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.
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.
Today the Supreme Court affirmed Wyeth v. Levine, as reported by Drug and Device Law.
As Point of Law pointed out on February 3, a move is afoot to "Revers[e] Preemption, One Bill At A Time," starting with industries regulated by the FDA.
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.
UPDATE: Drug and Device Law has posted Bert Rein On The Politics Of Preemption on this issue, and it is definitely worth a read.
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:
PREEMPTION
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.
FUTURE OF PREEMPTION
The Wyeth decision, of course.
But what about preemption in off-label cases? Sponsor can't change label without FDA approval. What if physician prescribes off-label because of some prompting by manufacturer? If plaintiff's tort suit says there should have been warnings for the off-label use, the defense is less strong as there is little federal interest in off-label promotion. This area of law needs more development to answer the question.
RIEGEL
There may be a legislative response, but again we will have to wait to see.
As to any exception for the manufacturer's alleged failure to disclose to the FDA, when the FDA has not found fraud, the preemption defense is stronger. It would create interference with the agency's decisions to allow courts to decide if the FDA was defrauded. Moreover, the FDA should decide what the punishment for it should be for manufacturer nondisclosure.
FDA WARNING LETTERS
FDA warning letters are a statement by the agency that someone is in violation of the law and legal action may be taken. For the past few years, the chief counsel's office has reviewed all of them.
Because they involve a legal determination, and are very serious for the recipients, they are appropriate for attorney review.
Even if counsel review leads to fewer letters, which is not clear, stronger letters with a stronger impact is a beneficial result of counsel review. It adds heft to both the letter and to the agency's decision to take an enforcement action, since recipients and the courts know the agency's counsel has decided that legal action will be appropriate (if the conduct is not remedied) when warning letter issued.
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.").
Over at Drug and Device Law Beck and Herrmann muse on the possible impact of a win by Sen. Obama on drug and device law. This blog takes no sides on the election - and this may mean nothing for the future development of the law - but it is interesting to note that in the past, Sen. McCain has supported the criminalization of product liability in certain circumstances, as Victor Schwartz explains in this March 2006 testimony before the Senate Judiciary Committee.
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.
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