Over on the Drug & Device Law blog, Reed Smith partner Eric Alexander calls attention to Booker v. Johnson & Johnson, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014), a recent decision from the Ortho Evra multi-district litigation (MDL) extending the U.S. Supreme Court’s decision in Mutual Pharmaceutical Co. v. Bartlett, 133 S.Ct. 2466 (2013) from warnings-based claims to design-based claims. Booker recognized that Georgia law was preempted under Bartlett because it was impossible for the pharmaceutical company to comply with both the state law (which mandates that the product’s design be changed) and the federal law (which mandates that the product’s design not be altered after commercial released). The Drug & Device Law blog had predicted that design-defect preemption would be a natural extension or application of Bartlett, and Booker now provides legal authority for that proposition. Read the full post here.
The Good, the Bad and the Ugly: Top 10 Best and Worst Prescription Drug and Medical Device Decisions of 2013
As they do every year, authors from the Drug and Device Law blog have published a list of the top 10 best and worst medical device and pharma decisions of the past year. In addition to their standard analysis, this year two of the Reed Smith authors, Eric Alexander and Jim Beck, will be hosting a teleseminar on Wednesday, January 8th at 12 p.m. ET to discuss the decisions in more detail. Information on how to register can be found here.
As reported on Drug and Device Law Blog, in a five-to-four decision by Justice Alito, the Supreme Court has decided Mutual Pharmaceutical Co. v. Bartlett, No. 12-142, slip op. (U.S. June 24, 2013), a generic drug preemption case out of the First Circuit where that court had permitted the plaintiffs to recover on a “design defect” claim alleging that the drug should not have been sold at all, despite its FDA approval. The Supreme Court reversed. To read more about the decision, see Jim Beck’s analysis in his “Bartlett – A Big Win For Preemption” blog post.
Over at the Drug and Device Law Blog, there are several posts analyzing the meaning of the Second Circuit’s opinion in United States v. Caronia, 703 F.3d 149, 160 (2d Cir. 2012), including this one and this one. Most Caronia commentary has focused on the court’s First Amendment holding, that the FDCA does not ban truthful off-label speech. But today’s Drug and Device Law Blog post zeroes in on the Second Circuit’s recognition that “[t]he FDCA and its accompanying regulations do not expressly prohibit the ‘promotion’ or ‘marketing’ of drugs for off-label use” (id. (emphasis added)), and what that may mean for regulation and for ancillary issues, like medical device preemption under 21 U.S.C. Section 360k(a).
This post was written by Christopher C. Foster.
As many of you no doubt have heard, the United States Supreme Court last week decided that FDA regulations applicable to generic drug manufacturers preempt state law "failure to warn" claims in PLIVA, Inc. v. Mensing, Nos. 09–993, 09–1039, and 09–1501, 564 U.S. ___ (2011). Among other sites, SCOTUSblog, the FDA Law Blog and the PharmaExec blog all have had interesting discussions of the decision.
To recap, Justice Clarence Thomas authored the Supreme Court's majority opinion in PLIVA. The court concluded that federal law preempts state law "failure to warn" claims asserted against generic drug manufacturers, because those manufacturers are required by federal law to use warnings that are identical to those used by brand name manufacturers. The case, which consolidated actions from Minnesota and Louisiana, involved plaintiffs who developed a condition called tardive diskinesia after taking metoclopramide--a generic of the brand name Reglan--for several years. Slip. op. at 3.
The Court's decision focused on the distinct requirements federal law places on generic drug manufacturers with respect to their labeling. The Court explained that while a brand name drug manufacturer is responsible for the adequacy and accuracy of its label, a generic drug manufacturer is responsible for making sure its warning label matches that of its brand name counterpart. Id. at 6. As the FDA explained in its amicus brief, the duty of generic drug manufacturers with respect to its labeling is one of "sameness." Id. The Court held plaintiffs' claims preempted, concluding it was impossible for the generic manufacturers to comply simultaneously with the federal requirement that their labeling be the same as the brand name drug, and to simultaneously adopt a stronger label to comply with state law. Id. at 10-11.
Further, the Court rejected plaintiffs' argument that generic drug manufacturers should not be permitted to raise preemption as a defense, unless they had discharged their duty to ask the FDA for help in convincing brand name manufacturers to strengthen labeling. Id. at 13. The Court found that such an exception would prove too much, because a scenario can often be imagined where federal law may have allowed a party to also follow state law. Id. at 13-14. Yet the Supremacy Clause does not demand that a court strain to find ways to reconcile federal and state law. Id. at 15. "When the 'ordinary meaning' of federal law blocks a private party from independently accomplishing what state law requires, that party has established preemption." Id. at 17.
The Court recognized the tension this decision created with Wyeth v. Levine, 555 U.S. 555 (2009), which rejected preemption for failure to warn claims against brand name manufacturers just two years ago. It noted that had the plaintiffs taken the brand name drug, Reglan, rather than the generic drug, their lawsuit would not have been preempted under Wyeth. Id. at 19. It nevertheless rejected that as a reason for allowing plaintiffs to pursue their claims, noting that it was not its task to decide whether a statutory scheme adopted by Congress creates bizarre results. Id. at 19.
