Wyeth Lawsuit Supreme Court Ruling March 2009
Wyeth Lawsuit Supreme Ruling March 2009
Fen Phen drug recall class action judge Harvey Bartle issued a federal court order today in Philadelphia approving a final distribution of the fen phen supplemental class settlement fund. Judge Bartle’s order authorized payment of $792,694,924 to consumers who suffered heart valve injury from the once popular diet drug combination known as fen phen. The drugs Pondimin and Redux were removed from the market in 1997 by Wyeth, a pharmaceutical manufacturer after it was shown that the drug could cause heart valve lesions and a usually fatal disease called Primary Pulmonary Hypertension or PPH. The diet drug class settlement agreement was reached in 1999 and billions of dollars have been paid since that time to fen phen users who sustained heart valve damage. Lawsuits are still being filed against Wyeth for primary pulmonary hypertension (PPH) now more properly know as arterial pulmonary hypertension. The fen phen class settlement process was fraught with delays and controversy. Beneficiaries of this multimillion dollar distribution have been waiting for over ten years to receive this compensation.
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With all the issues surrounding prescription drugs, the Bush Administration wants to give drug oversight exclusively to an already overburdened, underfunded FDA. Drugs such as Vioxx, Zetia, Vytorin, Seroquel, Chantix, and Avandia have all been linked to dangerous, sometimes lethal side effects. Most recently, the blood thinning drug heparin, imported from China, was found to be contaminated, resulting in 19 deaths. In the wake of the heparin debacle, consumers and physicians are calling on drug manufacturers to place the country of origin on the drug’s label. All this leads me to believe that we need more drug oversight not less. What the Bush Administration and the large pharmaceutical companies deem excessive regulation, the consumer rightly calls proper safeguards and consumer protection.
Pope Benedict will visit the United States for the first time as head of the Catholic Church. Already, the trip has drawn controversy because the pope has chosen not to meet with those sexually abused by Catholic priests. In fact, he won’t even discuss the sex abuse crisis during his trip. The decision has already been sharply criticized by SNAP (Survivors Network of Those Abused by Priests) who plan to protest his visit as well as place newspaper ads in NY and Washington decrying the decision.
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Pope faces protest over US priests’ sex abuse
In a major victory for the integrity of medical journals, the federal district court in Chicago has ruled in favor of the Journal of the American Medical Association (JAMA). Magistrate Judge Arlander Keys ruled that JAMA does not have to provide Pfizer with documents concerning how manuscripts are accepted or rejected for publication. In addition, the court denied Pfizer’s attempt to identify the names of peer reviewers as well as their reasons for rejecting certain manuscripts. This is an important victory for scholarly journals, but most especially medical journals which are viewed by large pharmaceutical companies as potential vehicles in their colossal marketing campaigns.
In an editorial reacting to the court ruling, JAMA counsel Joseph P. Thornton and JAMA editor, Dr. Catherine D DeAngelis, wrote: “We firmly believe that ensured confidentiality of reviews allows reviewers to provide professional critiques of manuscripts without fearing potential repercussions from authors. The subpoenas attempted to invade the peer-review process, and we are delighted that Magistrate Judge Keys said so when he ruled they could not be enforced against us.”
While lawsuits concerning mesothelioma don’t garner as much media attention as a few years ago, they are still occurring because workers are still contracting the deadly cancer as a result of being exposed to asbestos on the job. In this disease, malignant cells develop in the mesothelium, a protective lining that covers most of the body’s internal organs. Its most common site is the pleura (outer lining of the lungs and chest cavity), but it may also occur in the peritoneum (the lining of the abdominal cavity) or the pericardium (a sac that surrounds the heart).
Mesothelioma symptoms may not appear for 20-50 years after initial exposure to the asbestos! Symptoms of peritoneal mesothelioma include weight loss and cachexia, abdominal swelling and pain due to ascites (a buildup of fluid in the abdominal cavity). Other symptoms of peritoneal mesothelioma may include bowel obstruction, blood clotting abnormalities, anemia, and fever. If the cancer has spread beyond the mesothelium to other parts of the body, symptoms may include pain, trouble swallowing, or swelling of the neck or face.
These symptoms may be caused by mesothelioma or by other, less serious conditions.
Mesothelioma that affects the pleura can cause these signs and symptoms:
chest wall pain
pleural effusion, or fluid surrounding the lung
shortness of breath
fatigue or anemia
wheezing, hoarseness, or cough
blood in the sputum (fluid) coughed up
Diagnosis of mesothelioma can be difficult because the symptoms mimic other diseases. However, it is usually found through a chest x-ray.
Exposure to asbestos is the number one cause of mesothelioma and could have been avoided if workplaces had been free of the deadly asbestos. However, companies allowed workers to be exposed for years to the deadly asbestos without warning or precaution.
U.S. Marshals seized more than $1,301,712 of dietary supplements from LG Sciences, LLC, of Brighton, Mich., because the products contain unapproved food additives and/or new dietary ingredients that cause the products to violate the law. Labeled as dietary supplements, the products are marketed for use by body builders.
The dietary supplements seized were marketed and distributed on-line and in retail stores under the names “Methyl 1-D,” “Methyl 1-D XL,” and “Formadrol Extreme XL.”
The seized products previously were tested and found to contain one or more unapproved food additives and/or new dietary ingredients for which there is inadequate information to provide reasonable assurance that the ingredients do not present a significant or unreasonable risk of illness or injury.
This shows once again that the supplements industry needs to be regulated just as prescription drugs. Supplements can be just as dangerous as prescription medication especially when their labels do not conform to the actual ingredients in the products themselves. One of the most egregious examples of this need for regulation concerns kava kava which has been linked to severe liver disease and toxicity. Kava is still on the market and has been linked to liver toxicity and death in some users.
The most recent study concerning the Ortho Evra birth control patch confirms earlier tests that suggested that the patch increases the risk for venous thromboembolism, more commonly known as blood clots, in women aged 15-44 compared to women using birth control pills. Blood clots can lead to a pulmonary embolism.
The label changes are based on a study conducted by the Boston Collaborative Drug Surveillance Program on behalf of Johnson and Johnson. The patch was studied in women aged 15-44. These findings support an earlier study that also said women in this group were at higher risk for blood clots.
Botox can travel to the brain, a new study in rats shows. Botulinum neurotoxin type A – sold commercially under the name Botox, leaves a sign of its presence the remnants of a protein that botulinum breaks down. This is a cause for concern since it is not known at this time how Botulinum affects the brain.
Botox is currently the subject of an FDA investigation because it has been linked to respiratory problems and death in some instances. Botulinum neurotoxin type A – sold commercially under the name Botox – disrupts nerve signalling by targeting SNAP-25, a protein that helps carry neurotransmitters between adjacent nerve cells. It causes botulism, a paralytic illness that can be fatal.
Clinicians had assumed that the powerful poison is safe for use – including for cosmetic purposes – because studies suggest it sits at the site of injection and does not spread through tissue. That may be an assumption too far, however.
Several brands of fentanyl patches are being recalled due to a leak in the patch allowing the gel to leak. If the gel comes into contact with human skin it can cause respiratory depression and possibly death.
One recall affects all U.S. lots of 25 mcg/hr Duragesic patches sold by PriCara, and its generic equivalent sold by Sandoz. All these patches are manufactured by the ALZA Corporation and have expiration dates of December 2009 or earlier. