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.

 

It took us more than a week, but we finally put away the last serving pieces from last week’s family Hanukkah celebration.  We love Hanukkah, a festive holiday that celebrates victory over a tyrant king, a reclaimed temple, and a small quantity of oil that should have lasted only one night but that miraculously burned for eight nights.  In commemoration, we light candles for eight nights. And we use oil.  Lots and lots of oil.  Like, eight dozen potato latkes-worth of oil.   Though the holiday has far less religious significance than does Christmas, it is a time for family and gifts and food and song and celebrating the “miracle” of the bit of oil that improbably shed eight nights of light.

In a similar vein (pun intended), today we celebrate a very short, but surprisingly bountiful, decision out of the inferior vena cava (“IVC”) filter MDL pending in the Southern District of Indiana.  We love warnings causation, a potent doctrine too often rendered toothless by passive judges.  Not so in In re Cook, Inc. IVC Filters Marketing, Sales Practices, and Prods. Liab. Litig. (Tonya Brand), 2018 WL 6415585 (S.D. Ind. Dec. 5, 2018).   In the IVC filter MDL, the plaintiffs allege that the filters are prone to tilting, migrating, fracturing, and perforating the inferior vena cava.  In Brand, the defendants’ IVC filter was inserted in the plaintiff’s inferior vena cava to prevent pulmonary embolism during an upcoming spine surgery.  Two years later, the plaintiff began to experience pain on the inside of her right thigh.  Shortly thereafter, the plaintiff noticed something protruding from her thigh and pulled out a portion of her IVC filter.  The plaintiff was required to undergo open surgery to remove the rest of the filter.  The plaintiff sued, alleging that the instructions for use (“IFU”) that accompanied her filter did not adequately warn her physician of the risks associated with the filter.

The court explained that, under Georgia’s learned intermediary doctrine, the plaintiff could prevail on her warnings claims only by proving both that the warnings in the IFU were inadequate and that the inadequate warnings proximately caused her injuries.  The court emphasized, “Where the learned intermediary has actual knowledge of the substance of the alleged warning and would have taken the same course of action the plaintiff contends should have been provided, . . .  the causal link is broken and the plaintiff cannot recover.”  2018 WL 6415585 at *3.  The plaintiff’s physician testified that he was aware of all of the relevant risks when he implanted the Plaintiff’s IVC filter.  His knowledge of the risks was not based on the IFU; rather, it was based on his “education, training, and experience.”  Id.    Moreover, the doctor testified that he continued to use the defendant’s filter even after the plaintiff’s filter fractured, and that nothing about the plaintiff’s experience changed his mind about IVC filters in general or about the specific filter he used in the plaintiff.  The court held, “In the face of this devastating testimony, Plaintiff fails to raise a genuine issue of material fact on the proximate causation element” of her failure-to-warn claims.  Id.  at *4.

The plaintiff also argued that the defendants breached Georgia’s continuing post-sale duty to warn because they did not warn her physician, after he implanted her filter, of the filter’s propensity to  perforate and fracture.  She alleged that, if the defendants had provided such a warning, her doctor “potentially could have removed the filter before it fractured and pieces migrated throughout [her] body.” Id.   The court rejected this argument as well, holding that it was based on speculation and that the evidence, including the fact that the plaintiff’s physician continued to use the same filter in patients even after the plaintiff’s filter fractured, suggested that no post-placement warning would have prompted the doctor to retrieve the plaintiff’s filter any earlier.  As such, the plaintiff “fail[ed] to raise a genuine issue of material fact that any post-implant failure to warn caused her injuries.”   Id.   Because the plaintiff failed to sustain her burden of proving the causation element of her warnings claims, the court granted summary judgment for the defendants on those claims and on the claims that were based on them.

We make these same arguments over and over and over again in our medical device cases.  We often don’t prevail, even on clear records.  We wish that more courts had the clear-eyed approach to warnings causation that this MDL judge employed.  We will keep you posted on similar decisions.  And we still have a couple dozen potato latkes in the freezer, in case you are in our neighborhood.

Contrary to rumor, we are not on the verge of changing our name to the Filter Device Litigation blog. True, we are now on a several consecutive weeks run of sharing very good IVC opinions. In fact, we will likely have two this week. The recent outbreak of good sense largely emanates from Indiana, but today’s case, Broge v. ALN Int’l, Inc., 2018 U.S. Dist. LEXIS 204486 (N.D. Cal. Dec. 3, 2018), shows that logic can prevail even in (gasp) the Bay Area. Hold your nasty comments – we were born in the Bay Area and admire it endlessly. Our native-son regard for the place does not prevent us from acknowledging that defense-friendly product liability wins there are as rare as football wins this season on either side of the Bay. But the Raiders and 49ers both won last Sunday, and now we have a case from ND Cal. that insists that plaintiffs lob in the occasional fact in their complaints. Sometimes man bites dog. Sometimes Adam Sandler puts out a good movie. Sometimes a politician commits candor. Sometimes our kids answer our texts.

In Broge, the plaintiff’s IVC filter had become embedded in her vena cava wall. It took two surgeries to remove the filter. She sued in Santa Clara County Superior Court, alleging strict liability failure to warn and manufacturing defect, breach of warranty, negligent and fraudulent misrepresentation, and the inevitable violations of California Business & Professions Code sections 17200 and 17500. The only defendant was ALN International, though the complaint devoted a lot of space to the conduct and knowledge of other entities, including ALN Implants Chrirugicaux and ALN Implants. The case was removed to federal court on the basis of diversity of citizenship, and then the defendant filed a motion to dismiss. The court granted the motion in part, and its opinion noted that it was odd of the complaint to sue one entity based on alleged sins of another. That opinion can be found at Broge v. ALN Int’l, Inc., 2018 WL 2197524 (N.D. Cal. May 14, 2018). The plaintiff was given leave to amend and did so, but did not do so very well. The defendant filed another motion to dismiss. In scrutinizing the amended complaint, the Broge court did not merely cite the Twombly and Iqbal cases, it actually applied them. That spelled doom for the amended complaint, which did not contain much beyond bare conclusions.

