No. 17–290. Argued January 7, 2019—Decided May 20, 2019
Petitioner Merck Sharp & Dohme Corp. manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. However, the mechanism through which Fosamax treats and prevents osteoporosis may increase the risk that patients will suffer “atypical femoral fractures,” that is, a rare type of complete, low-energy fracture that affects the thigh bone. When the Food and Drug Administration first approved of the manufacture and sale of Fosamax in 1995, the Fosamax label did not warn of the then-speculativerisk of atypical femoral fractures associated with the drug. But stronger evidence connecting Fosamax to atypical femoral fractures developed after 1995. And the FDA ultimately ordered Merck to add a warning about atypical femoral fractures to the Fosamax label in 2011. Respondents are more than 500 individuals who took Fosamax andsuffered atypical femoral fractures between 1999 and 2010. Respondents sued Merck seeking tort damages on the ground that statelaw imposed upon Merck a legal duty to warn respondents and their doctors about the risk of atypical femoral fractures associated withusing Fosamax. Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-empted by federal law. Merck conceded that the FDA regulations would have permitted Merck to try to change the label to add a warning before 2010, but Merck asserted that the FDA would have rejected that attempt.In particular, Merck claimed that the FDA’s rejection of Merck’s 2008 attempt to warn of a risk of “stress fractures” showed that the FDA would also have rejected any attempt by Merck to warn of the risk ofatypical femoral fractures associated with the drug. The District Court agreed with Merck’s pre-emption argument and
granted summary judgment to Merck, but the Third Circuit vacatedand remanded. The Court of Appeals recognized that its pre-emption analysis was controlled by this Court’s decision in Wyeth v. Levine, 555 U. S. 555, which held that a state-law failure-to-warn claim is pre-empted where there is “clear evidence” that the FDA would not have approved a change to the label. The Court of Appeals, however,suggested that the “clear evidence” standard had led to varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d 268, 284.
1. “Clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve a change tothe drug’s label to include that warning. Pp. 9–15.
The Wyeth Court undertook a careful review of the history of federal regulation of drugs and drug labeling and found both a reluctance by Congress to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associatedwith their drugs and an insistence by Congress that drug manufacturers bear the responsibility for the content of their drug labels. Accordingly, this Court held in Wyeth that “absent clear evidence that the FDA would not have approved a change” to the label, the Court“will not conclude that it was impossible . . . to comply with both federal and state requirements.” 555 U. S., at 571. Applying that ruleto the facts of that case, the Court said that Wyeth’s evidence of preemption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. And second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. Pp. 10–13.
Thus, in a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfystate law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug’s label to include that warning. These conclusions flow from this Court’s precedents on impossibility pre-emption and the statutory and regulatory scheme thatthe Court reviewed in Wyeth. See 555 U. S., at 578. In particular,this Court has refused to find clear evidence of impossibility wherethe laws of one sovereign permit an activity that the laws of the othersovereign restrict or even prohibit. And as explained in Wyeth, FDA
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regulations permit drug manufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association.” 21 CFR §314.70(c)(6)(iii)(A). Pp. 13–14.
(c) The only agency actions that can determine the answer to thepre-emption question are agency actions taken pursuant to the FDA’s congressionally delegated authority. The Supremacy Clause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And pre-emption takes place “ ‘only when and if [the agency] is acting within the scope of its congressionally delegated authority.’ ” New York v. FERC, 535 U. S. 1, 18 (some alterations omitted). P 15.
2. The question of agency disapproval is primarily one of law for a judge to decide. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped toevaluate the nature and scope of an agency’s determination, and are better suited to understand and to interpret agency decisions in light of the governing statutory and regulatory context. While contested brute facts will sometimes prove relevant to a court’s legal determination about the meaning and effect of an agency decision, such factual questions are subsumed within an already tightly circumscribed legal analysis and do not warrant submission alone or together with the larger pre-emption question to a jury. Pp. 15–17.
852 F. 3d 268, vacated and remanded.
BREYER, J., delivered the opinion of the Court, in which THOMAS, GINSBURG, SOTOMAYOR, KAGAN, and GORSUCH, JJ., joined. THOMAS, J., filed a concurring opinion. ALITO, J., filed an opinion concurring in thejudgment, in which ROBERTS, C. J., and KAVANAUGH, J., joined.

