Mass Tort Litigation Blog

New Ford Recall

Earlier this week Ford recalled some 225,000 vehicles ranging in make and model over a concern about a faulty cruise control deactivation switch. Here’s an excerpt of the story from Forbes:

Ford discovered the wiring harnesses problem while repairing a vehicle in its own fleet and said no accidents or injuries have been caused by the problem.

The cruise control switch recall was due to engine fires linked to the cruise control systems in trucks, sport-utility vehicles and vans.

The vehicles in the new recall include 185,000 E-Series vans with model years ranging from 1992 to 2003.

Other affected vehicles include 1993-95 Ford Taurus SHO; 1992-98 Ford Crown Victoria and Mercury Grand Marquis; 1992-95 Lincoln Town Car; 1993 Ford Bronco; 1993 gas powered Ford Super Duty; and 1995-97 gas-powered Ford Super Duty stripped chassis.

Ford said not all vehicles in those model years had the faulty wiring harness installed, and it will contact affected owners.

ECB

Public Citizen Finds CPSC Delays its Warnings

Public Citizen released a report last week titled Hazardous Waits: CPSC Lets Crucial Time Pass Before Warning Public About Dangerous Products.  The report concluded that the Consumer Product Safety Commission (CPSC) takes roughly 2.7 years between learning about a defective product and warning the public.  As I've contended in my article, CAFA's Impact on Litigation as a Public Good, this type of bureaucratic lag time makes private decentralized enforcement essential.  Here's Public Citizen's press release:

U.S. Consumer Protection Officials Delay Months to Notify Public of Dangerous, Defective Products, Public Citizen Study Finds

Recalls of Hazardous Goods Often Take More Than Three Years to Begin

WASHINGTON, D.C. – Despite a law requiring manufacturers to provide the Consumer Product Safety Commission (CPSC) with “immediate” notification of dangerous products, the agency typically delays nearly seven months after learning of dangerous, defective products before telling the public, a Public Citizen study of CPSC settlements published in the Federal Register reveals.

The study, “Hazardous Waits: CPSC Lets Crucial Time Pass Before Warning Public About Dangerous Products,” covers 46 cases since 2002 in which the CPSC fined manufacturers for failing to adhere to the law requiring prompt reporting. In addition, companies fined for tardy reporting took an average of 993 days – 2.7 years – between learning of a safety defect in their products and notifying the CPSC. Because the agency publishes information about only those settlement agreements in which penalties are imposed, details about other delays and recalls are not publicly available.

Perhaps as shocking, the CPSC then took an average of 209 additional days before disclosing the information to the public – even though each case concerned a product defect so dangerous that the item was recalled. Under current law, the CPSC cannot disclose information about dangerous products without court approval or manufacturer agreement.

The products included coffee makers and vacuum cleaners prone to catching fire, treadmills that spontaneously accelerated to an Olympic miler’s pace, all-terrain vehicles with throttles that became stuck in the “go” position, bicycles with forks that could break under normal use, and infant swings that could cause strangulation and were implicated in the deaths of six infants.

“There’s no excuse for manufacturers waiting nearly three years before telling the CPSC about a defective product that can kill people – or for the CPSC taking another seven months to negotiate a recall and warn the public,” said Joan Claybrook, Public Citizen president. “Manufacturers now have the power to hamstring the agency. Given these inordinate delays, the law must be changed to allow the agency to inform consumers and give it enough money, authority and enforcement muscle.”

Details of the settlement agreements reveal that manufacturers have taken a cavalier attitude toward the disclosure law. In addition to failing to notify the CPSC of safety defects – often after receiving hundreds of notices from their customers – many manufacturers withheld key details from the agency when they finally did file. These details included customer complaints about products, efforts to redesign products to resolve design flaws and information about the death of a consumer.

Although the CPSC fined manufacturers for late reporting, the agency itself was slow in providing the same information to the public. For example, the agency received a report in February 2001 about an all-terrain vehicle with an oil line subject to disconnecting and spewing steaming oil on its driver and surroundings. The defect was eventually blamed for injuring 18 people, some with serious burns, and causing 42 fires. But the CPSC did not tell consumers until April 2003 – more than two years after the manufacturer informed it of the hazard.

One major cause of delay is the manufacturers’ ability to sue the agency to block public disclosure of information about hazards. The mere threat of lawsuits deters the agency from acting.

