Being that it was the Sixth Circuit that allowed a failure-to-update claim to proceed against a generic manufacturer, when we got the recent decision in McDaniel v. Upsher-Smith Labs, 2018 U.S. App. LEXIS 17884 (6th Cir. June 29, 2018), knowing it was about whether a claim for failure to distribute a medication guide was preempted, we flipped straight to the end looking for “affirmed” or “reversed.” We wanted to get into the proper frame of mind for reading the opinion. Were we going to be disheartened like we were by Fulgenzi v. Pliva, 711 F.3d 578 (6th Cir. 2013). Or pleased by the court’s distancing itself from its prior ruling. Fortunately, it’s the latter.

While failure to distribute medication guide claims have been previously ruled on by district courts, it was a matter of first impression on appeal. The Eleventh Circuit had the issue before it just a couple of months ago, but decided the case on learned intermediary rather than preemption grounds. See our post on that case here. And while we’re at it, here is where you can find our discussion of Fulgenzi. The Sixth Circuit took just the opposite approach deciding not to reach the learned intermediary question but instead to focus all of its attentions squarely on preemption.

At issue was plaintiff’s husband’s use of a generic form of amiodarone. Plaintiff alleged that her husband did not receive the Medication Guide for the drug when he filled his prescriptions because the manufacturer failed to make sure they were available. McDaniel, at *3. This failure to provide the Medication Guide was the sole basis for plaintiff’s strict liability and negligence failure to warn claims.

So, to be clear, nowhere in plaintiff’s complaint does she allege that the warning that was provided with the drug (in its accompanying labeling) was insufficient or inadequate. Her only allegation is that the Medication Guide, the substance of which she also does not take issue with, was not provided to her husband as required by the FDCA. Which the Sixth Circuit determined was the pleading of a federal duty without any Tennessee state court parallel duty. “Said differently, the claims would not exist in the absence of the FDCA.” Id. at *4. And, that’s Buckman implied preemption territory.

The court starts by directly citing Buckman for the ruling that there is no private cause of action for enforcing the FDCA. Id. at *5. The court then quotes quite heavily from plaintiff’s complaint to demonstrate that she has not pleaded a traditional state law failure to warn to claim – indeed neither plaintiff’s complaint nor briefing even mentions the Tennessee Products Liability Act. Id. at *8-9. Instead, her allegations talk about the defendant’s failure to provide the guide “as required by the FDA.Id. at *6-7 (emphasis added). As if that wasn’t enough, in her briefing, plaintiff explicitly disclaimed any inadequate content basis for her failure to warn claims:

The allegation is not one of adequacy or “content” failure to warn, (i.e., the verbiage or even the format fails), but an actual and physical negligent failure of [defendant] to fulfill its federally mandated responsibility to ensure Medication Guides are available for distribution directly to patients with each prescription.

Id. at *8 (quoting plaintiff’s brief). So, we think the basis for the claim is quite clear. Failure to distribute the Medication Guide as required by the FDCA. Nothing more.

The court next moves to the decisions by various district courts finding failure to distribute claims preempted. See id. at *10-11. To which plaintiff responded by relying on Fulgenzi. Like we mentioned above, Fulgenzi was a failure to update case. Plaintiff alleged that the generic manufacturer defendant failed to update its labeling to include new warnings added by the brand manufacturer thereby violating both the federal duty of sameness required of generic labeling and Ohio state law requiring adequate warnings. The Fulgenzi court found that because it was the adequacy of the warning that was at issue – a traditional state law claim – rather than the failure to update, the claim wasn’t preempted. In other words, the allegation of the violation of the federal duty of sameness was not a “critical element” of the claim in Fulgenzi. It was pleaded by plaintiff to demonstrate that her state law failure to warn claim was not preempted because it paralleled a federal requirement. Plaintiff in McDaniel, tried to argue that she too only pleaded the federal-law violation to avoid impossibility preemption. In fact, the only element of her failure to warn claim was failure to comply with a federal duty. Id. at *11-12. The court was not willing to “ignore the language of [plaintiff’s] allegations simply so that [it could] shoehorn her claims into Fulgenzi’s realm.´ Id. at *14.

While we disagree with where Fulgenzi came out, we agree that even if you found Fulgenzi’s reasoning sound, it doesn’t apply to McDaniel. In this case, the court correctly concluded that the FDA requirements regarding distribution of Medication Guides was a “critical element” – actually only element — of plaintiff’s case, and therefore the claim was impliedly preempted.

Note that there is a dissenting opinion that argues the McDaniel case does fit within the Fulgenzi framework by finding that Plaintiff McDaniel also pleaded a failure to warn claim alleging inadequacy of the warning. We certainly think the language cited by the majority demonstrates that’s not the case, but we aren’t going to spend time quibbling over it because we don’t think adequacy should be outcome determinative. As we said back when we posted on Fulgenzi, there is no question that the duty at issue (to update or to distribute) is federal. Only the federal government may enforce it. Whether the updated warning and/or Medication Guide is, or is not, also “adequate” under state law amounts to nothing more than coincidence. At least that’s how we saw it then and still see it now.

