This falls into the category of “almost breaking news”:

On Friday, Judge Todd Campbell, who’s handling the Aredia/Zometa MDL, entered an order granting partial summary judgment based on Texas Civil Practice and Remedies Code Sec. 82.007 as to all failure-to-warn claims. In re Aredia and Zometa Prods. Liab. Litig., 2008 WL 2944910 (M.D. Tenn. July 25, 2008).

(We’ve plowed this ground at this blog before. Please click here for the legal background; the following description is a shorthand version meant for folks already generally familiar with the underlying legal issue.)

Eight Texas residents sued for personal injuries allegedly caused by Novartis’ drugs. Seven filed their complaints in New York; one filed in Texas. The MDL Panel transferred all of the case to the Middle District of Tennessee for pretrial proceedings.

Under both New York and Texas choice of law rules, Texas law governed plaintiffs’ claims.

Texas Civil Practice and Remedies Code Sec. 82.007(a) provides that drug manufacturers are not liable for failure to warn if the warnings that accompanied their product had been approved by the FDA.

Plaintiffs can rebut that presumption by, among other things, proving that the defendant misrepresented to the FDA material information that was causally related to the plaintiff’s injury. Tex. Civ. Prac. & Rem Code Sec. 82.007(b).

Citing Buckman Co. v. Plaintiffs’ Legal Comm., 121 S. Ct. 1012 (2001), Judge Campbell found that the fraud-on-the-FDA exception is preempted, leaving only the immunity from failure-to-warn liability intact. Rejecting the magistrate judge’s contrary decision in Ackermann v. Wyeth, 471 F. Supp. 2d 739 (E.D. Tex. 2006), Judge Campbell granted partial summary judgment in favor of Novartis.

It has been a while since we’ve written about a case delivering a one-two punch against a plaintiff suing both brand and generic drug manufacturers for alleged injuries from ingesting generic drugs. Punch One is rejection of the claims against the brand manufacturers because they did not make or sell the products at issue in the product liability case. That is, the courts (the sane ones, anyway) turn thumbs down on innovator liability. Punch Two is rejection of failure to warn claims against the generics because, per the SCOTUS Mensing decision, such claims are preempted on the theory that the generic manufacturer was powerless to fiddle with the drug label.

In Johnson. v. Novartis, 2020 WL 2300139 (W.D. Texas May 7, 2020), the court actually delivered a one-two-three punch. The plaintiff had ingested two generic drugs and claimed that they gave him Peyronie’s Disease (PD). He asserted the usual battery of claims (strict liability, negligence, fraud, warranty), as well as a violation of the Texas Deceptive Practices Act. The Johnson court dispensed with the multiplicity of actions and treated the entire case as a products liability claim based on an alleged failure to warn.

    Punch One: Innovator Liability – Brand Name Manufacturers

The two brand name defendants each moved to dismiss the plaintiff’s claims as relying on innovator liability — i.e., claims against a brand name manufacturer for injuries caused by a generic drug. The plaintiff did not ingest the brand name drugs. His claims against the brand manufacturers relied on the other defendants’ generic drugs copying the information from the brand name labels.

Texas law rejects this theory of liability for the simple fact that “products liability law generally requires allegations that the defendant supplied the allegedly defective product to the plaintiff.” In Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674 (5th Cir. 2014), the Fifth Circuit upheld the district court’s dismissal of the plaintiff’s negligence, products liability, and fraud claims against the brand name manufacturers, reasoning that brand name manufacturers do not owe a duty to consumers of generic drugs. The Johnson court followed this ruling and dismissed the plaintiff’s claims against the brand manufacturers.

    Punch Two: Federal Preemption – Generic Manufacturers

The plaintiff’s state law claims against the generic manufacturers were preempted by federal law. This preemption stems from the Supreme Court’s decision in Mensing, which held that federal law preempted state law causes of action related to a generic drug manufacturers failure to warn. PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011) (holding it impossible for generic manufacturers to abide by state warning laws while also abiding by federal law mandating that they match brand name labels). The Fifth Circuit precedent followed Supreme Court precedent (because that is what lower courts are supposed to do) and interpreted Mensing as preempting Texas law claims such as those the plaintiff asserted in Johnson. The Johnson court followed both the SCOTUS and Fifth Circuit precedents (because that is what lower courts are supposed to do), and held that the plaintiff’s claims against the generic manufacturers based on their alleged failure to warn of the risk of PD were preempted.

    Punch Three: FDA Approval

All the defendants pointed to Texas law’s presumption of no liability for FDA-approved labels. Indeed, Texas Civil Practice & Remedies Code Section 82.007(a)(1) provides that FDA approval “presumptively insulates from liability, for failure to warn, defendants who made, prescribe, or sell drugs in accord with FDA standards.”