Much of the discussion about the case so far has focused on this issue of the tension between PLIVA and Wyeth, including what it means for implied preemption and how the lower courts should analyze preemption questions in the future. The decision is all the more interesting because it was authored by Justice Thomas, who garnered a fair amount of attention for stating in his concurring opinion in Wyeth that he was "increasingly skeptical of . . . the Court routinely invalidat[ing] state laws based on perceived conflicts with broad federal policy objectives, legislative history, or generalized notions of congressional purposes that are not embodied within the text of federal law." PLIVA makes clear that Justice Thomas does not require all federal preemption to be express, it is just that he wants implied preemption to also be firmly grounded in text as well.
Looking ahead, it seems likely that the Court's rejection of the argument that the generic manufacturers could have sought FDA assistance in changing the label is likely to create some interesting issues. The Court recognized that, in theory, the generic manufacturers could have acted under federal law to seek a change in its warning labels, but it rejected the argument because, even had the generic manufacturers done so, a label change ultimately depended on subsequent actions of the FDA and the brand name manufacturers. The Court seemed to accept the premise, though, that preemption could be denied to a party that "can act sufficiently independently under federal law to do what state law requires . . ." Slip. op. at 17. Just what "sufficiently independently" means, and the circumstances in which it may arise, remains an open question.
Regardless, this decision gives generic manufacturers a good defense to use in product liability cases going forward.
This post was written by Michelle L. Cheng.
One of the strongest defenses against product liability claims, including a failure to warn claim, is federal preemption. For cases against prescription drug manufacturers, defense lawyers have specifically asserted conflict preemption to argue that failure to warn claims are preempted by the FDA's regulations governing the content of labels for prescription drugs. Essentially, defense lawyers argue that the labeling's warnings cannot be altered in a manner sought by the plaintiff when the manufacturer is faced with conflicting directives from the FDA regarding that very content.
In ruling on this very issue, Wyeth v. Levine, 555 U.S. 555, 129 S.Ct. 1187 (2009) ("Levine"), the Supreme Court held that a "clear evidence" standard of proof was required to support a manufacturer's claim of conflict preemption defense. The Supreme Court held that unless the manufacturer presents "clear evidence that the FDA would not have approved a change" to the drug's label, which would make compliance with both the federal standard and the state standard espoused by the plaintiff "impossible," conflict preemption could not apply.
Post-Levine cases have grappled with this standard, with defendant manufacturers commonly failing to meet this "clear evidence" standard in asserting the defense of conflict preemption. Except recently. The latest decision from the Western District Court of Oklahoma demonstrates how the "clear evidence" of conflict standard provided (but not defined) in Levine could be met. Dobbs v. Wyeth Pharmaceuticals, No. 5:04-cv-01762 (W.D. Okla. June 13, 2011). In doing so, the District Court distinguished or rejected as unpersuasive five other decisions where courts applied the Levine evidentiary standard in failure to warn claims involving the same class of anti-depressant prescription drugs. Id. at p.21.
Dobbs is a case brought by the widow of a depressed patient who took several days' worth of a prescribed antidepressant called Effexor, before committing suicide. Among her claims, the widow plaintiff contended that Effexor's FDA-approved statements regarding suicidality in patients diagnosed with depression was inadequate in its failure to fully warn of the risk. Id. at p. 2. Wyeth, the manufacturer of Effexor, contested this assertion by pointing to a variety of the factors that the District Court found persuasive: 1) the FDA is statutorily responsible for continually monitoring the safety of approved drugs, and proposed changes to the labeling "must be 'based on 'reasonable evidence of' an association between a hazard and the drug at issue…." [id. at p.10-11]; 2) the FDA had repeatedly considered the "proper scope and content of suicidality warnings for the class of drugs that are used to treat depression [id. at p. 12]; 3) in addition to such consideration, the FDA had "consistently expressed concern that an enhanced suicidality warning [was] not supported by scientific evidence" which could create the adverse consequence of a "potential reduction" in the use of drugs for the treatment of depression [id.]; 4) in 2002, the same year the decedent committed suicide, the FDA concluded that a more extensive suicidiality warning was not supported by scientific evidence (and thus, would not have approved of the warning that the plaintiff argued should have been used) [id. at *16]; and 5) in 2004 and 2006, the FDA concluded that increased suicidal thinking or behavior in pediatric patients and patients under the age of 25 years using these class of drugs was supported by sufficient scientific evidence, but the decedent in this case was 53 years old when he committed suicide [id. at 17]. In sum, the District Court found that the "FDA's ongoing study and analyses" regarding these warnings, and the FDA's lack of any findings regarding scientific evidence to support the addition of suicidality warnings for patients in the decedent's age pool, compelled a finding of conflict preemption. Id. at p. 18-9; see also p. 21.
The District Court's extensive and careful recitation of the facts, along with its review and treatment of the other post-Levine decisions, provides a useful framework in which to advocate and win on the defense of conflict preemption for failure to warn claims.
On Tuesday, August 4, 2009, the Senate Committee on Health, Education, Labor and Pensions met for a hearing called "Protecting Patients from Defective Medical Devices" regarding Senate Bill 540, a companion bill to the House bill, H.R. 1346, the "Medical Device Safety Act of 2009." The House Subcommittee on Health, of the Committee on Energy and Commerce also met earlier this year on this issue, with some of the same speakers.
S. 150 and H.R. 1346 seek to overturn the Supreme Court's important ruling in Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that the PMA approval process for Class III devices imposes federal requirements that preempt state tort claims which would impose additional or different "requirements" regarding the safety and efficacy of the device, pursuant to the express preemption clause found in the Medical Devices Amendment of 1976.
