It was a Merry Christmas and a Happy New Year for Tucker EllisDustin Rawlin and his breast implant defense team – and they were considerate enough to share it with us.

Wait a minute, you might be saying, breast implant litigation?  Isn’t that passé? I n a sense, we’d agree with you.  This isn’t your father’s breast implant litigation.  Twenty or more years ago, one of the first wave of solicitation-driven medical device mass torts produced thousands of claims and multi-district litigation.  In another precursor of things to come, causation of almost all of the claimed injuries was scientifically discredited.  E.g., In re Silicone Gel Breast Implants Products Liability Litigation, 318 F. Supp.2d 879 (C.D. Cal. 2004); In re Breast Implant Litigation, 11 F. Supp.2d 1217 (D. Colo. 1998); In re Silicone Gel Breast Implant Products Liability Litigation, 1996 WL 34401766 (N.D. Ala. Oct. 31, 1996); Institute of Medicine, “Review of the Reports of the Independent Review Group and the National Science Panel on Safety of Silicone Breast Implants” (1999).  The litigation was thus 99.9% junk science, but in another portent of things to come, it was nonetheless sufficiently expensive to bankrupt some defendants and to force others to settle.

One other effect of the original breast implant litigation was to spook the FDA.  Motivated largely by fears of bad public relations – certainly not science – the FDA reclassified breast implants as Class III medical devices that required pre-market approval.  However disruptive the FDA’s action may have been on the market, and however many women might have been deprived of this product’s benefits in the interim, the FDA’s action is also why this isn’t your father’s breast implant litigation.

Product liability actions against PMA medical devices are subject to broad preemption, and that’s a new way for breast implant defendants to win such litigation.

On Christmas Eve came Cashen v. Johnson & Johnson, 2018 WL 6809093 (New Jersey Super. Law Div. Dec. 24, 2018), which granted the defendants’ motion to dismiss with prejudice on preemption grounds.  Cashen involved litigation tourists from Ohio who brought the usual strict liability, negligence, fraud, and consumer protection claims. Preemption wiped most of these out. Fraud claims “relating to the safety or effectiveness of the device” were preempted no matter how plaintiffs pitched them:

[C]laims of fraudulent misrepresentation and fraudulent concealment seek to either (1) impose different or additional requirements to those that the FDA has already determined to have been satisfied or (2) stand in the place of the FDA and enforce federal requirements.  The former would make the claims expressly preempted while the latter would be impliedly preempted.

Id. at *7.  Plaintiffs could not escape their complaint, which alleged fraud over the device’s “propensity to cause serious physical harm” and “misrepresentations and concealments regarding the safety” of the device.  Id. at *8.

In addition, the Ohio legislature, had had enough of judicial expansion of common-law product liability and enacted a statute (“OPLA”) that abolished the common law altogether and replaced it with statutorily defined causes of action.  The fraud claims also fell because they had been “abrogated.”  Id. at 8-9.

Cashen dodged the question of whether Ohio’s consumer protection statute was preempted, because “it clearly falls within the umbrella of the OPLA . . . and is appropriately dismissed.”  Id. at 9-10.

Finally, the statutory definitions of product liability claims was facially preempted, whether involving design, manufacturing, warnings, or warranty. Id. at *10-11.

Notably, Cashen appears to be the first claim of breast implant associated-anaplastic large cell lymphoma (“BIA-ALCL”) to be thrown out on a motion to dismiss.  This “new disease” isn’t related to silicone and thus wasn’t addressed by the aforementioned Independent Review Group.  It’s one way for plaintiffs to avoid the IRG’s devastating causation conclusions, thus it’s significant to see preemption stop a BIA-ALCL claim in its tracks.

Merry Christmas.

Then came Ebrahimi v. Mentor Worldwide LLC, 2018 WL 6829122 (C.D. Cal. Dec. 27, 2018).  This is the third judicial decision in this case.  We examined the other two, here and here.  This time, the plaintiff’s now third amended complaint alleged “a single cause of action for strict product liability arising out of a manufacturing defect,” since everything else had already been held preempted.  Id. at *1.  The remaining claim fared no better.

The purported manufacturing defect simply wasn’t.  Plaintiff in Ebrahimi had seized upon a descriptive sentence in the “product insert data sheet” (of which the court took judicial notice because “as it is available on the FDA’s website,” id. at 1 n.2.) and sought to convert it into a design specification.  Ebrahimi called out the plaintiff’s ruse:

The Sheet simply indicates that [defendant] conducted a laboratory test on one of its Implants, and [description of test results].  The Sheet does not state that the FDA required Mentor to manufacture a shell that [always matches those results].  In fact, the Sheet does not purport to announce the FDA’s manufacturing specifications.

Id. at *2.  That was pretty much all she wrote for plaintiff’s sole surviving claim.  It’s not easy to gin up a manufacturing defect for violating a specification without having a specification in the first place.  In judicial language, that’s “an unwarranted deduction of fact that is not entitled to the presumption of truth.”  Id. (citation and quotation marks omitted).

Since the third amended complaint’s remaining allegations were a rehash of claims that had already been dismissed, id., that was the end of the line.  Three strikes and yer out!  “As [plaintiff] has once again failed to allege such a claim, the Court shall not grant her leave to file yet another amended complaint.”  Id.

Happy New Year.  And to the plaintiffs − so long, and thanks for all the fish.

We have taken a daily multivitamin ever since our doctor told us that we were chronically deficient in a particular vitamin, the one you can get from being out in the sun.  Given our chosen line of work, we should not be surprised that we don’t get enough sunlight.  We should also not be surprised that dietary supplements—such as our daily chewable multivites—generate substantial litigation, usually based on the premise that the supplements don’t do what their sellers say they are supposed to do.