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NOTICE: This opinion is subject to formal revision before publication in thepreliminary print of the United States Reports. Readers are requested to notify the Reporter of Decisions, Supreme Court of the United States, Washington, D. C. 20543, of any typographical or other formal errors, in orderthat corrections may be made before the preliminary print goes to press.
No. 17–290
[May 20, 2019]
JUSTICE BREYER delivered the opinion of the Court. When Congress enacted the Federal Food, Drug, and
Cosmetic Act, ch. 675, 52 Stat. 1040, as amended, 21
U. S. C. §301 et seq., it charged the Food and Drug Administration with ensuring that prescription drugs are “safefor use under the conditions prescribed, recommended, orsuggested” in the drug’s “labeling.” §355(d). When the FDA exercises this authority, it makes careful judgmentsabout what warnings should appear on a drug’s label for the safety of consumers.
For that reason, we have previously held that “clear evidence” that the FDA would not have approved a changeto the drug’s label pre-empts a claim, grounded in statelaw, that a drug manufacturer failed to warn consumers of the change-related risks associated with using the drug.See Wyeth v. Levine, 555 U. S. 555, 571 (2009). We here determine that this question of pre-emption is one for a judge to decide, not a jury. We also hold that “clear evidence” is evidence that shows the court that the drugmanufacturer fully informed the FDA of the justificationsfor the warning required by state law and that the FDA, in
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turn, informed the drug manufacturer that the FDA would not approve a change to the drug’s label to include that warning.
I The central issue in this case concerns federal preemption, which as relevant here, takes place when it is“‘impossible for a private party to comply with both stateand federal requirements.’” Mutual Pharmaceutical Co. v. Bartlett, 570 U. S. 472, 480 (2013). See also U. S. Const., Art. VI, cl. 2. The state law that we consider is state common law or state statutes that require drug manufacturers to warn drug consumers of the risks associated withdrugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulatesthe information that appears on brand-name prescriptiondrug labels. The alleged conflict between state and federallaw in this case has to do with a drug that was manufactured by petitioner Merck Sharp & Dohme and was administered to respondents without a warning of certainassociated risks.
A The FDA regulates the safety information that appearson the labels of prescription drugs that are marketed in the United States. 21 U. S. C. §355(b)(1)(F); 21 CFR§201.57(a) (2018). Although we commonly understand a drug’s “label” to refer to the sticker affixed to a prescription bottle, in this context the term refers more broadly to the written material that is sent to the physician whoprescribes the drug and the written material that comeswith the prescription bottle when the drug is handed to the patient at the pharmacy. 21 U. S. C. §321(m). These (often lengthy) package inserts contain detailed information about the drug’s medical uses and health risks. §355(b)(1)(F); 21 CFR §201.57(a).
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FDA regulations set out requirements for the content, the format, and the order of the safety information on the drug label. §201.57(c). Those regulations require druglabels to include, among other things: (1) prominent “boxed” warnings about risks that may lead to death or serious injury; (2) contraindications describing any situation in which the drug should not be used because the riskof use outweighs any therapeutic benefit; (3) warnings and precautions about other potential safety hazards; and
(4) any adverse reactions for which there is some basis to believe a causal relationship exists between the drug and the occurrence of the adverse event. Ibid.
As those requirements make clear, the category inwhich a particular risk appears on a drug label is anindicator of the likelihood and severity of the risk. The hierarchy of label information is designed to “preventoverwarning” so that less important information does not “overshadow” more important information. 73 Fed. Reg. 49605–49606 (2008). It is also designed to exclude “[e]xaggeration of risk, or inclusion of speculative or hypothetical risks,” that “could discourage appropriate use of a beneficial drug.” Id., at 2851.
Prospective drug manufacturers work with the FDA to develop an appropriate label when they apply for FDA approval of a new drug. 21 U. S. C. §§355(a), 355(b),355(d)(7); 21 CFR §314.125(b)(6). But FDA regulationsalso acknowledge that information about drug safety may change over time, and that new information may requirechanges to the drug label. §§314.80(c), 314.81(b)(2)(i). Drug manufacturers generally seek advance permissionfrom the FDA to make substantive changes to their druglabels. However, an FDA regulation called the “changesbeing effected” or “CBE” regulation permits drug manufacturers to change a label without prior FDA approval if the change is designed to “add or strengthen a . . . warning”where there is “newly acquired information” about the
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“evidence of a causal association” between the drug and a risk of harm. 21 CFR §314.70(c)(6)(iii)(A).
B Petitioner Merck Sharp & Dohme manufactures Fosamax, a drug that treats and prevents osteoporosis in postmenopausal women. App. 192; In re Fosamax (Alendronate Sodium) Products Liability Litigation, 852 F. 3d 268, 271, 274–275 (CA3 2017). Fosamax belongs to a classof drugs called “bisphosphonates.” Fosamax and other bisphosphonates work by affecting the “bone remodeling process,” that is, the process through which bones are continuously broken down and built back up again. App.102, 111. For some postmenopausal women, the two parts of the bone remodeling process fall out of sync; the body removes old bone cells faster than it can replace them.That imbalance can lead to osteoporosis, a disease that is characterized by low bone mass and an increased risk ofbone fractures. Fosamax (like other bisphosphonates)slows the breakdown of old bone cells and thereby helps postmenopausal women avoid osteoporotic fractures. Id., at 102. However, the mechanism through which Fosamax decreases the risk of osteoporotic fractures may increase therisk of a different type of fracture. Id., at 400–444, 661–
663. That is because all bones—healthy and osteoporoticalike—sometimes develop microscopic cracks that are not due to any trauma, but are instead caused by the mechanical stress of everyday activity. Id., at 102. Those so-called “stress fractures” ordinarily heal on their own through the bone remodeling process. But, by slowing the breakdown of old bone cells, Fosamax and other bisphosphonates may cause stress fractures to progress to complete breaks that cause great pain and require surgical intervention to repair. Id., at 106–109, 139, 144–145. When that rare type of complete, low-energy fracture
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affects the thigh bone, it is called an “atypical femoral fracture.” Id., at 101.
The Fosamax label that the FDA approved in 1995 did not warn of the risk of atypical femoral fractures. 852
F. 3d, at 274–275. At that time, Merck’s scientists were aware of at least a theoretical risk of those fractures. Indeed, as far back as 1990 and 1991, when Fosamax was undergoing preapproval clinical trials, Merck scientists expressed concern in internal discussions that Fosamaxcould inhibit bone remodeling to such a “‘profound’” degree that “inadequate repair may take place” and “‘microfractures would not heal.’” App. 111–113. When Merck applied to the FDA for approval of Fosamax, Merck brought those theoretical considerations to the FDA’s attention. 852 F. 3d, at 274–275. But, perhaps because the concerns were only theoretical, the FDA approved Fosamax’s label without requiring any mention of this risk. Ibid.
Evidence connecting Fosamax to atypical femoral fractures developed after 1995. Merck began receiving adverse event reports from the medical community indicating that long-term Fosamax users were suffering atypical femoral fractures. App. 122–125. For example, Merckreceived a report from a doctor who said that hospital staffhad begun calling atypical femoral fractures the “‘Fosamax Fracture’” because “‘100% of patients in his practice who have experienced femoral fractures (without being hit by a taxicab), were taking Fosamax . . . for over 5 years. ’” Id., at 126. Merck performed a statistical analysis of Fosamax adverse event reports, concluding that these reports revealed a statistically significant incidence offemur fractures. 3 App. in No. 14–1900 (CA3), pp. A1272– A1273, A1443. And about the same time, Merck began to see numerous scholarly articles and case studies documenting possible connections between long-term Fosamax use and atypical femoral fractures. App. 106–110, 116–
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In 2008, Merck applied to the FDA for preapproval tochange Fosamax’s label to add language to both the “Adverse Reaction[s]” and the “Precaution[s]” sections of thelabel. Id., at 670. In particular, Merck proposed adding a reference to “‘low-energy femoral shaft fracture’” in theAdverse Reactions section, and cross-referencing a longerdiscussion in the Precautions section that focused on the risk of stress fractures associated with Fosamax. Id., at
728. The FDA approved the addition to the Adverse Reactions section, but rejected Merck’s proposal to warn of a risk of “stress fractures.” Id., at 511–512. The FDA explained that Merck’s “justification” for the proposedchange to the Precautions section was “inadequate,” because “[i]dentification of ‘stress fractures’ may not be clearly related to the atypical subtrochanteric fracturesthat have been reported in the literature.” Id., at 511. The FDA invited Merck to “resubmit” its application and to “fully address all the deficiencies listed.” Id., at 512; see 21 CFR §314.110(b). But Merck instead withdrew its application and decided to make the changes to the Adverse Reactions section through the CBE process. App.654–660. Merck made no changes to the Precautionssection at issue here. Id., at 274.
A warning about “atypical femoral fractures” did notappear on the Fosamax label until 2011, when the FDA ordered that change based on its own analyses. Id., at 246–252, 526–534. Merck was initially resistant to the change, proposing revised language that, once again,referred to the risk of “stress fractures.” Id., at 629–634. But the FDA, once again, rejected that language. And this time, the FDA explained that “the term ‘stress fracture’ was considered and was not accepted” because, “for most practitioners, the term ‘stress fracture’ represents a minorfracture and this would contradict the seriousness of the atypical femoral fractures associated with bisphosphonate
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use.” Id., at 566. In January 2011, Merck and the FDA ultimately agreed upon adding a three-paragraph discussion of atypical femoral fractures to the Warnings and Precautions section of the Fosamax label. Id., at 223–224. The label now refers to the fractures five times as “atypical” without using the term “stress fracture.” Ibid.
C The respondents here are more than 500 individuals who took Fosamax and who suffered atypical femoralfractures between 1999 and 2010. Brief for Respondents
7. Respondents, invoking federal diversity jurisdiction, filed separate actions seeking tort damages on the groundthat, during the relevant period, state law imposed uponMerck a legal duty to warn them and their doctors aboutthe risk of atypical femoral fractures associated with usingFosamax. Id., at 1. One respondent, for example, filed a complaint alleging that she took Fosamax for roughly 10years and suffered an atypical femoral fracture. One dayin 2009, when the respondent was 70 years old, she turned to unlock the front door of her house, heard a poppingsound, and suddenly felt her left leg give out beneath her.She needed surgery, in which doctors repaired her leg witha rod and screws. She explained she would not have usedFosamax for so many years if she had known that she might suffer an atypical femoral fracture as a result. See id., at 18–19.
Merck, in defense, argued that respondents’ state-law failure-to-warn claims should be dismissed as pre-emptedby federal law. Both Merck and the FDA have long been aware that Fosamax could theoretically increase the riskof atypical femoral fractures. But for some period of timebetween 1995 (when the FDA first approved a drug label for Fosamax) and 2010 (when the FDA decided to requireMerck to add a warning about atypical femoral fracturesto Fosamax’s label), both Merck and the FDA were unsure
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whether the developing evidence of a causal link between Fosamax and atypical femoral fractures was strongenough to require adding a warning to the Fosamax druglabel. Merck conceded that the FDA’s CBE regulationwould have permitted Merck to try to change the label toadd a warning before 2010, but Merck asserted that the FDA would have rejected that attempt. In particular,Merck pointed to the FDA’s rejection of Merck’s 2008 attempt to amend the Fosamax label to warn of the risk of “stress fractures” associated with Fosamax. On that basis, Merck claimed that federal law prevented Merck from complying with any state-law duty to warn the respondents of the risk of atypical femoral fractures associatedwith Fosamax.
The District Court agreed with Merck’s pre-emption argument and granted summary judgment to Merck, In re Fosamax (Alendronate Sodium): Products Liability Litigation, 2014 WL 1266994, *17 (D NJ, Mar. 22, 2017), but theCourt of Appeals vacated and remanded, 852 F. 3d, at 302.The Court of Appeals concluded that its pre-emption analysis was controlled by this Court’s decision in Wyeth. Ibid. The Court of Appeals understood that case as making clear that a failure-to-warn claim grounded in state law is pre-empted where there is “‘clear evidence that the FDA would not have approved a change to the . . . label.’” Id., at 280 (quoting Wyeth, 555 U. S., at 571). The Court of Appeals, however, suggested that this statement had ledto varying lower court applications and that it would be helpful for this Court to “clarif[y] or buil[d] out the doctrine.” 852 F. 3d, at 284.
In attempting to do so itself, the Court of Appeals held that “the Supreme Court intended to announce a standard of proof when it used the term ‘clear evidence’ in Wyeth.” Ibid. That is, the Court of Appeals believed that “[t]heterm ‘clear evidence’ . . . does not refer directly to the typeof facts that a manufacturer must show, or to the circumCite
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stances in which preemption will be appropriate.” Id., at
285. “Rather, it specifies how difficult it will be for the manufacturer to convince the factfinder that the FDA would have rejected a proposed label change.” Ibid. And in the Court of Appeals’ view, “for a defendant to establisha preemption defense under Wyeth, the factfinder must conclude that it is highly probable that the FDA would not have approved a change to the drug’s label.” Id., at 286. Moreover and importantly, the Court of Appeals also held that “whether the FDA would have rejected a proposed label change is a question of fact that must be answered by a jury.” Ibid.
Merck filed a petition for a writ of certiorari. Merck’s petition asked the Court to decide whether Merck’s case and others like it “must . . . go to a jury” to determine whether the FDA, in effect, has disapproved a state-lawrequired labeling change. In light of differences and uncertainties among the courts of appeals and state supreme courts in respect to the application of Wyeth, we granted certiorari. See, e.g., Mason v. SmithKline Beecham Corp., 596 F. 3d 387, 391 (CA7 2010) (“The Supreme Court . . . did not clarify what constitutes ‘clear evidence’”); Reckis v. Johnson & Johnson, 471 Mass. 272, 286, 28 N. E. 3d 445, 457 (2015) (“Wyeth did not define ‘clear evidence’ . . . ” (some internal quotation marks omitted)).
II We stated in Wyeth v. Levine that state law failure-towarn claims are pre-empted by the Federal Food, Drug, and Cosmetic Act and related labeling regulations when there is “clear evidence” that the FDA would not have approved the warning that state law requires. 555 U. S., at 571. We here decide that a judge, not the jury, must decide the pre-emption question. And we elaborate Wyeth’s requirements along the way.
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A We begin by describing Wyeth. In that case, the plaintiffdeveloped gangrene after a physician’s assistant injected her with Phenergan, an antinausea drug. The plaintiffbrought a state-law failure-to-warn claim against Wyeth,the drug’s manufacturer, for failing to provide an adequatewarning about the risks that accompany various methods of administering the drug. In particular, the plaintiff claimed that directly injecting Phenergan into a patient’s vein (the “IV-push” method of administration) creates a significant risk of catastrophic consequences. And those consequences could be avoided by introducing the druginto a saline solution that slowly descends into a patient’s vein (the “IV-drip” method of administration). A juryconcluded that Wyeth’s warning label was inadequate, and that the label’s inadequacy caused the plaintiff ’s injury.On appeal, Wyeth argued that the plaintiff ’s state-law failure-to-warn claims were pre-empted because it wasimpossible for Wyeth to comply with both state law dutiesand federal labeling obligations. The Vermont Supreme Court rejected Wyeth’s pre-emption claim. Id., at 563. We too considered Wyeth’s pre-emption argument, and we too rejected it. In rejecting Wyeth’s argument, we undertook a careful review of the history of federal regulation of drugs and drug labeling. Id., at 566–568. In doingso, we “assum[ed] that the historic police powers of theStates were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress.” Id., at 565 (internal quotation marks omitted). And we found nothing within that history to indicate that the FDA’s power to approve or to disapprove labeling changes, by itself, pre-empts state law.Rather, we concluded that Congress enacted the FDCA“to bolster consumer protection against harmful products;”that Congress provided no “federal remedy for consumersharmed by unsafe or ineffective drugs”; that Congress was
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“awar[e] of the prevalence of state tort litigation;” andthat, whether Congress’ general purpose was to protectconsumers, to provide safety-related incentives to manufacturers, or both, language, history, and purpose allindicate that “Congress did not intend FDA oversight to bethe exclusive means of ensuring drug safety and effectiveness.” Id., at 574–575 (emphasis added). See also id., at 574 (“If Congress thought state-law suits posed an obstacle to its objectives, it surely would have enacted an express pre-emption provision at some point during theFDCA’s 70-year history”).
We also observed that “through many amendments tothe FDCA and to FDA regulations, it has remained a central premise of federal drug regulation that the manufacturer bears responsibility for the content of its label at all times.” Id., at 570–571. A drug manufacturer “is charged both with crafting an adequate label and withensuring that its warnings remain adequate as long as the drug is on the market.” Id., at 571. Thus, when the risks of a particular drug become apparent, the manufacturerhas “a duty to provide a warning that adequately describe[s] that risk.” Ibid. “Indeed,” we noted, “prior to2007, the FDA lacked the authority to order manufacturers to revise their labels.” Ibid. And even when “Congressgranted the FDA this authority,” in the 2007 Amendments to the FDCA, Congress simultaneously “reaffirmed the manufacturer’s obligations and referred specifically to theCBE regulation, which both reflects the manufacturer’s ultimate responsibility for its label and provides a mechanism for adding safety information to the label prior toFDA approval.” Ibid.
In light of Congress’ reluctance to displace state laws that would penalize drug manufacturers for failing to warn consumers of the risks associated with their drugs,and Congress’ insistence on requiring drug manufacturers to bear the responsibility for the content of their drug
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labels, we were unpersuaded by Wyeth’s pre-emption argument. In Wyeth’s case, we concluded, “when the riskof gangrene from IV-push injection of Phenergan becameapparent, Wyeth had a duty” under state law “to provide a warning that adequately described that risk, and the CBEregulation permitted it to provide such a warning beforereceiving the FDA’s approval.” Ibid.
At the same time, and more directly relevant here, we pointed out that “the FDA retains authority to rejectlabeling changes made pursuant to the CBE regulation in its review of the manufacturer’s supplemental application, just as it retains such authority in reviewing all supplemental applications.” Ibid. We then said that, nonetheless, “absent clear evidence that the FDA would not have approved a change to Phenergan’s label, we will not conclude that it was impossible for Wyeth to comply with bothfederal and state requirements.” Ibid. (emphasis added).
We reviewed the record and concluded that “Wyeth has offered no such evidence.” Id., at 572. We said that Wyeth’s evidence of pre-emption fell short for two reasons. First, the record did not show that Wyeth “supplied the FDA with an evaluation or analysis concerning the specific dangers” that would have merited the warning. Id., at 572–573. We could find “no evidence in this record that either the FDA or the manufacturer gave more than passing attention to the issue of IV-push versus IV-drip administration”—the matter at issue in the case. Id., at 572 (internal quotation marks omitted). Second, the record did not show that Wyeth “attempted to give the kind of warning required by [state law] but was prohibited from doing so by the FDA.” Ibid., and n. 5. The “FDA had not made an affirmative decision to preserve” the warning asit was or “to prohibit Wyeth from strengthening its warning.” Id., at 572. For those reasons, we could not “credit Wyeth’s contention that the FDA would have prevented it from adding a stronger warning about the IV-push method
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of intravenous administration.” And we could not conclude that “it was impossible for Wyeth to comply withboth federal and state requirements.” Id., at 573. We acknowledged that meeting the standard we set forth would be difficult, but, we said, “[i]mpossibility preemption is a demanding defense.” Ibid.
