Negligence Per Se

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This isn’t the first time, but the Blog has a problem with its reporting on cases decided in the ongoing “Opioid” litigation.  As lawyers, our first obligations are to our clients, and in this instance some of our clients in the opioid litigation don’t want us talking about their cases.  So when that happens, we don’t.

That doesn’t mean that we aren’t looking for ways to help, but it can’t be through reporting on what went down in individual cases.  We can do concepts, however. That’s why we have been particularly intrigued with one aspect of the recent opioid decision in Floyd v Feygin, 2018 WL 6528728 (N.Y. Sup. Dec. 6, 2018), that dismissed the plaintiff’s “negligence” claim.  The defendant (not a RS client) in Floyd successfully argued the following:

In support of its motion, [defendant] argues that plaintiff’s negligence cause of action against it is, in effect, an attempt to privately enforce the Controlled Substances Act. [Defendant] asserts that plaintiff lacks the authority to regulate its conduct in this regard or to enforce the Controlled Substances Act since Congress has committed enforcement of the Controlled Substances Act exclusively to the Attorney General and the Department of Justice.

Id. at *5. Thus the defendant argued that this “negligence” claim was preempted.  Id.

As we discussed earlier, the Floyd court agreed that the Controlled Substances Act (“CSA”) could not be used in this way, because there isn’t any private right of action:

It has been held that pursuant to its plain terms, the [CSA] is a statute enforceable only by the Attorney General and, by delegation, the Department of Justice.  Based on the regulatory structure of the [CSA] federal courts have uniformly held that the [CSA] does not create a private right of action.  The manufacture, distribution, and dispensing of opioids is comprehensively regulated by the [CSA], and the DEA is the primary federal agency responsible for the enforcement of the Controlled Substances Act.

Id. (citing: Schneller v Crozer Chester Medical Center, 387 F. Appx. 289, 293 (3d Cir. 2010); Smith v Hickenlooper, 164 F. Supp.3d 1286, 1290 (D. Colo. 2016), aff’d, 859 F3d 865 (10th Cir. 2017); McCallister v Purdue Pharma L.P., 164 F. Supp.2d 783, 793 (S.D.W. Va. 2001); DEA, Practitioner’s Manual, at 4 (2006)) (citations and quotation marks omitted).  Further, the New York equivalent of the CSA likewise carried with it no private right of enforcement. Id. at *6 (discussing 10 N.Y.C.R.R. Part 80).

Because the CSA provided no means of private enforcement, its requirements could not create novel common-law duties that did not otherwise exist.

[P]ursuant to both the [CSA] and New York State regulations, [defendant’s] sole duty with respect to its manufacture and distribution of opioids was to collect and record data, and make reports to federal and state agencies.  Although these regulations define circumstances that trigger reports to federal or state agencies, there is nothing within these regulations that requires a manufacturer to stop or restrict its distribution of opioids. . . .  Thus, [defendant] had no duty to control the prescribing, dispensing, and use of its [drug].

Id. at *6 (citations omitted).

The rationale in Floyd – that a federal statute’s lack of a private cause of action preempts a common-law plaintiff from using its requirements to create a “duty” – is what Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), is all about.  Curiously, Buckman is nowhere cited in Floyd, although Buckman’s implied preemption principles are applicable to all similarly situated federal statutes.

Which raises the question – how much can we “Buckmanize” the CSA, replacing the FDA with the equivalent federal authority of the “Attorney General?  Buckman, of course depended on statutory designation of the FDA as the sole enforcer of the FDCA. So we looked through the CSA looking for similar designations. We found:

21 U.S.C. §811(a), which governs scheduling of the substances to be “controlled”:

The Attorney General shall apply the provisions of this subchapter to the controlled substances listed in the schedules . . . and to any other drug or other substance added to such schedules under this subchapter.

21 U.S.C. §821, which governs enforcement generally:

The Attorney General is authorized to promulgate rules and regulations and to charge reasonable fees relating to the registration and control of the manufacture, distribution, and dispensing of controlled substances and to listed chemicals.

21 U.S.C. §822(a), which governs registration of manufacturers and distributors generally:

(1) Every person who manufactures or distributes any controlled substance . . . shall obtain annually a registration issued by the Attorney General in accordance with the rules and regulations promulgated by him.

(2) Every person who dispenses, or who proposes to dispense, any controlled substance, shall obtain from the Attorney General a registration issued in accordance with the rules and regulations promulgated by him.

21 U.S.C. §823(a-b), which governs requirements imposed through registration

The Attorney General shall register an applicant to manufacture controlled substances in schedule I or II if he determines that such registration is consistent with the public interest. . . .

The Attorney General shall register an applicant to distribute a controlled substance in schedule I or II unless he determines that the issuance of such registration is inconsistent with the public interest.

Section 823 is particularly interesting because it also permits the federal government (through the attorney general) to register “practitioners” – that is, physicians – and contains a limited anti-preemption savings clause:

Notwithstanding section 903 of this title, nothing in this paragraph shall be construed to preempt any State law that . . . requires a qualifying practitioner to comply with additional requirements relating to . . . reporting requirements.

21 U.S.C. §823(l). Section 823 thus is further support for Buckman-type preemption arguments by manufacturers and distributors, since Congress only preserved state-law reporting requirements imposed on “practitioners,” but does not allow state law to impose reporting requirements on manufacturers or distributors of controlled substances.

