Late last year we happily blogged about Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2016 WL 7429449 (S.D.N.Y. Dec. 23, 2016), chiefly because it held that design defect claims against a branded prescription drug (Eliquis) were preempted under the impossibility preemption reasoning in PLIVA, Inc. v. Mensing, 564 U.S. 604 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013).  However, as we noted in that post, dismissal of the non-design aspects of complaint was with “leave to amend.” See also Utts, 2016 WL 7429449, at *1.

Of course, plaintiffs amended.

Now, they probably wish they hadn’t.

In a second opinion, issued earlier this month, the Utts litigation was dismissed a second time, this time with prejudice. Utts v. Bristol-Myers Squibb Co., ___ F. Supp.3d ___, 2017 WL 1906875 (S.D.N.Y. May 8, 2017) (“Utts II”).  Preemption was once again front and center, but this time an excellent preemption result was accompanied by a variety of equally pleasing common-law – California law – rulings.

Impossibility Preemption

First, preemption. Design defect claims had already been preempted under Mensing/Bartlett, as plaintiffs were reminded whenever they crossed the line into design-type claims. Id. at *1, 9, 10 n.10, 13 n.15, 16, 19.  But the major preemption issue this time around involved warnings – and whether any of the information that plaintiffs claimed required some kind of “better” warnings involved “newly acquired information” of the sort that a defendant could unilaterally add given the scope of the FDA’s “changes being effected” exception to preemption recognized in Wyeth v. Levine, 555 U.S. 555 (2009). See 21 C.F.R. §314.3(b) (known as the “CBE” regulation for drugs – note, there are similar CBE regulations for devices and biologics; we’ve discussed the device regulation here).

For a more detailed discussion of the “newly acquired information” aspect of preemption, see our post here about In re Celexa & Lexapro Marketing & Sales Practices Litigation, 779 F.3d 34 (1st Cir. 2015), which was the first appellate decision finding preemption where plaintiffs failed to come forward with any “new” information to support their warning claims. Utts II explained that, in the preemption context, “if the plaintiff can point to the existence of ‘newly acquired information’ to support a labeling change under the CBE regulation, the burden then shifts to the manufacturer to show by ‘clear evidence’ that the FDA would not have approved the labeling change made on the basis of this newly acquired information.”  2017 WL 1906875, at *9.

Plaintiffs threw a lot of mud at the drug and its manufacturer, but nothing they heaved against the wall stuck – everything plaintiffs cited all old information that did not go beyond what the FDA had before it when it approved the drug in the first place.

Why is that?

Basically, Eliquis is a next-generation anticoagulant, very effective at what it does, and not requiring the kind of dietary restrictions and constant blood testing that older blood thinners such as warfarin – originally sold as rat poison – do.  Utts II, 2017 WL 1906875, at *2 & n.4.  Unfortunately, the plaintiffs’ bar has decided that anybody needing anticoagulation therapy should be should only have such older drugs available, and has launched an ongoing litigation assault at practically every next generation anticoagulant (others include Xarelto and Pradaxa) – because of risks of serious and sometimes fatal bleeding inherent in what these drugs are supposed to do.

The FDA was well aware of the risks that Eliquis, like any other anticoagulant, could cause uncontrollable bleeding when it approved it. Indeed, the “label warns about the risk of serious bleeding no less than five times.” Id. at *3.  It “specifically warns about the risk of bleeding” during concomitant therapy “in conjunction with antiplatelet agents, such as aspirin.”  Id. at *4.  The labeling also “twice warns about the fact that there is no specific antidote” should serious bleeding occur.  Id.

That’s why plaintiffs lost in Utts II.

Basically, the well-known fact that anticoagulants carry with them serious bleeding risks is why none of the information that the plaintiffs in Utts II brought forward qualified as “new.”  “New” is defined in the FDA’s CBE regulation as “studies, events, or analyses [that] reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.  21 C.F.R. §314.3(b) (quoted at 2017 WL 1906875, at *8).  In the preemption context, “