B The underlying question for this type of impossibility pre-emption defense is whether federal law (includingappropriate FDA actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law. And, of course, in order to succeed with that defense the manufacturer must show that the answer to this question is yes. But in Wyeth, we confronted that question in the context of a particular setof circumstances. Accordingly, for purposes of this case,we assume—but do not decide—that, as was true of the warning at issue in Wyeth, there is sufficient evidence to find that Merck violated state law by failing to add a warning about atypical femoral fractures to the Fosamaxlabel. In a case like Wyeth, showing that federal law prohibited the drug manufacturer from adding a warning that would satisfy state law requires the drug manufacturer to show that it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that theFDA would not approve changing the drug’s label to include that warning.These conclusions flow from our precedents on impossibility pre-emption and the statutory and regulatory scheme that we reviewed in Wyeth. See 555 U. S., at 578. In particular, “it has long been settled that state laws thatconflict with federal law are without effect.” Mutual Pharmaceutical Co., 570 U. S., at 480. But as we have cautioned many times before, the “possibility of impossibil14
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ity [is] not enough.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 625, n. 8 (2011) (internal quotation marks omitted). Consequently, we have refused to find clear evidence of such impossibility where the laws of one sovereign permit an activity that the laws of the other sovereign restrict oreven prohibit. See, e.g., Barnett Bank of Marion Cty.,
N. A. v. Nelson, 517 U. S. 25, 31 (1996); Michigan Canners & Freezers Assn., Inc. v. Agricultural Marketing and Bargaining Bd., 467 U. S. 461, 478, and n. 21 (1984).
And, as we explained in Wyeth, 555 U. S., at 571–573, federal law—the FDA’s CBE regulation—permits drugmanufacturers to change a label to “reflect newly acquired information” if the changes “add or strengthen a . . . warning” for which there is “evidence of a causal association,” without prior approval from the FDA. 21 CFR §314.70(c)(6)(iii)(A). Of course, the FDA reviews CBE submissions and can reject label changes even after themanufacturer has made them. See §§314.70(c)(6), (7). And manufacturers cannot propose a change that is not based on reasonable evidence. §314.70(c)(6)(iii)(A). But in the interim, the CBE regulation permits changes, so adrug manufacturer will not ordinarily be able to show thatthere is an actual conflict between state and federal law such that it was impossible to comply with both.
We do not further define Wyeth’s use of the words “clear evidence” in terms of evidentiary standards, such as “preponderance of the evidence” or “clear and convincing evidence” and so forth, because, as we shall discuss, infra, at 15–17, courts should treat the critical question not as a matter of fact for a jury but as a matter of law for thejudge to decide. And where that is so, the judge must simply ask himself or herself whether the relevant federal and state laws “irreconcilably conflic[t].” Rice v. Norman Williams Co., 458 U. S. 654, 659 (1982); see ibid. (“Theexistence of a hypothetical or potential conflict is insufficient to warrant the pre-emption of the state statute”).
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Opinion of the Court
We do note, however, that the only agency actions thatcan determine the answer to the pre-emption question, of course, are agency actions taken pursuant to the FDA’scongressionally delegated authority. The SupremacyClause grants “supreme” status only to the “the Laws of the United States.” U. S. Const., Art. VI, cl. 2. And preemption takes place “‘only when and if [the agency] isacting within the scope of its congressionally delegatedauthority, . . . for an agency literally has no power to act,let alone pre-empt the validly enacted legislation of a sovereign State, unless and until Congress confers power upon it.’” New York v. FERC, 535 U. S. 1, 18 (2002) (some alterations omitted). Federal law permits the FDA to communicate its disapproval of a warning by means of notice-and-comment rulemaking setting forth labelingstandards, see, e.g., 21 U. S. C. §355(d); 21 CFR §§201.57,314.105; by formally rejecting a warning label that would have been adequate under state law, see, e.g., 21 CFR §§314.110(a), 314.125(b)(6); or with other agency actioncarrying the force of law, cf., e.g., 21 U. S. C. §355(o)(4)(A). The question of disapproval “method” is not now before us.And we make only the obvious point that, whatever the means the FDA uses to exercise its authority, those meansmust lie within the scope of the authority Congress has lawfully delegated.
III We turn now to what is the determinative questionbefore us: Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a questionof law, normally for a judge to decide without a jury?The complexity of the preceding discussion of the law helps to illustrate why we answer this question by concluding that the question is a legal one for the judge, not ajury. The question often involves the use of legal skills todetermine whether agency disapproval fits facts that are
Opinion of the Court
not in dispute. Moreover, judges, rather than lay juries,are better equipped to evaluate the nature and scope of anagency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize itsconsidered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges arebetter suited than are juries to understand and to interpret agency decisions in light of the governing statutoryand regulatory context. Cf. 5 U. S. C. §706 (specifying that a “reviewing court,” not a jury, “shall . . . determine the meaning or applicability of the terms of an agencyaction”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questionsrespecting the . . . terms of any agency action” and its“application” are “questions of law”). To understand the question as a legal question for judges makes sense giventhe fact that judges are normally familiar with principles of administrative law. Doing so should produce greateruniformity among courts; and greater uniformity is normally a virtue when a question requires a determination concerning the scope and effect of federal agency action. Cf. Markman, 517 U. S., at 390–391.
We understand that sometimes contested brute facts will prove relevant to a court’s legal determination about the meaning and effect of an agency decision. For example, if the FDA rejected a drug manufacturer’s supplemental application to change a drug label on the ground that the information supporting the application was insufficient to warrant a labeling change, the meaning and scope of that decision might depend on what information the FDA had before it. Yet in litigation between a drugconsumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision),the litigants may dispute whether the drug manufacturersubmitted all material information to the FDA.
17 Cite as: 587 U. S. ____ (2019)
Opinion of the Court
But we consider these factual questions to be subsumed within an already tightly circumscribed legal analysis. And we do not believe that they warrant submission alone or together with the larger pre-emption question to a jury.Rather, in those contexts where we have determined that the question is “for the judge and not the jury,” we have also held that “courts may have to resolve subsidiaryfactual disputes” that are part and parcel of the broader legal question. Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc., 574 U. S. ___, ___–___ (2015) (slip op., at 6– 7). And, as in contexts as diverse as the proper construction of patent claims and the voluntariness of criminal confessions, they create a question that “‘falls somewherebetween a pristine legal standard and a simple historicalfact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circum-stances, “‘the fact/law distinction at times has turned on adetermination that, as a matter of the sound administration of justice, one judicial actor is better positioned thananother to decide the issue in question.’” Markman, 517
U. S., at 388 (quoting Miller, 474 U. S., at 114). In this context, that “better positioned” decisionmaker is the judge.
IV Because the Court of Appeals treated the pre-emption question as one of fact, not law, and because it did not have an opportunity to consider fully the standards wehave described in Part II of our opinion, we vacate its judgment and remand the case to that court for furtherproceedings consistent with this opinion.
It is so ordered.
Cite as: 587 U. S. ____ (2019) 1
THOMAS, J., concurring
No. 17–290
[May 20, 2019]
JUSTICE THOMAS, concurring. I join the Court’s opinion and write separately to explainmy understanding of the relevant pre-emption principles and how they apply to this case. The Supremacy Clause of the Constitution provides: “This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall bebound thereby, any Thing in the Constitution or Laws of any State to the Contrary notwithstanding.” Art. VI, cl. 2.
Under this Clause, “[w]here state and federal law ‘directlyconflict,’ state law must give way.” PLIVA, Inc. v. Mensing, 564 U. S. 604, 617 (2011). Although the Court has articulated several theories of pre-emption, Merck’s sole argument here is that state law is pre-empted because it is impossible for Merck to comply with federal and state law.I remain skeptical that “physical impossibility” is a proper test for deciding whether a direct conflict exists between federal and state law. But even under our impossibility precedents, Merck’s pre-emption defense fails.
THOMAS, J., concurring
I As I have explained before, it is not obvious that the “‘physical impossibility’ standard is the best proxy for determining when state and federal laws ‘directly conflict’ for purposes of the Supremacy Clause.” Wyeth v. Levine, 555 U. S. 555, 590 (2009) (opinion concurring in judgment). Evidence from the founding suggests that, underthe original meaning of the Supremacy Clause, federal law pre-empts state law only if the two are in logical contradiction. See ibid.; Nelson, Preemption, 86 Va. L. Rev. 225, 260–261 (2000). Sometimes, federal law will logically contradict state law even if it is possible for a person to comply with both. For instance, “if federal law gives an individual the right to engage in certain behavior that state law prohibits, the laws would give contradictorycommands notwithstanding the fact that an individual could comply with both by electing to refrain from the covered behavior.” Wyeth, 555 U. S., at 590 (opinion of THOMAS, J.). Merck does not advance this logical-contradictionstandard, and it is doubtful that a pre-emption defense along these lines would succeed here. “To say, as thestatute does, that [Merck] may not market a drug withoutfederal approval (i.e., without [a Food and Drug Administration (FDA)] approved label) is not to say that federal approval gives [Merck] the unfettered right, for all time, to market its drug with the specific label that was federallyapproved.” Id., at 592. Nothing in the federal brand-name-drug “statutory or regulatory scheme necessarilyinsulates [Merck] from liability under state law simplybecause the FDA has approved a particular label.” Id., at
593. The relevant question would be whether federal law gives Merck “an unconditional right to market [a] federally approved drug at all times with the precise label initially approved by the FDA,” id., at 592, or whether it instead provides a federal floor that can be supplemented by difCite
as: 587 U. S. ____ (2019) 3
THOMAS, J., concurring
ferent state standards, see Brief for Cato Institute as Amicus Curiae 14, n. 4. Absent a federal statutory right tosell a brand-name drug with an FDA-approved label, FDA approval “does not represent a finding that the drug, aslabeled, can never be deemed unsafe by later federalaction, or as in this case, the application of state law.” Wyeth, supra, at 592 (opinion of THOMAS, J.).
II Applying the Court’s impossibility precedents leads tothe same conclusion. The question for impossibility iswhether it was “lawful under federal law for [Merck] to dowhat state law required of ” it. Mensing, 564 U. S., at 618. Because “[p]re-emption analysis requires us to compare federal and state law,” I “begin by identifying the [relevant] state tort duties and federal labeling requirements.” Id., at 611. Respondents’ claim here is “that state lawobligated Merck to add a warning about atypical femur fractures” to the Warnings and Precautions section of Fosamax’s label. In re Fosamax (Alendronate Sodium) Prods. Liability Litig., 852 F. 3d 268, 282 (CA3 2017).Under the Federal Food, Drug, and Cosmetic Act, a manufacturer of a brand-name drug “bears responsibility for thecontent of its label at all times.” Wyeth, 555 U. S., at 570– 571 (majority opinion). The manufacturer “is charged both with crafting an adequate label and with ensuringthat its warnings remain adequate as long as the drug is on the market.” Id., at 571. Generally, to propose labeling changes, the manufacturer can submit a Prior ApprovalSupplement (PAS) application, which requires FDA approval before the changes are made. 21 CFR §314.70(b)(2018). Alternatively, under the FDA’s Changes Being Effected (CBE) regulation, if the manufacturer would liketo change a label to “add or strengthen a contraindication,warning, precaution, or adverse reaction” “to reflect newlyacquired information,” it can change the label immediately
THOMAS, J., concurring
upon filing its supplemental application with the FDA,without waiting for FDA approval. §314.70(c)(6)(iii); see Wyeth, supra, at 568. If the FDA later disapproves theCBE application, “it may order the manufacturer to cease distribution of the drug product(s)” with the new labeling.§314.70(c)(7).
Here, Merck’s impossibility pre-emption defense failsbecause it does not identify any federal law that “prohibited [it] from adding any and all warnings . . . that would satisfy state law.” Ante, at 13. By its reference to “the Laws of the United States,” the Supremacy Clause “requires that pre-emptive effect be given only to those federal standards and policies that are set forth in, or necessarily follow from, the statutory text that was produced through the constitutionally required bicameral and presentmentprocedures.” Wyeth, supra, at 586 (opinion of THOMAS, J.).Merck’s primary argument, based on various agency communications, is that the FDA would have rejected a hypothetical labeling change submitted via the CBE process.But neither agency musings nor hypothetical future rejections constitute pre-emptive “Laws” under the SupremacyClause.
As the Court describes, in 2008 Merck submitted PAS applications to add certain language regarding fractures tothe Adverse Reactions and the Warnings and Precautions sections of Fosamax’s label. Ante, at 6. In 2009, the FDA sent Merck a “complete response” letter “agree[ing] thatatypical and subtrochanteric fractures should be added” tothe Adverse Reactions section. App. 510–511. But the letter said that Merck’s proposed Warnings and Precautions language, which focused on “the risk factors for stressfractures,” was “inadequate” because “[i]dentification of‘stress fractures’ may not be clearly related to the atypicalsubtrochanteric fractures that have been reported in theliterature.” Id., at 511. In accord with FDA regulations, the letter required Merck to take one of three actions: (1)
Cite as: 587 U. S. ____ (2019) 5
THOMAS, J., concurring
“[r]esubmit the application . . . , addressing all deficienciesidentified in the complete response letter”; (2) “[w]ithdraw the application . . . without prejudice to a subsequent submission”; or (3) “[a]sk the agency to provide . . . an opportunity for a hearing,” after which “the agency will either approve” or “refuse to approve the application.” 21 CFR §314.110(b); see App. 512. As this regulation suggests and the FDA has explained, complete response letters merely “infor[m] sponsors of changes that must be made before an application can be approved, with no implication as to the ultimate approvability of the application.” 73 Fed. Reg. 39588 (2008) (emphasis added). In other words, the 2009 letter neither marked “the consummation of the agency’s decisionmaking process” nor determined Merck’s “rights or obligations.” Bennett v. Spear, 520 U. S. 154, 178 (1997) (internal quotation marks omitted). Instead, it was “of a merely tentative or interlocutorynature.” Ibid. Therefore, the letter was not a final agencyaction with the force of law, so it cannot be “Law” with pre-emptive effect.
Merck’s argument that the 2009 letter and other agency communications suggest that the FDA would have denied a future labeling change fares no better: hypotheticalagency action is not “Law.” As Merck acknowledges, itcould have resubmitted its PAS applications, sought a hearing, or changed its label at any time through the CBE process. See Reply Brief 13. Indeed, when Merck instead decided to withdraw its PAS applications, it added atypical femoral fractures to the Adverse Reactions section through the CBE process. That process also enabledMerck to add language to the Warnings and Precautionssection, but Merck did not do so. If it had, it could have satisfied its federal and alleged state-law duties—meaning that it was possible for Merck to independently satisfyboth sets of duties. Merck’s belief that the FDA would have eventually rejected a CBE application does not make
THOMAS, J., concurring
an earlier CBE change impossible. As the Court correctly explains, “‘the possibility of impossibility [is] not enough.’” Ante, at 13–14. The very point of the CBE process is that a manufacturer can “unilaterally” make a labeling changethat does not violate other federal law, Wyeth, 555 U. S., at 573; see id., at 570; e.g., 21 U. S. C. §352, at least until the FDA rules on its application.*
Because Merck points to no statute, regulation, or other agency action with the force of law that would have prohibited it from complying with its alleged state-law duties, its pre-emption defense should fail as a matter of law.
—————— *In 2007, Congress “granted the FDA statutory authority to require a manufacturer to change its drug label based on safety information that becomes available after a drug’s initial approval,” but even after this amendment, brand-name-drug “manufacturers remain responsible for updating their labels.” Wyeth, 555 U. S., at 567–568; see 21 U. S. C. §355(o)(4). As I understand the Court’s opinion, if proper agencyactions pursuant to this amendment, or other federal law, “prohibited the drug manufacturer from . . . satisfy[ing] state law,” state law would be pre-empted under our impossibility precedents regardless of whetherthe manufacturer “show[ed] that it fully informed the FDA of the justifications for the warning required by state law.” Ante, at 13; see, e.g., Wyeth, 555 U. S., at 576; id., at 582 (BREYER, J., concurring). Of course, the only proper agency actions are those “that are set forth in, or necessarily follow from, the statutory text,” and they must have the force of law to be pre-emptive. Id., at 586 (opinion of THOMAS, J.). I am aware of no such agency action here that prevented Merck from complying with state law.
Cite as: 587 U. S. ____ (2019) 1
ALITO, J., concurring in judgment
No. 17–290
[May 20, 2019]
JUSTICE ALITO, with whom THE CHIEF JUSTICE and JUSTICE KAVANAUGH join, concurring in the judgment.
I concur in the judgment because I agree with the Court’s decision on the only question that it actually decides, namely, that whether federal law allowed Merck toinclude in the Fosamax label the warning alleged to be required by state law is a question of law to be decided by the courts, not a question of fact. I do not, however, jointhe opinion of the Court because I am concerned that itsdiscussion of the law and the facts may be misleading on remand.
I I begin with the law. The Court correctly notes that a drug manufacturer may prove impossibility pre-emption by showing that “federal law (including appropriate [Food and Drug Administration (FDA)] actions) prohibited the drug manufacturer from adding any and all warnings to the drug label that would satisfy state law.” Ante, at 13. But in expounding further on the pre-emption analysis,the Court provides a skewed summary. While dwelling on our decision in Wyeth v. Levine, 555 U. S. 555 (2009), see ante, at 9–14, the Court barely notes a statutory provisionenacted after the underlying events in that case that may have an important bearing on the ultimate pre-emption
ALITO, J., concurring in judgment
analysis in this case.
Under 21 U. S. C. §355(o)(4)(A), which was enacted in 2007, Congress has imposed on the FDA a duty to initiatea label change “[i]f the Secretary becomes aware of new information, including any new safety information . . . that the Secretary determines should be included in the labeling of the drug.”* This provision does not relieve drugmanufacturers of their own responsibility to maintain their drug labels, see §355(o)(4)(I), but the FDA’s “actions,” ante, at 13, taken pursuant to this duty arguably affect the pre-emption analysis. This is so because, if the FDA declines to require a label change despite having received and considered information regarding a new risk, the logical conclusion is that the FDA determined that a label change was unjustified. See United States v. Chemical Foundation, Inc., 272 U. S. 1, 14–15 (1926) (“The presumption of regularity supports the official acts of public officers and, in the absence of clear evidence to the contrary, courts presume that they have properly discharged their official duties”). The FDA’s duty does not depend on whether the relevant drug manufacturer, as opposed to some other entity or individual, brought the new information to the FDA’s attention. Cf. ante, at 13 (“the drugmanufacturer [must] show that it fully informed the FDAof the justifications for the warning required by statelaw”). Nor does §355(o)(4)(A) require the FDA to communicate to the relevant drug manufacturer that a label change is unwarranted; instead, the FDA could simplyconsider the new information and decide not to act. Cf. ante, at 13 (“[T]he FDA, in turn, [must have] informed the drug manufacturer that the FDA would not approve ——————
*Prior to October 2018, §355(o)(4)(A)’s language contained slight differences not relevant here. See Substance Use–Disorder Prevention That Promotes Opioid Recovery and Treatment for Patients and Communities Act, Pub. L. 115–271, §3041(b), 132 Stat. 3942–3943, effective Oct. 24, 2018.
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ALITO, J., concurring in judgment
changing the drug’s label to include that warning”).
Section 355(o)(4)(A) is thus highly relevant to the preemption analysis, which turns on whether “federal law (including appropriate FDA actions) prohibited the drugmanufacturer from adding any and all warnings to thedrug label that would satisfy state law.” Ante, at 13 (emphasis added). On remand, I assume that the Court of Appeals will consider the effect of §355(o)(4)(A) on the preemption issue in this case.
Two other aspects of the Court’s discussion of the legal background must also

