June 7, 2008
FDA Warning Letters Decline
Article in the Wall Street Journal -- FDA Warning Letters to Companies Decline Sharply, by Jared Favole. Here's an excerpt:
The number of Food and Drug Administration warning letters sent to companies dropped by half in the past 10 years, highlighting a change in enforcement tactics at an agency facing criticism about its policing of the food and drug industries.
In 2002, the FDA changed its policies and required that all warning letters go through the agency's chief counsel's office, a move it said was designed to strengthen the letters and make them legally consistent and credible.
In fiscal 2001, the year before this change took effect, the agency issued 1,032 warning letters. In 2006, the FDA sent 538 letters, and in 2007 sent 471, according to agency data. The FDA sends warning letters for an array of reasons, from the mislabeling of chocolate-chip cookies to the improper manufacturing of blood bags.
June 6, 2008
New Emprical Study on Summary Judgment
An article entitled "Summary Judgment Cases Over Time, Across Case Categories, and Across Districts: An Empirical Study of Three Large Federal Districts," by Theodore Eisenberg & Charlotte Lanvers, just posted on SSRN (available here) reaches some interesting conclusions about summary judgments. Good for mass tort plaintiffs: the summary judgment rate in tort cases remained steady after the summary judgment trilogy. Bad for civil rights plaintiffs: summary judgment rates increased in these cases. Here is the abstract:
Prior research on summary judgment hypothesizes a substantial increase in summary judgment rates after a trilogy of Supreme Court cases in 1986 and a disproportionate adverse effect of summary judgment on civil rights cases. This article analyzes summary judgment rates in the Eastern District of Pennsylvania (EDPA) and the Northern District of Georgia (NDGA), for two time periods, 1980-81 and 2001-02. It also analyzes summary judgment rates for the Central District of California (CDCA) for 1980-81 and for other civil rights cases in the CDCA in 1975-76. The combined sample consists of over 5,000 cases. The three-district sample for 1980-81 had an overall summary judgment rate of 4.5%. The summary judgment rate increased from 6.5% to7.0% in the two-district EDPA and NDGA sample from 1980-81 to 2001-02, a statistically insignificant difference. The pattern was inconsistent across case categories. For contract, tort, and a residual category of other noncivil rights cases, there was no evidence of a significant increase in summary judgment rates over time. Interdistrict differences were not dramatic in these three areas except that NDGA had a higher rate of summary judgment in tort and contract cases than did EDPA. The most striking effect was the approximate doubling - to almost 25% - of the NDGA summary judgment rate in employment discrimination cases and a substantial increase in the NDGA summary judgment rate in other civil rights cases. Subject to the limitation that both time periods studied are removed in time from the Supreme Court's 1986 summary judgment trilogy, the only strong evidence in this study of a post-trilogy increase is in NDGA employment discrimination cases. Civil rights cases had consistently higher summary judgment rates than noncivil rights cases and summary judgment rates were modest in noncivil rights cases.
June 4, 2008
NJ Supreme Court decides Sinclair v. Merck
The New Jersey Supreme Court issued its decision in Sinclair v. Merck, a medical monitoring class action filed against Merck on behalf of Vioxx users who had not filed personal injury claims. The opinion is available here. The court rejected the plaintiff's claims. This opinion joins a spate of recent decisions in Merck's favor. Vioxx continues to be a vehicle for making new law and rethinking old ones. Whether the New Jersey courts' tightening of medical monitoring claims is a good idea from a policy perspective will have to wait to another day.
For a defense-side take on this opinion, see the Drug and Device Law Blog here. Their analysis is useful. Thanks to Mark Hermann for bringing this to my attention.
Antiobesity Drug Linked to Deaths in U.K.
Today's Wall Street Journal reports that Acompli has been linked to several deaths in the United Kingdom. The U.S. FDA rejected Acompli for sale in the United States last year. Here's an excerpt from the Journal's report:
A spokesman for Paris-based Sanofi-Aventis said two of the deaths were the result of heart attacks, a risk that is linked to obesity. One patient died of infectious disease, and the fifth died from "sudden death," he said. The deaths occurred mostly before 2008, he said. He declined to comment further.
With such "real-world" reports, it is often unclear if the drug was the culprit. It isn't clear what actions regulators will take, if any. All approved drugs must have surveillance programs after they go on sale to record adverse reactions or deaths in patients taking them. The document, posted Tuesday on the agency's Web site, is a routine report.
That said, this report may draw more scrutiny, given Acomplia's difficulty getting approval in other countries.
With so many people suffering from obesity around the world, drug companies have been eager to find drugs to treat the disease. Before regulators' concerns, Acomplia and a drug from Merck & Co. had initially seemed promising, offering a new kind of obesity treatment that blocks certain brain receptors that regulate appetite.
June 3, 2008
Mel Weiss Receives 30-Month Sentence
Article in the Wall Street Journal -- Weiss Gets 30-Month Sentence, by Rhonda L. Rundle and Nathan Koppel. Here's an excerpt:
The career of one of the nation's most entrepreneurial, controversial, philanthropic and rich lawyers came to a close Monday, as Melvyn Weiss was sentenced to 30 months in prison for his role in a scheme in which he and his partners used kickbacks to gain an advantage in lucrative cases.