Plaintiffs often file these kinds of lawsuits in California because of California’s liberal consumer protection laws, but many of them find out that the FDA regulates dietary supplements as food.  Regular readers of the blog can see where this is headed.

That’s right.  Federal preemption.

Take for example the Ninth Circuit’s recent opinion in Dachauer v. NBTY, Inc., No. 17-16242, 2019 WL 150016 (9th Cir. Jan. 10, 2019).  In that case, the plaintiff purchased vitamin E supplements that claimed on their labels to “support cardiovascular health” and to “promote[ ] immune function.”  Id. at *1.  The court noted that the plaintiff “purchased one bottle of the supplements for health reasons.”  Id.  We think it is more likely that the plaintiff’s attorneys had an expert who questioned the value of vitamin E supplements and sent the plaintiff to buy his “one bottle” for litigation reasons, rather than “health reasons.”  But we don’t really know and are probably just being cynical.

Regardless, the plaintiff sued under California’s consumer statutes alleging that the supplements do not present cardiovascular disease and might increase the risk of all-cause mortality, rather than promote “immune function.”  Id.

Here is where the FDA’s regulation of dietary supplements comes into play, and there are only two things you really need to know.  First, the FDCA has an express preemption provision for certain food labeling claims, under which federal law preempts any state law that establishes “any requirement respecting any claim . . . made in the label or labeling of food that is not identical to [federal requirements].”  Id. at *3 (citing 21 U.S.C. § 343-1(a)(5)).  This is a strong preemption provision, and the “identical to” language is arguably even stronger than the “different from or in addition to” language that we are used to in the medical device context.”

Second, when it comes to dietary supplement labeling, the FDCA distinguishes between “disease claims” and “structure/function claims.”  A “structure/function claim” describes the role of a nutrient or ingredient intended to maintain the structure or function of the body.  By comparison, a “disease claim” claims to diagnose, mitigate, treat, cure, or prevent disease.”  Id. at *2.  An FDA guidance provides that structure/function claims can use general terms, such as “strengthen,” “improve,” and “protect,” so long as the claims “do not suggest disease prevention or treatment.”  Id. (quoting Regulations on Statements Made for Dietary Supplements Concerning the Effect of the Product on the Structure or Function of the Body, 65 Fed. Reg. 1000-01 (Jan. 6, 2000)).  Apropos to this case, the guidance identifies “helps maintain cardiovascular function” as an example of a permissible structure/function claim.  Id.

Having made labeling claims that are quite clearly permissible structure/function claims, the defendant moved for summary judgment on the basis that the plaintiff’s claims were preempted.  In other words, the plaintiff was asserting that state law required labeling different from the federally approved labeling.  The district court granted summary judgment, and the Ninth Circuit affirmed.  With regard to the labeling claim that the supplement “support[ed] cardiovascular health,” the plaintiff had an expert who disagreed, but the federal requirement was what it was, and the plaintiff’s expert could not just erase it:

The FDA allows manufacturers of supplements to make general claims—such as “promotes heart health”—and to substantiate them with evidence that a supplement has some structural or functional effect on a given part of the human body.  Manufacturers need not also have evidence that those structural or functional effects reduce the risk of developing a certain disease.  Plaintiff disagrees with the federal statutory scheme for dietary supplements, but we cannot accept his invitation to upend it.

Id. at *3 (emphasis added, citations omitted).  The Ninth Circuit came to a similar conclusion with regard to the plaintiff’s arguments targeting the “promoted immune function” claims.  The FDCA does not require that manufacturers substantiate structure/function claims about immune health with proof that their supplements reduce the risk of all-cause mortality.  Thus, “[b]ecause any such requirement under California law would differ from the FDCA’s labeling requirements, the FDCA preempts Plaintiff’s claim to the extent that he argues that Defendants make a false structure/function claim because their supplements fail to reduce the risk of all-cause mortality.”  Id. at *4.

The only claim that survived was the plaintiff’s claim that the defendant’s structure/function claim about immune health was misleading because the supplements actually increase the risk of all-cause mortality.  Because that claim would be misleading under either federal or state law, it was not expressly preempted.  Id.  The plaintiff, however, did not submit evidence sufficient to raise a triable issue of fact.  His expert cited four meta-analyses, but none concluded that vitamin E supplements caused an increased risk.  Id.  With no substantial evidence that the defendant’s “promoted immune function” claim was misleading, the plaintiff was not entitled to proceed.  Summary judgment affirmed.

The Dachauer opinion comes to the right result for the right reasons.  For our part, we will continue to take our daily multivitamin with modest expectations, and maybe we will try to get out into the sun more often.

While 2019 is solidly under way, we’re still catching up on a sizable number of favorable decisions to have come down right before the new year.  That’s certainly not a complaint.  We love a full plate of defense wins.  So, for today’s post we’re reaching back a few weeks to tell you about a decision coming out of Middlesex County Superior Court in New Jersey in what we believe is the first ever decision on a motion to dismiss in a case alleging breast implant associated-anaplastic large cell lymphoma (BIA-ALCL).  BIA-ALCL has been receiving a decent amount of publicity recently as well as significant regulatory activity since 2011.  And this is one of several BIA-ALCL cases pending in New Jersey.  So, the decision is significant as a case of first impression with hopefully trend-setting implications.