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Link to: FDA criminal-investigations/warning-letters/mentor-worldwide to Alex Gorsky CEO Mentor (J&J) March 18, 2019 -llc-acclarent-573520-03182019

Melissa Shirley vs. Mentor Worldwide (J&J) Complaint USDC ND Georgia (May 15, 2017)

By Mark A. York (May 8, 2019)








The primary makers of breast implants approved for use in the United States include:

Allergan, Inc.

Ideal Implant, Inc.

Mentor World Wide, LLC (Johnson & Johnson)

Sientra, Inc.

Breast augmentation remains the most common cosmetic surgical procedure in the U.S. with more than 300,000 performed each year, according to the American Society of Plastic Surgeons.

In addition to the warning notice to Mentor Worldwide in March 2018 (above), the FDA has taken additional steps to ensure the agency is monitoring the safety and risks of breast implants. The FDA shas  coordinated with the American Society of Plastic Surgeons and the Plastic Surgeons Foundation to develop the Patient Registry and Outcomes for Breast Implants and Anaplastic Large Cell Lymphoma (BIA-ALCL) Etiology and Epidemiology (PROFILE), which collects real world data regarding patients who have a confirmed diagnosis of BIA-ALCL. The data collected from this registry, have contributed to a better understanding of BIA-ALCL and FDA communication updates to the public regarding BIA-ALCL.

According to a complex analysis of FDA adverse event data, the number of suspected breast implant injuries jumped from an average of fewer than 200 a year through 2016, before the FDA’s more rigorous reporting rules, to 4,567 events in 2017 and at least 8,242 in the first half of 2018. More than 10 million women worldwide have received breast implants over the last decade, a remarkable comeback for a medical product that had suffered a crippling safety scandal and a lengthy ban in the United States.

The agency was aware of the true number of reported injuries but did not disclose them until recently. In Europe, some manufacturers have avoided reporting ruptures altogether, Dutch regulators were told. This was discovered during the  International Consortium of Investigative Journalists long term investigation titled, Implant Files investigation , which revealed the ongoing health problems plaguing many thousands of women with breast implants as part of its global research project that was released in November 2018.

In the U.S. and Canada, regulators did not impose any consequences after manufacturers lost track of most of the participants in a large-population health study within three years, although a 10-year study was ordered as a condition of allowing silicone implants back on the market.

Experts worldwide agree that more long-term studies are desperately needed, but neither Allergan nor Johnson & Johnson’s Mentor completed the studies of 40,000 women ordered by the FDA.  After two years, about 40 percent of the participants in the breast augmentation section of the Allergan study had dropped out; after three years, Mentor had lost about 80 percent of its breast augmentation study subjects.

The FDA now says that although it does not have evidence to support a link between breast implants and systemic illness, safety studies “would need to be much larger and longer than those conducted so far” to clearly rule out an association. Allergan and Mentor faced no consequences for failing to complete the mandatory studies.

In September 2018, researchers at the MD Anderson Cancer Center in Houston reported the results of the largest-ever long-term safety study of breast implants. The study found associations between silicone implants and three autoimmune diseases. In the same month, an Israeli study of tens of thousands of women also discovered a link between breast implants and autoimmune diseases. Several smaller studies conducted in recent years in the Netherlands and the U.S., reached similar conclusions.

In March 2017, the FDA issued a breast implant cancer warning, indicating that it was aware of at least 359 medical device reports involving women diagnosed with a rare form of non-Hodgkins lymphoma, known as breast implant-associated anaplastic large cell lymphoma (BIA-ALCL). The illness has been linked to at least nine deaths.

The agency indicated at the time that the lymphoma cases appeared to be more common among breast implants with textured surfaces, as opposed to smooth breast implants, but a definitive connection was not able to be made.

Australia’s Therapeutic Goods Administration (TGA) launched an effort monitor the association between breast implants and anaplastic large cell lymphoma, more than doubling the recognized number of cases identified among Australian patients between September 2016 and April 2017.

Researchers from the TGA published a study in May indicating that side effects of textured breast implants may be linked to a 14 times higher risk of ALCL in some cases.

The TGA has estimated that the breast implant lymphoma risk may be between 1-in-1,000 and 1-in-10,000, with most cases occurring between 3 and 14 years after implant, but the median being 8 years and some cases diagnosed as much as 37 years after breast surgery,

Due to the potential lymphoma risk with breast implants, regulators have made efforts to increase awareness among health care providers about cases of the rare cancer linked to textured breast implants, indicating that they should discuss the benefits and side effects of the implants with their patients.

The FDA has also recommended that doctors consider the possibility that a breast implant recipient is suffering from anaplastic large cell lymphoma (ALCL) when they present with late, onset, persistent peri-implant seroma.

Each year in the United States more than 300,000 women and undergo breast augmentation, with the total number of breast implants procedures each year being  anywhere between 5 to 10 million around the world.

Before the operations women are often told by their surgeons that it is a safe procedure with “very little” risk, with the . FDA generally supporting that incorrect statement, by offering that “breast implants are relatively safe” which is now being shown to be very inaccurate.

There is a growing body of evidence, now supported by  thousands of examples of adverse events from women all over the world who have had implants. Facts are emerging that breast implants have been and continue to cause  debilitating autoimmune disorders  as well as emerging evidence of links to certain types of cancer.

No implant on the market today can last a lifetime. Every type is prone to leaking and rupturing, and instance, the saline valve implants, can even become black with mold, causing a systemic fungal problem in a person’s body.

Typical Breast Implants Placement

Silicone Breast Implant History

History that breast implants have caused serious health problems, but for most of the public, that problem is assumed to be a historical reference, because those implants were removed from the market, so the current implants on the market must be very safe.

While the FDA now openly mentions problems that often occur in many women with breast implants, such as leaking and rupturing, they fail to warn the public about the more dangerous connection to auto-immune disorders.

The FDA actually allowed implants to be put onto the market for over 40 years without formally approving them, so it’s not a best practice to trust what the FDA says.

The lawsuits in the 1990’s involved 450,000 US women who sued  Dow Corning, one of the world’s largest manufacturers of silicone implants.

While Dow Corning never admitted that their implants were dangerous, they paid out enormous amounts to the victims. Their implants of the 1970’s had a very thin outer shell, and had a high leakage rate. Many women even lost their lives from illness caused by these implants, while waiting for a legal resolution of their lawsuits against Dow.

It was disclosed that Dow Corning knew for a very long time that their implants were toxic, yet covered it up for as long as they could.

In their own animal studies, researchers found that silicone could easily leak into the body, and caused tumours in up to 80% of the rats that were being tested on, see Fig. 7. The numbers were so alarming that the FDA, instead of being concerned, called these studies “erroneous,” which basically means they ‘must’ have been incorrect. The FDA then approved the Dow Corning implants, despite protests from some staff members that there were troubling warning signs.

We’ve also heard about the now infamous French PIP implant scandal which hit worldwide news recently. These implants (which were found to contain toxic chemicals used in mattresses and not approved for human use) are now banned, and women in the UK were offered free treatment to have them removed.

Shocking Ingredients Found In Dow Silicone Implants

When women are told that their implants contain silicone or saline, they often don’t tend to ask if anything else is being used alongside it. They certainly aren’t told this by the surgeons, who more than likely don’t even know themselves.

Check out the long list of alarming ingredients used in Dow’s silicone implants which came out during their court case when they were forced to disclose what was in their dangerous implants:

  • Methyl ethyl ketone (neurotoxin)
  • Cyclohexanone (neurotoxin)
  • Isopropyl Alcohol
  • Denatured Alcohol
  • Acetone (used in nail polish remover and is a neurotoxin)
  • Urethane
  • Polyvinyl chloride (neurotoxin)
  • Amine
  • Toulene
  • Dicholormethane (carcinogen)
  • Chloromethane
  • Ethyl acetate (neurotoxin)
  • Silicone
  • Sodium fluoride
  • Lead Based Solder
  • Formaldehyde
  • Talcum powder
  • Oakite (cleaning solvent)
  • Methyl 2- Cynanoacrylates
  • Ethylene Oxide (Carcinogen)
  • Xylene (neurotoxin)
  • Hexon
  • 2-Hedanone
  • Thixon-OSN-2
  • Stearic Acid
  • Zinc Oxide
  • Naptha (rubber solvent)
  • Phenol (neurotoxin)
  • Benzene (carcinogen/neurotoxin)
  • Lacquer thinner
  • Epoxy resin
  • Epoxy hardener
  • Printing Ink
  • Metal cleaning acid
  • colour pigments as release agents
  • heavy metals such as aluminium (neurotoxin linked to Alzheimer’s and auto immune disorders)
  • Platinium
  • Silica * (2)

What’s In Implants Today?

The current problem is we just don’t know. Its very difficult to find out exactly what is in current implants today. There nothing that shows a full ingredient list. Plastic surgeons state they have ‘never seen a full list’ and implant websites, do not disclose what is in their products.

Some scientists have been taking an in-depth look at the platinum, a toxic salt, found in silicone implants and its connection to ill health. However, after looking at this list above, it seems ludicrous to suggest that one individual ingredient would be the sole cause of these health problems. It’s clear that breast implants are completely toxic.

Its important to know that saline implants ALL have silicone outer shells, so these too can leak silicone and other ingredients into the body, either through rupturing or when the textured surface flakes off.

Types of Breast Implants Used Today

Silicone Implants

Many women opt out of having silicone implants due to the Dow Corning Lawsuit. But a growing number of women are now choosing to have them again due to the implant’s ability to look more natural than other types. These implants have an elastic type envelope which is pre-filled with a sticky, clear, jelly-like form of silicone. There are a few varieties of shapes to choose from, with smooth or textured surfaces.

With the FDA allowing silicone implants to come back on the market, it is very concerning to know that statistics show (according to Nancy Bruning, author of Breast Implants — Everything You Need To Know) that almost half of all women who have this type of implant will experience a rupture within 6-10 years, and one in five women were found to have silicone migrate to other parts of their bodies.







According to Dr Susan Kolb, world expert on breast implants, silicone implants should be completely avoided.






Saline implants – silicone outer shell, saline liquid inserted during surgery by surgeon

Saline Implants

Saline implants are commonly thought to be safer, yet they have their own problems. Saline implants have a silicone shell filled with a saline water, which is salt based and ‘sterile.’ Some types are inserted empty which the surgeon will inflate during surgery with this saline liquid. There is another type of saline implant, which also has a silicone shell, but the inside contains a gel like texture. There are smooth surface saline implants and textured surface saline implants.

According to research experts, 60% of women with these types of implants have complications within four years, and one out of five require additional surgery within three years.  This seems to be a cause for concern, since patients are commonly told that implants either never need to be removed or should be removed every ten years.

Possible Side Effects

This is what your surgeon does not tell you:

  • tenderness, lumpiness, or discomfort around the implants
  • change in the shape of your breast(s)
  • change in the consistency of your breast, such as increased softness
  • change in the way your breast moves – all of these symptoms may be a sign your implant has ruptured.
  • hardening of breast tissue
  • muscle pain
  • pain and swelling of the joints
  • pain in the soft tissues
  • a burning sensation of pain
  • tightness, redness, or swelling of the skin
  • swollen glands or lymph nodes
  • unusual, extreme, or unexplained fatigue
  • swelling of the hands and feet
  • unusualhair loss
  • rashes
  • skin thickening or hardening
  • dry eyes, mouth, or vagina
  • loss of memory, mental confusion, or ‘fogginess’
  • autoimmune disorders such as fibromyalgia, rheumatoid arthritis, scleroderma, multiple chemical sensitivity disorder, cancer, and biotoxicity problems.

Above is an excerpt from Breast Implants – All You Need To Know by Nancy Bruning.











A ruptured silicone implant. The red is tissue that had to be removed from the patient. The sticky consistency on the right is what comes out when ruptures and leakage occur.

Breast Implants Can Cause Cancer

It might not surprise some of you reading this to learn that there is a link between cancer and implants. Just recently in France, their National Cancer Institute released a study that found a “clearly established link” between Anaplastic large cell lymphoma (ALCL) and breast implants.

French officials have now recommended that breast implants in their country must carry a “cancer warning.”

There is also more evidence to back this connection now that a study conducted by Cambridge University in the UK found that nearly all cases of ALCL were discovered in women who had breast implants.

When you think about how breast implants are inserted — indeed it is quite gory and gruesome surgery — and about the horrific chemicals they are comprised of, it makes sense that they would, of course, pose a cancer risk. And now we have the data to support this.

Suicide Risk

Another little known factor about breast implants is that there is a connection between suicide. While this connection might be more about the woman’s mental status prior to having the surgery (perhaps she suffered from low self esteem and thought implants would make her much happier), it could also be because of the stressful impact the implants have on the body and its many important systems. As we have seen above, implants are linked to neurological disorders, amongst other concerns.

Women who have implants are at least 3 (some sources say 4) times more likely to commit suicide than those who do not have them.

The American Society of Plastic Surgeons (ASPS) reported that 329,396 women have undergone breast augmentation in the United States, an increase of 55% between 2000 and 2006, making it the most frequent US surgical cosmetic procedure for 2006 (ASPS, 2007). Although many studies have explored psychological aspects of this type of surgery, the consistently dramatic increase in numbers of breast augmentations, some that result in adverse psychological outcomes, remains a serious concern for health care providers. Surprisingly, very little is known about either the psychological characteristics of cosmetic surgery patients or the psychological impact of the surgical procedures. This literature review focuses on psychological issues in relation to breast augmentation procedures, including recent suicide findings related to this procedure. Conclusion of this review supports the necessity by health care providers to consistently screen patients for psychological disorders, such as Body Dysmorphic Disorder (BDD), prior to conducting cosmetic surgical procedures, specifically breast augmentation. See, Psychological Issues Associated With Breast Augmentation  2009 Jun;30(6):377-82

Mammograms Can Rupture Breast Implants








Mammogram on a patient without implants 

If you have implants, you need to be aware that having mammograms can actually do serious damage to them. Because the procedure involves intense squashing down of the breast tissue, this has been known to cause ruptures, and if the implants do begin to leak, what is inside them will likely leak into your body.

It must be said that there is also alarming information that mammograms are not safe to have, even if you don’t have implants.

Is There A Safe Implant?

If you choose to get implants, then according to breast implant expert Dr. Susan Kolb, the safest type is the saline implant that has a smooth surface and does not have a valve. This is because the textured implants have been found to have particles flake off into the person’s body which can then attack the immune system. If there is a valve, as mentioned previously, a systemic fungal infection can ensue.  But even with this type, problems can happen in the future and lead to drastic complications, and it now seems to be leading toward Breast Implant Litigation Round II.

As discussed in the article What You Need To Know About Breast Implants, the authors wrote about the concerns with breastfeeding and toxicity:

According to the Institute of Medicine (IOM), women with any kind of breast surgery, including breast implant surgery, are at least three times as likely to have an inadequate milk supply for breastfeeding. Concerns about the safety of breast milk have also been raised, but there has not been enough research to resolve this issue. A study of a small number of women with silicone gel breast implants found that the offspring born and breastfed after the mother had breast implants had higher levels of a toxic form of platinum in their blood than offspring born before the same women had breast implants.


The FDA has also posted an unusually blunt warning on its website. It advises patients that the risk of complications is high and says flatly:  “You should assume that you will need to have additional surgeries.”