  • “The table and the description from the ISMP report do not suggest − nor do the plaintiffs allege − that the real-world signal data for [the drug] shows a greater severity or frequency of bleeding events or deaths than previously disclosed in [defendant’s] submissions to the FDA. Accordingly, the information contained in this table does not constitute newly acquired information. Utts II, 2017 WL 1906875, at *13.
  • Plaintiffs argue “that the guidance regarding concomitant use of antiplatelet agents is inadequate because the label does not advise how or when to use combination therapy . . . or how commonly bleeding events will occur. This omission . . . was evident to the FDA when it approved the label and the plaintiffs have not identified any newly acquired information.” Id. (quotation marks and footnote omitted).
  • This observation does not constitute newly acquired information, as it simply speculates whether [drug] safety could be further improved. Id. at *14 (as to “improved dosage guidance”).
  • [E]mbolic-thrombotic events are . . . not bleeding events. Nor do the plaintiffs argue that any of this data comparing the incidence of embolic-thrombotic events . . . constitutes newly acquired information. Id. (footnote omitted).
  • [T]he findings directed towards the risk of ischemic stroke for [the drug] users do not constitute newly acquired information. Id. at *15.
  • [P]laintiffs do not allege, however, that this expert guidance contains, or is founded upon, any newly acquired information regarding reversal agents or the treatment of excessive bleeding.” Id.
  • “[P]laintiffs do not allege that this statement contains newly acquired information about what constitutes a safe residual drug level.” Id. at *16.
  • “[T]his article does not refer to any new information that would have permitted the defendants to amend the [drug’s] label. And, in their opposition to this motion, the plaintiffs do not argue that it does.” Id.
  • “[P]laintiffs do not contend that any of the five remaining documents . . . contains newly acquired information regarding an undisclosed risk of bleeding. Several of these articles merely express a desire for further investigation. Id.

Thus, although plaintiffs loaded up their amended complaint with no fewer than “34 warnings that the defendants allegedly failed to provide,” 2017 WL 1906875, at *11, there was no safety in numbers. None of their supposedly missing warnings was based on “newly acquired information” as defined and required by the FDA’s CBE regulation.

Because, plaintiffs could not point to any “newly acquired information” to support their warning-related allegations, those allegations fell outside the scope of the Levine CBE exception and were preempted, because under Mensing/Bartlett such warnings could not be added without prior FDA approval.  2017 WL 1906875, at *9.

Next, in accordance with practically all law, Utts II held that preemption could be decided on a motion to dismiss.  A “determination regarding preemption is a conclusion of law.” Id. at *19 (pointing out that Mensing had been decided on a motion to dismiss).  To the extent that the Third Circuit’s aberrant Fosamax decision was pertinent, it was distinguishable.  Fosamax was limited to “clear evidence” determinations, and in Utts II, because plaintiffs offered no “new” information, clear evidence was never at issue.  Id. at *19-20.  Finally, plaintiffs were “not entitled to discovery on preempted claims.”  Id. at *20 (discussing TwIqbal).

In a way, the new evidence requirement discussed in Utts II resembles the so called “public disclosure” requirement that is a defense to False Claims Act claims (see here for more discussion), except that the “newness” of the information in preemption of state-law warning claims is measured against the evidence presented to the FDA, as opposed to the public.

Buckman Preemption

Utts II also found fraud-on-the-FDA preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001).  Plaintiffs ran from their blatant fraud-on-the-FDA allegations, asking that they “be read merely as evidentiary background.”  2017 WL 1906875, at *26.  The court read them as they were written (and no doubt intended), and found preemption:

Each of the statements on which the fraud claim is premised depends on statements made to and approved by the FDA. There is no newly acquired information that required or suggested that the allegedly fraudulent statements should be altered to remain truthful and non-fraudulent.  Accordingly, the fraud claims are preempted.

Id.

Other FDCA-Related Issues

On other FDCA-related issues, Utts II ends up on our Adverse Drug/Device Event cheat sheet because of its discussion of how voluntarily reported adverse events aren’t legitimate proof of causation:

Federal regulations advise that a report submitted by a manufacturer “does not necessarily reflect a conclusion by the [manufacturer] or FDA that the report or information constitutes an admission that the drug caused or contributed to an adverse effect.” 21 C.F.R. § 314.80(l).  As the FDA Website explains:

FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. Further, FDA does not receive reports for every adverse event or medication error that occurs with a product. Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.

The Supreme Court has similarly warned that “[t]he fact that a user of a drug has suffered an adverse event, standing alone, does not mean that the drug caused that event.” Matrixx Initiatives, Inc. v. Siracusano, 563 U.S. 27, 44 (2011). I n sum, “the mere existence of reports of adverse events . . . says nothing in and of itself about whether the drug is causing the adverse events.” Id.

