[Drug and Device Law] Unfortunately Disappointing 3D Printing Law Review Article
We’ve blogged before about the interesting product liability issues created by 3D printing/additive manufacturing, in particular the novel separation that these techniques create (at least potentially) between “manufacturing” and “design” of products. With respect to medical devices, if an implant is custom produced from equipment owned by, and located at, the hospital where the surgery is conducted, who’s the manufacturer for product liability purposes if, say, the implant fails in some way? Our prior post provided some legal analogies that we thought might be useful. We didn’t claim to be comprehensive or conclusive.
It’s a “wild, wild west” legal issue, so we were predictably intrigued when the law review article, Park, “For A New Heart, Just Click Print: The Effect on Medical & Products Liability from 3-D Printed Organs,” 2015 U. Ill. J.L. Tech. & Pol’y 187 (Spring 2015), showed up on several of the half-dozen or so searches we run to stay current in our field. Continuing with our “we read law review articles so our readers don’t have to” philosophy, we took a look.
We were disappointed, not particularly by its pro-plaintiff tone (we’re used to that from the academy), but by its superficiality. Unfortunately, the article doesn’t seem to “get” the true legal complexities of 3D printing. From beginning to end, it remains mired in the traditional paradigm – a prescription medical product produced by a “manufacturer” who provides warnings to the treating/implanting physician under the learned intermediary rule. The paradigm shift that 3D printing promises, the devolution of the manufacturing function to on-site locations neither owned nor controlled by traditional Restatement of Torts “manufacturers,” goes totally unaddressed.
Maybe we were expecting too much. It’s a student, rather than a professorial, article. The best part of this article is its factual discussion of 3D printing in the field of medical devices. “New Heart,” 2015 U. Ill. J.L. Tech. & Pol’y at 189-93. These seections seem pretty current in the research and cite lots of interesting stuff, collecting it in one place. Unfortunately, it’s largely downhill from there. The article focuses in the most complex form of 3D printed medical device – artificial organs – and treats that in an utterly pedestrian manner.
We waded through a wholly unnecessary discussion of organ donation regulation, which is presented as some sort of alternative to the FDA. We’ve been around long enough that it’s blindingly obvious to us that 3D printing of medical devices (and drugs, which the article does not consider at all) is and will be subject to extensive FDA oversight. Thus, we think that the organ donation alternative discussed, and properly discarded, by the article (2015 U. Ill. J.L. Tech. & Pol’y at 193-95, 198-99) is a makeweight issue not worth the time spent on it.
Conversely, the article’s discussion of FDA regulation, id. at 195-97, is underpowered, not adequately addressing clinical investigations and modern post-marketing issues, such as REMS and the FDA’s Sentinel system. Rather, the discussion is limited to the dichotomy found in Supreme Court preemption cases (the article has an entire section, id. at 196-97 on Riegel v. Medtronic, Inc., 552 U.S. 312 (2008)) between §510k “substantial equivalence” clearance and premarket approval. To us that’s another false conflict. Device clearance under §510k is only available to devices “substantially equivalent” to those already on the market, usually going back to the 1976 (not 1975, as the article states) date of the statutory amendments that originally gave FDA authority over medical devices.
Once again, it’s blindingly obvious that 3D printed artificial organs (whether or not built from a biodegradable scaffold) aren’t “substantially equivalent” to anything that went before. Of course they will be pre-market approved devices, unless Congress steps in to create something altogether new, which is always possible. While some 3D printed devices (sized components of metal implants, come to mind) may fall within §510k, replacement organs are, almost by definition, life sustaining, and thus have to be PMA.
After these two strawmen are knocked down, 2015 U. Ill. J.L. Tech. & Pol’y at 198-201, the article moves on to PMA preemption under Riegel. It treats preemption mostly as a “how can we get past it” proposition, spending practically no time on why preemption exists in the first place, and lots of time on the existing/arguable exceptions to preemption. The 3D printinig context, unfortunately, receives only cursory attention. Parallel claims are mentioned (id. at 201-03), but without any discussion of what types of FDA regulations are/are likely to be applicable to 3D printing in particular. For example, dispersal of many manufacturing activities to numerous end users alone will require a huge change in FDA practice, since under current law each manufacturing “facility” is subject to registration, inspection, etc. The FDA can’t possibly keep that up when every hospital has a 3D printer creating bespoke medical devices. Not all 3D printed devices require dispersed production, but many will – and that’s precisely what makes this legal subject so interesting.
The article likes to cite Bausch discussed by us here), which involved parallel claims based on purported GMP violations, but omits what would be really interesting to read about – what kinds of GMPs are likely to be applicable to 3D printed medical devices, and thus possibly at issue in asserted parallel claims involving these devices? Will there even be Forms 483?
The purpose of law review articles – indeed, of most academic articles – is to synergize, to tell the reader something s/he doesn’t already know. That’s where this article falls down. It fails to extrapolate from the existing cases, all of which involve much different facts than would exist for 3D printed devices. 3D printing presents all kinds of fascinating scenarios, but they’re not in this article.
Take another example. The article spends all of three sentences on claims “against the representative of the manufacturer who provided the medical device to the physician.” 2015 U. Ill. J.L. Tech. & Pol’y at 201. Yes, the FDA “does not regulate,” id., those interactions, so preemption is in question. But with 3D printing, manufacturers in a lot of cases won’t be providing devices at all. Many such products will be created in hospitals (some already are), custom-fit according to information drawn from patient-specific scans. The software that interprets these scans and tells the printer what to do will come from one (FDA regulated) source, the printer itself will probably come from somebody else (likely FDA regulated), the raw material from yet another source (maybe FDA regulated), and actual production will take place in the hospital where the surgery is to be performed (not FDA regulated). There are all kinds of potential interactions here, with potential (or not) for liability. Not only does the article not discuss any of these; it never even acknowledges that they exist. These variables are precisely how 3D printing is most likely to scramble product liability.
The article also discusses pharmacovigilence (or whatever the device-specific equivalent term would be), but again solely in the context of an exception to preemption. 2015 U. Ill. J.L. Tech. & Pol’y at 204-05. Even there, how a law review discussion of “whether preemption would apply to common law claims when the manufacturers deceived the FDA,” id. at 204, can occur without citing Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001), even once is beyond us – and not just because of Bexis’ involvement in Buckman. A Supreme Court decision mandating preemption of “fraud on the FDA” claims seems directly on point.