Take the failure to warn claim, for example. The plaintiff alleged that another entity, ALN Implants, should have known and discovered the defects. That would not affix liability to the actual defendant in the case. Further, as is all too typical, the amended complaint contained mere conclusions that better warnings would have altered the physician’s decision to prescribe the IVC filter. The plaintiff’s curative amendment cured nothing.

The manufacturing defect claim fared no better. In an earlier complaint, the plaintiff simply said the product “contained manufacturing defects.” That is obviously not good enough. On the next go-round, the plaintiff said that the IVC filter at issue did not conform to a hook design that should have permitted easy removal. Well, that at least seems a bit better. But the amended complaint still failed to allege how the product deviated from the design – all it talked about was the result. Even worse, the amended complaint still, almost perversely, hung the alleged hook malfunction on an entity that was not in the lawsuit, ALN Implants.

The negligent misrepresentation claim offered no facts suggesting that the defendant lacked reasonable grounds to believe its safety and efficacy representations were not true, the warranty claim rested in part upon a representation by a third party, and the fraud claim lacked specificity on the who, what, when, where, and how. The Cal. Bus. Code claims were merely fraud claims in another guise, so they also did not make the grade. There was also a claim for punitive damages. Because that claim was derivative of the fraud claim, it, too, was a goner.

The Broge court dismissed the claims, but because California is a land of not just second, but third, chances, the plaintiff was given, again, leave to amend. Perhaps the court will eventually grow weary of reading threadbare complaints that contain more ambition than facts. As long as the court keeps coming out with precise, demanding opinion that respect pleading standards, we won’t grow weary of reading such opinions.

Today’s case is not our usual fare.  But we’ve never seen this kind of appeal succeed before, so we’re going to spare a few minutes for something a little odd but important.

First of all, the patient and the medical device manufacturer are on the same side – they’re both plaintiffs in Alcresta Therapeutics, Inc. v. Azar, 2018 U.S. App. LEXIS 33961 (D.C. App. Dec. 3, 2018).  Because in this suit, the medical device manufacturer and the patient are aligned in their desire to get the patient access to the device.  Defendant is the Secretary of Health and Human Services.  And the issue is the billing code, or lack thereof, assigned by HHS to the device.

The device, Relizorb, is a cartridge containing an enzyme that predigests fats in enteral formula.  So the device is designed to be used with enteral feeding via a stomach tube for people with illnesses who have difficulty digesting and absorbing essential fats.  Id. at *2.  Relizorb is expensive and is not needed by all enteral feeding patients.  Id. at *6-7.  Feeding tube systems consist of many different parts that are not pre-packaged together, but that are coded and priced together by the HHS as an “enteral feeding supply kit.”  Id. at *2.  Many other products used for enteral feeding are priced and coded separately.  HHS determined, however, that Relizorb should be coded as part of the supply kit rather than separately.  Id.  That decision has led Medicare and private insurers to deny reimbursement for Relizorb which in turn has prevented the patient from getting Relizorb and the manufacturer from selling it.  So, they sought a preliminary injunction ordering HHS to assign the device a temporary billing code that doesn’t treat Relizorb as a component of the enteral feeding supply kit allowing it be separately priced.

The district court denied the injunction and the only issue on appeal was whether plaintiffs had demonstrated irreparable injury.  Id. at *5.  That, and of course, whether they had standing to challenge HHS’s coding determinations.  HHS argued that coding decisions are not determinations of the reimbursement rates and that the only way plaintiffs should be allowed to proceed is to challenge a specific reimbursement denial through the Medicare appeals process.  Id. at *7.  But, in this instance, the coding decision dictated the reimbursement rate.  HHS had no evidence that it made any separate pricing determination separate from the coding decision.  Therefore, both the patient and the manufacturer had standing because they demonstrated “they are harmed by a lack of opportunity to obtain reimbursement that is caused at least in significant part by HHS’s coding determination” and a new, independent billing code would redress that harm.  Id. at *8.  The new billing code wouldn’t set the reimbursement rate, but it would allow the agency to set a reimbursement rate for the device.

A similar argument prevailed on irreparable harm.  The patient-plaintiff cannot afford to buy Relizorb without insurance reimbursement and the manufacturer-plaintiff can’t sell Relizorb because patients cannot get insurance reimbursement.  Id. at *10.  The detriment to the manufacturer threatened to put it out of business.  For the reasons noted above on standing, plaintiffs demonstrated a sufficient connection between the HHS coding decision and their irreparable harm “that success on the merits would meaningfully redress those injuries.”  Id. at *11.

This may be a rare situation, but important for our clients, and therefore us, to be aware of.

 

The FDA has recently released a proposed rule “to establish requirements for the medical device De Novo classification process” provided in 21 U.S.C. §360c(f)(2).  FDA, “Medical Device De Novo Classification Process,” 83 Fed. Reg. 63127 (Dec. 7, 2018).  This de novo classification option is a relatively recent addition to the FDCA (via the 1997 FDA Modernization Act), and provides:

(ii) In lieu of submitting a report under section 360(k) [a/k/a/ §510(k)] . . ., if a person determines there is no legally marketed device upon which to base a determination of substantial equivalence . . ., a person may submit a request under this clause for the Secretary to classify the device.

(iii) Upon receipt of a request . . ., the Secretary shall classify the device subject to the request under the criteria set forth in subparagraphs (A) through (C) of subsection (a)(1) [meaning Class I, Class II, or Class III] within 120 days.

(iv). . . .