21 U.S.C. §825(a), regarding labeling:

It shall be unlawful to distribute a controlled substance in a commercial container unless such container, when and as required by regulations of the Attorney General, bears a label . . . containing an identifying symbol for such substance in accordance with such regulations.

21 U.S.C. §825(c), regarding drug warnings:

The Secretary shall prescribe regulations under section 353(b) of this title which shall provide that the label . . . contain[s] a clear, concise warning that it is a crime to transfer the drug to any person other than the patient.

The “secretary” refers to the HHS and thus the FDA.  See 21 U.S.C. §802(24). Section 825(c) thus seamlessly integrates federal enforcement authority.  Go directly to Buckman; do not pass “Go.”

21 U.S.C. §826(a, b), governing amounts of controlled substances it is legal to make:

The Attorney General shall determine the total quantity and establish production quotas for each basic class of controlled substance. . . .

. . .[U]upon application therefor by a registered manufacturer, the Attorney General shall fix a manufacturing quota for the basic classes of controlled substances . . . that the manufacturer seeks to produce.

21 U.S.C. §827(b, d-e), dealing with reporting requirements:

Every inventory or other record required . . . shall be in accordance with, and contain such relevant information as may be required by, regulations of the Attorney General, . . . and [] shall be kept and be available . . . for inspection and copying by officers or employees of the United States authorized by the Attorney General.

Every manufacturer registered . . . shall, at such time or times and in such form as the Attorney General may require, make periodic reports to the Attorney General of every sale, delivery or other disposal by him of any controlled substance, and each distributor shall make such reports with respect to narcotic controlled substances. . . .

[E]ach manufacturer registered . . . shall, with respect to narcotic and nonnarcotic controlled substances manufactured by it, make such reports to the Attorney General, and maintain such records, as the Attorney General may require. . . .  The Attorney General shall administer the requirements of this subsection. . . .

That’s a lot of “attorney general” references, thus further demonstrating that Floyd reached the correct result.  It seems very clear from the statute that reports about controlled substances are not the kind of thing that states have traditionally required or administered.

21 U.S.C. §830(a-b), imposing record-keeping and additional reporting requirements:

(1) Each regulated person who engages in a regulated transaction . . . shall keep a record of the transaction for two years after the date of the transaction.  (2) . . . Such record shall be available for inspection and copying by the Attorney General.  (3) . . . The Attorney General shall specify by regulation the types of documents and other evidence . . . for purposes of this paragraph.

(1) Each regulated person shall report to the Attorney General, in such form and manner as the Attorney General shall prescribe by regulation–(A) any regulated transaction involving an extraordinary quantity of a listed chemical, an uncommon method of payment or delivery, or any other circumstance that the regulated person believes may indicate that the listed chemical will be used in violation of this subchapter. . . . A regulated person may not complete a transaction . . . unless the transaction is approved by the Attorney General. The Attorney General shall make available to regulated persons guidance documents describing transactions and circumstances for which reports are required. . . .

Again, all reports are to the federal government, about information specified by the federal government, and subject to the approval of the federal government.

21 U.S.C. §843, concerning fraudulent reporting:

It shall be unlawful for any person knowingly or intentionally . . . to furnish false or fraudulent material information in, or omit any material information from, any application, report, record, or other document required to be made. . . .

In addition to any penalty provided in this section, the Attorney General is authorized to commence a civil action. . . .

Who can sue over fraudulent reporting to the Attorney General? The federal government.

21 U.S.C. §871(b), regarding the role of the Attorney General generally:

The Attorney General may promulgate and enforce any rules, regulations, and procedures which he may deem necessary and appropriate for the efficient execution of his functions under this subchapter.

21 U.S.C. §880(b), concerning inspections of regulated facilities:

[T]he Attorney General is authorized, in accordance with this section, to enter controlled premises and to conduct administrative inspections thereof. . . .  [E]ntries and inspections shall be carried out through officers or employees (hereinafter referred to as “inspectors”) designated by the Attorney General.

21 U.S.C. §882(c), providing for state enforcement against internet pharmacies:

[T]he State may bring a civil action on behalf of such residents in a district court of the United States with appropriate jurisdiction. . . .  No private right of action is created under this subsection.

In this rare instance where the CSA authorizes independent state enforcement, the statute specifically prohibits a private right of action.

21 U.S.C. §902, preserving the FDCA:

Nothing in this chapter, except [additional reporting requirements to the Attorney General, and prescription restrictions] shall be construed as in any way affecting, modifying, repealing, or superseding the provisions of the Federal Food, Drug, and Cosmetic Act.

Nothing in the CSA impairs the basis for Buckman preemption.

21 U.S.C. §903, concerning “field” preemption:

No provision of this subchapter shall be construed as indicating an intent on the part of the Congress to occupy the field . . ., to the exclusion of any State law on the same subject matter which would otherwise be within the authority of the State, unless there is a positive conflict between that provision of this subchapter and that State law so that the two cannot consistently stand together.

States can enforce their own laws against illegal drugs.  Notably, this savings clause expressly limits its scope to “field” preemption, and does not address other types of implied preemption, such as Buckman or “purposes and objectives” preemption.  To avoid preemption, the “subject matter” of the state law must be “otherwise within the authority of the State,” which would seem to preclude ad hoc imposition of reporting requirements on interstate commerce.  No private right of action is provided.