Beyond that rather glaring omission, the article states that 3D printed organs are “years from becoming a reality.” 2015 U. Ill. J.L. Tech. & Pol’y at 188. We agree. As we’ve discussed in more detail here, the failure-to-report decisions that the article does discuss aren’t likely to be of any use by then, since the FDA is currently transitioning from affirmative reporting systems (voluntary or otherwise) to “big data” crunching of information derived from millions of electronic medical records (its “Sentinel” system). By the time that 3D printed organs have shed their investigational status, the kind of post-marketing claims addressed by the article in all likelihood won’t even be relevant. Once again, we find ourselves wishing that this article had displayed a little more of what a former president once called “the vision thing.”
Finally, the article discusses “good old negligence” – that is to say, malpractice – claims against physicians who will be implanting 3D printed organs. 2015 U. Ill. J.L. Tech. & Pol’y at 206-08, 210. Yes, those claims will exist, as they do with respect to every other aspect of medical practice. But what will they look like? The article calls that “speculative,” id. at 206, but isn’t that exactly what readers are interested in? 3D printing involves software. How much back-end testing of 3D printing software is properly held within the medical standard of care? To what extent must implanting physicians become engineers? We don’t know. The article hardly discusses the standard of care; focusing instead on state-by-state regulation of organ donation.
Nor does the article address the other relevant aspect of medical practice – informed consent. Instead it discusses the “learned intermediary doctrine.” Id. at 207-08. These aren’t the same thing, and only informed consent is a cause of action against physicians. 3D printed organs will “go through clinical trials and a review process that could take from three to ten years.” Id. at 208. During that time, these products will be considered “investigational” and subject to detailed FDA informed consent regulations pertaining to clinical trials. See 21 C.F.R. Part 50. None of this is discussed in the article.
We come away from this article badly disappointed. The product liability implications of 3D printing is a great topic for law review articles, and we had hoped when we saw the title that this article would be one of them. It wasn’t. The fundamental issue that 3D printing poses – what happens to product liability law when users become manufacturers? – wasn’t even faced here. Please try again. 3D printing is now where off-label use was in the late 1990s, waiting for somebody to pen (or type) the seminal article.
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Posted By Bexis to Drug and Device Law at 6/30/2015 09:32:00 AM --
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[Drug and Device Law] A "Too Old" OTC Product Does Not A Class Action Make
This past weekend, we attended a fundraising 5K race organized by a friend who lives with a form of muscular dystrophy. We volunteered to photograph the event, because the usual photographer was not able to attend. And so, we didn’t run – something we used to do, if the definition is expanded to include a shuffle befitting Tim Conway’s character on The Carol Burnett Show. Instead, we stood at the start line, snapping pictures and gazing longingly at the runners disappearing down the path. Observing our misty countenance, a friend asked us why we didn’t start running again if we missed it so much. In wordless response, we produced our yellowed and crumbling birth certificate. To which our friend replied, “’Too old’ is a meaningless phrase – you will have to do better than that.”
That is exactly what the Court of Appeal of Louisiana said to the plaintiff in Jean Cooper vs. CVS Caremark Corporation, et al., 2015 La. App. LEXIS 1201 (La. App. 1 Cir. June 17, 2015). Plaintiff purchased an over-the-counter allergy remedy at a CVS store. Before she used any of the medication, she noticed that the expiration date on the package had passed. She “did not request a refund, could not remember if she complained to the store, did not take any of the medicine, and, by her own admission, did not suffer any damages as a result of the purchase.” Cooper, 2015 La. App. LEXIS 1201 at *1-2.
We know what you’re thinking: “This is the heady stuff of a class action lawsuit.” Plaintiff had the same thought. She sued several CVS entities, alleging that they “had a long history of selling out of date medications” and that the expired allergy remedy “had exposed her to health risks.” Id. at *2 (internal punctuation omitted). Plaintiff requested an award of damages, as well as “injunctive relief to remedy violations of law,” and an order requiring CVS, inter alia, to stop selling expired products and to notify purchasers of “the true characteristics of the products sold.” Id. Plaintiff sought certification of the suit as a class action and requested that she be confirmed as class representative.
CVS moved for summary judgment, arguing: 1) Plaintiff lacked standing to pursue injunctive relief and could not prove the requisite “irreparable injury;” and 2) Plaintiff admitted in deposition that she had no damages and did not tender the product for refund or replacement. Plaintiff countered with an argument that she was not required to prove irreparable harm to be entitled to injunctive relief, because the sale of the expired medication violated 21 U.S.C.A. Section 331, of the FDCA, which prohibits introduction or delivery of an “adulterated drug” into interstate commerce. Id. at *4. In support of her argument, plaintiff cited a 1995 FDA guidance document, providing, “We regard expired drug products to be adulterated within the meaning of [the Current Good Manufacturing Practice (”CGMP”) statute],” but concluded that “it would not be appropriate to cite a retailer for deviation from the CGMP . . . regulations, because [the] regulations apply to drug product manufacturers.” Id. at *5-6 (emphasis in original). Plaintiff also introduced the affidavit of an individual who “visited 63 CVS stores and confirmed that expired product were purchased and/or documented at those stores . . . .” Id. at *6.
The trial court granted summary judgment for CVS on all of plaintiff’s claims, noting that the FDA guidance document plaintiff cited was “not appropriate summary judgment proof and was unpersuasive,” and that plaintiff “failed to establish irreparable harm or that the cited provisions of the FDCA established a prohibitory law that supported the claim for injunctive relief.” The Court also found no factual support for plaintiff’s damages claim, but recognized that plaintiff had testified in deposition that she was not seeking damages. Id. at *6-7.
On appeal, plaintiff argued that 1) the FDCA prohibits the sale of expired products; thus, a “prohibitory law” supported her claim for injunctive relief; and 2) her “shopping survey” demonstrated “irreparable injury,” because CVS was continuing to sell expired products.”
The appeals court was about as patient with plaintiff’s nonsense as we feel reading it. First, the Court noted that the FDCA language plaintiff cited did not support the interpretation she proposed. Specifically, there was no language supporting plaintiff’s argument that CGMP statutes and regulations should be construed to regulate the retail sale of OTC products, and the guidance document on which plaintiff relied was “not binding on the public or the FDA and it [did] not establish legally enforceable rights or responsibilities.” Id. at*10. Even if it did, it would not have supported plaintiff’s position on its merits, as it “also states that retailers should not be cited for deviations” from CGMPs. Id. As to plaintiff’s alternate argument – that she did suffer irreparable injury because she “was duped into buying unreliable expired medicine” – the Court similarly rolled its eyes, emphasizing that “[i]rreparable injury is a loss that cannot be adequately compensated in money damages . . . ,” id. at *12, while, in this case, plaintiff “presented no evidence of any physical, mental or emotional injury.” Id. at *13. Rather, “the only potential loss identifiable from the record is the purchase price [plaintiff] paid for the expired medication; however, that loss is compensable in money damages.” The Court concluded, “The record contains no evidence of a violation of a prohibitory law or proof of irreparable injury to [plaintiff] or any other purported member of the putative class. The trial court did not err in granting summary judgment and dismissing Cooper’s claims, both individually and on behalf of the putative class.” Id. at *15.
