APA: Bush Destroying Right To Sue For Damages
Submitted by early-bird on May 16, 2008 - 7:12am.
APA | bush | Right to Sue for Damages | Tort Law
May 16, 2008 crossposted from unbossedThis is part two of a discussion of a disturbing trend by the Bush Administration. They are using obscure parts of federal agency regulations to destroy the right to sue manufacturers who have caused serious injuries. Part one described the revelation made by reporter Pete Yost in hisWashington Post story - Bush administration rules limit lawsuits on May 13, 2008.This part explains what has gone wrong in the power grab being made by federal agencies and the way that courts have made this possible. This is a very technical area of law, but I have tried hard to make this explanation clear. But please ask questions if I have not achieved that goal. There will be another part that addresses the issue of preemption. You will see that word used several times here, but I think you can understand this part without an explanation of the impact of preemption.
- shirah's diary :: ::
To understand this trend, you need to understand some special issues related to federal administrative agencies.Administrative agencies are strange beasts, chimerical actually.They are not part of the government branches established by the US Constitution - the executive, the legislative, nor the judiciary. But agencies embody all of those functions. They can take actions such as investigations. They can issue regulations which operate like laws. And they can adjudicate.However, all of these functions operate under laws created by Congress. Some of these laws create administrative agencies and establish their functions. However, the fundamental law for federal agencies is the Administrative Procedure Act (APA). It governs the processes by which agencies "legislate" - that is, how they can lawfully issue regulations.Agencies may not legislate in the way that Congress does. They must do so only in limited circumstances, those governed by the APA and by the legislation that created the agency. To do otherwise would be an unconstitutional delegation of the legislative branch's power as set out in the United States Constitution: "All legislative Powers herein granted shall be vested in a Congress of the United States, which shall consist of a Senate and House of Representatives."The solution reached that allows federal administrative agencies to function is that they may only issue regulations by specific procedures.In the case of the FDA and other agencies, then, one question that arises from the new power grab is whether those procedures were used.There are essentially two processes. One is the notice and comment process. This is the one most likely to apply to this situation. The other is used only for housekeeping regulations. The notice and comment process requires that proposed regulations be published in the Federal Register, that the agency notify the public that it is taking public comments and the method for submitting them, and sometimes that there are hearings. The process for each agency is governed by the APA and its own founding law.An example is the process set up under OSHA in Sec.6(b) (29 USC Sec.655). LinkYou can see that is sets out the timing and other details for notice and comment and also the substantive standard a regulation must meet. In the case of OSHA that standard is set out in sec.6(b)(5).Here are the APA rules on notice and comment publication for promulgating regulations:
Administrative Procedure Act, 5 USC § 552§ 552. Public information; agency rules, opinions, orders, records, and proceedings(a) Each agency shall make available to the public information as follows: (1) Each agency shall separately state and currently publish in the Federal Register for the guidance of the public--
. . .
(C) rules of procedure, descriptions of forms available or the places at which forms may be obtained, and instructions as to the scope and contents of all papers, reports, or examinations;(D) substantive rules of general applicability adopted as authorized by law, and statements of general policy or interpretations of general applicability formulated and adopted by the agency; and(E) each amendment, revision, or repeal of the foregoing.Except to the extent that a person has actual and timely notice of the terms thereof, a person may not in any manner be required to resort to, or be adversely affected by, a matter required to be published in the Federal Register and not so published. For the purpose of this paragraph, matter reasonably available to the class of persons affected thereby is deemed published in the Federal Register when incorporated by reference therein with the approval of the Director of the Federal Register.
The right to challenge agency action, including agency regulationsThe OSH Act also provides methods for challenging a promulgated standard, for example:
(f) Any person who may be adversely affected by a standard issued under this section may at any time prior to the sixtieth day after such standard is promulgated file a petition challenging the validity of such standard with the United States court of appeals for the circuit wherein such person resides or has his principal place of business, for a judicial review of such standard. A copy of the petition shall be forthwith transmitted by the clerk of the court to the Secretary. The filing of such petition shall not, unless otherwise ordered by the court, operate as a stay of the standard. The determinations of the Secretary shall be conclusive if supported by substantial evidence in the record considered as a whole.
Here is the APA section on the right of review:
A person suffering legal wrong because of agency action, or adversely affected or aggrieved by agency action within the meaning of a relevant statute, is entitled to judicial review thereof.
So, did the FDA and other agencies discussed in the story go through this process?From what I can glean from the news article, it seems unlikely. And that seems even more to be the case from an April story describing one of the drug cases, a lawsuit against the manufacturers of Paxil and Zoloft that was handed down in April by the Third Circuit Court of Appeals. LinkIn the majority opinion in that case, they state:
The FDA has taken the position, both in the preamble to the 2006 amendments revising the drug labeling regulations and in its amicus brief in the Colacicco case, that plaintiffs’ claims are preempted as a result of the actions taken by the FDA pursuant to its regulatory authority. . ..