Speaking in support of the bill were William Maisel, Director of the Medical Device Safety Institute, Thomas McGarity, Professor at the University of Texas School of Law, and Michael Mulvihill, a patient who was formerly implanted with a medical device. The arguments they presented echoed those of preemption opponents.Continue Reading...
On August 4, 2009 at 2:30 p.m., it will be the Senate's HELP Committee's turn to hold a hearing entitled "Protecting Patients from Defective Medical Devices". No witness list is yet posted.
For our coverage on past hearings on this issue, click here.
Since last year, a number of courts have interpreted and applied the express preemption holdings of Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008). Miller v. DePuy Spine, Inc., 07-cv-01639, 2009 US Dist LEXIS 49602 (D. Nev. May 1, 2009), is another example and, although it was decided on May 1, has just recently been picked up by LEXIS.
In Miller, the Nevada District Court granted summary judgment for the manufacturer of a PMA approved spinal implant disc called the Charite Artificial Disc. While many courts, including this one, correctly follow Riegel and hold that the state law claims challenging the design, manufacture and labeling claims are expressly preempted, this court also entered judgment for the defendant on warranty and misrepresentation claims that have a received a more mixed reception in some courts.
As to express warranty, Miller concluded that the plaintiff failed to establish the receipt of any express warranties, and that such warranty claims directly challenged the safety and effectiveness established through PMA approval of the device. The Court further held that even when couched as a warranty claim , claims are preempted when they would "impose liability for the defendant's use of labeling approved and required by the FDA."
The plaintiff also claimed to assert "parallel claims" contending that the implanted device was "out of conformity with the materials or manufacturing specifications approved by the FDA," but the court dismissed these as well because plaintiff failed to meet his burden in demonstrating that there was a genuine issue of fact. As the Court succinctly noted: "Only a departure from such FDA-approved specifications could conceivably escape preemption, and absence of any evidence of such departure justifies summary judgment."
Plaintiff's claims that the manufacturer allegedly made misrepresentations or omissions of material information to the FDA in order to "secure or maintain the PMA" were also dismissed. Not only had the plaintiff offered only "argument about this hypothesis" rather than admissible evidence, under 21 U.S.C. Section 337(a), any attempt to enforce the FDCA and its regulations were preempted; and any contention that the manufacturer provided inaccurate or incomplete information to the FDA was impliedly preempted under Buckman v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001).
The White House Press Office just released a Memorandum for the Heads of Executive Departments and Agencies re Preemption. Regarding actions by the executive branch intended to preempt state law, it directs:
1. Heads of departments and agencies should not include in regulatory preambles statements that the department or agency intends to preempt State law through the regulation except where preemption provisions are also included in the codified regulation.
2. Heads of departments and agencies should not include preemption provisions in codified regulations except where such provisions would be justified under legal principles governing preemption, including the principles outlined in Executive Order 13132.
3. Heads of departments and agencies should review regulations issued within the past 10 years that contain statements in regulatory preambles or codified provisions intended by the department or agency to preempt State law, in order to decide whether such statements or provisions are justified under applicable legal principles governing preemption. Where the head of a department or agency determines that a regulatory statement of preemption or codified regulatory provision cannot be so justified, the head of that department or agency should initiate appropriate action, which may include amendment of the relevant regulation.
Washington Legal Foundation's latest Legal Backgrounder, the "Logic of Michigan's 'FDA Defense' Survives Recent Supreme Court Ruling", authored by Thomas J. Foley, explains why the Wyeth v. Levine, 129 S.Ct. 1187 (2009) ruling does not support a rationale to overturn Michigan law that provides a defense against drug product liability suits where the manufacturer obtained FDA approval.
House Subcommittee Holds Hearing To Overturn Riegel: H.R. 1346, the "Medical Device Safety Act of 2009"
On May 12, 2009 the Subcommittee on Health, of the Committee on Energy and Commerce, House of Representatives, held a hearing on H.R. 1346, the "Medical Device Safety Act of 2009". If passed, it would overturn the Supreme Court decision, Riegel v. Medtronic, Inc., 128 S.Ct. 999 (2008), which held that under the express preemption clause of the Medical Devices Amendment of 1976 (MDA), the federal requirements created by the premarket approval process for Class III devices preempted state law tort claims that added or differed from the federal requirements. This hearing comes at the heels of public and media scrutiny of this decision, including last year's House Committee on Oversight and Government Reform preemption hearing held May 14, 2008 and the Senate Judiciary Committee's preemption hearing held June 11, 2008.
Before the invited panel of witnesses spoke, numerous members of the subcommittee provided opening remarks, which reflected the division among those who argued that the Supreme Court's analysis in Riegel departed from the legislative intent of the MDA, and those who agreed that the pending legislation would prevent innovation and access to medical devices that are life-saving. Arguments against the bill also noted that moving against preemption would otherwise place safety concerns in the hands of juries across the country, instead of on the FDA's safety and efficacy evaluations. Some focus was also placed on the FDA's effectiveness in policing the manufacturers, with several congress members such as Representative John Dingell, MI and Henry Waxman, CA arguing that the FDA has not been able to identify and take action on defective products, therefore calling into question their effectiveness in ensuring safety, while other congress members such as Representatives Steve Buyer, IN and Michael Burgess, TX argued that if the FDA is underfunded and without resources, the Committee should focus on the FDA, not on tort reform.