Probably the provision of the CSA that is most analogous to Buckman’s 21 U.S.C. §337(a) is §871(b) concerning the Attorney General’s general authority, but as we’ve detailed above, a lot of other CSA provisions reject private enforcement or specify federal enforcement.  Thus, as did the court in Floyd, we think that the structure of the CSA fully supports a preemption rationale, similar to Buckman, that because there is no private right of CSA action, would be private enforcers of the CSA – and in particular its reporting requirements to the federal government – are preempted from doing so under state law.

As we roll out of bed on the day after Thanksgiving, we are often confronted with contradictory thoughts. For instance, “why did I have that third plate at dinner?” might be followed by “How can I eat some leftovers for breakfast?”  Leftovers are as much of an American tradition on this day as watching videos of altercations during frenzied early holiday shopping. Both celebrate wretched excess in their own way. Some leftovers, however, can be combined to create something tasty and worthwhile. Other leftover uses should not be attempted. We would put sandwiches of turkey, stuffing (dressing down South), and cranberry goop in the former category and Brussels sprouts omelets in the latter.

A while back, for a few years, we chronicled a real turkey of a case called Howard. The saga is recounted here, where the plaintiff’s expert was finally kicked for the unreliability of his defect opinion about the PMA device at issue in the case. Along the way, the case generated two notably foul (fowl?) opinions. Deciding on preemption in the context of a theoretical claim, the Sixth Circuit held that a negligence per se claim could be a parallel claim and avoid express preemption.  Years later, on a referred question, the Oklahoma Supreme Court okayed a negligence per se claim under Oklahoma law based on violations of the FDCA.  That gobbler took home the ribbon for third worst of 2013.  Our well-documented view that there can be no negligence per se claims based on violations of the FDCA notwithstanding, Oklahoma now has a claim that came from a case that was soon to be plucked and exposed as lacking merit.

A few years later, the plaintiffs in Cantwell v. De La Garza, No. CIV-18-272-D, 2018 WL 5929638 (W.D. Okla. Nov. 13, 2018), sued an implanting orthopedic surgeon, non-profit health care system, and medical device manufacturer for alleged injuries from the alleged off-label use of a PMA medical device in a spinal surgery. The manufacturer moved to dismiss. We do not have many details of the underlying facts or allegations, but we are focusing on the negligence per se claim—the leftover from the Howard turkey, in case you missed our less-than-subtle theme. A few weeks before the Oklahoma Supreme Court’s decision in Howard, the Western District of Oklahoma rejected the purported parallel claims in Caplinger. After a motion to reconsider was denied, the Tenth Circuit affirmed in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), one of our favorite preemption decisions and a 2015 winner.  In part because that decision was authored by future Justice Gorsuch, we have drilled down on Caplinger a few times and tracked its impact.

The Cantwell plaintiffs claimed that the manufacturer had promoted the device to be used off-label—it was approved for use in the thoracolumbar spine, but was used in the cervical spine—and that violated apparently unspecified provisions of the FDCA and its regulations. Under the Oklahoma Supreme Court’s decision in Howard, “To establish negligence per se, the plaintiff must demonstrate the claimed injury was caused by the violation [of a statute], and was of the type intended to be prevented by the statute . . . [and] the injured party [was] one of the class intended to be protected by the statute.” Pretty much the hornbook definition, along with the requirement that the plaintiff prove breach, causation, and damage. In the context of pleadings and the Howard decision, the court went back to basics. Plaintiffs did not plead a particular statute or regulation that had been allegedly violated, let alone that could be tied to the injuries attributed to the device at issue. Howard did not lower the pleadings bar: “The court said nothing to suggest, however, that a plaintiff wishing to bring such a claim could proceed without identifying the statute or regulation allegedly violated, and thus the duty allegedly breached by the defendant’s conduct.” Looking to Caplinger and the unaddressed but obvious issue of preemption, the court noted that “such identification is particularly important in the area of medical devices, where a state-law negligence claim must survive the FDCA’s provision of a federal preemption device.” So, no identified allegedly violated federal statute or regulation meant no properly pleaded claim for negligence per se. Citing to the FDCA in general or invoking the loaded term “off-label” was not enough to get past a motion to dismiss. Predictably, though, the dismissal was without prejudice, so we expect plaintiffs will try again. If they do, then we would not be surprised if Justice Gorsuch’s former colleagues on the Tenth Circuit get another chance to weigh in on express preemption with a re-heated version of Howard.

 

Way back in law school we learned that a plaintiff suing for negligence must satisfy four elements:  (1) duty, (2) breach, (3) causation, and (4) injury.  Every one of these elements can be a battleground.  Even what seems like the simplest inquiry – whether the plaintiff was injured – can be controversial.  We have seen cases where a plaintiff alleged increased chance, and consequent  fear, of injury.  Is that enough?  Psychological injuries present a host of difficulties.  Remember the “zone of injury” cases?  Some injury issues manage to be at once both straightforward and intractable.  One of the all-time great movies about litigation, The Fortune Cookie, centered around that great bugaboo of small-time litigation – soft tissue injury.  Not everyone who dons a neck-brace is really hurt. 

