Wednesday, July 22, 2009

The Advance and Retreat of Pre-emption

Was going through some old issues of the ABA Journal and found this interesting article from the May issue -- Business Downturn: As the market tumbles, so does the corporate pre-emption defense, by David G. Savage.  Here's an excerpt:

For much of the decade, business lawyers and the Bush administration insisted state liability laws and state regulation amounted to a costly nuisance and a drag on the economy. They said uniform national regulation of business made more sense, and they urged the Supreme Court to limit lawsuits and to pre-empt state regulations.

For years those arguments were winners. Last year, Riegel v. Medtronic barred most lawsuits against the makers of medical devices. Lawyers for the Bush administration and device makers said state jurors should not be permitted to second-guess Food and Drug Administration regulators once they have approved a device as safe and effective.

BGS

July 22, 2009 in FDA, Medical Devices - Misc., Pharmaceuticals - Misc., Preemption, Products Liability | Permalink | Comments (1) | TrackBack (0)

Monday, July 20, 2009

Federal Court in NJ Dismisses Off-Label-Marketing Suit Against Schering-Plough

Article in AmLaw Litigation Daily -- Schering-Plough Wins Dismissal of 'Off-Label' Suit, by Ben Hallman.  Here's an excerpt:

A recent decision by a New Jersey federal court sets a tough standard for plaintiffs trying to piggyback on government investigations of off-label drug marketing. In dismissing a lawsuit against Schering-Plough, federal district court judge Stanley Chesler ruled that even if the company has violated off-label marketing rules--as it seems to have done for two cancer drugs--plaintiffs must prove that the drug was marketed for an ineffective use, and that the patient received no benefit from it.

And here's a link to the opinion by Judge Chesler.

BGS

July 20, 2009 in Class Actions, FDA, Pharmaceuticals - Misc., Products Liability | Permalink | Comments (0) | TrackBack (0)

Sunday, July 5, 2009

Robert Rabin on Conflicting Conceptions of Tort Preemption

Rabin_Robert Professor Robert Rabin (Stanford) SSRN has posted on SSRN his article, Territorial Claims in the Domain of Accident Law: Conflicting Conceptions of Tort Preemption, Brook. L. Rev. (forthcoming 2009).  Here's the abstract:

Beginning in 1992, with the landmark decision in Cipollone v. Liggett Group, Inc., the U.S. Supreme Court has decided a burgeoning number of preemption cases, squarely challenging the continuing vitality of tort in many domains of accident law. Cipollone addressed the preemption question in an atypical context. The case did not involve competing claims to territorial authority between a regulatory regime and state tort law. Rather, Cipollone involved a challenge to the continuing viability of tort in the face of statutory directives mandating explicit industry conduct; more specifically, the explicit warnings required in the 1969 version of the cigarette labeling act.

In this article, I begin by revisiting Cipollone to reassess what it has to offer as a foundation for setting the boundaries of regulatory containment of the tort system. Next, I discuss three leading cases from the series of efforts by the Supreme Court to grapple with express preemption clauses in a variety of regulatory schemes. Against this backdrop, I then explore the circumstances under which it might be justified to imply preemption despite the absence of an express provision, with particular reference to the recent Supreme Court decision in Wyeth v. Levine, addressing preemption in the context of FDA regulation of prescription drugs. A concluding note ties the strands together.

BGS

July 5, 2009 in FDA, Mass Tort Scholarship, Medical Devices - Misc., Pharmaceuticals - Misc., Preemption, Tobacco | Permalink | Comments (0) | TrackBack (0)

Douglas Smith on Preemption After Wyeth v. Levine

SSRN Douglas Smith (Kirkland & Ellis) has posted on SSRN his article, Preemption After Wyeth v. Levine, Ohio St. L.J. (forthcoming 2009).  Here's the abstract:

This Article addresses the Supreme Court’s recent preemption decision in Wyeth v. Levine. In Wyeth, the Court held that the Food and Drug Act did not preempt a state law tort suit alleging that the labeling for an anti-nausea medication, Phenergan, failed to adequately warn about the risks associated with IV-push administration of the drug. Already, Wyeth has been interpreted by some as sounding the death knell for the preemption doctrine in the context of pharmaceutical products. However, a careful analysis of the Court’s decision indicates that this is far from the case. The majority underscored that its decision was a 'narrow' one based largely on the facts and circumstances before it. In particular, the Court made a point of noting that the record was devoid of evidence that the particular risks at issue had actually been considered by the FDA and that the defendant had thus failed to show that there was an actual conflict between FDA regulation and the state law tort suit. The majority’s analysis therefore suggests that state law tort suits based on an alleged failure to warn are preempted in cases in which the FDA has specifically considered the particular risks at issue and has determined that the pharmaceutical product’s labeling adequately warns of those risks. I argue that the ruling thus construed has significant benefits. As the Court has repeatedly recognized, there is an inherent tension between the congressional establishment of a federal regulatory regime for the labeling of pharmaceuticals and medical devices by experts at the FDA and allowing a jury of ordinary citizens with no specialized expertise to render their own judgment regarding, and in effect overrule, such expert determinations. As several members of the Court have noted, there is a potential danger in allowing these expert decisions to be undermined by state court juries. Moreover, such an outcome may have undesirable indirect effects, such as raising the prices of pharmaceutical products to satisfy state court judgments that are not warranted based on the best available scientific evidence and the potential confusion and inconsistency that may result with juries in fifty-two separate jurisdictions imposing different standards concerning what constitutes appropriate labeling. The Court’s decision properly balances these competing considerations.


BGS

July 5, 2009 in FDA, Mass Tort Scholarship, Pharmaceuticals - Misc., Preemption, Products Liability | Permalink | Comments (0) | TrackBack (0)

Friday, June 26, 2009

Nestle Not Completely Cooperative with FDA Inspections Prior to E. Coli Outbreak

Article in the Wall Street Journal -- Nestlé Unit Denied FDA Requests, by Jane Zhang.  Here's an excerpt:

The Nestlé USA plant at the center of a federal probe into an E. coli outbreak involving cookie dough refused to give inspectors access to pest-control records, environmental-testing programs and other information, according to newly released inspection reports covering the past five years.

In a September 2006 visit, for example, managers at the Danville, Va., plant refused to allow a Food and Drug Administration inspector to review consumer complaints or inspect its program designed to prevent food contamination. The inspector found dirty equipment and "three live ant-like insects" on a ledge but nothing severe enough to give the plant a failing grade.

A year earlier, officials at the Nestlé plant presented another FDA inspector with a list of things it wouldn't do. "Among these are the refusal to review the firm's consumer complaint file, refusal to permit photography, refusal to sign affidavits or receipts and refusal to provide specific information on interstate commerce," the inspector wrote.

BGS

June 26, 2009 in E Coli, FDA, Food and Drink, Food Poisoning | Permalink | Comments (0) | TrackBack (0)

Monday, June 22, 2009

President Obama Signs Tobacco Bill Giving FDA Oversight

Article on cnn.com -- Obama signs bill putting tobacco products under FDA oversight.  Here's an excerpt:

President Obama signed landmark legislation Monday giving the Food and Drug Administration new power to regulate the manufacturing, marketing and sale of tobacco.

The Family Smoking Prevention and Tobacco Control Act gives the FDA power to ban candy-flavored and fruit-flavored cigarettes, widely considered appealing to first-time smokers, including youths. It also prohibits tobacco companies from using terms such as "low tar," "light" or "mild," requires larger warning labels on packages, and restricts advertising of tobacco products.

It also requires tobacco companies to reduce levels of nicotine in cigarettes.

BGS

June 22, 2009 in FDA, Products Liability, Tobacco | Permalink | Comments (0) | TrackBack (0)

Tuesday, June 9, 2009

Tobacco Bill Giving FDA Regulatory Authority Progresses in Senate

As a follow-up to Byron's earlier post on the pending bill to give the FDA regulatory authority over tobacco products, here's a link to the Associated Press story and to the bill itself.  The bill responds to the Supreme Court's opinion in FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120 (2000), which held that the Food, Drug, and Cosmetic Act did not give the FDA authority to regulate tobacco products.  Accordingly, the FDA could not promulgate regulations governing tobacco companies' advertising, labeling, or accessibility.  A similar bill passed in the House on April 2, 2009, and it is currently under consideration by the Senate.

ECB

June 9, 2009 in FDA | Permalink | Comments (0) | TrackBack (0)

Monday, June 8, 2009

NIH Study Questions Benefits of Stents and Diabetes Drugs Avandia and Actos

Article in the Wall Street Journal -- Diabetes Study Questions Expensive Treatments: NIH Finds Patients With Heart Disease Fare Equally Well Without Stents and Drugs Such as Avandia, Actos, by Keith J. Winstein.  Here's an excerpt:

Aggressive use of expensive diabetes drugs and medical devices called stents did no better than cheaper treatments at preventing deaths, heart attacks or strokes in a large study of diabetics with heart disease.

