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

Last week the Third Circuit overturned the dismissal of thousands of cases in In re: Fosamax Products Liability Litigation, — F.3d –, 2017 WL 1075047 (3rd Cir. Mar. 22, 2017), finding that the trial court had improperly granted summary judgement on preemption grounds by misapplying the Supreme Court’s “clear evidence” standard announced in Wyeth v. Levine. It should come as no surprise that we firmly believe the trial court got it right and have lauded its decision in the past. So, it should be equally unsurprising that the Third Circuit’s abysmal “clear evidence” preemption decision is a front-runner for our list of the ten worst cases for 2017.

Regrettably, since Wyeth v. Levine, successful applications of preemption against warning claims asserted in litigation involving branded drugs have been few and far between. That is due in large measure to the both dauntingly high and utterly ill-defined preemption standard set by the Court in Levine, which requires an intensive fact-based analysis and a powerful regulatory case. So when the standard has been met, it is usually with facts that can hardly be described as equivocal. The district court in In re Fosamax, found as much and therefore a somewhat detailed recitation of the regulatory history is warranted.

Fosamax was approved by the FDA in 1995 for the treatment of osteoporosis in postmenopausal women. In re Fosamax, 2017 WL 1075047 at *4. Over the next 15 years, scientific studies were published concerning a possible link between long-term Fosamax use and atypical femur fractures (“AFF”). Merck kept the FDA aware of these studies and in June 2008, FDA asked Merck and other manufacturers to submit whatever data they had on the issue. Id. at *4-5. In September 2008, Merck submitted a “Prior Approval Supplement” (“PAS”) – the same thing as the “Changes Being Effected” (“CBE”) process discussed in Levine, only involving prior FDA review − seeking FDA approval to add information about AFF to both the Warnings & Precautions and Adverse Reactions sections of the Fosamax label. Because it is important to the arguments and the court’s conclusion, we quote some specific language from the requested change and the FDA’s response. Merck’s proposed language included:

Low-energy fractures of the subtrochanteric and proximal femoral shaft have been reported in a small number of bisphosphonate-treated patients. Some were stress fractures (also known as insufficiency fractures) occurring in the absence of trauma. . . . Patients with suspected stress fractures should be evaluated, including evaluation for known causes and risk factors . . . and receive appropriate orthopedic care. Interruption of bisphosphonate therapy in patients with stress fractures should be considered, pending evaluation of the patient, based on individual benefit/risk assessment.

Id. at *5. In April 2009, the FDA responded that Merck could add the information to the Adverse Reactions section of the label, but as to the Warnings/Precautions section, “more time [was] need[ed] for FDA to formulate a formal opinion on the issue of a precaution around these data.” Id. at *5. In its formal response the FDA wrote:

Identification of “stress fractures” may not be clearly related to the atypical subtrochanteric fractures that have been reported in the literature. Discussion of the risk factors for stress fractures is not warranted and is not adequately supported by the available literature and post-marketing adverse event reporting.

Id. at *6.

Almost a year later, the FDA issued a public statement that the data to date “had not shown a clear connection” between Fosamax and a risk of AFF. The FDA commissioned a task force, which after another six months (September 2010) reported a “relationship” between AFF and the class of bisphosphonate drugs, but not anything “proven to be causal.” Id. The FDA responded to the task force’s report with a statement also indicating that causation “is not clear,” and that the Agency was “considering label revisions.” Id. After another month, the FDA announced revised labeling for AFF for this class of drug. Causation was described as “not clear.” Id. at *7. The FDA’s proposed label change stated “[c]ausality has not been established.” Id. In response, Merck proposed adding additional language advising doctors to rule out stress fractures. The FDA ultimately rejected the addition of the term “stress fractures,” finding that the term “represents a minor fracture and this would contradict the seriousness of the atypical femur fractures associated with bisphosphonate use.” Id. The FDA’s approved language, including lack of causality, was added to the Fosamax label in January 2011. Id.

Against this regulatory background, the district court found that the claims of all MDL plaintiffs with injury dates before September 14, 2010 – when the FDA last reaffirmed its position that it did not have enough evidence of a causal association to allow a warning change – were preempted. Id. at *8. The district court ruled that the regulatory history “provided clear evidence that the FDA would have rejected a stronger Precautions warnings because the FDA did reject a stronger Precautions warning.” Id. at *9.

The Third Circuit clearly saw things differently. On appeal, it considered two questions: What is clear evidence? And who should determine whether clear evidence exists? Id.

As to the first question, and perhaps most significantly, this is the first case formally to make the leap from Levine’s amorphous “clear evidence” requirement for implied preemption of warning claims involving branded drugs, to a “clear and convincing” evidence standard for proof of preemption, which required a “highly probable” result. Our problems with Levine are many, and among them has always been this ill-defined standard. Coupled with the Court’s describing impossibility preemption as a “demanding defense,” district courts knew that the standard was high, but just how high was left completely open-ended and has resulted in a lineage of case law that is highly fact-specific with no clearly established definitions or guidelines.