Texas law provides five ways this presumption of no liability can be rebutted: (1) “fraud on the FDA”; (2) the product was sold after the FDA ordered the product removed from the market; (3) if the manufacturer promoted the product for a use not approved by the FDA; (4) off-label prescriptions; and (5) bribery of a public official.

The plaintiff in Johnson went the usual route and pleaded the “Fraud on the FDA” exception. Specifically, the plaintiff alleged that the defendants withheld from the FDA information related to the connection between the drugs and PD. But the “Fraud on the FDA” exception is preempted by federal law unless the FDA has found fraud. Thanks again, Buckman. Because the plaintiff could not allege that the FDA had found fraud on behalf of the defendants related to these drugs, this exception was preempted and could not provide the basis for liability.

The plaintiff sought to avail himself of another exception by contending that the defendants “recommended, promoted or advertised” these drugs “for an indication not approved by the [FDA].” But pleading this exception requires alleging that (a) the defendants marketed and promoted the unauthorized use of the drugs to the prescribing doctors, that (b) the plaintiff relied on that specifically promoted use, and that (c) the plaintiff’s injuries were caused by that off-label promotion. And yet the plaintiff in Johnson utterly failed to to allege any facts related to “off-label” marketing. The Johnson court therefore concluded that the plaintiff had not alleged any facts rebutting Texas law’s presumption of no liability resulting from FDA approval.

    Knock-out Punch: No Leave to Amend

Not surprisingly, the plaintiff moved for leave to amend his complaint. Federal Rule of Civil Procedure 15(a) governs amending pleadings, stating that Courts “should freely give leave when justice so requires.” But justice did not so require in Johnson. The plaintiff’s proposed amended complaint did not solve his problems. Instead, he reiterated that he ingested only the generic drugs, and thus his amendment would be futile as to the brand manufacturers. Nor could he get around Mensing preemption as to the generic manufacturers. Nor could he rebut Texas law’s presumption of no liability for drugs approved by the FDA. Accordingly, the Johnson court denied the plaintiff’s motion for leave to amend, and dismissed all of the claims with prejudice.

    Ain’t Gonna Be No Rematch

The Fifth Circuit subsequently affirmed the trial court’s decision, and the Supreme Court recently denied certification and a rehearing. Johnson v. Novartis Pharms. Corp., 845 F. App’x 305, 307 (5th Cir.), cert. denied, 142 S. Ct. 83 (2021), reh’g denied sub nom. JOHNSON, RAMON D. v. NOVARTIS PHARMACEUTICALS, ET AL., No. 20-1572, 2021 WL 5763397 (U.S. Dec. 6, 2021).

Delaware is having something of a moment in the sun.  Although the state’s license plates have long announced it as “The First State,” that refers to being the first to ratify the U.S. Constitution.  It is the second smallest in size and sixth smallest in population of the current fifty states.  The casual peruser of a map of the U.S. might miss it.  Even its state fish, the weakfish, is, well, weak.  (Disclaimer:  A few of us grew up and/or live in Delaware’s neighboring states.)  Now, though, Delaware is home to the President of the United States.  It also continues to be the preferred state of incorporation for publically traded companies, with about 300 of the Fortune 500 incorporated there.  That has led to a bit of a surge in product liability litigation in Delaware state courts.  Why now?  Well, the tightening of the rules on personal jurisdiction over the last several years means that many plaintiff lawyers have to choose between federal court, and possibly a slow MDL, or state court in Delaware, where the defendant is incorporated and/or based.  Before Bauman, it did not seem that Delaware was a popular choice for the plaintiff lawyers, certainly if proceeding in the state court where the plaintiff lived or where the plaintiff lawyer liked to bring many litigation tourism cases was an option.  Now, Delaware is getting more cases and Delaware courts are increasingly deciding cases under the law of another state, somewhat like a federal court sitting in diversity and hopefully practicing some Erie restraint.

In Pope v. Astrazeneca AB, No. N20C-06-116 FAR, 2021 Del. Super. LEXIS 281 (Del. Super. Ct. Apr. 5, 2021), we have just such a case.  The case involves a claim of Fournier’s gangrene, a nasty perineal infection, in connection with the use of a particular diabetes medication.  We have previously posted on decisions from the MDL and from the same Delaware state court about this same medication.  Like this case, the prior Delaware case even involved Texas law, which almost invariably means consideration of the second most famous “007,” § 82.007 of the Texas Code, which provides a presumption of adequacy for FDA-approved drug labels (like a license to kill warnings claims).  We have posted quite a bit on this provision, like here and here, and we can say it has been a key provision in some pretty effective tort reform.  There was a time when the suggestion that a Texan would chose to sue a Delaware drug company in its backyard would have drawn a hearty guffaw.  Times have changed.