 

The element of breach can also be knotty.  Was the defendant insufficiently careful?  How much care is reasonable?  What is the standard of reasonableness?  Reasonable person?  Reasonable riveter?  Reasonable podiatrist?  When we sat on a jury in a med-mal case a couple of months ago, pretty much the only issue in play was whether the doctor had paid close enough attention to his patient’s hemoglobin levels.   Some jurors wanted to throw up their hands, exasperated at the impossibility of knowing what a doctor should do.  Theoretically, the breach element drops out in strict liability cases.  Fault should not matter.  But when the claim is strict liability failure to warn, negligence principles creep back into the case.  It can be hard for a defendant to win summary judgment on breach.  Courts are quick to throw that issue to the jury.  And then, like the jury we sat on, some poor fact-finders will want to throw the issue right back.

 

More often, it is the causation element that constitutes summary judgment bait.  In this blog, we have spilled a lot of web-ink on the causation issue, whether it be medical causation (did this drug or device hurt the plaintiff?) or warning causation (would a different warning in the label have steered the doctor away from this product?).  If the doctor did not even read the label, our clients win.  Some commentators say that there are five, not four, elements, because causation actually involves separate questions of but-for causation and proximate causation.  That latter item has given rise to quasi-philosophical musings.  Maybe something played a role in the causal chain, but is it so remote or obscure that putting the defendant on the hook for damages would be unfair?  Maybe Donny was a dolt to leave a lit candle on the dresser in his rental apartment, but should he be on the hook if a burglar broke in, knocked the candle onto the rug, and set the place ablaze?  Proximate causation, in the views of some, can boil down to whether it was reasonably foreseeable that the breach of the duty of care would cause this particular harm.  But evaluating foreseeability can almost seem like an epistemological exercise.  Whose perspective counts?  What are the sources of foreseeability?  We’ve always thought that foreseeability was a fuzzy criterion, because it can be altered by so many things – including court opinions.  Now that we know how clumsy burglars can be, thanks to F. Supp. or Law360 or the Philly Inquirer or Eyewitness News, shouldn’t we be extra-careful about leaving lit candles behind?  (Similarly, in Fourth Amendment jurisprudence, the notion of reasonable expectation of privacy seems mercurial.  Don’t SCOTUS pronouncements themselves shape such expectations?  Once we read how cops can identify marijuana grow-rooms via thermal imaging, doesn’t our expectation of privacy somehow diminish?  But we digress.)   

 

If proximate cause turns, at least in part, on foreseeability, so does the first negligence element, duty.   Today’s case, Martinez v. Walgreen Co., 2018 WL 3241228 (S.D. Texas July 3, 2018),  is about the scope of duty.  Maybe the Martinez case will end up being one for the law books.  Even though the defendant in Martinez is not a drug or device company, we feel duty-bound to report on it.  The defendant was a pharmacy, and the claim was the pharmacy dispensed the wrong prescription to its customer.  The medication incorrectly given to the customer allegedly caused the customer to experience hypoglycemia, which adversely affected his ability to drive (blurry vision, dizziness, etc.), which resulted in a series of auto wrecks that killed the occupants of other vehicles.  Those other drivers/passengers happened to be in the wrong place at the wrong time.  The estates of those victims sued the pharmacy for dispensing the wrong drug.  Even assuming that the pharmacy was negligent and that such negligence caused the terrible injuries, and assuming that the pharmacy owed a duty to its own customer to get the prescription right, did the pharmacy owe a duty of care to the people in the cars struck by its customer?    

 

The federal court, applying Texas law, said No, and granted summary judgment to the pharmacy.  In Texas, pharmacists are considered health-care providers and owe their customers a duty of care.  That much is clear.  But Texas courts have not recognized a general common-law duty for health-care providers towards third parties for injuries that may be the result of the provider’s negligence to the patient.  So far, so bad for the plaintiff.  Nevertheless, Texas has recognized a duty for medical professionals towards third parties in very limited circumstances when the breach of a duty to the patient gives rise to a reasonably foreseeable harm to an identifiable person or class of persons as a consequence of that breach.  For example, if a medical facility housing a criminally insane patient – one who presented a clear danger to the public – failed to control that patient and permitted him to shoot someone, the facility could be liable for breach of the facility’s duty to control the patient.  Is that a good analogy to what happened in Martinez?  Perhaps the best case that plaintiffs cited was one in which a Texas court held that a doctor who failed to warn a patient who had a known history of drug abuse not to drive while under the influence of Quaaludes and the patient then drove and injured third party motorists.  Pretty close, right? 

 

But Texas courts over the years have considerably reined in the duty to third parties.  Thus, physicians have no duty to warn epileptic patients not to drive and mental health professionals have no duty to warn third parties about specific threats (the law might be different elsewhere).  Texas courts have also ruled that pharmacists have no duty to warn about the potential side-effects of medication.  Against this not entirely consistent or clear legal backdrop, the Martinez court asked the following question:  “Under Texas law does a pharmacist owe a duty to unconnected third parties for the negligent prescription of medication?”  The court answered that question in the negative because “In order for a third-party duty to arise, the breach of the health-care provider’s duty to the patient must create a reasonably foreseeable consequence to an identifiable party or class.  Here, Plaintiffs are not identifiable third parties.”  The defendant pharmacy had no duty to control its customer’s behavior or to warn him about side effects.  To find a duty to the plaintiffs, the court would have to find that “a pharmacist has a general duty to the public for negligent provision of medication.  The Texas Supreme Court has never held that such a duty exists, and thus, this Court, Erie-bound cannot so find now.”  Well, that sort of respect for Erie is eerily refreshing, isn’t it?