Despite 8 years of court rulings all over the country using the facts of Levine as a benchmark against which to assess the facts of a given case (if stronger facts than Levine then preemption might be possible, if less than Levine, no preemption), the Third Circuit retroactively undertook to read the Supreme Court’s mind, deciding that what Levine really meant when it used the term “clear evidence” was to announce a standard of proof. Id. at *11. The court parsed the ruling in Levine – that absent clear evidence that the FDA would not have approved the label change, it cannot be ruled that it is impossible for a manufacturer to comply with both federal and state law – into three parts. First, it established the legal rule — a manufacturer is “absolved of state-law liability” where it is impossible to comply with both federal and state law simultaneously (impossibility preemption). Second, it established the factual showing needed to satisfy the legal rule – the FDA would not have approved the label change. Third, it established the standard of proof specifying “how convincing the factual showing must be” – by clear evidence. Id. So, according to the Third Circuit:

The term “clear evidence” therefore does not refer directly to the type of facts that a manufacturer must show, or to the circumstances in which preemption will be appropriate. Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change. The manufacturer must prove that the FDA would have rejected a warning not simply by a preponderance of the evidence, as in most civil cases, but by “clear evidence.”

Id.

The principal problem with this aspect of Fosamax is that it flies in the face of other, binding United States Supreme Court precedent. Because the Third Circuit reached its conclusion without even mentioning the Supreme Court precedent that explicitly rejects any “special burden” in implied preemption cases, one wonders if the Third Circuit went off on its own adventure, beyond the scope of the parties’ briefing. The controlling case is Geier v. American Honda Motor Co., 529 U.S. 861, 872-873 (2000), which held that imposition of any “special burden” on the implied preemption defense both lacks “basis . . . in this Court’s precedents” and creates “practical difficulty by further complicating well-established pre-emption principles.” Geier not only rejected imposition of purported “special burdens” in the implied preemption context, but did so on a stronger set of facts for creating such a burden, where Congress had expressly spoken to preemption with both statutory preemption and savings clauses. In the FDCA, by contrast, Congress was merely silent.

Fosamax thus did just what Geier held was not the law. The Third Circuit determined that when the Court said “clear evidence” it really meant “clear and convincing evidence” as a heightened standard of proof requiring a defendant asserting a preemption defense to prove that it is “highly probable” or “reasonably certain” that the FDA would have rejected a label change. Id. at *12.

The court then moved on to the question of whether deciding what the FDA would have done was a question of law or fact. Disregarding uniform precedent since Levine that has treated the issue as a question of law, the Third Circuit determined it was a question of fact. The court found that none of those other cases explicitly addressed the issue and so could not be the basis for concluding that the “clear evidence” test is a legal question. Id. at *13. But if it sounds like a duck, and walks like a duck . . . . In so ruling, Fosamax violated 3d Cir. I.O.P. 9.1 on a truly epic scale. IOP 9.1 provides:

It is the tradition of this court that the holding of a panel in a precedential opinion is binding on subsequent panels. Thus no subsequent panel overrules the holding in a precedential opinion of a previous panel.

Fosamax conceded that its finding that preemption was a matter of fact for jury consideration was contrary to a number of prior Third Circuit statements, which the panel dismissed as “off-hand.” 2017 WL 1075047 at *12. That is not a legitimate characterization. Relegated to an “e.g.” citation in footnote 106 was the standard of review that controlled in In re Federal-Mogul Global Inc., 684 F.3d 355, 364 n.16 (3d Cir. 2012): “The scope of preemption presents a pure question of law, which we review de novo”; as well as the prior FDCA preemption case, Horn v. Thoratec Corp., 376 F.3d 163, 166 (3d Cir. 2004), which likewise held that preemption was a matter for “plenary review” because “it is a question of law.” But Fosamax ignored a lot more precedent than that, including the en banc decision in Orson, Inc. v. Miramax Film Corp., 189 F.3d 377 (3d Cir. 1999), which held specifically that, because it was not bound by “prior decisions, the court was “free to consider the preemption issue as a matter of law.” Id. at 380. Preemption being a matter of law was plainly the holding of the court in Taj Mahal Travel, Inc. v. Delta Airlines, Inc.:

[Plaintiff] argues that [defendant] waived the preemption defense by not raising it until it moved to dismiss [a different] claim, which occurred [later]. . . . However, the preemption defense is a pure issue of law . . . and could be dispositive. Since the parties have briefed and argued preemption on appeal, we will consider it.