In Pope, the plaintiffs brought claims relating to warnings, design, negligence, warranty, loss of consortium, and punitive damages, the defendants moved to dismiss, and the court addressed everything in a no-nonsense and sensible fashion.  The wrinkle in this case was that the plaintiff—the one who took the medication—claimed to have been prescribed it for weight loss as well as his diabetes.  The latter was on-label, but the former was off.  This might matter under § 82.007 because it provides an exception to the presumption of adequacy that would otherwise have applied if “the manufacturer promoted the product for a use not approved by the FDA.”  Id. at *4.  We note that the court did not get caught up in questions about how to deal with FDA approval—a fact often omitted from complaints and necessary for the presumption, which is arguably a defense—on a motion to dismiss.  Instead, it identified that the exception required pleading not just of promotion and reliance on it, but of a causal relationship between the off-label promotion and the plaintiff’s injuries.  Id. at *5.  Here, plaintiff admitted to being prescribed the medication on-label, but with the hope that it would also help him lose weight.  Common sense indicates that the alleged off-label promotion could not be the cause of plaintiff’s injuries in that situation.  Texas federal courts had addressed this in at least two cases, one of which we discussed here.  With its own Delaware version of Erie restraint (Rehoboth restraint or Appoquinimink restraint?), the court held that the exception did not apply:

Pope was using Farxiga for both an indicated and non-indicated use.  And Plaintiffs cannot establish, nor have they even pled, that Pope’s injuries were caused by his off-label use of Farxiga for weight loss, as opposed to his FDA approved use of Farxiga to treat his Type 2 diabetes.

Id. at *8.  The presumption of adequacy held and the warnings claim was dismissed.

Next up was the design defect claim.  As the court had held previously, an adequate warning defeats a design defect claim under Texas law.  Id. at *9.  As an added measure, the court looked at whether plaintiffs could carry their burden of showing a safer alternative design.  Noting that a manufacturer cannot change the design of an approved drug, “[t]o establish that a safer alternative design exists would invoke a state duty to change the design of the drug,” which meant the design claim was preempted.  Plaintiffs, however, attempted to parse the design claim into pre- and post-approval halves, the former of which they claimed was not preempted.  Relying on one of our favorites, Yates, the court rejected plaintiffs’ argument:

In order to find for Plaintiffs on such a claim, the Court would be required to engage in multiple levels of supposition. For instance, the Court would have to speculate about whether a pre-approval design change would have fixed the problem; whether the FDA would have approved such changes; whether Pope’s physician would have recommended and prescribed the differently designed drug, if it was FDA approved; and whether Pope would have taken the drug after such changes and processes were executed. The Court would be required to make unfounded inferences as to each of these questions to find for Plaintiffs, and thus is unable to countenance Plaintiffs’ pre-approval design defect argument.

Id. at *11.  Therefore, the design claim was also dismissed.

As to plaintiffs’ negligence claims, the court did not fall for the argument that merely asserted negligence is enough.  With the exception of negligent failure to test, the negligence claim was really duplicative of the warnings and design claims already dismissed.  Id. at *12.  The same went for express and implied warranty.  Id. at **13-14.  As to failure to test, this is where we have a gripe.  The statement that “[c]ourts in Texas have recognized an independent cause of action based on negligent failure to test” was based on the Murthy decision panned here for, among other problems, not making a proper Erie prediction.  Another case following Murthy (and discussed in not-so-glowing terms here) was cited, but is clearly part of a minority.  In any event, the assertions supporting a purported failure to tests were conclusory boilerplate and held to be inadequate.  Id. at *13.  Because this part of the dismissal was without prejudice, plaintiffs will get another shot at trying to plead negligent failure to test if they choose.  Should they try again, we hope the court will take a deeper dive into whether Texas really has adopted such a claim, which is logically just another version of failure to warn.

Back during the Orthopedic Bone Screw mass tort litigation, one of major avenues of attack on the plaintiffs’ novel claims was to pursue every state-law avenue for rejecting the assertion of negligence per se predicated on supposed violations of the Food, Drug & Cosmetic Act (“FDCA”).  That approach originally led us to 21 U.S.C. §337(a), the FDCA’s “no private enforcement” provision, which we later successfully repurposed to support preemption in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).

It also led to reliance on other limitations on negligence per se in other states.  We’ve already discussed Kentucky’s limitation of negligence per se to claimed violations of state, as opposed to federal, enactments.  We also had success with legislative intent arguments in Florida and Wisconsin, and with a licensing statute argument in Virginia.  Now, it turns out that some anti-negligence per se seeds we planted in Texas found some fertile ground.

