December 16, 2006
Sanofi-Aventis Reacts to Ketek FDA Panel
Article in the New York Times -- Drug Maker Takes Issue With F.D.A. Panel, from Reuters:
Sanofi-Aventis, the drug maker, said yesterday that it planned additional discussions with the Food and Drug Administration after an advisory panel to the agency said the company should not be allowed to continue marketing the antibiotic Ketek.
Ketek is used in the treatment of acute bacterial worsening of bronchitis or acute bacterial sinusitis.
The F.D.A. advisory panel earlier supported continued sales of Ketek for treating pneumonia acquired outside a hospital.
For additional coverage, see the Wall Street Journal article, Sanofi Antibiotic Takes Hit From FDA Advisers, by Anna Wilde Matthews.
Japan Tobacco to Buy Gallaher
Article in the New York Times -- Japan Tobacco to Buy a Big British Maker, by Martin Fackler:
Corporate Japan is once again on an overseas shopping spree.
On Friday, Japan Tobacco, the maker of Mild Seven cigarettes, announced that it would pay $19.1 billion to buy the British tobacco giant Gallaher in the largest-ever foreign takeover by a Japanese company. The offer was unanimously accepted by Gallaher’s board, but awaits the approval of shareholders, Japan Tobacco said Friday in a statement.
Analysts said the deal would help transform Japan Tobacco, the world’s third-largest cigarette maker, from a regional player in Asia into a global giant. The company will gain a hefty presence in Western Europe and Russia, and control of brands including Benson & Hedges.
Documents Allegedly Show Eli Lilly Downplayed Zyprexa Risks
Interesting and detailed article in the New York Times -- Eli Lilly Said to Play Down Risk of Top Pill, by Alex Berenson, pertaining to documents that allegedly show manipulation of Zyprexa information by Eli Lilly sales agents. Here's an excerpt:
The drug maker Eli Lilly has engaged in a decade-long effort to play down the health risks of Zyprexa, its best-selling medication for schizophrenia, according to hundreds of internal Lilly documents and e-mail messages among top company managers.
The documents, given to The Times by a lawyer representing mentally ill patients, show that Lilly executives kept important information from doctors about Zyprexa’s links to obesity and its tendency to raise blood sugar — both known risk factors for diabetes.
Lilly’s own published data, which it told its sales representatives to play down in conversations with doctors, has shown that 30 percent of patients taking Zyprexa gain 22 pounds or more after a year on the drug, and some patients have reported gaining 100 pounds or more. But Lilly was concerned that Zyprexa’s sales would be hurt if the company was more forthright about the fact that the drug might cause unmanageable weight gain or diabetes, according to the documents, which cover the period 1995 to 2004.
Zyprexa has become by far Lilly’s best-selling product, with sales of $4.2 billion last year, when about two million people worldwide took the drug.
December 15, 2006
FDA Panel Review of Ketek for Liver Problems
Article in the New York Times -- FDA to Assess Antibiotic Linked to Woes, by the Associated Press:
Federal health officials said Thursday they would ask outside experts whether the benefits of an antibiotic linked to rare reports of severe liver problems, including several deaths, outweigh its risks.
A Food and Drug Administration review found 13 reports of liver failure in patients treated with the drug, Ketek, through September. Doctors have prescribed the antibiotic, made by France's Sanofi-Aventis SA, more than 5.6 million times in the United States since the FDA approved it in 2004 to treat respiratory tract infections, bronchitis, sinusitis and community-acquired pneumonia.
Concerns about the rare but serious health problems seen in patients treated with the drug led the FDA to convene a two-day meeting of outside experts. The panel is expected to wrap up late Friday with a recommendation to the agency.
Merck Vioxx Win in Alabama Court
According to an article in the New York Times -- Ala. Jury Sides With Merck in Vioxx Case, by the Associated Press -- Merck has won another VIoxx case. The Merck win in Alabama state court leads to an updated scorecard of 8 Merck wins and 4 losses in Vioxx cases. Jurors deliberated for only 1 1/2 hours before delivering the verdict. The article notes that "[j]urors speaking with attorneys and reporters in the courtroom after the verdict said Albright had too many health problems before his heart attack to blame Vioxx."