164 F.3d 186, 190 (3d Cir. 1998). See also: South Jersey Sanitation Co. v. Applied Underwriters Captive Risk Assurance Co., 840 F.3d 138, 143 (3d Cir. 2016) (“preemption determinations are questions of law”); Roth v. Norfalco LLC, 651 F.3d 367, 374 (3d Cir. 2011) (“preemption … determinations [a]re based on questions of law”); Elassaad v. Independence Air, Inc., 613 F.3d 119, 124 (3d Cir. 2010) (“[w]e also exercise de novo review of a preemption determination, as it is a question of law”); Deweese v. National Railroad Passenger Corp., 590 F.3d 239, 244 n.8 (3d Cir. 2009) (“a preemption determination . . . is a question of law”; Travitz v. Northeast Dep’t ILGWU Health & Welfare Fund, 13 F.3d 704, 708 (3d Cir. 1994) (“[t]he issue of preemption is essentially legal”); Pennsylvania Medical Society v. Marconis, 942 F.2d 842, 846 (3d Cir. 1991) (“[t]he question of preemption involves an issue of law”); Ayers v. Philadelphia Housing Auth., 908 F.2d 1184, 1188 (3d Cir. 1990) (“we determine that as a matter of law the federal regulations . . . preempt the application of [state law]”) (citations and footnote omitted); Pokorny v. Ford Motor Co., 902 F.2d 1116, 1119 (3d Cir. 1990) (“the question of whether [plaintiff’s] action is pre-empted . . . involves a pure issue of law”). These are not “off-hand” statements or dicta of any sort. Some of them are even West case headnotes. In deciding, after decades of contrary precedent, to convert preemption into a factual issue, Fosamax blatantly disregarded the “tradition” of the Third Circuit and did what panels are forbidden to do by IOP 9.1. We have said many times before that strange things happen in tort preemption cases, but Fosamax goes beyond “strange.” If precedent means anything, this aspect of Fosamax is a lawless decision.

Having decided that preemption doesn’t necessarily have to be a question of law, the court’s next awful conclusion was that juries are to determine what the FDA might have done with a different warning. The court looked at the specific question to be answered under Levine – would the FDA have rejected the label change plaintiffs argue was required – and determined it was the type of fact question that could be decided by a jury. The court’s reasoning was threefold: (1) the question asks about the probability of a future event; (2) the question requires the decision maker to weigh conflicting evidence and draw inferences; and (3) the question requires predicting FDA’s actions which requires assessments of FDA official’s motives and thought processes. All of which the court says are functions left to juries. 2017 WL 1075047 at *15-16. Which leads to the court’s ultimate conclusion that “[a] state-law failure-to-warn claim will only be preempted if a jury concludes it is highly probable that the FDA would not have approved a label change.” Id. at *18. Thus the decision opens the door to dueling FDA experts speculating about how the FDA would have viewed some hypothetical proposed label change, while discovery from actual FDA employees is mostly prohibited. See United States ex rel. Touhy v. Ragen, 340 U.S. 462, 468 (1951); Giza v. HHS, 628 F.2d 748, 751-52 (1st Cir. 1980).

This kind of jury second-guessing creates the kind of practical problems that drove the preemption decision in Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001) (also not cited in Fosamax). It “will dramatically increase the burdens facing potential applicants-burdens not contemplated by Congress,” id. at 350, by encouraging plaintiffs to nit-pick FDA decisions – such as those involving bisphosphonates that we discussed above – without regard to the FDA’s actual decision-making process. It will expose “would-be applicants” to unpredictable civil liability,” id. for doing what the FDA directed them to do. Looking at how the plaintiffs in Fosamax discounted the FDA’s “don’t say that” decision, it is likewise plain that allowing such claims to survive preemption will “also cause applicants to fear that their [interactions with] the FDA, although deemed appropriate by the Administration, will later be judged insufficient in state court.” Id. at 351. Allowing jury speculation about what the FDA might have done, had it received a different submission from a regulated company is, as a practical matter, no different than allowing the same jury speculation about what the FDA might have done, had it not been “defrauded” in Buckman.

Since the court in Fosamax was no longer addressing a question of law, its role at the summary judgment stage was “therefore limited to determining whether there are genuine issues of material fact that preclude judgment as a matter of law.” Id. at *13. Remember, the court is imposing a heightened standard of proof, so to affirm summary judgment the court concluded it would have to find “that no reasonable juror could conclude that it is anything less than highly probable that the FDA would have rejected Plaintiff’s proposed atypical-fracture warning had Merck proposed it to the FDA in September 2010.” Id. at *19. Sure sounds like a “special burden” on preemption to us.

What does that mean in the context of Fosamax? Despite the FDA’s rejection of the defendant’s proposal to warn about the particular risk, the court, enforcing the clear and convincing standard against the defendant (preemption being an affirmative defense), holds that plaintiffs can get to the jury on their contention that the FDA’s rejection, after 10 months of review and back-and-forth, was merely a semantic quibble that the defendant could have fixed. See id. at *21 (“a reasonable jury could also conclude that the FDA rejected [defendant’s] proposed warning about femoral fractures in 2009 not because it denied the existence of a causal link between Fosamax and fractures, but because [defendant] repeatedly characterized the fractures at issue as “stress fractures.”). And when you read the court’s view of what Levine requires to get summary judgment, it leaves us very concerned that such a standard will ever be met: “Because the [Levine] test requires the factfinder to speculate about hypothetical scenarios using inferences drawn from historical facts, reasonable jurors could reach a broad range of conclusions.” Id. at *22.