In Baker v. Smith & Nephew Richards, Inc., 1999 WL 811334 (Tex. Dist. June 7, 1999), aff’d on other grounds, 2000 WL 991697 (Tex. App. July 20, 2000), a Texas trial judge in a Bone Screw case rejected FDCA-based negligence per se allegations every which way but loose.  “The pertinent question is whether the duties set forth in the federal law are analogous to those set forth in the local tort law.”  Baker, 1999 WL 811334, at *8 (quoting Johnson v. Sawyer, 47 F.3d 716, 729 (5th Cir. 1995)).  Thus, under Texas law, Baker held that the plaintiff:

must do more than simply denominate his claim for violations of the FDCA as a negligence per se claim.  [He] must demonstrate that the regulations in question establish suitable standards of conduct under preexisting, independent Texas tort law.

Id.  The plaintiff in Baker could not do so.  FDCA-based negligence per se flunked the criteria for allowing use of negligence per se established in Perry v. S.N., 973 S.W.2d 301 (Tex. 1998).

First, “the FDCA does not establish the sole duty of a manufacturer.”  Baker, 1999 WL 811334, at *9 (footnote omitted).  “While the FDCA is more precise than these general concepts, it varies significantly from common law negligence.  The Court in Perry cautioned against applying negligence per se if it causes a “great change” in the law.  Id.  “[A]bsence of a corresponding common law duty weighs against adopting negligence per se in the FDCA regulations.”  Id.  “[T]he [FDA’s] regulations do not merely serve to define more precisely what conduct breaches the common law duty.  To the contrary, a new and more stringent duty would be imposed.”  Id.

Second, FDA regulations do not “clearly define[] the prohibited conduct.”  Id. at *10 (quoting Perry).  That was particularly true of claims alleging off-label promotion:

This factor weighs against the imposition of tort liability.  The FDCA, MDA, and FDA guidelines are not clear about prohibited conduct. . . .  Therefore, it is difficult for a manufacturer to know exactly when the activities are promotional or scientific/educational.

Id. (quote from FDA guidance document omitted).

Third, negligence per se in Texas is improper where it would convert negligence into “liability without fault.”  Id.  Under the FDCA “the manufacturer’s acts may result in [FDA enforcement] if no scienter is shown.”  Id.  In product liability cases:

the negligence per se theory is surplusage if [plaintiff] prevails on . . . common law negligence or strict liability claims.  If [plaintiff] cannot succeed on either of these issues, an issue is raised as to the culpability of Defendant’s conduct. . . .  Therefore, applying negligence per se may create liability without fault that causes injury.


Fourth, “the only inquiry for the jury” in FDCA-based negligence per se “is whether the defendant violated the statute and, if so, whether this was a proximate cause of plaintiff’s injuries.”  Id. (citation omitted).  Thus, any FDCA violation could impose liability “without regard to the condition of the device itself (assuming provable causation).  The device could be absolutely safe (i.e., free from defects and not tainted by negligence), but [defendant] would still be liable.  Id.  This type of liability violated Perry’s rejection of negligence per se where it “would impose ruinous liability disproportionate to the seriousness of the defendant’s conduct.”  Id.

Fifth, a relevant factor “is whether [plaintiff’s] injury is a direct or indirect result of the violation of the statute.”  Baker, 1999 WL 811334, at *11.  “This factor also supports” rejection of negligence per se because an alleged FDCA violation “does not prove that the device was unsafe and therefore caused [plaintiff’s] injury.”  Id.  The claimed liability:

is too attenuated to impose liability automatically through a per se cause of action.  It may be an unreasonably dangerous and defective device, a manufacturer’s negligence, or the negligence of a learned intermediary that would directly cause plaintiff’s injury in this type of case, but it is not a failure to follow administrative regulations.


Since the Bone Screw litigation concluded, other courts applying Texas law have followed Baker’s thorough analysis.  In Hackett v. G.D. Searle & Co., 246 F. Supp.2d 591 (W.D. Tex. 2002), involving a drug rather than a device, plaintiff asserted negligence per se based on purported FDCA violations “by providing inaccurate information in their warnings, informational materials and package inserts.”  Id. at 594.  Starting, as Baker did, with Johnson v. Sawyer, Hackett recognized that “[c]ourts are not required to find negligence per se from a violation of a federal statute, particularly where the violation would not give rise to liability under state common law.”  Id.  “Because the FDCA does not provide for a private cause of action, many courts have held plaintiffs cannot seek to enforce it through negligence per se tort actions.”  Id. (citing three Bone Screw cases).  Hackett adopted Baker’s rationale.  “The Court finds the Baker Court’s application of the Perry factors persuasive and declines to create a new cause of action, particularly in a case where the Plaintiff has been so lackadaisical in pursuing his novel theory of liability.”  Id. (citations omitted).