The case is Cashen v. Johnson & Johnson, 2018 WL 6809093 (N.J. Super. Law Div. Dec. 24, 2018).  Plaintiff underwent surgery in 2008 during which defendant’s breast implants were implanted.  In 2016, plaintiff was diagnosed with ALCL requiring surgery to remove infected lymph nodes and chemotherapy.  Id. at *2.  The parties agreed that Ohio law governed plaintiff’s claims as that is where the alleged injury arose.  Plaintiff brought claims for fraudulent misrepresentation, fraudulent concealment, consumer protection, design/warning/manufacturing under the Ohio Products Liability Act (“OPLA”), and express warranty.  Defendant moved to dismiss all claims on both preemption and substantive state law grounds.  Id.

Because the breast implants are pre-market approved medical devices, they are subject to express preemption under Riegel v. Medtronic, 552 U.S. 312 (2008) if plaintiff’s claims seek to impose state law requirements that are different from or in addition to the federal requirements imposed as part of the PMA process.  Id. at *5.  The court found that was the case with respect to plaintiff’s fraudulent misrepresentation and concealment claims:

Inherent in the FDA’s approval of the product is its finding that the product and its label have met the federal requirements as a Class III medical device. Therefore, it stands that any claims of fraudulent misrepresentation and fraudulent concealment seek to either (1) impose different or additional requirements to those that the FDA has already determined to have been satisfied or (2) stand in the place of the FDA and enforce federal requirements. The former would make the claims expressly preempted while the latter would be impliedly preempted.

Id. at *7.  Plaintiff attempted to bypass preemption by arguing that her fraud claims were “not based on the safety or effectiveness of the implants.”  Id.  Which was belied by the allegations of the complaint that focus on “serious physical harm” and misrepresentations about “safety” of the product.

The court also found that under Ohio law, plaintiff’s fraudulent misrepresentation and fraudulent concealment claims were abrogated under the OPLA.  The text of the OPLA provides that it abrogates all common law products liability claims.  Id. at *8.  And Ohio courts have determined that fraud claims premised on a failure to warn or a duty to make additional warnings are products liability claims subsumed under the OPLA.  Again, plaintiff attempted to re-write her complaint and argued that her fraud claims were premised on a general duty not to deceive rather than on a duty to warn.  Id.  But the court again found that argument contradictory to the allegations of the complaint which were clearly focused on concealments regarding safety – like a failure to warn claim.

Next up was plaintiff’s claim for violation of the Ohio Consumer Sales Practices Act (”OCSPA”).  Here the court opted not to decide the federal preemption question, instead relying on the abrogation of the claim by the OPLA.  The court noted that under Ohio law, medical devices are not considered consumer goods under the OCSPA.   Id. at *9.

Which then brings us to the plaintiff’s OPLA claims for design, warning, and manufacturing defect.  Because the implants were PMA approved, they have “satisfied the FDA’s strictest requirements for medical devices.”  Id. at *10.  Therefore, any claim for design defect must be preempted “because any alternative design would violate the product’s PMA.”  Id.  As for plaintiff’s manufacturing defect claim, it was premised on “generic allegations” lacking the specificity required to overcome preemption.  Plaintiff’s warning claim likewise failed because the FDA had already approved the implant’s warnings, making any state law finding that the warning was inadequate a different requirement.  Id.

Plaintiff’s breach of express warranty claim suffered the same fate.  The claim would ask the jury to find that the product was not safe and effective as labeled – which would be in direct conflict with the FDA’s PMA conclusions.  Id. at *11.

As if that wasn’t enough – the icing on this cake is that the dismissals were with prejudice.  Plaintiffs had sought leave to amend but it appears the court concluded that amendment would be futile given the preemption analysis.

Congratulations to Dustin Rawlins, Peter Choate, Monee Hanne, and Rachel Byrnes at Tucker Ellis and Michael Zogby and Jessica Brennan at Drinker Biddle on this excellent decision.

Our last post talked about carbohydrate-rich Thanksgiving food. Today, we are talking about a putative class action on the labeling of certain diet foods, particularly in regard to “net carbs” and sugar alcohols. This was not planned. Colella v. Atkins Nutritionals, Inc., No. 17-cv-5867 (KAM), 2018 WL 6437082 (E.D.N.Y. Dec. 7, 2018), on the other hand, has all the hallmarks of a case brought for no reason other than to reward the lawyer. The same lawyer brought multiple cases in multiple courts raising the same allegations. The purported class representative in this one claimed to have bought only three of the thirty-one products he sued over and it is hard to imagine how he sustained any harm, let alone a harm that continues. Two of the other cases produced decisions on similar issues, which the Colella court cited frequently, so this was not really new ground. We will just cite those now and cut back on internal cites later: Fernandez v. Atkins Nutritionals, Inc., No. 3:17-CV-1628, 2018 WL 280028 (S.D. Cal. Jan. 3, 2018); Johnson v. Atkins Nutritionals, Inc., No. 2:16-CV-4213, 2017 WL 6420199 (W.D. Mo. Mar. 29, 2017). That will also be the last of our references to dieting, a subject with which we stubbornly deny knowledge.

Plaintiff centered his consumer fraud and warranty claims on the allegations that sugar alcohols in a number of the defendant’s products should count toward any tally of net carbohydrates and their consumption does affect blood sugar levels. Sugar alcohols are used as sweeteners in a number of foods and, as it turns out, FDA has a fairly developed history of addressing them in connection with labeling. Predictably, especially if you have read other posts on lawsuits over food labeling, the defendant’s motion to dismiss the amended complaint teed up express preemption under the FDCA and primary jurisdiction, along with TwIqbal and substantive state law. The end result was that plaintiff lost most of his claims, but will get a third chance to plead a consumer fraud claim as to a portion of his apparent issues with the labeling for defendant’s products. As we have noted before, we do think it is better to assess whether viable state law claims have been supported by factual pleading (with or without the heightened standard applicable for fraud-based claims like the plaintiff here was asserting) before turning to whether express preemption or primary jurisdiction would apply. The Colella court flipped the order of analysis, so something is left at least for now.