White the Third Circuit claims its adoption of a clear and convincing standard of proof is less than proof beyond a reasonable doubt, id. at *12, the piling of a special burden of proof atop the standard for summary judgment certainly sounds very close to indisputable proof. We used to be concerned that courts would only find “clear evidence” in the context of an outright rejection of a label change. But even that wasn’t enough in Fosamax to allow the court to find that jurors might not differ in their interpretation of that rejection. And it is those differences which bring us back to the fact that this should be a question for the court, not a jury. For a defense like preemption that is equally operative for all plaintiffs, there should be some element of consistency – which will be eradicated if the decision is left to multiple juries to decide. Moreover, deciding federal preemption is an analytical process where legal training adds value and where testing credibility, something usually reserved for a jury, is not as material.

There remain many questions about how this decision and the Fosamax MDL will play out and we’ll be watching it all closely. Definitely more commentary to come.

We recently read a recent (3/15) Bloomberg piece (here, for those with a subscription) entitled “Off-Label Promotion Could Mean More Drug Company Liability.”  This article consists largely of the interviews with two avatars of the other side of the “v.”:  fellow blogger Max Kennerly (who regularly writes intelligent critiques of our posts) and Lou Bogrod, with whom we’ve tangled before over off-label issues.  Needless to say, we disagree with the “more liability” spin they put on any would-be FDA retreat on off-label promotion.

Here’s why – and we apologize to all of you who can’t read the article we’re responding to, but it’s behind a paywall, but Michael Bloomberg didn’t get to be a billionaire by giving things away that he could charge for (that’s what we do).  Like the Bloomberg article, we’re also limiting our focus to product liability, recognizing that truthful off-label promotion also arises frequently in False Claims Act cases.

The first contention is that, once truthful off-label promotion is legal, “drug companies would lose the protection afforded by preemption.”  We don’t think that’s grounds for “more liability.”  First of all, “drug companies” – at least those making innovative branded drugs, don’t have much of a preemption defense.  The Supreme Court unfortunately took care of that in Wyeth v. Levine, 555 U.S. 555 (2009), limiting preemption to cases of “clear evidence” that the FDA would have rejected the label change in question.  There are other possible preemption grounds concerning design defect claims (which we’ve advocated here), but off-label promotion doesn’t involve design.  So, while there may be liability issues raised concerning specific instances of off-label promotion, we don’t see any basis for calling it “more” liability than already exists for on-label promotion.  Most branded drug warnings don’t have a preemption defense now.

Indeed, the result could very well be less liability. Even if truthful off-label promotion were to become broadly legal, the off-label use itself remains off-label.  The FDA, however, can order a drug’s label to contain statements (usually warnings) about an off-label use.  21 C.F.R. §§201.57(c)(6)(i), 201.80(e) (both phrased in terms of “required by” the FDA).  That’s important because, as we discussed in more detail here, only the FDA can do this.  Drug companies are not allowed to discuss off-label uses in their labels whenever they want.  Without the FDA telling them to, that is a form of misbranding.

Continue Reading What If We Win? Off-Label Promotion & Product Liability

If you have been following along for a while, then you have surely run across our posts making some combination of the following points:  1) design defect claims rarely make sense for a drug because changing the design in some material way will usually make it a different drug, 2) such design defect claims, if recognized by state law, will usually be preempted because FDA approval of a different drug cannot be assumed, and 3) courts really should analyze conflict preemption by first determining that there is an actual state law duty that has been asserted or supported (depending on the procedural posture).  One such post walked through why it took so long until a circuit court held that a design defect claim with a prescription drug was preempted.   That case, Yates, has been followed a number of times, including on motions to dismiss, but there are still some glitches.

The decision in Young v. Bristol-Myers Squibb Co., No. 4:16-CV-00108-DMB-JMV, 2017 WL 706320 (D. Miss. Feb. 22, 2017), counts as a glitch on the preemption front even though the court dismissed (without prejudice) the design defect claim and eight of the nine other claims asserted.  The plaintiff claimed to have suffered ketoacidosis and renal failure from taking a prescription diabetes medication right around the time FDA issued a Public Health Advisory about the risk of ketoacidosis for the class of medications, SGLT-2 inhibitors, to which it belonged.  Several months later, the drug’s label was revised to include warnings about ketoacidosis and urosepsis, a blood infection stemming from a urinary tract infection.  Plaintiff claimed that the inherent design of the drug, like all SGLT-2 inhibitors, created a risk of ketoacidosis.  When plaintiff sued, she asserted a wide range of claims and defendants moved to dismiss on various grounds.  We will address only some of them.