(v) The person submitting the request for classification under this subparagraph may recommend to the Secretary a classification for the device and shall, if recommending classification in class II, include in the request an initial draft proposal for applicable special controls, as described in subsection (a)(1)(B), that are necessary, in conjunction with general controls, to provide reasonable assurance of safety and effectiveness and a description of how the special controls provide such assurance. Any such request shall describe the device and provide detailed information and reasons for the recommended classification.

360c(f)(2)(ii-v) (emphasis added).  The emphasized statutory language establishes the standard to which these “de novo” devices are held: “reasonable assurance of safety and effectiveness.”  That’s important to preemption because of what Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996), had to say over twenty years ago:  “provid[ing] the FDA with a ‘reasonable assurance’ that the device is both safe and effective[,] [d]espite its relatively innocuous phrasing . . ., is a rigorous one.  Manufacturers must submit detailed information regarding the safety and efficacy of their devices, which the FDA then reviews.”  Id. at 477.

Famously, Lohr also declared that the 510(k) substantial equivalence process “[t]he 510(k) process is focused on equivalence, not safety.”  Id. at 493 (emphasis original).  That is certainly cannot the case with de novo devices, since by definition there is no equivalence determination to be made.  Indeed, the FDA “may decline to undertake a classification request submitted under clause (ii) if [it] identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence.”  21 U.S.C. §§360c(f)(2)(iv).

We’ve expounded at great length in our “Lohr Has Two Shadows” post about how Lohr had been an anachronism ever since it was decided because Congress toughened up the original 510(k) process that Lohr addressed with the Safe Medical Devices Act of 1990.  The SMDA imposed the same “reasonable assurance of safety and effectiveness” standard on substantial equivalence determinations that Lohr had praised as “rigorous in Lohr.  See 21 U.S.C. §§360c(a)(1)(B), 360c(f)(1)(A)(v).

Nevertheless, since Lohr, the judiciary has engaged in a conspiracy to ignore the SMDA and treat all 510(k) medical devices as if they were evaluated under minimalistic standard that the Supreme Court addressed in 1996.  With de novo devices, it’s going to be a lot harder for judges to continue sticking their heads in the sand and chanting “Lohr, Lohr, Lohr” every time a non-PMA device is at issue.

The FDA’s proposed rule makes clear that the de novo process is essentially the SMDA’s “special controls” regime without the fig leaf of substantial equivalence:

The De Novo classification process provides a pathway to ensure the most appropriate classification of a device consistent with the protection of the public health and the statutory scheme for device regulation. This pathway is intended to limit unnecessary expenditure of FDA and industry resources that may occur if devices for which general controls or general and special controls provide a reasonable assurance of safety and effectiveness are subject to a PMA due to a lack of a predicate.

83 Fed. Reg. at 63129 (emphasis added).  No longer can the SMDA standard for clearance of Class II devices be dismissed as involving “equivalence, not safety.”  It’s the same “rigorous” standard that Lohr equated with PMA – only extended to other classes of devices, in particular:

For any class II recommendation, the De Novo request must also provide an initial draft of proposed special controls along with a description of how the special controls provide reasonable assurance of safety and effectiveness.

Id. at 63130.

The proposed regulations firmly establish that de novo devices are to be evaluated for “safety and effectiveness,” not equivalence, in practically every aspect of their FDA review:

  • “If the submitter recommends that the device be classified as class II, FDA proposes that the recommendation must include a draft proposal for applicable special controls, and a description of how those special controls provide reasonable assurance of safety and effectiveness of the device.”  Id. at 63133.
  • “FDA proposes that the De Novo request include reference to any published standard relevant to the safety or effectiveness of the device.”  Id.
  • “For a clinical investigation involving human subjects, FDA proposes to require that a discussion of . . . safety and effectiveness data, adverse reactions and complications, patient discontinuation, patient complaints, device failures . . . and replacements. . . . FDA would use the summary of investigations in assessing safety and effectiveness of the device.”  Id.
  • Valid scientific evidence is evidence . . . from which it can fairly and responsibly be concluded by qualified experts that there is reasonable assurance of the safety and effectiveness of a device under its conditions of use.”  Id. at 63133-34.
  • “The proposed benefit and risk considerations section would expressly require that, “pursuant to the determination of safety and effectiveness section of the regulations, a discussion be included demonstrating that . . . the probable benefit to health from use of the device outweighs any probable injury or illness from such use (i.e., a discussion demonstrating the safety and effectiveness of the device) when the device is used according to its labeling.”  Id. at 63134.
  • “Any safety and effectiveness data to assist FDA in assessing whether the clinical investigation supports that a reasonable assurance of safety and effectiveness exists. FDA would assess reasonable assurance of safety and effectiveness by evaluating the valid scientific evidence submitted to support the De Novo request. FDA would review the data to assess whether the data supports the claims made in the indications for use and demonstrates that the probable benefits of the device outweigh the probable risks.”  Id.
  • “Discussion of data on any adverse reactions to the use of the device . . . or complications related to the use of the device. . . . Frequency data and severity data are particularly useful in safety and effectiveness determinations. FDA would review the rates of complications in clinical investigations in assessing the safety and effectiveness of the device.”  Id.
  • “FDA would need all discontinuation data in order to determine the safety and effectiveness of the device.” Id.
  • “Trends in complaints may point to possible risks posed by the device. FDA would review such trend analyses in assessing the safety and effectiveness of the device.”  Id. at 63135.
  • “In analyzing failures, factors such as location, user application, and repeat component failures may apply. FDA would review such analyses in assessing the safety and effectiveness of the device.”  Id.
  • “Statistical analysis of the results from each clinical investigation. The statistical analysis should specify and discuss all effects. FDA would review such analyses in assessing the safety and effectiveness of the device.”  Id.
  • Any “contraindication, precaution, warning, or other limiting statement relevant to the use of the device. . . . This includes information regarding any special care to be exercised by a practitioner or patient for the safe and effective use of the device.”  Id.
  • “[I]f a De Novo request relies primarily on data from a single investigator at one investigation site, the De Novo request must include a justification showing why these data and other information are sufficient to demonstrate the safety and effectiveness of the device.”  Id.
  • “FDA further proposes to require that a De Novo request include a discussion of the clinical significance of the results, pursuant to the determination of safety and effectiveness.”  Id.
  • “FDA proposes to require that the De Novo request include any other identification, discussion, and analysis of any other data, information, or report relevant to the safety and effectiveness of the device.”  Id.
  • “FDA proposes that the De Novo request must include other information that is necessary for FDA to determine whether general controls or general and special controls provide a reasonable assurance of safety and effectiveness of the device. Examples would include marketing experience outside the United States, medical device reporting (MDR) data . . ., and patient preference information.”  Id. at 63136.
  • “FDA proposes to require the De Novo requester to update its pending De Novo request with new safety and effectiveness information . . . as such information becomes available.”  Id.
  • “FDA proposes that FDA would be able to inspect relevant facilities prior to granting or declining a De Novo request. Such an inspection is intended to assist FDA in determining whether a reasonable assurance of safety and effectiveness can be provided by general or general and special controls.”  Id. at 63137.