We will follow the court’s order of analysis in our discussion after a little more on the claims. The products’ labeling, and the company’s website, made clear that all counts of “net carbs” excluded sugar alcohol (like they excluded fiber). They further touted the low number of net carbs and explained that sugar alcohols could be ignored because they do not impact blood sugar like other carbohydrates that count toward the net carbs total. Plaintiff claimed this was a misrepresentation of the available science and that sugar alcohol consumption did have an impact on blood sugar. He also claimed FDA agreed that sugar alcohol should be counted toward total carbohydrates (but not net carbs). Lastly, he claimed he had relied on the labeling’s statements about net carbs and sugar alcohol in buying three products (once, apparently). Based on this, he wanted a range of damages for a purported class of purchasers of a bunch of products.

The express preemption analysis was fairly thorough and technical, because non-identical state law claims as to nutrient content labeling and health-related claims are expressly preempted but the regulations are complicated on those issues. What was not complicated was the rejection of plaintiff’s call to a presumption against preemption. Bexis should be happy with the quotation of Puerto Rico v. Franklin California Tax-Free Tr., 136 S. Ct. 1938, 1946 (2016), for the proposition that where a statute includes an express pre-emption clause, “[the court] do[es] not invoke any presumption against pre-emption but instead ‘focus[es] on the plain wording of the clause, which necessarily contains the best evidence of Congress’ pre-emptive intent.’” It was also acknowledged that there is express preemption of “state law requirements regarding nutrient content claims” under the FDCA and POM Wonderful. Statutes and regulations require labeling of nutrients in food, including “[t]otal fat, saturated fat, cholesterol, sodium, total carbohydrates, complex carbohydrates, sugars, dietary fiber, and total protein contained in each serving size or other unit of measure.” The regs also spell out how sugar alcohols should be handled and we will just repeat what the Colella court wrote:

Relevant to the instant case, “§ 101.9(c)(6) …. requires that food labels include … a statement of the number of grams of total carbohydrate in a serving, and a statement of the number of grams of total dietary fiber in a serving.” Fernandez, 2018 WL 2128450, at *4. Dietary fibers and sugar alcohols are considered carbohydrates for the purpose of calculating “total carbohydrates,” and the FDA provides extensive guidance regarding the treatment of sugar alcohols. 21 C.F.R. § 101.9(c)(6)(i)-(iv). Disclosure of sugar alcohols and their weights in the nutrition facts panel of a label is voluntary, however, if a claim is made about the grams of sugar alcohol on the label, disclosure must be made in accordance with 21 C.F.R. § 101.9(c)(6). Section 101.9(c)(6)(iv) states: “[a] statement of the number of grams of sugar alcohols in a serving may be declared voluntarily on the label, except that when a claim is made on the label or in labeling about sugar alcohol or total sugars, or added sugars when sugar alcohols are present in the food, sugar alcohol content shall be declared.” 21 C.F.R. § 101.9(c)(6)(iv); see also Fernandez, 2018 WL 2128450, at *4.

Statements about nutrients, however, do not necessarily have express preemption.

Under § 101.13(i)(3), “the label or labeling of a product may contain a statement about the amount or percentage of a nutrient if … [t]he statement does not in any way implicitly characterize the level of the nutrient in the food and it is not false or misleading in any respect.” Thus, “A nutrient content claim governed by § 343(r)(2) is …any claim outside of the nutrition-facts box that the manufacturer has chosen to make about the same kind of nutrients discussed inside the … nutrition information box.” Id.

With that backdrop, the court came to different conclusions about express preemption as to claims based on simply listing the number of net carbs or explaining how calculated them, on the one hand, and claims based on characterizing the number of net carbs as “Only Xg Net Carbs” and discussing the impact of sugar alcohols on blood sugar, on the other. Much of the analysis related to plaintiff’s argument that statements about net carbs cannot be preempted because they are not explicitly mentioned in the regulations. “Plaintiff’s argument that Section 343(q) of the NLEA and its implementing regulations, do not specifically list Net Carbs as a nutrient nor require the inclusion of Net Carbs in the Nutrition Facts panel is unavailing. The broad language in Section 343(r)(1) includes claims regarding nutrients, and relationships of nutrients, ‘of the type’ required by paragraph (q)(1) or (q)(2), obviating the need for specific categorical references to nutrients and nutrient relationships . . . ” The court also did not require that the FDA had to have expressly permitted the challenged labeling language. Here, there was ample evidence that FDA considered the language without prohibiting them. Among that evidence was the rejection of a citizen petition on the net carbs description in one of the products, noting “The agency has not generally objected to the use of ‘net carbohydrate” type information on food labels if the label adequately explains how the terms are used. If [the] FDA determines that such statements or their explanations are false or misleading, we will take appropriate action.” Thus, the court concluded that, “while the FDA may not have considered the exact language addressed …, it had clearly addressed the substance of the claims at issue.”

Statements about the products having “only” a certain number of grams of net carbs and explaining whether sugar alcohols have an effect on blood sugar levels did not have the same record and were not preempted. Implied nutrient claims—the implication of “only” is the net cabs in these products was low—are subject to misbranding unless FDA has set a criteria and it has been met. That has not happened with net carbs yet. As to explaining blood sugar impact, the court did not consider that to be a claim about nutrient content or a health related claim. We get the former, but the explanation of the latter was lacking. At least in the lay sense, saying nutrients in the food do not impact blood sugar does seem like a claim about health.