“It is ridiculous that the CPSC has to obtain manufacturers’ consent before informing the public about hazardous products,” said David Arkush, director of Public Citizen’s Congress Watch division.    “The nation’s product safety agency shouldn’t have to ask for permission to do its job. The law must be changed.”

Among Public Citizen’s findings:

• Graco waited 11 years to report its faulty infant swing, which was linked to reports of 181 falls that resulted in six deaths and nine serious injuries, including bone fractures and concussions. Graco made the report only after CPSC staff contacted the company.
• Hoover waited five years to report a vacuum cleaner with a faulty switch that had caused at least 96 fires. The CPSC then took another 279 days before negotiating a recall and informing the public.
• By February 2000, Polaris Industries had received 1,147 reports of faulty oil lines on its ATV, including 42 instances where the hot oil started a fire and 18 cases in which the oil seriously burned a rider. But the company didn’t report the defect to the CPSC for another year.

The CPSC relies on prompt and thorough reporting by manufacturers because the agency conducts little independent testing and inspects few products. Public Citizen’s findings illustrate the need for Congress to give the agency more authority and resources. In crafting legislation to reauthorize the CPSC, which is currently under negotiation in Congress, lawmakers should:

• Provide the CPSC with the freedom to inform the public about risks promptly. Currently, the CPSC cannot act unilaterally to inform the public about hazards without risking lawsuits by manufacturers. Congress should give the agency the ability to provide critical information to the public without undue interference and delays by industry.
• Grant authority to levy higher fines and seek effective criminal penalties. The CPSC’s current cap on civil penalties of $1.8 million per violation of reporting requirements is a pittance compared to the cost of conducting recalls. This gives companies an incentive to leave the agency in the dark about defects. Congress should eliminate the cap or raise it to at least $100 million per violation.
• Provide the CPSC with a significantly larger budget and staff. The agency received a meager $63 million in 2007 to protect the public from dangers posed by millions of products. Congress should boost it to at least $150 million.
• Give state attorneys general broader enforcement powers. A major criticism of the CPSC is its failure to enforce the law effectively. Congress should allow state attorneys general to enforce the law and give them authority to seek all of the remedies available to the CPSC.

READ the study and more about the problems with the CPSC.

ECB

Plavix Cessation Linked to Heart Attacks and Death

This morning's Wall Street Journal reports on a recently released JAMA study that found that patients halting their Plavix use had an increased chance of heart attacks or death within 90 days after they stopped taking the drug.   Here's an excerpt:

The study, published in this week's Journal of the American Medical Association, focused on 3,137 patients discharged from 127 Veterans Affairs hospitals from 2003 to 2005. Plavix is generically known as clopidogrel.

The doctors found the increased rate of adverse events both in patients who initially received only medical treatment and in those treated with angioplasty and stents.

"We observed a clustering of adverse events in the initial 90 days after stopping clopidogrel," the researchers wrote, "supporting the possibility of a clopidogrel-rebound effect."

The doctors found that the rate of heart attack and death during the 90 days following cessation of Plavix therapy nearly doubled.

ECB

FDA Says Long-Acting Form of Zyprexa Effective, But Sedating

Article in the Wall Street Journal -- Lilly Gets Support for Version Of Schizophrenia Treatment, by Jennifer Corbett Dooren.  Here's an excerpt:

A Food and Drug Administration official said that a long-acting, injectable form of Eli Lilly & Co.'s top-selling drug Zyprexa was effective at treating schizophrenia, but caused "profound sedation" in certain patients.

A memo written by Thomas P. Laughren, the FDA's psychiatry products division director, and posted on the agency's Web site, said clinical studies of the drug showed 24 out of 1,915 patients exposed to the long-acting form of Zyprexa suffered from profound sedation after receiving the injection. The FDA said the sedation typically lasted about one to three hours.

The long-acting form of Zyprexa faces a review by an FDA panel of outside medical experts tomorrow. The panel will be asked if that form of Zyprexa has been shown to be "acceptably safe" and effective for the treatment of schizophrenia. The panel's decision will amount to a recommendation about whether the FDA should approve the product. The FDA usually follows its panel's advice but isn't required to.