Baker was also persuasive in Jackson v. Kim, 2004 WL 6040969 (E.D. Tex. Sept. 27, 2004):

Because the [statute] does not provide for a private cause of action, this Court is not inclined to enforce such standards through negligence per se tort actions. . . .  [O]ne Texas court has held the FDCA and FDA regulations do not give rise to a negligence per se cause of action under the standard . . . established in Perry. . . .  The Court finds the Baker Court’s application of the Perry factors persuasive and declines to create a new cause of action.

Id. at *4.  Without citing Hackett, Kim reached a virtually identical result – even though Kim was not an FDCA-based case, but rather a Fair Debt Collection Practices Act case.  See Bruce v. Nationstar Mortgage, 2015 WL 728028, at *4 (N.D. Tex. Feb. 19, 2015); Bent v. Mackie Wolfe Zientz & Mann, P.C., 2013 WL 4551614, at *6 (N.D. Tex. Aug. 28, 2013); Thompson v. Hughes, Watters & Askanase, LLP, 2013 WL 4441979, at *9 (N.D. Tex. Aug. 20, 2013) (all dismissing FDCPA cases for similar reasons).

In Holland v. Hoffman-La Roche, Inc., 2007 WL 4042757, at *3 (N.D. Tex. Nov. 15, 2007), another prescription drug case, plaintiffs primarily pursued warning claims, but those claims failed to overcome the Texas statutory presumption of adequacy in Tex. Civ. Prac. & Rem. C. §82.007(a)(1).  2007 WL 4042757, at *2-3.  Holland made short work of an FDCA-based negligence per se, based on prior precedent.  “Texas courts also refuse to recognize a cause of action for negligence per se based on violations of the Food and Drug Cosmetic Act (“FDCA”) and FDA regulations.”  Id. at 3 (citing Hackett).

More recently, in a generic drug case that (like the Bone Screw litigation) involved claims concerning off-label use, Monk v. Wyeth Pharmaceuticals, Inc., 2017 WL 2063008 (W.D. Tex. May 11, 2017), rejected FDCA-based negligence per se as inconsistent with Texas law.  Following Baker, Hackett, and Holland, Monk dismissed the negligence per se allegations.

[U]nder the applicable factors set forth by the Texas Supreme Court, the FDCA and FDA regulations did not give rise to a cause of action for negligence per se under Texas law . . . .  The Court is persuaded by the cases cited by Defendants, and agrees that Texas law likely does not recognize a cause of action for negligence per se based solely on the violation of the FDCA and FDA regulations.

Id. at *8 (citations omitted).  Monk rejected several arguments in favor on FDCA-based negligence per se.  First, the action failed as a matter of law.  “[A]ll of these cases, despite being postured as summary judgment decisions, conducted a legal (not factual) analysis of negligence per se claims.”  Id.  Non-Texas cases (primarily the infamous Oklahoma Howard decision) weren’t “binding in any respect” and were “countered by other out-of-circuit decisions that reach the opposite result.”  2017 WL 2063008, at *8.  Finally, while another judge had let FDCA-based negligence per se claims survive dismissal, negligence per se was “never analyzed” so those orders were “not an affirmation of the validity of these claims.”  Id.

Finally, several weeks ago, we saw Sweezey v. C.R. Bard, Inc., 2020 WL 1237394 (N.D. Tex. Mar. 12, 2020), which disposed of a negligence per se claim against a medical device manufacturer on the same basis, that “’Texas courts . . . refuse to recognize a cause of action for negligence per se based on violations of the FDCA and FDA regulations.”  Id. at *1. Since the plaintiff in Sweezey “d[id] not dispute that his negligence per se claim is based on Defendants’ alleged violations of the FDCA and FDA regulations . . ., the Court grant[ed] summary judgment as to Plaintiff’s negligence per se claim.”  Id. (citing Monk, Jackson, Hackett, and Baker).

It’s hard for a defendant to “win” a mass tort because of the mass.  But plaintiffs (or their counsel) will think twice if they think that their litigation is producing precedents that will negatively impact future cases.  From Buckman on down, that was how the Bone Screw litigation was litigated, and the fate of FDCA-based negligence per se claims in Texas is one more example that Bone Screw was a defense win.

Truly unique cases are, well, unique. Most cases involve variations or combinations of cases we have seen before. Sometimes you get different results between two decisions on basically the same case with a single fact different. In February, we posted on an Eastern District of Pennsylvania decision on a motion to dismiss in a case involving allegations about severe hypophosphatemia (“HPP”) with a prescription injection for iron deficient anemia. The decision applied Pennsylvania law and was a mixed bag.  Pennsylvania, of course, does not have strict liability for prescription medical products, so those asserted claims went away. Most of the rest of the decision was not so great for the good guys, though.

