When we were on a jury last month we were warned not to consult any outside sources.  And we didn’t.  When we were in high school last century and studied the works of Eliot, Lawrence, Joyce, Waugh, and (another) Eliot, we were instructed not to consider extraneous issues, such as biography or social conditions.  Our teachers were still in the grip of the New Criticism and, therefore, so were we. 

 

But we found today’s case, Lynch v. State, 2018 Conn. Super. LEXIS 851 (Conn. Superior Ct. April 17, 2018), tough sledding without doing some research beyond the four corners of the opinion.  The case is about a plaintiff who was inseminated by a sperm bank donor, came down with a cytomegalovirus (CMV), and gave birth to children with serious injuries.   What we learned courtesy of the internet is that CMV is fairly common and usually doesn’t cause terrible maladies.  The problem is that if a CMV-negative woman gets infected with CMV during pregnancy, there is a possibility of birth defects.  That is what happened here.  The plaintiff had been CMV negative.  That is something she knew and her doctor knew, but the sperm bank did not know it.  The sperm donor tested as CMV-positive, though he no longer actively suffered from CMV.  The sperm bank accurately disclosed the CMV-positive status of the sperm.  What the sperm bank did not do was tell the plaintiff that if she was CMV-negative, then CMV-positive sperm could pose a risk.  But, presumably, the plaintiff’s doctor would know that.  We know it from reading a Wikipedia article.  We never attended medical school, not even for ten seconds.  Call us a semi-learned, blogging defense hack.

 

The sperm bank moved for summary judgment, arguing that it did not owe the plaintiff a duty of care because a sperm bank does not have a duty to inquire into its clients’ CMV status, nor is it obligated to engage in an informed consent discussion with clients regarding the clients’ CMV status.  The Connecticut court agreed with the sperm bank and dismissed the case.  How is this a drug or device case?  It isn’t, but the scope of duty to warn and the relevance of the learned intermediary doctrine both poke their way into this case, and that is enough for us to stand up and take notice.    

 

Pursuant to the regulations, sperm banks are required to test their donors for certain diseases, including CMV. But the regulations do not impose on sperm banks an obligation to discuss the implication of the tests they run with the purchasers.  The evidence here showed that the sperm bank fulfilled its obligation to test for the sperm donor’s CMV status and to report the results accurately.  The results indicated that the donor was fully recovered and immunized from the virus, and that he was not actively infected with CMV at the time of the donation. Due to these test results, the defendants reported that the donor was CMV-positive.  The evidence did not show any knowledge on the part of the sperm bank that the plaintiff was CMV-negative.  The only duty the sperm bank had to the plaintiff was to conduct the required testing on the donor and to report the results of the tests, which it did.

 

The Connecticut court analogized to the duties that a pharmacy owes to its customers.  A previous Connecticut court applied the learned intermediary doctrine to pharmacists. Yay for the Nutmeg State. The court held that imposing a general duty on pharmacies and pharmacists to investigate and evaluate all of the medications that their customers’ physicians prescribed would impose a burden outside the scope of their normal duties, as the main job of pharmacists is to dispense the medications that their customers’ physicians prescribe. The learned intermediary doctrine makes sense in the pharmacist context given the fact that physicians have more knowledge than pharmacists about their patients’ needs and proclivities. Holding otherwise would put pharmacists between the physician-patient relationship.  The sperm bank is like a pharmacist.  (That’s a sentence we never thought we would write, but there it is.) The plaintiff’s doctor testified that he would typically advise CMV-negative patients to choose CMV-negative sperm. (The opinion does not make clear why that did not happen here.)  The court reasoned that holding that the sperm bank “had a duty to inform the plaintiff parents about the risks that CMV posed would also put the sperm bank in the middle of the physician-patient relationship.” 

 

Most of the Lynch opinion contains a discussion of the scope of duty.  There is a lot about foreseeability. (It throws us back to first year in law school, when we sat in the last row, next to the guy who always added to the seating chart a space for “Garth, the Most Savage Troll of All.”  Only one teacher ever had the temerity to call upon Garth.)  Even beyond foreseeability, the court asked whether the sperm bank might have assumed a duty to the plaintiff because either its failure to exercise care increased the risk of harm or the harm was suffered because of the plaintiff’s reliance upon the defendant’s undertaking. No and no.  First, the information that the sperm bank made available on its website about sperm CMV status did not appear to increase the risk of the type of harm that the plaintiff allegedly suffered. Although the website did arguably give some medical advice by saying that the risk of acquiring CMV from donor sperm is low, the website also informed its customers that this is a medical issue that clients should discuss with their physician. This language “clearly suggests that the sperm bank’s customers should not rely on the information provided on the website and that they should ask their physicians about CMV.”  Back to the learned intermediary.  Second, there is no evidence that the plaintiff relied on this information when selecting the donor’s sperm. The plaintiff testified that she did not discuss her or her donor’s CMV status with any representative from the defendant sperm bank, and there is no indication that she saw the page on the website that allegedly created a duty.  The Lynch court went back to the pharmacy example.  It is possible for a pharmacy or pharmacist to assume a duty when they have “specific knowledge of potential harm to specific persons in particular cases.”  But here, “this exception is not applicable because the defendant sperm bank had no knowledge of the plaintiff mother’s CMV status.” 

 

Applicable federal regulations did not help the plaintiff’s case.  Test results will show that a donor is CMV-positive even if the donor had contracted and then subsequently recovered from the virus. FDA regulations provide that a sperm donor who is actively infected with CMV is ineligible to donate. Here, the sperm bank tested the donor and determined that he was CMV-positive, but that he had fully recovered from the virus and was not actively infected with it at the time of his donation.  There was no violation of the regulations.

 

Finally, there was the usual argument from a plaintiff that summary judgment should be denied until discovery is complete.  But a party requesting more time to conduct discovery bears the burden of establishing a valid reason why the motion should be denied, including some indication as to what steps the party has taken to secure facts necessary to defeat the motion. That burden was not met here.  Thus, the court granted the defendant summary judgment.

This guest post is by Reed Smith associate Lora Spencer, who (as you might suspect) calls Texas her home.  In her first rodeo on the blog, she discusses a recent MDL decision that she thinks is a few pickles short of a barrel, and hopes it’s not a harbinger of things to come.  Not exactly a conniption fit, but close.  As always our guest posters deserve 100% of the credit (and any blame) for what they write.

**********

“Everything is bigger in Texas”—or is it? The plaintiffs in Aron v. Bristol-Myers Squibb, 2018 U.S. Dist. LEXIS 39146 (S.D.N.Y. Mar. 9, 2018), would have y’all believe that pharmaceutical manufacturer tort liability, at least, is bigger in Texas.  But, first, before getting to this “Texas Expansion,” here are some interesting “reported” facts about Texas.  Pay attention, there may be a pop quiz, if not now, perhaps at your next networking event.  Knowing such factoids will surely make your “lone star” shine brightly.

Texas is a really BIG state. Texas is ranked 2nd in the country in population and size.  Texas’s total area is twice the size of Germany (albeit half the size of Alaska).  Of 45 United States presidents – three of them hail from Texas—all of them since 1963, hence the slogan “read my lips, no new Texans.”  King Ranch, located in south Texas, is considered “the birthplace of Texas ranching” and is larger than Rhode Island.  Texas also has the most rattlesnakes of any state.  And the weight of the catfish consumed by Texans each year exceeds that of the Paris Eiffel Tower (at least the one in Texas).  “Texas is just too big,” said no Texan ever.  Apparently Aron takes the same view.

Aron purported to apply Texas law in what appears to be the first reported opinion from the Farxiga MDL.  Maybe future opinions will be better.  Aron denied the defendants’ motion to dismiss plaintiffs’ amended complaints under Rule 12(b)(6).  Id. at *9.  Farxiga has only one labeled indication—lowering blood glucose in adults with type 2 diabetes.  Id.  Because everything is bigger in Texas, so is the complaint, which included three Texas plaintiffs with no business being joined in the same complaint.  Getting a free pass on misjoinder, these three plaintiffs brought “causes of action claims, under Texas law, based on the defendants’ failure to warn of [drug] risks …, negligent testing, and gross negligence.” Id. *16.

Failure to Warn

The most important thing about Texas product liability law is that most of it is now statutory.  Under Texas law, in a products liability suit, a statutory presumption precludes a defendant drug manufacturer from being liable for failure to warn claims if its warnings were approved by the Food and Drug Administration (FDA).  Texas Civ. Prac. & Rem. Code Ann. § 82.007.  However, a plaintiff may rebut this presumption by establishing one or more of five statutory exceptions.  Id. at (b)(1-5).

In Aron, the relevant exceptions were § 82.007 (b)(1) and (3).  2018 U.S. Dist. LEXIS 39146, at *17.  Section (b)(1) allows a plaintiff to rebut the presumption by proving fraud on the FDA—that “the defendant, before or after pre-market approval … withheld from or misrepresented to the [FDA] required information that was material and relevant to the performance of the product and causally related to the claimant’s injury.”  Civ. Prac. & Rem. § 82.007(b)(1).  Section (b)(3) avoids the presumption if the plaintiff can show off-label promotion – that “the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the [FDA], the product was used as recommended, promoted or advertised; and the claimant’s injury was causally related to the recommended, promoted, or advertised use of the product.”  Id. at (b)(3).

As regular blog readers know, a claim predicated on fraud on the FDA should be preempted. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Unsurprisingly, the defendants argued the FDA fraud exception is preempted by federal law. Aron, 2018 U.S. Dist. LEXIS 39146, at *20.  The court noted conflicting Fifth and Second Circuit decisions concerning § 82.007(b)(1) and a similar Michigan statute. Compare Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (applying Texas law) (discussed here), with Desiano v. Warner Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006) (applying Michigan law), aff’d by equally divided court, 552 U.S. 440 (2008).  However, because the plaintiffs did not plead the fraud exception with “sufficient particularity,” Aron did not decide the preemption issue.  Id. at *21.  Given the other rulings in Aron, its punting on preemption is probably just as well.  In true Texas fashion, Hi-Yo Silver away!  The plaintiffs failed to rebut the presumption using §82.007 (b)(1). Id.

However, fraud on the FDA is only one of § 82.007’s five exceptions.  Properly raising any one of them will get a plaintiff past a presumption-based motion to dismiss.  Id. at *17.  Plaintiffs got away with pleading the “off-label” marketing exception, under § 82.007 (b)(3). Id. at *20.  Plaintiffs alleged:  (i) defendants promoted Farxiga to prescribing physicians for off-label uses, specifically obesity and hypertension, (ii) such off-label promotion caused the physician to prescribe Farxiga for off-label use, (iii) plaintiffs used Farxiga for off-label purposes, and (iv) off-label use caused the plaintiffs injuries.  Id. at *20-22.  Plaintiffs cited press releases, advertisements, and clinical trial protocols to support their claim that off-label marketing occurred.  Id.  However, Aron failed to discuss the pleading of causation  Not one of the various off-label statements was linked to any particular prescriber, let alone to a prescription that caused these plaintiffs’ injuries.  Never mind that physicians may, and often do, prescribe drugs for unapproved uses as part of their practice of medicine.  Aron let the plaintiffs slide on causation.  All hat and no cattle.

Negligent Testing

Aron also allowed the plaintiffs’ negligent failure to test claim to stand.  2018 U.S. Dist. LEXIS 39146, at *22.  The plaintiffs alleged the defendants negligently failed to test Farxiga thoroughly before releasing the drug into the market, failed to analyze pre-market test results, and failed to conduct sufficient post market testing and surveillance.”  Id. at *23.  Defendants argued the plaintiffs’ negligent testing claim is “inextricably intertwined” with the plaintiffs’ failure to warn claim and is inadequately pleaded. Id. The Fifth Circuit, applying Texas law, has so held—twice.  “[A] negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn.” Dow Agrosciences LLC v. Bates, 332 F.3d 323, 333 (5th Cir. 2003) (applying Texas law), reversed on other grounds, 544 U.S. 431 (2005) (preemption).  Plaintiff’s “negligence claims, such as the alleged failure to adequately test [the product], are subsumed within” a failure to warn claim. Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 n.5 (5th Cir. 1992) (applying Texas law).