Utts II, 2017 WL 1906875, at *12.

In addition, Utts II contains an excellent discussion of the harmful effects of overwarning.  The need to prevent overwarning is the reason that the CBE regulation does not apply to all information, new or old, that could in some way “strengthen” existing warnings:

The FDA has recognized that “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks, could discourage appropriate use of a beneficial drug . . . or decrease the usefulness and accessibility of important information by diluting or obscuring it.” Indeed, “labeling that includes theoretical hazards not well-grounded in scientific evidence can cause meaningful risk information to lose its significance.” For this reason, the CBE regulation requires that there be sufficient evidence of a causal association between the drug and the information sought to be added.

Utts II, 2017 WL 1906875, at *8 (all quotes from “Supplemental Applications Proposing Labeling Changes for Approved Drugs, Biologics, and Medical Devices,” 73 Fed. Reg. 2848 (FDA Jan. 16, 2008).

Another notable FDA-related aspect of Utts II has to do with so-called “comparative claims” – claims that one medication is better than another in some respect.  Plaintiffs often claim (as they did in Utts II) that there is some sort of duty to warn that ones product is less safe than its competition.  However, Utts II points out that the FDA does not permit such claims except when supported by specific types and amounts of scientific evidence.  “[A]ny claim comparing the drug to which the labeling applies with other drugs in terms of frequency, severity, or character of adverse reactions must be based on adequate and well-controlled studies.”  2017 WL 1906875, at *7 (citing 21 C.F.R. §201.57(c)(7)(iii)).  Further, “federal regulations do not require a manufacturer to include information about a competitor’s product or progress.” Id. at *16 (citing 21 C.F.R. §§201.56, 201.57, 201.80).

State-Law Warning Issues

Beyond its preemption and other FDCA-related aspects, Utts II has a load of other helpful holdings, mostly about California law.  The decision contains an excellent discussion of the state of the art defense.  2017 WL 1906875, at *10.  It also points out that, the California Supreme Court’s holding – quite apart from preemption – that as a matter of federal/state comity, warning liability does not exist as a matter of state law where the purported duty flies in the face of FDA regulation:

Even where a risk is “known” or “knowable” at the time of distribution, under California law, a manufacturer “may not be held liable for failing to give a warning it has been expressly precluded by the FDA from giving.” Thus, if the manufacturer disclosed to the FDA “state-of-the-art scientific data concerning the alleged risk” and the FDA determined, after its review, “that the pharmaceutical manufacturer was not permitted to warn − e.g., because the data was inconclusive or the risk was too speculative to justify a warning,” then the manufacturer could not be held strictly liable for failure to warn. “[T]he FDA’s conclusion that there was, in effect, no ‘known risk’ is controlling.”

2017 WL 1906875, at *11 (all quotations from Carlin v. Superior Court, 920 P.2d 1347 (Cal. 1996)).  Thus, the same grounds that support preemption as a matter of federal law – where, as here, the FDA says “no” – also preclude liability as a matter of state law.

In tandem with preemption, Utts II also holds that the defendant’s drug labeling was adequate as a matter of California law on the bleeding issues raised by plaintiffs – just as our prior post thought it should.  In general, the label “clearly discloses that there is a risk of excessive bleeding and that there is no known antidote if that occurs.”  2017 WL 1906875, at *21.  Nor could plaintiffs prevail with any of the usual nitpicking that goes on in this type of litigation.

  • Monitoring – “The label provides, in unambiguous terms, all of the scientifically reliable information that physicians may need to determine how to monitor their patients.” Id.
  • Bleeding Reversal – A “recommendation is to discontinue [the drug] and apply ‘standard supportive treatment and other local measures’ . . . does not supply a basis for a plausible claim that the label needed to add further guidance.” Id. at *22 (quoting medical article).
  • Dosage – Plaintiffs do “not identify any research or data that undermines or contradicts the dosing guidance” and “speculation about information that the defendants may possess is insufficient to plausibly plead a claim.” Id. (citing TwIqbal).