Getting past preemption did not mean plaintiff was done. Primary jurisdiction was looming. As would be expected, every claim that was preempted was also subject to primary jurisdiction. The net was cast a little broader, though.

Upon consideration of plaintiff’s claims and application of the four factors, primary jurisdiction applies with regard to plaintiff’s Net Carbs figures and calculations, and the “Only Xg Net Carbs” statements, as “[i]t is clear that it is the FDA’s role to decide what calculation methods manufacturers may use, not the courts.” Johnson, 2017 WL 6420199, at *9. Primary jurisdiction does not apply to plaintiff’s claims as to whether the labeling statements on the impact of sugar alcohols on blood sugar are false or misleading, as that is a factual issue within the traditional real of judicial competency.

Boiling it down, the distinction seemed to be that it is for FDA to determine the criteria for low net carbohydrate food, which is closely related to a number of issues it already decides. While there was not much analysis as to the discussion of blood sugar impact, the court clearly felt that was the sort of thing that it could decide as misleading or not without treading on regulatory toes.

Only after addressing preemption and primary jurisdiction did the court turn to whether New York state law claims for consumer fraud and warranty had been stated on the face of the complaint. Consumer fraud was not and it was not very close. Facts were not asserted that the challenged labeling was deceptive in a material way, which should require extra facts under Fed. R. Civ. P. 9(b). Nor did asserted facts establish any injury. Even with a reduced bar for economic injury from an allegedly over-priced product, “plaintiff only conclusorily asserts that Atkins Nutritionals charges a premium for its products and provides no facts regarding what the premium was, what price he paid for the products, or the price of non-premium products.” So, plaintiff did not assert any consumer fraud claim, regardless of what defense might apply.

He also did not have a warranty claim, because New York requires timely notice and that was not alleged. The court declined to adopt an exception to this rule for consumer products. This defect could not be cured with re-pleading. The plaintiff would get a third shot at pleading facts for some consumer fraud claim not subject to express preemption or primary jurisdiction. We have a hard time seeing a claim based solely on sugar alcohols and whether the amounts in these products affect blood sugar levels. Plaintiff can claim this information was material to his decision to buy this manufacturer’s Chocolate Chip Cookie Dough Bar, Sweet & Salty Trail Mix, and Chocolate Peanut Candies over other items at his local Wal-Mart, but it is hard to imagine facts supporting that convenient assertion.

 

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

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

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

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

When it comes to medical device preemption, having Pre-Market Approval (“PMA”) is like being dealt pocket aces in Texas Hold’Em Poker.  It’s the strongest starting hand you can have; a 4:1 favorite over any other two card combo.  It means you’re starting in the power position.  Since the Supreme Court’s decision in Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), manufacturers of PMA medical devices are in the power position in products liability litigation.  Very little slips by the double-edge sword of express and implied preemption in PMA cases.  The same can, and should be said for IDE cases as well.  And that’s what the Kentucky Court of Appeals said in Russell v. Johnson & Johnson, — S.W.2d –, 2018 WL 5851101 (Ky. Ct. App. Nov. 9, 2018).

Defendant manufactures medical catheters.  The catheter was approved by the FDA via the PMA process in 2004.  Id. at *1.  In 2015, the FDA approved use of the catheter under the Investigational Device Exemption (“IDE”) to the MDA which allowed the catheter to be used in a clinical trial to evaluate its safety in certain cardiac ablation procedures.  Plaintiff underwent a cardiac ablation procedure as part of the clinical trial in which defendant’s catheter was used.  Id.  After plaintiff’s procedure the catheter did receive full pre-market approval.  Id. at *4.

Plaintiff suffered complications during the procedure and subsequently filed suit alleging defendant was liable for strict liability, negligence, lack of informed consent, failure to warn, breach of warranties, fraud, and unjust enrichment.  Id. at *2.  Defendant moved to dismiss all claims on the grounds of preemption and the trial court, relying on Riegel, granted the motion.  Id.  Plaintiff later asked the court to set aside its ruling based on defendant’s voluntary recall of other catheters, but not the one used on plaintiff.  The court denied that motion.  Plaintiff appealed both rulings.

Not surprisingly, plaintiff’s primary argument was that the court should discount Riegel because at the time of plaintiff’s surgery, the device had not yet received pre-market approval.    Id. at *4.  But the court found the argument contradicted by numerous courts to have considered the issue.  Some courts find that timing of the grant of PMA to be immaterial.  Id.  While others find IDE approval to be synonymous with PMA.  Id.  This certainly follows the logic of Riegel.  Riegel adopted a two-step test for preemption and the first step is whether the FDA has established requirements applicable to the device.  Riegel concludes that a PMA does in fact establish such requirements.  Well, so does an IDE.

[b]ecause IDE devices are subject to a level of FDA oversight and control that is, for the purpose of a preemption analysis, identical to that governing PMA devices, the body of preemption law governing PMA devices applies equally to the IDE device at issue in this case.

Id. (citing Martin v. Telectronics Pacing Sys., Inc., 105 F.3d 1090 (6th Cir. 1997).

Thwarted by authorities from other jurisdictions on the issue, plaintiff next urged the court to rely on a Kentucky Supreme Court case decided before RiegelNiehoff v. Surgidev Corp., 950 S.W.2d 816 (Ky. 1997).  Id.  Niehoff rejected preemption in an IDE case relying on Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996).  But as we all know, Lohr dealt with a device approved via the §510k “substantial equivalence” process.  As pointed out above, the IDE process is more analogous to the PMA process and therefore, in a post-Riegel world, Riegel is controlling.   In Niehoff, the manufacturer also stopped the clinical trial before the FDA considered its PMA application.  Id.  Whereas in Russell, the device was granted PMA just over one year after plaintiff’s procedure.  Id. at *5.