Part of our point here is that the order can matter.  We do not have the briefs, so all we can go off of here is the opinion.  After the preliminary issue of whether common law claims are subsumed by the Mississippi Product Liability Act—the four here were—the court starts off the meat of the analysis with this:  “The defendants argue that Young’s claim for defective design must fail because Young has failed to plead a feasible design alternative and because federal law preempts the design defect claims.” Id. at *5. So, what gets analyzed first? Preemption. (Remember, federal courts are supposed to try to resolve disputes on nonconstitutional grounds if they can.) In so doing, the court has to hold out as unresolved whether Mississippi law imposes the very duties that might create the conflict leading to preemption. As the court recognized at the end of its, to us, flawed preemption analysis:

If there is no state law duty, the state law cause of action must certainly fail but there can be no conflict so as to justify preemption. Put differently, the absence of a state law duty is fatal to a claim but not under the doctrine of conflict preemption.

Id. at *8.  This logic suggests that the court needs to decide first whether there is a state law duty to do what the plaintiff urges was necessary.  Because the court never determined that there was such a duty, the whole discussion of preemption seems like a bunch of dictum to us.

Continue Reading Another Court Tackles Prescription Drug Design Defect

Back in October we posted about the Eastern District of Pennsylvania decision McLaughlin v. Bayer Corp, 2016 U.S. Dist. LEXIS 37516 (EDPA Mar. 22, 2016) saying that while we liked the ultimate result – tossing out most of plaintiffs’ claims – some pieces of the decision weren’t as strong as we would have liked. Well, McLaughlin’s back and it’s still not a slam dunk, but plaintiffs’ don’t have too much left of their cases either.

As a reminder, this is actually a decision in 5 cases each alleging injury from plaintiffs’ use of a Class III, PMA contraceptive device, Essure. McLaughlin v. Bayer Corp., 2017 WL 697047, at *1 (E.D.Pa. Feb. 21, 2017). Several of plaintiffs’ original causes of action were dismissed with prejudice, but they were given an opportunity to amend to try to salvage their claims for negligent training, negligent risk management, breach of express warranty, fraudulent misrepresentation, and negligent manufacture. Negligent misrepresentation and failure to warn premised on failure to report survived the first motion to dismiss.

The decision methodically goes through each cause of action.

Negligent Training: In its first decision, the court opined it was possible to state a parallel claim for negligent training, but since plaintiffs failed to specify how defendant’s training deviated from federal training requirements or how those deviations caused plaintiffs injuries, the claim had to be dismissed as insufficiently pled. Id. at *3. In the amended complaint, plaintiffs alleged 6 such failures by defendant. As to 3, the court couldn’t find any federal directive that required defendant to do what plaintiffs alleged it failed to do. So, as to those 3 allegations, the claim was dismissed as expressly preempted. Id. at *4-5. As to the remaining 3 alleged violations, defendant challenged them on causation grounds but was unsuccessful. The court found the complaint sufficiently alleged that because defendant failed to properly train the doctors, the doctors in turn did not properly place the device causing it to migrate and cause plaintiffs’ injuries. Id. at *5. The complaint, however, lacked any specific allegations about the actual doctors who performed plaintiffs’ surgeries. The court didn’t find that fatal at the pleadings stage – that was for discovery. Id. at *6. But if you look at what the 3 bases for the failure train claim are, they appear to all be things plaintiffs could have asked their doctors about before filing these lawsuits. Did the doctor successfully complete 5 preceptorings? Did the doctor read and understand the training manual? Did the doctor successfully complete the simulator training? If the answers to those 3 questions are yes in each case – this claim is over.

Continue Reading PMA Preemption Revisited in Pennsylvania

This post comes from the Cozen O’Connor side of the blog.

We’ve been following the Pinnacle MDL closely through the last two bellwether trials, starting with the news coming out of the second bellwether trial of particularly curious and prejudicial evidence being presented to the jury. Given that evidence, we expected a plaintiffs’ victory, an expectation that was borne out with a whopping $498 million verdict. It raised an immediate question: “What will the Fifth Circuit do?”

Well, we’re on our way to finding out. The defense recently filed their opening appellate brief. While it features the controversial evidentiary rulings, much more is in play. If you would like to take a look for yourself, here is the brief.  Below are some of the key issues, along with a quick description of the defense’s arguments:

Design Defect Claim against DePuy (Brief at 20-29): Claim that all metal-on-metal hip implants are defective is not viable under Texas law because a wholly different product cannot serve as a safer design; design claim is preempted because the FDA approved metal-on-metal hip implants; and design claim fails under Restatement (Second) of Torts 402A comment k (adopted in Texas), which recognizes that products like implantable devices are unavoidably unsafe and therefore not defective if properly made and warned about.