. . .
From [the Supreme Court's 2000] Geier’s discussion of an agency’s informal position regarding preemption, we conclude (1) that an agency’s position . . . need not be contained in a formal regulation in order to be considered, and (2) that such a position is subject to a level of deference . . ..
. . .
We need not decide whether the FDA’s position in this case is inconsistent, as plaintiffs argue, with the FDA’s 2000 rule proposal. We see no inconsistency between the FDA’s preamble to the 2006 amendments and its long-held position that it has the responsibility to determine whether a warning is required.
In other words, changes in legal rights, including the right to sue a drug manufacturer for negligence resulting in a death, standard tort law, can be overcome by subtle wording in an agency's regulations that appear not to have been intended to have that outcome. Or, if they were so intended by the agenc, did not contain wording that would have tipped the public off to that intent.And these regulations were never subjected to the notice and comment process. The public was not given notice that the preamble would be used to outlaw tort cases against drug manufacturers.This is hugeThis is an action on the level of Congress' outlawing all state laws on this issue, something that I doubt they would do. This is why this court interpretation of the FDA's action here would seem to be an unconstitutional delegation of legislative power.To go back to the APA, courts have the power to overturn agency actions for several reasons, two of which are relevant here:
- Does this violate the US constitution as an unconstitutional delegation of legislative power?
- Does this regulation or this interpretation of the regulation exceed the authority Congress gave the agency?
Here is the relevant section of the APA:
§ 706. Scope of review
The reviewing court shall—
. . .
(2) hold unlawful and set aside agency action, findings, and conclusions found to be—
(A) arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law;(B) contrary to constitutional right, power, privilege, or immunity;(C) in excess of statutory jurisdiction, authority, or limitations, or short of statutory right;(D) without observance of procedure required by law;(E) unsupported by substantial evidence in a case subject to sections 556 and 557 of this title or otherwise reviewed on the record of an agency hearing provided by statute; or(F) unwarranted by the facts to the extent that the facts are subject to trial de novo by the reviewing court.
There was a strong dissent in this case. Here is what the dissent had to say about the preamble as law:
The plaintiffs’ failure-to-warn claims stand near the heart of the states’ police powers over matters of health and safety. And the existence and detailed nature of the federal scheme does not change our imperative to require clear congressional intent (whether expressed directly in a preemption provision or implied by an authorizing statute enabling an agency to act) to preempt state tort law.
. . .
the FDA has not engaged in notice-andcomment rulemaking on this issue, instead promulgating its views in a preamble to a regulation and a series of amicus briefs in cases like these. As the majority notes, notice-and-comment rulemaking is not required to find conflict preemption. See Geier, 529 U.S. at 885. But the lack of notice-and-comment rulemaking should, all else equal, reduce the level of deference we give the FDA’s position. Similarly, the lack of institutional formality suggests a relatively low "degree of care" taken to outline its reasoning. In my view, a high degree of care on issues of preemption would involve scholarly, scientific, and public-health research into the complex matters of law and policy that these cases implicate. I see no evidence in the record that the FDA conducted or commissioned independent research of this nature in preparing the 2006 preamble.
The dissent also attacks the majority's claim that this expansive view is nothing new, that it has been the agency's consistent position for decades.
To review the history of this issue, the FDA has for over three-quarters of a century viewed state tort law as complementary to its warning regulations. Only for the last two years has it claimed otherwise. This "sea change" in the FDA’s conception of the relationship between federal and state law has not appeared in a regulation subject to notice and comment, but in a preamble to a regulation. With this background, I believe courts should fear to tread where Congress has not given us a clear statement. Because I see sound legal and policy reasons to hold that the presumption against preemption is not overcome, I would allow the plaintiffs’ suits to go forward. I respectfully dissent.
You can also find an analysis of this case and the trend it signals here.
http://www.washingtonpost.com/wp-dyn/content/article/2008/05/13/AR2008051301899.html
May 13, 2008
EXCERPT
WASHINGTON -- Faced with an unfriendly Congress, the Bush administration has found another, quieter way to make it more difficult for consumers to sue businesses over faulty products. It's rewriting the bureaucratic rulebook.
President Bush has campaigned for lawsuit reform since his days as Texas governor. As president, he has made little headway on the issue in Congress. He's been thwarted by Democrats every time he's tried to tackle the issue head-on.
Turns out there was another way, one little-noticed step at a time.
The real-world impact of preemption will be on display Wednesday when a congressional committee hears from actor Dennis Quaid and his wife, who have sued a maker of the blood-thinner heparin in Illinois state court.