Our jobs would be a lot less fun if plaintiffs’ lawyers only filed meritorious claims. But it makes our Monday to read a case in which plaintiff had no injury, no damages, and no cause of action, and in which the Court succinctly found just that. Yeah, the drug was “too old,” but that didn’t open the doors to a lawsuit. Just take it back for an exchange or a refund. As for our defunct running career, we’ll mull it over.
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Posted By Rachel B. Weil to Drug and Device Law at 6/29/2015 02:16:00 PM --
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[DK GreenRoots] Privatizing Our Public Places: Not Here, Not Today
Our public places are being converted to "beneficial use", one piece at a time. A tiny example at our local park.
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[Drug and Device Law] Check-Out Time at the Hotel California?
We love our home state of California, but we have long bemoaned the widespread practice of what we call litigation tourism. That is where unrelated plaintiffs, sometimes thousands of them, from all corners of the U.S. join together in mass complaints filed in California state court. For whatever reason, California courts have seemed open to hosting plaintiffs from everywhere, a point well exemplified by our Hotel California post discussing the now-vacated Bristol-Myers Squibb Co. v. Superior Court, No. A140035, 2014 WL 3747250 (Cal. Ct. App. July 30, 2014), review granted. That was where the California Court of Appeal did an end run on Daimler AG v. Bauman in a wrongly reasoned effort to find specific personal jurisdiction in California where there was none.
Maybe the wind is shifting. Our readers already know that it took the California Supreme Court less than four months to depublish Bristol-Myers Squibb (reported here). In addition, multiple recent cases in California have shipped “mass tort” plaintiffs off to parts from whence they came, and the courts who have sent these interlopers packing have done so for a variety of reasons. Is this a trend? We don’t know, but we’ve put together a checklist of issues based on the recent authorities that defendants may want to reference if they are named in lawsuits they don’t feel belong in California.
Personal Jurisdiction. The Supreme Court’s Bauman opinion was a game changer, and after the false state of Bristol-Myers Squibb, we were pleased with the California Court of Appeal’s opinion in BNSF Railway v. Superior Court, 235 Cal. App. 4th 591 (2015), which we discussed here. BNSF was an asbestos case, but it is important because it rejected general personal jurisdiction over a non-California defendant, even though the defendant had substantial business in California and California was convenient for the plaintiffs’ lawyers. The latter point is particularly important because the convenience of plaintiffs’ counsel is a recurring theme, and we have time and again heard plaintiffs’ lawyers urge California courts to hold onto masses of cases because it would be convenient. This argument is especially common in Judicial Council Coordination Proceedings, or JCCPs, which are California’s version of multidistrict litigation.
In that regard, an order entered a few days ago in the Transvaginal Mesh JCCP in Los Angeles is illuminating. (A copy is available here.) The court granted Johnson & Johnson’s motion to quash for lack of personal jurisdiction vis-à-vis the non-California plaintiffs because it is a New Jersey company and thus not “at home” in California. Robinson et al. v. Johnson & Johnson et al., No. BC531848, Minute Entry, at 10-14 (Los Angeles Super. Ct. June 22, 2015). In so holding, the court rejected the plaintiffs’ argument that the procedural joinder of litigation tourists under one caption justified jurisdiction and ruled that jurisdiction is decided on a plaintiff-by-plaintiff basis:
The Court agrees with moving party that defendant’s relationship with this forum can and should be tested plaintiff-by-plaintiff, and the motion is only brought as to the non-California plaintiffs. The mere happenstance of the joinder of those claims with the claims of the California plaintiffs does not cause the Court to doubt the correctness of the ruling above. That 67 plaintiffs have banded together (or found themselves joined together) in one suit brought by California counsel in conjunction with Texas counsel does not change the analysis.
Id. at 13. So the claims brought against J&J by non-Californians were quashed for lack of general jurisdiction. We suppose the Californians were allowed to proceed in California under specific personal jurisdiction, but we’re okay with that. The problem is litigation tourism, and Bauman and its progeny are becoming potent checks on that form of abusive forum shopping.
CAFA Removal and Transfer. Another strategy that has recently and successfully addressed litigation tourists in California is the removal and transfer of “mass actions” under the Class Action Fairness Act. We wrote on Corber v. Xanodyne Pharmaceuticals, Inc., 771 F.3d 1218 (9th Cir. 2014), here. That was where the Ninth Circuit addressed the brazenly manipulative tactic of joining hundreds of plaintiffs together in multiple mass complaints in California state court, each with just fewer than 100 plaintiffs. The stated purpose of that tactic was to avoid “mass action” removal jurisdiction under CAFA and thus remain in California state court. The Ninth Circuit correctly held that plaintiffs could not evade federal jurisdiction in this manner, reasoning that the plaintiffs’ own request to be coordinated into a JCCP was a request for a joint trial, which triggered CAFA. Id. at 1223-24.
The other shoe dropped this month in Corber’s companion case Romo v. McKesson Corp., No. ED 12-2036, 2015 WL 3622620 (C.D. Cal. June 9, 2015), which we discussed here. On remand from the Ninth Circuit, the cases were in federal court, but they could not be transferred to the Darvocet multidistrict litigation because CAFA mass actions cannot be transferred to MDLs, right?
Wrong. The district judge in Romo transferred the cases to the MDL transferor district under the general venue transfer statute, 28 U.S.C. § 1404, finding that the Eastern District of Kentucky was a more convenient forum based on one manufacturing defendant’s principal place of business there and other factors. Again, multiple claims brought by non-Californians against non-Californians dispatched from California, where they never should have been in the first place.
Severance and Forum Non Conveniens. Of course, there is the old standby, forum non conveniens. We have filed more forum non conveniens motions than we can remember, and have won some, lost others. We are encouraged by the recent California Court of Appeal opinion in David v. Medtronic, Inc., No. B254914, 2015 WL 3645254 (Cal. Ct. App. Jun. 12, 2015), where the California Court of Appeal affirmed an order dismissing claims on the basis of forum non conveniens and held that the non-Californians’ claims could be severed from the Californians to achieve that result. We discussed David here, a case that 37 plaintiffs filed together in California with just one of them actually residing in California. The crux of the ruling was that the plaintiffs’ claims were not properly joined together in one civil action because they did not arise out of “the same transaction, occurrence, or series of transactions or occurrences.” Being treated with the same medical device was not sufficient because the plaintiffs “had different surgeries, performed by different surgeons, with different knowledge and exposure to different representations.” We like that reasoning because it so widely describes the cases that we see, where the only common factor among plaintiffs is that they were treated with the same or similar products. That alone is not sufficient to meet California’s permissive joinder standards. The Court of Appeal similarly approved of the trial court’s severance of claims against a co-defendant doctor on the basis that he was “of no real importance to the outcome of the case.”
