Friday, February 8, 2008
Very interesting article on cnn.com -- FDA warns of Botox side effects, deaths. The FDA currently says it's only probing a "relative handful" of reports, but the widespread usage of Botox certainly raises the possibility of a mass tort. Here's an excerpt:
The popular anti-wrinkle drug Botox and a competitor have been linked to dangerous botulism symptoms in some users, cases so bad that a few children given the drugs for muscle spasms have died, the government warned Friday.
The Food and Drug Administration's warning includes both Botox, a wrinkle-specific version called Botox Cosmetic, and its competitor, Myobloc, drugs that all use botulinum toxin to block nerve impulses, causing them to relax.
In rare cases, the toxin can spread beyond the injection site to other parts of the body, paralyzing or weakening the muscles used for breathing and swallowing, a potentially fatal side effect, the FDA said.
Botox is best known for minimizing wrinkles by paralyzing facial muscles -- but botulinum toxin also is widely used for a variety of muscle-spasm conditions, such as cervical dystonia or severe neck spasms.
Other authors at this blog have been following the prosecutions of lawyers from Milberg, Weiss. Did those prosecutions have any effect on the world of class actions? The answer, according to lawyers at the Professional Liability Underwriting Society’s D&O Symposium on February 6, 2008 seems to be yes, but not in the way you would expect. There's no reduction in filings, but instead in collegiality. According to a defense-side lawyer at WilmerHale, "overcaffeinated 35-year-olds" are taking over some of the suits that Milberg Weiss would have brought. The article reporting on the conference, which you can find in the National Underwriter P&C, goes on to quote another defense side lawyer from Cravath:
the new lawyers are importing tactics from product liability cases, resulting in “an increasing inexorable tide of nastiness and incivility.” In particular, he referred to tactics such as filing discovery sanction motions, noting that while good-intentioned people on the defense side are trying to find “millions of pieces of paper,” they are being accused of “all sorts of high crimes and misdemeanors” by these younger attorneys who are “hijacking” the litigation process. [emphasis added].
These lawyers, at least, seem to be feeling the loss of repeat players. Securities litigation was rather predictable, they assert, allowing insurers to determine risk early on. The removal of these prominent plaintiff's attorneys from the scene is apparently changing all that. A couple of thoughts. First, I wonder if the Cravath lawyer concerned about good-intentioned people (and note that "good-intentioned" -- rather than well-intentioned -- are the words of the journalist and not the lawyer), had forgotten the recent flurry over the Qualcomm case when he made his comments. For more on Qualcomm, look in Law Technology Today and at the Legal Ethics Forum. Second, the overall tone seems to be that aggressive litigation is a bad thing (one lawyer is quoted as saying new lawyers make the case "about the process of litigation rather than about the merits"). But sometimes aggressive litigation is what addresses the merits, as compared with, say, just settling all cases in some smoky back room. I'm not saying that is what lawyers were doing before the entry of these over-caffeinated folks. But I'm also not against a cup or two if you're a bit slow in the morning. How do you determine the "merits" in the absence of litigation?
The Legal Intelligencer reports that Merck agreed to pay more than $671 million to settle whistleblower claims arising out of marketing tactics to encourage doctors to write more prescriptions for drugs like Vioxx and Zocor. I read an article that came out in Hastings Law Review last May, Informed Consent: Requiring Doctors to Disclose Off-Label Prescriptions and Conflicts of Interest (58 Hastings L. Rev. 967), by Margaret Johns (UC Davis) suggesting that patients should give informed consent before a doctor prescribes off-label prescription drugs. The informed consent would, in a nutshell, include not only information that the drug is being used "off-label" but any "perks" that the doctors received for prescribing the drug. From the Legal Intelligencer’s article this morning, it sounds like doctors should disclose their perks before prescribing drugs, period. Here’s an excerpt:
A settlement of almost $400 million in the Philadelphia case stems from a seven-year investigation that began when H. Dean Steinke, a former Merck district sales manager, blew the whistle by filing claims under the False Claims Act that alleged Merck was using several illegal marketing practices. Steinke -- who was represented by attorneys Steven H. Cohen of Chicago, BethAnne Yeager of Madison, Wis., and Mark Kleiman of Santa Monica, Calif. -- will be paid a reward of nearly $44.7 million, prosecutors said.
The $250 million settlement of the Louisiana case stemmed from a whistleblower suit brought by William St. John Lacorte, a physician who alleged that Merck gave steep discounts for Pepcid to hospitals that agreed to primarily use Pepcid instead of competitor drugs.
Prosecutors said both settlements include interest that will boost Merck's total payout to $671 million.
Under the terms of the Philadelphia settlement, federal agencies will receive $218 million and the 49 states with Medicaid programs and the District of Columbia will share $181 million.
The Louisiana settlement is similarly divided, with $137.5 million for the federal government and $112.5 million for the states. LaCorte's reward from the Louisiana settlement has not yet been decided, prosecutors said.
Steinke's suit also accused Merck of paying kickbacks to doctors under the guise of marketing training programs such as "preceptorships," in which physicians were paid to allow a Merck sales rep to "shadow" them for half a day, and "tutorials," in which doctors were paid to listen to a Merck employee's presentation and then evaluate it. The suit said one physician was paid 22 times by Merck, at $250 a session, and seven times at $300 a session, for preceptorships.
Steinke's suit also alleged that Merck treated high-prescribing physicians to lavish vacations that the company termed "consultant meetings." One such consultant meeting was held in September 1998 at the luxurious Crystal Mountain Resort in Thompsonville, Mich., the suit said. During the event, the suit said, doctors were asked to serve as a Merck representative training consultant and to evaluate the sales message of Merck sales reps. In return, Merck paid each physician a $500 honorarium for the training and consultative services, Friday and Saturday nights' lodging expenses and an additional $100 for incidental expenses.
Thursday, February 7, 2008
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.
Wednesday, February 6, 2008
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.
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.
Tuesday, February 5, 2008
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.
Sunday, February 3, 2008
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.