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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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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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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Minor Fall Leads to Death in Patient Taking Pradaxa

In late 2011, an 83-year-old man was taken to the emergency room after falling. Shortly after his arrival, his initial scans revealed that he has been taking the blood thinner, Pradaxa. His scans showed a surprising amount of bleeding in the brain, according to a doctor at the hospital.
Soon after, the man fell into a deep coma. Scans showed that blood had nearly filled the left side of his brain and also a good portion of the right side.
He died not long after, prompting doctors at the hospital to publish a case report alerting physicians and patients to the risks of Pradaxa, including uncontrollable bleeding.

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Dangerous Medical Devices not tested

According to Consumer Dangerous Medical Devices not testedReports, many dangerous medical devices were never tested for safety and effectiveness. The report claims that some manufacturers do nothing more than file paperwork and pay a fee to have their medical device approved by the Food and Drug Administration.

“Standards for devices exist, they just don’t make sense,” said Diana Zuckerman, Ph.D. and president of the National Research Center for Women & Families.

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Antidepressants May Raise Risk for Pregnancy Complication

Pregnant women that take antidepressants known as SSRIs (selective serotonin reuptake inhibitors) may have a slightly increased risk of developing a dangerously high blood pressure, according to Canadian researchers.

Preeclampsia, the condition linked to SSRI use, can be harmful to both mothers and their unborn babies, according to the research. Women taking these medications should consult their doctor with any concerns before stopping usage of the medicine. Paxil and Prazac are the two most commonly prescribed SSRIs.

“We know that antidepressants should be used during pregnancy, but they should be used with caution,” said lead researcher Anick Berard. She added that the association between hypertension and SSRI use is a new finding.

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Antidepressants May Affect Head Size of Newborns

Women who are pregnant and taking certain antidepressants may be more likely to deliver an infant with reduced head growth, according to a new study.

According to HealthDay News, the study also discovered that although SSRI drugs, such as Prozac and Paxil, are helpful at relieving depression in women, the drugs appear to be linked to a higher risk of preterm birth.

The lead researcher, Hannan El Marroun, said, “Fetal body growth is a marker of fetal health and fetal head growth is a marker for brain development.  We found prenatal exposure to SSRIs was associated with decreased growth of the head, but not decreased growth of the body”

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Takeda Hid Actos Adverse Effects, Regulators Said

According to a whistle-blower, a U.S. unit of Takeda Pharmaceutical Co. failed to accurately report hundreds of congestive heart failure cases associated with Actos, its diabetes drug.
 
Takeda did not properly classify “non-hospitalized or non-fatal” congestive heart failure cases as serious over a two-plus year span, according to the complaint.  Drug manufacturers are required to update the U.S. FDA’s Adverse Event Reporting System.
 
“These events were not properly identified or reported in the FDA’s safety database,” former Takeda medical review Helen Ge claimed in the complaint, filed in June 2010 and recently unsealed. “Takeda’s motivation to fraudulently report and under-report the serious adverse events was driven by an economic desire to falsely enhance Actos’s safety profile and to increase sales.”
 
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Birth Control Pills Recall

Seven lots of Glenmark Generics generic birth control pills Norgestimate and Ethinyl Estradiol have been recalled due some blister packs putting the tablets in the wrong order, causing the pills to be ineffective.
 
The recall includes oral contraceptives distributed nationwide between September 21 and December 30, 2011.  The mistake was discovered when a consumer of the pills told Glenmark the tablets in her package were in reverse order.
 
The blister packaging on the recalled pills was rotated 180 degrees, causing the pills to be in the reverse order.  The expiration date of the recalled pills is only visible on the outer pouch.  Any blister pack with no lot number or expiration date is subject to recall.
 
Consumers using the recalled pills should immediately begin using a non-hormonal form of contraception and notify their physician immediately.  The recalled pills should be returned to the pharmacy that administered them.

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