Since the FDA’s decision, the breast implant business has boomed, now exceeding $1 billion in revenue a year and projected to reach $2 billion by 2025. More than 1.6 million women worldwide received cosmetic breast implants in 2017, including an estimated 345,236 in the U.S., 235,950 in Brazil, 67,478 in Mexico and 54,045 in Italy. As of 2017, breast enlargement was the most common cosmetic surgery in the world.

A Clear Example of What Can Go Wrong

Please check out Susan’s experience that really turned into an utter nightmare for her, which is still affecting her health today. Below is a picture of her implants that she had recently removed.














Susan’s implants which were moved back in April this year. The one on the left was so ‘jelly like’ it had to be scraped off her ribs. The right one, although looks quite normal, actually had a small rupture too. The red tissue is what the surgeon also had to remove to ensure all the silicone was gone.

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MDL 2885 – “3M Combat Arms Earplug” JPML Hearing Was Today in Washington D.C.

 (MASS TORT NEXUS MEDIA) 3M Combat Arms earplugs were issued by the U.S. military between 2003 and 2015 and now litigation has begun asserting that 3M designed and distributed defective earplugs designed for use in combat and elevated noise situations, were defective and left hundreds of thousands of soldiers and veterans injured and suffering from hearing loss.

The March 28, 2019 JPML Initial Hearing on 3M Company Combat Arms Earplug MDL 2885 took place in Washington D.C. this morning. One of the lead counsel for plaintiffs, Mark Lanier, of The Lanier Law Firm, PC offered the following statement on MDL 2885, “This is one of the most important litigations in our generation.  It concerns real damage done to our soldiers by American industry, not enemy combatants.  We trust the MDL will go to a court that will prioritize the swift delivery of justice in a complicated and important litigation.”

Primary claims of the military personnel assert that the company defectively designed its earplugs such that they did not provide sufficient levels of hearing protection. The lawsuits also claim 3M misrepresented the effectiveness of the hearing protection devices to the military during the proposal process when as well as after they obtained the government contract as the exclusive earplug provider to the military and thereafter. As a result, service members who used the earplugs allege incurring noise-induced tinnitus and hearing loss.

Shelly Sanford of Watts Guerra LLP, in Austin, Texas, who spoke at today’s hearing offered this statement “We are keenly focused on the veterans who were sent into combat with these earplugs and came home with hearing loss. The vast majority of these Veterans reside in Texas, and that is just one of the reasons I am requesting that the MDL be assigned there.”

Ms. Sanford also added  “As Judge Charles Breyer, an esteemed former member of the JPML, pointed out in the opioid litigation MDL 2804 hearing, the only issue is ‘what did they know and when did they know it?” With 3M, that question is central to both the claims and potential defenses. I think the core issue is where will the JPML send the MDL.”


Combat Arms Earplugs, Version 2 (CAEv2) have been issued by the U.S. Military for each deployed soldier between 2003 and late 2015.

The dual-end or reversible earplugs were used during training and on the battlefield to provide ear protection during service. However, design defects may cause the earplug to imperceptibly loosen in the ear canal, rendering the earplugs useless or less effective.

Aearo Technologies first developed and tested the Combat Arms Earplugs in 2000, and began selling them to the U.S. Defense Logistics Agency in late 2003, at which time they became standard issue.

3M Company acquired Aearo in 2008, and continued to sell the earplugs to the military until at least 2015.


In July 2018, the U.S. Department of Justice reached a $9.1 million settlement with 3M Company over the Combat Arms earplugs, resolving claims that the manufacturer committed fraud by knowingly selling defective earplugs to the government.

According to allegations raised in a 3M earplug lawsuit that led to the settlement:

  • CAEv2 design defects cause the earplug to imperceptibly loosen in users ears over time, which was not disclosed to the U.S. government or end users;
  • 3M Company provided false and inaccurate noise reduction ratings (NRR) for the earplugs, which employed testing methods that did not comply with required or accepted standards;
  • Combat Arms noise reduction ratings listed on the packaging materials and instructions failed to accurately reflect the true characteristics of the earplugs.

The Justice Department found that the earplugs were too short to fit in many ears and imperceptibly would move out of place, making them ineffective. In addition, critics say neither 3M nor Aearo provided proper use instructions to soldiers, which should have told the wearers to fold back the flanges on the open end of the plug before inserting the closed end into their ears so that they properly fit.

  • Listening to television and radio at high volumes
  • Trouble understanding speech, particularly in noisy environments
  • Often asking people to repeat themselves
  • Needing a hearing aid

Following the announcement of the Qui Tam settlement, veterans started looking at the conduct of 3M and as the bad faith of 3M came to light, lawyers across the country became involved. Litigation against 3M was started by various law firms in late 2018 representing veterans who used the Combat Arms™ earplugs, as instructed and suffered noise-induced hearing loss. As of March 2019, there were over 200 lawsuits in various state and federal courts, which resulted in the JPML Motion for Consolidation. Resulting in the hearing earlier today in the 3M Company Combat Earplug Litigation MDL 2885 in Washington D.C., in front of the JPML Panel, who usually take between 7 and 14 days to issue a ruling.

Where MDL 2885 is finally assigned remains to be seen, as there were several venues presented by the parties and each has viable claims and reasoning. Locations include Texas for the military presence and judicial interest, Minnesota for 3M convenience and home court advantage, Washington D.C. where the military operations are at home or Indianapolis where there’s MDL judicial experience. Perhaps the 3M litigation will open the door for holding those responsible for Department of Defense contracting abuses and similar bad conduct being held accountable for their actions on a regular basis.


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Xarelto Litigation Settles for $775 million Bayer and Johnson & Johnson Split Bill  


March 25, 2019 Global Xarelto Blood Thinner Settlement Announced 








(MASS TORT NEXUS MEDIA) Bayer AG and J&J’s subsidiary Janssen Pharmaceuticals Inc. have now formalized a $775 million settlement of more than 25,000 lawsuits over their blood-thinning drug Xarelto. The cases are pending in both federal and state courts and this may be seen as a run up to Bayer’s next settlement, in their now seen as a bad-for-earnings purchase of Monsanto and its Federal Roundup MDL 2471 docket, as well as cases filed in state courts.

Plaintiffs alleged the drug caused uncontrollable bleeding, and said that Bayer and Janssen failed to adequately warn of that risk as well as manipulated data related to clinical trial and published studies. To date, plaintiffs have not done well in bellwether trials, having lost three in a row in the Xarelto MDL 2592 litigation in from of Judge Eldon Fallon in the US District Court of Louisiana. In those cases the defense asserted an “learned intermediary” defense which was very successful. The same defense was used in the state court trials in the Philadelphia Court of Common Pleas cases and proved a winning defense in the first two plaintiff bellwether losses there.

The upcoming third Philadelphia court bellwether trial was set for May 2019, and may have had an impact on the settlement timing, or Bayer may have been trying to get a major legal headache off the table in anticipation of the ever-expanding Monsanto Roundup litigation.

Judge Michael Erdos, Philadelphia County Court of Common Pleas, was the judge set to hear the upcoming May trial and also the judge who presided over the Hartmann 2018 verdict reversal, which was the first defense trial loss in litigation over the Xarelto blood thinner, and also the first trial outside the Xarelto MDL 2592. The prior losses  at trial were  heard in the  XARELTO MDL 2592 US District Court ED Louisiana litigation in front of Judge Eldon Fallon, US District Court of Louisiana.

Links to the settlement orders entered March 25, 2019 in the Xarelto MDL 2592 docket:

Xarelto MDL 2592 Settlement CMO No. 9 March 25, 2019 Stay on Litigation


Xarelto MDL 2592 Settlement CMO No. 10 March 25, 2019 Case Registration Protocol


Xarelto MDL 2592 Settlement CMO No. 11 March, 25, 2019 Docket Control Order

For complete docket information on the Xarelto Multidistrict and Philadelphia, PA state court docket see the Mass Tort Nexus briefcases below:–Complex-Litigation-(PA-State-Court)

More than five years after the Xarelto™ litigation began, and with Bayer and Janssen Pharmaceuticals prevailing in all six cases that went to trial, the companies have reached an agreement in principle to settle in the amount of 775 million U.S. dollars.

The settlement amount will be shared equally between the two companies. It is expected that Bayer’s share will be partially offset by product liability insurance.

The settlement is global and is designed to resolve all of the approximately 25,000 Xarelto™ claims in the US, based in the specific terms of the still confidential settlement agreement. The companies have reserved the right to withdraw from the settlement if certain participation rates of those who are eligible to participate are not satisfied.

Bayer continues to believe these claims are without merit and there is no admission of liability under the agreement. However, this favorable settlement allows the company to avoid the distraction and significant cost of continued litigation.

Both Bayer and Janssen have faced harsh and ever growing scrutiny related to the recent disclosures that the Rocket AF study and Einstein study data may not have been as favorable towards Xarelto’s push as a “miracle blood-thinner drug” as once viewed in the medical world.

The U.S. Food and Drug Administration approved Xarelto in 2011, to be prescribed for people with atrial fibrillation, a common heart rhythm disorder, and to treat and reduce the risk of deep vein thrombosis and pulmonary embolisms, often after implant surgeries.

Janssen and Bayer market Xarelto as a one-size-fits-all anticoagulant. Patients take one 20-milligram dose of Xarelto once a day and do not need to undergo routine monitoring. The plaintiffs contend that, because each person processes and metabolizes Xarelto at a highly-individualized rate, each patient’s reaction to the drug is decidedly variable, causing some patients to experience major bleeding events.

The plaintiffs acknowledge that the FDA approved Xarelto’s dosing and monitoring scheme. However, they claim that, given the high inter-patient variability, Xarelto is unreasonably dangerous in design because:

  1. Defendants should have designed, but failed to design, a Xarelto-specific Anti-Factor Xa assay so doctors could monitor Xarelto’s anticoagulation effect on each patient and could, along with the patient, weigh the risks and decide whether to continue taking Xarelto.
  2. Defendants have not designed and marketed an antidote to counteract a major bleeding event.
  3. In the absence of a Xarelto-specific Anti-Factor Xa assay, Xarelto’s label should have warned doctors about the availability of the Neoplastin PT test to measure patient’s anticoagulation.

“Because Defendants did not take any of the above three actions, Plaintiffs claim Xarelto is unreasonably dangerous under the LPLA,” the judge said.

To access the most relevant and real time information on Mass Torts  sign up for:

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May 31 to June 3, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or

  1. For the most up-to-date information on all MDL dockets and related mass torts visit and review our mass tort briefcases and professional site MDL briefcases.
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IN RE: CHILDREN BORN                       MDL – _________






Plaintiffs[1] respectfully move that the Judicial Panel on Multidistrict Litigation (“Panel”), pursuant to 28 U.S.C. § 1407 and Rule 6.2 of the Rules of Procedure of the Panel, transfer the actions on behalf of children born opioid-dependent listed in the attached Schedule of Actions and subsequent tag-along actions to a separate MDL before the Southern District of West Virginia.; alternatively, Plaintiffs request transfer to the Southern District of Illinois.

I.        Children Born Opioid-Dependent Need A Separate MDL From MDL 2804

Movants seek transfer and coordination or consolidation of all cases filed on behalf of opioiddependent infants into a new MDL for the reasons laid out

[1] Movants are: Deric Rees and Ceonda Rees, individually and as next friend and guardian of Baby T.W.B. on behalf of themselves and all others similarly situated (Illinois Class); Darren and Elena Flanagan, individually and as adoptive parents and next friends of Baby K.L.F., on behalf of themselves and all others similarly situated (Tennessee Class); Rachel Wood, individually and as next friend and adopted mother of Baby O.W., on behalf of themselves and all others similarly situated (Missouri Class); Melissa Ambrosio, individually and as next friend of Baby G.A., and on behalf of themselves and all others similarly situated (California Class); Shannon Hunt, individually and as next friend of Baby S.J., on behalf of themselves and all others similarly situated (Maryland Class); Bobbi Lou Moore on behalf of Baby R.R.C., and all other similarly situated (West Virginia Class); Walter and Virginia Salmons, individually and as the next friend or guardian of Minor W.D. and on behalf of all others similarly situated (National Class).

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Why Isn’t Medical Cannabis Used to Treat Opioid and Substance Abuse Disorders More Often, Since It Works?


By Mark A. York (September 20, 2018)








(MASS TORT NEXUS MEDIA) More and more medical treatment professionals, politicians and others have joined in the quickly emerging role of medical marijuana to help in treatment by patients struggling with opioid addiction. Now, two studies are reflecting this emerging treatment to be viable.

Recent studies, published journal JAMA Internal Medicine, compared opioid prescription patterns in states that have enacted medical cannabis laws with those that have not. One of the studies looked at opioid prescriptions covered by Medicare Part D between 2010 and 2015, while the other looked at opioid prescriptions covered by Medicaid between 2011 and 2016.

Additionally, three states have approved Medical Cannabis for alternative treatments related to both pain management and substance abuse disorders, where cannabis has been determined as an appropriate treatment. Pennsylvania, New Jersey and Illinois are at the forefront of using changes to state laws regarding medical cannabis in the most effective clinical settings when possible.


The Pennsylvania Department of Health approved major changes to the state’s medical marijuana program, when the  health department added opioid addiction to the list of conditions eligible for treatment with medicinal cannabis. With that decision, Pennsylvania joins New Jersey and Illinois as the only states that have done so.

Pennsylvania Secretary of Health Dr. Rachel Levine told local media that marijuana won’t be the first treatment for addiction to opioids. Instead, doctors will try more traditional therapies first.

“It’s important to note that medical marijuana is not a substitute for proven treatments for opioid use disorder,” Dr. Levine said. “In Pennsylvania, medical marijuana will be available to patients if all other treatment fails, or if a physician recommends that it be used in conjunction with traditional therapies.”

A related positive note by Pennsylvania is the Department of Health has approved cannabis research licenses for five Philadelphia area medical schools on Monday. With one topic of research at the institutions being the potential role of cannabis in addiction treatment as a normal treatment protocol.

The schools that received approval to study cannabis are Drexel University College of Medicine, Lewis Katz School of Medicine at Temple University, Sidney Kimmel Medical College at Thomas Jefferson University, Perelman School of Medicine at the University of Pennsylvania, and Philadelphia College of Osteopathic Medicine.


The researchers found that states that allow the use of cannabis for medical purposes had 2.21 million fewer daily doses of opioids prescribed per year under Medicare Part D, compared with those states without medical cannabis laws. Opioid prescriptions under Medicaid also dropped by 5.88% in states with medical cannabis laws compared with states without such laws, according to the studies.

“This study adds one more brick in the wall in the argument that cannabis clearly has medical applications,” said David Bradford, professor of public administration and policy at the University of Georgia and a lead author of the Medicare study.

“And for pain patients in particular, our work adds to the argument that cannabis can be effective.”