Most of the invited witnesses were repeat appearances from last year's hearing. David Vladeck, J.D., Professor of Law, Georgetown University Law Center presented his case in support of the bill, and repeated his concerns about the Riegel court's alleged deviation from congressional intent as reflected in legislative history. He also argued that manufacturers brought the express preemption defense to fore and that it was a more recent phenomena since the mid 1990s, after the Cipollone v. Liggett Group, Inc., 505 U.S. 504, 517, 112 S.Ct. 2608, 2618 (1992) decision.
William H. Maisel, M.D., M.P.H., Director, Medical Device Safety Institute, Department of Medicine, Beth Israel Deaconess Medical Center, Boston also testified, as both a practicing cardiologist and as a consultant and advisory committee member for the FDA. He provided anecdotal background with what he represented as an example of a man who was implanted with a St. Jude pacemaker that allegedly was subjected to a recall and resulted in additional surgical procedures. In making this example, Dr. Maisel argued that the self-interest of companies are at odds with the congressional goal of ensuring public safety. Gregory Curfman, M.D., Executive Editor, New England Journal of Medicine also echoed similar sentiments, and discounted the arguments made about innovation and safety for consumers being mutually exclusive.
Richard Cooper of the law firm Williams & Connolly LLP provided a big-picture review of what it would mean to have 50 state juries take the place of the FDA and seasoned clinicians when determining what constitutes a "defect" meriting liability. Mr. Cooper also emphasized that innovation would be hampered should preemption be denied to medical device companies, noting how many smaller companies that are focused on under-served areas of practice would be litigated out of their market share.
Bridget Robb of Pennsylvania and Michael Kinsley of Washington both presented anecdotal history with medical devices. Ms. Robb testified about her experience with a cardiac lead that she claimed unnecessarily shocked her and caused grievous subsequent emotional and physical injury, while Mr. Kinsley presented his story of how deep brain stimulation and other implanted medical devices has allowed him to lead a productive life despite a Parkinson's Disease diagnosis. Both presented different takes on the limits of how much risk a patient should face when balanced with the potential benefits offered by their medical devices.
Prior to the hearing, the Energy & Commerce Committee also published a letter asking the FDA to reexamine its decision to approve a medical device called the "collagen scaffold" that is used to reinforce and repair the meniscus, which is a natural cushion in the knee. This letter, as addressed to the FDA Principal Deputy Commissioner, seeks reexamination of the approval decision that the authors argue was made over the objection of FDA scientists.
For more information, please see the previous post "Will The May 12 Hearing On The "Medical Device Safety Act of 2009" Recognize The Costs Of Eliminating Preemption?"
Will The May 12 Hearing On The "Medical Device Safety Act of 2009" Recognize The Costs Of Eliminating Preemption?
The House Committee on Energy and Commerce's Subcommittee on Health will hold a hearing on Tuesday, May 12, 2009, at 2:00 p.m. regarding a bill to overturn medical device preemption (H.R. 1346 /S. 540), called the "The Medical Device Safety Act of 2009.” Although the hearing is not yet listed on the Subcomittee's website, hearing materials should become available here. (If you are interested, video and transcripts also are available from last year's lopsided House Committee on Oversight and Government Reform preemption hearing held May 14, 2008 and the Senate Judiciary Committee's preemption hearing held June 11, 2008.)
Those in the industry will find H.R.1346/ S. 540 ironically named, as patient access to critical new devices and public health would suffer if this bill passes. These ill effects are detailed in a new economics study, “The Economic Impact of Eliminating Federal Preemption for Medical Devices on Patients, Innovation and Jobs” by Ernst Berndt, PhD, and Mark Trusheim of the Massachusetts Institute of Technology’s Sloan School of Management. As the authors state in the executive summary to their article,
"Eliminating preemption protection for medical devices—as some currently advocate—will impact:
1. Patient access and public health
2. Medical technology innovation rates
3. Industry employment
4. Government expenses as a healthcare payer, regulator and judicial funder
The results from eliminating preemption are likely broad and generally negative across this host of categories."
The article is thoughtful and well worth reading.
The Supreme Court had held action on a petition in Colacicco v. Apotex, Inc., No. 08-437, an implied preemption decision out of the Third Circuit involving an anti-depressant, pending the outcome of Wyeth. The docket now reflects that the case has been distributed for the Court's March 6, 2009 conference. The most likely outcome is that the Court will issue an order remanding the case to the Third Circuit for reconsideration in light of Wyeth.
Section 2 of the FDA Globalization Act OF 2009, H.R. 759, merits the attention of the life sciences industry. It provides:
This Act and the amendments made by this Act may not be construed as modifying or otherwise affecting any action or the liability of any person (as defined in section 201 of the Federal Food, Drug, and Cosmetic Act) under the law of any State.
Although the life sciences industry continues to await the Supreme Court's decision in the Wyeth v. Levine preemption case, the court already is half-way through this term.
