Fosamax Ruling: “A Small Win for Defense, A Big Win for Plaintiffs”

SCOTUS Fosamax Ruling (May 20, 2019)

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning

Small Win for Defendants

Defendants Won the argument that a Judge not a jury is the proper authority to decide impossibility preemption arguments arising under the FDCA (Food and Drug Cosmetics Act, Title 21). However, the win on this one issue is a hollow victory for defendants considering the entirety of SCOTUS order and opinion.

SCOTUS ruled that judges not juries are the proper authority to decide the issue however, SCOTUS also placed significant limits on what those lower court judges could and could not consider when ruling on impossibility pre-preemption arguments like those raise by Merck in the Fosamax Case.

JUSTICE THOMAS SUMMARY OF RULING

JUSTICE THOMAS, concurring:

I join the Court’s opinion and write separately to explain my understanding of the relevant pre-emption principles and how they apply to this case.

“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”

Big Win for Plaintiffs

SCOTUS ruled that Judges decide however, SCOTUS went much further and defined limits on what facts and information could be considered by lower court judges when making decisions related to impossibly preemption arguments like those raised by Merck in Fosamax.

SCOTUS opinion limits the clear and convincing evidence standards to OFFICAL Acts taken by the FDA which would in general rise1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

1. If the defendant did not go through the CBE process and make the change (the exact warning plaintiffs allege was needed) and the FDA later told them to remove the warning, then FDA OFFICALLY told them to remove the warning, then no pre-emption exists.

2. If the defendant did not ask to make the specific label change (which plaintiffs allege was needed) having provided the FDA all relevant information, and the FDA OFFICIALLY denied the label change, then no pre-emption exists.

Arguments that postulate “hypotheticals” (absent either of the above official actions (facts)) are not to be considered. Communications between the defendant and the FDA, Statements by the FDA that do not constitute an official act under the law, are not to be considered.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court heard arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse event being that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referred solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

SCOTUS RULED 9-0

Additional Concurring Opinion on the judgment only (Jury vs Judge only) from Justices Cavanaugh, Alito’s  and Chief Justice Roberts could be interpreted as allowing lower court Judges to consider other Official acts by the FDA other than those delineated above however, the additional opinion did not define what official acts other than the two discussed could be considered and inasmuch as these two official actions are constitute the limit of the powers relevant to such matters, delegated to the FDA by Congress, it is doubtful that a defendant could show a lower court Judge any other document (without posing hypotheticals) that would constitute an official action taken by the FDA that would have prevented the defendant from meeting its State Law duties (impossibility preemption).

In that the only powers delegated to the FDA by Congress (powers under the law) are those defined in the two types of actions listed above, relevant to the type of impossibility preemption arguments that were raised in Fosamax, based on unofficial actions, communications and statements from the FDA (and that defendants hoped to raise in numerous other cases) the Fosamax ruling taken in its entity, is a major blow to defendants hoping to open major cracks in Wyeth v Levine.

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 state and 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 with drugs. The federal law that we consider is the statutory and regulatory scheme through which the FDA regulates the information that appears on brand-name prescription drug labels. The alleged conflict between state and federal law 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 certain associated risks.

FOSAMAX HISTORY

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

MERCK SHARP & DOHME CORP. v. ALBRECHT Opinion of the Court(excerpt)

III

We turn now to what is the determinative question before us:

Is the question of agency disapproval primarily one of fact, normally for juries to decide, or is it a question of 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 a jury. The question often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute. Moreover, judges, rather than lay juries, are better equipped to evaluate the nature and scope of an agency’s determination. Judges are experienced in “[t]he construction of written instruments,” such as those normally produced by a federal agency to memorialize its considered judgments. Markman v. Westview Instruments, Inc., 517 U. S. 370, 388 (1996). And judges are better suited than are juries to understand and to interpret agency decisions in light of the governing statutory and 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 agency action”); see also H. R. Rep. No. 1980, 79th Cong., 2d Sess., 44 (1946) (noting longstanding view that “questions respecting 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 given the fact that judges are normally familiar with principles of administrative law. Doing so should produce greater uniformity 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 drug consumer and a drug manufacturer (which will ordinarily lack an official administrative record for an FDA decision), the litigants may dispute whether the drug manufacturer submitted all material information to the FDA.

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 subsidiary factual 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 somewhere between a pristine legal standard and a simple historical fact.’” Markman, 517 U. S., at 388 (quoting Miller v. Fenton, 474 U. S. 104, 114 (1985)). In those circumstances, “‘the fact/law distinction at times has turned on a determination that, as a matter of the sound administration of justice, one judicial actor is better positioned than another 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 we have described in Part II of our opinion, we vacate its judgment and remand the case to that court for further proceedings consistent with this opinion.