Even though Fifth Circuit law should have controlled on this point of state law, Aron chose to follow cases that it asserted recognized “an independent cause of action based on negligent failure to test.”  Id. at *22-23.  The most significant of the three, Am. Tobacco Co. v. Grinnell, 951 S.W. 2d 420 (Tex. 1997), certainly did not.  Rather, the Texas Supreme Court’s holding was quite the opposite:

[Plaintiff’s] negligent testing claim is predicated on [defendants’] duty to test and ascertain the dangers inherent in its products about which it must warn consumers.  Because the negligent testing claim is inextricably intertwined with the [plaintiffs’] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437.  “Inextricably intertwined” is about as far from “an independent cause of action” as you can get.  Of the other two cases, Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Texas 2012), is notorious for improperly construing Texas law.  The other, Romero v. Wyeth Pharmaceuticals, Inc., 2012 WL 12547449, at *4 (E.D. Tex. Aug. 31, 2012), essentially followed Murthy. Aron is another instance of improper federal court judicial activism attempting to push state (Texas) law where no state court has ever gone.

Gross Negligence

Apparently, in Texas, it is not enough just to plead negligent testing. The plaintiffs also pled gross negligence.  2018 U.S. Dist. LEXIS 39146, at *24.  The defendants argued that “[i]t is merely a restatement of plaintiff’s deficient negligence count.” Id.  However, Aron looked to the elements of gross negligence, and held the plaintiffs sufficiently pled facts to support an inference of gross negligence.  Id. at *25.  Those facts oddly included a September 2013 “post market” study.  Id. at *26.  Supposedly, the defendants “terminated” that study in “2013 without posting any results.”  Id. at *9.  However, the FDA did not approve Farxiga until January 8, 2014. Id. at *9.  That does not sound like gross negligence, but rather a preempted fraud on the FDA claim.  Whether or not anything was “posted,” the alleged study termination occurred before the FDA’s approval of this product, so the only reporting duty was imposed by federal law—not Texas law—and it ran to the FDA.  Any public “posting” of product-related information before FDA approval would illegally promote an unapproved product, which almost certainly explains lack of any such post.

With Aron, the Farxiga MDL is not exactly off to a good start.  Will this be another instance of MDL abuse in the making?  Saddle up, and get ready for a wild ride, the prominent phrase “Everything is BIGGER in Texas” is unfortunately reflected in Aron’s approach to product liability.

Prescription drug manufacturers are not insurers of injuries sustained while taking their products. Even in the most plaintiff-friendly jurisdictions, there needs to be some fault—whether framed in negligence, strict liability, or something else—and causation between the fault and the injury. It is surely not easy to stomach for someone who sustains such an injury while taking a drug, but sometimes there is no fault even if there is a significant injury related to the use of the drug. If the drug’s manufacturer warned about the risk of plaintiff’s ultimate injury consistent with the available evidence, which it examined and shared with FDA appropriately in connection with approval and after approval, and the prescribing physician(s) gave due consideration to the risk in treating the patient, then the manufacturer did what it was supposed to do and the patient might suppress the urge to sue someone. Often, of course, such patients become plaintiffs and courts are faced with deciding summary judgment in cases with a real injury, related in some way to the use of the drug, but no real claim against the manufacturer. In those situations, the courts often get it wrong and allow some claim to get past summary judgment. Nelson v. Biogen Idec, No. 12-7317 (JMV) (MF), 2018 WL 1960441 (D.N.J. Apr. 25, 2018), got it right. Joe Blute and Yalonda Howze of Mintz Levin, who defended the case and told us about it, deserve some credit for that.

The facts of Nelson do not exactly scream failure to warn, even with the severity of the injury claimed by the plaintiff, who received Tysabri, a prescription medication for his multiple sclerosis. He claimed to have developed progressive multifocal leukoencephalopathy (“PML”), a condition about which the drug’s labeling contained black box warning, multiple other warnings in physician labeling, and warnings in a medication guide that the drug’s Risk Evaluation and Management Strategy (“REMS”) program required the patient acknowledge when receiving the drug through infusion provided by a healthcare provider. With such extensive warnings also comes the expected developed record of interacting with FDA about PML, which we will attempt to summarize. The medication was approved in 2004, but withdrawn because of PML cases the next year. PML results from exposure to the JC virus, which is prevalent in humans but only causes PML in vulnerable patients. Before seeking to bring the drug back to market, the manufacturer conducted FDA-requested research on testing for the JC virus. After taking an advisory committee recommendation, FDA re-approved the drug in 2006 with a slew of robust warnings on PML and a REMS program that essentially documented understanding and/or acceptance of the PML risk at each step of the prescribing chain every time the patient received the drug. The label was updated in August 2008, November 2009, and July 2010 to provide more information on the PML risk. Meanwhile, the manufacturer worked to develop a better assay to detect exposure to the JC virus. After years of research and interaction with FDA, in 2012, a new assay was approved and the label was amended to reference it.

Meanwhile, plaintiff was prescribed the drug for his MS in April 2008 after being advised of the PML risk. Plaintiff moved and continued on the drug when prescribed by two other physicians, each of whom also warned him of the risk of PML. Plaintiff was negative for the JC virus in 2009, but started demonstrating signs of PML in 2010, which was confirmed later that year by brain biopsy. Plaintiff sued and was on the fifth version of his complaint when the court considered summary judgment on plaintiff’s remaining claim for failure to warn under the New Jersey Product Liability Act (along with a Daubert motion that was denied as moot).

The court started its analysis with a discussion of three prior decisions on similar claims with the same drug. We will skip that, partly because we have discussed these cases before.  Because this was under the NJPLA, the first issue was whether the “super-presumption” of the adequacy of the PML warnings would apply given plaintiff’s argument about post-approval compliance. The presumption did not look to be dispositive, as the court noted that the substance of the warnings to both the prescribing physicians and the patient were clear, strong, and effective. Yet, the court found that there was no evidence of “manipulation of the post-market regulatory process,” the basis of the so-called “McDarby exception,” noting the interaction between the manufacturer and FDA on an assay that could be used to detect the JC virus in connection with the use of the drug. (The court also assumed without deciding that the McDarby exception could apply.) In the face of this presumption, plaintiff relied on proposed expert testimony that only indirectly addressed the adequacy of warnings. His expert claimed a better assay could have been developed and approved in time to affect the various physicians’ decision to prescribe the drug to plaintiff. Even if his testimony were admissible and if he took the next step of connecting a new assay to the content of the drug’s label—which he did not and could not as a non-physician—there were still obvious issues with relying on this testimony to establish an inadequate label and proximate cause for failure to warn, including that the prescribing physicians were aware of the PML risk and discussed it with the plaintiff on multiple occasions. Put it all together and there was no evidence to carry a failure to warn claim, with or without a presumption of adequacy

As a bit of overkill, the court went ahead and considered the manufacturer’s preemption defense, which argued that the proposed changes to the drug’s label would have been impossible to make during the relevant time. The prior decisions that we elided above also found impossibility preemption, but they were not decided in the Third Circuit after the Fosamax decision tried to make the application of Levine’s once-novel “clear evidence” standard just a question for juries. Even acknowledging the high standard and the decision in Fosamax (albeit with a recurring, and surely unintentional, misspelling), the court still found “There is clear evidence that FDA would not have approved an earlier change to the Tysabri label or have approved the JC Virus assay.” FDA specifically rejected similar proposals twice in 2010, before approving the assay and corresponding labeling change in 2012 after additional research had been committed. That was pretty clear evidence of impossibility back when plaintiff was taking the drug.

So, the manufacturer won summary judgment thrice over. The co-developer also won because it had no ability to change the label, a useful nugget as innovator liability and other theories to impose liability on other defendants continue to get raised when the logical defendant is not liable. In Nelson, no defendant was liable to an injury that, while unfortunate and serious, was warned of about as thoroughly as is possible with a prescription drug. We would prefer such a case never to have been brought or to have been dismissed for failure to state a claim, but summary judgment is still the right result.

 

Sure, it was enjoyable to read In re DePuy Orthopaedics, Inc., Pinnacle Hip Implant Product Liability Litigation, ___ F.3d ___, 2018 WL 1954759 (5th Cir. April 25, 2018) (“Pinnacle Hip”), to see plaintiffs’ counsel hoisted on their own petard of improper and prejudicial evidence and arguments.  But there’s more to Pinnacle Hip than “Lanier-on-a-spit,” as it has been described in these parts.  Indeed, blogging plaintiffs’ attorney Max Kennerly, dropped a comment to our first Pinnacle Hip post (which we published – we scrub only spam, not opposing views) asserting that “the rest of the opinion was a huge win for plaintiffs.”

We largely disagree with Max’s comment, and this post explains why.

Initially, we note that the defendant in Pinnacle Hip was swimming decidedly upstream in all of its legal arguments, since it was opposing a jury verdict entered against it and seeking entry of judgment as a matter of law in its favor.  2018 WL 1954759, at *2.  That means all the trial evidence is construed in the plaintiffs’ favor.  Id. at *3 (“JMOL is warranted only if a reasonable jury would not have a legally sufficient evidentiary basis to find for the nonmovant.”) (citations and quotation marks omitted).

Design Claims

The first claim addressed in Pinnacle Hip was design defect.  See 2018 WL 1954759, at *3-9.  The defendant raised several arguments, all unsuccessfully.  First, the defendant argued that plaintiff had failed to satisfy the Texas alternative design requirement because that alternative that the plaintiffs offered – a “metal on plastic” (“MoP”) hip implant – was really a “different product” from the defendants’ metal-on-metal design (“MoM”), and thus cannot serve as a design alternative.  This is an argument we have featured several times on the blog.  In Pinnacle Hip, the conclusion was that “based on the record, that MoP is a viable alternative design to MoM.”  Id. at *4.

While we would have liked to win this, on the facts, this distinction between alternative product and design is more difficult for the defense than in the cases we’ve discussed in our prior posts, which usually involve not using the product at all, or using some other product that is much less suited for the use in question.  Our classic example of alternative cause abuse is Theriot v. Danek Medical, Inc., 168 F.3d 253 (5th Cir. 1999), a Bone Screw case in which the supposed “alternative” was a different type of surgery not using the product at all.  That’s distinct from redesigning one part of a device system to use a different material, as indeed, Pinnacle Hip pointed out.  2018 WL 1954759, at *9.  Pinnacle Hip reaffirmed that similar-use products that “fail[] to perform the discrete kinds of functions for which the alleged defective was designed” or with a “wide disparity in price” cannot be considered alternative designs.  Id. at *4, *7.  However , the risk/utility defect test “contemplates that a proposed alternative design might reduce a product’s utility . . . without rendering the alternative an entirely different product.”  Id. at *5.  That means some variation has to exist without “moot[ing] the entire defect test.”  Id.

Construing the record to favor plaintiffs, Pinnacle Hip resulted in another point on the uncertain, “practically impossible to settle in the abstract,” id., at *4, line between different design and different product.  While we’d like to have won, Pinnacle Hip does not move the line itself in any lasting fashion prejudicial to the defense.  The ultimate holding was that a “cross-linked” MoP is not sufficiently different from the defendant’s MoP design to be considered a different product.  2018 WL 1954759, at *6 & n.13.  The underlying principle that the distinction between product and design seeks to protect is preventing automatic liability against whole classes of products – cigarettes, motorcycles, birth control pills, or pedicle screw fixation devices – for simply being what they are and having certain inherent risks.  That principle remains intact after Pinnacle Hip.