 

The plaintiffs still did not give up.  They argued that the pharmacy’s dispensation of the wrong medicine violated a statute and that, therefore, this was a case of negligence per se.  The negligence per se doctrine simply means that a defendant’s violation of a statute removes the need for a jury to assess whether the defendant was careless.  The statute itself sets the bar for due care.  But what that means is that negligence per se answers the breach question –  “negligence per se does not impose a duty.”  It is the absence of duty in the Martinez case that puts the plaintiff out of court.   It is the absence of duty in the Martinez case that puts that case in our blog. 

 

 

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

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

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

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

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

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

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

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

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

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

 

Several years ago, in a post entitled “Negligence Per Se Trivia,” we included the following:

In Kentucky, negligence per se has been codified, and claims based on federal (but not state) statutes or regulations (like the FDCA) are prohibited.  St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529, 534 & n.14 (Ky. 2011); T & M Jewelry, Inc. v. Hicks, 189 S.W.3d 526, 530 (Ky. 2006).

Our only other encounter with Kentucky FDCA-based negligence per se claims involved a misbegotten case that held such a claim wasn’t preempted, but didn’t address the claim’s viability under state law.  See Steiden v. Genzyme BioSurgery, 2012 WL 2923225 (W.D. Ky. July 18, 2012)

We thought we’d look at this issue more closely.  Here is what’s going on.  The earlier of these cases, T & M, involved a peculiar state statute that “codifies the doctrine of negligence per se in Kentucky.”  189 S.W.3d at 530.  That statute provides:

A person injured by the violation of any statute may recover from the offender such damages as he sustained by reason of the violation, although a penalty or forfeiture is imposed for such violation.

Ky. Rev. Stat. §446.070.  In determining the scope of this statute, T & M construed it in pari materia (that’s legal Latin for “in conjunction with other provisions about the same subject”) with the rest of that chapter, pointing out that “numerous provisions in KRS Chapter 446 refer to ‘the statute laws of this state,’ and also repeatedly refer to acts or intent of ‘the General Assembly.’”  189 S.W.3d at 530 (footnotes containing citations omitted).  Against that legislative background, the Kentucky Supreme Court concluded that plaintiffs claiming “injur[y] by the violation of any statute” in Kentucky were limited to asserting violations of Kentucky – not federal (or other state) – statutes:

Thus “any statute” in KRS 446.070 has been held to be limited to Kentucky statutes and not to federal statutes or local ordinances.  The Kentucky General Assembly did not intend for KRS 446.070 to embrace the whole of federal laws and the laws of other states and thereby confer a private civil remedy for such a vast array of violations.

189 S.W.3d at 530 (footnotes containing citations omitted).

That limitation has been the law of Kentucky ever since. In St. Luke Hospital, Inc. v. Straub, 354 S.W.3d 529 (Ky. 2011), a case involving (state) constitutional civil rights litigation, the Kentucky high court reiterated this holding while rejecting the plaintiff’s state-law analogy to 42 U.S.C. §1983:

Precedent acknowledges some restrictions on the applicability of KRS 446.070.  The “any statute” language used applies to Kentucky statutes. Our courts have considered the application of the statute to federal laws and regulations. . . .   Violations of federal laws and regulations . . . do not create a cause of action based on KRS 446.070.

354 S.W.3d at 534 & nn.10, 14 (citing T & M).  Other Kentucky courts continue to follow these holdings that plaintiffs claiming injuries from statutory/regulatory violations under Kentucky law cannot assert violations of federal enactments.  Harrison Memorial Hospital, Inc. v. Wellcare Health Insurance Co., 509 S.W.3d 69, 75 (Ky. App. 2016) (no negligence per se or other private recovery for alleged Medicaid reimbursement violations), review denied (Ky. Feb. 9, 2017); Brock v. Bennett, 2015 WL 136330, at *4 (Ky. App. Jan. 9, 2015) (no negligence per se based on alleged violation of Federal Building Code), review denied (Ky. Sept. 16, 2015); Jackson v. JB Hunt Transportation, Inc., 384 S.W.3d 177, 182-83 (Ky. App. 2012), review denied (Ky. Dec. 12, 2012) (no negligence per se based on alleged violation of federal trucking regulations); Gordon v. Turner, 2016 WL 3636073, at *7-8 (E.D. Ky. June 29, 2016) (same as Jackson); Gonzalez v. City of Owensboro, 2015 WL 4594505, at *8 (W.D. Ky. July 30, 2015) (no negligence per se based on alleged violation of National Electrical Code); Wise v. Pine Tree Villa, LLC, 2015 WL 1611804, at *3 (W.D. Ky. April 10, 2015) (no negligence per se based on alleged violation of federal regulations governing certification of long-term care facilities); Halcomb v. Britthaven, Inc., 2015 WL 998560, at *4 (E.D. Ky. March 5, 2015) (same as Wise); Vanhook v. Somerset Health Facilities, LP, 67 F. Supp.3d 810, 817-18 (E.D. Ky. 2014) (no negligence per se based on alleged violation of federal Social Security regulations); Kelter v. Wasp, Inc., 2014 WL 4639914, at *8 (W.D. Ky. Sept. 16, 2014) (no negligence per se based on alleged violation of federal OSHA regulations); McCarty v. Covol Fuels No. 2, LLC, 978 F. Supp.2d 799, 808-09 (W.D. Ky. 2013) (no negligence per se based on alleged violation of federal mine safety regulations); Pace v. Medco Franklin RE, LLC, 2013 WL 3233469, at *2 (W.D. Ky. June 25, 2013) (same as Wise); Cummins v. BIC USA, Inc., 2011 WL 1399768, at *3 (W.D. Ky. April 13, 2011) (no negligence per se based on alleged violation of federal childproofing regulation).