In Atkinson v. Luitpold Pharms., Inc., No. 19-277, 2020 WL 1330705 (E.D. Pa. Mar. 23, 2020), the same court ruled on a similar motion to dismiss involving pretty much the same complaint about the same injury with the same prescription drug. The main difference is that Atkinson applied Texas law. Texas really has not been the plaintiffs’ paradise of yore (and lore) for some time. This has been driven in part by the enactment in 2003 of §82.007 of the Texas Civil Practice and Remedies Code. In addition to having a cool number—we leave it to others to suggest a Bond movie marathon to pass the days or offer an appropriate recognition of the passing earlier this week of Honor Blackman—the provision creates a rarely rebuttable presumption on non-liability for failure to warn claims where a drug’s label has been approved by FDA. Among the enumerated bases for rebutting that presumption is where the defendant “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury”—i.e., committed fraud on the FDA in Buckman parlance. PA has nothing like that. The provision’s relative novelty has led to a fair amount of attention and a bunch of posts over the years.

Briefly, Atkinson involves a complaint alleging a range of design and warnings claims related to the risk of HPP with the drug, which was approved in 2013 after two prior non-approvable letters driven by concerns about HPP. As could be expected, the launch label contained information approved by FDA about HPP in multiple sections. Plaintiff, who was prescribed and administered the drug once in 2016, claimed to have developed HPP and criticized the strength of the HPP information in the label. (She also criticized changes to the label after her prescription, but that is of no matter.) Defendants—the NDA holder and three other companies—moved to dismiss, largely based on preemption given §82.007. Plaintiff’s response included the contention that she could rebut the presumption based on the fraud-on-the-FDA exception. Thus, the issue—the one we care most about—was joined.

The court started its analysis, from our perspective, a little backwards. Rather than starting with what plaintiff asserted and what Texas law said about it—e.g., what claims exist, what is required to prove them—the court started with a discussion of preemption, starting with this curious statement:

Defendants argue that any of Plaintiff’s claims that are premised on a failure to warn are preempted by federal law in that they boil down to the theory that Injectafer should have been labeled and designed differently despite FDA approval of the existing label and design.

Id. at *3. This came with a footnote saying the defendants challenged only pre-approval warnings and design claims, the plaintiff did not claim a post-approval design claim, and defendants did not challenge the post-approval warning claim. We will save our ink on all of that and simply note that the approach here allowed the court to follow its approach in Crockett and conclude a pre-approval design claim was not preempted. Id. As we have said before, if any claim is preempted in a prescription drug product liability case, then it is one premised on the argument that the drug should have had a different design when it was approved. With this issue punted away, the court turned to the Texas statute and, in short order, Buckman.

Plaintiff’s concession that she could avoid the presumption of non-liability for all the warnings claims she asserted only by proving that defendants had “withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant’s injury” teed up the precise issue about the Texas statute.

Although a handful and some cases have evaluated whether it (or a substantially similar Michigan statute) is preempted by the Buckman rationale, the Third Circuit has not.

Id. at *5. The court cited Lofton, Garcia, and some lower court cases in the Third and Fifth Circuits on the preemption side and Desiano and some lower court cases in the Third Circuit on the no preemption side. After reviewing the circuit cases in some depth—although with a bit too much on the debunked presumption against preemption for our taste—the court looked primarily to Lofton as the most persuasive and on-point. The “the only federal appellate court to have interpreted the Texas exception at issue here,” happened to be one “conversant in Texas law,” and “it did so in a factually analogous circumstance involving common law tort claims after carefully considering the counter-arguments made in Desiano.Id. at *7.

Following Lofton and noting that plaintiff’s fraud allegations did not include the claim that FDA had ever determined HPP risk information had been withheld, Buckman precluded plaintiff from trying to fight the presumption against warnings claims. Id. That did away with five of plaintiff’s counts grounded in failure to warn, including a fraud count that was based on “failure-to-warn allegations cast under a different heading.” Id. at *8.

Another domino fell because Texas follows comment k and, as discussed above, the presumption of adequate warnings held. That means plaintiff’s design defect claim was also dismissed. All that was left for the court was the issue of whether plaintiff had pled a failure to test claim, which Texas recognizes as a species of negligence. Her general negligence and “gross negligence” allegations did not come close, but, as with most initial challenges to the adequacy of pleading, plaintiff was permitted another shot to get it right. If she does not come up with enough allegations to revive a gross negligence claim, then her punitive damages claim will also stay dismissed. Even with something of plaintiff’s complaint remaining, there was not enough to support punitive damages. That last bit was a holding under either Texas or Pennsylvania law. The rest was pure Texas.

