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Unfortunately, the Third Circuit now seems to have a fetish with the presumption against preemption.  Not long after the Supreme Court abolished that presumption in express preemption cases in Puerto Rico v. Franklin-California Tax-Free Trust, 579 U.S. 115 (2016), the Third Circuit refused to go along.  See Shuker v. Smith & Nephew, PLC, 885 F.3d 760, 771 n.9 (3d Cir. 2018) (finding Puerto Rico v. Franklin not controlling because it was not a product liability case).  Since then, as we discussed here, every other circuit court to address the issue has recognized the demise of the presumption against preemption in express preemption cases – several of them doing so in product liability litigation.  The Third Circuit stuck out like a sore thumb.

Then along came Merck Sharp & Dohme Corp. v. Albrecht, 587 U.S. 299 (2019).  In our initial “breaking news” post when Albrecht was first decided, we pointed out an interesting fact.  Among other things, Albrecht spent several pages restating and reworking the Court’s poorly reasoned Wyeth v. Levine, 555 U.S. 555 (2009), decision.  See Albrecht, 587 U.S. at 310-13 (“describing” Levine for four pages).  Levine, of course, had been the high water mark of the presumption against preemption, which it called a “cornerstone” of “pre-emption jurisprudence” generally.  555 U.S. at 565.  But nowhere in Albrecht’s discussion of Levine – indeed, nowhere in the Albrecht decision anywhere – did the Court even mention any presumption against preemption.  (If you don’t believe us, search Albrecht for “presum!”)  As we said then, “conspicuously absent from that description is any express reference to any ‘presumption’ (as opposed to the older ‘assumption’) against preemption.”  So on that issue, be believe that the Court in Albrecht actually pulled back from that presumption.

Continue Reading Challenging The Role of the Presumption Against Preemption in Fosamax
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This has been a big year for blood and tissue statute decisions. Given their subject matter, we’ve previously lamented that the decisions didn’t fall closer to Halloween. While not quite coinciding with our doorbells ringing and handing out candy to the little ones, today’s decision is close enough for a little seasonal digression.

Continue Reading Another Blood and Tissue Statute Win
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We have no personal knowledge of the litigation concerning GLP-1 receptor agonist medications and the Blog has not posted on it yet, but we do know something about litigation over widely used prescription medications.  Over the decades, there have been many drugs or classes of drugs that became “blockbusters” because they were widely prescribed to treatment of fairly common medical condition.  Often, even without reliable scientific research indicating a new or worse than previously suspected risk of a serious complication, litigation starts.  It is both a numbers game and a waiting game.  If there are enough cases and the cost of defense is high enough, then maybe the defendants will pay to end the litigation while the medications continue to be well-accepted.  If the litigation drags on long enough, then maybe there will actually be some science or liability evidence to support the plaintiffs’ claims after the fact.

Unless you have been living under the proverbial rock for several years, you have probably heard of the GLP-1 receptor agonist medications developed for diabetes and now widely prescribed for weight loss.  As veterans of prior litigation over multiple prescription diabetes and weight loss medications, we are aware of the significant individual and public health benefits from obese patients maintaining intentional weight loss and diabetics lowering their glycosylated hemoglobin levels.  When we look at the primary alleged injury in the MDL created for product liability claims over the GLP-1 receptor agonist medications, gastroparesis, we are underwhelmed.  (Apparently, the JPML may add venous thromboembolism claims to the mix.)  A perusal of the first few sentences from the pertinent Wikipedia entry—surely, the most superficial of inquiries—tells us that gastroparesis results “in food and liquid remaining in the stomach for a prolonged period of time,” which can cause symptoms such as “nausea, vomiting, abdominal pain, feeling full soon after beginning to eat (early satiety), abdominal bloating, and heartburn,” and that it is often idiopathic or due to damage to the vagus nerve from uncontrolled diabetes.  Early satiety is the point of the use of a GLP-1 for weight loss and, as expected, delayed gastric emptying and all of those resultant symptoms are labeled.  So, at first and second blush, the litigation does seem to fit the pattern described above.

The defendants were wise to propose and the MDL court was wise to accept bifurcated discovery so that threshold (or “cross cutting” as used in the decision we will be getting to) issues could be addressed first.  The three issues to be decided first, after appropriately tailored discovery, are “(1) gastroparesis diagnostic testing, (2) preemption and adequacy of warnings, and (3) general causation.”  In re Glucagon-Like Peptide-1 Receptor Agonists Prods. Liab. Litig., MDL No. 3094, 2024 U.S. Dist. LEXIS 188802, *3 (E.D. Pa. Oct. 17, 2024) (“GLP-1”).  Plaintiffs being plaintiffs, they urged that they should be allowed to pursue unfettered discovery into the marketing of the five different prescription medications currently at issue in the MDL before the court decides those threshold issues.  Even without going into the arguments offered by plaintiffs for why they should get such broad early discovery, we can offer that there are three real reasons:  1) marketing discovery will be costly and burdensome for defendants (see above); 2) marketing discovery will likely take time and bog down with motions practice, meaning it takes even longer (see above); and 3) marketing discovery may turn up something sufficiently salacious, but not substantive, to deter the court from issuing rulings on the threshold issues that are favorable to the defendants.  The decision in GLP-1 was actually on a motion to reconsider from plaintiffs after they lost the issue originally.  They started with the dubious position that the standard for deciding this motion to reconsider should not be derived from Fed. R. Civ. P. 59(e) as it usually is, because somehow the original decision was not on a full record.  They lost this argument and the motion, which was decided on the applicable “clear error of law” standard.

Given that plaintiffs had recycled their arguments that were rejected originally, the focus of the GLP-1 decision was to clarify the court’s prior analysis on why alleged overpromotion of the drugs is irrelevant to whether the warnings in their respective labels were adequate and whether any claim of inadequacy as to the label would be preempted because the allegedly required changes were not possible.  Id. at *17-18.  Plaintiffs argued, largely based on an early decision from the Avandia MDL, that marketing conduct must be examined to determine the adequacy of warnings.  (We note that later decisions from that MDL, including those affirmed by the Third Circuit, granted summary judgment on a number of warnings claims.)  From our perspective, even though it came to the right conclusion, the analysis in GLP-1 was a bit too generous to plaintiffs’ position in two respects. 