FDA Preemption: When Tort Law Meets the Administrative State
Richard Nagareda has posted on SSRN a paper entitled FDA Preemption: When Tort Law Meets the Administrative State (also available at Berkeley Electronic Press). It's in the first issue of the Journal of Tort Law, a newly launched electronic peer-reviewed journal published by the Berkeley Electronic Press. Here's the abstract:
Conventional wisdom holds that regulation by the administrative state generally establishes minimum standards for product manufacturers that tort liability may usefully supplement. This account of the relationship between tort law and the administrative state has come under increasing attack in recent decades. This Article focuses on what many regard as among the most controversial settings for such attacks today: contentions that regulatory action by the federal Food and Drug Administration (FDA) operates to preempt product liability suits under state law against the manufacturers of medical devices and prescription drugs.
The Article initially explores the debate over FDA preemption as a doctrinal matter, drawing on insights from litigation over medical devices to parse the more difficult preemption issues presented in suits over prescription drug labeling. As to the latter, the Article focuses on recent litigation over an alleged causal link between the leading class of antidepressant drugs and suicide by some drug users.
The Article then shifts from doctrine to institutional design, explaining why tort law and the administrative state have come into conflict in recent years and considering how law reform might approach preemption questions based on a richer understanding of the two areas. The challenge for the future involves using the prospect of preemption to bolster the predicates for preemption itself within the regulatory system. Fresh thinking about preemption would challenge the pharmaceutical industry to act on its depictions of tort liability run amok by embracing enhanced information disclosure and policing of fraud in the regulatory process – the logical predicates for the kind of optimal risk regulation by the FDA that should carry preemptive effect. Under this approach, the prospect of preemption would function as a preference-revealing device for regulated industry and thereby position it to settle by way of its revealed behavior the seemingly intractable academic debate about the consequences of pharmaceutical liability.
There are implications for tort theory as well. A major trend in tort theory has been to think about tort liability as a form of privatized regulation. The approach offered here seeks to initiate a conversation about how the regulatory sphere might partake of the capacity of tort litigation to update information about the risks posed by pharmaceutical products in the marketplace.
December 14, 2006
A New 9/11 Fund?
Very interesting op-ed in the New York Times -- A Fair Deal for 9/11’s Injured, by Kenneth Feinberg, who was the special master who administered the 9/11 Fund. Mr. Feinberg notes that thousands of 9/11-related claims are pending in the courts, relating to those who were diagnosed with 9/11 injuries after the 9/11 Fund deadline and also potentially tens of thousands of claims in the future from those who suffered toxic exposures during the clean-up after 9/11. Mr. Feinberg advocates creating a new fund for these individuals, utilizing leftover funds from the 9/11 Fund and additional contributions from defendants in the litigation:
More than $1 billion in public funds is currently available for distribution as part of the initial federal appropriation earmarked for New York City’s 9/11 recovery. If you add financial contributions from those contractors and others involved in the litigation, and supplement that with funds from various city charities, a total of at least $1.5 billion is available to settle the pending lawsuits — more than sufficient to pay all eligible claims, as well as lawyers’ fees and costs.
Eligibility for compensation under the settlement would require proof that the victim was in the general proximity of the World Trade Center during the cleanup period. Each claimant would also supply medical documentation of an illness caused by exposure to harmful air at the site (the medical criteria would be negotiated as part of the settlement to avoid a rush of spurious claims).
New York City and the other defendants would not admit they were at fault for these injuries; they would merely agree to use available funds to pay all documented claims. (It remains an open question whether the defendants are legally responsible for such injuries.) Up to half of this money should be set aside to pay for claims stemming from future diagnoses of injuries caused by breathing the toxic air.
Report on FDA Review of Drug Ads
Article in the New York Times -- Group Wants FDA to Review More Drug Ads, by the Associated Press:
Regulators are issuing fewer citations to drug companies for false and misleading advertisements and are taking longer to do it, a congressional report says.
With annual spending on direct-to-consumer drug advertisements at $4.2 billion and growing, the government has limited ability to curb distribution of ads that violate federal rules, according to the report being released Thursday.
From 2002 through 2005, it took the Food and Drug Administration four months on average to draft, approve and send warning letters and other correspondence to companies that were in violation of the rules, government auditors said.
