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Posted by Brian Wolfman on Tuesday, December 18, 2012 at 08:59 AM | Permalink | Comments (0) | TrackBack (0)
by Jeff Sovern
I kid you not.
The House Committee on Oversight and Government Reform, chaired by Darrell Issa, and its Subcommittee on TARP, Financial Services and Bailouts of Public and Private Programs, chaired by longtime CFPB foe Patrick McHenry, has issued a report titled THE CONSUMER FINANCIAL PROTECTION BUREAU’S THREAT TO CREDIT ACCESS IN THE UNITED STATES. Here are the relevant paragraphs (footnotes omitted):
In addition to concerns over the Bureau’s powers and uncertainty about the validity of Mr. Cordray’s appointment, questions exist about the CFPB’s development as an independent regulatory agency. On January 6, 2012, two days after Mr. Cordray’s controversial "recess" appointment, President Obama visited the CFPB headquarters in what was described as a "victory lap" to celebrate the appointment. Later that month, Mr. Cordray attended the President’s State of the Union address as the guest of First Lady Michelle Obama. Since his appointment, Mr. Cordray has also met regularly with senior Administration officials, including White House Deputy Chief of Staff Nancy Ann DeParle, and he attended an event in April 2012 called the "White House Cabinet Affairs Chief of Staff Lunch."
Other CFPB employees have enjoyed similar access to White House officials. Meredith Fuchs, the then-CFPB Chief of Staff, and Lisa Konwinski, the CFPB’s Assistant Director of Legislative Affairs, met with Gene Sperling, the Director of the National Economic Council, in February 2012. Although these meetings are not inappropriate per se , the appearance of a close and coordinated relationship between CFPB officials and political elements of the executive branch undermines the Bureau’s authority as a neutral and independent regulator. The Committee is concerned that this appearance of impropriety could jeopardize the CFPB’s ability to act effectively and independently.
So apparently it is no longer proper for CFPB officials to have contact with the White House. I can't help noting the absence of listed contacts with Republicans. Is that because there weren't any (is this about jealousy?)? If there were some, should we also be concerned about meetings with Republicans tainting the Bureau?
The Report also contains the usual GOP talking points, although with more stridency than we normally see: they fear "the CFPB will become a run-away regulator unlike any other in American history." Sigh. Here's the Executive Summary (footnotes omitted):
The Consumer Financial Protection Bureau exercises tremendous and unmatched authority over American financial products and services. Created by the Dodd-Frank Wall Street Reform and Consumer Protection Act and given virtually limitless power, the CFPB has the real potential to severely reduce credit access for American consumers. Its unique structure, vague mandate, and lack of accountability position the Bureau to be an aggressive and heavy-handed financial regulator. The controversial and legally questionable selection of its first director – former Ohio Attorney General Richard Cordray – adds unneeded uncertainty to financial markets. The CFPB’s apparently close relationship with the Obama Administration has allowed the White House to attempt to use the Bureau to further its partisan agenda. These circumstances, and the manner in which the Bureau has begun to exercise its authority, suggest that the CFPB will become a run-away regulator unlike any other in American history.
At a time of prolonged economic strain, American consumers can ill-afford such an unaccountable, unresponsive, and all-powerful financial regulator. The Federal Deposit Insurance Corporation estimates that almost 30 percent of all Americans do not have adequate access to traditional financial services. Another study finds that half of all Americans could not produce $2,000 within 30 days in response to a financial emergency. Under the regulatory burden of the Dodd-Frank Act, financial products and services are costing more and small community banks are closing up shop at a pace of hundreds per year. Credit access has shrunk as lenders have raised lending standards and stopped offering some products and services. These effects have been felt most keenly by those borrowers at the margins, creating an economic divide in the United States between those with access to credit and those without. By all indications, the CFPB shows no signs of letting up. If the Bureau is not careful to add clarity and much-needed certainty to the financial sector, the CFPB may continue to drastically affect credit access for millions of American families and small businesses.
Yet the CFPB’s unprecedented structure and vague mandate threatens to restrict credit access even further. The regulator has refused to add certainty to its nebulous and overly burdensome regulatory authority, causing banks and credit unions to restrict certain credit products and services for fear of litigation and enforcement actions. The heavy-handed regulations proposed by the CFPB have proven costly for financial institutions, making borrowing more expensive and credit less available. In exercising its vast regulatory powers, the Bureau has not implemented adequate measures to fully assess and address the impact of its actions on credit access.