First, the GLP-1 court played along with some of the plaintiffs’ three-card monte with the words warnings, warn, label, and labeling.  The warnings in a label as to particular risks can be held to be adequate as a matter of law.  Claims based on the assertion that the label had to include specific additional information at a specific time to adequately warn of the true risks can be held to be preempted.  Either of those holdings usually will mean that the plaintiff loses her claim for failure to warn, but that is not always the case.  For instance, the warnings in the label could be adequate as to one but not both of the injuries the plaintiff alleges.  Or the asserted warnings claim could be preempted to the extent it is based on an alleged inadequacy during part of the time the plaintiff was prescribed the drug.  Or, in one of the few states that has law providing that “overpromotion” to the particular prescribing physician to undo the adequacy of the warning in the label, the plaintiff might have a chance to prove such an exception applies.  The court can decide the adequacy of the relevant warnings in the label and how impossibility preemption applies without looking at marketing broadly or individually.  Communications to physicians outside of the label (i.e., the package insert),

are not needed for the Court to determine whether a drug’s approved label already contains the warnings that Plaintiffs seek to add and if not, whether the FDA would have rejected additional warnings to the approved label, such that Plaintiffs’ state law failure to warn claims are preempted.

Id. at *28-29.

Second, in two footnotes, the GLP-1 court recapped that Avandia could identify Pennsylvania as the only state with an overpromotion exception and that its own research turned up a handful of other states that might also have some form of exception.  Id. at nn.7-8.  Generally, these cases involve, somewhat like Perez with direct-to-consumer advertising in New Jersey, the idea that the focus in an individual case should be on the warnings provided to the plaintiff instead of the warnings provided to the learned intermediary.  We will not belabor why those cases tend to be wrong, but we can say the substantive law of the forty-five or more states without such an exception would definitely not make marketing conduct relevant to determining label adequacy or the conflict with federal law.  Expanding the scope of discovery based on maybe 10% of the states instead of the other 90% or so would be strange. However, the court correctly concluded that the analysis of overpromotion where there is a recognized exception is a highly case-specific inquiry.  Id. at n.8.  The implication of that conclusion is that early generic discovery need not be expanded because of possible additional discovery in individual cases down the road.  Although the court did not have to go beyond relevance, a proportionality analysis under Fed. R. Civ. P. 26(b)(1) would have further supported the limit the court imposed.

At the end of the day, by keeping discovery focused on what the defendants knew, what the labels said, what FDA was told, and what FDA would have done with theoretical labeling changes, the court increased the chance of clean decisions on the adequacy of the warnings in the labels and the preemption of certain label-based warnings claims.  Along the same vein, we made sure to avoid any quips or wordplay about weight or weight loss so we could present what was really a fairly straightforward issue.

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We don’t usually weigh in on commercial disputes like antitrust cases. But In re Merck Mumps Vaccine Antitrust Litigation, 2024 U.S. App. LEXIS 25271 (3rd Cir. Oct. 7, 2024), is a 2-1 appellate decision that dismisses Sherman Act violation claims by favorably resolving allegations of fraud on the FDA.  We do like to talk about fraud on the FDA.

Plaintiffs were a group of end-user doctors who alleged that defendant prolonged its monopoly over its mumps vaccine by making false drug-label claims.  The drug’s labeling, however, was approved by the FDA as a result of the manufacturer’s successful petitioning of the agency.  So, defendant argued that it was entitled to summary judgment under the Noerr-Pennington doctrine.  The district court rejected that argument, but that decision was reversed by the Third Circuit.

Defendant was the sole manufacturer of a certain vaccine from 1967 to 2022.  Plaintiffs alleged that defendant prolonged its monopoly by fraudulently inducing the FDA to approve its license application which allowed defendant to maintain certain labeling claims regarding the vaccine’s shelf-life.  Id. at *4-6.  Because any new competitor would have to demonstrate that its vaccine was “not inferior” to defendant’s, the allegedly unsupported shelf-life claim raised a barrier to entrance into the U.S. vaccine market which delayed competition.  Id.

While the Sherman Act makes monopolies, or attempts to monopolize, unlawful, it has exceptions.  One such exception is petitioning immunity, also known as the Noerr-Pennington doctrine.  The doctrine provides that “a party who petitions the government for redress generally is immune from antitrust liability even if their petitioning causes an anti-competitive effect.” Id. at *9 (citation omitted).  The immunity is rooted in the First Amendment’s right to petition and the Supreme Court’s ruling that “Congress did not intend to proscribe harm to competition that is the result of valid government action, as opposed to private action.” Id. (citing Noerr, 365 U.S. 127, 136).

There are, however, exceptions to the exception. If a petition is “not genuinely aimed at procuring favorable government action,” it is deemed a sham and does not receive immunity.   Id. In lay terms, courts draw a distinction between the petition process and the result of that process.  To be a sham, the petition must be “objectively baseless”—no realistic expectation of success—and the petitioner must have intended to use the process to interfere with a competitor’s business.  Id. at *10.  If it is the result of the petition that has an anti-competitive effect, the sham exception does not apply.

Plaintiffs made three arguments why defendant in this case should not receive Noerr-Pennington immunity.  First, defendant did not “petition” the FDA so much as provide answers in a regulatory proceeding.  Id. at *12.  The court disagreed, finding defendant’s application “sought to persuade the FDA to approve or refrain from changing” its label-claims. 

Second, plaintiff alleged defendant’s petition was a sham because it contained misrepresentations that caused the FDA to approve defendant’s label.  Also known as fraud on the FDA.  But the Noerr-Pennington doctrine immunizes successful government petitions, whether or not the government was misled.  A winning petition necessarily has “objective merit,” and therefore is not a sham but rather is protected by the First Amendment.  As in products liability claims, it was important to the court that the FDA has not taken any action against defendant—has not found any fraud, ordered a label change, or issued a recall.  Id. at *7.  Nor could defendant have intended to commit a sham where it sought to use the result of petitioning the government (the FDA-approved drug shelf-life labeling claims) − as opposed to the petitioning itself − to harm competition.  This was not an attempt to enmesh competitors in harassing litigation.  Thus, summary judgment should have been granted.

Third, plaintiff argued that defendant’s misleading label claims were “private conduct, not government action.”  Id. at *12.  However, Noerr-Pennington is not an evidentiary privilege that simply bars the use of a petition to prove an antitrust violation.  Rather, it is substantive law that shields defendants from liability when it is the government’s “exercise of regulatory discretion” that causes the competitive harm.  Id. at *16.  The FDA’s approval of defendant’s label bars plaintiffs’ claims because it was the FDA’s decision (regardless of its basis) not defendant’s private conduct, that delayed competition.  Id. at *16-19.

