Monday, April 19, 2010
American Conference Institute will be hosting a conference on Chemical Products Liability and Environmental Litigation on April 28-29, 2010 in Chicago, IL. I will be speaking on mass torts and ethics, with particular attention to the ethics of mass settlements. Here's the brochure (Download ACI Brochure).
April 19, 2010 in Aggregate Litigation Procedures, Conferences, Environmental Torts, Informal Aggregation, Mass Tort Scholarship, Pharmaceuticals - Misc., Products Liability, Settlement | Permalink | Comments (0) | TrackBack (0)
Tuesday, March 16, 2010
The Albany Law Journal of Science & Technology has published a symposium issue on Regulating the Cure: Topics Arising Out of the Prescription of Drugs Off-Label. My article, Promotion of Off-Label Drug Use: In Favor of a Regulatory Retreat, 19 Alb. L.J. Sci & Tec. 609 (2009), is included.
March 16, 2010 in Aggregate Litigation Procedures, FDA, Mass Tort Scholarship, Off-Label Drug Use, Pharmaceuticals - Misc., Procedure, Products Liability, Regulation, Resources - Federal Agencies, Science | Permalink | Comments (0) | TrackBack (0)
Monday, February 22, 2010
Saturday, November 28, 2009
Last Monday Judge John Keenan of the Southern District of New York dismissed the second of three bellwether cases set for trial on Merck's osteoporosis drug, Fosamax. As David Bario of The American Lawyer reports, "the plaintiff in the second test case, a 74-year-old Mississippian named Bessie Flemings, had failed to present admissible evidence of specific causation tying her jaw problems to Fosamax." Judge Keenan found that one of Fleming's medical experts had no opinion and that the other did not qualify as an expert. Consequently, Fleming couldn't establish causation under Mississippi's Product Liability Act.
The first bellwether trial ended in a mistrial after a juror complained about physical threats from other jurors. That case is set for a new trial in the spring and the third test case is set for trial in April of 2010. Judge Keenan still has roughly 900 Fosamax cases consolidated before him through multi-district litigation.
Tuesday, November 10, 2009
Thursday, October 29, 2009
On October 14, 2009, the Washington Legal Foundation hosted a web seminar, Communicating on Off-Label Treatments: Navigating the Treacherous Path Paved by Civil and Criminal Law Enforcement, with speakers Robert Salerno and Adam Hoffinger of Morrison & Foerster. Streaming video of the event is available online.
October 29, 2009 in FDA, Off-Label Drug Use, Pharmaceuticals - Misc., Procedure, Regulation, Resources - Federal Agencies, Resources - Organizations, Science | Permalink | Comments (0) | TrackBack (0)
Tuesday, October 20, 2009
Litigator David I. Shapiro, founding partner of the firm Dickstein Shapiro, has died. In a career that spanned many areas of litigation, Mr. Shapiro also was active in several prominent mass tort litigations, and came to focus on mediation as a case management method. Here's an excerpt from the Wall Street Journal's obituary:
Mr. Shapiro branched out into class-action suits in the late 1960s. He handled the states' cases in a complex federal price-fixing lawsuit against manufacturers of the antibiotic tetracycline, winning a $100 million verdict for the states.
Later, Mr. Shapiro took on cases related to breast implants, asbestos and the Exxon Valdez oil spill. In 1984, he was assigned as a special master to handle a $180 million settlement resulting from the Agent Orange case, then among the largest class-actions suits to date.
But Mr. Shapiro came to feel that much of class-action litigation was driven by greed, and that cases could be better settled by other means. He developed an expertise in negotiations, and was chairman of the American Bar Association's National Institute on New Techniques for Resolving Complex Legislation.
"It's possible to get justice and recompense for consumers without the greed of the few that plagues the U.S. system," he told the Telegraph of London in 2007.
He taught mediation at the London School of Economics, and created a mediation practice at SJ Berwin.
October 20, 2009 in Aggregate Litigation Procedures, Class Actions, Environmental Torts, Lawyers, Mass Disasters, Pharmaceuticals - Misc., Procedure, Products Liability, Settlement | Permalink | Comments (0) | TrackBack (0)
Friday, October 16, 2009
Bad news for Glaxo. The first trial involving claims that the antidepressant Paxil causes birth defects ended with a $2.5 million jury verdict for the plaintiff. The family of Lyam Kilker sued GlaxoSmithKline in Philadelphia Common Pleas Court, blaming the boy's heart defect on his mother's ingestion of Paxil during pregnancy. The jury, by a 10-2 vote, concluded that Glaxo negligently failed to warn of the risk and that Paxil caused the child's heart condition. While the jury awarded notably large compensatory damages (the family sought $1.2 million), it rejected punitive damages by deciding that the defendant's conduct was not "outrageous." The case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline. Here are links to reports at Philadelphia Inquirer, Pharmalot, Point of Law, and Law.com.