Another example close on the heels of David v. Medtronic is the Transvaginal Mesh JCCP order. The Los Angeles court dismissed claims against J&J for lack of personal jurisdiction (see above), but the subsidiary that made and sold the products had already submitted to the court’s jurisdiction. The subsidiary therefore moved to sever the plaintiffs (again, multiple plaintiffs from all over the country joined under one caption) and to dismiss their claims under forum non conveniens. The court met the subsidiary defendant halfway: It severed the claims and established a separate civil action for each plaintiff, but it declined to dismiss the cases. Citing David and echoing its reasoning, the court ruled that “each of the female plaintiffs had her implant surgery on an individual basis in any number of locations spread throughout the United States” and thus had her own medical history and treatment “based on the specific facts know to [her] doctor.” Robinson, Minute Entry at 22.
So the J&J subsidiary did not get the claims dismissed, but the severance ruling is significant standing on its own. It is a direct strike at joinder, the procedural mechanism that facilitates litigation tourism more than any other. Moreover, the court’s reasoning (and that of the Court of Appeal in David) is widely applicable and should hold sway in future cases where the plaintiffs were treated with the same or similar products, but otherwise have nothing in common. The joinder ruling should also be helpful in contexts other than forum non conveniens. The improper joinder of non-diverse plaintiffs and/or forum defendants is often a barrier to removal jurisdiction. Authorities upholding severance of plaintiffs and defendants should support efforts to gain traction in federal court. We commented on a similar dynamic under Federal Rule 21 here.
California. Such a lovely place, such a lovely face. But what should we do with out-of-staters who import their claims into California for no reason other than their lawyers believe it to be a favorable forum? We ask that they be sent home. And if we do not succeed, we ask again in the next case, and then ask again, and so on. The above discussion is meant to help. Go forth.
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Posted By Steven Boranian to Drug and Device Law at 6/26/2015 02:30:00 PM --
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[Drug and Device Law] Pumped Up Protein Powder Preemption
While some of us are naturally jacked up—have you seen Bexis in short sleeves?—others turn to supplements to build up their beach bodies. We are not talking about the injectables favored by 1970s East German Olympians or 1980s NFL draft flops. And certainly not the supplements advertised on late night television as more targeted enhancers. (McConnell says that he heard they work as well as a Tarantino remake of a Kurosawa re-envisioning of a Shakespeare tragedy, whatever that means.) No, we are talking about protein powder, which people who lift weights often shake up with water or milk to chug after a workout. If you have ever cleaned the “shaker bottle” used by a high school athlete after his/her workouts, then you would know that the real problem with these powders is how much remains as a putrid clump in the bottle. If you have not had that pleasure, then you probably know that they sell protein powder in tubs ranging from large to ridiculously large at a variety of retailers. If you have glanced at the options among the protein powders on the retail shelves, then you may have noticed that they tout the number of grams of protein per serving and maybe something about the source of the protein. If you are the plaintiff in Gubala v. CVS Pharmacy, Inc., No. 14 C 9039, 2015 U.S. Dist. LEXIS 77509 (N.D. Ill. June 16, 2015), and you paid $20 for a container of this stuff, then you bring a purported class action for purchasers of the same product in ten different states. You also lose.
Plaintiff claims that the language on the front—a cylinder or truncated ovoid container does not really have a front, but we will let that slide—of the product he bought from his drug store was misleading because it said “Whey Protein Powder” and “26 grams of high-quality protein,” when each serving actually contains 21.8 grams of whey protein and 4.2 grams of other proteins plaintiff did not consider as high quality as the stuff left over from making cheese. Id. at **5-6. Based on this, plaintiff alleged violations of the ten consumer fraud acts, unjust enrichment and express warranty. The defendant moved to dismiss on several grounds, including on preemption based on the FDCA and National Labeling and Education Act, which is why we saw the case. As we have said before, the NLEA has an express preemption provision for any state requirements for food labeling—protein powder is food—that are not identical to its own. And the NLEA does have requirements on how protein content is to be discussed in labeling—by giving the “total protein contained in each serving size or other unit of measure.” Id. at *9. The regulations even say how total protein can be calculated, which appears to reject the plaintiff’s idea that the non-whey protein in the product he bought should not really count. Plaintiff wanted the product’s labeling to “differentiate between whey protein and protein from amino acids” and that “would not be identical to the labeling requirements imposed by federal law.” Id. at *11. That is pretty straightforward express preemption, but there was a cherry and whipped cream on top of this frothy vanilla shake. First, in adopting the protein labeling regulations, the FDA had considered and rejected the comment that labeling should specify how much of the protein in a food product was “high quality.” Id. at **11-12. Second, the same court had already rejected similar arguments in the context of labeling for fiber content and been affirmed by the Seventh Circuit. Among the previously rejected arguments was that preemption of food labeling claims under the NLEA can apply to complaints only about the content of the Nutrition Facts portion of the food product’s labeling. Id. at **14-16. So, plaintiff could not base his consumer fraud claims on the disclosure of the amount of whey protein in the product.
Fighting off its lactic acid build up, the court proceeded to address the non-preemption grounds for dismissal. Because the NLEA does provide for the possibility that the names of food products can be misleading by focusing on only one of its ingredients, there was a possibility of claim under the Illinois consumer fraud statute if the product’s name was misleading in the context of the entire labeling. Plaintiff contended that the name “Whey Protein Powder” was misleading because the product was not all whey protein. His problem, aside from being so litigious that he sued over allegedly overpaying for a $20 container of protein powder that had only 83% of its protein derived from his preferred source, was that the product’s name on the label was followed by “Vanilla” and “Naturally & Artificially Flavored Drink Mix.” It also lacked any descriptor like “only whey” or “100% whey” or “absolutely, exclusively whey” or “way, way whey.” Thus, it was “clear to any consumer upon first glance that the Product is not pure whey protein, and thus the label does not create a likelihood of deception or have the capacity to deceive based on the identifying name of ‘whey protein powder.’” Id. at *19. This meant the product name was not misleading as a matter of law and the non-preempted consumer fraud claim was dismissed. The express warranty claim was pressed aside because “26 grams of high-quality protein per serving” was considered “puffing” and not a potentially actionable express warranty. Id. at *22. The unjust enrichment claim fared no better because it was premised on dismissed consumer fraud claims. Id. at *23. The one down-side to the decision is that the dismissal of all of these claims was without prejudice. While we know that plaintiffs tend to get at least to their third set (i.e., the second amended complaint) before a dismissal under 12(b)(6) will be with prejudice, we doubt that any amount of stretching of the facts or law here will allow plaintiff to re-frame his allegations in a way to avoid preemption and state claims under state law. Maybe he can get those noted trainers Hans and Franz to pump—clap—him up before he tries.