BGS

Behavioral Economics Research on Contingency Fees

Point of Law's Marie Gryphon has a post, Contentious Contingent Fees Research, that discusses recent behavioral economics research by Eyal Zamir and Ilana Ritov on the subject.

BGS

FDA Says Connection Between Chantix & Serious Psychiatric Problems "Increasingly Likely"

Article on cnn.com -- FDA wary of Pfizer anti-smoking drug.  Here's an excerpt:

Government regulators said Friday the connection between Pfizer's anti-smoking drug Chantix and serious psychiatric problems is "increasingly likely."

The Food and Drug Administration said it has received reports of 37 suicides and more than 400 of suicidal behavior in connection with the drug. In November, the agency began investigating reports of depression, agitation and suicidal behavior among patients taking the popular twice-daily pill.

The agency's announcement comes two weeks after Pfizer added stronger warnings to the drug. In doing so, the company stressed that a direct link between Chantix and the reported psychiatric problems has not been established, but could not be ruled out.

These findings come as no surprise to me, given the over 140 comments on my original post about Chantix in November 2006.  Those comments detail terrible tales of people's difficulty with this drug.  No other post on the Mass Tort Litigation blog has generated so much feedback from potential plaintiffs.  And those posts started nearly immediately and have continued steadily nearly every day. 

BGS

More Scholarship on Preemption

Preemption seems to be the topic of the day.  In addition to Catherine Sharkey's article "Products Liability Preemption: An Institutional Approach," the following pieces have been posted on SSRN:

Trevor Morrison (Cornell) has posted "The State Attorney General and Preemption" on SSRN. In this book chapter, Morrison

examines the implications of agency preemption for state attorneys general, and vice versa. Its principal intended audience is not so much the courts as Congress and the federal agencies; its prescriptions are less about judicial doctrine (though there are implications along those lines) than about choices the legislature and agencies could make to better accommodate the important functions of democratically accountable state attorneys general. As to Congress, I suggest that it should directly address whether any or all of the work of state attorneys general should be preempted by any particular enactment it passes, and should include a provision making clear the extent of its intent to preempt. As to agencies, I suggest that, in the absence of clear statutory language addressing the question, they should be reluctant to promulgate regulations preempting the investigatory or enforcement authority of state attorneys general. Unlike the Supreme Court's current "presumption against preemption," the approach I advocate does not turn on the particular subject matter of the state or federal law in question. Instead, it focuses on the identity of the actor enforcing the state law.

Peter Schuck (Yale) has posted "FDA Preemption of State Tort Law: Finding the Sweet Spot" on SSRN.   He describes the contributions of this paper to the debate on FDA preemption as follows:

First, it augments prior analyses of the comparative institutional competence, going beyond the common emphasis on relative expertise to stress the agency's far greater democratic accountability and policy learning capacity.

Second, having made the case for broad FDA preemption in the drug area, it proposes an exception to FDA preemption that is both broader and narrower than under existing law or the existing scholarship. The exception to preemption would be broader in that it would go beyond fraud on the agency to encompass all disclosure deficits on the part of drug manufacturers, whether fraudulent, negligent, or innocent. The exception to preemption would be narrower in that in order to survive a motion to dismiss, the tort plaintiff would have to meet a hyper-heightened pleading standard requiring greater specificity with respect to both the allegations of disclosure deficit and the supporting factual evidence than that required by the already heightened standard that the Federal Rules of Civil Procedure now imposes on federal court complaints alleging fraud.

The third proposed change concerns the status under state tort law of a regulatory compliance defense, which only Michigan has adopted as a complete defenser state law. Although modifying FDA preemption principles as I propose would block much design and warning defect litigation in state courts (at least prima facie) as a matter of federal law, there is much to be said for also effecting this change as a non-constitutional matter under state tort law by crafting a regulatory compliance defense consistent with my other proposed changes. The paper concludes with a brief discussion of whether FDA preemption, properly designed, would leave a compensation void with respect to those harmed by FDA-regulated drugs.

ADL

Merck: Facing Grand Jury Probe and more Vytorin Suits

Merck’s made today’s headlines yet again. The Wall Street Journal Reports that a federal grand jury is investigating whether Merck appropriately handled Vioxx. Here’s a short excerpt:

The grand-jury investigation comes at a time when thousands of plaintiffs are weighing whether to enroll in the pending settlement.