Emphasis added in all cases.  Once all of these safety/effectiveness requirements are complied with, the FDA would issue an “administrative order” granting the request and specifying the de novo device’s classification.  Id.  By such orders “FDA would determine the safety and effectiveness of the device using the criteria specified in the determination of safety and effectiveness section of the regulations.”  Id. (citing 21 C.F.R. §§860.289(d), 860.7).

Given the proposed regulations’ emphasis on determinations of device “safety and effectiveness” throughout, as well as its reliance on “special controls” customized to each de novo request, we think that de novo devices should be protected by preemption under Lohr and Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).  We have here device-specific requirements intended “to provide reasonable assurance of safety and effectiveness” of these devices

Oddly, there is no explicit discussion – or even mention – of “preemption” in the FDA’s proposed rule.  So that nobody ends up buying a pig in a poke, we advise that industry-side comments to this proposal should request the FDA to specify explicitly that it believes the de novo process provides preemptive protection under 21 U.S.C. §360k(a), for all products that the FDA concludes have “reasonable assurance of safety and effectiveness” under 21 U.S.C. §360c(f)(2), and in accordance with Lohr‘s analysis .  While, in the past, FDA opinions on preemption haven’t always been helpful, or even intelligible, this time it might be.

A federal court in Utah ruled the other day that it had no personal jurisdiction over a corporate parent, even though the plaintiffs alleged that the defendant subsidiary was the “alter ego” of its owner.  We read the order with great interest for a couple of reasons.  First, one of our first assignments out of law school was to respond to discovery and write motions for an insurance company’s parent—a holding company that held considerable assets, but did not underwrite insurance policies.  We have learned over the years that some companies don’t care so much about corporate parents being sued, and others care a great deal.  Our insurance company client was in the “cared a great deal” bucket, leaving us to parse endlessly how the “company” differed from the “group,” how the company did all the business and had all the employees, and how they all scrupulously observed every corporate formality.  It usually worked, because it was all true.  The holding company was a holding company, and the insurance company had the wherewithal to answer for his own debts.  Ever since this experience, we have held a persistent (perverse?) interest in alter ego, agency, and other ploys to “pierce the corporate veil.”

The second reason the recent District of Utah case caught our interest is because one of the underappreciated aspects of the Supreme Court’s reset of general personal jurisdiction in Bauman is how the Court discarded so-called “agency jurisdiction.”  That was where a court could impute a subsidiary’s forum contacts to the corporate parent by applying a relaxed “agency” standard.  That form of jurisdiction does not exist anymore.  See Daimler AG v. Bauman, 571 U.S. 117, 134-36 (2014).  The Supreme Court closed the loop when it recalibrated specific personal jurisdiction in BMS and held that specific jurisdiction cannot be based on another defendant’s forum contacts.  See Bristol-Myers Squibb Co. v. Superior Court, 137 S. Ct. 1773, 1783-84 (2017).

So where did that leave the plaintiff in the recent Utah case who was trying to sue a medical device company and its corporate parent?  Because there was no general jurisdiction over the non-resident parent, the plaintiff had to prove specific jurisdiction through the rigorous and difficult-to-prove “alter ego” standard.  The case is Jorgensen v. Wright Medical Group, Inc., No. 2:18-cv-366, 2018 WL 6250606 (D. Utah. Nov. 29, 2018), and the plaintiff sued the medical device manufacturer (the “company”) and its holding company (the “parent”) alleging injuries resulting from treatment with the device.

The district court rejected jurisdiction over the parent, and there are three interesting points.

First, the district court considered evidence, even though it was ruling on a motion to dismiss.  In an attempt to establish sufficient forum contacts, the plaintiffs alleged that both the company and the parent “sold, distributed, and marketed” the device within Utah.  Id. at *2.  But the parent submitted uncontroverted affidavits explaining that it did no business in Utah and had no place or business or property there.  Id.  The plaintiff submitted press releases and SEC filings where the parent spoke of its medical device business generally, but the district court found that consolidated statements are a “common business practice” that did not undermine the specific facts in the sworn affidavits.  Id. at *3.  The lesson is that unproven allegations will not carry the jurisdictional day.  Even on a motion to dismiss, courts can and should consider evidence.

Second, the alter ego standard is difficult to meet.  In attempting to attribute the company’s forum contacts to the parent, the plaintiff relied on the same press releases and SEC filings as before, but they were not sufficient.  Rather, “(1) there must be such unity of interest and ownership that the separate personalities of the corporation and the individual [shareholder] no longer exist . . . and (2) the observance of the corporate form would sanction a fraud, promote injustice, or an inequitably result would follow.”  Id at *4.  This standard is based on Utah law, but it is similar to standards we have seen in other states.  Here, the parent’s affidavits again held sway:  They attested that the parent “maintains separate accounting and banking records from the accounting and banking records of [the company].”  Id.  The plaintiff neither rebutted this evidence, nor alleged that any fraud or injustice would result from observance of the corporate form.  Id.