The defendants also lost a preemption argument – that design defect claims “’stand[] as an obstacle to the accomplishment and execution of the full purposes and objectives’ reflected in the MoM-related regulations of the FDA.”  2018 WL 1954759, at *7.  According to the defendants, because the plaintiffs were seeking “categorical” liability, that all MoMs should be “banned outright,” there should be preemption. Id. at *8.  But that’s not what the Fifth Circuit found was what happened:

[I]t is not the case that plaintiffs’ theory reached all possible MoMs.  All would agree that, despite the sweeping language with which plaintiffs presented their case, their claims were impliedly limited to presently available technologies and the adverse health effects they allegedly engender.

Id.  But the record showed that “[t]he FDA effectively withdrew all MoMs from the market . . . and left open a single door in the form of PMA.”  Id.  On this set of facts, it could not be said that banning something that the FDA had already essentially removed from the market, save for an alternative that has not yet produced an FDA-approved product, was an interference with “the FDA’s regulatory objectives.”  Id.

While losing a preemption argument is not something we would recommend, this particular type of preemption argument has never been successful that we are aware of, so it’s no great loss.  We’ve advocated at some length that the Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), decision be overturned.  But that argument is predicated on changes to 510(k) clearance created by Congress in 1990.  In Pinnacle Hip, “MoMs were sold before 1976 and have traditionally been treated as pre-amendment class III devices.”  2018 WL 1954759, at *8.  So Pinnacle Hip doesn’t affect even the distinctions that we draw from Lohr.  The preemption argument rejected in Pinnacle Hip would require the complete reversal of Lohr, even on Lohr’s facts, to succeed.

By far the better preemption argument, based on current law, with respect to 510(k) design defect claims, is that they amount to “major changes” that require prior FDA review, and probably an entirely new supplemental submission, before they could be implemented.  That should put design defect claims at odds with the “independence principle” in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), resulting in preemption of all design claims that could make a difference in a product liability action.  That argument, which does not depend on Lohr either way, was not addressed at all in Pinnacle Hip.

Finally, the defendants in Pinnacle Hip also lost on their Restatement (Second) of Torts §402A, comment k (1965), argument, which was that Texas law holds all prescription medical products, including medical devices, to be “unavoidably unsafe” within the meaning of comment k, so that those “unavoidable” risks can only be warned about and not treated as design defects.  Pinnacle Hip was unwilling to expand Texas’ application of comment k from prescription drugs to include prescription medical devices.  2018 WL 1954759, at *9.  That places Pinnacle Hip in a distinct minority position, since literally hundreds of cases, and the Third Restatement, apply limits on design defect claims equally to all types of prescription medical products.  Bexis’ book collects these cases.  Drug & Medical Device Product Liability Deskbook §2.02[2] at pp. 2.02-13 to -16 n.14 (for the proposition that “almost all courts have extended the unavoidably unsafe product exception to medical devices”).  However, as the Fifth Circuit correctly pointed out, not many of those opinions are under Texas law.

The further discussion of case-by-case versus across-the-board comment k application in Texas, 2018 WL 1954759, at *9, is more troubling, as the trend in Texas courts (in drug and vaccine prescription product cases) has favored the “blanket” approach.  Pinnacle Hip complained, in a footnote, that “Texas caselaw offers almost no guidance on how to go about that case-by-case inquiry.”  Id. at *9 n.22.  There is good reason for that lack of precedent – because Texas law has not employed tests that require such inquiry.  See Reyes v. Wyeth Laboratories, 498 F.2d 1264, 1273 (5th Cir. 1974) (applying comment k without case-by-case analysis to a vaccine; holding that the only viable claim was inadequate warning); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 817-18 (S.D. Tex. 2013) (applying comment k to prescription drug without case-by-case analysis); Woodhouse v. Sanofi-Aventis United States LLC, 2011 WL 3666595, at *3-4 (W.D. Tex. June 23, 2011) (holding, without further analysis, that “comment k applies to products such as [defendant’s prescription drug]”); Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007) (“Prescription drugs are not susceptible to a design defect claim where, as here, the drug is ‘accompanied by proper directions and warning.’”) (quoting comment k); Carter v. Tap Pharmaceuticals, Inc., 2004 WL 2550593, at *2 (W.D. Tex. Nov. 2, 2004) (“Under Texas law, all FDA-approved prescription drugs are unavoidably unsafe as a matter of law”); Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591, 595 (W.D. Tex. 2002) (“under Texas law and comment k of the Restatement, Defendants can only be held strictly liable if the drug was not properly prepared or marketed or accompanied by proper warnings”).  Contra: Adams v. Boston Scientific Corp., 177 F. Supp.3d 959, 965 (S.D.W. Va. 2016) (refusing to apply comment k across-the-board in medical device case) (applying Texas law).  The comment k portion of Pinnacle Hip is where we think that Max is on the firmest ground.  The decision made Texas law worse.  This issue will ultimately be won in Texas appellate courts or perhaps before the Texas legislature, where it would be quite simple to extend the warning related presumption of §82.007 to all medical devices approved or cleared by the FDA.

Warning Claims

As to warning claims (which Texas law calls “marketing defects”), the defendants lost on adequacy as a matter of law.  Pinnacle Hip, 2018 WL 1954759, at *10.  Unfortunately, defendants usually lose on this ground, so it’s big news – and trumpeted on this blog – when a defendant wins a judicial holding that its warning is adequate as a matter of law.  No surprise there.  In Pinnacle Hip, that discussion ended:

Not until after the FDA issued its proposed rule in 2013 did defendants specifically warn about the metallosis, pseudotumors, and tissue necrosis − the sorts of conditions that plaintiffs maintained caused their revision surgery.

Id. at 11.  As defense counsel, we interpret the Fifth Circuit’s observation as an invitation to seek an adequacy as a matter of law ruling as to post-2013 claims (if there are any) in the litigation.

In the causation discussion pertaining to the warning claims, Pinnacle Hip of course followed the learned intermediary rule.  It discussed the role of “objective” evidence of causation:

At the threshold, the parties debate the relevance, under Texas law, of “objective evidence” − that is, evidence “that a different warning would have affected the decision of a reasonable doctor.” . . . Here, plaintiffs proffered objective evidence in [expert] testimony that, if the full risks of MoM were known to physicians, “they would run to [a different product].”

2018 WL 1954759, at *11 (citations omitted).  As we’ve discussed before, “objective” expert testimony about what “reasonable physicians” would have done is usually disallowed in learned intermediary cases.

On this point, however, Fifth Circuit law, has not been as favorable as other courts.  In Thomas v. Hoffman-LaRoche, Inc., 949 F.2d 806, 812 (5th Cir. 1992), the court actually allowed expert testimony on what a “reasonable” physician might have done – but that case was under Mississippi law.  See Ackermann v. Wyeth Pharmaceuticals, Inc., 526 F.3d 203, 212 (5th Cir. 2008) (suggesting that Thomas would not apply to Texas law).  We’ve been aware of the brief Texas Supreme Court passing reference to “objective” evidence in Centocor, Inc. v. Hamilton, 372 S.W.3d 140, 171 (Tex. 2012) (plaintiffs “presented no objective evidence”), but felt no reason to let the other side know it was there.

Now it’s been discovered, however.  The Fifth Circuit allowed such evidence to be admissible, 2018 WL 1954759, at *12 (“objective evidence is at least relevant”), but did not find it decisive in situations where the plaintiff would otherwise have suffered dismissal.  Critically, Pinnacle Hip did not allow unsupported “expert” testimony about what an objectively “reasonable physician” would have done be enough to let plaintiffs survive when they didn’t have prescriber testimony – which would have been the equivalent of allowing a heeding presumption in Texas, something the Fifth Circuit rejected outright in Ackerman, 526 F.3d at 212-13.

Relevance, however, does not imply sufficiency.  In the [learned intermediary] context, causation entails two distinct factual predicates:  first, that the doctor would have read or encountered the adequate warning; and second that the adequate warning would have altered his treatment decision for, or risk-related disclosures to, the patient.  Centocor addressed only the latter, suggesting a jury might be allowed to presume a particular physician would respond “reasonably” to fuller disclosure.  But that presumption must yield to contrary subjective testimony by the treating physician, and Centocor fails to explain how objective evidence would apply to whether that doctor would have read or encountered the warning in the first instance.  When considered for the limited purpose intimated in Centocor, objective evidence would have little bearing on any of [these] plaintiffs’ claims.

Pinnacle Hip, 2018 WL 1954759, at *12 (footnotes omitted) (emphasis original).  Thus, where the plaintiffs had no testimony from their prescribing physicians, those claims continue to fail, and some “expert” claiming otherwise cannot change the result.  Id. (granting JMOL in no-prescriber testimony cases).  Likewise, any “objective” testimony “must yield to contrary subjective testimony by the treating physician.” Id.  So plaintiffs cannot create questions of fact with expert testimony where the prescriber has affirmatively testified that a different warning would not have changed what s/he did.

Only what the Fifth Circuit described as “mixed bag” prescriber testimony (the prescriber said different things in different parts of his testimony) cases got to the jury in Pinnacle Hip, id. at *13, and those have always been harder cases for the defense anyway.  At best, for plaintiffs, paying some expert to opine that a “reasonable” physician would have heeded a warning won’t save any plaintiff who lacked a plausible warning causation case in the first place.  At worst, Pinnacle Hip means more plaintiff-side noise at trial in cases already going to trial on warning causation.  All in all, the defense side is better off after Pinnacle Hip than where it had been in the Fifth Circuit with only the Thomas precedent.  We definitely don’t agree with Max here.

Personal Jurisdiction

In Pinnacle Hip, the manufacturer’s parent corporation was held potentially liable because of the amount of guidance and control permitted by an inference from the facts (based on a “clear error” standard).  2018 WL 1954759, at *15.  Those facts allowed the court to conclude that more than a “passive parent-subsidiary relationship” existed as to this product.  Id. at *16.  To us that’s “big whoop” for two reasons.  First, the “clear error” standard does not apply at the district court level where jurisdictional motions are initially decided.  Second, and more important going forward, the plaintiffs proceeded under a “stream of commerce” theory where the Fifth Circuit had previously “embraced [the] more expansive” (Brennan) side of the 4-4 split in Asahi Metal Industry Co. v. Superior Court, 480 U.S. 102 (1987).  Pinnacle Hip, 2018 WL 1954759, at *15.  As we’ve discussed, that broad “stream of commerce” jurisdictional theory is probably toast after Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773 (2017).  Pinnacle Hip did not even cite BMS in its discussion of personal jurisdiction, so we guess that this argument wasn’t raised.  In light of the BMS precedent, the Pinnacle Hip jurisdictional holding should be treated as something of a “one-off” applicable to this MDL, but not to future litigation where BMS will stand front and center.

Miscellaneous Claims

Pinnacle Hip includes the Fifth Circuit’s full-throated reaffirmance of our favorite Erie principle:

[T]hat debate [about what a Texas court might do] is beside the point.  When sitting in diversity, a federal court exceeds the bounds of its legitimacy in fashioning novel causes of action not yet recognized by the state courts.  Here, despite ample warning, the district court exceeded its circumscribed institutional role and expanded Texas law beyond its presently existing boundary.

2018 WL 1954759, at *17 (footnote, citations, and quotation marks omitted) (emphasis added).  The court therefore threw out the spurious invention of an “aiding and abetting” cause of action that had no reasonable predicate in Texas law.  Id.