The Washington Legal Foundation (WLF) will be holding its annual Midterm Supreme Court Media Briefing event on Wednesday, February 11 at 9:00 a.m. EST:
The program will be moderated by WLF’s Legal Policy Advisory Board Chairman, The Honorable Dick Thornburgh, and feature Akin Gump partner and SCOTUSblog creator and editor Thomas Goldstein, Gibson, Dunn & Crutcher partner and former Deputy Solicitor General Thomas Hungar, and WLF Chief Counsel Richard Samp. In addition to reviewing key Court rulings, previewing upcoming oral arguments, and assessing pending cert petitions, our speakers will discuss the impact a new Solicitor General will have on current cases and petitions, as well as positions taken by the Federal Government in future cases.
The FDA last Monday issued a proposed rule to classify "tissue expanders" as Class II (special controls) medical devices. These devices are "intended for temporary (less than 6 months) subdermal implantation to stretch the skin for surgical applications."
What makes this notice interesting is preemption. In Riegel v. Medtronic, 128 S.Ct. 999 (2008), the Supreme Court upheld preemption in part because it concluded that the premarket approval (or PMA) process for Class III medical devices results in "federal requirements" specific to the approved device. In the tissue expander proposed rule, the FDA explains its view that these special controls also amount to federal requirements that should result in preemption. It states:
"In this proposed rulemaking, FDA has tentatively determined that general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and that there is sufficient information to establish special controls to provide such assurance. FDA therefore proposes to establish special controls to address the issues of safety or effectiveness identified in the special controls draft guidance document. If this proposed rule is made final, these special controls would create 'requirements' for specific medical devices under 21 U.S.C. 360k, even though product sponsors would have some flexibility in how they meet those requirements (Papike v. Tambrands, Inc., 107 F.3d 737, 740-42 (9th Cir. 1997)). In addition, if this rule becomes final, as with any Federal requirement, if a State law requirement makes compliance with both Federal law and State law impossible, or would frustrate Federal objectives, the State requirement would be preempted. (See Geier v. American Honda Co., 529 U.S. 861 (2000); English v. General Electric Co., 496 U.S. 72, 79 (1990); Florida Lime & Avocado Growers, Inc., 373 U.S. 132, 142-43 (1963); Hines v. Davidowitz, 312 U.S. 52, 67 (1941).)"
Although this is the first reference we have seen to Riegel in a proposed rule to establish Class II special rules, the FDA is actually not breaking new ground. In 1997, the Papike upheld preemption in a case involving tampons (a Class II device) and an alleged failure to adequately warn of toxic shock syndrome since the FDA had issued regulations specifying the toxic shock syndrome required for tampon packaging. Other tampon cases have followed Papike, and there have been a few latex glove cases, too. See, e.g., Whitson v. Safeskin Corp., 313 F.Supp.2d 473, 479 (M.D. Pa. 2004); Busch v. Ansell Perry, Inc., 2005 WL 877805 (W.D. Ky. Mar. 8, 2005).
UPDATE: Mark Hermann and Jim Beck at druganddevicelaw.blogspot.com have posted some interesting commentary on this proposed rule, noting - among other things - that even without reference to preemption, "both a 1998 regulation applicable to latex gloves, and a 1997 regulation applicable to contact lens care products, have likewise been accorded preemptive effect due to their specificity. See Morgan v. Abco Dealers, Inc., 2007 WL 4358392 (S.D.N.Y. Dec. 11, 2007) (latex gloves); Tuttle v. Ciba Vision Corp., 2007 WL 677134 (D. Utah Mar. 1, 2007) (contact lens care products)."
Their Top 10 lists of the good and bad drug and device cases from 2008 also are not to be missed.
Below are some notes regarding the presentation by the FDA's Gerald Masoudi today at the ACI Drug and Device Conference. Every effort was made to capture his comments accurately, but please excuse any errors created by capturing these comments on a BlackBerry:
FDCA gives FDA role of determining safety and efficacy and warnings, considering factors including patient profile and public health considerations.
Labeling is key method by which FDA communicates risks and benefits. FDA decides for populations, not individuals, and requiring safety and efficacy for every individual would lead to the absence of treatments.
Even with proper risk benefit judgment and prescribing, injuries can occur.
Products should neither under- nor over-warn.
State tort lawsuits decrease patient access, limit treatment options and interfere with the agency's judgments.
Preemption does not reach manufacturers' failure to comply with federal requirements (such as contamination with toxic substance) since there would be no interference with the FDA's judgment.
FDA will make mistakes, but allowing juries to make failure-to-warn determinations would not be superior to the current system and the current role of FDA.
In Wyeth v. Levine, the court may issue a narrow decision--we all will have to wait to see. But it is not new for FDA to support preemption. It has been the agency position in litigation, testimony, and preambles to rules. FDA reiterated its support recently in a pregnancy labeling proposed rule and CBE rule from earlier this year. This readoption should answer any question that the agency's Final Rule on drug labeling, which also had preemption in a preamble, was improperly promulgated.Continue Reading...
The gap that the Supreme Court's non-precedential decision, Warner-Lambert Co., LLC v. Kent, 128 S.Ct. 1168 (2008), left open earlier this year continues to force the lower courts to take sides, as was done in the latest case - Grange v. Mylan Labs., Inc., Case No. 1:07-CV-107 (N.D. Utah Oct. 31, 2008). Specifically, the controversy remains on whether fraud-on-the-FDA claims ruled preempted by the Supreme Court in Buckman Co. v. Plaintiffs' Steering Committee, 531 U.S. 341 (2000) will preempt exceptions that are put forth to overcome a statutory presumption that would otherwise bar recovery. So far, the Sixth Circuit in Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004) has held that such claims are preempted; the Second Circuit in Desiano v. Warner-Lambert & Co., 467 F.3d 85, 97 (2d Cir. 2006) has held that they are not.