Third, in what might be the most useful part of the order, the district court denied “jurisdictional discovery.”  Id. at 5.  The following standard applied:  “‘The district court does not abuse its discretion by denying jurisdictional discovery where there is a very low probability that the lack of discovery’ would affect the outcome of the case.”  Id.  The plaintiff had to suggest specific discovery that would lead to a different result, and he came up with just one set of documents that purportedly would show the parent’s “direct involvement” in the medical device at issue.  But another plaintiff had offered those same documents to establish liability against the parent in another case, and the parent was dismissed, making is “highly unlikely” that the documents would make a difference here.  Id.

All is not lost for this plaintiff.  He still has jurisdiction over the medical device company, although we know nothing from this order about the arguable merits of his claims.  He will not, however, be allowed to reach into the parent company’s pockets.

Late last month Bexis attended the annual ACI Drug and Medical Device Conference in New York.  In between helping to lead the discussion in the pre-conference Defense Counsel War Room and speaking on 3D printing and product liability, Bexis picked up a couple of interesting ideas about dealing with problems concerning federal multi-district litigation (“MDL”) that he hadn’t heard before.  We’re passing them along.  Even if they don’t ultimately get anywhere, at least our readers will be aware of these possibilities.

The first idea relates to the currently pending examination of MDL practices by the federal Advisory Committee on Civil Rules.  One of several proposals under consideration is some sort of interlocutory appellate review of “important” MDL rulings.  This recurring problem was described in the latest Lawyers for Civil Justice submission to the Advisory Committee:

Certain issues − such as pre-emption, jurisdiction and Daubert on general causation − are key legal questions that affect large number of cases in an MDL proceeding.  However, appellate review of critical motions in MDL cases is very rare, occurring only when a trial results in judgment for the plaintiff.  As a result, a large number of cases that should not have been brought are allowed to proceed through a costly litigation process without appellate review.  In many MDL cases, the overall litigation is settled without ever receiving the benefit of a definitive ruling as to the legal validity of critical issues.

LCJ (9/14/18) Proposals for Discussion, at 4-5 (footnote omitted).

The realistic prospects for MDL interlocutory appeal, however, seem low, as district court judges have complained about both the delay and loss of discretion such review would entail.  The appellate judiciary has not yet engaged, but it is questionable that they would support something that would add to their workload.

The version of MDL interlocutory review floated at the ACI meeting was different in that it paralleled the existing Judicial Panel on Multi-District Litigation.  Rather than adding to the dockets of existing courts, the proposal was to create an Appellate Panel on Multi-District Litigation that could come to be seen as the same sort of plum assignment for the appellate bench that the JPML has become for district court judges.  The Appellate Panel could consist of one judge from each circuit, appointed by the Chief Justice of the United States, to a fixed term (5 to 7 years seems adequate).  The 12-member panel could sit in groups of three, as is current appellate practice.  Four three-judge panels should be sufficient to hear the limited number of interlocutory appeals that MDLs would generate.

Although the details would have to be spelled out, it is probably a good idea to require one of the judges on any panel to be from the circuit where the affected MDL is located.  Appellate Panel decisions would have precedential effect within the MDL system, but not beyond it, as current circuit court practice.  There could also be an en banc procedure to resolve conflicts or particularly important issues.

This idea is neither perfect nor fully formed, and would probably require action by Congress (which created the original JPML), but in several ways it seems superior to the current proposals, which are unloved by practically all of the judges, who would have to approve any system of interlocutory appeals.

The second proposal arises from the much discussed drawbacks of the current MDL system of “bellwether trials.”  While we remain of the opinion that the MDL statute does not confer authority on an MDL judge to try any case (even in the same state or judicial district), not routinely assigned to him/her in the normal process, that view has yet to prevail.  Thus, one of the recurrent frustrations – shared by both MDL judges and defense counsel – is plaintiffs gaming the system by dismissing any “bellwether” cases that they don’t want to try, even though they helped create the bellwether selection process in the first place.  As the same LCJ submission described this problem, “plaintiffs will often voluntarily dismiss proposed bellwethers that might prove adverse to them, thus skewing any sample towards greater recoveries than average.”  LCJ (9/14/18) Proposals for Discussion, at 6.

As long as a party has the absolute right to dismiss that party’s case, there is no way to prevent strategic bellwether dismissals.  The thought we heard expressed at the ACI conference was that it is possible to “hit them where it hurts” when such shenanigans happen.  In this instance that means sanctioning the dismissal of bellwethers by reducing the plaintiffs’ side common-benefit fund.  That could be accomplished in two ways, perhaps enforced in tandem.  First, the common-benefit fund could be reduced by a certain percentage (say, one tenth of one percent) for each previously agreed-upon bellwether case that is voluntarily dismissed prior to trial.  The second approach would be to reduce the common-benefit fund by the amounts actually expended by both sides preparing any dismissed bellwether case for trial, since those expenditures are no longer of “benefit” to anyone after a voluntary dismissal.  Some bookkeeping would be required, but keeping track of case-specific expenses is hardly a rare thing in litigation.

The ideas explained in this post are one of the reasons we enjoy going to conferences such as ACI or DRI.  Nobody has a monopoly on creative ideas, and the more people we can trade ideas with, the better off we all are.

We typically steer clear of discussing any opioid cases for client reasons. But today we have a case that did not involve our client in any way and that involves a discrete and important issue. Accordingly, we hereby render a bare-bones report.