Plaintiffs made a few additional arguments, none with any merit.  For example, plaintiff argued that defendant engaged in private conduct every time if printed or distributed its allegedly misleading label.  If that were the case, it would essentially overrule Noerr-Pennington in drug and device cases by switching the focus to the content of the label instead of the FDA’s approval decision. Id. at*20.  That was a step too far for the court.  Plaintiffs also tried to argue that omitting information in an FDA petition is different than actively misrepresenting facts to the FDA and that the former should be considered private conduct. The court also viewed this as creating a “vast” exception that would allow plaintiffs to evade the doctrine completely by focusing on omissions in petitions rather than on the petitions themselves.  Id.at *22-23. 

The Third Circuit concluded that defendant genuinely petitioned the FDA to obtain approval for its vaccine label claims and that plaintiffs’ antitrust injury flows from the FDA’s decision to approve the label, not from defendant’s private conduct.  Therefore, defendant was entitled to summary judgment.

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In the law, both form and substance matter.  At the same time, we frequently see judicial opinions making the point that form should not be elevated over substance. Mottern v. Baptist Health System, Inc., 2024 WL 4097539 (Alabama Sept. 6, 2024), supplies a recent example.  In Mottern, the Alabama Supreme Court permitted a plaintiff to assert various theories in a wrongful death case.  That’s all fine and good (we guess). But because all such theories addressed an alleged injury caused by a medical procedure, everyone of them had to satisfy the requirement in the Alabama Medical Liability Act (AMLA) of showing a breach of the medical standard of care.

The Mottern case was brought by the estate of a woman who allegedly died from a blood infection caused by a bacterially contaminated intravenous infusion of total parenteral nutrition (TPN), which is a method of providing nutrition to patients who cannot digest foods.  The estate sued the hospital, the manufacturer of the TPN, and three individuals associated with the manufacturer. The case against the manufacturer and individuals was settled. What remained in the amended complaint were claims against the hospital for negligence, wantonness, an action under the Alabama Extended Manufacturer’s Liability Doctrine (AEMLD), and breach of implied warranty under the Uniform Commercial Code (UCC). 

The issue was whether those claims were subject to the requirement under the AMLA that claims against medical providers alleging medical injury must be supported by “substantial evidence of a breach of the applicable standard of care.”  The estate wanted to dodge the AMLA standards, at least for the AEMLD and UCC claims, arguing that all that was required under those claims were allegations that the TPN was defective, that the hospital was a seller of the TPN, that the hospital sold the TPN to the decedent, that the TPN caused the death, and that there was no substantial change to the TPN from the time it left the hospital’s possession until it reached the decedent.  

Mind you, a defendant in this scenario could make a cogent argument that the AMLA should be the exclusive avenue of relief. But the Alabama Supreme Court did not accept that argument.  Those other causes of action could go forward. But while plaintiffs might be allowed to pursue claims captioned as such, those claims nevertheless remain governed by the AMLA.  Thus, plaintiffs cannot avoid having to establish a breach of the medical standard of care.  Any claimant alleging “medical injury” must establish breach of the relevant standard of care, no matter what the claim is called.
In arriving at this conclusion, the Alabama Supreme Court emphasized that the Alabama Legislature enacted the AMLA based on a recognition of an “increasing threat of legal actions for alleged medical injury” that was causing “a crisis threaten[ing] the delivery of medical services to the people of Alabama.”  The Legislature believed that such threat “contributes to an increase in health care costs and places a heavy burden upon those who can least afford such increases.”  The Legislature also saw that the proliferation of legal actions resulted in “a limitation on the number of physicians providing specialized health care in this state.”
In some quarters, it has become unfashionable to consult legislative history as an aid to statutory interpretation.  But no one doubts the primacy of legislative intent.  (Good luck fitting those concepts together.). The Mottern court was right to take into account the scope and purpose of the AMLA.  The AMLA was not, as the plaintiff contended, merely “procedural” in nature.  Because the Mottern case alleged injuries caused by the administration of medical care, the substantive standard of care requirements of the AMLA should and did apply.

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Recently we discussed the latest opinion in the ongoing “controversy” over the application of Pennsylvania’s comment k across-the-board rule to cases involving medical devices.  Douglas v. Atrium Medical Corp., 2024 WL 4364950 (M.D. Pa. Sept. 20, 2024).  We use “controversy” advisedly, because as Douglas held, there is “no substantial ground for difference of opinion as to whether plaintiffs’ strict liability claims should be dismissed” under controlling Pennsylvania law.  Id. at *4.  As we discussed at length here, no less than eight Pennsylvania Supreme Court decisions since 1942 have unanimously rejected various attempts to impose strict liability of one form or another in prescription medical product liability litigation.

  • Henderson v. National Drug Co., 23 A.2d 743. 748 (Pa. 1942) (rejecting an “ex contractu” warranty-type liability in action against a drug manufacturer).
  • DiBelardino v. Lemmon Pharmacal Co., 208 A.2d 283, 283 (Pa. 1965) (rejecting implied warranty of merchantability against a drug manufacturer).
  • Incollingo v. Ewing, 282 A.2d 206, 219-20 (Pa. 1971) (rejecting §402A strict liability in action against a drug manufacturer under Restatement (Second) of Torts §402A, comment k (1965), and allowing solely negligence claims).
  • Baldino v. Castagna, 478 A.2d 807, 810 (Pa. 1984) (reiterating Incollingo).
  • Coyle v. Richardson-Merrell, Inc., 584 A.2d 1383, 1384 (Pa. 1991) (rejecting “strict liability independent of the issue of inadequate warning” in action against a drug manufacturer).
  • Cafazzo v. Central Medical Health Services, Inc., 668 A.2d 521, 527 (Pa. 1995) (rejecting intermediate seller/marketer strict liability in action against a medical device manufacturer).
  • Hahn v. Richter, 673 A.2d 888, 891 (Pa. 1996) (reaffirming Incollingo in action against a drug manufacturer).
  • Lance v. Wyeth, 85 A.3d 434,446 (Pa. 2014) (reiterating “this Court’s adoption of comment k in the strict-liability setting” in action against a drug manufacturer).