Similarlly, plaintiffs other warning-based claims failed due to the adequacy of the warning.  Id. at *24 (implied warranty), *26-27 (fraud); *29 (consumer fraud)

Finally, here are some other California warning-related nuggets we can use:  (1) Under the learned intermediary rule, “a manufacturer discharges its duty to warn if it provides adequate warnings to the physician about any known or reasonably knowable dangerous side effects, regardless of whether the warning reaches the patient.”  2017 WL 1906875, at *11. (2) “[P]harmaceutical manufacturer[s] may not be required to provide warning of a risk known to the medical community.” Id. (quoting Carlin).  (3) “[W]arnings relevant to any breach of warranty claim are those directed to the physician rather than the patient.” Id. at *22 (quoting Carlin) (emphasis original).  (4) The opinion notes that the learned intermediary rule applies to California consumer fraud claims.  Id. at *28 n.32.

Looking Forward

Utts II contains by far the most detailed discussion to date of the interplay between preemption and the “newly acquired evidence” requirement of the FDA’s CBE regulation.  It would be notable for that reason alone.  However, it also finds the labeling adequate as a matter of law, which is second highly significant ruling in any prescription medical product litigation.  What’s more, since the entire Utts amended complaint is now dismissed with prejudice, not only Utts II, but also the original Utts design defect preemption ruling, is now appealable.

Any appeal would be interesting.  Every ruling in Utts II is double-breasted, in that preemption is bolstered by independent state law grounds.  That is not the case with design defect preemption in the original Utts decision, where preemption is the sole basis for dismissal.  Utts, 2016 WL 7429449, at *12.  So, if plaintiffs were to appeal, their only clean shot at preemption would involve their design claim.  In any event, the preemption rulings in both Utts (Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015)), and Utts II (Celexa, 779 F.3d 34) are supported by court of appeals decisions, as our preemption cheat sheet demonstrates.  At best, in a hypothetical appeal, we would get an affirmance and reinforcing appellate precedent supporting preemption in innovator drug cases.  At worst, there would be a circuit split, which would offer the further (double-hypothetical) possibility of additional Supreme Court review of what Utts II called the Levine “trilogy.”  2017 WL 1906875, at *9.  While we always prefer to win, whenever, however, and as quickly and as thoroughly as possible, we certainly would find another shot at innovator drug preemption in the Supreme Court an interesting proposition.

Today’s case is a partially published decision about a partial reversal of a plaintiff verdict in California. So, we are only going to discuss select parts of the decision. It’s a long one and there are large sections about plaintiff’s counsel’s misconduct during trial and excessive damage awards. It is also a joint medical malpractice and product liability case. So, when you strip away the rest, we get down to a handful of legal rulings that we are truly interested in.

The case is Bigler-Engler v. Breg, Inc., 2016 Ca. App. LEXIS 921 (Cal. App. Oct. 28, 2016) and involves the use of a cold therapy medical device, available only upon prescription. Plaintiff underwent arthroscopic knee surgery, following which her surgeon prescribed use of the device to aid in recovery. Id. at *5-6. Plaintiff rented the device from her surgeon’s medical practice. Id. at *7. Upon discharge after surgery, plaintiff was advised to use the device at a certain temperature “as much as possible.” Id. at *8. Plaintiff’s use of the device and the instructions she received from her surgeon are explained in more detail in the opinion, but ultimately, plaintiff developed severe skin damage that required multiple plastic surgeries and scar reduction surgeries. Id. at *9-13.

Plaintiff file suit against her surgeon, the medical practice, and the device manufacturer. The jury found against the manufacturer on plaintiff’s claims for design defect, failure to warn, and intentional concealment. Id. at *19. The jury also awarded punitive damages against the manufacturer on the intentional concealment claim. Id. On appeal, the court overturned the intentional concealment verdict, which also meant reversing the punitive damages verdict. But, the court upheld the trial court’s decision not to instruct the jury on the learned intermediary doctrine finding it did not apply to a medical device intended to be operated directly by the patient.

Continue Reading A Fraudulent Concealment Win Coupled with an Unfavorable Learned Intermediary Ruling

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

Choice of law doesn’t get too much attention here at the DDL blog. That is due in some part to the fact that there really isn’t a defense-oriented position to take on it. Which state’s law should apply is a very case-specific analysis and in any given case, you might come out differently. It really depends on which state’s law is more favorable to your legal arguments in a particular scenario. The second reason it probably doesn’t get much attention from us is that in most personal injury, products liability cases, plaintiff’s home state’s law governs – the law where the injury occurred.

But what about when a plaintiff lives in one state but seeks medical treatment in another. Not to be considered disparaging of the many excellent healthcare facilities in southern New Jersey (where this blogger resides), but when you live a stone’s throw from some of the leading specialists in the country who happen to be across the state line in Philadelphia, you take that ride across the Ben Franklin Bridge. That’s not an unusual situation, making the choice of law question of interest.