Mr. Weiss pleaded guilty this year to conspiracy in a long-running prosecution of him and his famed law firm, now known as Milberg LLP, in which the government alleged that the lawyers paid kickbacks to clients to serve as name plaintiffs in class actions. The scheme, prosecutors said, allowed Milberg to have a ready stable of plaintiffs that filed cases quickly, enabling the firm to become lead counsel in a case and claim a larger share of the fees.
In handing down a sentence near what prosecutors sought -- 33 months -- Judge John Walter noted the seriousness of the offense, which he said involved a "nationwide conspiracy that continued for decades." But the judge, in sentencing him three months shy of the maximum plea term, also appeared moved by Mr. Weiss's good works and his age, 72.
June 2, 2008
Milberg LLP Nears Settlement Deal
Today's Wall Street Journal reports that prosecutors are close to reaching a $75 million deal with Milberg LLP, although both sides declined to comment. Here's an excerpt:
If the amount under discussion in the Milberg talks holds, the government will be able to claim more than $100 million in fines and penalties in the case -- factoring in the more than $30 million that other defendants in the case have agreed to pay. That total figure would make the case one of the largest-netting prosecutions of a law firm. Last year, Jenkens & Gilchrist, a now defunct Dallas firm, agreed to pay $76 million to resolve a federal tax-shelter investigation.
Milberg has asked Coughlin Stoia Geller Rudman & Robbins LLP, a powerful San Diego law firm that spun off from Milberg several years ago, to chip in part of its payout in the settlement, but the Coughlin firm has refused, say two people familiar with the matter. The Coughlin firm hasn't been charged in the case.
Since its 2006 indictment, Milberg has lost many lawyers and considerable business, but it has continued to earn fees, including some large sums from its previously filed class actions. This year, it was paid more than $120 million as part of a settlement of a class action alleging securities fraud at Tyco, according to two lawyers in the case.
June 1, 2008
Florida Asbestos Cases Revived
The Fourth District Court of Appeal in Florida revived thousands of Florida asbestos suits last week by ruling that the Florida Asbestos and Silica Compensation Fairness Act couldn't be applied retroactively. Here's an excerpt of the Daily Business Review's story:
Judge Gary Farmer wrote for the unanimous court that the Florida Asbestos and Silica Compensation Fairness Act "may not constitutionally be applied to eliminate the existing vested rights in the lawsuits pending when the act became effective" July 1, 2005. Judges W. Matthew Stevenson and Carole Taylor concurred.
The ruling reversed 13 decisions by Palm Beach Circuit Judge Elizabeth Maass upholding retroactivity. Some of the cases date back to 1999. The decision revives them in the lower court.
"It certainly means that there are thousands of cases that were in the pipeline that were retroactively thrown out by this legislation that now may see new life," said Miami solo practitioner Joel Perwin, who helped handle the 4th DCA appeal for plaintiffs.
The 2005 law set impairment standards for plaintiffs. People with nonmalignant asbestosis must have lost at least 20 percent of their breathing capacity to sue, and those with lung cancer would have to have asbestosis and diminished breathing capacity to discount the effects of smoking.
"There are limits to legislative power," Perwin said. "You don't take away rights that have already been accrued when you're passing new laws."
Coral Gables, Fla., attorney David Jagolinzer, a partner in the Ferraro Law Firm who has represented asbestos victims at the trial level, said he is "extremely happy" with the new ruling. He said it could restore as many as 4,000 asbestos illness cases statewide.
"The importance of this decision is that the whole statute is unconstitutional," Jagolinzer said. The law "established a level of sickness, a level of impairment which you never had before" as a threshold for a lawsuit.
The appeals court said it could not sever the provisions of the act dealing with retroactivity from other provisions.
"The act in its entirety may not constitutionally be applied to require claimants with accrued causes of action for damages resulting from exposure to asbestos to plead and prove that any malignancy or physical impairment results from their exposure to asbestos," the court ruled. "Instead, their accrued causes of action required them to show only that they suffered from an injury from an asbestos-related, nonmalignant disease." The ruling means the 2005 law cannot be applied to anybody with an asbestos-related disease whether or not they sued before the law took effect, Jagolinzer said.
Judge Grants Initial Approval to Pet Food Class Settlement
Article in the Associated Press -- Recalled pet food settlement gets initial approval, by Geoff Mulvihill. Here's an excerpt:
A judge granted initial approval Friday to a settlement in which companies that manufactured or sold contaminated pet food would compensate pet owners for all costs related to the death or illness of their dogs and cats.
Under the deal, granted initial approval by U.S. District Judge Noel Hillman, pet owners in the United States and Canada would be notified of the settlement by June 16 and would have until early December to submit claims. A final hearing on the $24 million settlement is scheduled for Oct. 14.
The settlement doesn't pay pet owners for pain and suffering from injuries to their pets.