to its basics.  The case is Sanchez v. Boston Scientific Corp., No. 2:12-cv-05762, 2014 U.S. Dist. LEXIS 114122 (S.D. W. Va. Aug. 18, 2014), which is one of many cases in the various pelvic mesh MDLs currently ongoing in West Virginia.  In Sanchez, the defendant surgical mesh manufacturer moved for summary judgment with mixed results, but we like the district court’s no-nonsense approach to the learned intermediary doctrine.  The district court also ruled on design defect, punitive damages, and preemption, which we will get to at the end.  For now, the focus is on our favorite topic, the LID.

The best part is the court’s rejection of the plaintiffs’ argument that the learned intermediary doctrine “does not apply when a plaintiff alleges that a manufacturer failed to adequately warn a plaintiff’s doctor of a device’s risks.”  Id. at *5.  This, of course, is a silly argument, but it is based on careless language in a number of cases applying multiple states’ laws, including California.  Some courts have said that the learned intermediary “does not apply” when the plaintiff alleges inadequate warnings, but they really mean that the defendant can be liable under the learned intermediary doctrine for an inadequate warning if all the elements of a failure-to-warn claims are established.

The district court in Sanchez was not fooled:

The learned intermediary rule is part and parcel of a failure-to-warn analysis in California. Under the learned intermediary rule, manufacturers of prescription drugs and medical devices satisfy their duty to warn if they provide adequate warnings to the prescribing physicians, rather than the patients.  A pharmaceutical manufacturer is not required to warn anybody other than prescribing physicians about the dangerous propensities of their prescription drugs and medical devices.  Period.

In order to satisfy the element of causation under the learned intermediary doctrine, a plaintiff must demonstrate that the prescribing physicians would have acted differently had he or she received adequate warnings.

Id. at *7 (Emphasis added, citations omitted).  The learned intermediary doctrine therefore regulates cases where the warnings allegedly were inadequate.  That is to say, it not only “applies,” it is the governing principle, which makes it a total non sequitur to say that it would not apply where plaintiffs alleged inadequate warnings.

For those for whom this point is not self-evident, the district court explained it this way:

To the extent that . . . cases suggest that the learned intermediary doctrine has no effect where plaintiffs allege that warnings are inadequate, I respectfully believe that these cases are incorrect. . . .  California holds that in the case of prescription drugs and medical devices, “the duty to warn runs to the physician, not to the patient.”

It does not withstand scrutiny to say that the learned intermediary doctrine suddenly becomes inapplicable when a plaintiff alleges that warnings are inadequate.  If the learned intermediary doctrine became inapplicable when a plaintiff alleged that warnings were inadequate, the doctrine would never operate in California.  Plaintiffs could simply plead around the doctrine by alleging inadequate warnings—which they must necessarily do to state a claim for failure to warn. . . .

Even where a plaintiff proves that warnings were inadequate, the learned intermediary doctrine still applies.  A plaintiff must prove that inadequate warnings altered the prescribing physician’s decision to prescribe.  Anything to the contrary would violate the California Supreme Court’s clear holding that “the duty to warn runs to the physician, not to the patient.”

Id. at **10-11 (citations omitted).  If you skipped over the long block quote, go back and read it because you’re going to want to use it the next time a plaintiff tries to argue that the learned intermediary doctrine “does not apply.”  It may be from a judge more than 2,000 miles from California, but this issue is not unique to the Golden State, and the judge’s analysis is darn persuasive.

The result was pretty good, too.  Because the treating physician did not rely on the defendant’s warnings in connection with one device, the district court granted summary judgment for lack of warnings causation in connection with that device.  Id. at **15-16.  With regard to a second device, the physician said that she reviewed the device’s instructions for use, but could not remember when.  It seems to us the defendant had a good motion, since it was plaintiff’s burden to prove that the physician reviewed the instructions before using the device to treat the plaintiff.  But the uncertainty as to timing resulted in an order denying summary judgment as to that device, leaving us to observe only that half a win is better than none.  Id. at *15.

The remainder of the court’s order provides mixed results as well, and we will keep it brief:

Design Defect:  The defendant moved for summary judgment on design defect under California law. Strict liability is easy because California law does not recognize strict liability for an allegedly defective design in prescription drugs and medical devices.  Summary judgment granted.  Id. at **16-17.  The result is different for negligent design.  Plaintiffs have been pursuing design defect under negligence theories in drug and medical device cases in California for quite some time, and while we vigorously resist, we sometimes lose that battle.  So did the defendant in Sanchez.  Id. at *17.

Punitive Damages:  The court’s order on punitive damages turned mainly on the choice of law.  The plaintiff was from California, and the defendant is based in Massachusetts.  Because the parties agreed that Massachusetts law prohibited an award of punitive damages, it is not difficult to guess which side urged which state’s law.  The district court applied California’s choice of law rules to find that California law would apply, and thus denied the defendant’s motion for summary judgment.  We have argued both side of this, depending on the applicable states’ laws and our clients’ interests.  This time, the state where the plaintiffs resided won out, which is not an uncommon result.  Id. at **19-29.

Preemption:  When we’re not writing on the learned intermediary doctrine, we can be found musing on the various forms of federal preemption.  The defendant in Sanchez raised two kinds—express preemption under the Medical Device Amendments and implied conflict preemption.  The court’s order on preemption could fill another blog post—and maybe it will someday.  For today, we will observe only that the surgical mesh at issue was not a premarket approved device.  The FDA cleared it for marketing under the 510(k) process, which makes preemption—especially express preemption—a really tough row to hoe.  The defendant in Sanchez found it to be no easier and lost this part of its motion.  There is history here, with the court observing that “I have repeatedly addressed preemption issues throughout this multidistrict litigation, and I have consistently found that federal preemption does not apply.”  Id. at *33.

With this mixed bag, we think the takeaway is on the learned intermediary doctrine, where the district court provided clear and useful analysis, if not all the results that the defendant wanted.