As if anything more were needed, Pennsylvania’s intermediate appellate court has also weighed in on this issue three times:

  • Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 377-78 (Pa. Super. 1987) (rejecting implied warranty of merchantability in action against a drug manufacturer).
  • Creazzo v. Medtronic, Inc., 903 A.2d 24, 31 (Pa. Super. 2006) (applying Hahn and Incollingo broad application of comment k in in action against a medical device manufacturer).
  • Daniel v. Wyeth Pharmaceuticals, Inc., 15 A.3d 909 (Pa. Super. 2011) (following Hahn, et al. in action against a drug manufacturer).

However, after Tincher v. Omega Flex, Inc., 104 A.3d 328 (Pa. 2014), plaintiffs have mounted an attack – in federal court, mostly, which is contrary to Erie principles – on 80+ years of Pennsylvania rejection of strict liability in any form in prescription medical product liability litigation.  They’ve done so by standing on its head the Tincher court’s acknowledgement of Hahn as an exception to a general “presumption . . . that strict liability may be available with respect to any product.”  104 A.3d at 382 (“but see” citation to Hahn).

Plaintiffs tease some sort of implied criticism of Hahn from that dictumTincher involved pipe, not any sort of prescription medical product – and use it as an excuse to ignore all pre-Tincher precedent.  That’s a blatant heads-you-lose-tails-I-win argument, since Tincher retained §402A as the basis for Pennsylvania strict liability, 104 A.3d at 399, of which comment k is a part.  Had Tincher adopted the Third Restatement, plaintiffs surely would have taken that as a rejection of comment k as an aspect of § 402A.

Beyond using Tincher as an excuse to ignore the eight prior Pennsylvania Supreme Court rejections of strict liability in prescription medical product liability litigation, plaintiffs have also misrepresented the Superior Court’s directly-on-point Creazzo decision as supposedly the product of poor advocacy by a pro se appellant plaintiff.  That was a lie.  West Publishing made a mistake in the listing of counsel because the lawyer representing the Creazzo plaintiffs-appellants was a relative with the same name.  We thoroughly debunked that misrepresentation in this blogpost, and the Creazzo online opinion has been corrected.  A search of the Creazzo opinion (on Lexis or Westlaw) for “pro se” now produces nothing.

But the plaintiffs’ misinformation campaign successfully hoodwinked four federal judges, three of whom repeated that lie in published opinions.

  • Spear v. Atrium Medical Corp., 621 F. Supp.3d 553, 556 (E.D. Pa. 2022) (“Courts that have not barred strict liability have noted that Creazzo was argued by pro se plaintiffs and therefore unpersuasive”) (Hon. Gerald McHugh).
  • Gross v. Coloplast Corp., 434 F. Supp.3d 245, 250 (E.D. Pa. 2020) (“[t]he pro se plaintiffs in Creazzo do not appear to have litigated the point thoroughly”) (Hon. Michael Baylson).
  • Moultrie v. Coloplast Corp., 2020 WL 1249354, at *9 (Mag. W.D. Pa. March 16, 2020) (describing Schrecengost as “noting that the pro se plaintiffs in Creazzo did not offer a different interpretation”) (Hon. Patricia Dodge).
  • Schrecengost v. Coloplast Corp., 425 F. Supp.3d 448, 465 (W.D. Pa. 2019) (“[T]he Pennsylvania Supreme Court would likely decline to adopt Creazzo’s rationale. . . .  There is no indication that the parties presented a full and balanced record of policy considerations to the court in Creazzo.  In fact, the opposite was true. The court acknowledged that the appellants, who were pro se, offered no analysis or authority for a different interpretation of Hahn”) (Hon. Kim Gibson).

Unfortunately, while the underlying basis of the phony p-side arguments made to these four federal judges has been corrected in Creazzo itself, those four decisions remain on the books – the fruit of a poisonous tree.  Schrecengost has been cited in ten Pennsylvania cases that also mention “comment k” (including by Gross and Moultrie).  Moultrie (which is the only one of the four that is unpublished) has been cited in four Pennsylvania cases that also mention “comment k.”  Gross has been cited in nine Pennsylvania cases that also mention “comment k” (including Moultrie).  Spear has been cited in three Pennsylvania cases that also mention “comment k.”

So here is the list of federal cases that were indirectly influenced by the plaintiffs’ misrepresentation campaign concerning Creazzo

  • Ebert v. C.R. Bard, Inc., 2021 WL 2656690, at *5 (3d Cir. June 24, 2021) (citing Schrecengost and Gross).
  • In re Philips Recalled CPAP, Bi-Level PAP, & Ventilator Products Litigation, 2024 WL 278641, at *9 (W.D. Pa. Jan. 24, 2024) (citing Moultrie).
  • In re Philips Recalled CPAP, Bi-Level PAP, & Ventilator Products Litigation, 2023 WL 7019287, at *54 (W.D. Pa. Sept. 28, 2023) (citing Spear).
  • Cohen v. Johnson & Johnson, 634 F. Supp.3d 216, 227-28 (W.D. Pa. 2022) (citing Schrecengost and Moultrie).
  • Maietta v. C.R. Bard, Inc., 2022 WL 3577374, at *4-6 (E.D. Pa. Aug. 19, 2022) (citing Schrecengost, Gross, and Spear).
  • Ebert v. C.R. Bard, Inc., 459 F. Supp.3d 637, 647-53 (E.D. Pa. 2020) (citing Schrecengost, Gross, and Moultrie).
  • Patchcoski v. W.L. Gore & Associates, Inc., 2020 WL 4335016, at *6-7, 11 (M.D. Pa. July 28, 2020) (citing Schrecengost, Gross, and Moultrie)

Thus, it is evident that several other cases, particularly Maietta, Ebert, and Patchcoski, are also fruit of the poisonous tree, since they cite multiple cases in which the judges deciding them had been bamboozled by lies from the plaintiffs’ side that attacked the directly on point Creazzo decision.

We strongly encourage defendants in Pennsylvania prescription medical product liability litigation who are faced with similar attempts to assert strict liability claims to explain to the courts that much of the decisional law that their opponents cite is – directly or indirectly – based on lies about Creazzo.  Don’t let plaintiffs get away with this deception.

Finally, we also strongly recommend that medical device manufacturers, in particular, faced with strict liability claims in Pennsylvania also rely upon the Pennsylvania Supreme Court’s decision in Cafazzo, 668 A.2d 521.  Cafazzo is a device case.  While it is somewhat farther afield in context, as the plaintiffs were asserting strict liability claims against health care providers as supposed intermediate sellers, it applies the same principles that the Pennsylvania high court has used in other cases to preclude assertion of strict liability, and does so in a case involving medical devices.  It is certainly much more on point than Tincher, which did not involve prescription medical products at all.