In addition to about 600 cases involving claims that Paxil causes birth defects, Glaxo has faced claims that Paxil increases the risk of suicide and homicide. The company has reportedly settled some suicide claims, and in 2001 a Wyoming jury rendered a $6.4 million verdict against Glaxo in a case involving a man who shot his family and himself after taking Paxil.
Tuesday, October 13, 2009
Friday, September 18, 2009
The FDA recently sent a warning letter to Bayer, which manufacturers Yaz and Yasmin (both types of birth control pills), that it has quality control problems at its German plant. The FDA claims that Bayer's testing method averaged out the test results as opposed to reporting results for each batch. Bayer had the batches shipped to the U.S. between 2007 and 2009.
This news is simply the most recent concern about Yaz. Litigation is already pending in Pennsylvania in front of Judge Sandra Mazer Moss of the Philadelphia Court of Common Pleas, alleging that the drug causes severe side effects including blood clots, strokes, heart attacks, gallbladder disease, deep vein thrombosis, pulmonary embolisms and even sudden death. There has been some speculation around the internet that the FDA will recall the drug. As the U.S. Recall News reports:
"In July 24, 2009, a petition was filed to consolidate the many lawsuits against Bayer over Yaz and Yasmin into a multidistrict litigation (MDL). There is a hearing scheduled for September 24, 2009 to decide whether or not they will be consolidated."
"Andrew Gillin, an attorney handling several California Yaz lawsuits says the litigation is still in the early stages. “A petition has been filed to combine all of the federal lawsuits into a multi-district litigation (MDL) case. Later this month, a panel of federal judges will determine whether the cases involve sufficiently common questions of fact, and whether or not to consolidate,” explained Mr. Gillin."
Friday, September 11, 2009
Judge John Keenan declared a mistrial today in Boles v. Merck, the first bellwether trial in the Fosamax litigation. As we mentioned yesterday and the day before, tensions have run high in the jury room. Here's an excerpt from the Wall Street Journal's report:
A judge declared a mistrial Friday in a closely watched case involving Merck & Co.'s osteoporosis drug Fosamax after a jury failed to reach a verdict amid tense jury deliberations. The mistrial came two days after U.S. District Judge John F. Keenan in Manhattan called for a daylong "cooling off" period as one juror claimed in a note to have been the subject of physical threats and that a chair was thrown in the jury room. The judge declared a mistrial Friday after the jury's forewoman indicated the jury remained deadlocked and a lawyer for Shirley Boles, a 71-year-old Florida woman who sued Merck, again asked for a mistrial.
According to Merck's lawyer, the jury appeared to be "seven-to-one in Merck's favor." The natural tendency of litigators to put favorable spin on a mistrial might make one skeptical of such an assertion, but it's noteworthy that the plaintiff's lawyer pushed hard for the mistrial while Merck opposed the mistrial motion.
The WSJ report mentioned that a conference has been scheduled for October and the plaintiff's lawyer said he expects a retrial in the spring.
The next two trials are scheduled for Dec. 1, 2009 and Jan. 11, 2010.
Update: here's a link to the New York Times article, which contains a multimedia link to the juror's notes and the request for a new trial.
Thursday, September 10, 2009
CNN reports this morning that Judge Keenan has "called for a daylong 'cooling off' period" in the Fosamax (an osteoporosis drug) litigation. Apparently jury deliberations became quite tense; the jurors have been deliberating for the last week over Shirley Boles's case. Boles is a 71-year old retired deputy sheriff that lives in Ft. Walton Beach, Florida. She claims that Fosamax caused her jawbone tissue to die. By itself, the case is relatively small. But, because Schering-Plough is looking to merge with Merck, all eyes are on the jury to see how vulnerable Merck is financially. According to the New York Times, there are roughly 900 state and federal Fosamax cases with around 1,280 plaintiffs.
One of the jurors in Boles's case claimed that she was being both intimidated and threatened. Judge Keenan has given the jury until 11:15 a.m. on Friday (tomorrow) to reach a decision before declaring a mistrial.
Wednesday, September 9, 2009
Two news items from the Fosamax front, one involving jury deliberations in the Boles trial, the other involving Merck's effort to win summary judgment in 24 other cases. The Fosamax litigation involves about one thousand plaintiffs' claims against Merck alleging that its popular osteoporosis drug caused necrosis of the jaw. Most of the litigation is in federal court, where Judge John Keenan of the SDNY is overseeing the MDL.