In this latest case, the District Court of Utah found the Sixth Circuit's reasoning more persuasive in deeming the exception to a statutory presumption for punitive damages preempted, because the exception was triggered where there was evidence that the manufacturer of a manufacturer's knowing withholding or misrepresentation of information required to submit to the FDA. The court in Grange stated:
"That said, the Sixth Circuit's decision in Garcia is more persuasive here. The chief problems that Buckman sought to counteract are present whenever a plaintiff, as a prerequisite to collecting damages, is required to put on evidence that there was what amounts to fraud on the FDA. When such evidence is considered, state courts are essentially second-guessing the FDA and drug companies, nervous about state litigation, will have an incentive to flood the FDA with information. The court accordingly agrees with Garcia, and holds that Utah Code Ann. § 78B-8-203(2) is, in part, preempted. Specifically, to the extent that Utah Code Ann. § 78B-8-203(2) allows for an exception in cases where a plaintiff puts on his or her own independent evidence of information being withheld from the FDA, this statute is preempted. There is no preemption, however, in a situation where a plaintiff invokes Utah Code Ann. § 78B-8-203(2) to seek punitive damages in cases where the FDA itself has found that there was fraud in the application process."
For more, see Drug and Device Law's post about this case from earlier this morning.
In its November 2008 issue, the Harvard Law Review will publish "Preemption of State Common Law Claims," 122 Harv. L. Rev. 405, an article that discusses Riegel v. Medtronic, Inc., 128 S.Ct 999 (2008) and its impact on state law claims.
Of note, the authors state: "Despite criticisms that it leaves tort victims uncompensated, preemption is necessary to ensure that federal regulatory agencies, like the Food and Drug Administration (FDA), are the only governmental actors able to impose requirements on manufacturers – thereby ensuring a nationally standardized system of safety regulations without myriad local variations."
The authors also tackle an issue Riegel left open: "How to treat preemptive force of FDA regulation if agency approval is obtained by fraud." The authors acknowledge Buckman Co. v. Plaintiffs' Steering Committee, 531 U.S. 341 (2001), noting that if a state fraud claim "interferes with FDA regulatory decisions, preemption is likely to be (correctly) found." The authors opine that such actions should go forward only in situations "that would not impede the FDA's ability to choose its own enforcement strategy." Id.
In "Ex Parte Talks Allowed Under Georgia Law For Counsel, Doctors Preempted by HIPAA" (password required), the United States Law Week discusses in detail Moreland v. Austin, Georgia Sup. Ct. No. S08G0498, a November 3, 2008 decision holding that defense attorneys who wish to engage in ex parte communications with plaintiffs' treating physicians must comply with HIPAA privacy rules. Since HIPAA affords more patient privacy than a Georgia law that permitted ex parte contact once a plaintiff put his or her medical condition at issue, the Georgia law was preempted.
Preemption giveth, and preemption taketh away.
In Carter v. Novartis Consumer Health, Inc., --- F. Supp. 2d --- , No. EDCV08-0334 MRP (JCRx) (C.D. Cal. Aug. 5, 2008) and its companion cases, the Central District of California addressed the express preemption clause of Section 379r of the Food, Drug and Cosmetic Act governing OTC drugs. Here, the parents of children younger than age 6 filed a complaint against manufacturers alleging that the OTC cough and cold medicines "d[id] not work" and were dangerous to their children. There were no requests for damages based on injuries, but rather for the economic harm of purchasing these products. Plaintiffs also sought injunctive relief, pursuant to various state consumer fraud statutes, and each case sought to certify a class on behalf of all others similarly situated.
The court granted the defendants' motion to dismiss based on federal preemption for all of the claims (unjust enrichment, false and misleading advertising, fraudulent concealment, unfair and deceptive business practices, and breach of express and implied warranties), noting that OTC cough and cold medicines are regulated by the FDA pursuant to the OTC monograph, generally described within 21 CFR part 341. Such OTC monographs set forth approved indications for use and age-dependent dosage instructions that must comply with all FDA regulations, and are therefore generally recognized as safe and effective. Claims attacking these federal "requirements" therefore preempted the state "requirements" established by the state law claims. Of particular note was the court's understanding that the state requirements were not defined by its label, but "its ultimate outcome: would a finding of liability impose requirements that are different from or in addition to FDA requirements?" p. 13. Because the claims were premised on attacks based upon FDA-approved statements in product labeling and advertising, such claims were preempted.
Tomorrow's JAMA contains an editorial entitled, "Prescription Drugs, Products Liability, and Preemption of Tort Litigation" (subscription) by Catherine D. DeAngelis; Phil B. Fontanarosa (JAMA. 2008;300(16):1939-1941 (doi:10.1001/jama.2008.513)).
Suffice it to say, the premise that tort litigation safeguards patient health is faulty. Ensuring patient access to innovative and needed medical options is essential. See Riegel v. Medtronic, Inc., 128 S. Ct. 999, 1009 (2009) (discussing the express preemption statute for medical devices and stating, "the text of the statute - suggests that the solicitude for those injured by FDA-approved devices, which the dissent finds controlling, was overcome in Congress's estimation by solicitude for those who would suffer without new medical devices if juries were allowed to apply the tort law of 50 States to all innovations.").