The court did allow two arguably weird theories against the parent corporation – all product liability theories imposing liability against a non-manufacturing parent under a theory not also cognizable against the manufacturing subsidiary are likely to be weird − to survive.  One of those, so-called “nonmanufacturer seller” was tied to statutory exceptions to immunity for nonmanufacturers.  Id. at*18.  The court held, instead, that the parent was only held liable for old-fashioned design or warning liability, after the record (again, construed in favor of plaintiffs as verdict winners) established one of statutory exceptions from nonmanufacturer immunity.  Id. That’s a little peculiar to non-Texas lawyers, but since Texas has this statute, it must mean something.

The other oddball claim that survived is one of those “last refuge of a scoundrel” theories, negligent undertaking” (a/k/a “Good Samaritan”) liability.

Texas caselaw reveals no precise control threshold a parent must cross before undertaking a duty to its subsidiary’s customers.  Texas courts have made clear that mere possession of “the authority to compel” a subsidiary is not enough − the parent “must actually” exercise that authority in a manner relevant to the undertaking inquiry.

Pinnacle Hip, 2018 WL 1954759, at *19 (footnote omitted).  Based on the stringent standard for interpreting record evidence, the court let this one slide.  Id.  Not good, but not likely to arise very often.

But there’s more afoot than just these three theories. Two years ago, we awarded In re DePuy Orthopaedics, Inc., 2016 WL 6268090 (N.D. Tex. Jan. 5, 2016), our ranking as the number six worst decision of that year, chiefly because of the large number of unprecedented theories under Texas law that this opinion permitted:

(1) extending negligent misrepresentation beyond “business transactions” to product liability, unprecedented in Texas; (2) ignoring multiple US Supreme Court decisions that express and implied preemption operate independently (as discussed here) to dismiss implied preemption with nothing more than a cite to the Medtronic v. Lohr express preemption decision; (3) inventing some sort of state-law tort to second-guess the defendant following one FDA marketing approach (§510k clearance) over another (pre-market approval), unprecedented anywhere; (4) holding that the learned intermediary rule does not apply whenever a defendant “compensates” or “incentivizes” physicians to use its products, absent any Texas state or appellate authority; (5) imposing strict liability on an entity not in the product’s chain of sale, contrary to Texas statute (§82.001(2)); (6) creating a claim for “tortious interference” with the physician-patient relationship, again utterly unprecedented; (7) creating “vicarious” breach of fiduciary duty for engaging doctors to serve as expert witnesses in mass tort litigation also involving their patients, ditto; and (8) construing a consulting agreement with a physician as “commercial bribery” to avoid the Texas cap on punitive damages, jaw-droppingly unprecedented.

While only item (5) was at issue in Pinnacle Hip, the Fifth Circuit’s invocation of Erie conservatism bears ill for all of the other judicial flights of fancy that have been allowed during the course of the Pinnacle Hip litigation.

Constitutionality of Punitive Damages Cap

For completeness, plaintiffs also lost their constitutional challenge to the Texas statute capping punitive damages at twice compensatory damages.  “Plaintiffs’ cross-appeal is meritless, and we dispose of it by footnote.”  Pinnacle Hip, 2018 WL 1954759, at *1 n.4.  That footnote went further, and characterized those constitutional claims as “frivolous.”  Id. at *23 n.72.  No matter what the constitutional challenge, a punitive damages cap “need only survive rational-basis review,” which it did in Pinnacle Hip “by injecting predictability into exemplary damages awards and preempting potentially unconstitutional awards.”  Id. (citations omitted).

Conclusion

When all is said and done, we view Max’s characterization of Pinnacle Hip as a “huge win for plaintiffs” as mostly overblown hyperbole, perhaps worthy of inclusion in the closing arguments that the Fifth Circuit held warranted a new trial.  The Fifth Circuit did some damage to comment k, but all the rest of the legal holdings were trivial, fact-bound, not likely to be useful in future cases, or some combination of those.  The forceful reiteration of conservative principles of Erie predictions of state law leave us hopeful that the Pinnacle Hip MDL will see some Fifth Circuit-mandated clean up – or, if not, perhaps the appellate court’s not-so-veiled Parthian, parting shot may have to be fired in earnest:

[D]efendants, despite their serious critiques of the district judge’s actions in this case and related MDL proceedings, see In re DePuy Orthopaedics, Inc., 870 F.3d 345, 351 (5th Cir. 2017) (finding “grave error”), have not asked us to require these cases to be reassigned to a different judge under “this court’s supervisory power to reassign,” United States v. Stanford, 883 F.3d 500, 516 (5th Cir. 2018).  We express no view on the issue but note that reassignment is both “extraordinary” and “rarely invoked.”  Id. (citation and internal quotation marks omitted).

Pinnacle Hip, 2018 WL 1954759, at *27, n.83.  Obviously, the Fifth Circuit in Pinnacle Hip was uncomfortable with the prospect of overruling the JPMDL’s assignment of this MDL, but this final footnote stands as a clear warning that, if further provoked (such as by continuing consolidated trials, or resort to other prejudicial evidence that the court noted but did not rule on), it will consider doing so.

We don’t normally comment on verdicts, whether they favor our side or the plaintiffs, because the bare fact of a verdict doesn’t give us much to analyze, and analysis is what this blog is about. But we make an exception for the bizarre verdict handed down last week in the first bellwether trial in the Bard IVC Filter MDL.

We’ve seen the verdict form, and the plaintiffs submitted four theories of liability to the jury:  (1) strict liability design defect; (2) strict liability failure to warn; (3) negligent design; and (4) negligent failure to warn.  According to the 360 story (unfortunately behind a paywall to non-subscribers), the jury found that the defendant’s IVC filter wasn’t defectively or negligently designed, and – more importantly for our purposes – also held that there was no strict liability warning defect (the case was under Georgia law, and Georgia is a Restatement §402A state).

After having rendered defense verdicts on the first three theories, the IVC jury found that, somehow, the defendant had negligently failed to warn about the same risks as to which there was no strict liability warning defect.

That’s inconsistent, if not impossible.

We haven’t looked at Georgia law, but the exact same thing happened not too long ago in California, in Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127 (App. 2017), review denied (Cal. Oct. 11, 2017), a case we blogged about here.  In Trejo, we were mostly interested in the fate of the plaintiff’s design-related claims (they were preempted), but the court also held that, where the jury had determined that no warning-related, strict-liability defect existed, it was inherently inconsistent for the jury to turn around and find negligent failure to warn:

Considering that both the strict liability and negligence theories were premised on a single alleged defect – failure to warn of [the same risk] – the jury’s findings meant, in substance, that [defendant] was not strictly liable for failure to warn of those possible reactions because they created no substantial danger, but was liable for negligent failure to warn because those possible reactions were, or were likely to be, dangerous.  As we next explain, we conclude that these verdicts are fatally inconsistent.

Trejo, 220 Cal. Rptr.3d at 142.

Why is that?  We’ll let the California Court of Appeals explain.

“[A] finding of negligent failure to warn is logically and legally inconsistent with the jury’s finding [in favor of defendants] on plaintiffs’ strict products liability failure to warn.”  Id. (quoting Oxford v. Foster Wheeler LLC, 99 Cal. Rptr.3d 418, 435 (App. 2009)).  That’s because “the manufacturer’s strict liability duty to warn is greater than its duty under negligence, and thus negligence requires a greater showing by plaintiffs.”  Id. (Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 263 (App. 1999)).

Strict liability was invented precisely so it would be easier to prove than negligence.  Thus a “defense verdict . . . on strict liability failure to warn subsume[d] the cause of action for negligent failure to warn so that” the proper result was “to direct a defense judgment on that negligence count.”  Trejo, 220 Cal. Rptr.3d at 142 (quoting Valentine again).  “[T]he defense verdict on strict liability failure to warn mandated a defense verdict on negligent failure to warn as well.”  Id.

A negligence formulation of a warning claim – that a defendant “has a duty to use reasonable care to give a warning” of a risk that makes the product “likely to be dangerous” to users whom “the supplier has reason to believe . . . will not realize [the product’s] danger,” id. – requires greater proof of failure to warn than strict liability, which allows recovery whenever a “substantial” danger requires a better warning than what the plaintiff (or the physician in a learned intermediary case) received:

[A] product is defective if the use of the product in a manner that is reasonably foreseeable by the defendant involves a substantial danger that would not be readily recognized by the ordinary user of the product and the manufacturer knows or should have known of the danger but fails to give adequate warning of such danger.  A manufacturer has a duty to provide an adequate warning to the user on how to use the product if a reasonably foreseeable use of the product involves a substantial danger of which the manufacturer is either aware or should be aware, and that would not be recognized by the ordinary user.

Id. at 142-43 (mostly quoting Valentine again).  “[T]he strict liability definition of defective product, coupled with . . . the strict liability duty to warn physicians of the potential risks or side effects of [a medical device] that were ‘known or knowable,’ more than subsumed the elements of duty to warn set forth in the negligence instructions.”  Id. at 143.

[T]he ‘known or knowable in light of’ language in the strict liability instruction at a minimum encompasses the ‘knows or has reason to know’ language in the negligence instruction.  Under a negligence standard, a reasonable manufacturer would not be charged with knowing more than what would come to light from the prevailing scientific and medical knowledge.”

Id. at 144 (quoting Valentine again).

The Trejo decision goes on, reviewing other cases in which courts have found inherently inconsistent verdicts where the jury found for the defendant on strict liability warning defect but for the plaintiff on negligent failure to warn.  Id. at 143-48 (discussing, both Valentine, supra (a medical device case), and Oxford, supra at great length).  Trejo also rejected the plaintiff’s attempted counter that “negligence and strict products liability are not identical doctrines”:

True enough − the two theories of products liability are not identical. . . . the difference between strict liability failure to warn and negligent failure to warn [is] . . . that, unlike negligent failure to warn, strict liability is not concerned with the standard of due care or the reasonableness of a manufacturer’s conduct. . . .  [A] manufacturer could be held liable under strict liability principles even if its failure to warn conformed to industry-wide practices and thus was not negligent.  [The law does] not, however, indicate that a manufacturer could be held liable for negligent failure to warn despite being found not liable for strict liability failure to warn.  Indeed, as illustrated by Valentine and Oxford, this cannot be so where, as here, only one viable factual basis supports both theories.

Id. at 148 (citations and quotation marks omitted).

A similar result to Trejo and Valentine was reached decades earlier in Werner v. Upjohn Co., 628 F.2d 848 (4th Cir. 1980):

The effect of the jury verdict on negligence was to find that [defendant] failed to use due care to give an adequate warning of the propensities of the drug marketed, and, in the same breath, the verdict on strict liability found that the drug marketed with such an inadequate warning was not unreasonably dangerous.  The verdicts in the context of this failure to warn case involving prescription drugs are obviously inconsistent and cannot stand.

Id. at 860.  See Witt v. Norfe, Inc., 725 F.2d 1277, 1280 (11th Cir. 1984) (defense verdicts on strict liability and warranty were “irreconcilably contradictory” with plaintiff’s verdict on negligence) (applying Florida law); In re Baycol Products Litigation, 2008 WL 6155700, at *13 (D. Minn. Sept. 22, 2008) (“failure of a plaintiff’s strict liability failure to warn claim, results in the same fate for a plaintiff’s negligent failure to warn claim”), aff’d, 596 F.3d 884 (8th Cir. 2010) (applying California law).