It is so ordered.

____________________________________________________________

How Big Pharma’s cadre of lobbyists and congressional insiders attempt to reap major dividends, as we address the Fosamax ruling remains to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is paying off very well.

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Why is the US Solicitor General Supporting Merck in Supreme Court Fosamax Preemption Appeal?

WILL BIG PHARMA LOBBYING EFFORTS BE PAYING DIVIDENDS IN 2019?

By Mark A. York (December 7, 2018)

The Supreme Court’s decision involving Merck’s osteoporosis drug Fosamax could have a ripple effect across Big Pharma and Mass Torts.

 

 

 

 

 

 

 

 

 

 

 

 

(MASS TORT NEXUS MEDIA) The U.S. Supreme Court agreed in June to hear Merck & Co.’s appeal in the long running Fosamax liability litigation, (MDL No. 2243, District Judge: Honorable Joel A. Pisano, USDC New Jersey) where plaintiffs are suing Merck & Co over its osteoporosis drug Fosamax, (see Fosamax [Merck] Appeal U.S. Court of Appeals 3rd Circuit).

The plaintiffs have requested the U.S. Supreme Court uphold a federal appeals court ruling that allowed their cases to move forward, however acting U.S. Solicitor General Jefferey Wall asked for permission to present oral arguments. It would be a plus for Merck, because Wall has been a major supporter of the Big Pharma position on the issue of preemption, which revolves around the question of whether FDA decisions protect pharma companies from state legal challenges.

How the Court answers this question will no doubt shape the drug and device industry for years to come. Levine provided that a drug manufacturer could not be held liable under a failure-to-warn theory if the FDA had previously considered—and rejected—a proposed amendment to the product’s warning label. But Levine did not clearly define when preemption would apply in these circumstances, and as a result, lower courts have struggled to uniformly apply this rule.  With Albrecht, the Court now has an opportunity to clear up the ambiguities left in Levine’s wake.

On December 3, 2018 the Supreme Court agreed to let the Solicitor General’s office participate in the oral arguments, which probably caused the executive suites at Big Pharma to raise a toast to Jeffrey Wall.

The pre-emption question dates back to the original Fosamax case, which was filed by patients who suffered femoral fractures while taking the osteoporosis drug. Merck added language to the product’s label about the risk in 2011, but more than 500 patients claimed that their injuries occurred before then, and Merck should have warned them sooner.

In January 2019, the full Supreme Court will hear arguments in Merck Sharp & Dohme Corp. v. Albrecht, a case arising out of the In Re: Fosamax (Alendronate Sodium) Products Liability Litigation. Fosamax is a drug used to treat osteoporosis, with a cited adverse evenet bieng that it may inhibit bone repair, which could result in an atypical femoral fracture.

The central claim at issue concerns the Fosamax warning label, which initially did not warn of the risk of an atypical femoral fracture. Plaintiffs contend that the label should have included such a warning, while Merck counters that it tried to add language addressing the risk of a “Low-Energy Femoral Shaft Fracture,” but was prevented from doing so by the FDA, who affirmatively told Merck to “hold off” on adding any such language until the FDA could decide on “atypical fracture language, if it is warranted.”  Ultimately, the FDA rejected Merck’s proposed warning label, stating that the justification for such language was “inadequate.” The FDA reversed course the following year, and Merck then added a risk of atypical femoral fracture to Fosamax’s label.

Based on these facts, Merck moved for summary judgment on the plaintiff’s failure-to-warn claims, arguing that such claims were preempted under Wyeth v. Levine because “clear evidence” demonstrated that the FDA would not—and did not—approve of the proposed label change.  The District Court agreed, but the Third Circuit did not, holding instead that: (1) Levine’s reference to “‘clear evidence’ referr[ed] solely to the applicable standard of proof,” which Merck failed to satisfy; and (2) the issue of whether the FDA would have rejected the label change was a fact question for the jury.

Merck said it tried to update the label earlier, but failed because the FDA rejected its proposed wording. Because it was the FDA’s call, pre-emption should apply, Merck claimed and Wall concurred. Now, the Supreme Court will offer 10 minutes for the U.S. to make its case.

“The government has a significant interest in the proper resolution of the case, which concerns the manner in which the scope and effect of an FDA labeling decision is determined in private tort litigation,” asserted Wall in his MOTION OF THE UNITED STATES AS AMICUS CURIAE FOR LEAVE TO PARTICIPATE IN ORAL ARGUMENTS.