The case, Floyd v. Feygin, et al., No. 507458/17 (Kings County, N.Y. Supreme Court Nov. 28, 2018) (available here: https://www.druganddevicelawblog.com/wp-content/uploads/sites/30/2018/12/Dabiri.pdf) is a civil case, but it pretty much was a follow-on to a criminal investigation involving, among others, the DEA, the Brooklyn District Attorney’s office, and the Department of Health and Human Services. That criminal investigation culminated in indictments of doctors, nurse practitioners, and even a member of the New York Assembly, all charged with running pill mills that issued medically unnecessary painkiller prescriptions and bilked funds from the Medicaid program.

The plaintiff filed a complaint that mostly tracked the criminal case, while also adding some entities that were not part of the criminal case, including the pharma company and a drug store. Here is the theory of the plaintiff’s negligence claim against the pharma company:

“Plaintiff alleges that Actavis had a duty to ensure that its Oxycodone product was not being prescribed, dispensed, and used in a fraudulent and harmful manner. Plaintiff further alleges that Actavis breached its duty by failing to take appropriate action to stop and prevent Oxycodone from being prescribed for fraudulent and illegal purposes, and by failing to maintain effective controls against having prescriptions for Oxycodone being written where such prescriptions were not for legitimate medical purposes. Plaintiff also claims that Actavis breached its duty by failing to design, implement, and operate a system to disclose suspicious orders of Oxycodone, and by failing to establish, implement, and follow an abuse and diversion detection program consisting of internal procedures designed to identify potential suspicious prescriptions of Oxycodone. Plaintiff claims that he suffered injuries by improperly receiving Oxycodone and becoming addicted to it.”

The plaintiff also alleged that the pharma company “keeps a close eye on how many pills a doctor or practice is prescribing” and that it is required to report any suspicious prescribing, pursuant to the Controlled Substances Act (both federal and the New York equivalent). And there’s the rub. Actavis filed a motion to dismiss, arguing that the plaintiff’s negligence cause of action was an attempt at private enforcement of the Controlled Substances Act. Neither the federal nor New York statute provide for private enforcement. The plaintiff was forced to concede that there was no private right of action, and then tried to escape preemption by arguing that the statutes “created a responsibility that Actavis failed to meet.” But the plaintiff encountered additional problems. First, the statutes imposed reporting requirements, but did not compel manufacturers to stop or restrict distribution. Second, the distributions of painkillers at issue were all made pursuant to purportedly valid prescriptions by licensed physicians. Third, the creation of pill mills by other defendants “was an intervening act which was of an extraordinary and criminal nature so as to break any causal nexus between any reporting requirement on the part of Actavis and plaintiff’s addiction to Oxycodone.”

Seeing that his negligence cause of action against the pharma company was going down the drain, the plaintiff argued that he needed more discovery. The court denied this request, reasoning that the pharma company simply had not breached any duty owed to the plaintiff. Discovery was not going to change that.

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

 

Last year, we favorably cited Canary v. Medtronic, Inc. 2017 WL 1382298 (E.D. Mich. April 18, 2017), on two occasions, once to highlight its use of TwIqbal at the motion to dismiss stage and again as a part of our preemption scorecardCanary was a winner.

That decision, however, dismissed only plaintiff’s product liability claims, letting her fraud claim move forward. Last month, the court issued a summary judgment decision on that fraud claim. Canary is not such a winner anymore.

Backing up a little bit, the product was Medtronic’s PrimeAdvanced spinal cord stimulator. It was implanted in plaintiff to address her neck and back pain. Canary v. Medtronic, Inc., 2018 U.S. Dist. LEXIS 192794, at *2 (E.D. Mich. Nov. 13, 2018). Yet, after the surgery, plaintiff complained that she was experiencing hives all over her body, abdominal pain and bowel inflammation. Id. at *3-4. Almost a month later, she had the device removed. She claimed that her problems stopped. Id. at *4.

During discovery, however, plaintiff produced no causation opinion from an expert—to be clear, no expert on either general or specific causation. Instead, she relied exclusively on the testimony of her treating doctors. Their testimony, however, was only marginally helpful to her, as it was laced with words like “possible” and “plausible” and missing any declaration that the opinions were reached to a degree of medical certainty or even probability. Yet the court allowed her fraud claim to survive summary judgment.

In particular, Plaintiff’s internal medicine doctor testified that the device was a possible cause, one of the top possibilities, and that allergy and skin testing was needed. But he offered no opinion to a reasonable degree of medical certainty:

Dr. Thammineni, the internal medicine doctor who treated Plaintiff when she was admitted to the intensive care unit on May 28, 2013, explained during his deposition that while he stated that Plaintiff had “contact dermatitis secondary to spinal cord stimulator” in his notes, he recommended that she get allergy and skin testing to ascertain exactly what caused the reaction. When Dr. Thammineni was asked if the spinal cord stimulator was more of a possibility than other causes, he responded with a “yes.” And when asked “[c]an you say to a reasonable degree of medical certainty that the hives were caused by the implantation of the spinal cord stimulator on May 16th and not some other source,” he stated that the stimulator was “one of the top possibilities.”

Id. at *6.

Plaintiff’s dermatologist testified that something at the time of the surgery triggered the hives, that the timing of the implant and removal created an “association,” but that there was no test to determine the cause of the hives:

There was something around the time of the surgery that triggered a hive-like reaction. The device was used, but other things were used at the time of the procedure, such as prep and — however, when the device was removed, her hives and itching in that area went away, so there’s an association with that. Unfortunately, there’s no test for [these types of] reactions in this situation.

Id. at *6-7. She did not testify on causation to a reasonable degree of medical certainty.

Finally, plaintiff’s allergist stated that it was “plausible” that plaintiff had an allergic reaction to the device, and later said that she “believed” the device caused the hives:

Q: You stated it was plausible that she had an allergic reaction to the device; is that correct?

A: I think everything is plausible, but, yes.

Q: Okay. The fact that she reported she had hives after the device, and her hives stopped after the device was removed, would that further support the conclusion that it was plausible that the device caused a reaction?

[Defense counsel]: Object to the form.

The witness: I would — yes.