Finally, the irreconcilability of the verdict in IVC Filter may well be a fortiori from the Trejo/Oxford/Valentine cases out of California.   The California law at issue in those cases was crystal clear that, in both negligence and strict liability warning claims, liability is limited by the state of the art defense.  Georgia law, on the other hand, lacks definitive precedent imposing state of the art as a limitation on strict liability.  The closest precedent we have found is McCombs v. Synthes (U.S.A.), 587 S.E.2d 594, 596 (Ga. 2003), a medical device decision recognizing that warning claims generally are held to a “reasonableness” standard.  Thus, strict liability warning claims may be even easier for plaintiffs to prove, compared to negligence, under Georgia law.  That would make the irreconcilability of the IVC Filter verdict for plaintiff on negligence even greater than is the case under Trejo/Oxford/Valentine.

Exactly why the jury in IVC Filter returned such blatantly irreconcilable verdicts is, of course, something we will never know.  From the 360 article, however, we spotted a couple of things that couldn’t have contributed to the mix-up.  First, punitive damages were also at issue in the case.  Our views on the prejudicial nature of evidence relating to that kind of claim are already set forth at some length in our post advocating that MDL defendants limit any so-called “Lexecon waivers” to compensatory damages.  It may well be that prejudicial intent evidence, relating solely to punitive damages, inflamed the jury on the liability question so that even though they could not find that the product was defective, the jury was dead set on finding for the plaintiff anyway.  Don’t know, but certainly plausible.

Second, and possibly related, the 360 article also quotes plaintiffs’ counsel as arguing that the “simple fix” was “[d]on’t put it [the device] on the market.”  To us, that kind of rhetoric is unacceptable because it encourages the jury to disregard the FDA’s decision that initially allowed the product to be marketed.  A claim that a defendant manufacturer should not have sold a product that the FDA has determined should be sold in the United States inherently conflicts with the power that Congress has vested in the FDA specifically to make those decisions.  See Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472, 489-90 (2013) (claims “that a regulated actor could avoid liability under both state and federal law by simply leaving the market” held impliedly preempted).  Plaintiffs should never have been allowed to make that sort of appeal to the jury to nullify what the FDA decided.

It seems quite evident that the jury got confused and went astray in the first Bard IVC Filters bellwether trial.  The result was a verdict that can’t logically be a bellwether of anything.  The jury found for the defendant on a warning claim for which the plaintiff had a lesser standard of proof, and then found for the plaintiff on identical warning-related facts where the law required stronger evidence for liability.  That’s what precedent means by “irreconcilable.”

 

This post does not come from the Reed Smith side of the blog.

 

Favorable New Jersey appellate court decisions in product liability cases are almost always worthy of mention here. So we bring you Goodson v. C.R. Bard, 2018 WL 1370652 (N.J. App. Div. Mar. 19, 2018). To be truthful, we’re bringing it back to you. Bexis discussed the trial court’s decision to grant summary judgment to defendants last year.

As we discussed then, this is a case involving mesh used in hernia procedures. The particular mesh product involved in this case is not involved in the pelvic mesh MDL proceedings. And that may be reflected in the strength of the plaintiff’s expert reports, which is to say that they are not strong at all.  While the plaintiff used experts who have been involved in the pelvic mesh MDL, not one of them seemed to give the right opinions.

In particular, even though plaintiff brought a design defect claim, none of his experts gave an opinion that the design of this particular product was actually defective or that such a defect caused the plaintiff’s injuries. Id. at *4-5. Rather, his experts simply described various alleged risks of the product. This is not even close to sufficient to support a design defect claim. Id. Nor did any of the experts opine that there was a safer, feasible alternative design. Id. Similarly, even though plaintiff also brought a negligent failure to wan claim, none of the experts gave an opinion on the standard of care for issuing a warning or whether defendants met that standard. Id. at *5-6. In other words, plaintiff didn’t have a warnings expert to opine on whether the warning was adequate.

In short, plaintiff’s experts struck out looking.

To make matters worse, the treating doctor testified that he was aware of the potential risks of this mesh product and informed plaintiff of them. Id. at *6. There goes proximate causation under the learned intermediary doctrine.

Accordingly the New Jersey appellate division upheld the trial court’s grant of summary judgment to defendants. Unfortunately, it designated its opinion “not for publication.” That’s too bad. But rest assured: it happened. Westlaw already has it on-line. And the trial court’s decision, which Bexis’s post from last year lays out in considerable detail, has an excellent analysis of all the weaknesses in plaintiff’s case, an analysis that was essentially adopted by the Appellate Division. And, of course, we’ve written on it twice now. With all of that, we’re confident that you’ll find some way to make use of this appellate decision in your cases.

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

Last week when we posted about some motion in limine rulings coming out of the IVC Filters MDL, most of our blogging team were enjoying a calm week after being hit by two nasty Nor’easters. We were turning our thoughts to spring. Birds chirping, flowers blooming, sunshine and rainbows. Now a week later as we officially head into spring, bam. Here we go again. The predictions vary and it may only be a few more inches of snow, but March has pretty been all lion and we really hoping to see a little lamb in our future. Mother Nature has decided she’s not quite ready to let go of her grasp on winter. Much like the court in the IVC Filter MDL wasn’t quite ready to let go of the bellwether case Jones v. C.R. Bard, Inc, 2018 U.S. Dist. LEXIS 40020 (D. Ariz. Mar. 12, 2018).

At the heart of the Bard IVC Filters Litigation is an allegation that defendant’s filters have a higher comparative risk rate than other filters and that defendant failed to warn physicians about the higher risk. Id. at *319-20. In the context of this bellwether case set for trial in May, defendant moved for summary judgment on failure to warn, misrepresentation, negligence per se, and punitive damages and won on misrepresentation and negligence per se.

The court was applying Georgia law and therefore the learned intermediary doctrine. Id. at *322-23. Defendant’s first argument was that plaintiff lacked proof of proximate cause on her failure to warn claim because her surgeon testified that he did not read the Eclipse filter label. You all know this argument – even if the defendant had included the very warning plaintiff contends should have been made, it doesn’t matter if the physician wouldn’t have seen it. If the doctor’s testimony is clear, this should shut the door on failure to warn. The court here, however, found a way to prop that door back open by holding that a defendant can breach its duty to warn not only by having a deficient warning but also “by failing to adequately communicate the warning.” Id. at *324. The court looked beyond the label to “dear doctor letters, product pamphlets, and statements by company sales representatives.” Id. at *325. If this is an escape hatch for plaintiffs on failure to warn, then we have more questions for doctors at their depositions.

Defendant’s second argument on failure to warn causation was that the physician was already aware of the very risk which occurred in this case, device fracture – which was also a well-known risk in the medical community. Id. at *326-27. Plaintiff’s countered that the lack warning wasn’t about the general risks of filters but that this particular filter had a higher risk of complication than other filters. On this point, plaintiff’s surgeon testified that higher complication rates is something “he would have wanted to know” before plaintiff’s surgery. That was enough for the court to find a jury question as to prior surgeon knowledge. Id. at *328.

Taking these two rulings together serves to emphasize the critical importance of the physician’s deposition. This court wanted “unequivocal” evidence that the doctor would have made the same prescribing or surgical decision even in the face of different warning information. Id. at *328-29. Only such a response would have cutoff causation with regard to any avenue by which the defendant could have communicated warnings to the surgeon. It’s a risk to ask the ultimate question – would a different warning have mattered – but without it, the risk is a disputed fact issue for the jury.

The court turned next to the adequacy of the warning provided, which it was undisputed did contain a warning regarding fractures. But as noted above, did not contain information about the comparative risk rates for this filter as against other filters. Id. at *330-31. We had the same gut reaction that defendant in this case appears to have had – 1) how can you possibly provide reliable information comparing risks among products and 2) is this even allowed by the FDA. Id. at *334. It’s not for prescription drugs. See 21 C.F.R. §201.57(c)(7)(iii) (“For drug products . . . any claim comparing the drug . . .with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”). But the same logic should apply. Unless the adverse reactions or complications being discussed have been studied side-by-side to account for variables and assorted other unknowns, the comparison is meaningless and potentially more harmful than helpful. It’s one thing to suggest that the label warning of the risk of fractures was insufficient given the state of knowledge defendant had or should have had at the time, but finding that a defendant could be liable for breaching its duty to warn for failing to provide comparative risk rates that are unverified, unapproved, and inherently unreliable puts a defendant in a really precarious position. Don’t include and face tort liability; include a face FDA violations for misbranding and misleading information.

Moving on to the two claims that were dismissed – misrepresentation and negligence per se. The court found that Georgia does not recognize an independent claim for misrepresentation in a products liability case. It is subsumed in failure to warn. Id. at *336-37. Similarly, plaintiffs could not maintain a negligence per se claim based on alleged FDCA violations because there is no private right of action to enforce the Act. The court’s preemption analysis is emphatic and strongly reasoned. Id. at *338-40. Plaintiff’s attempt to sidetrack the court with talk of the difference between PMA and 510(k) devices falls on deaf ears, as it should when talking about Buckman implied preemption. Id. at *340-41. As did plaintiff’s attempt to argue that Georgia allows negligence per se claims based on laws that do not create a private right of action. The difference between those laws and the FDCA is “the plain language of §337(a) and the Buckman decision indicate that, where the FDCA is concerned, such [a] claim fails.” Id. at *341.

Finally, the court also allowed plaintiff to keep her punitive damages claim based on a design claim that was not otherwise part of the motion. The discussion focuses on the state of the evidence regarding what defendant knew and when and what actions it took regarding the design of the device at issue. It is fairly case specific and so we won’t delve into the details here.

Not a banner decision and frankly it raises more questions than it answers about warnings based on comparative risk rates. Hmm, perhaps a deeper dive and a subsequent post is in order. Something for the next snowy day.

 

Claims predicating prescription medical product liability claims on purported failure to report adverse events to the FDA – á la Stengel v. Medtronic Inc., 704 F.3d 1224 (9th Cir., 2013) (en banc), Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), and Coleman v. Medtronic, Inc., 167 Cal. Rptr.3d 300 (App. 2014), were almost unheard of prior to the recognition of preemption in medical device cases in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We know of only one decision, a prescription drug case at that, Axen v. American Home Products Corp., 974 P.2d 224, 235 (Or. App. 1999), that addressed such claims pre-Riegel.

Because failure-to-report claims are transparent attempts at common-law enforcement of FDA reporting requirements, our first reaction to such claims is that they should be impliedly preempted under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), and 21 U.S.C. § 337(a), as purely FDCA-based claims.  Some courts have agreed, others (like the three cases cited above) – have been reluctant to put plaintiffs totally out of court on preemption grounds – so they have distorted the law by jamming the square peg of failure-to-report claims into the round hole of plain vanilla failure-to-warn product liability claims.

But what about that square peg?  We’ve never (and we haven’t seen it anywhere else, either) taken a look at the purely state-law issue of whether, in contexts beyond prescription medical products, the common law has ever given thumbs up – or thumbs down – to state-law tort claims actually predicated on failure to report something to some governmental body (excluding the FDA for these purposes).

Such laws do exist in a variety of areas.  The most significant example are so-called “mandated reporting statutes” that obligate differing groups of statutorily designated persons to report child abuse (and more recently, elder abuse) to state or local authorities.  The details differ, but from what we can tell, practically every state has a mandated reporting statute.

With plaintiffs being always on the lookout for extra deep pockets, no matter how bizarre the liability theory, surely somebody out there has tried to predicate liability on a purely state-law failure to report.

So we did some research that validated that gut feeling.  Indeed, it turns out that state-law failure-to-report claims have been asserted fairly often.

Fortunately for the good guys, most states have rejected those claims, and even the minority of adverse decisions are mostly distinguishable.

Here goes.