The study, sponsored by the National Institutes of Health and several drugmakers, is the latest to humble fancy new treatments by finding them no better than older medicines at preventing the deadly consequences of major diseases. The results add to a debate about alleged overuse of stents, made by companies including Abbott Laboratories, Boston Scientific Corp. and Johnson & Johnson, and controversial diabetes drugs from GlaxoSmithKline PLC and Takeda Pharmaceutical Co.

BGS

June 8, 2009 in FDA, Medical Devices - Misc., Pharmaceuticals - Misc. | Permalink | Comments (2) | TrackBack (0)

Tobacco, the FDA, and Preemption

Op-ed in today's Wall Street Journal -- Tobacco and the Tort Bar, by Mark H. Berlind.  Here's an excerpt:

Congress is on the verge of passing sweeping legislation that would empower the Food and Drug Administration (FDA) to regulate tobacco products. Antitobacco activists are cheering, while some tobacco companies are raising the specter of First Amendment violations. Lost in the debate is the fact that this bill will continue to allow consumers to sue manufacturers that fully comply with the FDA's content and labeling rules.

...

Today's legislation would impose strict limits on tobacco advertising and labeling, mandate stronger warning labels, and require advance FDA approval of any reduced-risk claims. It would also empower the FDA to change cigarettes' content to make them less addictive and lethal.

However, in a little-noticed provision, the bill also expressly provides that "no provision of this chapter . . . shall be construed to modify or otherwise affect . . . the liability of any person under the product liability law of any State." In other words, the regulatory regime that the legislation would establish can't protect companies from tort liability -- even if they rigorously follow every FDA rule.

BGS

June 8, 2009 in FDA, Preemption, Tobacco | Permalink | Comments (1) | TrackBack (0)

Monday, April 20, 2009

Wall Street Journal on Provenge & the FDA

Editorial in today's Wall Street Journal on the delay in approving prostate-cancer drug Provenge by the FDA -- Prostate Cancer and FDA Politics: Their first priority should be to save patients.  Here's an excerpt:

The larger question is why Provenge wasn't made available sooner to the 30,000 American men who die each year from prostate cancer. The FDA regularly -- and pointlessly -- slow-walks potentially revolutionary therapies, relying on overly simplistic and unscientific statistical models that don't take into account the fact that some drugs may work better in certain subgroups than in others. Its regulatory blockade is especially cruel to terminally ill patients for whom drugs like Provenge may mean extra months or years of life.


Id.  One wonders if rather than an FDA-centric regulatory approach, a flexible negligence standard incorporating evolving industry custom for testing would better serve public policy by expeditiously moving safe and effective drugs to market.

BGS

April 20, 2009 in FDA, Pharmaceuticals - Misc., Products Liability | Permalink | Comments (0) | TrackBack (0)

Sunday, March 22, 2009

Split FDA into Separate Food Administration and Drug Administration?

According to this article in today's L.A. Times, pharmaceutical companies are quietly pushing to break up the FDA into separate entitites, in hopes of speedier drug approvals.  President Obama yesterday appointed a group to reassess the FDA, so there may be an opportunity for change.

BGS

March 22, 2009 in FDA, Food and Drink, Food Poisoning, Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Friday, March 20, 2009

Albany Law School Symposium on Off-Label Prescription of Drugs

As I previously briefly noted, Albany Law School is hosting on Friday, March 27 a symposium entitled, Regulating the Cure: Topics Arising Out of the Prescription of Drugs Off-LabelI will be speaking about liability from off-label promotion of drugs.  Other participants include Dean Thomas Guernsey (Albany Law); Professors Beverly Cohen (Albany Law), Michael Kane (Albany College of Pharmacy & Health Sciences), Alicia Ouellette (Albany Law), Sarah Scarpace (Albany College of Pharmacy & Health Sciences), and Dan Thompson (Alden March Bioethics Institute); Mollie Hertel (U.S. Government Accountability Office); and practitioners Eric Chaffin (Bernstein Liebhard), Arnold Friede (McDermott, Will & Emery), Patrick Igoe (Registered Patent Attorney), and Raul Tabora (Ruffo, Tabora).  Here's a link to the brochure.