Between 1997 and 2001, before FDA lawyers began reviewing the letters as a matter of policy, it took just two weeks on average to issue the letters. The number of letters fell off by about half between the two time periods.
Lettuce Is Chief Taco Bell E.Coli Suspect
Article in the New York Times -- Shredded Lettuce Is Now Chief Suspect in E. Coli Outbreak, by Bruce Lambert:
Shredded lettuce was the “most likely” ingredient that spread E. coli bacteria in the recent outbreak among hundreds of customers of Taco Bell restaurants in the Northeast, federal health officials said last night.
The new conclusion was not based on testing of food samples, which so far have been negative for E coli. Instead, investigators surveyed what the stricken people ate and compared that with what their dining companions who remained healthy had eaten.
Those statistics narrowed the potential sources to lettuce, cheddar cheese and ground beef — all common to many Taco Bell items. Investigators then reviewed the record of those foods in past E. coli outbreaks and the way those foods are handled. The beef, for example, is cooked, and Taco Bell says the cheese is pasteurized.
“We think that shredded lettuce consumed at Taco Bell restaurants was the most likely cause of the outbreak,” Dr. Christopher Braden, an epidemiologist for the federal Centers for Disease Control and Prevention, said in a telephone news conference. “We’re fairly confident” that lettuce is to blame, he said, but added, “we’re not done with the investigation.”
December 13, 2006
2006 ATRA List of "Judicial Hellholes" for Defendants
Naming the entire state of West Virginia, South Florida, Southeast Texas and three notoriously plaintiff-friendly counties in Illinois, the American Tort Reform Foundation (ATRF) today released its annual Judicial Hellholes® report, shining a bright spotlight on "America's worst jurisdictions in which to face a lawsuit."
American Tort Reform Association president Sherman Joyce explained to a gathering of reporters in Washington that "Judicial Hellholes are places where judges systematically apply laws and court procedures in an unfair and unbalanced manner, generally against defendants, in civil lawsuits.
"What many will find interesting about this year's report is that the top six Hellholes are in states that recently enacted significant tort reforms, yet a handful of judges are either ignoring those reforms or otherwise abusing their discretion to distort cases in favor of plaintiffs."
Another Merck Vioxx Win
According to an article in the Wall Street Journal -- Merck Wins Another Vioxx Trial, by Heather Won Tesoriero -- Merck won another Vioxx trial, in New Orleans. The scorecard is now 7 wins for Merck and 4 wins for plaintiffs. With regard to mass tort management, the article provides this interesting update:
Over the past year, Judge Eldon E. Fallon, who presides over the federal Vioxx litigation, heard five bellwether cases, which were selected through a process involving both parties. Merck won four of these five federal cases, which were meant to be instructive to both sides about how they might fare in a negotiated settlement. Judge Fallon has said he would like the parties to meet following these trials and gauge where the litigation stands.
The approach taken by Judge Fallon is consistent with the emerging consensus management approach to mass torts that I sketched out in response to the recent American Lawyer cover article on mass torts.
The Wall Street Journal also provides a trial scorecard for Vioxx.
FDA Plans Anti-Depressant Suicide Warning for Those Up to 24 Years Old
Article in the New York Times -- FDA May Expand Antidepressant Warning, from the Associated Press:
Antidepressants increase the risk of suicidal behavior for people up to age 24, the government said Wednesday. It plans new warning labels and says users of all ages should be closely monitored.
The label change proposed Wednesday would expand a warning now on the antidepressants that applies only to children and adolescents.
The Food and Drug Administration put forth its plan to update the drug labels at a meeting of outside advisers on the issue. The changes also would include a recommendation for careful monitoring, especially when patients are beginning treatment.
Public reaction was split, with some saying the changes were overdue and others arguing they could keep drugs from those who need them.
The Washinton Post published a related article -- Antidepressants a Suicide Risk for Young Adults, by Shankar Vedantam.
Still Searching for E.Coli Source at Taco Bell
Article in the New York Times -- With Onions No Longer the Top Suspect, the Search for E. Coli Resumes, by Andrew Martin. The article notes that there are at least 466 confirmed or suspected cases of E.coli related to Taco Bell. Here's an excerpt:
Nearly two weeks ago, on Nov. 30, Taco Bell officials learned that several customers had become sick with a virulent strain of E. coli after eating at one of the chain’s restaurants in New Jersey.
