Personal Injury Lawyer Blog
Wyeth in Trouble with FDA - Friday, January 4, 2008
Following a loss in a suit against it for the relationship between breast cancer and its menopause hormone replacement therapy (HRT) drugs Premarin and Prempro, pharmaceutical manufacturer Wyeth has been struggling with the FDA over several drugs, including two products designed to fill the market niche earlier occupied by the HRT products. The most recent hang-up is the FDA's demand that Wyeth answer more questions and hand over more data before the agency rules on the new experimental osteoporosis medicine bazedoxifene. This demand for additional information is a good thing, since hearings on Premarin and Prempro have revealed that the company had reason to expect the various problems that arose from users of the drugs. Suspicions about the drugs became clear as soon as sufficiently large studies were conducted. Hopefully, the new data demanded by the FDA will prevent a similar situation from occurring with the new drug. Wyeth claims it has already submitted data supporting approval of the drug, a study covering nearly 1,000 women, that had not yet been considered by the agency.
Osteoporosis is the loss of calcium-based minerals in the bones, making them more susceptible to breakage, and particularly affects women immediately following menopause. The disease only hit public awareness after Wyeth promoted its cure as a side effect of HRT.
Wyeth has a separate application in for approval of bazedoxifine for the treatment of osteoporosis in progress, although a decision on that application is not expected until May.
Other recent setbacks for Wyeth include the August 10 rejection of its experimental schizophrenia drug, bifeprunox, because the drug was not as effective as other treatment options available. The main advantage claimed by Wyeth for this drug is that it did not result in weight gain for its users. The FDA also declined to approve Pristiq, a nonhormonal menopause treatment, because of possible side effects on the heart and liver, until Wyeth conducts additional trials to ensure the drug's safety. (Note that Wyeth was hoping to replace HRT with two separate products, doubling its sales for the same treatment.)
Although these struggles may signal that the FDA is not so much in the power of the pharmaceutical companies as some fear, these demands for more information and study are as much a show to prove the agency's power as real attempts to protect the public health. In December alone, the FDA approved or gave tentative approval to over 30 new drugs, many of which will be manufactured and marketed under numerous trade names by several companies. With this flood of new drugs, how can we hope to know which will prove dangerous in the near future?
If you or someone you love has been injured as a result of a pharmaceutical, or you fear that you may be suffering unanticipated side effects of your medication, contact PersonalInjury.com today to get in touch with a pharmaceutical injury lawyer who can get compensation for you and protect others by getting those dangerous drugs off the market.
Labels: defective pharmaceutical, FDA, HRT
Couple Sues after Second Fatal Helicopter Crash on Kuai in 4 days - Thursday, January 3, 2008
After the second fatal helicopter crash on the beautiful island of Kuai in just four days, a New Hampshire couple who survived the crash filed a law suit against Boeing, the parent company of the manufacturer, and a subcontractor, Aluminum Precision Products, as well as the operator, Inter-Island Helicopters and the pilot. The wife suffered a paralyzing spinal injury, while the husband suffered a broken arm. The suit seeks unspecified damages, and is the second suit filed in this crash, the first suit having already been settled for an undisclosed amount.
The suit claims that the design of the aircraft was faulty and that substandard materials were used in what is called a root fitting in the tail rotor section, which witnesses say blew apart before the helicopter crashed. Although the pilot claims that an inspection of the tail section showed no unusual circumstances, such as loose bolts or delamination of the tail rotor blades, the tail section came apart mid-flight, and could not be found.
It is likely that this case will also be settled in the near future. If you or a loved one has suffered as a result of an aviation accident, contact PersonalInjury.com today to get in touch with a local lawyer who can stand up for your rights.
Labels: defective part, helicopter accident, spinal injury
Insurance Company Holds the Law of the Land in Contempt -
Allstate Insurance Company has been ordered to produce key records in a case pending in Missouri, the so-called McKinsey documents. In fact, it has been fined $25,000 dollars a day until it produces the documents. These are the same documents at issue in a bad-faith insurance case. According to plaintiffs' lawyers in bad-faith insurance suits against Allstate, mostly revolving around auto accidents or truck accidents, the documents detail the company's attempts to raise profits over $700 million annually by habitually denying valid claims and making motorists and other insured persons fight for their awards. Allstate, however, claims that the excerpts of the documents seen have been taken out of context and that an analysis of the full policies will reveal there is nothing morally wrong about the company's policies at all.
What the company will not say is how anyone is supposed to make a judgment about the McKinsey documents when Allstate refuses to produce them? Allstate's rationale for not producing the documents is that they contain "trade secrets." Now, Allstate is refusing not only to produce the documents, but to pay the fine as well, expressing complete contempt for the power of Missouri courts to compel them, another expression of the need for federal regulation of the insurance company.
Insurance companies sell you an image of assistance when you are in trouble, an image of a safe place from the storms of fate battering you. But when you come to them with a legitimate claim, you realize just how false that image is. That is the heart of bad faith insurance practices: selling you a lie that you are supposed to hang your life on.
If you or someone you love has come up against the bad-faith insurance practices of Allstate or another insurance company contact PersonalInjury.com today to get in touch with a local bad faith insurance lawyer who can help you.
Labels: auto accident, bad faith insurance, federal government, state government
Contact our Personal Injury Lawyers and Attorneys today to find an experienced motor vehicle accident lawyer near you.