In Parker v. Stryker Corp., 2008 WL 4457864 (D. Colo. Oct. 1, 2008), the District of Colorado addressed Riegel v. Medtronic, Inc., 128 S. Ct. 999 (2008), and the applicability of the express preemption clause of the Medical Device Amendments in a case where the manufacturer sought a discovery stay pending resolution of its motion to dismiss product liability claims regarding its PMA device, a hip implant. Although the motion to dismiss has not yet been resolved, the court exercised its discretion to decline the stay to allow discovery into plaintiffs' claims which supposedly parallel federal requirements. The case is not reported, and its lack of detail means it has limited value (if any) to future courts. So does Parker's failure to address authorities that shape and define what this so-called "parallel requirements" exception really takes. Medtronic, Inc. v. Lohr, 518 U.S. 470, 495 (1996) (state duty must be "identical" to the corresponding existing federal requirements for a plaintiff to survive preemption); see also McMullen v. Medtronic, Inc., 421 F.3d 482, 489 (7th Cir. 2005) (even a permitted act that is turned into a state requirement will not constitute a "parallel" requirement).
Preemption issues reach many products in the life sciences industry, and for preemption geeks, one category of over-the-counter (OTC) drugs is frequently featured in preemption jurisprudence: head lice treatments. Mills v. Warner-Lambert Co., --- F.Supp.2d ----, 2008 WL 4488308 (E.D.Tex. Sept. 30, 2008) is the latest. In Mills, the Eastern District of Texas interpreted and applied the express preemption provision for nonprescription drugs, Section 379r of the Federal Food, Drug and Cosmetic Act. Plaintiffs asserted that the lice treatment medications manufactured and sold by the defendants were ineffective, and asserted claims of breach of implied warranty of merchantability and violation of the Texas Deceptive Trade Practices Act. Defendants argued that Section 379r preempted these claims because they constituted a requirement on the marketing and sale of the products that differed from that provided under the FDCA. The district court agreed, holding that (1) while the medication was not approved through the NDA process but through the "monograph system for over-the-counter drugs," the FDA's oversight and review over the medication constituted a federal requirement within the meaning of Section 379r; (2) the plaintiffs' lawsuit would create a state requirement related to the medications, which followed that same holding in Riegel; (3) this state requirement would be different from, and in addition to, the federal requirement that allowed these manufacturers to sell the lice medication labeled as they were; and (4) the savings clause of Section 379r(e), which saved product liability claims from preemption, would not operate the same as for claims that were based on a contractual ground.Continue Reading...
SCOTOSblog has its usual comprehensive coverage of the first Supreme Court case of this term, Altria Group v. Good, which involves questions of express and implied preemption in the context of tobacco.
As Lyle Denniston explains, "More than four decades ago, the Federal Trade Commission – the federal government’s main regulator of business conduct – told the major companies making and selling cigarettes that it would not challenge factual statements they made about the tar and nicotine content of cigarettes, if the claims were based on tests done using what is called the “Cambridge Filter Method.”
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Three individuals who live in Maine – Stephanie Good, Lori A. Spellman and Allain L. Thibodeau – filed a class-action lawsuit, based on state law . . . . The low yields of the test method, according to the lawsuit, were offset by the actual smoking habits of users: they “compensated” by taking deeper puffs, holding the smoke in their lungs longer, or smoking more cigarettes. The lawsuit did not seek compensatory damages, but rather a return of the money smokers had paid for “light” cigarettes, along with a claim for punitive damages and recovery of their attorneys’ fees.
Philip Morris sought dismissal of the case, contending that state law claims had been displaced by the federal cigarette labeling and advertising law or FTC actions. The company made two claims of “preemption” of such state law claims: it said they were expressly pushed aside by the federal law controlling cigarette marketing, and were impliedly preempted by the FTC’s four-decades-long effort to implement a uniform policy on disclosing the health risks of smoking. A U.S. District Court dismissed the lawsuit on preemption grounds, but the First U.S. Circuit Court of Appeals in Boston reinstated it."
Links to the full analysis and briefs are on the case's SCOTUSwiki page, and links to the argument should be up very soon.
UPDATE: The transcript is now available.
The California Court of Appeal reversed a lower court's holding for a generic pharmaceutical manufacturer and distributor, and held that implied preemption principles did not preempt the state law claims challenging the labeling for a generic drug. In McKenney v. Purepac Pharms. Co., --- Cal. Rptr. --- , 2008 WL 4355425 (Cal. App. Sept. 25, 2008), the lower court granted the manufacturer's demurrer without leave to amend, holding that because the defendant was a manufacturer of the generic drug, metroclopramide, it could not deviate from the original FDA approved warnings for the product. The reviewing court rejected this specific holding by stating that the FDA allows generic manufacturers to change its labeling with new safety information given the existence of supporting evidence. (57 Fed. Reg. 17950, 17961). The court also examined the Carlin v. Superior Court, 13 Cal. 4th 1104 (1996) decision that imposed liability for labels that failed to warn of risk that were known or reasonably known by the manufacturer. The court in Carlin noted the company's argument that the FDA evinced no intent to impliedly preempt state law claims, and nothing indicated that this intent had changed now. While the manufacturer showed more recent changes indicative of the FDA's intent, the court stated that this was particular case did not demonstrate the type of conflict preemption upheld in other cases, such as instances where the FDA precluded the manufacturer from including certain warnings for the drugs.