Medicare Part D, the optional prescription drug benefit plan for those enrolled in Medicare, covers more than 42 million Americans, including those 65 or older. Medicaid provides health coverage to more than 73 million low-income individuals in the US, according to the program’s website.

“Medicare and Medicaid publishes this data, and we’re free to use it, and anyone who’s interested can download the data,” Bradford said. “But that means that we don’t know what’s going on with the privately insured and the uninsured population, and for that, I’m afraid the data sets are proprietary and expensive.”

Republicans Support Legalizing Medical Cannabis

Earlier this year, the National Academy of Sciences, in a 395-page report, refuted the official US Department of Justice position that cannabis is a “gateway drug” and that using marijuana can lead to opioid addiction and instead found evidence of cannabis having therapeutic and health benefits. Joe Schrank, a social worker who worked at various detox centers and clean houses, is now practicing the report’s findings at High Sobriety treatment center in Los Angeles, where he offers clients medical and therapeutic sessions, and daily doses of marijuana to treat a variety of addictions.

The Opioid Crisis Is Here

The new research comes as the United States remains entangled in the worst opioid epidemic the world has ever seen. Opioid overdose has risen dramatically over the past 15 years and has been implicated in over 500,000 deaths since 2000 — more than the number of Americans killed in World War II.

“As somebody who treats patients with opioid use disorders, this crisis is very real. These patients die every day, and it’s quite shocking in many ways,” said Dr. Kevin Hill, an addiction psychiatrist at Beth Israel Deaconess Medical Center and an assistant professor of psychiatry at Harvard Medical School, who was not involved in the new studies.

“We have had overuse of certain prescription opioids over the years, and it’s certainly contributed to the opioid crisis that we’re feeling,” he added. “I don’t think that’s the only reason, but certainly, it was too easy at many points to get prescriptions for opioids.”

Today, more than 90 Americans a day die from opioid overdose, resulting in more than 42,000 deaths per year, according to the US Centers for Disease Control and Prevention. Opioid overdose recently overtook vehicular accidents and shooting deaths as the most common cause of accidental death in the United States, the CDC says.








Doctors must lead us out of our opioid abuse epidemic

Like opioids, marijuana has been shown to be effective in treating chronic pain as well as other conditions such as seizures, multiple sclerosis and certain mental disorders, according to the National Institute on Drug Abuse. Research suggests that the cannabinoid and opioid receptor systems rely on common signaling pathways in the brain, including the dopamine reward system that is central to drug tolerance, dependence and addiction.

“All drugs of abuse operate using some shared pathways. For example, cannabinoid receptors and opioid receptors coincidentally happen to be located very close by in many places in the brain,” Hill said. “So it stands to reason that a medication that affects one system might affect the other.”

But unlike opioids, marijuana has little addiction potential, and virtually no deaths from marijuana overdose have been reported in the United States, according to Bradford.

“No one has ever died of cannabis, so it has many safety advantages over opiates,” Bradford said. “And to the extent that we’re trying to manage the opiate crisis, cannabis is a potential tool.”

Comparing states with and without medical marijuana laws

  • Researchers compared prescription patterns in states with and without medical cannabis laws
  • States with medical marijuana had 2.21 million fewer daily doses of opioids prescribed per year
  • Opioid prescriptions under Medicaid dropped by 5.88% in states with medical cannabis laws

In order to evaluate whether medical marijuana could function as an effective and safe alternative to opioids, the two teams of researchers looked at whether opioid prescriptions were lower in states that had active medical cannabis laws and whether those states that enacted these laws during the study period saw reductions in opioid prescriptions.

Both teams, in fact, did find that opioid prescriptions were significantly lower in states that had enacted medical cannabis laws. The team that looked at Medicaid patients also found that the four states that switched from medical use only to recreational use — Alaska, Colorado, Oregon and Washington — saw further reductions in opioid prescriptions, according to Hefei Wen, assistant professor of health management and policy at the University of Kentucky and a lead author on the Medicaid study.

“We saw a 9% or 10% reduction (in opioid prescriptions) in Colorado and Oregon,” Wen said. “And in Alaska and Washington, the magnitude was a little bit smaller but still significant.”

Cannabis legalization by the numbers

The first state in the United States to legalize marijuana for medicinal use was California, in 1996. Since then, 29 states and the District of Columbia have approved some form of legalized cannabis. All of these states include chronic pain — either directly or indirectly — in the list of approved medical conditions for marijuana use, according to Bradford.

The details of the medical cannabis laws were found to have a significant impact on opioid prescription patterns, the researchers found. States that permitted recreational use, for example, saw an additional 6.38% reduction in opioid prescriptions under Medicaid compared with those states that permitted marijuana only for medical use, according to Wen.

The method of procurement also had a significant impact on opioid prescription patterns. States that permitted medical dispensaries — regulated shops that people can visit to purchase cannabis products — had 3.742 million fewer opioid prescriptions filled per year under Medicare Part D, while those that allowed only home cultivation had 1.792 million fewer opioid prescriptions per year.

“We found that there was about a 14.5% reduction in any opiate use when dispensaries were turned on — and that was statistically significant — and about a 7% reduction in any opiate use when home cultivation only was turned on,” Bradford said. “So dispensaries are much more powerful in terms of shifting people away from the use of opiates.”

The impact of these laws also differed based on the class of opioid prescribed. Specifically, states with medical cannabis laws saw 20.7% fewer morphine prescriptions and 17.4% fewer hydrocodone prescriptions compared with states that did not have these laws, according to Bradford.







This is fentanyl: A visual guide

Fentanyl prescriptions under Medicare Part D also dropped by 8.5% in states that had enacted medical cannabis laws, though the difference was not statistically significant, Bradford said. Fentanyl is a synthetic opioid, like heroin, that can be prescribed legally by physicians. It is 50 to 100 times more potent than morphine, and even a small amount can be fatal, according to the National Institute on Drug Abuse.

“I know that many people, including the attorney general, Jeff Sessions, are skeptical of cannabis,” Bradford said. “But, you know, the attorney general needs to be terrified of fentanyl.”


This is not the first time researchers have found a link between marijuana legalization and decreased opioid use. A 2014 study showed that states with medical cannabis laws had 24.8% fewer opioid overdose deaths between 1999 and 2010. A study in 2017 also found that the legalization of recreational marijuana in Colorado in 2012 reversed the state’s upward trend in opioid-related deaths.

“There is a growing body of scientific literature suggesting that legal access to marijuana can reduce the use of opioids as well as opioid-related overdose deaths,” said Melissa Moore, New York deputy state director for the Drug Policy Alliance. “In states with medical marijuana laws, we have already seen decreased admissions for opioid-related treatment and dramatically reduced rates of opioid overdoses.”

Sessions: DOJ looking at ‘rational’ marijuana policy

Some skeptics, though, argue that marijuana legalization could actually worsen the opioid epidemic. Another 2017 study, for example, showed a positive association between illicit cannabis use and opioid use disorders in the United States. But there may be an important difference between illicit cannabis use and legalized cannabis use, according to Hill.

“As we have all of these states implementing these policies, it’s imperative that we do more research,” Hill said. “We need to study the effects of these policies, and we really haven’t done it to the degree that we should.”

The two recent studies looked only at patients enrolled in Medicaid and Medicare Part D, meaning the results may not be generalizable to the entire US population.

But both Hill and Moore agree that as more states debate the merits of legalizing marijuana in the coming months and years, more research will be needed to create consistency between cannabis science and cannabis policy.

“There is a great deal of movement in the Northeast, with New Hampshire and New Jersey being well-positioned to legalize adult use,” Moore said. “I believe there are also ballot measures to legalize marijuana in Arizona, Florida, Missouri, Nebraska and South Dakota as well that voters will decide on in Fall 2018.”

Hill called the new research “a call to action” and added, “we should be studying these policies. But unfortunately, the policies have far outpaced the science at this point.”

There are no U.S. Food and Drug Administration (FDA)-approved painkillers derived from marijuana, but companies such as Axim Biotechnologies Inc, Nemus Bioscience Inc and Intec Pharma Ltd have drugs in various stages of development.

The companies are targeting the more than 100 million Americans who suffer from chronic pain, and are dependent on opioid painkillers such as Vicodin, or addicted to street opiates including heroin.

Opioid overdose, which claimed celebrities including Prince and Heath Ledger as victims, contributed to more than 33,000 deaths in 2015, according to the Centers for Disease Control and Prevention.

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VERDICT FOR PLAINTIFF! Monsanto Loses First “Roundup” Cancer Trial in San Francisco Courtroom

 Verdict of $288 Million Against Monsanto: “Trial Loss Shows There Was Collusion to Stop Release of Cancer Link For Years”

Regular Damages: $38,819,000 (million)

Punitive Damages: $250 million

Claims Proven by Plaintiffs: Design Defect, Failure to Perform, Design Factor Caused Cancer, Monsnato Failed to Warn of Cancer Risks, “NEGLIGENT FAILURE TO WARN” and others

By Mark A. York (August 10, 2018)








DeWayne Johnson vs. Monsanto Is The First Lymphoma Cancer Trial

A verdict in favor of plaintiff DeWayne Johnson was reached earlier today in the first trial versus Monsanto and claims that the weed-killer Roundup causes cancer.

On Thursday, afternoon, the jury requested additional data on the various studies referenced by expert witness in expert witness testimony.

Case is DeWayne Johnson vs. Monsanto Company Case No. CGC-16-550128 in the  SUPERIOR COURT OF CALIFORNIA, SAN FRANCISCO COUNTY, Judge Bolanos.

Johnson Trial Transcripts: Monsanto-roundup-lawsuit/dewayne-johnson-v-monsanto-transcripts(baum-hedlund)

Here is the day one opening statement by Brent Wisner, plaintiff trial counsel with Baum Hedlund Aristei & Goldman.


(MASS TORT NEXUS MEDIA) Glyphosate is the most widely used agricultural based chemical product in history, starting when Monsanto introduced it in 1974, and worldwide use exploded after 1996 when Monsanto began selling “Roundup-ready” seeds- engineered to resist the herbicide, with now possibly catastrophic consequences in the United States.

More than 2.6 billion pounds of the chemical has been spread on U.S. farmlands and yards between 1992 and 2012, according to the U.S. Geological Survey. Roundup traces have been detected in over 50% of the food products being consumed in the US marketplace in numerous independent studies.

Monsanto earns $1.9 billion a year from Roundup and $10.2 billion from “seeds and genomics,” most of that category being Roundup-ready seeds.

In June, German pharmaceutical giant Bayer completed its $63 billion acquisition of Monsanto after approval by U.S. and European regulators, even though the Monsanto name may disappear, the link between cancer and glyphosate will remain long after the merger. Will Bayer decide to settle or take the thousands of lawsuits to trial that are pending in federal and state courts across the country? Although U.S. and European regulators have concluded Roundup’s active ingredient glyphosate is safe, the World Health Organization’s International Agency for Research on Cancer classified it in 2015 as a probable human carcinogen, triggering over 5,000 lawsuits against Monsanto in the United States.

Plaintiff DeWayne Johnson’s skin-based non-Hodgkin lymphoma, was caused by his use of Monsanto’s “Roundup Weed Killer” and Monsanto has gone to great lengths to suppress any links between Roundup and cancer.

The current state court trial in California has shown the extraordinary lengths that Monsanto has gone to in order to suppress and manipulate hard core science and research results around the world that showed clear links between Glyphosate and Cancer, specifically non-hodgkins lymphoma.

To show the high level of interest in the Monsanto “Roundup” abuses, last week musician Neil young and actress Darryl Hannah were in the DeWayne Johnson courtroom, which reflects Young’s ongoing campaign against the many abuses of Monsanto placed upon the US farmers and others around the world. He even released a 2015 album titled “The Monsanto Years” along with a documentary “Seeding Fear” of which Young co-produced related to Monsanto legal action against Alabama farmer Michael White, over its GMO patented seeds. Link to “Seeding Fear can be found here.

In addition to the Johnson state court case, there is the Monsanto Roundup Multidistrict Litigation No. 2741 in the US District Court of California, Northern District where the same cancer links are claimed. Documents released in the Johnson trial and in the MDL ( see Roundup (Monsanto) MDL 2741 USDC ND California) have raised many new questions about the company’s efforts to influence the public opinion by collusion and steering of data published by the media, authors and scientific research publications, and revealed internal debate over the safety of the Monsanto’s weed killer Roundup.

The active ingredient is glyphosate, the most common weed killer in the world and is used around the world on farm crops and by home gardeners, with the largest market being the USA. While Roundup’s relative safety has been upheld by most regulators, the thelitigation against Monsanto and Roundup, pending in US District Court in San Francisco continues to raise questions about the company’s practices and the product itself. Thousands of plaintiffs from across the USA have filed suit against Monsanto-Roundup and as details of Monsanto’s attempt to suppress and influence the release of damaging scientific data are released the number of cases will only increase. There has been documented evidence introduced that shows Monsanto influenced high level US Environmental Protection Agency (EPA) executives to suppress data and the release of reports that showed Roundup (glyphosate) was dangerous and suspected of causing cancer. Jess Rowland, EPA Regulatory Affairs Manager, stopped the release of a government study that was key in the investigation into the carcinogenic effects of Roundup’s primary ingredient glyphosate by the Agency for Toxic Substances and Disease Registry, see EPA’s Jess Rowland Stops Release of Report on Glyphosate as Cancer Agent. Rowland left the EPA in early 2017 and went on to become a highly paid consultant for Monsanto.

There are numerous documents and media articles that underscore the lengths to which the agrochemical company has taken to protect its image, and the dangers of Roundup.  Documents show that Henry I. Miller, an academic and a vocal proponent of genetically modified crops, asked Monsanto to draft an article for him that largely mirrored one that appeared under his name on Forbes’s website in 2015. Mr. Miller could not be reached for comment.

A similar issue appeared in academic research. An academic involved in writing research funded by Monsanto, John Acquavella, a former Monsanto employee, appeared to express concern with the process see Monsanto internal e-mail expressing concern over Roundup , in the 2015 email to a Monsanto executive, “I can’t be part of deceptive authorship on a presentation or publication.” He also said of the way the company was trying to present the authorship: “We call that ghost writing and it is unethical.”

A Monsanto official said the comments were the result of “a complete misunderstanding” that had been “worked out,” while Mr. Acquavella stated via mail that “there was no ghostwriting” and that his comments had been related to an early draft and a question over authorship that was resolved. Even though there are other documents that refute this version of Monsanto’s “official” statement.

Monsanto has been shown to have actively ghostwritten, drafted and offered direction on formal EPA studies, press releases and other “official” documents, introduced in the pending Roundup federal litigation.