At least three court members (Thomas, Gorsuch, and Roberts) appear likely to support preemption under this set of facts, and it would not be unreasonable for Kagan, Ginsburg, and/or Breyer to hold similarly, given that the latter two were both part of the Levine majority, which stated that preemption would apply if there existed “clear evidence that the FDA would not have approved a change[.]” Wyeth v. Levine, 555 U.S. 555, 571 (2009). The odds of a five-justice majority favoring preemption could be buttressed if Kavanaugh is confirmed. Regardless, all one can truly hope for is that the Court avoids a plurality decision, since such an outcome would leave the Third Circuit’s opinion intact and muddy the waters further.

SCOTUS Docket: Merck Sharp & Dohme Corp. v. Albrecht

17-290 3d Cir.  Hearing Date January 7, 2019

Issue: Whether a state-law failure-to-warn claim is pre-empted when the Food and Drug Administration rejected the drug manufacturer’s proposal to warn about the risk after being provided with the relevant scientific data, or whether such a case must go to a jury for conjecture as to why the FDA rejected the proposed warning. CVSG: 05/22/2018.

Date Proceedings and Orders (key to color coding)
Jun 23 2017 Application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, submitted to Justice Alito.
Jun 27 2017 Application (16A1264) granted by Justice Alito extending the time to file until August 22, 2017.
Aug 22 2017 Petition for a writ of certiorari filed. (Response due September 25, 2017)
Aug 31 2017 Waiver of right of respondents Affronti, Joanne, et al. to respond filed.
Sep 11 2017 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp. on 09/12/2017
Sep 19 2017 Waiver of right of respondents Esther Parker & Pamela Paralikis to respond filed.
Sep 20 2017 Blanket Consent filed by Respondents, Albrecht, Doris, et al. on 09/21/2017
Sep 21 2017 Order extending time to file response to petition to and including October 25, 2017, for all respondents.
Sep 22 2017 Because Justice Alito now realizes that he should have recused himself from consideration of this application, the order of June 27, 2017, is vacated. Pursuant to Rule 22.2, the application (16A1264) to extend the time to file a petition for a writ of certiorari from July 23, 2017 to August 22, 2017, has been submitted to Justice Sotomayor.
Sep 22 2017 Application (16A1264) granted by Justice Sotomayor extending the time to file until August 22, 2017. (Justice Alito is recused)
Sep 25 2017 Brief amicus curiae of Pharmaceutical Research and Manufacturers of America filed.
Sep 25 2017 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Oct 25 2017 Brief of respondents Doris Albrecht, et al. in opposition filed.
Nov 08 2017 DISTRIBUTED for Conference of 12/1/2017.
Nov 08 2017 Reply of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Dec 04 2017 The Solicitor General is invited to file a brief in this case expressing the views of the United States. Justice Alito took no part in the consideration or decision of this petition.
May 22 2018 Brief amicus curiae of United States filed (to be corrected and reprinted).
May 22 2018 Brief amicus curiae of United States filed (Corrected brief received 5/29/18).
Jun 05 2018 DISTRIBUTED for Conference of 6/21/2018.
Jun 05 2018 Supplemental brief of respondents Doris Albrecht, et al. filed. (Distributed)
Jun 07 2018 Supplemental brief of petitioner Merck Sharp & Dohme Corp. filed. (Distributed)
Jun 27 2018 DISTRIBUTED for Conference of 6/27/2018.
Jun 28 2018 Petition GRANTED. Justice Alito took no part in the consideration or decision of this petition.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits granted. The time to file the joint appendix and petitioner’s brief on the merits is extended to and including September 13, 2018. The time to file respondents’ brief on the merits is extended to and including November 14, 2018.
Jul 27 2018 Motion for an extension of time to file the opening briefs on the merits filed.
Sep 12 2018 Blanket Consent filed by Respondents, Doris Albrecht, et al..
Sep 13 2018 Brief of petitioner Merck Sharp & Dohme Corp. filed.
Sep 13 2018 Joint appendix (2 volumes) filed. (Statement of costs filed)
Sep 17 2018 Blanket Consent filed by Petitioner, Merck Sharp & Dohme Corp..
Sep 20 2018 Brief amicus curiae of Washington Legal Foundation filed.
Sep 20 2018 Brief amici curiae of Product Liability Adisory Council, Inc., et al. filed.
Sep 20 2018 Brief amici curiae of Pharmaceutical Research and Manufacturers of America, et al. filed.
Sep 20 2018 Brief amicus curiae of United States filed.
Oct 12 2018 Motion of the Acting Solicitor General for leave to participate in oral argument as amicus curiae and for divided argument filed.
Oct 26 2018 Justice Alito is no longer recused in this case.
Nov 14 2018 Brief of respondents Doris Albrecht, et al. filed.
Nov 21 2018 Brief amicus curiae of Public Citizen filed.
Nov 21 2018 Brief amici curiae of Commonwealth of Virginia, et al. filed.
Nov 21 2018 Brief amici curiae of Joseph Lane, M.D., and Vincent Vigorita, M.D. filed.
Nov 21 2018 Brief amici curiae of MedShadow Foundation, et al. filed.
Nov 21 2018 Brief amicus curiae of The Cato Institute filed.
Nov 21 2018 Brief amici curiae of Tort Law Professors John C. P. Goldberg and Benjamin C. Zipursky filed.
Nov 21 2018 Brief amici curiae of Public Law Scholars filed.
Nov 21 2018 Brief amici curiae of Jerome P. Kassirer, M.D., et al. filed.
Nov 21 2018 Brief amicus curiae of American Association for Justice filed.
Nov 28 2018 SET FOR ARGUMENT ON Monday, January 7, 2019
Nov 30 2018 CIRCULATED