[Plaintiff’s counsel]: And earlier you testified regarding the correlation and the difference between general hives versus local hives.

A: Yes.

Q: Do you believe the stimulator caused the local hives she reported to you?

A: Yes.

[Defense counsel]: Object to the form.

[Plaintiff’s counsel]: That was a yes?

A: Yes.

Id. at *7. Again, there is no indication that the allergist testified that her “belie[f]” was held to a reasonable degree of medical certainty, or to any degree of certainty or even probability.

The court, discussing two cases involving less complex science, one of which did actually involve a plaintiff’s general causation expert, held that this treater testimony, along with the general sequence of events, was enough. In fact, while Medtronic had two experts opine to a reasonable degree of medical certainty that the device did not cause the allergic reaction—the only two causation experts in the case—the court noted that these experts “did not eliminate the possibility that it could have done so.” Id. *15.

If the analysis comes down to this, it’s not clear that a defendant could ever win summary judgment. Almost any causation issue would be trial ready, despite what could be a lack of any real science behind it or an expert to opine on that science to a reasonable degree of medical certainty.

The Canary doesn’t look so good anymore. Time to get out of the coal mine.

That is the intriguing title of the latest law review article written by the “Rabbi of Torts,” Prof. Aaron Twerski (we’re not making this up, Prof. Twerski’s Wikipedia page is the fifth result when we just Googled that phrase).  Prof. Twerski, one of the ALI’s reporters for the Restatement (Third) of Torts:  Products Liability, has probably spilled as much ink as anyone in making sense of Restatement (Second) of Torts §402A, comment k (1965), one of the more opaque parts of the venerable §402A.  Indeed, in a prior article, Prof. Twerski divined fully eight different interpretations of comment k, the Second Restatement’s discussion of, among other things, design defect claims involving prescription medical products (mostly drugs and vaccines, as medical devices were much less common back in 1965).  See James A. Henderson, Jr. & Aaron D. Twerski, “Drug Design Liability: Farewell to Comment K,” 67 Baylor L. Rev. 521, 542-44 (2015).

Then there’s the Third Restatement, which sought to replace comment k’s approach to design defect claims involving “unavoidably unsafe” products with:

§6 Liability of Commercial Seller or Distributor for Harm Caused by Defective Prescription Drugs and Medical Devices

*          *          *          *

(c) A prescription drug or medical device is not reasonably safe due to defective design if the foreseeable risks of harm posed by the drug or medical device are sufficiently great in relation to its foreseeable therapeutic benefits that reasonable health-care providers, knowing of such foreseeable risks and therapeutic benefits, would not prescribe the drug or medical device for any class of patients.

Restatement (Third) of Torts, Products Liability §6(c) (1998).

As we’ve chronicled on the blog, most courts still continue to grapple with comment k.  Conversely, §6(c) has received a mixed and tepid response from the courts.  Now Prof. Twerski has essentially concluded that further explication of the courts’ Talmudic approach to comment k and design defect claims in our sandbox is futile – such claims are all federally preempted.  That, of course, is something we’ve been saying on the Blog since the moment Mutual Pharmaceutical Co. v. Bartlett, 570 U.S. 472 (2013), was decided five years ago.  See, e.g., here, here, here, and here.  But we’re just bloggers; Prof. Twerski is an institution.  We’re flattered simply to be cited as authority on par with law reviews and other scholarly works.  See footnotes 6 & 19.

Here’s a link to Prof. Twerski’s latest article on SSRN.  Its formal citation is, 68(1) Am. Univ. L.R. 281-304 (2018).  The first thing we note about the article is that the title is limited to “drugs,” as opposed to medical devices.  Nothing in the article, however, expressly distinguishes medical devices, and Prof. Twerski concludes that the limited cause of action permitted by Restatement (Third) §6(c) – which treats prescription drugs and medical devices identically – is, indeed, preempted:

The Restatement test ultimately allows a common law design defect claim to prevail over the FDA’s approval of a drug.  The only thing that a defendant can do to escape liability is to stop selling the drug − a position that is in direct contravention of Bartlett.  Perhaps for a drug that is so egregiously dangerous, the Supreme Court might craft an exception to Bartlett.  But, otherwise, the Bartlett dissent is quite correct in predicting that the majority has rendered drug design defect immune from common law actions.

“Demise of Drug Design Litigation,” 68(1) Am. Univ. L.R. at 302 (footnotes omitted).

As we’ve pointed out on a number of occasions, most recently in our discussion of Gustavsen v. Alcon Laboratories, Inc., 903 F.3d 1 (1st Cir. 2018), the Mensing/Bartlett basis for impossibility preemption – that the FDA must pre-approve “major changes” to product designs, and therefore regulated manufacturers cannot act immediately and unilaterally to change “defective” designs, as state tort law requires − applies equally to design changes for both drugs and medical devices.

Interestingly, we also note that Prof. Twerski speculated that the Gustavsen preemption decision – then in the district court (the First Circuit decision was too recent to be in his article) – might be within “a small subset of design claims [that] may not be preempted.”  68(1) Am. Univ. L.R. at 303.  Prof. Twerski’s reasoning was “that the Supreme Court might take issue with the FDA characterization of a change in volume of the drops created by the bottle’s stopper as a ‘major change’ requiring FDA approval.”  Id.  Well, the First Circuit affirmed preemption of “major changes,” and it doesn’t seem like the plaintiffs in Gustavsen are as optimistic about their case as Prof. Twerski’s supposed they might be.  They did not bother appealing to the United States Supreme Court, and the deadline for doing so has expired.

Another interesting perspective offered by Prof. Twerski is that Bartlett was improperly decided – not on preemption, but as a matter of New Hampshire state law.  68(1) Am. Univ. L.R. at 284.  The Court in Bartlett held, as to New Hampshire product liability law:

But respondent’s argument conflates what we will call a “strict-liability” regime (in which liability does not depend on negligence, but still signals the breach of a duty) with what we will call an “absolute-liability” regime (in which liability does not reflect the breach of any duties at all, but merely serves to spread risk).  New Hampshire has adopted the former, not the latter.  Indeed, the New Hampshire Supreme Court has consistently held that the manufacturer of a product has a “duty to design his product reasonably safely for the uses which he can foresee.”