Permit us to recount a recent travel misadventure, though whatever eventual connection we draw to today’s case will be specious at best. Last Friday, we traveled from Philadelphia to Hartford, Connecticut for a deposition.  We were fresh off of a long flight home from Europe and were hesitant to take on a couple hundred miles of driving at each end of the day, so we investigated our options.  In the morning, direct flights from PHL to BDL abound.  But after 6 p.m., when our deposition was scheduled to end, there are no direct flights home. Nor are there Amtrak trains leaving Hartford after that hour.  So we threw up our hands and reserved a connecting flight home, reasoning that sleeping, reading, and eating Biscoff cookies would be more relaxing than driving.  This even though, to get from Hartford to Philadelphia, we had a totally illogical connection at Dulles, many miles out of the way.

Our originating flight landed at Dulles early.  And our 9:30 pm connection was showing “on time” on the board.  At 9:15 pm, the following announcement came over the loudspeaker: “We are very sorry, but your first officer is coming in on a flight that is delayed, so we need to delay your 9:30 pm flight until 11:30 pm.”  We were not pleased, but the new schedule would still get us home, crucial because we were leaving at noon on Saturday for an overnight trip.  At 11:20, the gate agent announced, “Your first officer’s flight has landed.  Give us a few minutes and we’ll get you boarded.”  At 11:30, we heard the following, dripping with contrition: “We are SO SORRY, but we are unable to put together a crew for your flight tonight, so we are delaying this flight until NOON TOMORROW.” [Emphasis added.]  Turns out that the long-awaited first officer had now exceeded his maximum hours for the day.

We did not react politely to this. We asked, “You mean to tell us that nothing in your computer could have told you this before we sat here for two hours and lost all other options??”  We did not receive a satisfactory response.  Ultimately, we took a 45-minute cab ride to Union Station (cavernous, pitch-black, and empty) and caught a 3:10 a.m. (!!) Amtrak train to Philadelphia.  When all was said and done, that was all that was left.

“Not much left” also describes (we warned you) today’s case, an excellent PMA and Buckman preemption decision out of the Northern District of Illinois.  In Gravitt v. Mentor Worldwide, 2018 WL 2933609 (N.D. Ill. June 12, 2008), the plaintiff alleged that she was injured by the defendant’s silicone breast implant.  Her complaint asserted claims under Illinois law, alleging design and manufacturing defects, failure to warn, and the defendant’s alleged failure to comply with the FDA’s pre-market approval (“PMA”) process for Class III medical devices, including numerous allegations of deficiencies in the defendant’s design and execution of post-PMA studies ordered by the FDA.

In earlier motion practice, the court dismissed most of the plaintiff’s claims without prejudice.  (We published a guest post on the first dismissals here.)  The plaintiff filed an amended complaint, which the court commented “strongly resemble[d] the original complaint.” Gravitt, 2018 WL 2933609 at *1.  The defendant again moved to dismiss, arguing that the plaintiff’s claims were expressly preempted under the Medical Device Amendments (“MDA”) to the FDCA or impliedly preempted under Buckman.

Express Preemption

The defendant argued that the plaintiff’s claims were expressly preempted to the extent that they were based on alleged methodological defects in the defendant’s post-PMA studies. The Court explained that under SCOTUS’s Lohr decision, as construed by the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), as well as SCOTUS’s Riegel decision, state law tort claims related to Class III medical devices granted PMA are allowed to proceed if they: 1) allege violations of common-law duties that parallel federal requirements; or 2) claim violations of federal law.  Conversely, state law claims that “would impose on [the defendant] a requirement that is in addition to federal requirements” – in other words, claims that the defendant “violated state tort law notwithstanding compliance with the relevant federal requirements” – are preempted. Gravitt, 2018 WL 2933609 at *4 (internal punctuation and citations omitted).

The court held that, while the complaint alleged numerous deficiencies in the defendant’s post-PMA studies and alleged that each deficiency amounted to an “independent failure to comply with the FDA’s post-approval requirements” and thus a ground for withdrawal of PMA, the plaintiffs “simply assume[d], without legal or other support, that those deficiencies amount[ed] to violations of the FDA’s conditions for PMA.” Id. at *6 (citations omitted).   The court concluded that “such an assumption may not ground a viable claim,” id., and held that certain categories of the plaintiff’s allegations were expressly preempted.

Implied Preemption

But the court held that other categories of the plaintiff’s allegations were not expressly preempted. Specifically, the court held that “the complaint plausibly alleged that [the defendant] violated federal law” by failing to satisfy several categories of requirements related to, inter alia, follow-up of study participants, collecting and reporting of data at required intervals and related updates to labeling, warning of newly-discovered risks of the device, and failing to comply with requirements for manufacturing facilities.  Because the plaintiff “plausibly alleged” that these “shortcomings in [the defendant]’s post-PMA testing and manufacturing processes violated federal law,” section 360(a) of the MDA did not preempt those claims. Id. But the court emphasized, “Plaintiffs may proceed with those claims, however, only if they pass through a second legal filter” – the “filter” of implied Buckman preemption of “fraud on the FDA claims.” Id. at *7.