"The potential of an indictment can clearly be an incentive for [Merck] to settle civil cases," said Joseph L. Doherty, of Doherty & Quill, a Boston law firm. Mr. Doherty has one Vioxx client, whom he says he hadn't intended to enroll in the settlement. "The mere potential of an indictment probably won't change too many people's minds about whether to enter the proposed settlement."

In February 2007, the Whitehouse Station, N.J., company disclosed in its regulatory filings that the Justice Department issued a subpoena requesting information relating to the company's research, marketing and sales of Vioxx as part of a federal investigation under criminal statutes.

Merck disclosed in that filing that 31 state attorneys general and the District of Columbia are investigating its sales and marketing of Vioxx. The company said it is cooperating with authorities in all of these investigations.

And the Daily Record in Kansas City, Missouri reported last Wednesday that there are more than 50 Vytorin cases pending against Merck in Missouri’s Eastern and Western districts. Several of these suits seek class action status and damages of over a billion dollars. The theory, according to Benjamin Bertram of Bertman & Graf, is that "By not releasing data from the study . . patients were buying Vytorin when they could have had the same results from Zocor for a third of the costs."

ECB

Vladeck on Direct-to-Consumer Drug Advertising

Professor David Vladeck (Georgetown) has posted his article, The Difficult Case of Direct-to-Consumer Drug Advertising, Loyola L.A. L. Rev. (forthcoming 2008).  Here's the abstract:

This article will appear in a symposium to pay tribute to Professor Steven H. Shiffrin, one of the leading First Amendment theorists of our time. The author was asked to focus on Professor Shiffrin’s contribution to the development of the commercial speech doctrine. To reflect on the wisdom of Professor Shiffrin’s refusal to rely on general First Amendment theories, the article focuses on the difficult First Amendment problem of regulating direct-to-consumer (DTC) advertising of prescription drugs. In his famous dissent in Virginia Pharmacy Board, then-Justice Rehnquist forecast that, as a consequence of the Court’s ruling, drug companies would soon advertise directly to consumers on television and other media. Justice Rehnquist argued that “there are sufficient dangers attending” the use of drugs “that they simply may not be promoted in the same manner as hair creams, deodorants, and toothpaste.”

Today drugs are promoted in much the same way as other products. Drug companies devote forty percent of their advertising expenditures — over $4 billion per year — to DTC ads. The average American views as many as 16 hours of prescription drug ads per year, far exceeding the average time spent with a primary care physician. The question is whether proposals before Congress to limit or ban DTC advertising would pass constitutional muster. The article canvasses the arguments in some detail and concludes that legislation restricting DTC advertising to enable the FDA to assess the risks of a drug might withstand constitutional attack, but that an all-out ban on DTC advertising would not likely be sustained. The point of this discussion is to illustrate the complexity of commercial speech questions and to demonstrate that Professor Shiffrin was correct when he observed that “the commercial speech problem is in fact many problems,” and that “the small questions [it poses] will not go away.”

BGS

Kessler and Vladeck on FDA Preemption of Failure-to-Warn Claims

Former FDA commissioner David Kessler and Professor David Vladeck (Georgetown) have posted their article, A Critical Examination of the FDA’s Efforts to Preempt Failure-to-Warn Claims, Georgetown L. J. (forthcoming 2008).  Here's the abstract:

This article explores the legality and wisdom of the FDA’s effort to persuade courts to find most failure-to-warn claims preempted. The article first analyzes the FDA’s justifications for reversing its long-held views to the contrary and explains why the FDA’s position cannot be reconciled with its governing statute. The article then examines why the FDA’s position, if ultimately adopted by the courts, would undermine the incentives drug manufacturers have to change labeling to respond to newly-discovered risks. The background possibility of failure-to-warn litigation provides important incentives for drug companies to ensure that drug labels reflect accurate and up-to-date safety information. The article next explains why the agency’s view that it is capable of singlehandedly regulating the safety of drugs is unrealistic. The agency does not have the resources to perform the Herculean task of monitoring the performance of every drug on the market. Both the Institute of Medicine and the Government Accountability Office have explained the shortcomings in the FDA’s recent performance, and they express doubt that the FDA is in capable of facing an increasingly challenging future.