BGS

March 20, 2009 in Conferences, FDA, Mass Tort Scholarship, Pharmaceuticals - Misc. | Permalink | Comments (0) | TrackBack (0)

Tuesday, March 17, 2009

Margaret Hamburg Picked to Head FDA

Article in the Wall Street Journal -- Hamburg, Pick for FDA, Faces an Agency in Crisis, by Alicia Mundy.  Here's an excerpt:

President Barack Obama's choice to lead the Food and Drug Administration faces several crises at the beginning of her term.

If confirmed by the Senate, Margaret "Peggy" Hamburg will take the helm of an agency under investigation on multiple fronts on Capitol Hill. It has struggled to address problems involving imported drugs such as heparin from China. There have been high-profile outbreaks of illness from peanut butter and tomatoes. And a seemingly endless line of FDA scientists have complained to Congress about agency decisions.


BGS

March 17, 2009 in FDA | Permalink | Comments (0) | TrackBack (0)

Wednesday, February 11, 2009

Roderick Hills and Catherine Sharkey on Preemption

The Fall 2008 NYU Law School magazine includes A Presumption Against Preemption, by Professor Roderick Hills (NYU), and A Model for Products Liability Preemption, by Professor Catherine Sharkey (NYU).  (Scroll down the .pdf link to page 60 for the Hills piece, and page 63 for the Sharkey piece.)

BGS

February 11, 2009 in FDA, Mass Tort Scholarship, Preemption, Procedure, Products Liability | Permalink | Comments (0) | TrackBack (0)

Albany Law School Symposium on Off-Label Prescription of Drugs

Albany Law School is hosting a symposium entitled, Regulating the Cure: Topics Arising Out of the Prescription of Drugs Off-Label, in Albany, New York on Friday, March 27, 2009.  Papers will subsequently be published in the Albany Law Journal of Science and Technology.  I'll be speaking as part of a panel on current topics in off-label drug-use litigation.

BGS

February 11, 2009 in Conferences, FDA, Mass Tort Scholarship, Pharmaceuticals - Misc. | Permalink | Comments (2) | TrackBack (0)

Sunday, February 8, 2009

Richard Epstein and Rick Hills Debate When FDA Regulation Should Preempt State Tort Liability

Professor John McGinnis (Northwestern) is moderator for a January 9, 2009 Federalist Society debate between Professors Richard Epstein (Chicago) and Rick Hills (NYU) on When Should FDA Regulation Preempt State Tort LiabilityI attended, enjoyed the debate, and asked a question, which is toward the end of the audio/video.

BGS

February 8, 2009 in FDA, Mass Tort Scholarship, Preemption | Permalink | Comments (0) | TrackBack (0)

Saturday, January 31, 2009

Erin Glenn Busby on Wyeth v. Levine

In a Federalist Society SCOTUScast, appellate lawyer Erin Glenn Busby discusses Wyeth v. Levine, the pending Supreme Court case involving whether state tort lawsuits are preempted by FDA approval of prescription-drug labeling.

BGS

January 31, 2009 in FDA, Mass Tort Scholarship, Pharmaceuticals - Misc., Preemption, Procedure, Products Liability | Permalink | Comments (0) | TrackBack (0)

Wednesday, January 28, 2009

Investigation into FDA's Medical Device Approval

The New York Times reports that several dissident FDA scientists may be under criminal investigation for their role in approving high-risk medical devices. In response, they wrote a letter to President Obama stating, "It is an outrage that our own agency would step up the retaliation to such a level because we have reported [the FDA's] wrongdoing to the United States Congress. Here's an excerpt of the Times piece:

The letter is the latest escalation in a highly unusual internal battle that has been simmering for nearly a year within the agency’s device division. The nine scientists have banded together and charged that agency officials have acted illegally and that patients are routinely put at risk from high-risk medical devices that are approved for sale even though manufacturers have never proved that the products are either safe or effective.

The scientists complained in May to Dr. Andrew C. von Eschenbach, who was then the F.D.A. commissioner, and the agency began an internal review that continues. Dissatisfied with the pace and results of that review, the scientists wrote a letter to Congress in October pleading for an investigation, and the House Committee on Energy and Commerce announced in November that it would begin one, which also continues.

Three weeks ago, the scientists wrote a similar letter to the president-elect’s transition team. And on Monday, the scientists wrote another letter to President Obama.

Confidential agency documents, which include both e-mail messages and medical reviews detailing the internal dispute were provided to The Times.

It can be a crime for agency employees to reveal documents or information considered confidential by companies seeking agency approval for medical products.

Some of the scientists’ claims about the agency’s device approval process were echoed in a report released two weeks ago by the Government Accountability Office that was also critical of the agency’s device center.