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Posted By Eric Alexander to Drug and Device Law at 6/26/2015 10:07:00 AM --
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[DK GreenRoots] Breaking: Big, BIG Positive Climate Change News
This is big news coming out of Washington State that has national implications.
Please, if you see this, take the time to read and recommend. Thanks!
J.C.
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[Drug and Device Law] No Prescription For Consumer Protection
Allowing plaintiffs to pursue claims under consumer protection statutes in prescription medical product liability litigation is trying to pound a square peg into a ham sandwich. It doesn’t fit, and the combination isn’t very appetizing. FDA regulated manufacturers of prescription medical products aren’t snakeoil salesmen, payday lenders, reverse mortgage peddlers, or participants in some other “relatively common cash and credit transactions in which [consumers] engage on a regular basis.” West Virginia ex rel. McGraw v. Bear, Stearns & Co., 618 S.E.2d 582, 587 (W. Va. 2005). These statutes almost universally exempt government regulated activity, and instead of personal injuries consumer protection statutes typically allow recovery of non-tort damages such as monetary loss, attorney fees and multiple damages.
That’s one reason we were particularly pleased with the non-preemption part of the recent decision in Otis-Wisher v. Medtronic, Inc., ___ F. Appx. ___, 2015 WL 3557011 (2d Cir. June 9, 2015) (blogged about here), that dismissed the Vermont consumer protection act claims:
[T]he Vermont Consumer Protection Act . . . defines a “consumer” as a “person who purchases, leases, contracts for, or otherwise agrees to pay consideration for goods or services . . . for his or her use or benefit or the use or benefit of a member of his or her household.” Plaintiff did not constitute a “consumer” under the statute because she did not, for her personal use, purchase [the product], which in any event is not available for consumer purchase, but rather was prescribed the medical device by her doctor. Though Vermont has apparently not addressed this issue in the specific context of medical devices, the District Court’s ruling here is consistent with that of courts in other jurisdictions interpreting similar consumer protection laws.
Id. at *2 (emphasis added).
Otis-Wisher, being non-precedential, simply cited to the cases in the defendant-appellee’s brief. Id. That isn’t good enough for us, so we decided to see what was out there. Probably the most far-reaching opinion along these lines is White v. Wyeth, 705 S.E.2d 828 (W. Va. 2010), in which West Virginia’s highest court (not usually particularly friendly to our clients) held that prescription medical products were not subject to that state’s consumer fraud act because of the restricted way in which they were distributed. “Prescription drug cases are not the type of private causes of action contemplated under the terms and purposes of the [statute] because the consumer can not and does not decide what product to purchase.” Id. at 838.
[T]he high degree of federal regulation of prescriptive drug products attenuates the effect product marketing has on a consumer's prescriptive drug purchasing decision. . . . There is a strong argument that the scope of consumer protection acts was never meant to include FDA-approved drugs. The clear public policy behind these provisions is that consumer protection laws were meant to fill a gap by protecting consumers where product safety was not already closely monitored and regulated by the government.
Id. (citations and quotation marks omitted).
In part, White relied on a New Jersey intermediate appellate court decision which reached a similar conclusion:
[T]he intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication protects consumers in ways . . . that are lacking in advertising campaigns for other products. . . . [W]ithin a highly regulated industry in which the ultimate consumer is not in fact free to act on claims made in advertising in any event, the relationship between words used in the advertising and purchase of the product is at best an attenuated one.
New Jersey Citizen Action v. Schering-Plough Corp., 842 A.2d 174, 177-78 (N.J. Super. App. Div. 2003). Since then, the New Jersey Supreme Court more broadly ruled that consumer fraud claims were simply subsumed by that state’s product liability statute. See Runner v. Bard, ___ F. Supp.3d ___, 2015 WL 3513424, at *13 (E.D. Pa. June 3, 2015) (discussing Sinclair v. Merck & Co., 948 A.2d 587 (N.J. 2008) (blogged here)). Nonetheless, the reasoning in NJCA remains relevant to similar statutes in other states – as White demonstrates – or in other New Jersey situations beyond the reach of product liability. See In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *32 (D.N.J. July 10, 2009) (third party payers are not “consumers” under New Jersey consumer fraud statute because they “do not use or consume the drugs they purchase”) (we note that there is other similar TPP precedent; it is beyond the scope of this post).
The Illinois Supreme Court likewise found the “mere sale” of prescription medical products beyond the scope of that state’s consumer protection statute:
The risks associated with pharmaceuticals are a large part of the reason why a doctor’s prescription is required for these medications. A drug often can affect different patients differently, causing adverse side effects in one but not another. [This] approach reflects the reality that even in their intended and ordinary use, prescription drugs may nonetheless cause harmful side effects in some patients. A drug manufacturer cannot say with complete certainty that its product, when used as intended, will be reasonably safe for all patients. As a result, the mere sale of a prescription medication cannot be a representation which serves as the basis for a consumer fraud claim.
De Bouse v. Bayer, 922 N.E.2d 309, 318 (Ill. 2009).
For similar reasons – the “learned intermediary rule” − the Pennsylvania Unfair Trade Practices & Consumer Protection law (“UTPCPL”) was interpreted as excluding prescription medical products in In re Avandia Marketing, Sales & Products Liability Litigation, 2013 WL 3486907 (E.D. Pa. July 10, 2013):
Media dissemination of information concerning the existence of these drugs does not enhance the public’s ability to acquire them, as the skill and knowledge of the physician still must be brought to bear in a determination of whether the pharmaceutical is appropriate for the patient. Because Plaintiff could not obtain Avandia without a physician’s prescription, and the allegations with regard to the prescribing physician’s exposure to, and justified reliance on, misleading information from Defendant are insufficient to state a cause of action, the learned intermediary doctrine bars Plaintiffs claim.
Id. at *2. Accord Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 374 (D.N.J. 2004) (UTPCPL claims barred under Pennsylvania law because there is “no duty to disclose any information directly to Plaintiff”).