By the following Monday, Dec. 4, it became clear that the outbreak was spreading beyond that restaurant, in South Plainfield in central New Jersey, and Taco Bell issued its first public statement, saying it had closed nine restaurants in New Jersey and New York.
Two days later, Taco Bell appeared to have a major break: Preliminary tests by a private laboratory showed that green onions were the probable culprit, and it ordered them out of all 5,800 restaurants nationwide. Now, almost a week after saying they had zeroed in on a possible cause of the outbreak, investigators say that those early indications appear to be wrong and that they may never learn the cause with certainty.
More sophisticated testing of the green onion samples — the required next step — actually found no traces of E. coli O157:H7. Although additional testing continues, the authorities now say the source of the E. coli outbreak could be any number of ingredients used by Taco Bell, but probably not onions.
An article in the Washington Post -- Lettuce Suspected in Taco Bell E. Coli, by Andrew Bridges of the Associated Press -- notes that interviews with the ill indicated that lettuce may be the source of the E.coli.
December 12, 2006
FTC Requires Interest Disclosure of Word-Of-Mouth Marketers
Article in the Washington Post -- FTC Moves to Unmask Word-of-Mouth Marketing: Endorser Must Disclose Link to Seller, by Annys Shin:
The Federal Trade Commission yesterday said that companies engaging in word-of-mouth marketing, in which people are compensated to promote products to their peers, must disclose those relationships.
In a staff opinion issued yesterday, the consumer protection agency weighed in for the first time on the practice. Though no accurate figures exist on how much money advertisers spend on such marketing, it is quickly becoming a preferred method for reaching consumers who are skeptical of other forms of advertising.
Word-of-mouth marketing can take any form of peer-to-peer communication, such as a post on a Web blog, a MySpace.com page for a movie character, or the comments of a stranger on a bus.
As the practice has taken hold over the past several years, however, some advocacy groups have questioned whether marketers are using such tactics to dupe consumers into believing they are getting unbiased information.
Source of E.Coli in Taco Bell Still Unclear
Article in the Washington Post -- Source of Taco Bell E. Coli Remains Unknown, by Steven Reinberg:
Investigators are no closer to determining the source of an outbreak of E. colithan they were when the first of 64 people in the Northeast became ill in early November, federal health officials said Monday.
Tests on green onions, believed to have been a possible cause, were negative, they said.
But the outbreak, linked to Taco Bell restaurants, may be winding down. No new cases have been added to those reported in five states since late last week, the U.S. Centers for Disease Control and Prevention reported.
Dr. Christopher Braden, an epidemiologist with the U.S. Centers for Disease Control and Prevention, told a news teleconference there may yet still be unconfirmed cases of people sickened by E. coli.
Blogs of Interest
For your surfing pleasure, here's a list of some of the blogs that address mass tort litigation and related topics:
Blogs by law professors
- Mass Torts
- Mass Tort Litigation Blog (Byron Stier, Howard Erichson)
- Federal Civil Practice Bulletin (Benjamin Spencer)
Blogs by practitioners
- Plaintiffs' Lawyers
- Defense Lawyers
Blogs by reporters and think-tankers
- WSJ Law Blog (Wall Street Journal)
- Legal Pad (Roger Parloff)
- Overlawyered (Walter Olson & Ted Frank)
- Point of Law (Manhattan Institute & American Enterprise Institute)
- Tort Deform (Drum Major Institute for Public Policy)
- The Tortellini (Stephanie Mencimer)
If you know of other blogs that readers of the Mass Tort Litigation Blog would find useful, please let us know by leaving a comment.
FDA Stopping Sale of Some Quinine Drugs
Article in the New York Times -- FDA Halts Sales of Some Quinine Drugs, by the Associated Press:
Companies have 60 days to stop selling unapproved prescription drugs made with quinine and dispensed by the millions each year.
The new Food and Drug Administration order, released Tuesday, applies to the roughly eight companies that make and sell the drugs, most commonly prescribed to treat leg cramps. It does not affect the single FDA-approved quinine drug sold to treat some types of malaria.