The article then explains how state damages litigation helps uncover and assess risks that are not apparent to the agency during a drug’s approval process, and why this “feedback loop” enables the agency to better do its job. FDA approval of drugs is based on clinical trials that involve, at most, a few thousand patients and last a year or so. These trials cannot detect risks that are relatively rare, affect vulnerable sub-populations, or have long latency periods. For this reason, most serious adverse effects do not become evident until a drug is used in larger population groups for periods in excess of one year. Time and again, failure-to-warn litigation has brought to light information that would not otherwise be available to the FDA, to doctors, to other health care providers, and to consumers. And failure-to-warn litigation often has preceded and clearly influenced FDA decisions to modify labeling, and, at times, to withdraw drugs from the market.

BGS

Reports of Lilly Reaching Settlement with Federal Prosecutors

With all of the attention Merck’s been receiving lately, it’s nice (in an abstract sense) to see some headlines about Zyprexa. The New York Times reported today that Eli Lilly is discussing the possibility of settling civil and criminal investigations by federal prosecutors, with Lilly paying more than $1 billion to federal and state governments. Here’s a bit of the New York Times piece, Lilly in Settlement Talks with U.S.:

Zyprexa has serious side effects and is approved only to treat people with schizophrenia and severe bipolar disorder. But documents from Lilly show that between 2000 and 2003, Lilly encouraged doctors to prescribe Zyprexa to people with age-related dementia, as well as people with mild bipolar disorder who had previously been diagnosed only as depressed.

Although doctors can prescribe drugs for any use once they are on the market, it is illegal for drug makers to promote their medicines any uses not formally approved by the Food and Drug Administration.

Lilly may also plead guilty to a misdemeanor criminal charge as part of the agreement, the people involved with the investigation said. But the company would be allowed to keep selling Zyprexa to Medicare and Medicaid, the government programs that are the biggest customers for the drug. Zyprexa is Lilly’s most profitable product and among the world’s best-selling medicines, with 2007 sales of $4.8 billion, about half in the United States.

Lilly would neither confirm nor deny the settlement talks.

"We have been and are continuing to cooperate in state and federal investigations related to Zyprexa, including providing a broad range of documents and information," Lilly said in a statement Wednesday afternoon. "As part of that cooperation we regularly have discussions with the government. However, we have no intention of sharing those discussions with the news media and it would be speculative and irresponsible for anyone to do so."

Lilly also said that it had always followed state and federal laws when promoting Zyprexa.

The Lilly fine would be distributed among federal and state governments, which spend about $1.5 billion on Zyprexa each year through Medicare and Medicaid.

The fine would be in addition to $1.2 billion that Lilly has already paid to settle 30,000 lawsuits from people who claim that Zyprexa caused them to suffer diabetes or other diseases. Zyprexa can cause severe weight gain in many patients and has been linked to diabetes by the American Diabetes Association.

Stay tuned.

ECB

Philip Morris to Spinoff International Operations

Article in the Wall Street Journal -- Philip Morris Readies Aggressive Global Push, by Vanessa O'Connell.  Here's an excerpt:

Sitting in his office overlooking Lake Geneva, Philip Morris International Chief Executive André Calantzopoulos takes a long drag from an unusually short cigarette. Called Marlboro Intense, the product has been shrunk down by about a half inch, and offers smokers seven potent puffs apiece, versus the average of eight or so milder draws.

The idea behind Intense is to appeal to customers who, due to indoor smoking bans, want to dash outside for a quick nicotine hit but don't always finish a full-size cigarette. Pointing to his lit Intense, the CEO says there are "possibly 50 markets that are interested in deploying it."

Marlboro Intense is likely to be part of an aggressive blitz of new smoking products PMI will roll out around the globe once the company -- now a unit of New York-based Altria Group Inc. -- becomes a standalone entity. That change will be set into motion tomorrow, when the Altria board is expected to approve a long-awaited decision to split PMI from Philip Morris USA. The move would free the tobacco giant's international operations of legal and public-relations headaches in the U.S. that have hindered its growth.

The separate entity, for example, would be exempt from U.S. tobacco regulations and out of reach of American litigators. Importantly, its practices would no longer be constrained by American public opinion, paving the way for broad product experimentation.