The court explained that, under Buckman, “federal law preempts claims to the extent they seek to deploy state law in the service of policing fraud against federal agencies based on statements that federal  law required the defendant to make to the agency, id. (internal punctuation and citation omitted), but doesn’t preempt traditional tort law claims involving breach of a duty to the plaintiff.  The court held:

Here, several of the claims that survive express preemption – for example, claims that the defendant reported results of the core study for fewer than the required number of years and recruited fewer than the required number of patients for a large post-approval study – are impliedly preempted under Buckman because those shortcomings breached no . . .  [tort duty to the plaintiff].  Rather, as in Buckman, those claims are unconnected to any traditional state tort duty, meaning that the existence of the relevant federal enactments is a critical element of those claims.

Id. (internal punctuation and citation omitted).  The court noted that the plaintiff attempted to tie the defendant’s alleged misconduct to her state tort claims, alleging that, if the defendant had more fully complied with the PMA process, its “disclosures would have led to much wider knowledge of the risks associated with its product.” Id. (internal punctuation and citations omitted).  But, it emphasized, “the Buckman analysis centers on the nature of the asserted claim and the source of the violation, not on the violation’s effects . . . . A claim arising entirely out of a violation of [the defendant’s] compliance with the FDA’s requirements in granting PMA is . . . . preempted under Buckman. Id.

Two categories of claims remained. The court dismissed the plaintiff’s claims alleging that the defendant’s manufacturing facilities failed to comply with applicable law and regulations, holding that the complaint had not adequately alleged a true manufacturing defect claim.  In addition, the plaintiff had failed to respond to the defendant’s arguments against these claims.  The last claim alleged that the defendant learned, but did not disclose, that its device had a higher likelihood of rupture than had been reported.  The court acknowledged that these claims were not fully developed in the complaint, but held that Rule 9(b)’s particularity requirement did not apply to the claims.  Holding that the plaintiff’s pleading “cross[ed] the line from conceivable to plausible,” satisfying Twiqbal, the court allowed the claims to proceed.

But that was all that was left.  The claims that were preempted – expressly and impliedly – were dismissed with prejudice, in an infrequent and laudable turn of events.   We would wax on at greater length, but today’s flight is boarding in a few minutes.  At least that’s what the board says.  We’ll keep you posted.

We immediately called for the further appeal and reversal of the hideous decision in In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F.3d 268 (3d Cir. 2017).  However, we’re just bloggers.  Thus, we were greatly pleased when the United States Supreme Court, on December 8, 2017, requested the views of the Solicitor General on whether to grant certiorari in the Fosamax appeal, now known as Merck, Sharp & Dohme Corp. v. Albrecht, No. 14-1900 (U.S.).

We’re even more pleased, now that we have read the Solicitor General’s responsive brief, which we have just received.  Getting right to the point – the bottom line:

In the view of the United States, the petition for a writ of certiorari should be granted.

United States Amicus br. at 1.  Even though “[n]o circuit conflict yet exists,” the issue in its MDL context is sufficiently “significant” to grant certiorari now.  Id. at 12.

Although the question is close, . . . this Court should grant certiorari.  The underlying issue in this preemption case is a significant one:  whether the meaning and effect of an FDA labeling decision is a question of law for courts to resolve or a question of fact for lay juries to determine.  The petition cleanly presents that issue in an MDL context in which hundreds of separate cases . . . turn on its proper resolution.

Id. at 22-23.

First, the Solicitor General believes that preemption is a legal issue, not one for the jury, as the Third Circuit held in its unprecedented ruling:

The court of appeals erred in holding that a jury must determine whether FDA’s . . . decision − which declined to approve petitioner’s proposal to revise [the drug’s] Warnings and Precautions section . . . − preempted respondents’ state-law failure-to-warn claims arising from that same type of injury.  Where, as here, FDA renders a decision declining to approve a drug-labeling change, the interpretation of that administrative decision and its significance for a failure-to-warn claim are legal questions for a court to resolve, not factual questions for a jury.

Id. at 12.  “The meaning and effect of such agency action is a legal question within the exclusive province of a court.”  Id. at 13.  “Judges, rather than lay juries, are best suited to evaluate the scope of an agency’s legal determination in light of the relevant statutory and regulatory context.”  Id. at 14.

Second, the Solicitor General believes that the FDA’s rejection of the defendant’s request for a label change was “clear evidence” supporting preemption:

[B]ecause FDA’s decision here prevented petitioner from modifying the relevant labeling before late 2010, the court of appeals erred in rejecting petitioner’s impossibility-preemption defense.

Id. at 12.  “Nothing is ‘hypothetical’ about FDA’s actual 2009 decision in this case.”  Id. at 16.

[Levine] did not resolve how to determine the meaning and effect of an actual FDA labeling-supplement decision. . . .  [T]he court of appeals erred in transplanting [Levine’s] discussion about a hypothetical regulatory scenario to support a requirement for “clear evidence” about the scope and effect of the actual agency labeling decision in this case.

Id. at 16-17 (emphasis added).  The FDA was not quibbling about language when it rejected the label change at issue, but instead the “FDA’s decision thus was based on the lack of adequate data to support a warning.”  Id. at 21.  “Indeed, nearly a year later, FDA announced − after reviewing further data − that it had yet to find any ‘clear connection’” between the drug and the alleged risk.  Id. at 22.