In Finnerty v. Howmedica Osteonics Corp., 2016 U.S. Dist. LEXIS 123071, *2 (D. Nev. Sep. 12, 2016), plaintiff, a resident of Nevada, sought medical treatment from an orthopedic oncologist located in California. Plaintiff had cancer in his left leg that required either amputation of the leg or a total knee replacement. Plaintiff opted for the replacement and defendant’s modular replacement device was implanted. Id. At the time of surgery, plaintiff was “clinically obese.” Id. The surgery took place in March 2005 and plaintiff had no complications until 2011 – over 6 years later. Id. at *2-3. In August 2011, plaintiff started working as a shuttle driver for a car rental company. The job required him to lift luggage, weighing up to 80 pounds, on a repetitive basis. Id. at *3. In December 2011, while lifting luggage, plaintiff heard a “pop” in his left knee. During revision surgery, it was discovered that the implanted device had fractured. Id. Plaintiff continued to suffer complications and eventually his left leg was amputated.

Plaintiff sued the device manufacturer alleging failure to warn, negligence, strict liability design defect, manufacturing defect, and breach of express and implied warranty. Id. Defendant moved for summary judgment on all counts.

Continue Reading An Interesting Choice of Law Question

It’s been two years since the First District California Court of Appeals issued its ill-founded decision in Bristol-Myers Squibb Co. v. Superior Court, 175 Cal. Rptr. 3d 412 (Cal. App. 2014), which used specific personal jurisdiction to accomplish what the United States Supreme Court had, only six months earlier, condemned as “grasping” and “exorbitant” when attempted through general personal jurisdiction in Daimler AG v. Bauman, 134 S. Ct. 746 (2014).  We immediately blogged about that decision in our “Hotel California” post – describing the California court’s rationale in considerable detail.

Fortunately, the California Supreme Court promptly granted an appeal, which we duly noted here, of the following two questions: “(1) whether after Daimler AG v. Bauman, 571 U.S. ––––, 134 S.Ct. 746, 187 L.Ed.2d 624 (2014), general jurisdiction exists; and (2) whether specific jurisdiction exists.” Bristol-Myers Squibb Co. v. S.C., 337 P.3d 1158 (Cal. 2014).

Thereafter “prompt” dropped out of the lexicon.

But today the wait is over.  The California high court has answered the two questions “no” and “yes.”  This latter ruling – a 4-3 decision − is almost certain to be appealed to the United States Supreme Court, as it creates a form of “specific” jurisdiction in mass tort cases that is every bit as “grasping” and “exorbitant” as that rejected as a Due Process violation in Bauman.  See Bristol-Myers Squibb Co. v. Superior Court (Anderson), S221038, slip op. (Cal. Aug. 29, 2016) (hereafter Anderson). Anderson involved mass tort litigation in California against a defendant that was neither headquartered nor incorporated in California, nor had any peculiar ties to the state.  The plaintiffs in question were also nonresidents of California, so the jurisdictional questions boiled down to whether California can constitutionally provide a forum for non-resident plaintiffs to sue a non-resident defendants.

This is quite apart from the practical question of why, given the severe funding crisis everyone recognizes as facing the California judiciary, California taxpayers should be burdened by thousands (or more) of suits by non-residents against non-residents.

Continue Reading Breaking News – California High Court Expands “Specific” Personal Jurisdiction To Recreate “Exorbitant” Personal Jurisdiction Rejected by Daimler v. Bauman

We’ve always hated Conte v. Wyeth, 85 Cal. Rptr.3d 299 (Cal. App. 2008), and the whole concept of innovator liability (imposing liability on the original innovator drug manufacturer for injuries allegedly caused by a generic drug equivalent).  As amicus for PLAC, Bexis tried to strangle Conte in its cradle, as discussed here, but failed, as the California Supreme Court denied review.

Good news. Others have succeeded where Bexis failed.  The California Supreme Court has just granted an appeal in T.H. v. Novartis Pharmaceuticals Corp., 199 Cal. Rptr.3d 768 (Cal. App. 2016), an even more extreme Conte follow-up that imposed innovator liability in perpetuity − for injuries occurring even after an innovator manufacturer had sold all rights and left the relevant market altogether.  For full discussion of T.H., see our post here.  The order, entered yesterday, states:

The applications to appear as counsel pro hac vice are granted. The petition for review is granted.  The issue to be briefed and argued is limited to the following:  May the brand name manufacturer of a pharmaceutical drug that divested all ownership interest in the drug be held liable for injuries caused years later by another manufacturer’s generic version of that drug?

