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Texas Woman Says Avandia Killed Her Husband

Mike Simon — Sat, 07 Jul 2007 08:19:09 GMT

Peggie Stanford has filed a wrongful death suit against GlaxoSmithKline, the maker of diabetes drug Avandia, in the U.S. District Court for the Eastern District of Texas. Stanford claims her 60-year-old husband, Larry, had been using an Avandia variant when he died of a heart attack earlier this year. Stanford suffered the fatal heart attack the same day that the New England Journal of Medicine published findings that from a study aimed at discovering whether Avandia exposes users to a heightened risk of heart attack.

This is the first wrongful death suit aimed at GlaxoSmithKline for its Avandia product, but the company is facing a shareholder suit, a class action, and a personal injury suit in other federal courts. Peggie Stanford alleges that GlaxoSmithKline "unjustly enriched itself by deceiving Larry Stanford, his family, and the public by not disclosing its knowledge of the 'various studies' allegedly showing an increased heart attack risk with Avandia." The pharmaceutical giant recorded $2.2 billion in Avandia sales in 2006.

Peggie Stanford is seeking at least $75,000 in punitive, compensatory, and exemplary damages citing strict product liability for the "defective design and marketing of the drug."

For more information on this subject, please refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Mike Simon

Fen-Phen User Wins $75K Jury Award

Mike Simon — Mon, 09 Jul 2007 08:24:11 GMT

Virginia Cavender has been awarded $75,000 from a federal court jury in St. Louis for claims that pharmaceutical giant Wyeth's diet drug Fen-Phen caused damage to her heart valves. The jury needed less than seven hours to deliberate her claims of failure to warn and breach of implied warranty.

Cavender says that she used Wyeth's Pondimin (fenfluramine) and the generic phentermine for a period of two months in 1996 in an attempt to lose weight. Fenfluramine, as well as dexfenfluramine, were pulled from the market in 1997 in response to growing evidence linking the drugs with heart valve damage.

The Plaintiff prevailed on her claims of failure to warn and breach of implied warranty; however, U.S. District Judge Richard Webber granted Wyeth's motion for judgment as a matter of law, dismissing Cavender's claims for negligent failure to test and breach of express warranty. Following the verdict, Wyeth said it was, "reviewing its post-trial options" in the case.

For more information on this subject, pelase refer to our section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Mike Simon

AP Study Shows U.S. Painkiller Purchases Almost Double

Courtney Mills — Mon, 20 Aug 2007 11:12:35 GMT

According to a recent study of DEA statistics carried out by the Associated Press, consumers have nearly doubled the amount of money spent on narcotic analgesics between 1997 and 2005.

According to the study, the consumption of five major painkillers - codeine, morphine, oxycodone, hydrocodone, and meperidine - rose 88 percent between 1997 and 2005. Oxycontin is primarily responsible for that increase in painkiller use. This drug's use has jumped nearly six fold according to the report in that time frame.

The AP cited several reasons for the increase in painkiller use: aging populations, marketing campaigns by drug companies, changes in pain management philosophy by doctors, and abuse of/addiction to opiate analgesics.

In May 2007, Purdue Pharma - maker of Oxycontin - was in the news for pleading guilty to 'misbranding' Oxycontin, essentially soft-pedaling the addictive properties of the drug to doctors and pharmacists. The company was forced to pay over $600 million in fines and three company directors pleaded guilty to 'misbranding' Oxycontin. These executives together were required to pay over thirty million dollars in fines.

For more information on this subject matter, please refer to the section on Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Courtney Mills

Thousands in US Claiming Vaccine-Autism Link Get Their Day in Court

Mike Simon — Tue, 19 Jun 2007 10:50:27 GMT

Nearly 5,000 families with an autistic child have filed claims against the U.S. government, alleging that their children's autism resulted from childhood vaccinations. The first test case began in a hearing last Monday in the U.S. Court of Federal Claims, and was presided over by three special masters. Should the courts find in favor of the families, they will receive vindication and monetary compensation from a multibillion-dollar trust fund.

