The third trial against Wyeth Pharmaceuticals and its menopause drug Prempro is underway in Little Rock, Arkansas, as the company tries to defend itself against charges of negligence and intentionally misleading consumers about the drug’s connection to breast cancer. On Tuesday, Wyeth chairman and CEO Robert Essner delivered a videotaped deposition in which he says the company was “concerned” about the breast-cancer risks associated with Prempro as far back as 1991.

Wyeth is facing more than 5,000 lawsuits with regard to Prempro, a hormone-replacement drug that uses doses of estrogen and progestin to treat menopausal symptoms, including hot flashes and mood swings. So far, the drug maker has fared well in the previous two cases that have gone to trial. In one trial, an Arkansas woman’s case was dismissed by the jury; in the second, a Pennsylvania couple was initially awarded a $1.5 million jury judgment before a mistrial was declared in October. (A new trial is in progress in Philadelphia.)
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This week, the U.S. Food and Drug Administration’s Reproductive Health Drugs Advisory Committee is meeting to discuss the efficacy and safety of hormonal contraceptive products. According to an FDA briefing document about the general meeting, government scientists are concerned that newer versions of the birth-control pill are not as effective at preventing pregnancy as older treatments were. Failure rates among some newer contraceptives are roughly double that of the older drugs.

The meeting will focus on oral, transdermal, and vaginal contraceptive products only. The FDA hopes to establish clear guidelines regarding clinical trials for hormonal contraceptives. Among the topics to be discussed at this week’s meeting: clinical trial design issues, contraceptive efficacy and risk/benefit assessment, cycle control (scheduled and unscheduled bleeding and spotting), translation of clinical trial findings of efficacy and safety into “real world” effectiveness and safety, extended dosing regimens, and the role and impact of labeling in communicating product efficacy, risk, and other benefits.
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After several weeks of negotiation, State Farm Fire & Casualty Co. has reached an agreement to settle all of its Mississippi lawsuits stemming from Hurricane Katrina. The settlement must now be approved by Judge L.T. Senter, the federal judge who ruled against the company in a damage-liability suit earlier this month. The settlement does not address damages to neighboring states.

The agreement calls for an initial payment by State Farm of $130 million, a tab that may grow several times larger depending on the number of policyholders who decide to reopen their claims. About $80 million will be used to settle the more than 600 existing lawsuits in Mississippi, with an additional amount of at least $50 million earmarked for settlement of reopened claims. There are roughly 35,000 policyholders who own homes on the Mississippi coast and are eligible to have their claims revisited.
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A new Canadian study has found a correlation between the use of antidepressants and lower bone strength in elderly patients. The findings pertain to the class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs), which includes such popular drugs as Prozac, Zoloft, and Paxil. The results of the study, known as the Canadian Multicentre Osteoporosis Study (CaMos), were published in today’s issue of the Archives of Internal Medicine, a publication of the American Medical Association.

According to researchers at McGill University in Montreal, daily intake of SSRIs may double the risk of bone fractures in individuals aged 50 and older. The group studied 5008 community-dwelling adults and followed them for five years, looking for incident fractures. Of the total cohort, 137 individuals (average age of 65) reported that they used SSRIs on a daily basis.
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Perhaps shaken by a ruling against them earlier this month, State Farm Fire & Casualty Co. announced that they’ve agreed to a settlement in another Katrina-related case in Mississippi. Although the terms of the settlement were not disclosed, legal analysts believe that the insurance company agreed to pay roughly $1 million to settle.

On January 11, a federal judge in Mississippi declared that State Farm was liable for damage to a couple’s Biloxi home following Hurricane Katrina. In a case brought by Norman and Genevieve Broussard, the company was not only responsible for paying $223,292 in damages to the home, but more significantly, a jury awarded $2.5 million in punitive damages to the Broussards.
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A new study published in the current issue of the American Journal of Epidemiology has established a link between exposure to chlorinated water and an increased risk of bladder cancer. According to researchers, ingestion of and bathing, showering, and swimming in chlorinated water can all lead to increased incidence of cancer.

The study, led by Cristina M. Villanueva of the Municipal Institute of Medical Research in Barcelona, Spain, found that “long-term THM exposure was associated with a twofold bladder cancer risk” in households with high levels (50 or more micrograms per liter) of THM. (THMs, or trihalomethanes, are chemical by-products of chlorination.) Researchers discovered that these chemicals may invade the human body not only through ingestion of water, but by inhalation and dermal absorption as well. They also believe that THM that is absorbed or inhaled into the body does not go through a detoxification process in the liver, which may make the chemical much more dangerous in those situations.
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According to a newly released Harvard School of Public Health (HSPH) study, tobacco companies in the United States have added more nicotine to their cigarettes during the last decade. According to HSPH, “A reanalysis of nicotine yield from major brand-name cigarettes sold in Massachusetts from 1997 to 2005 has confirmed that manufacturers have steadily increased the levels of this agent in cigarettes.”

Researchers found that “increases in smoke nicotine yield per cigarette averaged 1.6 percent each year, or about 11 percent over a seven-year period (1998-2005).” Nicotine is considered the primary addictive agent in cigarettes.
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The U.S. Department of Health and Human Services (HHS) is investigating the sales and promotional practices of Endo Pharmaceuticals with regard to their Lidoderm product. HHS is requesting documents dating back to 1999 that might shed light on the issue. Apparently at the heart of the matter is Endo’s alleged marketing of Lidoderm for off-label uses, a practice that is illegal in the United States.

HHS wants to determine what knowledge the company had internally of inappropriate off-label prescription practices. Although marketing of drugs for non-approved usage is not allowed, doctors still have the freedom to prescribe the medications for any purpose as they see fit.
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After receiving 18 reports of highchairs collapsing, Graco announced a voluntary recall of approximately 100,000 highchairs sold between December 2005 and December 2006.

According to the U.S. Consumer Product Safety Commission (CSPC), “The highchair can collapse if it is not fully opened and locked into place from the storage position prior to use. If the highchair collapses, a child occupying the highchair can be injured.” So far, the only report of injury consists of one child with a bruised foot.
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Two lawsuits filed last month in federal court in Washington State seek to hold Coleman responsible for a series of carbon-monoxide-related deaths. At issue are Coleman’s PowerMate 5045 propane heaters, which plaintiffs claim have a defect that “produces deadly levels of carbon monoxide.”

Coleman, a division of Jarden Corporation, is one of the most popular brands of outdoor and camping equipment. The first suit against the company was filed on behalf of a 5-year-old boy who lost his parents and his sister to CO poisoning while they were sleeping this past May. The other was filed by a woman whose husband and father both died from carbon monoxide poisoning on a hunting trip in September. In both cases, the Coleman heater had been employed. (Coleman has discontinued production of the allegedly faulty model, but roughly 1 million of those heaters, or similarly designed ones, remain in use.)
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