Already, according to estimates, the CFPB has increased the cost of consumer credit by a total of $17 billion and depressed job creation by about 150,000 jobs. By all indications, the CFPB shows no signs of letting up. If the Bureau is not careful to add clarity and much-needed certainty to the financial sector, the CFPB may continue to drastically affect credit access for millions of American families and small businesses.
Posted by Jeff Sovern on Monday, December 17, 2012 at 02:30 PM in Consumer Financial Protection Bureau | Permalink | Comments (0) | TrackBack (0)
Posted by Brian Wolfman on Monday, December 17, 2012 at 12:03 PM | Permalink | Comments (0) | TrackBack (0)
Revelations that banks manipulated the benchmark Libor rate sent shockwaves across the financial world this summer. (Libor, despite sounding like a Tolkien villian -- "People of Middle Earth! We must unite in defense of the realm against the forces of Mordor and Libor!" -- stands for "London interbank offered rate" and forms the basis for trillions of dollars worth of lending transactions around the world.)
This week, an interesting juxtaposition: We learn from Bloomberg that banking giant UBS will pay a settlement of up to $1.6 billion to various government entities on both sides of the Atlantic for participating in the manipulation of Libor. We also read in Washington Post how, despite its vulnerability to such manipulation, Libor is such an ingrained part of the system that no one seems to be able to stop using it. It appears that financial constructs, like banks, can be too big to fail.
Posted by Scott Michelman on Monday, December 17, 2012 at 08:55 AM | Permalink | Comments (1) | TrackBack (0)
by Brian Wolfman
Indiana University medical school professor Jon Duke and two co-authors have published this study entitled "Consistency in the safety labeling of bioequivalent drugs." The study could have been entitled "Inconsistency in the safety labeling of bioequivalent drugs" because it finds that the warnings on generic drug labels often deviate from the brand-name labels on which they are supposed to be based -- sometimes quite significantly. The study maintains that, overall, "68% of multi-manufacturer drugs [studied] had discrepancies in ADR [adverse drug reaction] labeling."
The problems identified by Duke raise concerns for patients and their prescribing doctors who, when labels are inaccurate, may be in the dark about a generic drug's adverse effects, contraindications, and other hazards. The study concludes that doctors prescribing generic drugs should review the branded label as well as the generic label. In a press statement, Duke also said that the best solution
may be a centralized listing of drug side-effects, maintained independently of individual manufacturer labels. Drug labels would simply reference this common repository rather than attempting to maintain all the information within a single document. Clinicians could refer to this resource for the most up-to-date safety information regardless of generic manufacturer.
Duke's study also raises legal concerns. Generic drugs are supposed to be bioequivalent to the brand-name drug on which they are based, and the FDA's marketing approval for a generic drug is premised largely on the FDA's finding of bioequivalence. When the FDA approves a generic drug, it requires the generic's label to ape the label on the equivalent branded drug. Although lawyers, drug companies, and advocacy groups have disagreed over the years about whether a generic manufacturer may make safety-related label changes without FDA pre-approval -- as the generic manufacturer learns over time about the drug's hazards -- the FDA takes the position that a generic manufacturer may not alter the label on its own. (In this regard, note that Public Citizen has filed a petition with the FDA asking that generic manufacturers be authorized to warn of drug hazards that come to their attention without prior FDA approval on the same or similar terms currently available to brand-name manufacturers.)
Last year, in PLIVA v. Mensing, the Supreme Court held 5-4 that state-law damages claims premised on generic drug manufacturers' failures to warn of a generic drug's hazards were preempted by federal law because federal law prohibited the generic manufacturers from changing their labels to meet the dictates of state law, but rather required that the labels stay the same as the branded labels. The Court explained that if the defendant generic drug manufacturers had
independently changed their labels to satisfy their state-law duty, they would have violated federal law. Taking [the plaintiffs'] allegations as true, state law imposed on the [generic] Manufacturers a duty to attach a safer label to their generic metoclopramide. Federal law, however, demanded that generic drug labels be the same at all times as the corresponding brand-name drug labels. See, e.g., 21 CFR §314.150(b)(10). Thus, it was impossible for the [generic] Manufacturers to comply with both their state-law duty to change the label and their federal law duty to keep the label the same.