California courts did pretty much the same thing in Kanter v. Warner-Lambert Co., 122 Cal. Rptr.2d 72 (Cal. App. 2002), holding that FDA-regulated products were not “consumer product[s],” under a statutory definition reading “any tangible personal property which is distributed in commerce and which is normally used for personal, family, or household purposes.” Id. at 86. Neither prescription drugs nor medical devices were considered “consumer products” because “the FDCA and its implementing regulations govern the labeling at issue here.” Id. See Stein v. Sonus USA, Inc., 2005 WL 6198234, at ??? (Ariz. Super. Sept. 8, 2005) (“medical devices are not consumer products because they are not available directly to the general public and they are already protected by the Food, Drug, and Cosmetic Act”) (following Kanter), aff’d, 150 P.3d 773 (Ariz. App. 2007). Cf. Forcellati v. Hyland’s, Inc., 876 F. Supp. 2d 1155, 1165-66 (C.D. Cal. 2012) (homeopathic products, as opposed to prescription products, insufficiently regulated to fall within Kanter rule).
In Maryland, dental fillings installed by a professional dentist were not “consumer” products within the meaning of that state’s consumer fraud statute because they were “selected and used” by a required “professional” health care provider, and thus fell within a statutory exception:
Consumer goods are defined by the Act as goods “which are primarily for personal, household, family, or agricultural purposes.” Dental fillings are not purchased by consumers as a good but are selected and used by a practitioner as part of a professional service. The Consumer Protection Act expressly exempts professional services.
Hogan v. Md. State Dental Ass’n, 843 A.2d 902, 906 (Md. Spec. App.2004); Accord Pease v. Abbott Labs., Inc., 2013 WL 174478, at *2 (D. Md. 2013) (“prescription drugs are not ‘consumer goods’” under Maryland statute; drug “was selected by her physician and prescribed for her, not as a consumer good, but as part of her course of medical treatment”).
Quite a few other federal district court cases also hold that FDA-regulated, prescription-only products are not “consumer” products in one consumer protection context or another. The most recent of these is Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164 (E.D.N.Y. 2014), which we previously discussed here. Under the New York consumer fraud statute, information about prescription medical products is not a “consumer oriented” act, for many of the reasons discussed above:
It is uncontroverted that Section 349 of the New York General Business Law prohibits deceptive practices that are directed to consumers. . . . It is further uncontroverted that under New York law, drug manufactures do not owe consumers a duty to warn of a drug’s risks, but instead owe such a duty to the prescribers of that drug. This is because unlike other consumer products that may be freely purchased by consumers, prescription drugs may only be purchased by pursuant to a prescription issued by a medical doctor. . . . Accordingly, because the defendants’ alleged deceptive practice of failing to provide adequate warnings by concealing information is not, as a matter of law, a practice directed at consumers, plaintiff has failed to allege a consumer-oriented practice cognizable under [the statute].
Id. at 173-74 (citations omitted). Accord Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514, 552, (E.D. Pa. 2006) (“securities and prescription drug labeling are highly regulated by the federal government . . ., like securities, prescription drugs are not available in the same manner as usual consumer products”) (applying New York law), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008) (preemption), vacated on other grounds, 556 U.S. 1101 (2009) (preemption).
Several courts have also reached this result under Ohio law. Smith v. Smith & Nephew, Inc., 5 F. Supp.3d 930, 932 (S.D. Ohio 2014) (the prescription medical product “was purchased by the hospital, not Plaintiffs, and therefore it was not a part of a consumer transaction within the [statutory] definition”); Reeves v. PharmaJet, Inc., 846 F. Supp.2d 791, 798 n.2 (N.D. Ohio 2012) (a “prescription medical device is not a good for personal, family or household use and thus is not a consumer good as defined by the OCSPA.”); Williams v. Boston Scientific Corp., 2013 WL 1284185, at *6 (N.D. Ohio Mar. 27, 2013) (“the device was not a ‘consumer good’”; individual plaintiff was not a “consumer participating in a consumer transaction”).
Other decisions along the same lines include: Collins v. Davol, Inc., 56 F. Supp.3d 1222, 1232 n.9 (N.D. Ala. 2014) (medical “device is clearly inconsistent with the [Alabama statute’s] definition of ‘consumer good,’ i.e. ‘goods that are used or bought for use primarily for personal, family, or household purposes’”); Herzog v. Arthrocare Corp., 2003 WL 1785795, at *10 (D. Me. 2003); (“the [Maine] Act does not extend protection to individuals who pay the bill for a medical service provider’s acquisition of a medical device, even though that device is ‘used’ on them”); In re Minnesota Breast Implant Litigation, 36 F. Supp.2d 863, 876 (D. Minn. 1998) (“Plaintiffs’ [products] do not constitute ‘consumer products’ under the Act because these implants are not readily accessible to all consumers”); Goldsmith v. Mentor Corp., 913 F. Supp. 56, 63 (D.N.H. 1995) (“the prosthesis, a medical device regulated under the MDA, is not a consumer product”; “it is not ‘tangible personal property . . . normally used for personal, family, or household purposes’”); Kemp v. Pfizer, Inc., 835 F. Supp. 1015, 1024-25 (E.D. Mich. 1993) (“prescription drugs and medical devices are not listed among the examples of consumer products”; “Medical devices that are surgically implanted are not consumer products. The ordinary consumer has no access to such devices.”); see also Williams v. Purdue Pharma Co., 297 F. Supp.2d 171, 174-75 (D.D.C. 2003) (“difficult to discern a consumer-merchant relationship” if defendants had “promoted [the drug] only to physicians and other non-patients”; claim might be stated based on allegations concerning “brochures and a videotape directed to consumer-patients”).
In light of what we’ve found, we have to agree with Otis-Wisher. Widespread precedent exists to challenge statutory consumer protection/fraud claims asserted against prescription medical products. While there might be adverse precedent out there, we repeat: we do not do our opponents’ research for them. Given these products’ restricted distribution, heavy regulation, and lack of direct seller/patient contact, they shouldn’t qualify as “consumer” oriented within the meaning of most state statutory schemes.
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Posted By Bexis to Drug and Device Law at 6/25/2015 08:00:00 AM --
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[DK GreenRoots] New EPA report lays out the future of climate inaction vs action
This is pretty significant but probably won't get a lot of press, so please spread far and wide:
http://www.dailykos.com/story/2015/06/24/1396121/-New-EPA-report-estimates-benefits-of-reducing-global-greenhouse-gas-emissions
Cheers!