Perhaps the leading case is Perry v. S.N., 973 S.W.2d 301 (Tex. 1998).  In Perry, “[t]he sole issue [was] whether plaintiffs may maintain a cause of action for negligence per se based on the Family Code, which requires any person having cause to believe a child is being abused to report the abuse to state authorities.”  Id. at 302.  Before the Texas Supreme Court, that dog didn’t hunt.  “[W]e will not apply the doctrine of negligence per se if the criminal statute does not provide an appropriate basis for civil liability.”  Id. at 304 (footnote omitted).  That the injured plaintiff was a person within the scope of the statute’s protection was not enough.  Id. at 305.  The claim being asserted “corresponds to no common law duty.”  Id. at 306.

[W]e have considered the following factors regarding the application of negligence per se to the . . . child abuse reporting provision:  (1) whether the statute is the sole source of any tort duty from the defendant to the plaintiff or merely supplies a standard of conduct for an existing common law duty; (2) whether the statute puts the public on notice by clearly defining the required conduct; (3) whether the statute would impose liability without fault; (4) whether negligence per se would result in ruinous damages disproportionate to the seriousness of the statutory violation, particularly if the liability would fall on a broad and wide range of collateral wrongdoers; and (5) whether the plaintiff’s injury is a direct or indirect result of the violation of the statute.  Because a decision to impose negligence per se . . . would impose immense potential liability under an ill-defined standard on a broad class of individuals whose relationship to the abuse was extremely indirect, we hold that [liability] is not appropriate.

Id. at 309.

Another interesting case is Ward v. Greene, 839 A.2d 1259 (Conn. 2004), which held that, while a cause of action for failure to report might be brought on behalf of the “identified” abused child him or herself, the statute did not protect other “unidentified” abused children allegedly injured by the same pattern of failure to report child abuse:

[W]e conclude that the [statute] appears to be directed at the child, or children in the case of multiple children placed at risk in a singular incident, who should be the subject of a report of abuse or neglect under the statute and are, accordingly, in need of services.  The policy statement thus suggests that the legislature intended to focus on children who already have been exposed to conduct that amounts to a reportable event, and we do not find merit in the plaintiff’s argument that the statute creates a duty of care to every child who has been in the care of the defendant.

Id. at 1266-67.  The limited claim in Ward can’t translate to drug/device liability because a similar construction of the FDCA’s reporting requirements would not do plaintiffs any good.  Causation in product liability doesn’t work the same way.  In drug/device cases, every court to consider the issue has held that failure to report a plaintiff’s own adverse event cannot possibly be causal, since any failure to report necessarily happens after the plaintiff was injured.  See Johnson v. Hologic, Inc., 2015 WL 75240, at *4 (Mag. E.D. Cal. Jan. 5, 2015), adopted, 2015 WL 4745264 (E.D. Cal. March 6, 2015); Malonzo v. Mentor Worldwide, LLC, 2014 WL 2212235, at *3 (N.D. Cal. May 28, 2014); Simmons v. Boston Scientific. Corp., 2013 WL 1207421, at *5 (C.D. Cal. March 25, 2013).

Perry and Ward are examples of the distinct majority of precedent addressing similar claims of injury due to somebody’s failure to report child abuse.  Most states do not recognize any purely common-law, or negligence per se state-law, duty to report child abuse.  “The vast majority of courts . . . have held that their reporting statutes do not create a civil cause of action.”  Becker v. Mayo Foundation, 737 N.W.2d 200, 208 (Minn. 2007).

Alabama: C.B. v. Bobo, 659 So.2d 98, 102 (Ala. 1995) (“there is no indication of any legislative intent to impose civil liability for failure to report”).

Connecticut: Ward, supra, 839 A.2d at 1266-67.

Delaware: Doe 30’s Mother v. Bradley, 58 A.3d 429, 452 (Del. Super. 2012) (“the statutory obligation to report [suspected child abuse] does not equate to a common law duty to act”).

Florida: Welker v. Southern Baptist Hospital, Inc., 864 So. 2d 1178, 1182 (Fla. App. 2004) (the statute that “address[es] the subject of penalties for failure to report known or suspected child abuse . . . says nothing about the availability of a cause of action for damages.  Moreover, those courts which have been presented with the same question regarding predecessor versions . . . have all concluded that no cause of action was created”), quashed on other grounds, 908 So. 2d 317 (Fla. 2005); Mora v. South Broward Hospital Dist., 710 So. 2d 633, 634 (Fla. App. 1998) (recognizing, while rejecting analogous cause of action for failure to report elder abuse; that “Florida courts have consistently refused to impose civil liability for the failure to report suspected child abuse”); Fischer v. Metcalf, 543 So.2d 785, 790-91 (Fla. App. 1989) (“To find a legislative intent to provide a private right of action against non-reporters, we would have to ignore . . . the plain purpose and language of the statutes”).

Georgia: McGarrah v. Posig, 635 S.E.2d 219, 222 (Ga. App. 2006) (“The legal duty to report, however, is imposed in Georgia by statute, and . . . this statute does not give rise to a private cause of action for damages”) (emphasis original); Vance v. T.R.C., 494 S.E.2d 714, 716 (Ga. App. 1997) (“nothing within the provision of the law purports to create, or indicates an intention to create, a private cause of action in tort in favor of a child whose abuse is not detected or reported”); Cechman v. Travis, 414 S.E.2d 282, 284 (Ga. App. 1991) (child abuse reporting requirements not enforced by private liability).  Cf. Govea v. City of Norcross, 608 S.E.2d 677, 683 (Ga. App. 2004) (no negligence per se claim based on failure to report reasons why police officer had been terminated).

Illinois: Varela v. St. Elizabeth’s Hospital, Inc., 867 N.E.2d 1, 8 (Ill. App. 2006) (“it would be illogical to argue that although the Illinois legislature has not expressly or impliedly created a private right of action for violation of the Reporting Act individuals may nevertheless assert a private right of action for violation of the Reporting Act, so long as those individuals allege they are proceeding at common law rather than on a statutory basis”); Doe v. North Central Behavioral Health System., Inc., 816 N.E.2d 4, 8 (Ill. App. 2004) (“no evidence that the statute was designed to provide monetary remedies for victims of abuse or to impose civil liability on those who fail to report”); Sheetz v. Norwood, 608 F. Appx. 401, 406 (7th Cir. 2015) (following Doe and Cuyler); Doe-2 v. McLean County Unit Dist. No. 5 Board of Directors, 593 F.3d 507, 514 (7th Cir. 2010) (a “mandate to report child abuse does not create any duty to the abused child enforceable under Illinois tort law”); Cuyler v. United States, 362 F.3d 949 (7th Cir. 2004) (“Illinois common law did not impose on [defendant’s] employees a tort duty” and “an imposing line of cases from other jurisdictions dealing with the private-right question . . . have held that a private right should not be implied”) (Posner, J.) (emphasis original); Willis v. Williams, 2010 WL 4683965, at *3 (Mag. C.D. Ill. Sept. 27, 2010) (“Illinois common law creates no legal duty to report suspected sexual abuse of a child”), adopted, 2010 WL 4683624 (C.D. Ill. Oct. 26, 2010); Doe v. White, 627 F. Supp. 2d 905, 920 (C.D. Ill. 2009) (“there is no underlying common law duty to report” and “there is no tort liability for [a statutory] violation”).

Indiana: Sprunger v. Egli, 44 N.E.3d 690, 693 (Ind. App. 2015) (“Indiana does not recognize a private right of action for failure to report abuse”); C.T. v. Gammon, 928 N.E.2d 847, 854 (Ind. App. 2010) (“our legislature has declined to codify a civil cause of action against an adult who knowingly fails to report alleged child abuse”); J.A.W. v. Roberts, 627 N.E.2d 802, 813 (Ind. App. 1994) (“Absent codification, we are not convinced that extending a civil remedy to a victim of abuse or neglect against all persons who know of child abuse and fail to report child abuse is good public policy.”), abrogated on other grounds, Holt v. Quality Motor Sales, Inc., 776 N.E.2d 361 (Ind. App. 2002); Borne v. Northwest Allen County School Corp., 532 N.E.2d 1196, 1202-03 (Ind. App. 1989) (“the legislature did not intend to confer a private right of action for any breach of the duty to report imposed by the statute”).

Kansas: Kansas State Bank & Trust Co. v. Specialized Transportation Services., Inc., 819 P.2d 587, 604 (Kan. 1991) “There is no express indication of legislative intent to impose any liability for failure to report.”); E.P. v. United States, 835 F. Supp.2d 1109, 1117 (D. Kan. 2011) (the “common law does not recognize a cause of action for medical negligence based on failure to report child abuse”), aff’d, 520 F. Appx. 707, 716 (10th Cir. 2013) (“Kansas law does not hold healthcare professionals liable for failing to report child abuse”).

Massachusetts: Doe v. D’Agostino, 367 F. Supp.2d 157 (D. Mass. 2005); (“it is implicit from the penalty imposed for failure to report that the legislature did not intend to create a private cause of action for a statutory violation”).

Minnesota: Becker, 737 N.W.2d at 208 (“The plain language of the statute indicates that the legislature chose to impose criminal, but not civil, penalties on mandatory reporters who fail to report.”); Meyer v. Lindala, 675 N.W.2d 635, 641 (Minn. App. 2004) (the statute “does not create a private cause of action for violation of its reporting requirements or create a duty which could be enforced through a common-law negligence action”); Kuelbs v. Williams, 609 N.W.2d 10, 155 (Minn. App. 2000) (“Minnesota courts have been reluctant to recognize private causes of action under reporting acts”); Valtakis v. Putnam, 504 N.W.2d 264, 266-67 (Minn. App. 1993) (“There is no mention of a civil cause of action for failure to report nor is a civil action implied by the language of the subdivision;” “there was no underlying civil cause of action for failure to report suspected child abuse”).

Missouri: Bradley v. Ray, 904 S.W.2d 302, 312-15 (Mo. App. 1995) (“no private cause of action can be implied under the Child Abuse Reporting Act, [so] the alleged breach of the Act also does not amount to negligence per se”; no prima facie tort for non-reporting); American Home Assurance Co. v. Pope, 360 F.3d 848, 851 n.7 (8th Cir. 2004) (Missouri “has prohibited” claims for failure to report child abuse); Letlow v. Evans, 857 F. Supp. 676, 678 (W.D. Mo. 1994) (“the vast majority of courts . . . have found that reporting statutes such as the one at issue here, do not create a private right of action”); Thelma D. v. Board of Education, 669 F. Supp. 947, 950 (E.D. Mo. 1987) (plaintiffs “cannot recover under the Statute which only creates a public duty”); Doe “A” v. Special School District, 637 F. Supp. 1138, 1148 (E.D. Mo. 1986) (the Statute “creates a duty owed to the general public, not to specific individuals”); Nelson v. Freeman, 537 F. Supp. 602, 611 (W.D. Mo. 1982) (“the applicable [reporting] provisions of the Missouri Child Abuse statute cannot be said to support a private cause of action in favor of individuals”).

New Hampshire: Marquay v. Eno, 662 A.2d 272, 278 (N.H. 1995) (“imposition of civil liability for all reporting violations would represent a sharp break from the common law and neither the statute nor the legislative history directly reveal any such intent, we are unwilling to say that violation of the child abuse reporting statute supports a private right of action”).  Cf. Gauthier v. Manchester School Dist., 123 A.3d 1016, 1021 (N.H. 2015) (“declin[ing] . . .  to create a duty to report bullying”).

New Jersey: J.S. v. R.T.H., 714 A.2d 924, 934 (N.J. 1998) (“we do not conclude that the Legislature intended that the child-abuse reporting statute constitute an independent basis for civil liability or that its violation constitute negligence per se”); Zelnick v. Morristown-Beard School, 137 A.3d 560, 568 (N.J. Super. Law. Div. 2015) (“Child abuse reporting statutes do not typically create a duty of care or a basis for civil liability.”).