Notably in Young v. Carran, 289 S.W.3d 586 (Ky. App. 2008), a plaintiff seeking to recover for purported HIPAA violations, after losing under Ky. Rev. Stat. §446.070, tried to maintain the same claim under some sort of residual “common law” negligence per se theory that supposedly survived the legislature’s action.  That gossamer-thin attempted distinction also failed, with a unanimous court holding:

[Plaintiff] next contends that [HIPAA regulations] impose a duty of care on Appellees allowing for a Kentucky “common law” negligence per se claim.  [plaintiff’s] reliance upon T & M . . . in support of her argument is misplaced.  In that case, the Supreme Court of Kentucky used provisions of [a] federal [statute] to define a duty of care for purposes of a common law negligence action − not a KRS 446.070 negligence per se claim.  Indeed, the Court expressly refused to apply the act in a negligence per se context.  Therefore, her claim must be rejected.

Id. at 589 (citations omitted).  There is thus no “lingering” common law out there.  Sadler v. Advanced Bionics, Inc., 929 F. Supp.2d 670, 681 n.10 (W.D. Ky. 2013).

In drug/medical device litigation, Kentucky courts that have addressed the issue have held that Ky. Rev. Stat. §446.070 bars all negligence per se claims asserting violations of the FDCA or FDA regulations.  Waltenburg v. St. Jude Medical, Inc., 33 F. Supp.3d 818, 837 (W.D. Ky. 2014); Sadler, 929 F. Supp.2d at 681.

We think that these cases, while correctly decided, do not do §446.070 justice. The statute isn’t limited to negligence per se, indeed the statute is not targeted against any particular cause of action.  Rather, the legislature cast its statutory net much more broadly − the universe of claims covered by §446.070 extends to any “person injured by the violation of any statute.”  That language reaches any supposed “parallel” claim, no matter how captioned.  The recent decision, Moore v. Zydus Pharmaceuticals (USA), Inc., ___ F. Supp.3d ___, 2017 WL 4365162 (E.D. Ky. Sept. 29, 2017), involving generic drugs, rather than medical devices, thus took a step in the right direction in holding that §446.070 precluded any “negligence” claim, not merely one denominated “negligence per se.”

The Kentucky Supreme Court’s holding in T & M . . . offers binding and unequivocal precedent concerning the scope of KRS 446.070 and demonstrates that [plaintiff] does not have a state based right to sue for negligence in this matter.

Id. at *7.  We think the same thing could be said for any “parallel” claim, whether purporting to sound in strict liability, warranty, or any other theory.  As long as the claim is brought by a “person injured by the violation of any statute” – which parallel claims, by their nature, must be – then, quite apart from preemption, they may not be brought under Ky. Rev. Stat. §446.070.  We also note that the same result could also be reached under implied preemption under Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), since in §446.070 the Kentucky legislature abolished any “parallel” state-law action.

Implied Preemption.  Off-label promotion. TwIqbal.  They make up a core of our posts, yet we never seem to tire of them.  Maybe our readers, especially interlopers from the other side of the v., tire of reading about them, but we can often find a wrinkle in a case that merits our huzzahs or inspires a rant.  Today’s case falls into the praiseworthy category, as the court dismissed a complaint predicated on violations of the FDCA in spite of sympathetic allegations that might have carried the day with some other courts. Markland v. Insys Therapeutics, Inc., — F. Supp. 3d –, 2017 WL 4102300 (M.D. Fla. Sept. 15, 2017), involved the alleged death of a patient as a result of respiratory distress from the defendant’s sublingual spray prescription painkiller drug, which she had started the day before.  Rather than offer the typical product liability claims under Florida law, perhaps because the labeling had extensive warnings on respiratory distress, plaintiff asserted only a claim for negligent marketing.  Calling it “negligent marketing” does not really identify what duty was allegedly breached, whether state law recognizes a claim for such a breach, and such a claim would be preempted.  The allegedly actionable conduct in Markland was promoting the drug for off-label use, like the chronic back pain of plaintiff’s decedent, as opposed to the approved indication for breakthrough pain with cancer.  While we do not know the merits, there were many allegations about off-label promotion, which seem to tie to the conduct at issue in well-publicized federal and state investigations.