Continue Reading Briefing Underway in Appeal of Half-Billion-Dollar Verdict in Pinnacle MDL

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

Within days of each other, courts in Ohio and California entered decisions finding all claims brought against Medtronic’s pre-market approved (“PMA”) pain pump device completely preempted – Warstler v. Medtronic Inc., 2017 WL 769810 (N.D. Ohio Feb. 28, 2017) and Martin v. Medtronic Inc., 2017 U.S. Dist. LEXIS 26350 (E.D. Cal. Feb. 24, 2017). While the two courts eventually reached the same destination – the route each took to get there was a little bit different. So, let’s compare the journey.

Manufacturing defect: In both cases plaintiffs appear to attempt to base their claims on alleged violations of Current Good Manufacturing Practices (“CGMPs”) – general, open-ended, non-device specific regulations. There is a current split in authority on whether CGMPs are specific enough to support a parallel violation claim. We think not. Ohio leaned more toward our thinking on this issue. Plaintiff Warstler failed to allege that the defendant deviated from any “specific FDA-prescribed manufacturing requirement.” Warstler, at *6. Without an alleged violation, plaintiff is essentially arguing that the FDA’s manufacturing process is insufficient. That would make Ohio state law different from or in addition to federal law and therefore the claim is preempted. When the court looked at the CGMPs cited by plaintiff, it couldn’t find one that “is not so vague as to be incapable of enforcement.” Id. at *7. In California, on the other hand, the court found that plaintiff’s allegations about CGMP violations were sufficient to state a parallel claim so that plaintiff’s claim survived express preemption. Martin, at *18-19. But, because plaintiff based his claim entirely on alleged violations of federal requirements, the claim was impliedly preempted. Id. at *19. To have a non-preempted parallel claim, plaintiff must be suing for conduct that violated the FDCA but not because the conduct violates the FDCA. The Martin complaint apparently gave only a cursory nod to the state law basis for his claim, alleging only generally that plaintiff did not take reasonable care in manufacturing. Id. at *20.

Continue Reading A Pair of Pain Pump PMA Preemption Cases

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel “clear evidence” standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a branded prescription drug was preempted.  Courts were chilled for a while, but eventually the right sort of cases found their way to judges who understood preemption.  Now, we have a pretty big list of decisions finding preemption of such claims, along with decisions exhibiting supportive reasoning.  We are not yet at the point where preemption of failure to warn claims with branded prescription drugs—for a long time, the core claim in the biggest litigations in our bailiwick—is no longer news.  Preemption is still the exception—limited to cases with a strong regulatory history of FDA rejecting the warning plaintiff wanted—rather than the rule, particularly when it comes to favorable appellate decisions.

Rheinfrank v. Abbott Labs., Inc., __ Fed. Appx. __, 2017 WL 680349 (6th Cir. Feb. 21, 2017), is another favorable appellate decision on preemption.  You may recognize the name—especially if you are a blog aficionado—from our prior posts on the case.  We posted on partial summary judgment being granted as to part of the failure to warn claims being offered—on preemption—and the punitive damages claim—on lack of proof of relevant FDA fraud to meet the exception under the Ohio Product Liability Act provision generally precluding punitives for FDA-approved drugs.  We posted on the expansion of the preemption ruling on motion to reconsider to include design defect.  (These garnered an honorable mention in our list of the best decisions of 2015.)  We even posted on motions in limine rulings.  Even with all of those posts, a brief recap of the facts might help.  The minor plaintiff’s mother took the prescription anti-seizure medication at issue for fifteen years, including through four pregnancies, before she became pregnant with plaintiff.  She kept taking the medication at issue, along with another anti-seizure medication she had been taking, through the birth of plaintiff, who was diagnosed with “physical deformities and cognitive disabilities, including Fetal Valproate Syndrome.”  2017 WL 680349, *1.  The label for the medication at issue had long featured a black box warning and other warnings about birth defects, focusing on neural tube defects like spina bifida and discouraging use during pregnancy unless use of the medications “are clearly shown to be essential in the management of their seizures.” Id. at *2.  Over the course of seven years after plaintiff’s birth, FDA refused the manufacturer’s repeated efforts to revise the label to address developmental delays in offspring based on data from a study that was ultimately published in the New England Journal of Medicine. Id. at **2-4.  A revision of the labeling was ultimately submitted by CBE and accepted by FDA in 2011. Id. at *4.  The prescriber back in 2003 and 2004 testified that she was aware of the black box warning on birth defects, would have relayed it to plaintiff, and would not have relied on other materials outside the label. Id. at *2.