It appears online here.  Fingers crossed folks, but this is the necessary first step towards eliminating Conte.

There is a lawyer we worked with at another firm who had a standard move, kind of the way that Jerry Seinfeld had a standard “move” – and, come to think of it, with a similar intention. (“The Move” shows up in “Fusilli Jerry,” the 107th episode of Seinfeld.)   In the face or fear of a hostile action against our client, this lawyer would file a declaratory judgment action in a friendly federal court.  The concept, of course, was to seize the initiative and do some forum-shopping.  Sometimes the action would be preemptive and sometimes it would be reactive. One would think that the timing would make a difference.  But as today’s case, Monster Beverage Corp., v. Herrera, 2016 U.S. App. LEXIS 9012 (9th Cir. May 17, 2016), demonstrates, that ain’t necessarily so.  We discussed the Monster case a couple of days after Labor Day in 2013, when Monster survived an attack on its preemptive preemption position.  Here it is just a couple of days after Memorial Day in 2016, and the Ninth Circuit has ended the case on grounds of Younger abstention and the Anti-Injunction Act.  That’s a long passage of time.  The judicial process, especially the appellate phase (doubly so in the Ninth Circuit), can take a while. What happened in the interim?

First, please enjoy this reminder of what the Monster case was about.   The San Francisco City Attorney wrote a letter to Monster informing it of an investigation into whether Monster’s marketing of its energy drinks was deceptive and bad in various other ways.  Needless to say, the City Attorney’s beef was really with the federal regulatory regime that already governed what Monster could and could not say about its products.  But San Francisco has been known to try to conduct its own foreign policy, so why should federal regulations stand in the way of its persistent effort to impose a nanny-state on its benighted citizens?   Monster filed a preemptive declaratory judgment action in C.D. Cal. (good idea to drag the San Francisco City Attorney down to SoCal), seeking to shut down the investigation because it was preempted by federal law.  Then the San Francisco City Attorney filed a complaint in San Francisco Superior Court, which Monster removed to federal court on grounds of federal question (preemption again), which the federal court remanded after rejecting the preemption argument. For those of you keeping score at home, that means there was a federal case in Dodger-land and a state case in Giant-land.

The San Francisco (honestly, by this point we are tired of writing the city name out in full, but Boranian warned us that we’d be jeered if we abbreviated the city’s name in any way) City Attorney, as is the case with all Bay Area denizens forced to contemplate anything south of Big Sur, must have seen the C.D. Cal. case as a vast annoyance.  That was certainly the idea behind Monster’s maneuver.  Not surprisingly, then, the City Attorney filed a motion to dismiss the declaratory judgment action in C.D. Cal., arguing that the preemption argument stood no chance. The federal court denied that motion to dismiss.  That is the ruling we applauded back in September 2013.

Continue Reading San Francisco vs. The Monster (aka Federal Regulation)

The plaintiff in Frere v. Medtronic, Inc., 2016 WL 1533524 (C.D. Cal. April 6, 2014), was an 80 year-old woman who had an infusion pump implanted to treat her chronic low-back pain. According to the plaintiff, the device never delivered the pain relief she had experienced during her pre-implantation pump trial, and she ultimately suffered complications. The device is a Class III medical device, requiring FDA premarket approval. Product liability litigation involving Class III devices does not get very far without bumping into federal preemption issues. Frere is no exception.

The problem with the plaintiff’s complaint was that it was either unclear or clearly preempted. The strict liability claims failed because they consisted of conclusory allegations that the purported defects or failure to warn caused her injuries. For example, in the manufacturing defect claim, the plaintiff alleged: (1) that “the catheters at issue were occluded, fractured, obstructed, and/or malfunctioning, which caused Plaintiff to suffer severe injuries and which required multiple surgeries and medical procedures to correct these defects”; and, (2) “as a direct result of the defects, Plaintiff suffered crippling injuries which left Plaintiff with permanent and significant disabilities compensable under the law.” There is no there there. Similarly, in connection with her failure to warn claim, the plaintiff alleged that “[a] foreseeable, direct and proximate result of [Defendants’] failure to warn Plaintiff, Plaintiff’s medical providers, and the FDA . . . about the defective condition of the [Device], Plaintiff suffered crippling injuries that left Plaintiff with permanent and significant disabilities.” The court refused to accept those mere “labels and conclusions.” The complaint was bereft of any facts as to how the alleged manufacturing defect and failure to warn caused her injuries. All we get is the conclusion of causation itself.