Third, “clear evidence” was used in Levine “not in its ‘strict evidentiary sense’ but merely as a ‘useful reminder’ that a general presumption concerning a legal interpretation should control if substantial doubt exists.”  Id. at 18.  Thus, the Third Circuit’s “clear and convincing” evidentiary gloss in Fosamax was also error.  Rather, “to establish impossibility preemption, a name-brand drug manufacturer cannot rely on speculation or merely plausible interpretations of ambiguous features of FDA’s regulatory framework and practices.  Id. at 18-19.

Now we wait. If the Court grants review, Albrecht will likely be the most significant preemption decision since Levine itself.

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

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

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

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

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

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

 

This one comes from Alabama and it’s pretty straightforward – plaintiff’s claims are preempted and therefore dismissed with a little wiggle room left for an attempted amended complaint. But as we know, for Pre-Market Approved (PMA) devices, there is only a “narrow gap” between express and implied preemption through which a claim must fit to survive. And so far, plaintiff has been ping-ponging off the sides but hasn’t made it through the gap.

The case is Rice v. Allergan USA, Inc., 2018 WL 1618036 (N.D. Ala. Apr. 4, 2018). Plaintiff had LAP-BAND surgery to aid with weight loss. The LAP-BAND is a PMA device. After seven years, plaintiff started to experience difficulty swallowing and frequent vomiting and upon investigation it was discovered that the LAP-BAND had eroded into plaintiff’s stomach and had to be removed. Id. at *2. Plaintiff conceded several of her claims. Those that remained for ruling by the court were negligence, failure to warn, and negligent or fraudulent misrepresentation. Id. at *3. Plaintiff’s primary allegation in support of these claims was that while defendant’s label reported a 1% risk of erosion, studies revealed a higher complication rate. Id. at *2.

Because the LAP-BAND went through the PMA process, plaintiff’s claims are preempted unless they satisfy the “parallel claim doctrine.” That means plaintiff has to show that the state law duties she alleges defendant violated and for which she seeks damages are “genuinely equivalent” to the federal requirements imposed on the device. Id. at *5. Only when the state and federal duties are parallel will plaintiff’s claim not run afoul of the provision of the Medical Device Amendments (“MDA”) that a state not impose requirements that are “different from or in addition to” federal requirements. Id.

Plaintiff’s first negligence claim was for negligent design and manufacture. However, while she made several allegations about the device having significant risks, nowhere did plaintiff allege how the manufacturer’s duty of care under state law “parallels the federal requirement that the [device] be manufactured according to the approved specifications for the medical device.” Id. at *6. If the device was designed and manufactured according to its PMA specifications, then allowing a jury to find it was negligently designed or manufactured would be imposing a different or additional requirement on the manufacturer. Therefore, claim preempted.

Next up was plaintiff’s negligent failure to warn claim. The court actually broke the claim down into 5 theories on which failure to warn was premised: negligent marketing, negligent labeling, negligent failure to update labeling, negligent reporting, and negligent surveillance. Id. It’s worth noting here that the court applies all the same reasoning in concluding that plaintiff’s strict liability failure to warn claim is similarly preempted. Id. at *8.

Here plaintiff did cite federal regulations but still missed the mark. For instance, plaintiff cited 21 C.F.R. §99.101 which provides:

[a] manufacturer may disseminate written information concerning the safety, effectiveness, or benefit of a use not described in the approved labeling…provided that the manufacturer complies with all other relevant requirements under this part.

Plaintiff alleges that the defendant violated this federal regulation by failing to provide additional risk information about the device. But all this section does is provide a guideline should a manufacturer choose to disseminate additional information. Choosing not to do so doesn’t violate the provision. Id. at *6.

Plaintiff also cites to the Changes Being Effected (“CBE”) provisions arguing that the defendant violated those provisions by failing to implement a CBE warning. However, a CBE labeling-change is permission to change a label “while a manufacturer awaits a written FDA order approving the PMA supplement.” Id. at *7. But plaintiff did not allege that the defendant was awaiting an FDA order on a PMA supplement, so it is unknown if the provision even applies.

Plaintiff also tried to base her failure to warn claim on an alleged violation of defendant’s federal duties to report adverse events to the FDA and to conduct post-market surveillance. Id. But the court considered both of those claims impliedly preempted on the grounds that they were unlawful attempts to privately enforce the FDCA. The court said failure to report sounds like it could be failure to warn, but the requirement is to report to the FDA, not to plaintiff. And there simply is no state law cause of action for post-market surveillance. Id.

Finally, the court had to dismiss plaintiff’s misrepresentation claim based on plaintiff’s vague pleadings. If what plaintiff was alleging is that defendant should have disclosed additional information and such a disclosure requirement exceeded FDA’s requirements, the claim would be preempted as not parallel. If, on the other hand, plaintiff was alleging that the defendant “held its product out as meeting a higher standard than that required by the FDA,” such a claim would not be preempted. Id. Since the former is more likely, it appears that a properly pleaded claim is likely preempted.

Yesterday happened to be the deadline for plaintiff to file an amended complaint, which she did. A quick skim of the amended complaint leads us to believe it contains most of the same allegations and therefore deficiencies the court has already addressed. And, plaintiff re-pleaded the claims she conceded as insufficiently pleaded the first time around. We suspect another round of preemption briefing in this case’s future.