BOLES: In the first bellwether trial, Shirley Boles v. Merck, the jury has so far been unable to reach a verdict. The trial began on August 11, and the jury got the case on September 2. According to this Bloomberg report, the jury informed the judge that it was unable to reach a decision, and the judge yesterday told the jury to keep working:
A federal judge instructed a jury to continue deliberating whether Merck & Co.'s osteoporosis drug Fosamax caused a Florida woman’s “jaw death,” after the panel told the judge it couldn’t decide.
U.S. District Judge John Keenan in Manhattan told the jurors to keep working today. He explained that the case is important to both the plaintiff and Merck.
“It’s very stressful to sit here and an agreement cannot be reached,” a juror wrote in one of four notes to Keenan today about the lack of unanimity among the eight-member panel. “I feel that we never will reach a verdict because everyone has a different opinion.”
SUMMARY JUDGMENT: According to a Reuters report, Judge Keenan decided today that he would permit testimony by two plaintiff experts concerning causation based on relatively short-term exposure, and the court therefore rejected Merck's motion for summary judgment in 24 Fosamax cases:
In an opinion released Wednesday, U.S. District Judge John Keenan ruled that the plaintiffs could introduce testimony by two doctors to show that the drug can cause jaw damage after less than three years of continuous use. Keenan said the evidence is sufficiently reliable to allow a rational jury to establish such a connection. He said individual plaintiffs will then be allowed to present expert testimony that Fosamax caused them to suffer such damage, and that such testimony could by itself "make causation a genuine issue of fact for trial."
Monday, August 24, 2009
In his July 14 Forbes column, Vanguard or Rearguard?, Richard Epstein (Chicago & NYU) recounts the history of the FDA, as well as other regulatory frameworks, and concludes that "[r]egulatory failure is, on average, a far greater risk than market failure."
Sunday, August 23, 2009
For a past article of mine that set forth problems in the main study underlying the opinions of plaintiffs' experts in the phenylpropanolamine (PPA) litigation, see here.
Tuesday, August 18, 2009
Saturday, August 15, 2009
Tuesday, August 11, 2009
Am Law Daily's Priti Patnaik writes about the Boles case:
Starting Tuesday, pharma giant Merck & Co., Inc. faces the first trial over its osteoporosis drug Fosamax. More than 900 such lawsuits have been filed by more than 1,200 plaintiffs in state and federal courts. The suits claim that doctors were not warned that the drug may hamper blood flow to the jaw, causing jawbone-tissue death--osteonecrosis of the jaw, or ONJ. In some cases, ONJ leads to partial removal of the jaw.
Plaintiff Shirley Boles, 71, is represented by partner Timothy O'Brien and associates Meghan Tans and Ned McWilliams of Levin, Papantonio, Thomas, Mitchell, Echsner & Proctor. Michelle Parfitt and James Green at Ashcraft & Gerel are also working on the case.
Merck's trial team includes Paul Strain of Venable in Baltimore and Christy Jones of Butler, Snow, O'Mara, Steves & Cannada. Both represented Merck in the marathon Vioxx litigation. The company declined to name the other attorneys working on the case, saying that the information was part of its litigation strategy.
Interestingly, Judge Keenan has ruled that no punitive damages may be sought.
Friday, August 7, 2009
The New York Times reported yesterday that Merck and Schering-Plough have agreed to pay $41.5 million to settle class claims that they withheld the results of an unfavorable clinical trial. The clinical trial apparently linked Vytorin and Zetia to harmful side effects that included cancer. Of course, this news comes as both companies are in merger talks, which would make Merck the second largest pharmaceutical company in the world. The New York Times article is available here.
Thursday, August 6, 2009
The first Fosamax trial is set to begin Tuesday in federal court in New York. Merck is facing about 850 lawsuits alleging that Fosamax, a widely used osteoporosis drug, increases the risk of osteonecrosis of the jaw (ONJ). Most of the cases have been transferred to multidistrict litigation before Judge John Keenan in the Southern District of New York. Over 100 other cases are pending before Judge Carol Higbee (who oversaw much of the Vioxx litigation) in New Jersey Superior Court. In the MDL, Judge Keenan has scheduled three cases to go forward as bellwether trials. Plaintiff Shirley Boles is set for August 11, Bessie Fleming for Dec. 1, 2009, and Karen Greene for Jan. 11, 2010.
Last week, according to a Bloomberg news report, Judge Keenan rejected Merck's motion for summary judgment on Boles' compensatory damages claims but he granted the motion as to punitive damages, so the Boles trial will go forward solely on compensatory damages.
Since this is the first trial in the Fosamax mass tort litigation, lawyers involved in Fosamax cases undoubtedly will be paying close attention both to see the other side's trial strategy and to see how a jury responds to the evidence.
Here are links to a Bloomberg report on the upcoming trial and the court's rejection of punitive damages, entries of July 24 and July 31 on AboutLawsuits.com, and a statement released last week by Merck putting its own spin on Fosamax and ONJ.