Defendants moved to dismiss on various grounds, the most relevant of which (for our purposes) were that there was no claim under Florida law for this conduct and it would be impliedly preempted under Buckman anyway.  These had been hot topics recently in some Florida state and federal cases we have discussed, like Mink (here and here) and Wolicki-Gables, but those dealt with PMA devices and the additional issue of express preemption.  Here, with a prescription drug marketed under an NDA approval, there is no express preemption to navigate, but the plaintiff still had to walk a narrow path to state a claim that would not be impliedly preempted.  As we have said before, we think the appropriate order of analysis here would be the determine if there was a cognizable state law claim asserted and then determine if it was preempted, but the Markland court did not separate out its analysis.  It also did not weigh in on whether the allegations here were of truthful off-label promotion that might implicate First Amendment protection.  Instead, it assumed that the off-label promotion alleged violated the FDCA’s prohibition on misbranding.  2017 WL 4102300, *6 & n.4.

The court could take this approach because the plaintiff’s claim was so squarely focused on alleged violations of the FDCA.  Since Buckman, plaintiffs tend to be a bit cagier in making it look like their claims were not predicated on violations of the FDCA or fraud on the FDA.  The Markland plaintiff, however, labeled the defendant’s alleged conduct as violating the FDCA, “federal law,” and “requirements imposed by the FDA regarding the condition that this drug should be utilized to treat cancer patients with breakthrough cancer pain.” Id. at *9.  “Hence, [the claim], while framed in the language of negligence, appears to derive from [defendant’s] alleged off-label promotion of [the drug]” and “the very concepts of off-label use and off-label marketing are born out of the FDCA.” Id.   This was well phrased, as was the later statement that “it is only because of the existence of the FDCA’s restrictions on off-label marketing that Mr. Markland claims [defendant’s] actions were improper or otherwise violated a duty.” Id.

This is the recipe for implied preemption under Buckman.  It also means there is no negligence claim under Florida law, “which bars plaintiffs from using state negligence actions to seek recovery for FDCA violations.” Id. at 10 (citing negligence per se cases).  Of course, Buckman recognized that the FDCA does not provide for a private right of action, and preempts claims with FDCA violations as “critical element[s],” which should prevent such piggybacking.  So, plaintiff’s case was done and could not be revived by amending the complaint.  In other words, there was no need for a second and third strike before judgment could be entered.  This was so despite the Court’s expression of compassion:

The Court does not question for a moment the grievous nature of Carolyn Markland’s death, nor the deep sadness Mr. Markland must face on a daily basis as a result of his wife’s untimely passing. Nonetheless, the Court must act within the bounds of the law.

Id. at *11.  This a good lesson, especially for courts sitting in diversity, that the law should not be expanded to allow for recovery by sympathetic who cannot make their case under accepted tort theories.

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

A federal judge in Texas recently ruled that Texas law does not allow a claim for negligence per se based solely on alleged violations of the FDCA or FDA regulations. Monk v. Wyeth Pharmaceuticals, Inc., 2017 U.S. Dist. LEXIS 72477, *21-23 (W.D. Tex May 11, 2017). That seems pretty straightforward to us. Plaintiffs typically use negligence per se to try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that. Monk doesn’t say all of that explicitly, but it relies on cases that do. That’s good enough for us.

Plaintiff based her negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at *3, *6 (citing 21 C.F.R. § 208.24(b)).

And this is where things get confusing, because while the court dismissed plaintiff’s negligence per se claim based on violation of this regulation, the court reached the opposite conclusion regarding plaintiff’s negligent failure to warn claim based on exactly the same thing.  A state law failure-to-warn claim based on a violation of federal prescription drug regulations? Sounds like implied preemption to us, but the court concluded that this very federal-sounding claim was actually a parallel state law failure to warn claim. But wait. Isn’t plaintiff suing because the defendant allegedly violated the FDCA.  That’s Buckman implied preemption. As many courts have noted, plaintiffs seeking to avoid preemption have to weave their way through a “narrow gap” by alleging they are suing for conduct that violated the FDCA, but not because the conduct violated the FDCA. But the only allegation here is that defendants did not provide the medication guides as required by federal regulations.

The court’s reasoning is based entirely on dicta in the Fifth Circuit’s decision in Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 679 (5th Cir. 2014) that “failing to provide FDA-approved warnings would be a violation of both state and federal law, this is a parallel claim that is not preempted.” Id. But the claim that defendants provided no warnings was not alleged in the complaint and so was not allowed by the court. There is no information in Eckhardt regarding the basis for plaintiff’s claim that defendant failed to provide any warnings and so it is unknown if it was “because” defendant’s violated a federal regulation.

In Monk, the court knew precisely the basis for plaintiff’s failure to warn claim – 21 C.F.R. § 208.24(b); the same basis as plaintiff’s negligence per se claim. That the result is different on both claims is really difficult to reconcile. So we won’t try. We’ll instead reiterate – no negligence per se based on FDCA in Texas.

 

What follows is a guest post by Cara DeCataldo, a Reed Smith associate, who gamely stepped up to the plate to research one of a number of blogging topics that have been hanging fire for some time now.  This topic is a type of “no good deed goes unpunished” liability – whether a defendant whose internal policies aspire to a degree of care that exceeds legal requirements can be sued solely because it allegedly failed to live up to those high aspirations.  The two most common theories that purportedly support such a result are negligence per se and negligent undertaking.  Thankfully, Cara’s research indicates that such liability is not recognized.

As always, our guest posters are entitled to all of the credit, and any blame, for their efforts.