This post was written by Michelle Lyu.
The plaintiff in Hearn v. Advanced Bionics Corporation, No. 06cv114-KS-MTP, 2008 WL 3896431 (S.D. Miss. Aug. 19, 2008) attempted to win a do-over of a straightforward defense preemption win.
The district court had granted in part and denied in part the defendant's motion for summary judgment based on preemption as a result of the Class III PMA approval of the medical device in question, a cochlear implant that malfunctioned and was replaced with surgery. After the court's ruling, the parties settled and the court entered judgment of dismissal. Id. at p. 2.
Approximately five months later, plaintiff moved for a relief from judgment, arguing that after the settlement, she discovered that the manufacturer had "knowingly misrepresented the true facts of the status of the FDA approval" to induce a settlement. Id. Having relied on such representations and "discovery fraud," plaintiff did not seek a rescindment of the settlement agreement (in fact, she kept the settlement proceeds!), but sought sanctions and damages under various claims for relief. Id. Essentially, the plaintiff argued that the defendant "knowingly misrepresented" that an FDA investigation was commenced post-approval, "at the conclusion of which the FDA would challenge Advanced Bionics' compliance with the pre-market approval process." Id. at p. 5.
Based on these allegations, the plaintiff unsuccessfully sought to have the judgment vacated using Rule 11, Rule 60 and the court's inherent powers. On denying these requests, the court made clear that even if the plaintiff were to succeed in establishing misconduct, the court's ruling on the motion for summary would be unchanged. That is, even if the plaintiff's claims were accurate, "the Defendant would still be protected by the preemption defense for items that received and complied with pre-market approval from the FDA." Id. at p. 6. Further, the court's order granting the summary judgment did not detail which state law claims were preempted, but only stated a point of law; thus, had the case continued and the evidence demonstrated either non-compliance with the federal requirements or the manufacturer failed to properly obtain the premarket approval for the device, the preemption argument might have "presumably fail[ed]." Id. at p. 8. However, given the procedural status of the case, the court denied the plaintiff's motion and advised that her recourse--if any--was to file a new action against the manufacturer for fraudulent misrepresentation or to seek other similar relief.
This post was written by Michelle Lyu.
Earlier this week, in Uhm v. Humana, Inc., --- F.3d --- , 2008 WL 3891592, No. 06-35672 (9th Cir. Aug. 25, 2008), the Ninth Circuit upheld a lower court ruling that the express preemption provision of the Medicare Prescription Drug Improvement and Modernization Act preempted state law claims arising from the plaintiffs' prescription drug benefits provided by a Medicare supplement insurer.
On behalf of a putative class, plaintiffs asserted claims for breach of contract, violation of state consumer protection statutes, unjust enrichment, and fraud arising from allegations that the class enrolled in a plan for prescription drug coverage but the insurer failed to cover their prescription medication purchases as promised. But the Act specifies that for Medicare prescription drug plans and sponsors, "[t]he standards established under this part shall supercede any State law or regulation (other than State licensing laws or State laws relating to plan solvency) with respect to MA ["Medicare Advantage"] plans which are offered by MA organizations under this part." 42 U.S.C. § 1395w-26(b)(3).Continue Reading...
This post was written by Michelle Lyu.
This case provides an interesting glimpse of what could happen if the plaintiffs are successful in persuading Congress to change the import of Riegel v. Medtronic, Inc.'s, (552 U.S. ___, 128 S.Ct. 999, (Feb. 20, 2008)) holding through legislation.
In Lundeen v. Canadian Pacific Railway Company, 532 F.3d 682 (8th Cir. July 2, 2008), the Eighth Circuit addresses the retroactive effect of an amendment to the Federal Railroad Safety Act, which removed the Act's preemptive effect over state law claims. When plaintiffs first brought this case for personal injuries and property damage from a freight train derailment in state court against railroads, the case was first removed and then later dismissed on the basis of preemption under the Federal Railroad Safety Act. While the cases were pending on appeal, Congress amended FRSA, "clarifying" that the state law causes of action seeking damages for personal injury, death, or property cases were not preempted. Congress made the amendment retroactive to the day of the derailment at issue, and effectively removed the basis of the court's former holding on preemption. The Eighth Circuit majority panel held that the amendment was constitutional despite arguments re separation of powers doctrine, due process, equal protection, and the Ex Post Facto Clause, and remanded the case.
A recent Virginia federal court decision demonstrates the powerful effect of the Riegel v. Medtronic precedent in product liability cases where PMA-devices are subject to claims-sounding in negligence or breach of duty related to the design, manufacturing, and labeling of the device. According to this court, however, the preemption defense of Riegel reaches only those allegations based on the safety and efficacy of the device itself, not on the alleged conduct of a company representative in the operating room during use of the device.Continue Reading...
Bi-Annual Update Regarding Pharmaceutical Drug and Medical Device Federal Preemption: The Supreme Court Speaks In Riegel v. Medtronic
In This Issue…
- U.S. Supreme Court Activity in Medical Device and Drug Preemption Cases
- Express Preemption in the Lower Courts
- Preemption and Buckman
- Implied Preemption in the Lower Courts
- Recent Legislation
- Miscellaneous Cases