The SCOTUS ability to resolve the preemption question could have a ripple effect on the entire pharma industry. The issue generated heated debate a few years back, when a liability case raised questions about whether generics makers can be held responsible for patients’ injuries, given that they must use label language the FDA approved for branded versions of the drugs.

In a close 5-4 decision, the justices ruled that generics makers could not be held liable in those cases.

Initially, it looked as if Merck would prevail in its preemption argument, too, as the  defense had won two bellwether lawsuits filed over alleged Fosamax injuries. Then, in 2014, a federal judge tossed out 5,000 lawsuits from patients who claimed their fractures were caused by Fosamax, followed by a federal appeals court reviving those cases by over-ruling that dismissal.

Lawyers representing the patients in this case have argued that Merck’s preemption argument is faulty because it’s largely based on an internal memo recounting a phone conversation one of its employees had with the FDA.

“Respondents are aware of no other preemption case in which the manufacturer relied on hearsay accounts of informal FDA communications,” the lawyers said in a recent brief.

Merck developed Fosamax to strengthen bones and reduce the risk of fractures from osteoporosis. However, numerous studies have linked the medication to an elevated risk of abnormal femur fractures. Furthermore, plaintiffs in the litigation argue that Merck had an intrinsic obligation to its consumers to provide stronger warnings that users could experience femur fractures from little or no trauma while taking the medication. This includes falling from standing height or less.

Merck introduced Fosamax in 1995, and the company didn’t add a thigh bone fracture risk warning label to the drug until 2011. Plaintiffs claim Merck knew about the risk for years but concealed it to maximize sales and profits.

Fosamax was a blockbuster drug with annual sales of over $3 billion, until the company  lost its exclusive patent rights in 2008, even then the brand name drug still brought in $284 million in sales in 2016.

Both Merck and the Solicitor General contend that if the FDA believed there was scientific reasoning to support a labeling change, the agency would have added the warning, because federal laws require it to do so.

As SCOTUS gets set to hear the case, many individuals and organizations have filed briefs in support, urging the justices to uphold the lower court ruling that would allow those thousands of Fosamax suits to go forward. Consumer watchdog group Public Citizen, for example, filed a brief earlier this month suggesting that Merck’s pre-emption argument is invalid because federal statutes do not support the idea that “the FDA’s rejection of a particular proposed warning constitutes a determination ‘that no new labeling language is warranted.’”

Besides, Public Citizen argued (PDF), SCOTUS should preserve patients’ rights to pursue drug liability claims in state courts, and by siding with Merck, the judges might make it much harder for those suits to be filed.

“Allowing patients to pursue tort claims against pharmaceutical manufacturers for injuries caused by inadequate warnings is important as both an incentive for manufacturers to be vigilant about product safety and a means to provide remedies to patients,” Public Citizen wrote. “For this reason, the case has important implications that go well beyond the interests of the parties.”

How Big Pharma’s cadre of lobbyists and congressional insiders appears to be paying major dividends as we approach 2019 remaons to be seen, but considering the wide-open lack of federal oversight for pharmaceutical and medical device manufacturers by the current administration, it would appear that Big Pharma investments in the FDA and related oversight agencies is apying off very well.

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

Mass Tort Nexus “CLE Immersion Course”

March 8-11, 2019 at The Riverside Hotel in Fort Lauderdale , FL

For class attendance information please contact Jenny Levine at 954.520.4494 or Jenny@masstortnexus.com.

       1. For the most up-to-date information on all MDL dockets and related mass torts visit  www.masstortnexus.com and review our mass tort briefcases and professional site MDL briefcases.

      2. To obtain our free newsletters that contains real time mass tort updates, visit www.masstortnexus.com/news and sign up for free access.

 

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