ECB

January 28, 2009 in FDA | Permalink | Comments (0) | TrackBack (0)

Friday, January 16, 2009

GAO Criticizes FDA

The New York Times reports that the Government Accountability Office recently criticized the Food and Drug Administration's device approval process. Here's an excerpt:

Created in 1976, the F.D.A.’s process for approving devices divides the products into three classes and three levels of scrutiny. Tongue depressors, reading glasses, forceps and similar products are called Class I devices and are largely exempt from agency reviews. Mercury thermometers are Class II devices, and most get quick reviews. Class III devices include pacemakers and replacement heart valves.

Congress initially allowed many of the Class III products to receive perfunctory reviews if they were determined to be nearly identical to devices already on the market in 1976 when the rules were changed. But the original legislation and a companion law enacted in 1990 instructed the agency to write rules that would set firm deadlines for when all Class III devices would have to undergo rigorous testing before being approved.

The agency laid out a plan in 1995 to write those rules but never followed through, the accountability office found. The result is that most Class III devices are still approved with minimal testing.

Agency officials told the accountability office investigators that writing the new rules was still important.

“When asked for their time frame for doing so, however, the officials did not provide one,” the report stated.

Dr. Susan Alpert, the chief regulatory officer of Medtronic, the leading maker of heart devices, said that many of the Class III devices that currently receive less scrutiny before approval would, once the agency completed its overhaul, be reclassified as less risky Class II devices.

“So the impression that F.D.A. is approving new technologies with little review is erroneous,” Dr. Alpert said.

Still, she said, “there is no question” that F.D.A. needs to fix its reclassification process.

ECB

January 16, 2009 in FDA | Permalink | Comments (0) | TrackBack (0)

Thursday, January 15, 2009

Today's $1.4 billion Zyprexa deal

As expected, the Justice Department and Eli Lilly today announced that Lilly will pay $1.4 billion in a criminal plea deal and civil settlement.  The deal includes $615 million as a criminal penalty and $800 million to settle civil claims by the United States and over 30 states.  Speculation about the negotiations goes back nearly a year.

Here are some details from today's report on Bloomberg:

Eli Lilly & Co. will plead guilty to a criminal charge of promoting its antipsychotic drug Zyprexa for unapproved uses, pay $1.42 billion in fines and submit to U.S. monitoring against future lawbreaking.   ...

Lilly resolved federal and state probes into how it marketed the drug and will plead guilty in U.S. District Court in Philadelphia in the next few weeks, the Indianapolis-based drugmaker said in a statement. Lilly said it promoted Zyprexa in elderly people to treat dementia, a use not approved by the Food and Drug Administration, between September 1999 and March 2001, a criminal violation of the Food, Drug and Cosmetic Act. ...

As part of the settlement, Lilly agrees to operate under a federal monitor’s review for five years.

Twelve states' claims remain unresolved.

Two things strike me about the deal.  First, it is huge, and it had to be.  From the perspective of the Department of Justice, the U.S. Attorney's Office, and the state attorneys general, anything less than a billion would have seemed an ineffective deterrent given the revenues that Zyprexa generated.  In an era of multi-billion dollar revenues for blockbuster drugs, we are bound to see more 10-figure resolutions.

Second, today's deal drives home how multi-faceted mass tort litigation has become.  I used to think of "mass tort litigation" as, well, litigation involving massive numbers of tort claims.  The Zyprexa litigation is mass tort litigation, but "the Zyprexa litigation" includes wrongful death claims, personal injury claims, consumer fraud claims, securities claims, third-party payor claims, federal and state government civil claims, and federal criminal charges.

When Eli Lilly settled the bulk of the tort claims, it wasn't nearly done with the Zyprexa litigation.  Lilly settled tens of thousands of individual claims through mass aggregate settlements -- 8000 plaintiffs for about $700 million in 2006 and 18,000 plaintiffs for about $500 million in 2007.  Judge Jack Weinstein in the MDL treated the litigation and settlement as a "quasi-class action."  At the time, one might have thought that those gargantuan settlements resolved the bulk of the Zyprexa dispute.  With today's deal, we are reminded that the personal injury and wrongful death claims were only one piece of the Zyprexa litigation.

Over a billion dollars in tort settlements.  Tens of millions more for state consumer protection claims.  Over a billion dollars today for the government criminal and civil claims.  A billion here, a billion there, and pretty soon we're talking about real money. 

HME

January 15, 2009 in FDA, Settlement, Zyprexa | Permalink | Comments (0) | TrackBack (0)