The documents also show internal discussions about Roundup’s safety. “If somebody came to me and said they wanted to test Roundup I know how I would react — with serious concern,” one Monsanto scientist wrote in an internal email in 2001.

Monsanto said it was outraged by the documents’ release by a law firm involved in the litigation, although the documents are now public court records, which Monsanto attempted to suppress being introduced into the litigation again and again since the start of the Roundup lawsuits.

  1. Brent Wisner, a partner at Baum, Hedlund, Aristei & Goldman, the firm that released the documents, said Monsanto had erred by not filing a required motion seeking continued protection of the documents. Monsanto said no such filing was necessary.

“Now the world gets to see these documents that would otherwise remain secret”, per Mr. Wisner.

To reflect “official corporate collusion and influence”  see Mr. Miller’s 2015 article on Forbes’s website which was an attack on the findings of the International Agency for Research on Cancer, a branch of the World Health Organization that had labeled glyphosate a probable carcinogen, a finding disputed by other regulatory bodies. In the email traffic, Monsanto asked Mr. Miller if he would be interested in writing an article on the topic, and he said, “I would be if I could start from a high-quality draft.”

The article was authored by Mr. Miller and with the assertion that “opinions expressed by Forbes Contributors are their own.” The magazine did not mention any involvement by Monsanto in preparing the article, as most co-authored articles provide.

“That was a collaborative effort, a function of the outrage we were hearing from many people on the attacks on glyphosate,” Mr. Partridge of Monsanto said. “This is not a scientific, peer-reviewed journal. It’s an op-ed we collaborated with him on.”

After disclosure of the stories origin, Forbes removed the story from its website and said that it ended its relationship with Mr. Miller amid the revelations.

“All contributors to Forbes sign an agreement requiring them to disclose any potential conflicts of interest and only publish content that is their own original writing,” stated a Forbes representative. “When it came to our attention that Mr. Miller violated these terms, we removed his blog from and ended our relationship with him.”

Mr. Miller’s work has also appeared in the opinion pages of The New York Times, which reflects the long reach of Monsanto’s attempts to influence public opinion.

“We have never paid Dr. Miller,” said Sam Murphey, a spokesman for Monsanto. “Our scientists have never collaborated with Dr. Miller on his submissions to The New York Times. Our scientists have on occasion collaborated with Dr. Miller on other pieces.” This statement alone reflects the formal relationship between Miller and Monsanto.

James Dao, the Op-Ed editor of The Times, said in a statement, “Op-Ed contributors to The Times must sign a contract requiring them to avoid any conflict of interest, and to disclose any financial interest in the subject matter of their piece.” Miller and Monsanto did not comment on the apparent violation of this Times policy.

The documents also show that the ongoing debate outside Monsanto about glyphosate safety and Roundup, was also taking place within the company.

In a 2002 email, a Monsanto executive said, “What I’ve been hearing from you is that this continues to be the case with these studies — Glyphosate is O.K. but the formulated product (and thus the surfactant) does the damage.”

As to the internal Monsanto views of a causation relationship between cancer and Roundup, where a different Monsanto executive tells others via e-mail see 2003 Monsanto email, “You cannot say that Roundup is not a carcinogen … we have not done the necessary testing on the formulation to make that statement.”

She adds, however, that “we can make that statement about glyphosate and can infer that there is no reason to believe that Roundup would cause cancer.”

The documents also show that A. Wallace Hayes, the former editor of a journal, Food and Chemical Toxicology, has had a contractual relationship with Monsanto. In a further example of Monsanto collusion and influence in 2013, while he was still editor, Mr. Hayes retracted a key study damaging to Monsanto that found that Roundup, and genetically modified corn, could cause cancer and early death in rats.

Mr. Hayes made a statement that he wasn’t under contract with Monsanto at the time of the retraction,  however he was compensated by Monsanto for the article after he left the journal. This seems to be a very indirect method of exerting influence on the public opinion via a direct method of paying for favorable treatment and influence by Monsanto.

“Monsanto played no role whatsoever in the decision that was made to retract,” he said. “It was based on input that I got from some very well-respected people, and also my own evaluation.” If this statement is accurate, why would Monsanto pay Mr. Hayes for an article determined to be inaccurate or misleading other than the retraction was of some benefit to Monsanto.

Monsanto has been proven time and time again to be directly responsible for corporate sponsored  collusion, influence peddling in both the public and private sectors and manipulation of data released to the public regarding the now known carcinogenic links of exposure to Monsanto’s primary product, Roundup and the main ingredient glyphosate.


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In re: MDL 2846 Davol, Inc./C.R. Bard, Inc. Polypropylene Hernia Mesh Products Liability Litigation

By Mark A. York (July 18, 2018)













MASS TORT NEXUS MEDIA) In what may become one of the largest single-defendant multidistrict litigation cases ever consolidated, the U.S. Judicial Panel on Multidistrict Litigation (JPML) hearing on consolidation is set for July 26, 2018 when the JPML will be requested to consolidate cases filed against C.R. Bard/Davol, alleging injuries related to their polypropylene hernia mesh products. See JPML Hearing Order July 26, 2018 (In re: Davol, Inc./C.R. Bard, Inc. Polypropylene Hernia Mesh Products Liability Litigation)

Lead counsel on the consolidation are Fleming, Nolen & Jez, L.L.P., Houston, Texas; Brenes Law Group, P.C., Aliso Viejo, California; Chapin Legal Group, LLC, Columbus, Ohio; and Hollis Law Firm, P.A., Prairie Village, Kansas who jointly filed the motion to consolidate on April 10, 2018.

The hernia mesh products at issue were manufactured by C.R. Bard, Inc. and its subsidiary, Davol, Inc., which control close to 70 percent of the U.S. hernia mesh implant market.  There are close to 100 hernia mesh lawsuits currently pending against C.R. Bard and Davol in federal courts around the country, which is expected to increase drastically upon formal consolidation into MDL 2846..  All claims involve injuries allegedly related to the companies’ polypropylene hernia mesh implants, including the Ventralex and Perfix devices and several others, the product pool encompasses almost all Bard/Davol polypropylene hernia mesh products. Plaintiffs allege that the devices were defectively designed and caused extensive long term complications, debilitating post-surgery injuries and adverse reactions.

The motion, also supported by Bard/Davol, has proposed the U.S. District Court Southern District of Ohio, or alternatively, the Western District of Missouri, as possible venues for the multidistrict litigation. Bard alternatively requested the MDL be transferred to U.S. District Court in New Jersey or the Southern District of New York.

Discussions on Bard MDL 2846 took place with co-lead counsel Kelsey L. Stokes of Fleming, Nolen & Jez, L.L.P., Houston, Texas and Adam Evans of Hollis Law Firm, P.A., Prairie Village, Kansas.

Ms. Stokes commented: “We represent hundreds of clients that have been seriously injured by hernia mesh products manufactured by Davol/C.R. Bard.  We have observed that these devastating injuries are occurring all across the United States.   Because of this widespread harm, we moved for coordination and consolidation under Section 1407.  We believe the suggested venues offer convenience to all parties and have docket conditions that are conducive to the most efficient path to a fair and just resolution for our clients.”

Ms. Stokes added, “Considering Davol/CR Bard is the market leader for products used in the most commonly performed surgery in the United States, this MDL has the potential to be one of the largest medical device MDLs ever.  The number of cases could very well reach into the hundreds of thousands.”

Adam Evans clarified the role of revision surgeries in determining eligibility to file a claim: “Having undergone a revision surgery is not a precondition to filing a case. Nor does a revision surgery, in itself, give rise to a viable case.  The question of whether or not a person has undergone a revision surgery presents a sort of false dichotomy as we evaluate these cases. All that is necessary to file a case is that a plaintiff has suffered an injury, which evidence indicates was caused by a defect in the product.  A revision surgery often provides us with the evidence with which we can connect the injury with the product defect, but there are oftentimes other sources of evidence that a defective product has caused an injury.

For example, treating physicians can conduct imaging studies, nerve conduction studies, and other types of tests, the results of which would permit them to conclude that the product is causing the symptoms of which the plaintiff complains.  On the other hand, regarding revision surgeries, a second surgical prodedure may result in findings that rule out the product defects as a cause of the patient’s symptoms.  In the end, a medical determination that the plaintiff has been injured by the mesh in some way is generally necessary in order to justify filing.”

Both Ms. Stokes and Mr. Evans are available to discuss the Bard MDL, as well as any other questions or concerns you may have regarding hernia mesh issues in general.  The list of Bard/Davol products sought to be included in MDL 2846 is fairly significant and covers almost all of the Bard polypropylene hernia mesh products.


  • Composix
  • Composix E/X
  • Composix L/P
  • Ventralight
  • Spermatex
  • Sepramesh
  • Ventralex
  • Ventralex ST
  • Kugel Patch
  • Composix Kugel
  • Ventrio
  • Visilex
  • Ventrio ST
  • Marlex (AKA Flat Mesh; Bard Mesh)
  • Perfix Plug
  • Perfix Light Plug
  • 3D Max Light
  • 3D Max


Many of the complications associated with hernia repair involving mesh are multi-factorial, and any case must undergo in-depth analysis to ascertain whether the defects of a hernia mesh played a role in the complications.  Here are some of the injuries which patients throughout the country are reporting following implantation of one of these hernia mesh products:

  • Mesh infection
  • Chronic, debilitating pain
  • Mesh migration
  • Mesh contracture
  • Hernia recurrence (as a result of migration and/or contracture)
  • Mesh rupture (aka “mechanical failure”)
  • Wound dehiscence
  • Fistula or sinus tract formation
  • Adhesions of mesh to bowel
  • Bowel perforation
  • Bowel obstruction (as a result of adhesions)

There are many other types of adverse health effects which can stem from these complications, and research is ongoing as to the direct relationship between polypropylene mesh implants and other conditions such as auto-immune disorders.

Joshua S. Kincannon, Lomurro Law Firm in Freehold, New Jersey is counsel in another emerging hernia mesh litigation, the Ethicon “Multi-Layered Hernia Mesh” Litigation, which is the subject of a pending MCL application in New Jersey State Court. Mr. Kincannon stated in support of the Bard MDL 2846: “For decades, medical device manufacturers have utilized polymers that are not safe or effective for permanent implantation in the human body.  The hernia mesh litigation is just another example of what happens when there is little to no oversight into how these products are designed, manufactured and sold to the public.”

 The moving plaintiffs are represented by Kelsey L. Stokes and George M. Fleming of Fleming, Nolen & Jez in Houston; Adam M. Evans and C. Brett Vaughn of the Hollis Law Firm in Prairie Village, Kansas; Troy A. Brenes of the Brenes Law Group in Aliso Viejo, Calif.; and Steven C. Babin Jr. of the Chapin Legal Group in Columbus, Ohio.

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Big Pharma’s Litigation War Chest: The 10 best-selling U.S.prescription drugs for the last 25 years are also all in pharmaceutical litigation

Mark A. York (May 25, 2018)











(MASS TORT NEXUS MEDIA) How many of these drugs have also been or will become involved in litigation related to the dangers of the drugs?  Shareholders see amazing investment returns, Big Pharma see earnings based bonuses for everyone and for the millions of unsuspecting consumers, WHAT’S THEIR RETURN? It’s a trail of Adverse Events, Medical Complications, Extreme Medical Bills and for thousand of patients who were prescribed these drugs, it equates to a death sentence and/or long term critical healthcare problems.

As you will see below of the Top 10 best selling drugs of the last 25 years, more than half have pharmaceutical litigation associated with the prescribing practices, failure to warn and numerous other major issues affiliated with these billion dollar drugs.

Next to each of these blockbuster drugs, you will find information regarding the legal issues and ongoing litigation if that drug is involved in current or historical litigation.

For more information on these drugs and many other pharmaceutical products putting consumers at risk see


  1. Lipitor

U.S. sales 1992-2017: $94.67 billion
Company: Pfizer
Indications: Treat high cholesterol and reduce the risk of heart disease

  1. Humira

U.S. sales 1992-2017: $75.72 billion
Company: AbbVie
Indications: Inflammatory diseases

  1. Nexium

 U.S. sales 1992-2017: $72.45 billion
Company: AstraZeneca
Indications: Stomach acid reflux, peptic and duodenal ulcers

     4. Advair

U.S. sales 1992-2017: $69.08 billion
Company: GlaxoSmithKline
Indications: Asthma and COPD

  1. Enbrel

U.S. sales 1992-2017: $67.78 billion
Company: Amgen
Indications: Autoimmune diseases

  1. Epogen
    U.S. sales until 1992-2017:$55.63 billion
    Companies: Amgen
    Indication: Anemia
  1. Remicade

U.S. sales 1992-2017: $54.67 billion
Company: Johnson & Johnson
Indications: Autoimmune diseases


U.S. sales 1992-2017: $54.67 billion
Company: Johnson & Johnson
Indications: Autoimmune diseases

  1. Abilify

U.S. sales 1992-2017: $51.34 billion
Companies: Otsuka/Bristol-Myers Squibb
Indications: Schizophrenia, bipolar disorder, and other CNS indications.

     9. Neulasta

U.S. sales 1992-2017: $47.40 billion
Company: Amgen
Indication: Boost white blood cells in patients undergoing chemotherapy

  1. Plavix

U.S. sales 1992-2017: $46.48 billion
Companies: Sanofi/Bristol-Myers Squibb
Indication: Prevent heart attack and stroke

When taking a look at 25 years’ worth of drug sales you will see some very familiar names popping up, including the megablockbuster cholesterol drug Lipitor and others that are very common across America.  But you’ll also find some drugs that aren’t the mass-market successes

Amgen’s staple anemia treatment Epogen, for one, even though its sales are in the multi-billions of dollars.

Beyond the drugs themselves, we gleaned some tried-and-true advice for drugs looking to make the top 10 two and a half decades from now. Launch timing, medical need, scientific improvement and marketing efforts all factor into a drug’s success. Often part of the business of Big Pharma are the cost of litigation. This means defending products, paying billion dollar settlements and the increased cost of marketing, damage control, placating the FDA and the American consumer to blindly accept these drugs as “good for you and in your best interests” all the while Big Pharma is concealing the litigation, fines, trial verdicts and governmental investigation into the failings of the pharmaceutical industry as a whole.

Ranked below are the 10 best-selling drugs in the U.S. by the revenue they accumulated from 1992 to 2017. In addition to Lipitor and Epogen, they include the blood thinner Plavix—long a cash cow for Bristol-Myers Squibb and Sanofi and still a big seller as a generic. And the big 3 immunology mainstays led by AbbVie’s Humira, which is predicted to become the first drug ever to pass $20 billion in annual sales.