570 U.S. at 481 (string citation of New Hampshire cases omitted).  Prof. Twerski’s analysis, turning on a case Bartlett did not cite, Vautour v. Body Master Sport Industries, Inc., 784 A.2d 1178 (N.H. 2001), posits, instead, that in Vautour New Hampshire product liability became “absolute liability” based on pure risk/utility balancing, without any need for the plaintiff to assert an alternative design.

This is not the forum to rehash our strong objection to [absolute liability].  The point is that New Hampshire has embraced it.  Thus, liability was not regulatory in the sense that Justice Alito set forth in Bartlett.  New Hampshire did not impose a duty on [defendant] to develop a better warning nor did it require [defendant] to redesign [the drug].  It simply allowed a jury to find that the [drug], as designed with the warnings as given, was unreasonably dangerous.

68(1) Am. Univ. L.R. at 292-93 (footnotes omitted).

Pointing to the footnote in Bartlett (570 U.S. at 482 n.1) “sav[ing] for another day” the issue “whether a true absolute-liability state-law system could give rise to impossibility pre-emption,” Prof. Twerski suggests that Bartlett should have come to grips with the application of impossibility preemption to an absolute liability system of product liability.  68(1) Am. Univ. L.R. at 293-94.  We think that Bartlett actually did address absolute liability, perhaps back-handedly, in its discussion of the plaintiff’s claim that the defendant should never have sold its FDA-approved product.  What is that theory, if not absolute liability?  Liability, under a stop-selling theory seems pretty “absolute” to us, since the only way to avoid liability would be not to sell the product at all. Bartlett had no trouble holding that theory preempted:

The incoherence of the stop-selling theory becomes plain when viewed through the lens of our previous cases.  In every instance in which the Court has found impossibility pre-emption, the “direct conflict” between federal- and state-law duties could easily have been avoided if the regulated actor had simply ceased acting. . . .  Adopting the First Circuit’s stop-selling rationale would mean that not only [Mensing], but also the vast majority − if not all − of the cases in which the Court has found impossibility pre-emption, were wrongly decided.  Just as the prospect that a regulated actor could avoid liability under both state and federal law by simply leaving the market did not undermine the impossibility analysis in [Mensing], so it is irrelevant to our analysis here.

570 U.S. at 488-90 (detailed description of particular cases omitted).

So, did Bartlett mess up New Hampshire law?  Prof. Twerski makes a pretty convincing case as to what New Hampshire law actually is, but ultimately we don’t think it makes much difference.  First, we think that the majority in Bartlett was not interested in deciding the case based on New Hampshire having some sort of bats**t crazy tort regime, but rather wanted to emphasize preemption of more mainstream forms of product liability.  Second, nothing in Bartlett, and in particular in its affirmance of “stop-selling” preemption, indicates that absolute liability would escape the fate of other, more widely accepted, design defect liability theories.

Ultimately, Prof. Twerski concurs in that assessment.  Pure risk/utility balancing amounts to a definitively preempted stop-selling claim:

Can the state allow a common law remedy based on a finding of unreasonable danger, thus negating the FDA’s determination that the drug is reasonably safe so that it is approved for marketing? . . .  After running out of state common law duties to make the drug safer, the defendant was left with the sole option of not marketing a FDA approved drug to avoid tort liability.  This remaining option, however, is an option that Bartlett teaches flies in the teeth of preemption jurisprudence.

68(1) Am. Univ. L.R. at 300-01 (footnotes omitted).

Second, the most widely followed design defect rationale – risk/utility balancing of reasonable alternative designs (“RAD”) is precisely what Bartlett preempted:

[P]ost-Bartlett, it would seem quite clear that, for a drug that has received FDA approval, any argument that it can be modified by a RAD is federally preempted.  Justice Alito’s reasoning leaves little doubt when he said that “once a drug − whether generic or brand name- − is approved, the manufacturer is prohibited from making any major changes to the ‘qualitative or quantitative formulation of the drug.”’  If a court were to find a post-FDA approval drug to be a RAD, it would almost certainly be struck down on the same impossibility grounds set forth in Bartlett.

Id. at 295 (footnotes omitted).

Third, Prof. Twerski (like us) has only scorn for the “pre-approval design defect” theory that plaintiffs have turned to as an argument to avoid preemption.

How a court could censure a manufacturer for not developing a different drug without any assurance of its safety by the FDA is beyond comprehension.  As to preemption, the court in [Mensing] made short order of the argument that a plaintiff could challenge an FDA approved drug based on the supposition of what the FDA might do if asked to respond to a change. . . .  None of the cases opting for the “pre-approval theory” have adequately responded to either the common law or preemption arguments that negate this novel theory.

Id. at 296-97 (footnotes omitted).

Finally, as already discussed, the design defect theory enshrined in Restatement (Third) §6(c) also runs afoul of preemption.  Id. at 302 (footnote omitted).

Thus, Prof. Twerski concludes that design defect claims involving prescription drugs are preempted no matter how the plaintiffs package them.  In the end, however, Prof. Twerski sheds no tears over the demise of design defect litigation against FDA-approved drugs.  Design-based theories have never really amounted to very much:

The overwhelming majority of cases against pharmaceuticals have always been based on failure to warn. . . . Drug design, despite the fascination of scholars with this issue, has played only a minor role in drug litigation. The pillars of the republic will not fall if this questionable theory is laid to rest.

Id. at 304. That’s a sentiment with which we whole-heartedly agree.  We are always interested in reading more of Prof. Twerski’s views on design defect preemption – particularly with respect to prescription medical devices.