 

This is not new. PMA devices should have broad preemption against product liability claims. Not just from the express preemption provisions of the MDA, but from attempts to get around express preemption by basing claims on violations of the FDCA and running smack into implied preemption under Buckman. We have talked about the narrow gap a claim needs to squeeze through to not be subject to either version of preemption. We have, when we were feeling mythological, likened this to traversing the Strait of Messina between Scylla and Charybdis. Without overdoing the analogy, each state law claim must neither 1) impose a requirement that is “different from or in addition to” the PMA approval requirements, nor 2) have federal requirements as a “critical element,” or it will be smashed or swallowed into preemption oblivion. A good analysis of these issues starts with looking at what plaintiffs have alleged and how that fits within the cognizable causes of action under applicable state law.

In In re Smith & Nephew BHR & R3 Hip Implant Prods. Liab. Litig., No. CCB-172775, 2018 U.S. Dist. LEXIS 49021 (D. Md. Mar. 26, 2018), more than two hundred plaintiffs purported to assert fairly standard state law product liability causes of action against the manufacturer of a PMA hip implant. The actual allegations of what the manufacturer did wrong and what was bad about the device were not so standard. They were very heavy on alleged non-compliance with a range of FDA requirements. The defendant moved to dismiss under express and implied preemption and TwIqbal. We will focus on the preemption part and will resist griping about how the TwIqbal analysis should have come before the preemption analysis. We cannot, however, avoid commenting on the decision to address whether state law claims—under the law of forty-two states—are preempted without looking at state law. While the defendant may have liked the court’s willingness to address preemption on a motion to dismiss—something the plaintiffs resisted—the limited analysis helped to predict the result. The court said that “there is little need to analyze the elements of underlying state laws” and that it was “merely deciding which claims, and which arguments within those claims, would run afoul of state requirements that differ from and add to federal regulations,” but states do not impose requirements unless there is some statutory or common law claim that fits what plaintiff is complaining about in the case. Id. at **61-62.

The court started its preemption analysis by citing some cases we like, such as Mensing and the Bexis favorite Puerto Rico v. Franklin California Tax-Free Trust, 136 S. Ct. 1938, 1946 (2016), on no presumption against preemption. It then cited some cases we do not like, such as Mink and Bausch on parallel claims. Id. at *66. When it said this, we knew where things were headed:

So, if a plaintiff may succeed on her state law claim by proving conduct that violates federal requirements, then that claim parallels federal requirements. The state law reliance on a federal regulation need not be explicit. Rather the elements of traditional state laws need only be satisfied by conduct leading to a violation of a federal regulation.

Id. Not only is that bit of bad logic eerily reminiscent of another case following Bausch that we lambasted, but you might want to look at the “elements of traditional state laws” before you declare them parallel to federal requirements. And there is that whole Scylla/Buckman part of the preemption analysis that cannot be defined away. With this background, the court’s analysis actually started out pretty well with strict liability design defect claims getting sucked down into the sea. “[P]remarket approval is FDA recognition of a particular medial device’s fitness for the market. Having received that approval, the BHR system cannot be labeled unreasonably dangerous by state law without imposing requirements on medical devices different from or in addition to federal regulations.” Id. at **67-68 (citing Reigel). Not bad.

The rest was. Claims for undifferentiated negligence, negligence per se—with no separate analysis—failure to warn, negligent misrepresentation, express warranty, and manufacturing defect were all considered parallel claims because they were based on the manufacturer’s “alleged failure to comply with duties already required by the FDA.” Id. at **69-70. Even if were not for Buckman, this is not what makes a state law claim parallel to a federal requirement. There needs to be a state law requirement that exists independent of FDA requirements and then it has to be parallel to the federal requirements. If state law required truthful communications about the risks and benefits of all products sold in the state and FDA required specific formats for communications about an approved device, but generally that communications about its risks and benefits be truthful, then that could be parallel. Those state law requirements probably apply equally to mushrooms as they do to implanted prescription medical devices.

By contrast, the purported state law requirement to train surgeons would be different than and in addition to federal requirements, because there is neither a federal requirement that surgeons be trained—states regulate the practice of medicine—nor a state law requirement that a manufacturer train surgeons before they can use its products. The court is correct that this claim is not impliedly preempted—it is not based on a federal requirement—but there needs to be a cognizable state law duty requiring training in the first place. Id. at *69 n.11. Similarly, the court held that a “failure to warn” claim based on reporting adverse events to FDA would not be expressly preempted, without considering whether state law imposes any duty to report—it does not. Id. at * 71. A claim for failure to warn “the general public or the medical community is, however, expressly preempted because there is no such parallel federal requirement”—but there is similarly no actual state law duty. Id. For negligent misrepresentation and express warranty, there are state law duties independent of any federal obligations and, here, we are not critical of the analysis. False marketing claims that a product is safer than it is or safer than a competing device can give rise to liability regardless of FDA requirements. So, we are fine with the court’s statement that “any state law claim that imposes liability for making false statements regarding the device’s relative safety parallels federal requirements,” even if we do not think the cases cited for that proposition are all good law. Id. at **72-73. We also agree that misrepresentation and warranty claims cannot be based on the alleged falsity of FDA-required statements about the device. Id. at *73. On manufacturing defect, the court reverted to an incomplete analysis, assuming that deviations from “the FDA’s approved design of the BHR device” could give rise to non-preempted state law claims, ignoring state law claims require manufacturing defects to render a product dangerous. Id. at *73.