The case alleges that thimerosal, a preservative found in the measles, mumps, and rubella vaccine (MMR), is to blame for the children's conditions. The thimerosal, which was also in other childhood vaccines, is about 50 percent mercury by weight. Common childhood vaccines no longer contain the preservative.

One of the plaintiffs contends that there exists "special outcomes in their children that are consistent with exposure to mercury, and those outcomes did not present themselves until after they received their vaccinations."

However, a 2001 report from the Institute of Medicine points to the findings of five large studies from the United States and abroad. The studies observed thousands of children since 2001 without finding any indication of a link between autism and vaccines containing thimerosal. However, the CDC has indicated that it supports additional research on the issue.

For more information on this subject, please see our section related to Drugs, Medical Devices, and Implants.

Originally posted at InjuryBoard by Mike Simon

Vioxx Plaintiff Has Choice of $1.6 Million or New Trial

Mike Simon — Fri, 15 Jun 2007 10:53:54 GMT

Retired FBI agent Gerald Barnett, who claims that the painkiller Vioxx caused his 2002 heart attack, must choose between $1.6 million and a retrial of his claims, a federal judge ruled. Last September a jury awarded Barnett $1 million in punitive damages and $50 million in compensatory damages, but U.S. District Judge Eldon E. Fallon ordered a retrial on damages, ruling that $50 million in compensatory damages was "excessive under any conceivable standard of excessiveness."

Taking evidence into consideration, Fallon ruled that $600,000 is a reasonable amount for compensatory damages. Barnett's attorney, Mark Robinson, declared that he would advise his client to accept the reduced damages.

Drug maker Merck & Co. stopped selling Vioxx in 2004 in response to evidence linking the painkiller with an increased risk of heart attack and stroke. Merck did, however, file a motion for a new trial on all issues, but was denied when Fallon ruled that it was sufficient that a jury found Merck liable of negligence for concealing risks from Barnett's doctors.

Originally posted at InjuryBoard by Mike Simon

Avandia Linked to Increased Risk of Heart Problems

Mike Simon — Thu, 24 May 2007 08:47:11 GMT

On May 21, the FDA issued a warning to endocrinologists, doctors, and consumers that the Type 2 diabetes drug Avandia has been link to an increased risk of heart attack and other ischemic heart-related problems. The link was discovered in a study published by the New England Journal of Medicine, which found that the risk of heart attack was 43% greater in persons taking the drug. The study also found that the drug increased the risk of death from a cardiovascular event by 64%.

GlaxoSmithKline, the maker of Avandia, has stated that it strongly disagrees with the study, and maintains that Avandia is safe. Approximately 1 million Americans are currently prescribed the drug to treat their Type 2 diabetes.

The FDA is being criticized for the initial approval of the drug, and for not taking action sooner. Several members of Congress have stated intention to hold hearings on the matter.

Originally posted at InjuryBoard by Mike Simon

OxyContin Maker, Executives Plead Guilty

Mike Simon — Tue, 22 May 2007 08:45:17 GMT

On May 10, in Abingdon, Virginia, the maker of the powerful painkiller OxyContin and three of its current and former executives pleaded guilty to misleading the public about the drug's risk of addiction. Purdue Pharma, LP, its president, top lawyer, and former chief medical officer will pay $634.5 million in fines for claiming the drug was less addictive and less subject to abuse than other pain medications.

OxyContin, or oxycodone, is a time released painkiller designed to be swallowed whole and digested over 12 hours. If crushed and swallowed, snorted, or injected, the pills can produce a heroin-like high. In 2002, the Drug Enforcement Administration said OxyContin caused 146 deaths and contributed to another 318.

The fines will be distributed to state and federal law enforcement agencies, the federal government, federal and state Medicaid programs, a Virginia prescription monitoring program, and the individuals who had sued the company.