  1. Lipitor
    U.S. sales 1992-2017:$94.67 billion
    Indications: Treat high cholesterol and reduce the risk of heart disease

Pfizer’s cholesterol-lowering drug Lipitor is by far the best-selling drug of all time. But it wasn’t a sure thing in the megablockbuster races. Originally developed by Warner-Lambert—bought by Pfizer in 2000 for a whopping $90 billion—and approved by the FDA in late 1996, Lipitor wasn’t even the first statin on the market.

But in a historic trial run by trailblazer Merck & Co., statins showed they could not only lower cholesterol but also lower heart attack incidents. Pfizer then padded its Lipitor case with some massive clinical studies proving its own worth. Meanwhile, increased public awareness of the potential link between bad cholesterol and the risks of heart disease, plus Pfizer’s marketing clout and the FDA’s relaxation of consumer advertising rules in 1997, together boosted Lipitor to the throne. Though sales declined dramatically after its patent expired in late 2011, even today, Lipitor is still a force to be reckoned with, with 2017 sales of $1.92 billion.     

  1. Humira
    U.S. sales 1992-2017:$75.72 billion
    Indications: Inflammatory diseases

Humira, first approved as a rheumatoid arthritis treatment, is the heir apparent, thanks to astronomical growth of its own and Lipitor sales declining post-patent cliff. On the last day of 2002, the anti-inflammatory therapy became the first fully human monoclonal antibody to reach the market. At that time, two TNF-alpha inhibitors, Enbrel and Remicade, had already been sold for more than four years.

But Humira’s convenience in administration—as a self-injection rather than IV—and AbbVie’s (then Abbott Laboratories) quick work at adding indications in other inflammatory diseases such as psoriatic arthritis, Crohn’s disease and juvenile idiopathic arthritis, helped it surpass the other two. Price hikes have also played a part in keeping Humira at the top. Just over the past five years, its price has more than doubled, according to Wells Fargo analyst David Maris. Thanks to a patent settlement, AbbVie will continue to rake in megablockbuster sales from Humira in the U.S. until 2023.       

  1. Nexium
    U.S. sales 1992-2017:$72.45 billion
    Indications: Stomach acid reflux, peptic and duodenal ulcers

Nexium, known as “the purple pill,” was AstraZeneca’s follow-up to its first reflux remedy, Prilosec (omeprazole). Approved in the U.S. in 2001, Nexium showed in clinical trials that it was better at treating gastroesophageal reflux disease, with higher healing rates compared to omeprazole. But some other studies didn’t find much difference among proton pump inhibitors, the class that includes both Nexium and Prilosec.

Because of the similarity in the two drugs, AZ was criticized for pushing for the new, more expensive Nexium. The drug was previously also at the center of a pay-for-delay lawsuit, where AZ allegedly paid Ranbaxy Laboratories to abandon its patent challenge. But Nexium kept on bringing in cash: Before Teva’s generic version and Pfizer’s OTC version hit in 2015, Nexium was returning around $3 billion in annual sales.

  1. Advair
    U.S. sales 1992-2017:$69.08 billion
    Indications: Asthma and COPD

GlaxoSmithKline’s Advair, a combination of fluticasone and salmeterol, is meant to treat asthma and COPD, two chronic respiratory diseases with high prevalence in the U.S. Delays in generic competition due to the hard-to-copy Diskus inhaler technology are a key reason why it still racked up £3.48 billion in 2016 sales.

Though it lost patent protection back in 2010, Teva only launched AirDuo RespiClick and its authorized generic last April. They come at a huge discount to Advair but aren’t readily substitutable for the GSK behemoth at the pharmacy. A long list of generic drugmakers, including Novartis’ Sandoz, Hikma and Mylan, are still struggling to get their versions past the FDA. Mylan said in early May that it’s expecting a generic approval in 2018.

  1. Enbrel
    U.S. sales 1992-2017:$67.78 billion
    Indications: Autoimmune diseases

Enbrel was the first TNF-alpha inhibitor, approved by the FDA in 1998 to treat rheumatoid arthritis and later expanded into other autoimmune diseases. Like latecomer Humira, Enbrel also comes with a big price tag. Even though it doesn’t boast as many FDA-approved indications as Humira, it’s still among doctors’ favorites. In 2017, the drug racked up $5.21 billion in U.S. sales, and Amgen has been able to stall the launch of a biosim from Sandoz with a patent suit.

  1. Epogen
    U.S. sales until 1992-2017:$55.63 billion
    Indication: Anemia

Approved in 1989, Epogen soon moved to dominate the kidney disease-related anemia market. With orphan drug status, it enjoyed a long exclusivity period, and it has contributed billions of dollars year after year to Amgen and Johnson & Johnson, which sells the drug under the Procrit brand (sales not included here). It could have faced direct competition from Roche’s Mircera as early as 2007, but an injunction prevented the Swiss drugmaker’s competitor from launching in the U.S. until 2014. Even after Medicare instituted new rules for use of anemia drugs in some patients, Epogen prevailed; for 2017, Epoetin alfa brought in $1.77 billion in U.S. sales. And it’s set for more despite expired patents. Efforts to bring biosimilars to the U.S. market have suffered several setbacks.

  1. Remicade
    U.S. sales 1992-2017:$54.67 billion
    Company: Johnson & Johnson
    Indications: Autoimmune diseases

Remicade emerged almost at the same time as Enbrel, but it was first approved as a treatment for Crohn’s disease, only later expanding into other inflammatory diseases such as rheumatoid arthritis and psoriatic arthritis. The requirement for intravenous infusion—which means inconvenience for patients and the additional cost of outpatient administration—marked a key disadvantage for Remicade against its TNF counterparts. Pfizer launched a biosim version in the U.S. back in 2016, but it hasn’t been able to steal much share from J&J, thanks to the branded drugmaker’s aggressive deals with payers.

  1. Abilify
    U.S. sales 1992-2017:$51.34 billion
    Companies:Otsuka/Bristol-Myers Squibb
    Indications: Schizophrenia, bipolar disorder, and other CNS indications.

Discovered by scientists at Otsuka, Abilify was greenlighted by the FDA in 2002 to treat acute episodes of schizophrenia and as a maintenance therapy in the same group of patients. More indications followed; the drug racked up approvals for bipolar disorder, add-on treatment of major depression, and autism. The antipsychotic later acquired a long-lasting sister called Abilify Maintena, an injectable that freed patients from daily pill-taking. The drug caught the industry’s attention last November when Otsuka won an FDA approval for Abilify MyCite, a digital version of the drug that has a sensor that digitally tracks patients’ dosing.

  1. Neulasta
    U.S. sales 1992-2017:$47.40 billion
    Indication: Boost white blood cells in patients undergoing chemotherapy

Approved in the U.S. in 2001, Neulasta is designed to help chemotherapy patients fight infection by boosting their white blood cell counts. Each year, about 650,000 cancer patients undergo chemotherapy in an outpatient setting in the U.S., according to the CDC. To help patients self-manage injections, Amgen rolled out the Neulasta Onpro kit in 2014. In 2017, Neulasta returned $4.53 billion in sales, and about 87% of that came from the U.S.

Though Neulasta’s shorter-acting predecessor Neupogen now faces biosimilar competition from Sandoz’s Zarxio, Neulasta doesn’t yet have a rival. Would-be biosim makers fell short with their FDA applications last year. But 2018 could well change that. Mylan says it’s on track for a Neulasta copy this year; the FDA is set to decide by June.

  1. Plavix
    U.S. sales 1992-2017:$46.48 billion
    Companies:Sanofi/Bristol-Myers Squibb
    Indication: Prevent heart attack and stroke

Plavix was approved in 1998 and became the standard-of-care blood thinner, earning a place on the WHO’s list of essential medicines. Plavix and Lipitor were the mainstays of the drug industry in the 1990s, so when Plavix’s patent expired in 2012—about half a year after Lipitor’s—it marked a major shift away from the mass-market megablockbuster era. With an influx of multiple generics from the get-go, Bristol-Myers Squibb and Sanofi were hit hard, as Plavix’s $7.1 billion in 2011 sales accounted for a third of BMS’ revenue for the year. But its legacy remains. Even today, new drugs like AZ’s Brilinta still use it as a comparator to demonstrate their products’ safety and efficacy.

For more information on these drugs and emerging pharmaceutical litigation across the country see the Mass Tort Nexus Emerging Litigation Briefcase: Emerging-Phase-Litigation

(images reposted from original content of

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Abilify Bellwethers Settle Right Before Trial Over Impulsive Gambling-Sexual Activity Claims

“With global settlement talks now in place less than a week later”

By Mark A. York (May 3, 2018)

Will Abilify MDL Settle By September 15, 2018?

(Mass Tort Nexus Media) The first pool of three bellwether trial plaintiffs have settled just before trials started in the Abilify MDL 2734 in front of Judge Casey Rodgers earlier this week, see Abilify Settlement Order Re First Bellwether Trial Pool Cases Entered April 28, 2018 (, related to the antipsychotic drug Abilify. The plaintiffs claimed after being prescribed the drug, Abilify made them gamble compulsively. All three cases were settled against the drug makers  Bristol-Myers Squibb Company and Otsuka America Pharmaceutical, for undisclosed amounts. The three Florida residents’ cases were scheduled for trial starting in June as bellwether trials, for case information see the Mass Tort Nexus Abilify briefcase, ABILIFY-MDL-2734-USDC-MDL-Florida (Briefcases/Drugs).

The Abilify multidistrict litigation includes 808 cases, as of April 16, and as of May 2, 2018 there is a Global Settllement Order in place, see Abilify MDL 2734 Global Settlement Order No. 1 Entered May 2, 2018, where Judge Rodgers gave the parties 120 days to finalize a framework of a global settlement, including a first phase outline of what will be classified as “no pay” cases, with these cases to be identified within 14 days of the global order or by May 16, 2018. Upon identification of the no pay cases, they will be removed from the MDL.

Also of note is language in the April 28th settlement order for the three bellwether trials, is a requirement that defendants must pay the settlement proceeds to plaintiffs, who in turn must execute full release and then, within 10 days, parties must file a stipulation of dismissal. Judge Casey has ordered the three cases to remain on the trial docket until the stipulated dismissals are filed. This appears to be another federal judge asserting direct control over the often lengthy and drawn out settlement talks  in MDL’s across the country. Judges are now moving cases toward settlement or setting them for trial, pursuant to the JPML rules of civil procedure outline.


The Abilify litigation is against defendants Japanese drugmaker Otsuka and Britsol-Myers Squibb, which marketed the drug in the U.S. until 2013 and related to plaintiffs being prescribed Abilify, an anti-psychotic medication commonly prescribed to treat a variety of mental disorders, which caused impulse control problems in users. The two primary impulse control claims are “impulsive gambling” and “uncontrollable sexual urges” with several plaintiffs claiming to have lost millions of dollars in gambling sprees brought on after consuming Abilify, while never having gambled before. The other control issue is “inability to control sexual urges or engaging in sexual promiscuity” resulting in ruined personal relationships and adverse health conditions, as well as related financial consequences.











Aripiprazole is available under the brand names Abilify, Abilify Maintena, Aristada, and also as generics. A search of the FDA Adverse Event Reporting System (FAERS) database and the medical literature in the 13 years since the approval of the first aripiprazole product (Abilify) in November 2002 identified a total of 184 case reports in which there was an association between aripiprazole use and impulse-control problems.

May 5, 2016 FDA Drug Safety Notice: FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)

ABILIFY (aripiprazole) – FDA: Adverse Reactions…/021436s038,021713s030,021729s022,021866s023…

Seizures/Convulsions. 5.10 Potential for Cognitive and Motor Impairment. 5.11 Body Temperature Regulation. 5.12 Suicide. 5.13 Dysphagia. 6. ADVERSE REACTIONS. 6.1. Clinical Trials Experience. 6.2. Postmarketing Experience. 7. DRUG INTERACTIONS. 7.1. Drugs Having Clinically Important Interactions with Abilify.


On October 3, 2016, the JPML consolidated pretrial proceedings for In Re: Abilify (Aripiprazole) Products Liability Litigation, MDL No. 2734, in the US district Court Northern district of Florida. The transferred actions share factual issues arising from allegations that Abilify (aripirazole), an atypical anti-psychotic medication commonly prescribed to treat a variety of mental disorders, can cause impulse control problems in users. All the actions involve factual questions of whether Abilify was defectively designed or manufactured, whether defendants knew or should have known of the alleged propensity of Abilify to cause compulsive gambling behaviors in users, and whether defendants provided adequate instructions and warnings with this product.

These cases were  assigned to the Honorable M. Casey Rodgers for coordinated discovery and pretrial matters.

Abilify Linked to Compulsive Behaviors

Details of the three Abilify settlements were not made public. But include payment by the defendants to the plaintiffs, as well as apparently opening the door for a full global settlement of the remaining 800 plus cases.

Introduced in 2002, Abilify became a blockbuster drug, generating nearly $8 billion a year by 2013. The following year, it was the top-selling drug in the U.S. Sales fell in 2015 when the first generic versions of the drug were approved.

The drug is prescribed to treat psychiatric conditions including bipolar disorder, schizophrenia and major depression.

Off-label uses include anxiety disorders, dementia and post-traumatic stress disorder. The drug has been linked to severe, compulsive behaviors, mainly gambling, sex and shopping.

Gambling Warning Added in 2016

About a week before the settlement was reached, the plaintiffs sought a court order allowing them to secure documents from Otsuka regarding Rexulti, the drug that was introduced when Abilify’s patent expired.

Plaintiffs argued in court filings that Rexulti had the same mechanism of action. The company didn’t begin to warn that Rexulti could cause compulsive gambling until January of this year. That warning was added to the Abilify label in the U.S. in August 2016.

The cases that settled are plaintiffs, Jennifer Lilly, David Viechec and Fanny Lyons.

Lyons’ lawsuit was scheduled to start trial June 18. According to court filings, she began taking Abilify around January 2009 and soon began compulsive gambling. She stopped taking the drug in January 2014 and stopped gambling soon after that. She claims to have lost more than $75,000.

Viechec was scheduled to have his case heard by a jury beginning Aug. 6. According to court filings, he was prescribed Abilify for bipolar symptoms from 2012 until late 2016. He also claimed to have lost more than $75,000 from gambling, which stopped after he stopped taking the drug.

Lilly’s case was scheduled to start trial on Aug. 27. According to her lawsuit, she took Abilify from 2003 to 2016. Her lawsuit claims unspecified gambling and other losses, including the loss of the ability to earn money.

The settlement of the three initial trials and entry of a global settlement order less than a week later seems to point to a decision by Bristol Myers and Otsuka that perhaps settling now versus waiting until adverse material and testimony come out at trial is the prudent legal strategy at this point.

Congratulations to Judge Casey for putting a timer on the settlement discussions and directing legal traffic in his MDL docket.



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