In deciding the preemption question in the current case, the court started its analysis with the clear cut statement that “there is no presumption against preemption” in an express preemption case.  Id.  After checking that box, the court looked at the device at issue and concluded that “approval after being subject to both the IDE and PMA processes, satisfies the first prong of Riegel.”  Id. at *6.  So, to survive preemption, plaintiff cannot be alleging a claim that is different or additional to FDA’s requirements regarding safety and effectiveness.  Id.  That means, plaintiff in his complaint must allege three things: “violation of a federal requirement; violation of an identical state violation; and a link between the federal violation and [plaintiff’s] injury.”  Id.  Plaintiff went 0 for 3.

The court could find no allegations of federal violations, or even a cite to a federal regulation.  No factual support for any alleged violation.  No allegations that his injury was caused by a federal violation.  All plaintiff did was allege the device was defective – “in other words, the FDA should have imposed more stringent requirements – an attack precisely prohibited by the MDA.”  Id. at *7.

Failure to allege a parallel violation required dismissal of plaintiff’s strict liability, negligence, failure to warn, and fraud claims.  Id. at *7, *8.    Plaintiff’s informed consent claim failed because plaintiff signed a detailed consent form that was approved by the FDA.  Any claim that the consent was inadequate would impose a different or additional requirement on the defendant.  Id. at *7.  Claims that the device breached warranties regarding safety and effectiveness “directly contradict the FDA’s conclusion that the catheter was safe and effective.”  Id. at *8. As would an unjust enrichment claim premised on a claim that plaintiff did not receive safe and effective medical care.  Id.  Finally, plaintiff failed to allege a parallel federal statute to the Kentucky Consumer Protection Act.  Id.  So, all of the claims were properly dismissed as preempted.  The appellate court also upheld the trial’s court’s decision that any attempt at amendment would be futile.  “Additional time would not have transformed [plaintiff’s] claims into parallel state claims.”  Id.

As for the motion to set aside the dismissal based on the recall, the court again upheld the trial court’s decision.  A final judgement can be set aside based on newly discovered evidence which could not have been learned via due diligence in time for a new trial.  Id. at *9.  But new evidence is not events that occur after entry of a final judgment – such as the recall here.  Id.  Moreover, the new evidence needs to be relevant.  The recall was of different catheters, not the one used in plaintiff’s procedure.  Id.  Next, the voluntary recall “negated neither federal preemption nor FDA approval.”  Id.  The FDA was aware of adverse events and of the recall, but did not withdraw its approval of the device.  And, a recall is not a presumption that FDA regulations have been violated.  A recall doesn’t turn a “preempted claim into a parallel cause of action.”  Id.

             No doubt defendant had pocket aces going into this appeal, but Jim Murdica and Kara Kapke from Barnes & Thornburg and Lori Hammond from Frost Brown Todd deserve a shout out for knowing when to go all in!

Recently, the Enviably Youthful Drug and Device Law Mother has been pushing us to plan a mother/daughter vacation.   Her longtime companion no longer enjoys travel, and few of her friends share her sense of adventure. So we set about finding a suitable trip for next spring. Threshold categorical decisions proved troublesome. Our normal instinct, given the pace of our everyday life, is to sit still on vacation. We are fond of cruises, and we don’t care to where because we don’t get off of the boat.   The EYDDM prefers an eight-cities-in-seven-days pace. If we have to move, we prefer to rent a car and explore – we are not fond of printed itineraries. And we lean toward countries with national languages other than English. So, in the spirit of compromise, we booked eight days on a bus in Ireland over Memorial Day. Yeah, we know. But you should have seen the EYDDM’s smile. Sometimes, the answer is simple.

As it was in today’s case.   In Romer v. Corin Group, PLC, et al., 2018 WL 4281470 (M.D. Fla. Sept. 7, 2018), the plaintiff alleged that he was injured by when the defendant’s artificial hip implant released metallic contaminants into his body, causing pain and malfunction of the device and ultimately requiring another surgery. He sued in state court on the usual product liability theories, and the defendants removed the case on diversity grounds. After removal, the defendants moved to dismiss the negligence, negligence per se, and strict liability claims.

Listing seven alleged manufacturing defects in the hip implant, the negligence per se claim alleged that the defendants failed to comply with the manufacturing standards the FDA approved as “conditions of FDA’s approval [as well as] the general regulations applicable to Class III medical devices.” Romer, 2018 WL 4281470 at *3. A second negligence per se count alleged that the defendants’ simulator testing of the device was inadequate and violated federal regulations related to the compliance with Approved Design Standards. Id.   The defendants argued that both counts failed as a matter of law because Florida does not recognize a claim for negligence per se based on alleged violations of the federal FDCA or its implementing regulations. The court agreed, holding that, “[u]nder Florida law, the violation of a federal regulation does not create civil liability based upon a theory of negligence per se in the absence of a legislative intent to create a private cause of action.”   Id. at *4 (citations omitted). Because the FDCA and its implanting regulations do not “expressly create civil liability for non-compliance, strongly suggesting a legislative intent not to create a private cause of action,” id., the plaintiffs could not base negligence per se claims on the violations they alleged.

The defendants argued that the design defect claims sounding in both strict liability and negligence were preempted under Riegel because the hip implant device was a Class III medical device subject to pre-market approval (“PMA”) by the FDA. While the plaintiffs argued that the design defect claims escaped preemption because the claims were “based on defendants’ alleged failure to comply with federal laws after the FDA already approved the design of the device,” id. at *5, they made no allegation that the defendants had altered the design approved by the FDA during the PMA process.   The court concluded, “To the extent plaintiffs are asserting parallel claims, . . . . a valid parallel claim cannot challenge the rigorous PMA process itself or the requirements imposed by the FDA pursuant to that process. However, plaintiffs’ design defect claim does just that,” id at *6, and it was therefore expressly preempted.