Somehow, on this record, the plaintiff got to trial.  Under the logic of “all’s well that ends well,” we will limit our rant on this point.  After all, we have discussed other birth defect cases that got to trial despite obvious issues, resulted in big verdicts, and got affirmed on appeal. Rheinfrank proceeded to trial under the portion of the strict liability failure to warn claim that was not preempted, a strict liability claim for failure to confirm to representations, the portion of a common law negligent failure to warn claim that was not preempted, and a common law negligent design claim.  Among the reasons why the two failure to warn claims should not have seen a court are that 1) Ohio law requires the allegedly inadequate warning to relate to the injury plaintiff claims, 2) claims relating to developmental delays (including as part of Fetal Valproate Syndrome) were preempted, and 3) the prescriber was aware of black box warnings about really serious birth defects and the recommendation against prescription during pregnancy in most situations.  It is hard to see how plaintiff mustered evidence of proximate cause—that is, that a proposed (non-preempted) alternative warning as to a risk of an injury the plaintiff had (based on evidence that existed when the prescription was written) would have changed the prescriber’s decision to prescribe—to survive summary judgment.  Based on the jury instructions that plaintiff proposed at trial, it seems like a broader discussion of risks and the impact of different warnings about risks was permitted than maybe should have been, which is often a reason why failure to warn claims get past summary judgment.  Given that the prescriber denied reliance on any representations outside the label, it is hard to see how that claim got to the jury.  As for the negligent design claim, it is hard to see how the same reasoning for preempting the strict liability design claim would not have applied or how a design of the drug—without being a different drug—that lacked the same birth defect risk could have been offered.  Anyway, the trial judge may have known what was coming, because the jury listened to the just about the best plaintiff could offer and returned a defense verdict on all counts after two weeks.

Continue Reading Sixth Circuit Affirms Branded Drug Preemption and Trial Win

That’s Engle v. Liggett Group, Inc., 945 So. 2d 1246 (Fla. 2006), the most bizarre use of res judicata that we’ve ever seen – giving preclusive effect to a class action verdict despite also finding that the class was not certifiable.  Anyway, continuing in the tradition of unusual, pro-plaintiff results from the Florida Supreme Court (but not necessarily the district courts of appeals), we have two more to discuss.

First, since we blogged about the preemption result in Charles v. Southern Baptist Hospital, Inc., 178 So.3d 102 (Fla. App. 2015), we feel we ought to warn you that the favorable preemption decision was reversed late last month by the Florida Supreme Court.  Charles v. Southern Baptist Hospital, Inc., ___ So.3d ___, 2017 WL 411333 (Fla. Jan. 31, 2017).  Basically, the court held that the provisions of the federal Patient Safety and Quality Improvement Act (“PSQI”), didn’t preempt (expressly or impliedly) an unusual Florida constitutional provision (called “Amendment 7”) granting patients (read:  plaintiff lawyers) access to “adverse medical incidents” – even though these incidents were compiled and provided to PSQI evaluation committees in accordance with the statute.  Anything that had been initially created for any other purpose couldn’t qualify as protected “patient safety work product” under the PSQI.  2017 WL 411333, at *8.  The statute provided:

Notwithstanding any other provision of Federal, State, or local law, and subject to subsection (c) of this section, patient safety work product shall be confidential and shall not be disclosed.

42 U.S.C. §299b-22(a)-(b).  Tort litigation was not mentioned in subsection (c), but the court in Charles grabbed a “rule of construction” from elsewhere in the statute, and used that to create an exception to confidentiality that Congress has not seen fit to create in subsection (c).  Charles has a lot of mumbo-jumbo about not reading statutes in “isolation” and giving “every portion” meaning, 2017 WL 411333, at *4-5, but none of that can hide that the decision ignored the “notwithstanding any other provision” language and used something other than “subsection (c)’ to create a huge hole in confidentiality that Congress did not authorize.

That’s one.

In In re Amendments To Florida Evidence Code, ___ So.3d ___, 2017 WL 633770 (Fla. Feb. 16, 2017), the same court showed the same lack of respect for the state legislature that Charles had shown to the United States Congress.  In 2013, the legislature passed a statute to replace the prior Frye-based analysis of expert testimony with that of Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).  2017 WL 633770, at *2-3.  In re Amendments refused to amend the Florida Rules of Evidence to comply with this legislative directive.  This result followed a narrow 16-14 vote to that effect by a rules committee (no doubt packed, like Pennsylvania’s, with plaintiff-side members).  Id. at *1.

The reason for refusing to follow the Legislature’s directive was as bizarre as Engle – that Daubert may well be unconstitutional:

[T]he Committee and commenters who support the recommendation raised what we consider “grave constitutional concerns.”  Those concerns include undermining the right to a jury trial and denying access to the courts.  While the Court does not address the constitutionality of a statute or proposed rule within the context of a rules case, the fact that there may be “grave concerns about the constitutionality of the amendment” has been a basis previously for the Court not adopting an amendment to the Evidence Code. . . .  [W]e decline to adopt the Daubert Amendment to the extent that it is procedural, due to the constitutional concerns raised, which must be left for a proper case or controversy.

