Woman Wins Transvaginal Mesh Verdict

 $5.5 Million Bard Health CareJury Award in Case against C.R. Bard

On July 23, 2012, a California jury awarded a 53-year-old Bakersfield woman $5.5 million for transvaginal mesh injuries. A former runner, Christine Scott first saw doctors in 2008 for stress urinary incontinence. She was implanted with transvaginal surgical mesh to treat it, but that “solution” morphed into a nightmare. The synthetic mesh eroded into her colon. In the product liability action, Ms. Scott said that the Avaulta Plus Biosynthetic Support System left her in chronic pain, incontinent and unable to have intercourse. She could urinate only with a catheter for five months. The jury returned the verdict in Kern County Superior Court before Judge William Palmer.

Ms. Scott also underwent eight additional removal surgeries, but the Avaulta still remains in her body. Many surgeons feel it cannot be removed safely. The jury awarded Ms. Scott $5 million, her husband $500,000 for the loss of their relationship.

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Public Citizen: FDA Reckless

Despite a 20-2 FDA advisory committee panel vote this week to approve the diet drug Qnexa, Director of Public Citizen’s Health Research Group, Dr. Sidney Wolfe, called the approval “reckless.” Evidence shows the drug poses significant risks and little evidence of long-lasting weight loss, wrote Dr. Wolfe. He compares Qnexa’s approval to the diet drug lorcaserin (Belviq), which the FDA approved last month despite concerns about heart valve damage. Research shows Qnexa increases heart rate, and four patients in the clinical trial suffered heart attacks compared to no heart attacks for the placebo group.

Dr. Wolfe also writes, “It is magical and delusional thinking for anyone to believe that a drug will turn off hunger without hitting other targets where it will do harm, usually to the cardiovascular system.” Therein seems to lie the entire problem of Western medicine, the belief that a single pill can magically cure any ill.

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FDA Targets Own Scientists

Do FDA administrators work for the public whom the agency is entrusted to protect, or pharmaceutical corporations who count on FDA approval? If they work for the public, why are they spying on their own scientists when those scientists raise questions about drug safety and the agency’s approval processes? The New York Times reported in July 2012 that the FDA conducted a vast surveillance operation against a group of its own scientists. Records that were accidentally released show the agency captured thousands of e-mails that concerned FDA scientists sent congressional members, lawyers, labor officials, journalists, and even President Barack Obama.

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Accutane Maker’s 80,000 Oversights

The European Medicines Agency said on June 21 that it was investigating Swiss group Roche Holding AG after a routine inspection found it had failed to properly assess 80,000 cases of possible adverse drug reactions dating from 1997 to the present.  Among that alarming number of failed assessments were 15,161 deaths, which may have been due to the progression of natural diseases, but may have included deaths connected to Roche drugs.

Roche said that despite its failure to properly investigate the 80,000 adverse event reports, there is no evidence (regarding that failure) of a negative impact for patients. Neither, of course, is there any evidence that the company’s failure to investigate the 80,000 has NOT resulted in a negative impact for some patients.

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Transvaginal Mesh recalled by Johnson & Johnson / Ethicon

A transvaginal mesh recall Ethicon_Transvaginal_Meshcould be the opening gong of the death knell for the plastic mesh catastrophe unfolding across the nation. At the very least, transvaginal mesh (TVM) litigation took a step forward for plaintiffs this week when Johnson & Johnson’s Ethicon division informed the FDA that it intended to recall four of its Gynecare products: the Prolift Kit, Prolift +M Kit, Prosima Kit and TVT Secur.

The announcement is the latest in a series of troubling developments that began in July last year when the FDA reported a five-fold increase in deaths, injuries and/or malfunctions associated with transvaginal mesh (TVM) used in pelvic organ prolapse repair (POP) procedures. That report was followed in September 2011 by an advisory panel which urged the FDA to reclassify mesh products as “high-risk.” Then in January 2012, the FDA ordered several manufacturers to conduct further studies regarding the “side effects” and complications associated with their products.

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Takeda’s Successor Drug to Actos Fails to Win Approval

Takeda Pharmaceutical Company’s new diabetes treatment was not approved for sale in the United States, as U.S. regulators asked for more information on the medicine than other countries.

The Food and Drug Administration requested information through a letter, according to Takeda. The company responded by stating that the necessary data can be supplied from information collected outside the U.S. and from patient studies already under way.

The drug, known chemically as alogliptin, is used to treat type-2 diabetes. The rejection of the drug slows down Takeda President Yasuchika Hasegawa’s plan for it to become the new revenue generator when Actos loses patent protection in four months. The initial rejection took place in 2009 when the FDA asked for more information on cardiovascular risks associated with use of the drug.

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J&J fined $1.1 Billion in Risperdal Case

Johnson & Johnson .1 Billion in Risperdal Case">First Risperdal Verdict $2.5 Millionand its subsidiary, Janssen Pharmaceuticals, received a $1.1 billion fine by an Arkansas judge for allegedly lowering the profile of the risk of certain side effects in off-label uses and hiding risks associated with Risperdal, an antipsychotic drug.  The ruling could affect dozens of pending lawsuits concerning the drug.  This verdict is one of many brought against the pharmaceutical giants by state governments.  Additional lawsuits are pending in other states.

Circuit Judge Tim Fox ruled Janssen Pharmaceuticals Inc. and Johnson & Johnson must pay $5,000 each for 240,000 Risperdal prescriptions paid for by the state Medicaid program during a three and one half year span.  He also fined the companies an additional $2,500 for more than 4,500 letters Janssen sent to Arkansas doctors, totaling more than $11 million.

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FDA Recalls Thoratec HeartMate II Pump

The U.S. Food and Drug Administration has issued a recall of Thoratec Corp’s HeartMate II pump after it was found that a critical part of the surgical procedure was left out of the instructions. This error could lead to serious side effects or even death.

The missing step might cause detachment of the bend relief from its intended position around the proximal outflow graft, which could allow the graft to kink of deform, resulting in reduction of blood flow from the pump, according to the Food and Drug Administration.

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FDA Drug Safety: New Warning for Blood Pressure Medicines

The United States Food and Drug Administration released a safety announcement stating possible risks associated with using blood pressure medicines containing aliskiren with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in patients with diabetes or kidney impairment.

The combination of these drugs should be avoided in patients with diabetes. The FDA is adding a new warning stating that patients with kidney impairment should avoid the use of these drug combinations as well, according to preliminary data from the clinical trial, “Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).”

Aliskiren is a renin inhibitor used to treat high blood pressure (hypertension) by lowering blood pressure.

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FDA Consumer Update: Limit Use of 80 mg Simvastatin

The United States Food and Drug Administration recommends that users of drugs containing 80 mg of simvastatin watch their intake of the drug, due to a risk of muscle injury.  80 mg is the highest approved dose of this cholesterol lowering statin.

The FDA stated that the dose should only be taken by patients who have been taking it for one year or more with no ill effect.

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