Sven
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[Drug and Device Law] Louisiana Appellate Court Overturns Improper Application of "Law of the Case" Doctrine
Today is the day when we will learn whether the Governor of Louisiana will enter the 2016 presidential race. That reminds us of Louisiana’s rather colorful collection of politicians, including Huey Long and Edwin Edwards. You probably already know that Louisiana boasts an unrivaled array of colorful characters in every field of endeavor, from chefs (Emeril Lagasse, Paul Prudhomme), sports (Peyton Manning, Pistol Pete Maravich), music (Louis Armstrong, Dr. John – and about a million others), and philosophy (Huey Newton, Uncle Si). Louisiana has added its own spicy flavor to the law, as well. If you asked drug and device defense lawyers who is the single most flamboyant, unpredictable plaintiff lawyer in the land, we bet a certain lawyer from Louisiana would garner the most votes. Pelican State courts have also given us some of the highest highs and lowest lows in product liability litigation.
Examples of both such highs and such lows reside in the recent case of Ezeb v. Sandoz Pharmaceuticals, No. 2015-C-0204 (Ct. App, 4th Cir. La June 17, 2015). What we have in the Ezeb case is one of the very worst summary judgment rulings by a court we have ever seen, ultimately reversed by an eminently sensible appellate court decision. Usually when we talk about a bad summary judgment decision, we are bemoaning a court’s failure to grant some virtuous defendant a ruling that dismisses some ill-conceived case. But in Ezeb the trial court granted partial summary judgment to a plaintiff on grounds so wrong-headed as to beggar belief.
While we supply the requisite procedural background, you might want to supply appropriate background music by a Louisiana legend – perhaps the smooth stylings of Harry Connick, Jr., Gino Delafose, or Lil Wayne. In or about 1990, the plaintiff filed a lawsuit against numerous doctors, hospitals, and pharmaceutical companies claiming that they played a role in overdosing him with a drug and thereby causing him various injuries. He sued the medical professionals for negligence, and sued the drug manufacturer under the Louisiana Products Liability Act (LPLA) for failing to warn of the side effects of the medication. One of the defendants was Caremark, the company that employed a treating nurse at the medical center where the plaintiff was administered the medicine. The plaintiff had alleged that the nurse played some role in the overdose. In 2008 (so now we are 18 years after the case was initiated), Caremark filed a motion for summary judgment. Reading between the lines of the decision, it appears that Caremark argued that there was no evidence establishing that its nurse was responsible for the dosing decision. Caremark’s summary judgment motion was unopposed, and the court, not surprisingly, granted the motion. All of the plaintiff’s claims against Caremark were dismissed with prejudice.
On December 4, 2014 (so now we are 24 years after the case was filed – can that possibly be right?!), the plaintiff filed a motion for partial summary judgment against the drug manufacturer. The plaintiff argued that the trial court’s dismissal of the claims against Caremark was the law of the case and constituted a finding that that the drug manufacturer was responsible for goading the treating physician into prescribing a dose that was too high. Amazingly, the trial court held that the law of the case doctrine applied and granted the plaintiff’s motion for partial summary judgment. Wow. We will readily agree that Louisiana probably has the best food in the republic, but this ruling smells like a kind of home cooking that we could not stomach.
What is “law of the case"? We generally think of it as encapsulating the principle that when an appellate court has passed on a legal question and remanded the case for further proceedings, the legal question thus determined by the appellate court will not be differently determined on a subsequent appeal in the same case where the facts remain the same. That clearly is not what happened in Ezeb, so what gives? Sometimes we hear the phrase “law of the case” applied in the sense that once the trial court has ruled on a certain specific issue between certain specific parties, that ruling must be followed. If only that were true! In every trial we have ever had, every morning we were greeted by plaintiff lawyers badgering the judge to revisit rulings of the prior day that had inconvenienced the plaintiff lawyers by, for example, excluding prejudicial, irrelevant evidence. Even accepting a loosened definition of law of the case that would apply to a lower court’s earlier summary judgment ruling, that earlier ruling must involve precisely the same issue and precisely the same parties. Nothing like that happened in the Ezeb case. When Caremark moved for summary judgment, it merely needed to establish that the plaintiff could not prove its case against Caremark, and that no rational jury could find against Caremark. As a defendant moving for summary judgment, Caremark did not need to prove anything at all. It certainly did not need to prove that some other defendant was responsible for the dosing decision, and it did not prove that. Moreover, the decision granting summary judgment in favor of Caremark simply did not involve the manufacturer at all. The manufacturer remained gloriously mute. It filed no papers – no one did, actually. Accordingly, applying that earlier ruling against the manufacturer smacks of fundamental unfairness. The manufacturer was never heard on the issue. And it was not even the same issue.
There is also a practical dimension to the trial court’s overbroad application of law of the case. If the trial court’s approach held sway, then every defendant would have to think long and hard about filing its own position paper on every motion brought by other defendants, even when such motions do not on their face implicate anyone else’s rights or interests. Does anyone really want that? That framework would greatly add to the tons of paper resting in case files and would tax the time of judges and clerks. It would add to the expense of all litigants. It would also (and maybe this is something that plaintiff lawyers would find appetizing) introduce tensions in the codefendant relationship. In most drug and device cases the defendants try to get along. Manufacturers seldom blame the doctors and doctors seldom blame the manufacturer. When someone breaches this typical truce, things get messy and plaintiffs sit back and delight in the internecine strife. As defense lawyers, we are happy to point the finger at the empty chair, but when the chair is filled we tend to stick to defending our client and not diming out anyone else. But if we now are charged with the obligation of scanning every motion in the case to see if some penumbra of every possible ruling might harm our client’s interest, then we will encounter something we never thought possible: an American litigation system even more complicated and clunky than what we already have.
Thus, the Louisiana appellate court did the right thing in reversing the partial summary judgment granted in favor of the plaintiff. The appellate court understood that the purpose of the law of the case doctrine is “to avoid relitigation.” That purpose was not served here, because the trial court had not previously ruled upon the manufacturer’s “acts under the LPLA.” The plaintiff had “failed to establish a prima facie case by relying on the facts established in the Caremark case.” Further, the plaintiff failed to offer any evidence with his motion for partial summary judgment that the manufacturer had failed to warn medical professionals and consumers of any dangers of the drug – which was, after all, what the claim was supposed to about.