Continue Reading C.D. Cal. Dismisses Infusion Pump Complaint

We have closely followed the development (or perhaps more accurately, stagnation) of so-called “innovator liability.” It started with the wrongly reasoned and wrongly decided opinion from the California Court of Appeal in Conte v. Wyeth, 168 Cal. App. 4th 89 (2008), where the court held that an innovator drug company could be liable for injuries allegedly caused by generic products it did not make and did not sell. We rolled our collective eyes at this unmooring of tort law, where lines of cases dating back to cars with wooden wheels placed responsibility with parties who made and sold the allegedly offending product.

In the eight years since Conte, courts throughout the country in more than 100 different cases have roundly rejected innovator liability, with only a few exceptions. You can view our innovator liability scorecard here, and you can click on the “Conte” link on the side of the page to see all of our commentary on the subject. There is a lot of it. Our 50-state survey of innovator liability is here, which is as good a place to start as any. The upshot is that innovator liability should become another Sindell v. Abbott Labs, which introduced market share liability in 1980, only to become nothing more than a curious historical footnote in product liability law.

We revisit the issue now because the California Court of Appeal has gone off the rails again. In T.H. v. Novartis Pharmaceuticals Corp., No. D067839, 2016 Cal. App. LEXIS 179 (Cal Ct. App. Mar. 9, 2016), the court held that a listed drug manufacturer can be liable for injuries alleged caused by a generic version of the drug terbutaline sulfate, even though the listed manufacturer divested itself of the product six years before the plaintiff even used it. At least in Conte the plaintiff alleged that Wyeth still held the NDA. Here, the listed manufacturer had been completely out of the terbutaline business for several years.

Continue Reading Another Outlier From California On Innovator Liability

California rejected another attempt by the class action bar to extend the already questionable fraud-on-the-market theory from Basic v. Levinson, 485 U.S. 224 (1988), a securities class action, to what amount to failure to warn claims for consumer products or, as we’ve seen before, drugs and medical devices.  This time the class action plaintiffs’ bar was focused on e-cigarettes.  See In re NJOY, Inc., Consumer Class Action Litig., 2016 U.S. Dist. LEXIS 24235 (C.D. Cal. Feb. 2, 2016).  A handful of hopeful consumers claimed that they were misled by an e-cigarette’s labeling and were not warned about its ingredients or risks.  Id. at *3.  As is often the case with these types of class action claims, however, the plaintiffs did not allege an injury—well, at least not a physical injury.  They suffered no side effects.  They had no physical ailments.  The risks didn’t affect them.

Continue Reading California Rejects Class Certification for Claims Alleging Misrepresentations and Deficient Warnings But No Method to Establish Damages

Last month, in Quesada v. Herb Thyme Farms, Inc., 361 P.3d 868 (Cal. 2015), the California Supreme Court did to “organic” foods what it had done to most other foods in Farm Raised Salmon Cases, 175 P.3d 1170 (Cal. 2008) – which is to expose them to still more garbage class actions over labeling that complies with federal government standards.  As we discussed here, in the Salmon cases the court had to work reasonably hard to come up with an (uncodified) food-related exception to the general ban on private enforcement of the Food, Drug & Cosmetic Act (“FDCA”).

The court had an easier job of it in Quesada because the federal statute that conferred on the Department of Agriculture the power to certify food as “organic” didn’t have a private enforcement provision similar to the FDCA’s 21 U.S.C. §337(a).  Rather, “With respect to enforcement, . . . [t]he act contemplates a cooperative state-federal enforcement regime.”  361 P.3d at 871 (citations omitted).  See also Id. at 875 (with respect to act’s section on “sanctions for misuse of the organic label,” “nothing in [it] suggests these federal remedies are intended to displace whatever state law remedies might exist”).

So why are we telling you this?  We’re not the food blog, after all.  Unlike the Salmon decision, this latest addition to food class action mania in California doesn’t even involve the FDCA.

Continue Reading California Supreme Court – Presumption Against Preemption Still Around