Similarly, the defendants argued that the plaintiff’s negligence claims, based on the defendants’ alleged failure to warn of defects in the hip implant device or to report adverse events to the FDA, were expressly preempted because they sought “to second-guess the FDA’s determination that the warning language [was] adequate and [to] force [the defendant] to meet an additional standard beyond what the FDA requires.” Id. The defendants also argued that the reporting violations claims were impliedly preempted.

The court held that the warnings claims “imposed requirements that [were] different from, or in addition to, the federal requirements under the MDA,” and were thus expressly preempted. To the extent that the plaintiffs claimed that the defendants failed to comply with FDA reporting requirements, the claim was “simply an attempt to recast a claim for violation of the FDCA as a state law negligence claim.” Id. at *7. As such, it was “premised upon an FDA-reporting requirement that [was] not paralleled by a Florida law duty,” and was impliedly preempted under Buckman, which permits such claims to survive only to the extent that they “do not seek to privately enforce a duty owed to the FDA.” Id.

And so the court dismissed the plaintiffs’ design defect, failure to warn, and “failure to report” claims, leaving manufacturing defect claims pending. The dismissal was without prejudice, and the plaintiffs were given fourteen days to file an amended complaint. We’ll keep you posted

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.

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

You’re likely all familiar with the phrase, “don’t look a gift horse in the mouth.” Checking out a gift horse’s teeth is like looking for the price tag of the gift to see how much it’s worth. The expression is meant to convey that upon receiving a gift you should accept it gratefully. But what happens when you don’t accept the gift at all. In many instances, politely declining a gift is completely acceptable. When the gift actually comes in the form of help, passing it up may well be to your own detriment. Sure, it looks good to stand on your own two feet. To accomplish something on your own. But sometimes offers of help are extended because they are needed. A parent offers to help a child tie his shoe. A teacher offers to guide a student through a math lesson. A young man offers to cut the grass for an elderly neighbor. Or perhaps a judge offers plaintiff an opportunity to take discovery to save her case. And that plaintiff says: No thanks. I’ll stand “on the allegations contained in [my] original complaint.” That plaintiff shouldn’t be surprised that what wasn’t good enough the first time around, isn’t good enough the second.

The case is Benyak v. Medtronic, Inc., 2018 Ill. App. Unpub. LEXIS 998 (Ill. App. Jun. 14, 2018) and involves an implanted intrathecal pump that plaintiff alleges became inverted in her body causing her pain. Id. at *2. Plaintiff alleged only negligent design and manufacturing defect and negligent education of medical providers. Id. at *2-3. The medical device underwent pre-market approval by the FDA and so defendant moved to dismiss the claims as preempted. That motion was granted but the court granted plaintiff leave to serve written discovery on the manufacturer and then to file an amended complaint. Plaintiff opted to do neither and so the court dismissed her claims with prejudice. Id. at *2. Plaintiff then appealed that dismissal arguing that her original allegations should have survived defendant’s motion to dismiss.

The Illinois Appellate Court authored a nice accounting of PMA preemption, see id. at *5-15, which we won’t completely recount here because if you are even an infrequent reader of this blog, you’re likely well-versed in PMA preemption. And if not, check out this scorecard to start your PMA preemption education. We will point out the court’s proper conclusion that because of the MDA’s express preemption provision, there is no presumption against preemption. Id. at *10. Also that the court landed where most court’s do, finding that there is only “a small window in which a state-law claim may escape express or implied preemption.” Id. at *13. Finally, before turning to the case-specific details, the court notes that “the manner in which allegations are pled guides the analysis of whether a state-law claim involves requirements different from, or in addition to, the federal requirements.” Id. at *15.

Since it was undisputed that the device at issue was a PMA device, there was also no dispute that the FDA had established requirements applicable to it. Id. So the court moved on to the next part of the PMA-preemption analysis – did plaintiff’s state law claims involve requirements related to safety and effectiveness different from or in addition to federal requirements. Because safety was at the heart of plaintiff’s claims, the only real issue was the “different or in addition to” standard. In other words, did plaintiff’s claim parallel the federal requirements established by the FDA for this device.

As for design and manufacturing defect – plaintiff’s complaint was completely silent as to whether the device was designed or manufactured differently or out of compliance with the FDA’s approval and protocols. Id. at *16-17.

Absent such factual allegations, plaintiff, in essence, posits that the [device] should have been designed and manufactured differently than what the FDA approved during the premarket approval process, which necessarily would impose a requirement for the [device] that is different from, or in addition to, the requirements already imposed by the FDA.

Id. at *17.

On appeal, plaintiff argued that “the ability of the [device] to remain upright” was a premarket requirement that defendant failed to meet. However, the complaint “never specifically identified any specific requirement resulting from the premarket approval process.” Id. at *19. And this brings us back to that gift horse:

Understandably, at the time plaintiff filed her complaint, she might not have had enough facts to support her allegations, which is why the circuit court allowed her leave to serve written discovery on defendants and file an amended complaint. Had she taken the opportunity to conduct the discovery, she could have bolstered the allegations of her complaint and perhaps, her state-law claim would not have been expressly preempted by the MDA. But she chose not to conduct the discovery nor file an amended complaint, resulting in her design and manufacturing defect claim, as pled in her complaint, being expressly preempted.