In addition to the majority opinion, there is a very helpful concurring opinion by Judge Landrieu. The concurrence points out that the trial court’s judgment “lacks the necessary decretal language.” We are not sure whether “decretal” is a Louisiana term of art. Our ancient Black’s Law Dictionary (5th ed. 1979) defines “decretal order” as a “preliminary order that determines no question upon the merits and establishes no right.” Hmmm. A grant of summary judgment does seem to address merits and rights. Black’s Dictionary also tells us that “decretals” were letters of the pope determining points of ecclesiastical law. Double hmmm. Either way, we are grateful to the concurrence for pointing out that the trial court had supplied virtually no explanation to justify the vast overapplication of law of the case, and we are always pleased to learn a new word. The concurrence also lays out the issues and the necessary conclusion quite nicely: “Caremark’s motion, however, involved different parties – Caremark and the plaintiff – under a different theory of liability – negligence as opposed to liability under LPLA. Findings in granting Caremark’s motion other than to find that there were no material issues of fact in dispute as to Caremark’s liability. There is nothing in Caremark’s 2008 motion for summary judgment that establishes Novartis’ duty under the LPLA, and the trial court made no such finding.”
The mystery writer James Lee Burke has spent a great deal of time in Louisiana and has described it as a “fresh air mental asylum.” At least for a moment, in the Ezeb appellate decision, that description is not quite applicable.
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Posted By Steve McConnell to Drug and Device Law at 6/24/2015 07:30:00 AM --
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[Drug and Device Law] A Word to the Wise from the Garden State
This post is from the non-Reed Smith side of the blog.
A long time ago in a town not so far away, a teacher offered a piece of advice to his students:
A word to the wise is sufficient. A word to the foolish is a great waste of time. If I had not been so foolish and listened to the wise, then I would not have to write this silly, silly phrase.
No inference should be drawn that simply because this blogger can recall that sentence from so long ago that she was ever compelled to write it – over and over and over again. Sentence writing as punishment may be “old school,” but there is some truth to this adage. Whether they are words of admonishment, caution, praise, or suggestion – a wise person listens and contemplates before taking action. Of course, the source of the word plays directly into how closely we heed it. As litigators, we get such words from our colleagues, our clients, our experts, sometimes a sound word even emanates from our adversaries. And perhaps most importantly, we sometimes get “advice” from judges. They’ll couch it to be clear that they aren’t pre-judging an issue or offering an advisory opinion – but we all know too well that judges have their ways of “suggesting” approaches or “hinting” at potential problems. And we all know how important those cues can be.
What we’re pondering today is whether the plaintiff in Clements v. Sanofi-Aventis, U.S., Inc., 2015 WL 3648911 (D.N.J. Jun. 11, 2015) will take note of the cue left for her in this decision dismissing her case without prejudice.
This case involves a Class III, PMA medical device. In other words, it should be preempted. And for the most part, the court agreed – but with a little latitude. First, plaintiff originally filed her complaint in state court. Defendants removed it. So the judge was willing to give plaintiff some leeway on compliance with TwIqbal. Id. at *1. Second, some limited discovery had been conducted, so defendant filed a motion for summary judgment. Although plaintiff argued that she needed more discovery, she failed to file the appropriate affidavits and declarations under local federal rules – deficiencies which are usually fatal. Again, because plaintiff had not chosen federal court, the judge was lenient. Finding that really all of the arguments in the summary judgment motion were legal arguments, the judge converted the motion into a motion to dismiss (sort of a reverse twist). Id. at *4-5.
Next the court pared down the plaintiffs’ case by dismissing the claims that are subsumed by the New Jersey Products Liability Act (NJPLA) – implied warranty, negligence, and strict liability. Id. at *6. That left plaintiffs’ breach of express warranty claim, NJPLA claim and a derivative punitive damages claim. On the NJPLA claim, the court undertook a straightforward PMA preemption analysis. Plaintiff alleged that defendant violated the NJPLA because the device’s design and manufacture were defective and its warnings inadequate. Id. at *8. However, “[b]y approving Sanofi’s PMA application, the FDA determined that [the device’s] manufacture, design, and warnings were safe and effective.” Id. Therefore, the claim is preempted and since plaintiff pleaded no “parallel” violation of a federal standard, the claims warranted dismissal.
But again, the judge decided to offer a bit of leniency. In her response to the motion to dismiss, plaintiff argued that her claims should survive preemption because she was alleging a parallel violation claim -- defendant promoted its device for off-label uses in violation of federal regulations on misbranding. Id. at *9. On this point, the court could not ignore that plaintiff failed to satisfy even minimal pleading standards. None of plaintiffs’ allegations mention off-label promotion, they don’t cite the federal regulations, and most importantly “the Complaint contains no facts from which the reader could conclude that [the device’s] manufacture, design, warnings, or alleged off-label promotion actually violated any of the federal provisions [plaintiff] cites in her brief.” Id. So while the claims were dismissed, it was without prejudice to afford plaintiff an opportunity to amend to allege her off-label promotion claim.
This is where the word to the wise comes in. The court offered plaintiff some “guidance;” a little food for thought as plaintiff re-drafted her complaint: “An off-label promotion theory may fail to state a cause of action to the extent that it illegitimately shifts the risk of off-label use from prescribing doctors and patients to manufacturers.” Id. at *10. Here, much to our liking, the court cited the recent Tenth Circuit ruling in Caplinger v. Medtronic, which we talk about here. The court appears particularly to embrace the Caplinger reasoning that there is nothing in §360k(a), the MDA express preemption provision, that suggests that preemption turns on how a device is used. Id. Coupled with the fact that Congress explicitly acknowledged and protected off-label use by physicians and thus understood the difference, the absence of a mention of off-label use in §360k(a) is “hard[] to ignore.” Id. The court went even further in analyzing plaintiff’s potential amended claim:
A hypothetical claim (not pled in the current complaint) that Sanofi’s design, manufacture, or warnings were defective because they ignored the possibility that doctors would prescribe [the device] for off-label cosmetic use, would not necessarily constitute a non-preempted, “parallel” state-law claim. It might well constitute a state law requirement that is expressly preempted by § 360k(a). An allegation that a product’s warnings were inadequate, for example, may be tantamount to a requirement that Sanofi must do something “different from, or in addition to” what the FDA had already approved. That is to say, a jury would have to find either that Defendants were required to include warnings beyond those in the FDA-approved label ... or that Defendants were obligated to issue post-sale warnings about potential adverse effects of using [the product] in an off-label manner.
Id. We agree. As evidenced by the overwhelming case law developed in the InFuse litigation, simply adding off-label to your complaint doesn’t cut it. Further, we think the judge has more than fairly put this plaintiff on notice that her next complaint better be TwIqbal compliant – which is where the few off-label claims that have survived preemption often fall short.
We think these are astute observations by the court and signal that plaintiff’s pursuit of an off-label claim won’t be easy. We’ll just have to wait to see if the judge’s words will be sufficient or simply a waste of time.
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Posted By Michelle Yeary to Drug and Device Law at 6/23/2015 05:20:00 PM --
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