BGS

SEALS Mass Tort Related Panels

The Southeastern Association of Law Schools (SEALS) has released a draft of its 2008 meeting program, which is at the Ritz Carlton in West Palm Beach from July 27-August 2, 2008. (If you haven't been before, it's a wonderful conference.)  There are several panels that may be of interest to mass tort scholars on Friday, August 1. Tom Metzloff (Duke) has put together a civil procedure workshop that includes a luncheon where Francis McGovern (Duke) will speak about Handling Hurricanes and Other Mass Litigation Problems: Lessons from Katrina, and, later that evening, Bob Klonoff (Lewis & Clark), Lonny Hoffman (Houston), Scott Dodson (Arkansas) and I will speak about Frontier Issues in Civil Procedure. My talk will be on Aggregate Procedural Justice, a piece that’s currently in its nascent stages but is largely directed toward mass torts. Here’s the full tentative civil procedure line up for many of you with broader civil procedure interests. And thanks to Tom Metzloff for all of his efforts in organizing the workshop.

Workshop on Civil Procedure

10:15- 10:25 Welcome and Overview

Workshop Organizers: Professor Thomas B. Metzloff, Duke University School of Law (& SEALS President-Elect); Professor Michael P. Allen, Stetson University College of Law (& SEALS Board of Directors)

10:25- Noon Reflections on the Federal Rules at 70

This panel will address varying perspectives on the history behind and the impact of the adoption of the Federal Rules of Civil Procedure in 1938. Among other issues, the panelists will discuss whether the Rules have been a "success" as well as where they may be headed in the future.

Moderator: Professor Michael Kelly, University of San Diego School of Law.

Speakers: Professor Paul Carrington, Duke University School of Law; Professor Richard Freer, Emory University School of Law; Professor Carl Tobias, University of Richmond School of Law?

Noon- 1:30 Luncheon: Handling Hurricanes and Other Mass Litigation Problems: Lesson from Katrina (ticket required)

This program will be a moderated discussion among academics, practitioners and judges concerning the role of the legal system when facing mass litigation.

Speaker: Professor Francis McGovern, Duke University School of Law.

1:30 - 3:00 Challenges (and Solutions) Teaching Civil Procedure

This panel will discuss the challenges associated with teaching Civil Procedure. The Panelists will suggest innovative means to deal with the topic.

Moderator: Professor Carol Andrews, University of Alabama School of Law.

Speakers: Professor Mary Alegro, Loyola University, New Orleans, School of Law; Professor David Hricik, Mercer University Law School; Professor Benjamin Madison Regent University School of Law; Professor A. Benjamin Spencer, Washington & Lee University School of Law.

3:00-3:15 Break (Sponsored by Aspen Publishing Co.)

3:15-4:45 "The Devil is in the Details" -- The Rules in Operation

This panel will focus on the detailed operation of the Rules as interpreted by the federal courts in a number of contexts including pleadings, discovery and resolution.

Moderator: Professor Trina Jones (invited)

Speakers: Professor Dwight Aarons, University of Tennessee College of Law; Professor Michelle Slack, Southern Illinois University School of Law; Professor Suzette Malveaux, Catholic University of America, Columbus School of Law.

4:45-5:00 Break (Sponsored by Aspen Publishing Co.)

5:00- 6:30 Frontier Issues in Civil Procedure

This panel will address cutting-edge issues in Civil Procedure today. Among such issues are developing class action practice, issues associated with electronic discovery, potential development in notice pleading standards, and personal jurisdiction to just name a few.

Moderator: Professor Louis Virelli, Stetson University College of Law.

Speakers: Professor Beth Burch, Samford University, Cumberland School of Law; Professor Scott Dodson, University of Arkansas, Fayetteville, Leflar Law Center; Professor Lonny Hoffman, University of Houston Law Center; Dean Robert Klonoff, Lewis & Clark Law School.

ECB

FDA Difficulties in Inspecting Medical Devices

Article in the Wall Street Journal -- FDA Faulted for Scrutiny Of Medical-Device Makers, by Anna Wilde Mathews.  Here's an excerpt:

The Food and Drug Administration can't keep up with requirements to inspect domestic makers of medical devices to assure manufacturing quality, and the agency rarely examines foreign facilities, according to congressional investigators.