That FDA-approved medicine, heir to a traditional use of the drug that dates to the 1800s, today accounts for just one-half of 1 percent of the estimated 4 million annual prescriptions written for quinine drugs. Doctors prescribe the vast majority of the drugs for leg cramps, a use that the FDA warned patients and doctors could pose serious safety risks.
Many unapproved quinine drugs don't bear warnings of those risks, including the toxic effects of even a slight overdose, agency officials said.
Vioxx Litigation Update
An article in the New York Times -- Merck Reports Progress on Overhaul, by the Associated Press -- provides an update on the Vioxx litigation:
The company provided an update on the mounting litigation over Vioxx, the former blockbuster painkiller it pulled from the market on Sept. 30, 2004 after its own research showed Vioxx doubled the risk of heart attacks and strokes. Merck said Tuesday it now faces about 27,200 personal injury lawsuits over Vioxx, representing about 45,900 plaintiff groups, plus 265 potential class action suits.
Another 14,000 plaintiffs have entered agreements with Merck suspending the time limit for lawsuits. Suits by more than 3,000 plaintiff groups have been dismissed, although about two-thirds of those may be refiled later.
So far, Merck has reserved nearly $1.6 billion for its legal defense costs but has resisted setting aside any money to pay jury awards or settlements with plaintiffs.
Scott Dodson has posted a paper on SSRN addressing FRCP 23(c)(4)(B): Subclassing, 27 Cardozo L. Rev. 2351 (2006). In mass tort class actions, Amchem and Ortiz brought the question of subclassing to the fore, especially as a possible solution to the problem of adequacy of representation for present and future claims. Subclassing also has been discussed as a possible solution to choice of law problems in nationwide or multistate class actions, or to solve predominance and adequacy problems related to different disease categories or other issues. But despite the Supreme Court's nudge, there's a sense that as a practical matter, subclassing has not taken hold in mass torts or elsewhere. Here's a copy of Prof. Dodson's abstract:
This article is the first to take a hard look at Federal Rule of Civil Procedure 23(c)(4)(B), an oft-slighted part of the class action scheme that permits a court to create subclasses when appropriate. Despite its tautologically unhelpful text, no other court or commentator has undertaken a comprehensive analysis of this provision. The time to do so is certainly now. As class actions grow bigger, plaintiffs seek new ways to meet Rule 23's certification requirements. Just in the last few years, plaintiffs have turned to subclassing's sister provision, Rule 23(c)(4)(A), which has consequently received a flurry of commentary from courts and academics. The subclassing provision, which provides an alternative mechanism to Rule 23(c)(4)(A), is therefore ripe for a similar spate of commentary and conflict. This article sets the stage for that discussion by formulating two conflicting theories of subclassing: the replacement theory, which posits that subclasses can be certified without regard to the certifiability of the global class action, and the contingency theory, which requires any subclass to be a part of a certified global class. Testing these interpretations of Rule 23(c)(4)(B) against the traditional tools of statutory interpretation - text, context, structure, drafting history, precedent, and functionality - the article concludes that the replacement theory is the best interpretation of the subclassing provision. Nevertheless, the article notes the contrary arguments and suggests that they serve as a call to the Rules Committee and the Court to clarify the meaning and scope of the subclassing provision.
December 11, 2006
FDA Plan for Easier Access to Experimental Drugs
Article in the Washington Post -- FDA Reveals Plan for Wider Access to Experimental Drugs, by Rob Stein:
The Food and Drug Administration yesterday unveiled a proposal designed to give thousands of seriously ill patients easier access to experimental treatments.
The proposal would clarify how patients can become eligible to get drugs that are showing promise but have not been fully tested to determine their safety and effectiveness, officials said. The plan would make it easier for researchers, drug companies and research institutes to determine how much they could charge patients getting drugs early, they said.
"People feel like there's a need to have access earlier," the FDA's Janet Woodcock said. "We're simplifying the process."
The FDA has allowed some patients access to experimental drugs since the 1970s, a practice that began to expand under pressure from AIDS activists in the early days of the epidemic. Since then, advocates for patients suffering from cancer and many other diseases have pressed the agency to further relax its requirements.