Id. at *19-20. It jumped right up and bit her.

As for plaintiff’s other claim, negligent instruction, it is not a recognized claim under Illinois law. Id. Even if it were, plaintiff didn’t allege that the instructions defendant provided deviated from those approved by the FDA during the PMA process. Id. at *21. So, that’s two grounds to affirm the dismissal. Plaintiff attempted to turn the claim into a learned intermediary claim arguing it was really a failure to warn the doctor claim. But, that’s not what plaintiff alleged in the complaint. The complaint never mentions learned intermediary and the court was unwilling to construe it as such.

Finally, plaintiff asked for the case to be remanded with leave to amend her complaint. Wow. Once you refuse a gift it’s much less likely you’ll get offered it again. The appellate court found that because plaintiff had “intentionally” chose not to take discovery and amend her complaint when that opportunity was afforded to her, “she has waived any right to a remand with leave to amend.” Id. at *22.

We often talk about giving plaintiffs second bites at trying to plead their claims. But if you’re going to toss the apple away without so much as a nibble, don’t be surprised when the gift horse you decided to ignore gobbles it up and spits it out with nothing left for you to chomp on.

 

We have made it no secret that we think the Ninth Circuit wrongly decided Stengel v. Medtronic.  That is the case where the Ninth Circuit reversed express preemption of claims involving a pre-market approved medical device by divining a “parallel” state-law duty to report adverse events to the FDA.  As we have said here and here (and other places), we are not convinced that such a duty even exists.  That is why we liked the district court’s order from last year dismissing the Complaint in Ebrahimi v. Mentor Worldwide LLC, mainly because the district court emphasized another befuddling aspect of Stengel:  How on Earth can a plaintiff plead and prove that a purported failure to report adverse events to the FDA caused him or her any injury?

The plaintiff in Ebrahimi could not allege causation last year, and despite multiple opportunities to amend, she still can’t, resulting in another order granting another motion to dismiss.  The order is Ebrahimi v. Mentor Worldwide LLC, No. 16-cv-7316 (C.D. Cal. May 25, 2018) (you can view the order here), and the pleading at issue was the Second Amended Complaint.  The plaintiff again alleged injuries resulting from treatment with silicone-gel breast implants, and as in the initial Complaint, she alleged two failure-to-warn theories:  (1) The defendant allegedly failed to report “adverse events” to the FDA, and (2) the defendant allegedly failed adequately to warn patients and doctors. Id. at 3.

But neither of those theories stated a parallel claim sufficient to avoid express preemption. The Medical Device Amendments expressly preempt any state-law requirement that is “different from or in addition to” any federal requirement related to safety or effectiveness. See 21 U.S.C. § 360k(a).  Under the much-misunderstood “parallel claim” exception, a plaintiff can sometimes plead a non-preempted state-law claim if the asserted state law duty “parallels” the federal requirement.  Theoretically, that claim would not be “different from or in addition to” federal requirements.

The alleged failure adequately to warn doctors and patient was clearly preempted. Imposing a state-law duty to warn that is different from what federal law requires runs headlong into the Medical Device Amendments’ express preemption provision.  That is Riegel v. Medtronic to a tee.

As for the alleged failure to report adverse events to the FDA, that was not an actionable “parallel claim.” As the district court observed, “To state a parallel claim under California law, Ebrahimi ‘will ultimately have to prove that if [the manufacturer] had properly reported the adverse event to the FDA as required under federal law, that information would have reached [her] doctors in time to prevent [her] injuries.’” Id. at 3 (quoting Stengel v. Medtronic, Inc., 704 F.3d 1224, 1234 (9th Cir. 2013)).

Of course, this gloss on a parallel claim assumes that a state-law claim for failure to report claim to the FDA actually exists, and we don’t think one does. But setting aside that fundamental disagreement, this district court has again correctly zeroed in on causation as essential to pleading a claim based on an alleged failure to report adverse events.  This plaintiff failed for two reasons.  First, the “adverse events” that she alleged were not “events” at all.  Plaintiff alleged “potential statistical issues” with six post-approval studies, but none of those “issues” was an “ailment or injury resulting from gel bleed.” Id. at 3-4.  Second, and we think more importantly, the plaintiff failed to allege a “causal nexus” between her injuries and the manufacturer’s alleged failure to report:

In particular, she does not allege any specific facts showing that had [the manufacturer] not “covered up” these purported adverse events, the FDA would have required [the manufacturer] to modify its labeling and marketing materials or otherwise warn patients and doctors that “significant gel bleed was a potential risk. . . .” Therefore, Ebrahimi’s failure-to-warn claim cannot escape express preemption because she has not shown that [the manufacturer’s] failure to report adverse events to the FDA resulted in her injury

Id. at 5. We have blogged on parallel claims on multiple occasions, but Ebrahimi is particularly strong on folding causation (or lack thereof) into defining which claims avoid express preemption and which do not.  This is more than TwIqbal.  This is a district court ruling that federal law preempts your claim unless you can allege specific facts showing that the violation of a “parallel” state-law duty actually caused you harm.  Other courts should do this, too.

This time around, the district court dismissed the failure-to-warn claims without leave to amend, which makes sense. The plaintiff filed a First Amended Complaint, and then a Second, and if she has not alleged a non-preempted claim by now, she never will.  The district court did grant leave to amend for the manufacturing defect claim, based on allegations that the implant suffered from “poor workmanship” and the like. Id. at 5-6.  So she gets another chance, but if all she is left with is a manufacturing defect claim in a medical device case, she does not have much.

Kudos to the attorneys at Tucker Ellis for achieving this result, and our thanks to Dustin Rawlin for sending the order our way.