In testimony scheduled to be delivered today before a House Energy and Commerce subcommittee, the Government Accountability Office will tell lawmakers that it found "weaknesses" in the agency's oversight of an industry that makes products ranging from contact lenses to defibrillators. According to FDA officials' own estimates, overseas makers of the riskiest products, such as pacemakers, were examined only every six years, and moderate-risk device manufacturers on average went an estimated 27 years between FDA inspections.

The GAO testimony on medical devices will be a part of the hearing's broader effort to highlight an issue that has turned up in reports and critiques over the past few years: concerns the FDA's resources and technology aren't enough to meet its regulatory responsibilities to oversee drugs, food and other products.

BGS

Vioxx - The End of Lawyer's Ethics?

Adam Liptak of the NY Times published a piece on January 22 basically arguing that the duty of loyalty is dead and the Vioxx settlement dealt the final blow.  You can find the piece here.  He quotes Richard Nagareda arguing that “Speaking of individualized notions of lawyer loyalty is sort of like the mindset of the French military in 1940. The French generals hunkered down in a series of reinforced bunkers along the German border called the Maginot Line, meanwhile, the new world of warfare literally blitzed right past them."  The analogy is a particularly good use of the war metaphor in litigation.

Liptak's view is that any change to the duty should come from the legislature or state bar, not individual lawyers and legal developments on the ground.  (This type of thing is what the ALI is trying to do with the Project on Aggregate Litigation.)  But people that do not like what the existence of inventory cases does to the lawyer-client relationship shouldn't like it any better when the outcome is legislated.  See Howie Erichson's post on the aggregate settlement rule here, Nancy Moore's article here for some criticisms. 

What appears as a new development is old wine in new bottles.  See, for example, Judge Weinstein's classic (and excellent) article Ethical Dilemmas in Mass Tort Litigation, 88 Nw. U. L. Rev. 469 (1994) (which Howard Erichson blogged about here). Samuel Issacharoff and John Fabian Witt have shown this pretty convincingly in The Inevitability of Aggregate Settlement which was published by the Vanderbilt Law Review and can be found on SSRN.  That the problem is old doesn't mean that it isn't real, but it does show that its not a problem that can be resolved by process (it doesn't matter if the rule comes from the ALI, the bar, Congress, or the norms of the profession as they develop over time) but a structural problem of the mismatch between mass industrial harms and the tort system.

ADL 

FDA Analyzing Vytorin Study Results

Article on cnn.com -- FDA scrutinizes Vytorin.  Here's an excerpt:

Government regulators said Friday they are analyzing recent study results regarding cholesterol drug Vytorin, but that it's too early to tell whether it will take any regulatory action.

The Food and Drug Administration is focusing on study results from drugmakers Merck (MRK, Fortune 500). and Schering-Plough (SGP, Fortune 500), who unveiled their study on Jan. 14. The study failed to prove that Vytorin, a combination drug containing Schering's Zetia and Merck's generic drug Zocor, is better than Zocor alone in reducing plaque in neck arteries.

But Vytorin is still seen as effective in lowering harmful types of cholesterol, which is the drug's FDA-approved purpose.

Vytorin is a $4 billion-a-year treatment, with sales split between Schering and Merck. Vytorin is a name-brand drug, and triple the cost of generic Zocor.

BGS

Merck and Schering-Plough Defend Vytorin and Zetia

Article in the Wall Street Journal -- Merck, Schering-Plough Defend Efforts for Vytorin, Zetia, by the Associated Press.  Here's an excerpt:

Merck & Co. and Schering-Plough Corp. defended their actions Friday involving a recently released study that raised questions about the effectiveness of cholesterol drugs Vytorin and Zetia.

The Food and Drug Adminstration, meanwhile, said it will review the partially completed study once it has been finished.

The companies are being sued in several states over allegations they misled consumers into thinking the drugs were more effective than generics. In a statement Friday, the companies said they acted "with integrity and good faith."

Last week, Merck and Schering-Plough released partial data from the controversial Enhance study, which ended in April 2006. The study results revealed cholesterol drug Vytorin is no more effective than a high dose of one of its components, Zocor, which is available generically at a third of the cost. Vytorin, developed by Merck and Schering-Plough, is a combination of Schering-Plough's Zetia and Merck's Zocor, which lost patent protection in June 2006. Zocor had been Merck's top-selling drug, with annual sales of about $5 billion, roughly the amount Vytorin and Zetia now bring in together.

BGS