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Several of your Reed Smith bloggers are making plans to be in New York on December 3 – 4 to attend ACI’s Annual Conference on Drug and Medical Device Litigation. We’re looking forward to great content and numerous networking opportunities – and maybe even the chance to catch up with some of our loyal readers.

The good people at ACI asked the blog to be a media sponsor this year – and are offering a special registration discount for the conference for the blog’s readers. Make sure to use the code D10-999-DDLB25 when you register. You’ll save 10 percent off your conference registration.

If you want to register, you can do so here. We look forward to seeing you in New York!

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Preemption is one of our favorite topics, not only because it is a powerful defense, but also because the intricacies of preemption and its many flavors make it inherently interesting—at least to us.  We lamented just yesterday that many judges reflexively deny motions to dismiss on preemption, but others see the light from the get go.  Take for example Shawver v. Zimmer Biomet Spine, Inc., No. 3:24-cv-00454-JGC, 2024 WL 4458261 (N.D. Ohio Oct. 10, 2024).  In Shawver, a federal judge in Ohio granted a motion to dismiss because federal law preempted state-law claims premised on the implantation of a pre-market approved, Class III medical device.  That was the correct result.

The plaintiff in Shawver was treated with the defendant’s cervical disk replacement device and later experienced alleged symptoms that included numbness, tingling, and weakness—resulting in a second surgery and a lawsuit claiming personal injury.  The district court, however, made short shrift of the plaintiffs’ claims.  As mentioned, the implant was a Class III medical device that has undergone the “rigorous regime” of premarket approval (“PMA”).  As the district court observed, that process involves FDA review of “any probable benefit to health from the use of the device against any probable risk or injury or illness,” and PMA-approved devices are subject to continuing FDA oversight.  Id. at *1-*2. 

Most importantly, the Medical Device Amendments to the FDCA include an express preemption provision, which mandates that no state may impose any safety-related or efficacy-related requirement that “is different from or in addition to” any federal requirement.  Id. at *6.  As we have written more times than we can count, this provision preempts state-law tort claims seeking to impose standards different from or in addition to federal requirements governing PMA-approved devices. 

How then did this district court get to its order dismissing the plaintiffs’ claims?  The district court first rejected the defendant’s argument that the Ohio Products Liability Act abrogated the plaintiffs’ express warranty and fraud claims, although it dismissed those claims anyway on other bases (we will come back to that).  The OPLA creates a cause of action for design defect, manufacturing defect, and inadequate warnings, among other things.  But, it also expressly abrogates “all common law product liability claims or causes of action.”  According to the court, the plaintiffs had sufficiently pleaded fraud claims outside the OPLA because their allegations “might relate to instances of active misrepresentation,” as opposed to a failure to warn.  Id. at *5.  Express warranty escaped OPLA abrogation because it was a statutory claim, not common law.  Id. at *3 n.6. 

The marquee holding though was on express preemption.  The district court set forth the usual two-step analysis:  (1) Has the federal government established requirements applicable to the device?; and (2) if so, will state law impose requirements for that device that are different from or in addition to federal requirements on safety and effectiveness?  The court also, however, acknowledged the often-cited and poorly understood “parallel claim” exception, under which the MDA purportedly does not preempt a state from providing a damages remedy for claims premised on violations of FDA regulations.  Id. at *6. 

Whether you embrace the parallel claim exception or not (we do not), it did not help these plaintiffs.  The complaint alleged no way in which the device deviated from its specifications, and it was not sufficient for the plaintiffs to assert blithely that “discovery will uncover further details.”  Id. at *7.  The complaint similarly failed to allege any way in which the device had deviated from the FDA-approved design.  Somewhat quizzically, the plaintiffs argued that their claim would be “parallel” to federal claim if the device had deviated from the approved design.  But they alleged no such deviation.  The plaintiffs further alleged that the defendant failed to provide information about “comparative safety and efficacy; failed to perform adequate testing; and failed to warn adequately of “enhanced risk compared to other options.”  Id. at *8

These allegations did not state a claim for manufacturing defect, and the MDA preempted the design defect and warnings claims.  The FDA granted this device premarket approval under a process that required the FDA to conduct its own risk-benefit analysis.  The plaintiffs’ design defect claim thus was “a frontal attack[ ] on the risk/benefit analysis that led to the FDA to approve the device.”  Id. at *7 (citations omitted).  The warnings claims similarly threatened state requirements different from or in addition to federal requirements because the plaintiffs did not allege that the defendant had issued anything other than the FDA-approved warnings.  Id. at *8.  These are classic applications of MDA express preemption, as these plaintiffs were plainly trying to hold defendants to standards different from federal mandates. 

The plaintiffs’ express warranty claim fared no better.  The court expressed the view that a claim for breach of express warranty can avoid preemption where it alleges violations of federal requirements and where it “rest[s] on the defendant’s voluntary statements made separately from the FDA’s regulatory process.”  Id. at *9-*10.  We’re not totally sure what that latter part means, but it doesn’t matter.  These plaintiffs did not allege any details and did “not describe in any fashion what the express warranty made by Defendant[ ] was and how that express warranty could be enforced by Ohio law in a parallel fashion.”  Id. at *10 (citations omitted).  The claim for negligent misrepresentation was likewise “far too general to survive preemption under the MDA.”  Id. 

Plaintiffs received leave to amend for many of their claims, but not all.  We frankly are not sure what they can do with that dispensation, since they pleaded directly into preemption in the first place.  We will see.  

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Note: There is a table in this post that may be easier to view on a phone than on a computer.

Medical device preemption provides powerful protection from litigation involving Class III devices with premarket approval (or “PMA”). 

These devices are a very small subset of FDA-regulated medical devices – around 1% — and they are, by definition, cutting-edge.  They preserve health or protect life, but because they are so complex and novel and because medicine is still part art, they inherently involve risks.  Congress recognized that such devices thus required some protection from litigation—lest the burdens of litigation stifle innovation and drive essential devices off market.

In fact, Congress did not just intend to protect these devices from litigation judgments, they hoped to protect against even from the costs of discovery which alone can impose a considerable burden.  Preemption arguments are often appropriately upheld on motion to dismiss.