In re Amendments, 2017 WL 633770, at *3.  The court cited no precedent at all for this jaw-dropping proposition.  Daubert – a United States Supreme Court decision – has been around, now, since 1993.  The Federal Rules of Evidence (Rule 702) have been amended to conform to Daubert.  As the dissent points out, no court anywhere has ever declared Daubert unconstitutional before:

[T]he United States Supreme Court decided Daubert in 1993, and the standard has been routinely applied in federal courts ever since.  The clear majority of state jurisdictions also adhere to the Daubert standard.  In fact, there are 36 states that have rejected Frye in favor of Daubert to some extent.  Has the entire federal court system for the last 23 years as well as 36 states denied parties’ rights to a jury trial and access to courts?  Do only Florida and a few other states have a constitutionally sound standard for the admissibility of expert testimony?  Of course not.

In re Amendments, 2017 WL 633770, at *6 (dissenting opinion).  The dissent cited two cases directly rejecting this sort of constitutional challenge to Daubert. Id. (citing Junk v. Terminix International Co., 628 F.3d 439, 450 (8th Cir. 2010), and E.I. du Pont de Nemours & Co. v. Robinson, 923 S.W.2d 549, 558 (Tex. 1995)).  That’s two more cases than the majority cited.  It’s also probably the tip of the iceberg.  The relevant West keynote for Junk is #24, and for Robinson is #8.  According to Westlaw, these two keynotes, between them, have been cited by 97 other cases.

We agree with the dissent in In re Amendments – the proposition that, after a quarter century, Daubert is unconstitutional is absurd.

Not only absurd, but utterly unsupported by precedent.

Fish rot from the head, and there is currently something very rotten in the State of Florida.

When we heard about Judge Neil Gorsuch being nominated for the United States Supreme Court, our first move was to enter his name in Westlaw along with the term “preemption.” That’s the constitutional doctrine most important to our medical device, generic drug, and (unfortunately to a lesser extent) innovator drug clients.  It’s also a doctrine more likely to get less attention in what promises to be the upcoming brouhaha.

By far the most important Gorsuch preemption decision is Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), cert. denied, 136 S. Ct. 796 (2016), the very favorable PMA medical device preemption decision that we discussed previously here and named as our #2 best case of the year for 2015.  We’re not reprising those posts here.  Rather, we’re examining Caplinger for what it might tell us about Judge Gorsuch’s broader views of FDCA preemption.  His dissatisfaction with the Supreme Court’s tortured approach to express preemption in medical device product liability cases is very clear.

Caplinger begins with the strong statement that, in enacting the Medical Device Amendments, Congress “[e]xercis[ed] its authority under the Supremacy Clause” in enacting 21 U.S.C. §360k(a). 784 F.3d at 1336.  Before looking at relevant Supreme Court authority, Caplinger comments:

At first glance the answer to this appeal might appear easy enough.  Section 360k(a) preempts “any requirement” imposed by states on manufacturers that differs from or adds to those found in the FDCA.  Given this expansive language one might be forgiven for thinking all private state law tort suits are foreclosed.  After all, a “requirement” usually means a request, need, want, or demand.  And an adverse tort judgment seems to involve just that: a demand that a defendant appear to answer for its conduct and pay damages for failing some state law duty.

Id. at 1337 (dictionary citation omitted).  A string citation about the lower courts’ “struggles” to make sense of medical device preemption followed.  Id. at 1337-38.

The problem was, when the Supreme Court got involved, rather than interpreting Congress’ “expansive” preemptive language according to its terms, the Court “issued a number of opinions that embody ‘divergent views’ about the proper role of the MDA’s preemption provision, a fact that has yielded considerable ‘uncertainty’ among the lower courts.”  Id. (citation omitted).

Continue Reading Gorsuch Looks Pretty Good On Preemption

Remember how Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), dismissed the §510k “substantially equivalence” medical device clearance as non-preemptive because it was supposedly “focused on equivalence, not safety”?  Id. at 493.  In the same vein:

“[S]ubstantial equivalence determinations provide little protection to the public. These determinations simply compare a post − 1976 device to a pre − 1976 device to ascertain whether the later device is no more dangerous and no less effective than the earlier device. If the earlier device poses a severe risk or is ineffective, then the later device may also be risky or ineffective.”

Id. (quoting from pro-plaintiff law review article).

Most of our readers know that this characterization, assuming it was true for the 1980s-era (implanted 1987) device that the Court considered in Lohr, was no longer true, even at the time Lohr was decided, and certainly hasn’t been the case since the FDAAA was passed a year after Lohr was decided.  Still, this anachronistic view of §510k has flourished for twenty years, affecting first preemption and now (thanks mostly to Mesh MDL rulings) admissibility of evidence.

That’s why we were interested in what the FDA had to say about today’s §510k clearance process in its recent memorandum entitled “Public Health Interests and First Amendment Considerations Related to Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products,” which is available here.  One of our guest bloggers, Liz Minerd, recently discussed the First Amendment aspects of that document, here.

Continue Reading FDA Off-Label Promotion Memo Should Affect §510k Preemption & Evidence