Having found all these claims based on purported violations of FDA requirements to escape express preemption, without considering whether any state law authorized them, the court gave short shrift to implied preemption

All of the plaintiffs’ claims in the MACC fall within the states’ traditional power to regulate matters of health and safety. Not one cause of action tries to enforce a legal right held by a federal agency or relies on the statutory scheme for its existence—they all long predated modern medical devices.

Id. at **75-76. This is neither an accurate recap of what Buckman means, nor consistent with how the court had characterized plaintiffs’ causes of action as not seeking to impose liability based on violating requirements that were different from or in addition to FDA requirements. Rather than belabor the problems with this court’s analysis, we will end with pretty obvious gaffe. In returning to the purported state law claim for “failure to warn” by failing to report adverse events to FDA, the court concluded that “plaintiff’s failure to warn claims do not attempt to enforce the FDA’s right to be warned of information concerning the safety of approved medical devices” because plaintiffs claimed failing to report adverse events to FDA “violated a legal right owed to them.” Id. at *77. Presumably, that would be a right that the law of a state—or, rather, the law of 42 separate states—bestowed on private citizens based solely on federal law. To put it mildly, this is the kind of mess than can happen when preemption analyses skip steps and make unwarranted assumptions.

 

It took a while for courts to catch on that implied preemption in drug cases depends on whether the plaintiffs can present “newly acquired evidence” of a relevant risk, but the argument seems to be gaining some traction. The first case to recognize the “newly acquired evidence” argument was the First Circuit’s Marcus v. Forest Pharmaceuticals opinion in 2015, which we covered here.  Since then, we have covered the topic at some length in connection with orders coming out of the Eliquis MDL in New York, which you can revisit here, here, here, and here.  These posts report on a series of orders in which the district judge dismissed multiple cases because federal law impliedly preempted the plaintiffs’ claims.

A district judge has now issued a similar dismissal ruling in a prescription drug case in the Northern District of Alabama, McGee v. Boehringer Ingelheim Pharm., Inc., No. 4:15-cv-2082, 2018 WL 1399237 (N.D. Ala. Mar. 20, 2018).  Here is the gist of it.  We all understand that Wyeth v. Levine opened the anti-preemption door by recognizing that an innovator drug manufacturer could sometimes change its label without the FDA’s pre-approval through the Changed Being Effected (or “CBE”) process.  Because that allowed the manufacturer, under some circumstances, to change its label to accommodate state law without running afoul of federal law, implied preemption did not necessarily apply.  Then came PLIVA v. Mensing, which held that federal law impliedly preempted state-law failure-to-warn claims against generic drug manufactures because generic manufacturers cannot use the CBE process, and therefore cannot change their labels without pre-approval.  Because generic manufacturers cannot change their labeling to comply with state law without violating federal law, state law claims must give way.

In McGee, the district court joined others in recognizing that even an innovator manufacturer cannot use the CBE process unless there is “newly acquired evidence” of a causal association between a risk and the drug.  In that event, the innovators cannot change their drug labeling without the FDA’s pre-approval and implied preemption applies.  Id. at **3-4.  “So, if a plaintiff can allege the existence of newly-acquired information that supports a labeling change under the CBE regulation, and if the manufacturer subsequently fails to show by ‘clear evidence’ that the FDA would not have approved a change to the label, then a failure-to-warn claim will survive the manufacturer’s preemption defense.” Id. at *4.

In other words, before we even get to Wyeth v. Levine’s “clear evidence standard,” the plaintiff has to plead facts establishing that the manufacturer had newly acquired information and that the new information provides reasonable evidence of a causal association between the alleged risk and the drug.

The plaintiff in McGee failed.  He alleged that the product manufacturer failed to warn adequately regarding the risk of diabetic ketoacidosis, or “DKA.” McGee, 2018 WL 1399237, at *1.  But the complaint was ambiguous on what the manufacturer knew about that condition and when the manufacturer knew it. Id. It all came down to timing.  The plaintiff alleged that there were reports of DKA before the FDA approved the defendant’s drug, but reports that pre-date drug approval obviously are not “newly acquired” information.  In addition, any allegation that the manufacturer should have alerted the FDA about the DKA risk before approval is a fraud-on-the-FDA claim preempted under Buckman. Id. at *4.

The plaintiff also alleged that the FDA issued a warning with reference to adverse events after the plaintiff allegedly experienced DKA, but “common sense dictates that any information [the manufacturer] obtained after January 17, 2015, when Mr. McGee suffered DKA, is irrelevant to Mr. McGee’s claims because [the manufacturer] could not have used that information to change its label and prevent Mr. McGee’s injury.” Id.