But not always.  Often enough to be frustrating, we encounter judges who reflexively deny motions to dismiss on preemption grounds.  Sometimes, the same judges eventually see the preemption light on summary judgment, and that is better than the defendant having to wait to get the problem fixed on appeal.  But we really wish courts would take preemption authorities to heart at the outset of a case, as Congress intended.

Today’s decision involves just that sort of scenario.  Last year, the Middle District of Alabama denied the defendants’ motions to dismiss raising federal preemption in Mack v CooperSurgical, Inc., 2023 U.S. Dist. LEXIS 51402, 2023 WL 2653365 (M.D. Ala. March 27, 2023) (Mack I).  Earlier this month, the same judge granted defendants’ motions for summary judgment on the same ground in Mack v. CooperSurgical, Inc., 2024 U.S. Dist. LEXIS 181699 (M.D. Ala. Oct. 4, 2024) (Mack II).  In the intervening 15 months, we are sure the parties spent tons and tons of unnecessary money on discovery, experts, and additional motions.

The Mack case involves an implanted contraceptive medical device known as Filshie Clips.  Blog readers know that contraceptive products are a litigation magnet, so you won’t be surprised to learn that we have discussed Filshie Clips before here, here, and here.

Filshie Clips are silicone-lined titanium medical devices used in tubal ligation procedures, to permanently block the fallopian tubes.  The FDA granted PMA for Filshie Clips in 1996, and has never suspended or withdrawn that approval.  As the Mack court noted, premarket approval includes FDA approval of device warnings and precautions which, for Filshie Clips, included a potential risk of clip migration of 0.13%.

The Mack plaintiff alleged that she experienced Filshie Clip migration-related symptoms soon after her 2017 implant procedure, with migration confirmed in 2020 when the Clips were explanted and a fallopian tube was removed, eventually followed by a complete hysterectomy.

Her complaint alleged that migration was occurring much more frequently than the FDA-approved warnings specified, “in over 25% of patients.”  The complaint alleged that defendants were aware of the higher rate of migration through adverse event reports that they allegedly failed to report to the FDA, and that they failed to update their “marketing materials” to advise physicians and patients about the higher rate.

The plaintiffs’ theories of liability did not change between the motion to dismiss phase and summary judgment, and to be frank, it also does not look like there is much difference between the well-pleaded facts assumed to be true on motion to dismiss and the undisputed evidence before the court on summary judgment.

So we put the relevant portions from the two opinions side-by-side to see if we could determine what was the inflection point for this judge, and nothing super-obvious jumps out at us.  The court makes the obligatory “on summary judgment plaintiff needs evidence” decree, employs some different language between the two opinions, and emphasizes some different authorities.  But we don’t see anything that should have precluded a preemption-based dismissal at the pleading stage while allowing it on summary judgment. 

What we do see are errors in Mack I more-or-less corrected in Mack II, without much discussion of why. Take a look:

Order Denying MTD/Mack IOrder Granting MSJ/Mack IIOur Commentary
Statement of Law re Express
Preemption
“The express preemption provision bars any claim based on a state law requirement ‘which is different from, or in addition to, any requirement’ under the MDA that ‘relates to the safety or effectiveness of the device’ or any other MDA requirement.”  [Godelia v. Doe 1, 881 F.3d 1309, 1317 (11th Cir. 2018)] (quoting 21 U.S.C. § 360k(a)). “State requirements are pre-empted under the MDA only to the extent that they are ‘different from, or in addition to’ the requirements imposed by federal law.” [Riegel v. Medtronic, Inc., 552 U.S. 312, 330  (2008)] (quoting 21 U.S.C. § 360k(a)). The MDA does not expressly preempt state law claims based upon “state duties [that] . . . ‘parallel,’ rather than add to, federal requirements.” Id. (citation omitted).The express preemption provision “does not allow a state to impose a requirement on a [medical device that has gone through the premarket approval process] that is ‘different from, or in addition to’ any federal requirement on the device.” Mink v. Smith & Nephew, Inc., 860 F.3d 1319, 1325 (11th Cir. 2017) (quoting 21 U.S.C. § 360k(a)). However, a “plaintiff’s state common law claims . . . [are] not preempted to the extent their claims parallel[] federal requirements.” Id. at 1326.Other than adopting the parallel claim rubric, this is a fair statement of what 21 U.S.C. § 360k(a), as interpreted by Riegel, means.
Application of Express PreemptionThe Macks’ state law claims are … not expressly preempted. This Court finds the district court’s decision in Blevins-Ellington v. Coopersurgical, Inc., No. 1:22-CV-00197-LMM, 2023 U.S. Dist. LEXIS 28936, 2023 WL 2111346, at *13 (N.D. Ga. Jan. 17, 2023), which reaches a similar conclusion as to Defendants’ liability under state law for injuries caused by Filshie Clips, persuasive and instructive on this point. Alabama law permits negligence and strict liability claims against product manufacturers and distributors that rest on common law duties owed to individuals…. Like the plaintiffs in Mink and Blevins-Ellington, the Macks have alleged violations of these state common law duties owed to them. … Among others, the Macks assert that the Defendants owed them a duty to prevent manufacturing and design defects, to warn of the risk of harm, and to exercise ordinary care, each of which the Macks connect to parallel federal requirements—for example, the requirement that the Defendants “obtain[] approval for changes in the design, manufacture, and warnings/marketing approved by the FDA.”The Macks do not argue and have not provided any evidence that the Defendants ever deviated from the FDA-approved warnings and instructions concerning Filshie Clips. In fact, their experts are quick to acknowledge that. . . . [T]he Macks consent to summary judgment on their manufacturing defect [claim]. . . . As to the Macks’ design defect theories of liability, the Macks do not provide evidence of any failure by the Defendants to adhere to the FDA-approved design of Filshie Clips. Their experts ([Dr. James] Wheeler, [Dr. Bruce] Rosenzweig and [Dr. Lisa] Harris) acknowledge as much.  Mack I seems to get side-tracked by the wrongly-decided Blevins-Ellington.  It blurs express and implied preemption concepts.  And the idea that needing federal approval for design or warning changes constitutes a parallel claim?  We don’t even understand what Mack I was trying to suggest with that. By contrast, Mack II gets it – did the defendant violate federal warning or design requirements in a way material to plaintiff’s theory of liability?  If not, the claim is expressly preempted.  Short and sweet.
Implied
Preemption Law
[Implied preemption] bars claims “that merely attempt to enforce duties owed to the FDA, so-called ‘fraud-on-the-FDA claims.'” Godelia, 881 F.3d at 1317 (citing Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 348, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001))). The MDA “leaves no doubt that it is the Federal Government rather than private litigants who are authorized to file suit for noncompliance with the medical device provisions.” Buckman, 531 U.S. at 349 n.4; 21 U.S.C. § 337(a). Causes of action not arising from “traditional state tort law which . . . predated the federal enactments in question[]” are preempted. See Buckman, 531 U.S. at 353. Specifically, actions arising “solely from the violation of [MDA] requirements,” are impliedly preempted because “Congress intended that the MDA be enforced exclusively by the Federal Government.” Id. at 352.  The implied preemption provision states, in relevant part: “[A]ll such proceedings for the enforcement, or to restrain violations, of [the FDCA] shall be by and in the name of the United States.” 21 U.S.C. § 337(a). This provision has been applied to so-called “fraud-on-the-FDA claims”—where the manufacturer makes misrepresentations or non-disclosures to the FDA. Mink, 860 F.3d at 1327 (quoting Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341, 353, 121 S. Ct. 1012, 148 L. Ed. 2d 854 (2001) (holding fraud-on-the-FDA claims are impliedly preempted because they “exist solely by virtue of the [Food, Drug, and Cosmetic Act’s] disclosure requirements”))). In sum, “traditional state-law tort claims survive implied preemption so long as they don’t seek to privately enforce a duty owed to the FDA.” Id.; see also Jacob v. Mentor Worldwide, LLC, 40 F.4th 1329, 1336 (11th Cir. 2022) (“Put another way: a plaintiff cannot seek to privately enforce a duty that is owed to the FDA.”). “So, even if a plaintiff’s claim is not expressly preempted, it is impliedly preempted if it is cognizable only because of duties owed to the FDA.” Jacob, 40 F.4th at 1336.  Both Mack I and Mack II discuss “MDA” (or “Medical Device Amendments”) implied preemption, which isn’t quite correct.  21 U.S.C. § 337(a) – which is the Food, Drug and Cosmetics Act’s “no private right of action” provision, is not located in the Medical Device Amendments, and thus isn’t limited to the medical device context.  Similarly, implied preemption principles are not limited to the medical device context. Otherwise, the statement of implied preemption law is a better organized in Mack II, perhaps suggesting a deeper understanding of the issue over time.
“Narrow Gap”As the Eleventh Circuit has recognized, “[t]aken together, these two types of preemption leave a ‘narrow gap’ through which plaintiffs making medical device claims must proceed.” Godelia, 881 F.3d at 1317 (citation omitted). “To make it through, a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption), but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).” Mink, 860 F.3d at 1327.These express and implied preemption provisions, operating in tandem, have created what some federal courts have described as a “narrow gap.” [Jacob, 40 F.4th at 1336] (quoting Mink, 860 F.3d at 1327 (11th Cir. 2017)). To make it through, “a plaintiff has to sue for conduct that violates a federal requirement (avoiding express preemption) but cannot sue only because the conduct violated that federal requirement (avoiding implied preemption).” Id. (quoting Mink, 860 F.3d at 1327)).  These statements about the “narrow gap” are similar enough, but neither Mack I nor Mack II really discuss or attempt to apply it to the case.
Failure
to Warn and “Fraud on the FDA”
[T]he Macks “acknowledged the risk of preemption and explicitly limited their pleadings to parallel violations of federal law.” See Blevins-Ellington, 2023 U.S. Dist. LEXIS 28936, 2023 WL 2111346, at *13; Mink, 860 F.3d at 1329. … [T]he Macks’ failure to warn claim is based on their contention that the Defendants had a continuing duty to warn the Macks regarding the Filshie Clips’ “unreasonable risk of migration” but failed to do so. … The Macks thus rely on “traditional state tort law which had predated the federal enactments,” see Buckman, 531 U.S. at 353, and their claims do not “implicate a duty owed to the FDA,” see Mink, 860 F.3d at 1330 (reaching a similar conclusion about Florida state law claims).While they do not affirmatively claim in their Complaint that the Defendants should have used more or different language in their FDA-approved warnings and instructions than those previously approved by the FDA, in their summary judgment briefing, they do seem to suggest that the Defendants should have.  For example, in arguing for application of fraudulent concealment and equitable tolling in opposing the Defendants’ statute of limitations assertions, the Macks repeatedly emphasize the Defendants’ alleged suppression of information (for example, that labeling should reflect a reported 25% migration rate and not a 0.13% rate) from physicians and the general public in the Instructions for Use that accompanied their Filshie Clip product in 2017. … This argument demonstrates that the Macks are indeed making state law claims based on a fraud-on-the-FDA theory and that Defendants’ warnings and labeling should have been different, i.e., reflecting different migration statistics and complications. Such claims clearly are preempted.The Court’s discussions of the complaint in the two opinions make it clear that if plaintiffs had been required to articulate the specifics of the alleged failure to warn at the pleading stage, or if the Court had looked at the complaint with a more rigorous eye, the complaint would have been held preempted on motion to dismiss.  Both opinions recognize that the plaintiffs’ contention was that the FDA-approved warning about a .13% risk of clip migration was too low, and any claim requiring a different warning is a squarely preempted claim.
“Failure to Report to FDA”[Defendants] insist that because the Macks allege in nearly every count that the Defendants failed to report adverse events about the Filshie Clips to the FDA, the Macks’ claims are impermissible “fraud-on-the-FDA” claims and therefore impliedly preempted. The Court is not persuaded. [Defendants’] focus on the allegations regarding the failure to report to the FDA ignores the other allegations that do not implicate a duty owed only to the FDA: that the Defendants owed common law duties to the Macks to not negligently design, manufacture, or fail to warn the Macks about the alleged dangers of the Filshie Clips. Reading the Complaint as a whole and construing it in the light most favorable to the Macks, the allegations regarding the failure to report to the FDA do not render the Macks’ claims impliedly preempted at this stage.The Macks further claim that the Defendants failed to report to the FDA, the Macks, and the medical community “the hundreds of adverse events reports they received from patients and medical professionals of instances where the migrating Filshie Clips …. [But Plaintiffs] point to no Alabama law that parallels the federal requirement to report adverse events to the FDA nor to any federal law that requires reporting of adverse events to the Macks or the medical community. Therefore, such an assertion here under the Macks’ state law theories would impose requirements on the Defendants that are different from or in addition to the requirements imposed by the FDA. . . . This “failure to report” theory of liability recently was addressed by the Eleventh Circuit in Mink. … The Eleventh Circuit held that this theory was impliedly preempted, stating: “Because this theory of liability is based on a duty to file a report with the FDA, it is very much like the ‘fraud-on-the FDA’ claim the Supreme Court held was impliedly preempted in Buckman.” . . . The Macks do not attempt to distinguish Mink, other than to say that [Mack I] previously refused to dismiss their claims under Mink at the motion to dismiss stage. … Like they did in their opposition to the Defendants’ motion to dismiss, they argue that their Complaint was “carefully drafted” to stay within the bounds of the MDA. … Despite how they couch it, their claims are now subject to an evidentiary standard, not self-described careful drafting. As such, the Macks must actually present evidence that their failure to warn claims consist of more than a failure to report adverse events to the FDA. Here, they have failed to do so.Mack I cannot be reconciled with Mack II in its treatment of an alleged failure to report to the FDA claim.  As Mack II recognized, that is a federal law duty, and there is no Alabama law equivalent. Mack II got it right, but its discussion of pleadings-versus-evidence doesn’t explain the different outcome, nor does its discussion of the “recent” Mink decision, which (as a 2017 opinion) predated Mack I as well. The right result, but too long in coming.
Design and Manufacturing Defect[T]he Macks’ design defect and manufacturing defect claims are based on their contentions that (1) the Filshie Clips used in Mrs. Mack were “defective in design” because their “risk of harm exceed[s] their claimed benefits,” specifically as it relates to the device’s alleged migration from the implantation site, … and (2) the Filshie Clips were “unreasonably dangerous” and “failed to perform as safely as the ordinary consumer would expect, causing injury[.”] …   The Macks thus rely on “traditional state tort law which had predated the federal enactments,” see Buckman, 531 U.S. at 353, and their claims do not “implicate a duty owed to the FDA,” see Mink, 860 F.3d at 1330.[I]t appears that the Macks’ design defect claims are premised upon the theory that the Defendants failed to make adequate disclosures to the FDA of adverse event reports about migration and complications. These claims focus on the Defendants’ alleged failure to disclose adverse events to the FDA both before and after premarketapproval.  And again, this is the type of fraud-on-the-FDA claim that the Supreme Court determined was preempted in Buckman, 531 U.S. at 343-44 (footnote omitted).As above, Mack II got it right, eventually.  But it doesn’t square with Mack I, and putting the defendants through the expense of litigating to summary judgment contravenes the intent Congress had in limiting liability involving medical devices.  