PLIVA had an immediate impact, making it nearly impossible for a plaintiff to maintain a state-law damages claim based on a generic drug manufacturer's failure to warn. For more detail on PLIVA's reasoning and future implications, see this article I wrote with Dena Feldman.
Duke's study challenges the existence, in fact, of the "sameness" that formed the legal premise for the Court's decision in PLIVA. It also suggests that implementation of PLIVA is no easy task for the courts. If actual sameness is lacking between the generic label and the branded label with respect to an allegedly inadequate warning that a plaintiff says caused her generic-drug-based injury, what is the basis for preemption under PLIVA? [Note: The Supreme Court recently granted review in Mutual Pharmaceutical Co. v. Bartlett,
which presents the question whether FDA approval of a generic drug preempts a state-law damages claim premised on the
drug's design defect. I wonder whether Duke's study will play a role in the briefing in Bartlett. For more on Bartlett, go here.]
Here are the Duke study's "Key Points":
• FDA mandates identical labeling between bioequivalent brand and generic medications, but
this consistency has never been validated
• Analyzing structured product labels, we found the majority of bioequivalent drugs show differences in safety warnings between manufacturers
• Reasons for these differences included missing tables, outdated post-marketing reports, and
formatting issues
• New strategies should be considered for harmonizing bioequivalent labels
Here is the study's conclusion:
Despite existing mandate, bioequivalent medications from different manufacturers often differ in their safety labeling. This variation stands in contrast to the expectations of providers, the FDA, and, more recently, the United States Supreme Court. While the clinical significance of such labeling discrepancies remains unclear, we suggest for now that physicians review branded drug labeling even when a patient is taking a generic version of a medication. Further research will be necessary to determine the clinical importance of these labeling discrepancies as well as to identify optimal solutions for ensuring ongoing harmonization of safety data across bioequivalent drugs.
The study's abstract is reproduced after the jump. You may also want to look at Indiana University's press release.
Posted by Brian Wolfman on Monday, December 17, 2012 at 08:27 AM | Permalink | Comments (1) | TrackBack (0)
In Devlin v. Scardelletti, the Supreme Court held that a class member who objects in a federal district court to a proposed class-action settlement may appeal approval of that settlement without moving for (and being granted) intervention. As I explained in this article, despite efforts by settling parties to limit Devlin to members of non-opt-out classes, the right to appeal approval of a class settlement should extend to all class members.
Devlin proceeded on the (correct) assumption that a class member could object to a proposed settlement in a district court without intervening. But what about the rights of non-class members to object to a class certification and settlement that could adversely affect their interests? Those issues are addressed in a new decision of the Third Circuit, Benjamin v. Department of Public Welfare. There, the objectors were intellectually impaired residents of state-run care facilities who objected to a settlement that favored community placement. The class definition excluded people who opposed community placement. The district court denied the objectors' motion to intervene for the purpose of challenging class certification and the proposed settlement.
The Third Circuit reversed, holding that the objectors' interests were not adequately representated by the existing parties, including the state of Pennsylvania, which ran the care facilities. The court noted that although ordinarily a government is an adequate representative of the public, the objectors here had their own personal interests at stake and should not be forced to accede to Pennsylvania's position, which was "necessarily colored by its view of the public welfare."
The Third Circuit remanded to allow the objectors to raise their concerns with the class certification and settlement. Armed with intervention status, presumably the objectors will be able to appeal any adverse rulings on their merits. Worth reading.
Posted by Brian Wolfman on Monday, December 17, 2012 at 08:23 AM | Permalink | Comments (1) | TrackBack (0)
by Paul Alan Levy
The New York Times carries an exceptionally detailed report of the controversy over the rape of a high school girl and the libel case brought by the parents of a player against an online blogger and several anonymous commenters, discussed here two weeks ago. A reminder that reporting can be dangerous -- the football coach, who had been criticized for not benching the players involved in the rape, apparently threatened one of the reporters who was asking questions, saying "you’re going to get yours. And if you don’t get yours, somebody close to you will." One can understand why the anoymous commenters who live in the community are afraid about the consequences of being identified.