In theory, the plaintiff could have stated a claim with reference to information newly acquired after approval but before he used the product.  “But Mr. McGee lumps together claims and facts from before, during, and after this brief time period” and “[w]ithout clarification, the court cannot tell when Mr. McGee alleges [the manufacturer] had what information.” Id.  Alas, the court granted leave to amend.  But the district court in the Eliquis cases gave the plaintiffs additional chances to plead too, and they were unable to come up with the facts.

The plaintiff in McGee may have similar difficulty.  We know from Eliquis that dumbing down the complaint and making the allegations more vague will not work, and the district court in McGee has already faulted this plaintiff for his imprecise pleadings in any event.  The court had particular distaste for allegations that were “nothing but a useless set of legal conclusions.” Id. at *5.  The court continued:

Worse, the complaint spews these legal conclusion with few supporting facts that would assist [the defendant] in understanding what the company did wrong. This type of “shotgun” pleading fails to plead a cognizable cause of action.  If Mr. McGee chooses to file an amended complaint, he must eliminate the unnecessary and unhelpful “shotgun” assertions and claims.

Id. (citations omitted). These are pretty strong words, but nothing beyond what any court should expect under Rule 8 and TwIqbal.  The takeaway is that the “newly acquired evidence” argument is well-grounded in the law and supported now by substantial precedent.  Moreover, plaintiffs will not always have the facts to get around it.

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.

 

At times, we have given a glimpse into the sausage making that goes into our production of posts on recent interesting cases and developments.  Part of the process involves standing searches for “published” (including by the electronic services) decisions from trial courts and appellate courts.  Sometimes, the trial court decisions are unpublished but interesting, and the appellate decisions are published but not too interesting.  When we saw the Sixth Circuit decision in Agee v. Alphatec Spine, Inc., — Fed. Appx. –, 2018 WL 1020078 (6th Cir. Feb. 22, 2018), on one of our standing searches, it was not interesting enough to merit a post.  A short per curiam decision noted how awful plaintiffs’ complaint was and how they had waived their position on preemption by mixing up express preemption with the implied preemption raised by the defendant’s motion to dismiss.  We were feeling sleuthy, however, so we tracked down the district court’s decision from a year ago.  It has a nice discussion of Buckman, and will now be published, so we are going to discuss it.

Agee v. Alphatec Spine, Inc., No. 1:15-cv-750, 2017 WL 5706002 (S.D. Ohio. Mar. 27, 2017), reads like the sort of case brought when the plaintiffs are looking for someone on whom to pin liability in the absence of a claim against the most logical defendant.  The plaintiffs claimed that a surgeon used defendant’s product in connect with unnecessary spinal surgeries without proper informed consent, but the surgeon fled the country with criminal charges pending.  So, the plaintiffs asserted various product liability claims against the manufacturers of the product, PureGen.  Usually, we would state clearly what type of product is at issue, but neither decision really says, other than to say the defendants are medical device companies and the product was used to stimulate bone growth.  We did a little looking and saw that PureGen is an “osteoprogenitor cell allograft” derived from donated adult stem cells.  We also saw that there was some history with FDA over whether this was a biologic, requiring approval of a Biologics License Application, or a device that might go through the 510(k) pathway.  In any event, plaintiffs seemed to claim defendants should be liable for their injuries—it was unclear that there were any physical injuries—solely because PureGen “had never been approved by FDA for use in the spine.”  Defendants moved to dismiss.

We will skip over the TwIqbal part of this—although there are nice statements and the interesting fact that some of the plaintiffs were suing in the same court with contrary allegations about another product—and the some of the details of Ohio law to get to the Buckman part.  After reiterating the Buckman standard and the cases explaining that a court is to look at the asserted claims to see if a violation of the FDCA is a critical element, the court did just that, providing something of a roadmap on what is preempted under Buckman.  The claim for defective manufacturing alleged that the failure to obtain FDA approval made the product produce injury.  (That is not close to a manufacturing defect claim under Ohio law, which has codified the claim under ORC 2307.74.)  The design defect claim was identical (and similarly off-target from ORC 2307.75).  The warning defect claim was also predicated on lack of approval of the product, but not even that the warning misrepresented the regulatory status.  The misrepresentation claim was predicated on a representation to plaintiffs and their doctors that the product was approved or concealing from them that it was not.  A similar claim for nonconformance with representation (under ORC 2307.77) was slightly less clear, in that it referenced “representations made by defendants concerning the product and/or with applicable federal requirements.”

The court’s analysis of these claims was clear and quotable:

Each of the above-quoted claims is clearly dependent upon the FDCA to a degree that the claims would not exist but for the statute. It may or may not be the case that the promotion and distribution of PureGen for use in the surgeries references in the complaint was in violation of the FDCA and relevant FDA regulations.  However, if that is the case, it is the sole responsibility and privilege of the federal government, and not private plaintiffs, to bring a suit to enforce those violations.

Well-reasoned. And dispositive.  And now affirmed on appeal.

The Seventh Circuit taught us recently that the letter “A” is a powerful thing. Of course, we already knew that a well-placed A can convert the ordinary (“typical”) into the extraordinary (“atypical”), the melodic (“tonal”) into the dissonant (“atonal”), and the virtuous (“moral”) into the indifferent (“amoral”).  Adding a single A to a Scrabble board can result in a seriously high-value word, provided you can manage to place it on a triple word score appended to a word that already has high value letters, like H or Y, or if you are really lucky, X.