So there you have it.  A good outcome in Mack II, and unanswered questions about why it took so long.

Before we close out our discussion of the Mack saga, there are two side items worth mentioning.

First, the Court also granted summary judgment for Defendants on statute of limitations grounds.  We don’t talk about statutes of limitations often because they are fact-specific, but there is a legal angle to file away in your noggin:  Under Alabama law, a cause of action accrues when the first legal injury, and the discovery rule does not apply unless there was fraudulent concealment by the defendant, or a basis for equitable estoppel.  Those of us who practice in states where plaintiffs get the benefit of the discovery rule with any vague suggestion the plaintiff didn’t know of the injury or its cause may find Alabama’s standard refreshingly more rigorous.   “[P]laintiff’s ignorance of the tort or injury, at least if there is no fraudulent concealment by defendant, [does not] postpone the running of the statute until the tort or injury is discovered.”

And second, Alabama requires proof of a feasible alternative design for a design defect claim—but the alternative has to be an alternative device, not an alternative surgical procedure.  While acknowledging that they must show a safer, practical, alternative design was available to the Defendants at the time they manufactured Filshie Clips …, the Macks fail to proffer one. Instead, they only offer alternative methods of tubal ligation. … That is not the type of evidence needed to show that a safer, practical, alternative design was available to the Defendants.

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Here is a brief and happy follow up to our stupid expert tricks redux post.  That post by Bexis involved a purported talc plaintiff-side expert who authored what could charitably be called a “junk science” medical article (now two such articles) on cosmetic talc causation of mesothelioma.  This “research” (we grin as we write that word) was based on 33 anonymous asbestos claimants with, purportedly, “no known asbestos exposure” other than talc.  The prior post discussed how that basis for the article appears to be … well, there’s no polite way to say it … false.  

Last week we received a copy of In the Matter of Johnson & Johnson et al. v. Northwell Health Inc., 2024 WL 4438319(N.Y. Ct. App., 1st Dept. Oct. 8, 2024), a to-be-published case, in which the New York Appellate Division ordered the plaintiff expert (and her employer at the time) to comply with discovery revealing the names and information about all 33 of the subjects of her “scholarly” articles.  (Those quotation marks are appropriate because the word was used in the court’s opinion, but we apply them out of sheer irony and defense-hack surliness.)  This appellate decision overruled the lower court’s denial of a petition to enforce an out-of-state subpoena. The lower court quashed the subpoenas.  The doctor’s lawyers tried to save that result, and shield the subject information, by arguing that the lower court applied the correct legal standards and acted within its proper discretion. The appellate court disagreed.   

The appellate court had no problem ruling that the information sought was “clearly relevant” to the underlying personal injury action.  After all, the information went “directly to the credibility of these articles, which speak to the central issues in dispute and are relied on by three testifying experts, and whose author was to testify as an expert until she voluntarily withdrew.”  That withdrawal of the expert was clearly an effort to keep the lid on the information about the 33 subjects.  It didn’t work.

The expert’s arguments to quash the subpoena did not impress the appellate judges. First, the information sought was not HIPAA protected.  The subjects were never the good doctor’s patients. Second, the federal “common rule” involving protection of human research subjects did not apply, because of the exception for “secondary research based on publicly available identifiable private information.”  The burden was on the party opposing the subpoena to prove that the information sought had been produced in the underlying litigations subject to a protective order.  No such proof was forthcoming.  Third, production of the information “would not be unduly burdensome, nor is it likely to have a chilling effect on future medical research.”  The information sought “consists of just a few pages, is easily located, does not concern ongoing research, and does not reveal the unpublished thought processes of the researchers.”  Further, disclosure would be unlikely to “deter future research participation” because the subjects did not agree to be research subjects; rather their information had been previously released via public litigation. 

Score one for transparency and fairness.  Score one against junk science.  Praise is due to both the defense lawyers for unearthing this tawdry story of questionable science, and to the New York Appellate Division for allowing that story to be told.