Posted by Paul Levy on Monday, December 17, 2012 at 07:33 AM | Permalink | Comments (2) | TrackBack (0)
by Jeff Sovern
I've moved on to the privacy chapter of our casebook, and in that regard I just finished reading M. Ryan Calo's (Calo is at the University of Washington and affilated with Stanford) intriguing Against Notice Skepticism In Privacy (And Elsewhere), 87 Notre Dame Law Review 1027 (2012). Before I add my two cents, here's the abstract:
What follows is an exploration of innovative new ways to deliver privacy notice. Unlike traditional notice that relies upon text or symbols to convey information, emerging strategies of “visceral” notice leverage a consumer’s very experience of a product or service to warn or inform. A regulation might require that a cell phone camera make a shutter sound so people know their photo is being taken. Or a law could incentivize websites to be more formal (as opposed to casual) wherever they collect personal information, as formality tends to place people on greater guard about what they disclose. The thesis of this Article is that, for a variety of reasons, experience as a form of privacy disclosure is worthy of further study before we give in to calls to abandon notice as a regulatory strategy in privacy and elsewhere.Calo is clearly more a fan of notice than outright regulation. At one point he paraphrases Winston Churchill and writes that “notice is the worst regulatory mechanism, except for all of the alternatives." Regular readers of this blog know that I am less fond of notice as a way of conveying information to consumers. Still, notice may yet have a role to play in privacy, in the form of the single letter-grade approach. As I have blogged about before, restaurant grades have been effective to convey health department assessments to consumers, and have improved the health not only of consumers who pay attention to the grades, but also of those who don't. Surely it would be possible for some external agency to devise criteria for privacy policies, so that companies that don't use consumer information at all would get an "A", those who use it only internally would get a "B", and so forth. That way, consumers could continue to forego reading privacy policies, but still know what privacy choices they are making. And just as restaurateurs strive for better health department grades, to attract the business of those who care about the grades, which helps all consumers, perhaps businesses would strive for better privacy grades. It seems like such an obvious idea, I wonder if someone has already tried it.
Calo calls for more research, and I agree. We need to try different ways of providing notice to see what consumers actually use. The CFPB is willing to do this with its notices. Perhaps the FTC will follow suit on privacy. I would love to see one of those Innocentive contests for notices that convey privacy policies to consumers in such a way that consumers will actually use them.
Posted by Jeff Sovern on Sunday, December 16, 2012 at 09:41 PM in Consumer Law Scholarship, Privacy | Permalink | Comments (0) | TrackBack (0)
In this piece, Bruce Bartlett has the audacity to bring facts to the discussion of the so-called budget crisis. It's mainly about how "entitlements" are a small part of the problem despite what we hear from the Republicans. Here's an excerpt about social security, where he explains that if we simply subjected the same percentage of wages to social security tax as we have historically (90%), concerns about the solvency of the social security system would be resolved:
To be sure, some restraint is needed in federal entitlement programs. But the idea that we are facing a crisis is complete nonsense. Spending for Social Security, in particular, is very stable. Relatively modest changes, such as raising the taxable earnings base slightly, would be sufficient to put the program on a sound footing virtually forever. As a Nov. 28 Congressional Research Service report explains, historically 90 percent of covered earnings was subject to the Social Security tax. In recent years, this percentage has fallen to 84 percent, as the bulk of wage gains has gone to those making more than the maximum taxable income, currently $110,100. Raising the share of covered earnings back to 90 percent would be sufficient to eliminate almost half of Social Security’s long-run actuarial deficit, according to the Social Security actuaries.
Posted by Brian Wolfman on Friday, December 14, 2012 at 06:04 PM | Permalink | Comments (0) | TrackBack (0)
This week, the Ninth Circuit agreed to rehear en banc a case about a cop who revealed the abuse of suspects inside his department. The Ninth Circuit has developed a troubling line of cases to the effect that, under the Supreme Court's 2006 decision in Garcetti v. Ceballos, any time a police officer in the state of California reports misconduct, he is just doing his job -- which means he is speaking as an employee not as a member of the public and is therefore not protected by the First Amendment. Most other circuits (and indeed some decisions within the Ninth Circuit) hold that whether a whistleblower is speaking as an employee is a question of fact and no categorical rule is appropriate. Hopefully the Ninth will resolve this conflict when it rehears the case in March.
Disclosure: Public Citizen is co-counsel on the petition for rehearing. The panel decision (criticizing but reluctantly following the reporting-misconduct-is-part-of-the-job rule) is here.
Posted by Scott Michelman on Friday, December 14, 2012 at 05:43 PM | Permalink | Comments (0) | TrackBack (0)