Originally posted at InjuryBoard by Mike Simon

Wyeth Must Face Fen-Phen Negligence, Warranty Claims

Mike Simon — Thu, 21 Jun 2007 08:30:34 GMT

U.S. District Judge E. Richard Webber has upheld Virginia Cavender's claims of design-defect, breach-of-warranty, and negligence against pharmaceutical company Wyeth. Cavender, who took the weight loss combination drug fen-phen, claims that it caused heart damage in the form of "moderately severe aortic regurgitation."

Judge Webber denied Wyeth's motion for partial summary judgment, ruling that the company had not provided sufficient evidence to show that Cavender lacked any chance of success on her claims. The plaintiff alleges that she took the diet drug for a two-month period in 1996. The drug was removed from the market in late 1997 amid fears of heart valve injury.

According to Judge Webber, Cavender may submit her negligent-failure-to-test claim to the jury "because the court has concluded that there is a genuine issue of material fact that the drug at issue was defectively designed." However, he went on to inform the plaintiff that she must now show "what tests should have been performed and how any such testing would have prevented her injuries."

For more information on this subject matter, please refer to our section detailing Drugs, Medical Devices, & Implants.

Originally posted at InjuryBoard by Mike Simon

FDA Warns of Rare Sleeping Pill Side Effects

Mike Simon — Fri, 06 Apr 2007 10:53:44 GMT

The Food and Drug Administration has issued a warning regarding unusual side effects of prescription sleeping pills. The makers of 13 prescription sleeping aids will now be required to put warnings on their labels cautioning that the drug may cause sleep-driving, along with other less dangerous "complex sleep-related behaviors" - like making phone calls, fixing and eating food, and having sex while still asleep.

In short, the FDA advises that people taking the drugs may get up in the middle of the night and drive, or engage in other behavior and have no memory of doing so.

The more dangerous side effects like sleep driving are rare, but the FDA is requiring the warning because of the obvious danger involved, and because there are precautions patients can take to avoid the problem. To lower the risk, patients should never take a prescription sleep aid with alcohol or any other sedating drug, or take a dosage higher than is recommended.

The drugs affected by the FDA's warning are: Ambien; Butisol sodium; Carbrital; Dalmane; Doral; Halcion; Lunesta; Placidyl; Prosom; Restoril; Rozerem; Seconal; and Sonata.

Originally posted at InjuryBoard by Mike Simon

Antibiotics Linked to Tendon Rupture

Staff Writer — Wed, 06 Sep 2006 11:02:53 GMT

In late August the consumer watchdog group petitioned the FDA to place stronger warnings about the possibility of tendon rupture on the labels of the Fluoroquinolone class of antibiotics. The drug makers say that they do in fact warn of tendon rupture, but Public Citizen argues the warnings a buried in a list of adverse events and calls for a "black box" warning - the FDA's strongest warning for prescription drugs.

The tendon that most frequently ruptures is the Achilles tendon, which causes sudden and severe pain, swelling and bruising, and difficulty walking. Other tendon ruptures have occurred in the rotator cuff (the shoulder), the biceps, the hand and the thumb. One theory is that fluoroquinolones are toxic to tendon fibers and may decrease blood supply in tendons that already have a limited blood supply.
These antibiotics, which are widely prescribed for gastrointestinal, respiratory and genitoâ€‘urinary tract infections, include Cipro (Ciprofloxacin, made by Bayer), Penetrex (Enoxacin, made by Aventis), Tequin (Gatifloxacin, made by Bristol-Myers Squibb), Levaquin (Levofloxacin, made by Ortho-McNeil), Maxaquin (Lomefloxacin, made by Unimed), Avelox (Moxifloxacin, made by Bayer), Noroxin (Norfloxacin, made by Merck) and Floxin (Ofloxacin, made by Daiichi-Sankyo).

Tom Lamb at Drug Injury Watch also has the story and additional links.

Originally posted at InjuryBoard by Staff Writer