Some states seem stronger on FDA preemption than SCOTUS was in the Wyeth v. Levine decision. For example, Michigan, New Jersey, and Texas prevent or limit the ability of plaintiffs to sue over an FDA-approved drug, including attacks on the FDA-approved label. See, e.g., Texas Civ. Prac. & Rem. Code Ann. § 82.007. Sometimes those statutes afford plaintiffs an out under certain circumstances. Some of those outs make sense (e.g., if the medicine was sold after it had been ordered withdrawn by the FDA) and some do not (e.g., off-label use or promotion). The most controversial out allows plaintiffs to sue over an FDA-approved drug if the plaintiff can show that such approval happened only because the FDA had been hoodwinked. That translates into a claim of fraud on the FDA, and that, in turn, is preempted by Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). If anyone is going to decide whether the FDA had been defrauded, it should be the FDA, not some state jury whipped into a frenzy by cherry-picked documents and reptilian rhetoric. Thus, the exception is null and void and the plaintiff is still out of luck.

That’s our position, of course. We could say that reasonable minds can disagree, but we don’t believe that for a second. When appellate courts come out on opposite sides as to whether a state fraud-on-the-FDA exception was preempted, we have no trouble saying that the courts holding preemption — Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (applying Texas law) (discussed here), and Aron v. Bristol-Myers Squibb, 2018 U.S. Dist. LEXIS 39146 (S.D.N.Y. Mar. 9, 2018) (applying Texas law) (discussed here) — were right, while the courts holding no preemption — 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), and Tigert v. Ranbaxy Pharmaceuticals, Inc., 2012 WL 6595806 (D.N.J. Dec. 18, 2012) (applying Texas law) — were wrong.

The plaintiff in Kumaritakis v. AstraZeneca Pharmaceuticals LP, 2020,WL 1024933 (Del. Super. Ct. March 2, 2020), was apparently spoiling for a fight on this issue. She claimed that she had been injured by taking an FDA-approved diabetes drug. Her causes of action included negligence and failure to warn. The parties agreed that Texas law governed, so the plaintiff ran smack against section 82.007. Right out of the chute, the plaintiff argued that the FDA fraud exception was not preempted. That should be a flat-out loser. And so it was in this case, but not for the reason you’d expect. The Delaware court was able to side-step the preemption point because the plaintiff never bothered to argue that any of the exceptions actually applied. Indeed, the plaintiff said she was not alleging that the defendant misrepresented or withheld information from the FDA.

Well, that was easy.

Why are we even writing about the Kumaritakis case? Isn’t this just an odd instance of a plaintiff shooting herself in the foot? What useful lesson emerges from this case? Well, one lesson might be to check whether the plaintiff has skipped a step or two in the rush to join issue on the most difficult or important legal dispute. (Think of so-called “parallel claim exception” cases in which plaintiffs never bothered to show any legitimate state law claim.)

There is another aspect of the Kumaritakis case that is interesting. The plaintiff also brought a cause of action for design defect She claimed that a safer design existed. Maybe so, but under FDA regulations, once a drug is approved “the manufacturer is prohibited from making any major changes in the ‘qualitative or quantitative formulation of the drug product, including inactive ingredients, or in the specifications provided in the approved application.’” Essentially, the plaintiff was singing that old Huey Lewis and the News song, “I Want a New Drug.” The court’s response was, “Yeah, well you’re not getting one until the FDA approves it.” The defendant could not change its medicine without FDA approval. That is straight-on impossibility preemption.

It seems to us that this sort of preemption is ineluctable and obvious, and should consign almost all pharma design defect claims to the litigation boneyard.

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.

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).


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’ve addressed many times Texas Civil Practice & Remedies Code §82.007, a tort reform statute that, essentially, creates a presumption in drugs cases that a drug’s warning is adequate if the FDA approved it. See §82.007(a)(1). The statute gives plaintiffs with five ways to rebut that presumption, one of which is to show that the defendant withheld information from, or misrepresented information to, the FDA. §82.007(b)(1). That means of rebuttal, however, was held to be preempted by the Fifth Circuit under Buckman because it requires a plaintiff to prove fraud on the FDA. Lofton v. McNeil Consumer & Specialty Pharma., 672 F.3d 372 (5th Cir. 2012).

We recently uncovered a case in which a plaintiff actually tried to expand the Fifth Circuit’s ruling as a way around §82.007’s presumption of warning adequacy. See T.R.M. v. GlaxoSmithKline LLC, 2015 U.S. Dist. LEXIS 183272, (S.D. Tex. Aug. 21, 2015). In particular, the plaintiff argued that, if Buckman preemption applies at all, it must invalidate all of §82.007, not just its fraud-on-the-FDA based rebuttal. In short, even though the statute created a presumption of adequacy and five ways to rebut it, the plaintiff asked the court to scrap the entire presumption regime because one means of rebuttal was preempted.