For today, A stands for “Abbreviated”—as in Abbreviated New Drug Application, or ANDA. It’s important because the Seventh Circuit held in Guilbeau v. Pfizer, Inc., No. 17-2056, 2018 WL 476343 (7th Cir. Jan. 19, 2018), that implied preemption of a failure-to-warn claim under Pliva v. Mensing depends not on a drug’s colloquial description as “generic” or “brand name,” but rather on the nature of the drug’s approval process.  If a drug is approved through an ANDA, federal regulation of drug labeling preempts state-law failure to warn claims—even if the drug is technically the “Reference Listed Drug.”

This ruling makes perfect sense, and here is how it works. In Guilbeau, the plaintiffs alleged that manufacturers of a testosterone replacement therapy product called Depo-T failed adequately to warn regarding cardiovascular events. Id. at *1.  Depo-T, however, had a slightly unusual regulatory history.  When a manufacturer applies for drug approval under an ANDA, it has to demonstrate that the drug has the same active ingredients, effects, and labeling as a predecessor drug that the FDA has already approved. Id. at *2.  The predecessor drug is called the Reference Listed Drug. Id.

The Reference Listed Drug is usually the innovator product, approved through the NDA process and often referred to as a “brand-name” drug. The ANDA drug is often called “generic.”  If, however, an original innovator drug has been discontinued, the FDA can designate the remaining market-leading drug to take its place as the Reference Listed Drug. Id. Something like that (but not exactly) happened to Depo-T.  Because of unique circumstances surrounding the timing of the drug’s approval, the FDA classified Depo-T as an ANDA-approved drug, but the product also was designated the Reference Listed Drug for its kind of testosterone injection. Id. at *4.

So which is it? “Generic” or “brand name”?  It turns out those terms are neither useful nor dispositive when applying implied preemption.  Or, as the Seventh Circuit observed, “These colloquial terms are not quite precise enough for our purposes in this case.” Id.  The relevant distinction is NDA-approved versus ANDA-approved.  That distinction determines whether a drug manufacturer can unilaterally update its labeling through the changes being effected (or “CBE”) process and thus potentially lose the protection of implied preemption recognized in Pliva v. Mensing.  The Seventh Circuit explained it this way:

[D]espite potentially confusing references to brand-name and generic drugs—recall that the relevant FDA terms are NDA-approved and ANDA-approved—Mensing itself unambiguously refers to the lines drawn in the drug approval process as determining access to the CBE regulation. Mensing concludes that while NDA holders may use the CBE regulation to add warnings, ANDA holders (like [the manufacturer] here) may not. . . .

Despite their occasional use of these terms, the Supreme Court, Congress, and the FDA all agree that the meaningful difference is found in approval process classifications, not shorthand terms like brand-name and generic.

Id. at *6. The key point for the Seventh Circuit was that the CBE regulation is unavailable for products approved through the ANDA process.  And that goes for every ANDA product, even if it is the Reference Listed Drug—like Depo-T.  Because ANDA product manufacturers cannot change their labels unilaterally, it is impossible to change a label in response to state tort law without violating the federal duty of “sameness” that applies to all ANDA products.  That is Pliva v. Mensing implied preemption. Id. at **4-5.

The Guilbeau plaintiffs tried to avoid preemption by arguing that, because Depo-T was itself the Reference Listed Drug, the manufacturer’s duty was to have labeling the same as its own labeling.  According to the plaintiffs, that means the manufacturer could change the label all it wanted to and it would still be the “same” as itself. Id. at *5.  We appreciate the metaphysical nature of this argument:  How can something ever be different from itself?  But the answer is pretty easy.  The duty of “sameness” means that ANDA holders must match the labeling for the Reference Listed Drug as approved by the FDA, “not whatever the RLD’s manufacturer currently thinks would be best.”  Id. at *7.  In other words, “The statutes, the regulations, and the Mensing opinion do not draw the distinction plaintiffs advocate:  a difference in abilities and responsibilities between RLD ANDA holders and other ANDA holders.” Id.

In the end, ANDA drugs that are also Reference Listed Drugs are subject to a “duty of sameness indistinguishable from that of all other ANDA drugs.” Id. at *8.  They all must show that their labeling is the same as the approved labeling. Id. Thus, because Depo-T’s manufacturer “may not unilaterally change the FDA-approved language on Depo-T’s label,” a lawsuit under state law that seeks damages for the manufacturer’s failure to do so is preempted by federal law. Id.

One more important note: The Seventh Circuit held that the plaintiffs were not entitled to conduct further discovery.  The district court decided this case on a motion to dismiss, and because “preemption is a legal question for determination by courts . . . , discovery of facts may not be as vital to this inquiry as it could be to others.” Id. at *10.  With recent opinions from the Third Circuit and Ninth Circuit treating preemption as a factual issue on which discovery might be appropriate (discussed here  and here), the Seventh Circuit’s holding on discovery is most welcome.  Preemption can and should be decided on the pleadings in many instances, including the circumstances presented here.  The district court in Guilbeau correctly did exactly that, and the Seventh Circuit gave the order an A grade.