The Quaids sued after their newborn twins were given massive doses of the blood thinner at a hospital. The Quaids claim the manufacturer was negligent in packaging different doses of the product in similar vials with blue backgrounds.
The company _ Baxter Healthcare Corp. _ is seeking to use the doctrine of preemption to shield it from any civil liability, claiming that once FDA approved the labeling and packaging at issue in the case, the company is immune from civil suits for money damages.
Later this year, the Supreme Court will wade into the issue of federal preemption as it relates to lawsuits and prescription drug labeling. The defendant drugmaker contends it should not be in the lawsuit because the FDA had approved the warning label on the drug.
The company is trying to overturn a $6.8 million award given a woman whose arm had to be amputated after anti-nausea medication was inadvertently injected into an artery.
In some instances, judges seem as exercised as consumer advocates about the FDA's undermining of lawsuits under state tort law.
In a recent decision, a federal appeals court judge wrote that the FDA has for over three-quarters of a century viewed state tort law as complementary to the agency's safety warnings on prescription drug packages and "only for the last two years has it claimed otherwise."
The judge, Thomas Ambro, was dissenting from a ruling by two of his colleagues throwing out lawsuits in New Jersey and Pennsylvania. The allegations in the suits against pharmaceutical companies linked two suicides to antidepressants.
Judges have cited FDA's regulatory preamble in its prescription drug rule in more than a dozen favorable rulings for pharmaceutical companies. Despite the FDA frequently showing up on the side of industry, judges have ruled for consumers' right to sue about as often as they have ruled against them in cases touching on the regulatory preamble for prescription drug labels.
One expert in the field says the trend may be shifting to industry's favor, in part due to the FDA's regulatory preamble.
"The last four or five cases, industry has been on a roll," says Chicago attorney Mark Herrmann, who defends pharmaceutical companies in liability cases.
Hold on there sweety we'll get to you in a second. - Obama before he apologized
http://library.findlaw.com/2000/Feb/1/128333.html
By Tydings & Rosenberg LLP
Manufacturers of medical devices suffered a major setback recently when a federal appellate court held that "premarket approval" of medical devices by the Food and Drug Administration ("FDA") has no preemptive effect on product liability claims brought under state law. As a result of the court's holding, manufacturers of medical devices may face continuing exposure to product liability suits, even when there has been full compliance with the FDA requirements during the "rigorous" premarket approval process.
In Goodlin v. Medtronic, Inc., No. 97-5801, 1999 U.S. App. LEXIS 2507 (11th Cir. Feb. 18, 1999), the plaintiff was a pacemaker recipient who underwent open-heart surgery after the manufacturer issued a warning about the risk of a defect in the lead to the pacemaker. The plaintiff underwent open-heart surgery to replace the lead, but surgery revealed no signs of a defect. Thereafter, plaintiff asserted claims against the manufacturer for negligent design and strict product liability. The district court concluded that the FDA had found the pacemaker to be safe and effective during the premarket approval process. As a result, the court found that the plaintiff's claims were preempted, and entered judgment for the manufacturer.
The United States Court of Appeals for the Eleventh Circuit reversed. The appellate court recognized that Section 360k(a) of the Federal Food, Drug and Cosmetic Act contains an express provision that federal law will preempt conflicting requirements of state law. Citing Medtronic, Inc. v. Lohr, 518 U.S. 470, 501 (1996), the court noted that the plaintiff's claims would not be preempted unless the premarket approval process imposes a "specific federal requirement" on a "particular device."
The court recognized that during the often "rigorous" premarket approval process, the FDA demands the "submission of detailed information regarding the safety and effectiveness of the device under review." Goodlin, id. at 5-6. The court also conceded that after FDA approval, a manufacturer may not alter its labeling, product design, or manufacturing process in any way. Nevertheless, the court of appeals determined that the FDA's premarket approval process imposes no "specific federal requirement" because the process does not impose "any ascertainable substantive prerequisite for approval." Goodlin, id. at 29.
The court also determined that the premarket approval process does not apply to a "particular device." Instead, the court observed that "[t]he federal requirements reflect important but entirely generic concerns about device regulation generally, not the sort of concerns regarding a specific device or field of device regulation which the statute or regulations were designed to protect from potentially contradictory state requirements." Goodlin, id. at 33.
Finding that the premarket approval process imposes "no specific federal requirement," on a "particular device," the Eleventh Circuit expressly rejected the Seventh Circuit's resolution of the same issue in Mitchell v. Collagen Corp., 126 F.3d 902 (7th Cir. 1997), cert. denied, __ U.S. __, 118 S. Ct. 1300 (1998). As a result, there now exists a split of authority among the circuits, and Supreme Court resolution appears necessary.
For more information on this article, contact James J. O'Neill III at 410/752-9751.
Hold on there sweety we'll get to you in a second.- Obama before he apologized