Oklahoma: Paulson v. Sternlof, 15 P.3d 981, 984 (Okla. App. 2000) (“the child abuse reporting statutes do not create a private right of action.  Knowing and willful failure to report is a criminal misdemeanor.  There is no provision, however, for civil liability.”).

South Carolina: Doe v. Marion, 645 S.E.2d 245, 249 (S.C. 2007) (“the statute in question is concerned with the protection of the public and not with the protection of an individual’s private right”).

Tennessee: Ham v. Hospital of Morristown, Inc., 917 F. Supp. 531, 534 (E.D. Tenn. 1995) (“the common law of Tennessee does not impose a duty on a treating physician to either report suspected child abuse or to prevent any such child abuse”).  However, Ham allowed a statutory cause of action (see below).

Texas: Perry, supra; Childers v. A.S., 909 S.W.2d 282, 289-90 (Tex. App. 1995) (rejecting civil liability for failure to report child abuse before Perry); Doe v. S & S Consolidated I.S.D., 149 F. Supp.2d 274, 299 (E.D. Tex. 2001) (following Perry), aff’d, 309 F.3d 307 (5th Cir. 2002).

Utah: Owens v. Garfield, 784 P.2d 1187, 1191 (Utah 1989) (“Although the statute is intended to address the problem of child abuse, we are not persuaded that it can be read to create a legally enforceable duty on the part of the [mandated reporter] to protect all children from child abuse in all circumstances”).

West Virginia: Barbina v. Curry, 650 S.E.2d 140, 145-46 (W. Va. 2007) (Arbaugh rationale precludes common-law negligence action for failure to report); Arbaugh v. Board of Education, 591 S.E.2d 235, 241 (W. Va. 2003) (the law “does not give rise to an implied private civil cause of action . . . for failure to report suspected child abuse where an individual with a duty to report under the statute is alleged to have had reasonable cause to suspect that a child is being abused and has failed to report suspected abuse”).

Wisconsin: Isely v. Capuchin Province, 880 F. Supp. 1138, 1148 (D. Mich. 1995) (“find[ing] nothing to indicate that the Wisconsin legislature intended to authorize a private cause of action for failure to report”) (applying Wisconsin law).

There are a number of states where the mandated reporting statute expressly includes a statutory right of action for non-reporting (Arbaugh listed Arkansas, Colorado, Iowa, Michigan, Montana, New York and Rhode Island, 591 S.E.2d at 239 n.3).  While not all of those states appear to have considered the issue, those that have hold the there isn’t any common-law liability for failure to report beyond the scope of the statutory action.  See:

Arkansas: First Commercial Trust Co. v. Rank, 915 S.W.2d 262, 268 (Ark. 1996) (affirming defense verdict on statutory failure to report claim) (note:  private cause of action repealed in 2009, and there have been no further failure to report claims).

Michigan: Murdock v. Higgins, 559 N.W.2d 639, 647 (Mich. 1997) (predicates to statutory cause of action “serve as deliberate limits to the scope” of civil liability); Marcelletti v. Bathani, 500 N.W.2d 124, 127 (Mich. App. 1993) (“the Legislature intended that liability under the statute be limited to claims for damages” meeting statutory requirements); Brent v. Wenk, 555 F. Appx. 519, 537, 2014 WL 486192 (6th Cir. 2014) (no liability for failure to report except for what statute allows).

New York: Heidt v. Rome Memorial Hospital, 724 N.Y.S.2d 139, 787 (N.Y. App. Div. 2007) (“Plaintiff has cited no authority to support the proposition that a physician has a common-law duty to report actual child abuse, let alone suspected child abuse.  There are good reasons for the absence of such a duty.”); Diana G-D v. Bedford Central School Dist., 932 N.Y.S.2d 316, 329 (N.Y. Sup. 2011), aff’d, 961 N.Y.S.2d 305 (N.Y. App. Div. 2013) (“there is simply no evidence that defendants’ failure to make such a report was knowingly and willful,” which was required for civil liability under child abuse reporting statute).

A few states have allowed private persons (usually in distinguishable situations) to bring civil actions seeking damages for failure to report child abuse.  Most notable – no surprise for its receptivity to novel claims – is:

California.  In Landeros v. Flood, 551 P.2d 389 (Cal. 1976), the plaintiff sued a doctor who had treated her in the emergency room for negligently failing to diagnose, and thus to report, her medical condition as “battered child syndrome.” Id. at 405-06.  The court recognized a private cause of action exists for intentional violation of the reporting statute.

If plaintiff wishes to satisfy that requirement [violation of statute], it will be necessary for her to persuade the trier of fact that defendant . . . treating doctor[] actually observed her injuries and formed the opinion they were intentionally inflicted on her.

Id. at 397-98.  The statutory language in Landeros, however, was amended to express “the Legislature’s . . . intent to create an objective standard in order to broaden the circumstances under which reporting is required.”  People v. Davis, 25 Cal. Rptr. 3d 92, 100 (Cal. App. 2005).  Thus the private cause of action originally recognized in Landeros has also been broadened. Pipitone v. Williams, 198 Cal. Rptr.3d 900, 917 (Cal. App. 2016) (applying lesser standard of amended statute to civil action).  See Garcia v. Clovis Unified School Dist., 627 F. Supp. 2d 1187, 1205 (E.D. Cal. 2009) (mandated reporter statute “may form the basis of a negligence per se claim”).

Other states allowing private suits for failure to report child abuse are:

Kentucky: Vanhook v. Somerset Health Facilities, LP, 67 F. Supp. 3d 810, 826 (E.D. Ky. 2014) (finding liability for failure to report child abuse based on unique Kentucky statute codifying negligence per se).  Note:  As we discussed at length here, the same statute precludes negligence per se statute for violations of federal enactments, so no failure to report analogy can help drug/device plaintiffs.

Nebraska: Chapa v. United States, 2005 WL 2170090, at *5 (D. Neb. Sept. 7, 2005) (a medical malpractice claim incorporating a duty to report was allowed; “the Court finds that there is a genuine issue of material fact regarding whether the applicable standard of care required the Physicians to report suspected child abuse”).  This decision disregards Erie to create liability never recognized by any state court.

Ohio: Yates v. Mansfield Board. of Education, 808 N.E.2d 861, 871 (Ohio 2004) (“a board of education may be held liable when its failure to report the sexual abuse of a minor student by a teacher . . . proximately results in the sexual abuse”).  Yates is a holdover from the Ohio dark ages when a pro-plaintiff high court majority was recognizing novel liability theories right and left.  Whether Yates would be decided the same way today is doubtful.

Pennsylvania:  In K.H. v. Kumar, 122 A.3d 1080, 1095-96 (Pa. Super. 2015), the court allowed a medical malpractice claim predicated on a doctor’s failure to report child abuse.  In Doe v. Liberatore, 478 F. Supp.2d 742, 763-64 (M.D. Pa. 2007), a similar claim was allowed against the clergy.  Failure-to-report has not been recognized in Pennsylvania outside the context of professional liability.  Even there, a contrary line of Pennsylvania precedent exists with respect to the duty of doctors to report to the state their patients’ medical conditions that would disqualify the patients from driving.  No liability for failure report has been recognized in those circumstances.  See Estate of Witthoeft v. Kiskaddon, 733 A.2d 623, 630 (Pa. 1999); Hospodar v. Schick, 885 A.2d 986, 989-90 (Pa. Super. 2005); Crosby v. Sultz, 592 A.2d 1337, 1345 (Pa. Super. 1991).  See also Gabriel v. Giant Eagle, Inc., 2015 WL 13240267, at *7 (Pa. C.P. June 30, 2015) (“members of a group of people harmed by the diversion of controlled substances” could not sue drugstore for failure to report thefts of such substances because “these reporting requirements are intended to protect the interests of the general public”).

South Dakota: Aman v. Cabacar, 2007 WL 2684866, at *2-3 (D.S.D. Sept. 6, 2007) (violation of mandatory abuse reporting statute can be negligence per se).  As with Chapa, above, Aman is another episode of a federal court predicting liability well beyond what any state court has done.

Tennessee: Doe v. Coffee County Board of Education, 852 S.W.2d 899, 909 (Tenn. App. 1992) (“teachers . . . have a non-discretionary duty to report students’ complaints of child sexual abuse.  Their failure to do so can give rise to liability.”); Ham v. Hospital of Morristown, Inc., 917 F. Supp. 531, 537 (E.D. Tenn. 1995) (following Doe).

Washington: Kim v. Lakeside Adult Family Home, 374 P.3d 121, 126 (Wash. 2016) (applying Beggs rationale to reporting statute concerning vulnerable adults); Beggs v. State, Dept. of Social & Health Services, 247 P.3d 421, 424 (Wash. 2011) (“the mandatory child abuse reporting statute, implies a cause of action against a professional named in the statute who fails to report suspected abuse”); Doe v. Corp. of President of Church of Jesus Christ of Latter-Day Saints, 167 P.3d 1193, 1201 (Wash. App. Div. 1 2007) (“it is reasonable to imply an intended remedy for child victims of sexual abuse when those required to report the abuse fail to do so”).

That completes what we’ve found on failure-to-report claims under child abuse/elder abuse mandated reporting statutes.  But that’s not all that’s out there for counsel tasked with debunking failure-to-report claims.

Various other statutes exist that require persons to report things to government entities.  One that popped up fairly often recently is the federal Bank Secrecy Act, which requires that certain financial transactions be reported.  This statute, being federal, is analogous in that respect to the FDCA.  These banking cases are good place to look for favorable precedent rejecting alleged reporting violations of a federal statute when asserted as negligence per se, or otherwise actionable, under state law.  “[I]t is now well settled that the anti-money-laundering obligations of banks, as established by the Bank Secrecy Act, obligate banks to report certain customer activity to the government but do not create a private cause of action permitting third parties to sue for violations of the statute.” El Camino Resources, LTD. v. Huntington National Bank, 722 F. Supp. 2d 875, 923 (W.D. Mich. 2010), aff’d, 712 F.3d 917 (6th Cir. 2013) (applying Michigan law). Accord, e.g., Belle Meade Title & Escrow Corp. v. Fifth Third Bank, ___ F. Supp.3d ___, 2017 WL 4837474, at *4 (M.D. Tenn. Oct. 17, 2017) (applying Tennessee law); Towne Auto Sales, LLC v. Tobsal Corp., 2017 WL 5467012, at *2 (N.D. Ohio Nov. 14, 2017) (applying Ohio law); Lundstedt v. Deutsche Bank National Trust Co., 2016 WL 3101999, at *5 (D. Conn. June 2, 2016) (applying Connecticut law); Taylor & Co. v. Bank of America Corp., 2014 WL 3557672, at *3 (Mag. W.D.N.C. June 5, 2014), adopted, 2014 WL 3557679 (W.D.N.C. July 18, 2014) (applying North Carolina law); Shtutman v. TD Bank, N.A., 2014 WL 1464824, at *2 (D.N.J. April 15, 2014) (following child abuse reporting cases) (applying New Jersey law); Spitzer Management, Inc. v. Interactive Brokers, LLC, 2013 WL 6827945, at *2 (N.D. Ohio Dec. 20, 2013) (reporting duty “owed to the government of the United States,” not to injured third parties) (applying Ohio law); Public Service Co. v. A Plus, Inc., 2011 WL 3329181, at *7-8 (W.D. Okla. Aug. 2, 2011) (applying Oklahoma law); In re Agape Litigation, 681 F. Supp.2d 352, 360-61 (S.D.N.Y. 2010) (applying New York law); Armstrong v. American Pallet Leasing, Inc., 678 F .Supp.2d 827, 874-75 (N.D. Iowa 2009) (applying Iowa law); Marlin v. Moody National Bank, N.A., 2006 WL 2382325, at *7 (S.D. Tex. Aug. 16, 2006) (the “obligation under that statute is to the government rather than some remote victim”), aff’d, 248 F. Appx. 534 (5th Cir. 2007) (applying Texas law); Aiken v. Interglobal Mergers & Acquisitions, 2006 WL 1878323, at *2 (S.D.N.Y. July 5, 2006) (applying New York law).  Both Ohio and Tennessee state law thus reject failure to report under this federal statute as a basis for state-law liability, notwithstanding adverse precedent under state mandated reporting statutes.