Uh, no.

Rules of statutory construction require courts to give effect to as much of a statute as possible while maintaining its original purpose, severing only as little as necessary. Preempting only the fraud-on-the-FDA rebuttal provision of §82.007 accomplishes that. Plaintiffs still have the potential options of four other means of rebuttal and, in fact, might even be able to use the fraud-on-the-FDA rebuttal if the FDA itself made such a finding.

Continue Reading Texas Federal Court Rejects Attempt to Misapply Buckman to Invalidate Statutory Rebuttable Presumption of Warning Adequacy

Here’s another guest post by Reed Smith’s own Kevin Hara, this time about a recent Texas case holding that health care providers involved in clinical trials are still protected by a state medical malpractice statute, and thus were fraudulently joined.  While we are of two minds about such statutes (making it harder to sue HCPs increases litigation against our clients), since HCPs are our clients’ clients, and thus the heart of their businesses – and we’re defense lawyers by temperament – in the end we come out in favor of less liability generally.  This is an interesting use of fraudulent joinder that could well apply to the definition of “health care provider” under similar statutes in other states.

As always, our guest posters deserve all the credit and any blame for the contents of their posts.


When it comes to Texas, one might never know based on its jurisprudence that the state motto, and indeed the state’s moniker, is derived from “Tejas,” a Native American term for Friendship.  At least from a defense perspective, the Lone Star State at times seemed mighty inhospitable; after all, Texas invented that awful “heeding presumption” back in 1972, touching off a Reign of Fire, as states followed suit, adopting a variety of feeding presumptions.  It also allowed personal injury recovery under its consumer protection statute, made a big deal of Restatement Second §402B, and was the last of the large states to adopt the learned intermediary rule.  While we’re at it, let’s not forget the decision that would never die, the Murthy case, making the worst decisions list in consecutive years in 2011 and 2012, giving us not just one opinion to lament, but Two for the Money.

But we’re forgiving, and won’t “mess with Texas” too much.  Although it took until 2012, with some help from Bexis, for the Texas Supreme Court to finally adopt the learned intermediary doctrine, deciding that it was A Time to Kill an awful decision from 2010 whose name should have been Mud.  Texas adopted the Third Restatement, which should kill the heeding presumption, and even if it doesn’t, that presumption now excludes prescription drugs and medical devices, at least forcing it into Submission.  The Legislature amended the DTPA to eliminate personal injury damages, and we haven’t heard a peep from §402B in a while, and this section’s Failure To Launch into widespread acceptance is a good thing.  Texas Daubert decisions have been outstanding.  Not only that, a lot of excellent Reed Smith practitioners are based in our Houston office.

Texas has other positive attributes as well, including being the birthplace and home of Matthew McConaughey, and of baseball standout Nolan Ryan, who we believe, despite numerous accolades, remains underrated because of his somewhat pedestrian won loss record (which for pitchers reveals more about the team and much less about the individual).  Seriously, seven no-hitters?  Ryan pitched in an era where starters routinely went the distance, and they were their own closers; we urge you to check out his career innings pitched, hits allowed, complete games, and well, the strikeouts speak for themselves. No disrespect to Madison Bumgarner, who was otherworldly in the 2014 World Series, but who has 6 complete games in his career.  Ryan had an incredible 222, including several years where he had more than 20.  We realize that people smarter and more knowledgeable than we are will correctly we might add, mention that Ryan also walked many hitters and never won the Cy Young. That’s the beauty of sports.

And then there’s ZZ Top and Janis Joplin and Beyonce.

But we digress.  Back to the legal issues.  It would be remiss not to note that Texas also has some very favorable statutes, including Civil Practice and Remedies Code 82.007, which provides a rebuttable presumption of nonliability for manufacturers and prescribers in pharmaceutical product liability actions involving failure to warn for FDA approved warnings, and 82.008, which provides a presumption of nonliability for compliance with government standards.  See Tex. Civ. Prac. & Rem. Code §§ 82.007(a)(1) and 82.008.  We were concerned that a recent Southern District of Texas decision would a la Murthy, run roughshod over state law like the TCU Horned Frogs in an 82-27 rout of Texas Tech this year or UCLA in a 66-3 drubbing of Texas in 1997 (the Longhorns’ worst loss ever).  Fortunately, we were pleasantly surprised.

Continue Reading Guest Post – When It Comes To Fraudulent Joinder In Texas, Let’s Hail The Glory Daze And Just Keep Winning