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Clearly articulated company policies imposing heightened safety standards on a company and its employees can’t be a bad thing, right?  But what happens when a Plaintiff attempts to use a company’s alleged failure to comply with its own corporate aspirations as the basis for a lawsuit?  There is an inherent tension between a company’s desire to set high standards for employee conduct and/or its products, and the fear of liability if those standards are not met.  With this in mind, we thought it would be a worthwhile to take an in-depth look at whether internal company policies that exceed what the law requires, can also pose the risk of creating a legal duty.

For those companies seeking to hold employees and/or products to ambitious standards of care, the news is largely good.  Most courts to address the issue support these endeavors and recognize the value of encouraging companies to maintain high voluntary standards.  They also recognize the potential negative impact if those goals were misused to create legal duties to the public.  Negligence per se claims consistently fail when citing various official pronouncements that encourage, but do not mandate, conduct, such as company credos, internal agency manuals, protocols, policy statements, and the like, as relevant evidence of the alleged negligence. Many states take matters a step further and bar the admission of company policies even as evidence of negligence. The most frequently applied rationale barring the admission of internal policies is that to the extent internal rules and regulations exceed the standard of care, then they are not admissible.

Continue Reading Guest Post – Tis Better to Try and Fail, Then to Have Never Tried At All: Internal Corporate Policies Do Not Create a Heightened Legal Duty

A federal judge in Wisconsin issued an order a few weeks ago that covers two topics on which we often write—negligence per se and implied preemption. The two concepts are not unrelated.  We most commonly see negligence per se when plaintiffs try to privately enforce a provision of the FDCA, i.e., by using an alleged violation of a safety-related provision of the FDCA as the basis for their state law claim.  State law does not always allow this, but even when it does, such a claim should not withstand implied preemption under Buckman.  That is because Buckman and section 337(a) of the FDCA make it clear that litigants cannot privately enforce the FDCA, and a negligence per se claim based on a purported violation of the FDCA is an unveiled attempt to accomplish exactly that.

It seems pretty straightforward to us, but some courts still resist. That is what happened in Marvin v. Zydus Pharmaceuticals (USA) Inc., No. 15-cv-749, 2016 U.S. Dist. Lexis 112047 (W.D. Wis. Aug. 23, 2016), where the plaintiffs based their negligence per se claim on the defendants’ alleged failure to provide medication guides for distribution with amiodarone prescriptions.  The basis for the claim was the federal regulation requiring manufacturers of some prescription drugs to make medication guides available either by providing a sufficient number of guides to distributors and dispensers or by providing the means to produce guides in sufficient numbers. Id. at **2-3 (citing 21 C.F.R. §§ 208.1, 208.24(b)).

The defendants allegedly did not provide medication guides to the decedent’s pharmacy, but do the decedent’s heirs have a private right of action? The defendants justifiably did not think so, and they moved to dismiss on the basis that the plaintiffs’ claims were impliedly preempted.  Along the way, the district court ordered supplemental briefing on whether Wisconsin law would recognize a claim of negligence per se in the first place.

We are fond of Wisconsin. We once drove from a deposition in Marquette, Michigan, to visit family in Minneapolis.  As students of the geography of the Upper Midwest will tell you, that took us across the entire width of Wisconsin.  One day we will return to partake of “fresh cheese curd,” which we saw advertised at multiple roadside markets along the way.  We have more recently learned that it is commonly deep fried and served at carnivals and county fairs across the region.

But for now, we will respectfully state that the district court in Marvin came to the wrong result.  The district court held first that federal law did not impliedly preempt the negligence per se claim, and in reaching that result, it cited and quoted extensively from the Seventh Circuit’s abominable Bausch opinion.  Faithful readers will be familiar with the disdain we have heaped on Bausch for, among other things, its recognition of a “parallel claim” based on even the most general FDA regulations and its blithe rejection of implied preemption without citing or even acknowledging section 337(a).  The posts are too numerous to list, but you can get the gist here and here.

Continue Reading Wisconsin Preemption Ruling Makes Our Cheese Curdle

This post is not from the Dechert side of the blog.

The United States Supreme Court has said it – the test for implied preemption under 21 U.S.C. §337(a) (the FDCA’s no-private-enforcement provision) is whether the purported state-law cause of action would exist even in the absence of the FDCA/FDA: Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341, 353 (2001) (preemption applies to “claims exist solely by virtue of the FDCA disclosure requirements” and to all claims where “existence of these federal enactments is a critical element”).  So have federal courts of appeals.

If the claim would not exist in the absence of the FDCA, it is impliedly preempted. In other words the conduct on which the claim is premised must be the type of conduct that would traditionally give rise to liability under state law − and that would give rise to liability under state law even if the FDCA had never been enacted.

Loreto v. Procter & Gamble Co., 515 F. Appx. 576, 579 (6th Cir. 2013) (citations and quotation marks omitted). Accord Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1339 (10th Cir. 2015) (“§337(a) preempts any state tort claim that exists ‘solely by virtue’ of an FDCA violation”); Perez v. Nidek Co., 711 F.3d 1109, 1119 (9th Cir. 2013) (preempting a “fraud by omission claim [that] exists solely by virtue of the FDCA  requirements”) (citation and quotation marks omitted); Lofton v. McNeil Consumer & Specialty Pharmaceuticals, 672 F.3d 372, 379 (5th Cir. 2012) (following Buckman; “tort claims are impermissible if they existing solely by virtue of the FDCA disclosure requirements”).

Continue Reading Another Make Work Project In New Jersey – Duty To Update Claims