Thus, the first takeaway from our look at state-law failure-to-report claims is that most states don’t allow them. The second takeaway is that, if one is looking for state-law precedent to oppose the existence of failure-to-report claims, there are multiple, potentially fruitful avenues.  Failure to report child (or elder) abuse cases are a good place to start, but there are lots of others, such as financial reporting statutes, the drivers license revocation cases litigated in Pennsylvania, and even requirements to report things such as drug diversion and bullying.  If at first we don’t succeed, we should keep looking.

This year’s Academy Award nominations came out last week. That means that we have spent the past few days setting a schedule for seeing all of the Best Picture nominees (well, most – we don’t do war movies and tend to opt out of love stories involving semi-animate objects) and scouring recipe blogs for perfect Oscar party buffet items.  We have also reminisced, with amusement, about the climactic moments of last year’s show, during which the presenters announced the wrong Best Picture winner before an Academy official shoved them out of the way and corrected the error.  As we recall, it turned out (not surprisingly) that the mistake was caused by sloppiness.  The Academy’s accountant handed the presenters a duplicate envelope for an award that had already been presented, starting the embarrassing domino cascade.  We recall that heads rolled in the ensuing days.

Today’s case also involves the consequences of sloppiness, along with a couple of interesting legal rulings. In its unpublished decision in Small v. Amgen, Inc., et al., 2018 WL 501354 (11th Cir. Jan 22, 2018), the Eleventh Circuit considered the plaintiff’s appeal of two summary judgment orders:  a grant of partial summary judgment for the defendants, and a later grant of summary judgment on all of the remaining claims.

The plaintiff was prescribed the defendants’ drug to treat her rheumatoid arthritis. She took the drug for nearly six years then suffered a perforated bowel and a diverticulitis infection, for which she underwent multiple surgeries.  She sued the drug’s manufacturers, asserting all of the usual claims. In 2014, the district court granted summary judgment on the plaintiff’s failure-to-warn claims, holding that Florida’s learned intermediary doctrine precluded the claims.  Later, when the plaintiff’s expert disclosures revealed her sloppy omissions — although she identified five treating physicians she intended to use as non-retained experts, she had no expert to testify to general or specific causation — the defendants moved for summary judgment on the plaintiff’s remaining claims.  In 2017, the district court granted the defendants’ motion.

On appeal, the plaintiff did not dispute or even address the 2017 summary judgment order. Instead, she argued that the 2014 dismissal of her warnings claims was improper because there were factual issues “regarding the district court’s treatment of [her prescriber] as a learned intermediary.” Small, 2018 WL 501354 at *2.  She also argued that “the district court incorrectly decided that the direct ‘patient labeling requirement’ in the FDA medication guidelines did not preempt Florida’s learned intermediary doctrine.” Id.

With respect to the prescriber-as-learned-intermediary argument, the court explained that the plaintiff’s prescribing physician had 22 years of experience in rheumatology and “intentionally selected [the drug] for [the plaintiff], despite the risk of possible infections, because other forms of rheumatoid arthritis therapy had failed.” Id. What’s more, the prescriber was involved in clinical trials with the drug, and the plaintiff was a participant, giving the prescriber “more reason to know of and discuss possible side-effects or concerns” associated with the drug.” Id. The prescriber “knew that infections were possible but prescribed the drug anyway . . . because the benefits outweighed the risks.” Id. As such, because “the prescribing physician had substantially the same knowledge as an adequate warning from the manufacturer should have communicated,” the plaintiff could not prove warnings causation and her warnings claims failed as a matter of law. Id. (internal punctuation and citation omitted).   In other words, “the failure of the manufacturer to provide the physician with an adequate warning . . . is not the proximate cause of a patient’s injury if the prescribing physician had independent knowledge of the risk that the adequate warning should have communicated.” Id. (citation omitted).

Next, the plaintiff argued that Florida’s learned intermediary doctrine was preempted by the FDA’s requirement that the manufacturers provide patients with a “medication guide” for the drug. The court emphasized that “the historic police powers of the State [were] not superseded unless that was the clear and manifest purpose of Congress.” Id. at *3 (internal punctuation and citation omitted).   To discern such “clear and manifest purpose” in cases of implied preemption, the court explained that it considered “the promulgating agency’s contemporaneous explanation of its objectives as well as the agency’s current views of the regulation’s preemptive effect.” Id. (internal punctuation and citation omitted).

In the case of the medication guide regulation, the FDA had specifically addressed concerns that the regulation would alter the framework for manufacturers’ liability by abrogating the learned intermediary doctrine.  In response, the agency stated that “the written patient medication information provided did not alter the duty, or set the standard of care for, manufacturers [or] physicians . . . .” Id. (citation omitted).   Given this “contemporaneous explanation” from the FDA, coupled with the reality that “courts have not recognized an exception to the learned intermediary defense in situations where the FDA has required patient labeling . . . ,” the court held that there was no preemption.  We love this holding, and we believe this is the first time that an appellate court has so held.

No preemption, no warnings causation – summary judgment on warnings claims affirmed. And, because the plaintiff did not address her inexplicable failure to identify causation experts, the court held that she had waived any appeal of the 2017 summary judgment order.   Case (tidily) dismissed, in a no-nonsense decision we like very much.  We’ll let you know if we are similarly pleased by this year’s Oscars.

We’re now into the New Year but aren’t completely done with the old one.  The name of the first month of the year, January, is conventionally attributed to Janus, the Roman god of beginnings, gates, transitions, and doorways.  (We say “conventionally” because some sources report that January is actually named after its tutelary deity, Juno.) Janus, like some of our opponents, is two-faced.  Janus looks both forward and backward.  Bexis last month took a couple of long looks backward at 2017’s best and worst cases.  We’re still scrolling through the various Ten Best of 2017 culture lists for ideas, confirmations, and occasional outrages.  An in-house lawyer we endlessly respect pointed us to The New Yorker’s  list of top tv programs.  It’s hard to quarrel with Emily Nussbaum’s choice of The Leftovers, a fever-dream about love and loss (and a lion sex boat) as the best drama.  She was also right to praise American Vandal, the show that made us laugh out loud the most.  (The Good Place came in second on that score.)  Nussbaum also gave honorable mention to Halt and Catch Fire, an AMC show that really did seem to catch fire after its first, flawed season.  HACF stopped acting like a Mad Men, difficult-guy retread, shifted focus to the female protagonists,  and successfully steered us through the digital revolution – from PC clones to gaming to community chat boards to security to the web to PayPal to Yahoo to something even sexier than a lion sex boat: the Next Idea.  In seasons 2-4, HACF managed to show us (rather than merely tell us) how “computers aren’t the thing; they are the thing that gets us to the thing.”  That ‘thing’ is human connection. But you already knew that, right? There is an episode after the death of a major character that is the best depiction of grief and its clumsy toggling between the transcendent and the quotidian that we’ve seen.  The dead leave a lot behind.  Some of it goes to Goodwill.  Some of it survives in silly stories.  Some of it gets caught in our throats and some of it squeezes our tear ducts hard.  If you are looking for something to binge, consider The Leftovers, American Vandal, and Halt and Catch Fire (and maybe Patriot, The Americans, and Mindhunter).  You might also want to set aside an hour to take in episode 8 of Twin Peaks: The Return because you need to relive your college experience of attending a midnight showing of something arresting and supremely weird. 

Today’s post takes us back to 2017 for a case that is neither particularly arresting nor even a little bit weird.  Rather, the result seems inevitable.  In Siddoway v. GlaxoSmithKline LLC (In re Avandia Mktg., Sales Practices & Prods. Liab. Litig.), 2017 U.S. Dist. LEXIS 203885 (E.D. Pa. December 12, 2007), the plaintiff alleged that he sustained a heart attack from taking Avandia, and that the label did not warn him adequately.  The facts here, both regarding the plaintiff’s use and the regulatory backdrop, lead ineluctably to the defendant’s victory on summary judgment.   The plaintiff was initially prescribed Avandia from 2001 through 2002. In 2003, the plaintiff suffered two heart attacks, and ultimately underwent a successful heart transplant operation. He blamed Avandia for those heart attacks.  Following the heart transplant, a different doctor prescribed Avandia to the plaintiff. The plaintiff continued to take Avandia from December 2003 through June 2007, and did not experience any other adverse cardiovascular condition.

Let’s go backward for a moment.  When Avandia was initially approved by the FDA in 1999 to treat Type II diabetes, the drug’s label contained no warning of an increased risk of heart attack. But in 2007 – four years after the plaintiff’s heart transplant — the FDA issued a safety alert for Avandia, notifying consumers that “data from controlled clinical trials have shown that there is a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.”  The FDA directed that a boxed cardio warning be added to the Avandia label.  So there’s your lawsuit, right?

Not quite.  Now let’s go forward.  After the label change and after the plaintiff filed his lawsuit, the manufacturer and the FDA conducted extensive research on Avandia’s safety. In 2013, the FDA ultimately concluded that there was no increased risk of heart attack associated with Avandia use compared to alternative diabetes medications. Thus, in 2014, the FDA approved an updated Avandia label that removed the boxed warning for a potential increased risk of heart attack.  Good science led to good news for patients, but not such good news for this particular patient’s lawsuit.  All of the plaintiff’s nine causes of actions essentially boiled down to failure to warn theories, and the facts on the ground had removed all support for that theory.  Even putting aside the question of whether the original label was inadequate because it lacked a warning that had now been repudiated by the FDA, the plaintiff’s case failed for inability to show that the alleged failure to warn was the proximate cause of the plaintiff’s injuries.  To the extent that specific claims bumped against the learned intermediary doctrine (Utah law governed, so the learned intermediary doctrine was alive and well), the plaintiff faced a huge problem when it came to posing the usual question to the prescriber:  knowing what you know today, would you still have prescribed this medicine to the plaintiff?  From his deposition testimony, it is clear that the prescriber’s “understanding of Avandia’s risk profile today is the same as it was when he prescribed Avandia to [the plaintiff]—that Avandia is not associated with an increased cardiovascular risk compared to other diabetes drugs.  He also testified that, if the current package insert were in place when he was prescribing Avandia to [the plaintiff], he still would have prescribed it.”  That is pretty inescapable logic.  John Adams once said that “facts are stubborn things.”  So is science.  So are label changes. 

But the plaintiff did try to escape the facts, the science, and the label changes.  He pointed to the prescriber’s testimony that he “quit using” Avandia for patients after 2007.  But that same prescriber’s testimony made clear that even when the 2007 data on which the plaintiff based his claims is considered along with the other Avandia risk data available today, he would still prescribe Avandia to the plaintiff, just as he had in 2001 and 2002, when there was no heart attack risk warning in the Avandia label. It is as if the plaintiff tried to preserve his case by seizing upon one favorable moment in time and excluding any other, subsequent facts that might prove inconvenient.  Don’t look forward, and don’t look backward.  Just look at the evidence in that nanosecond that might support a claim.  But no decent doctor would do that.  Nor would any sensible court.  Hence, the Siddoway court held that the plaintiff had failed to establish a genuine issue of material fact as to whether the prayed-for warning would have deterred the doctor from prescribing Avandia to the plaintiff before he suffered the 2003 heart attacks.  The court looked at all the evidence, forward and backward, and saw its way clearly towards complete dismissal of the case.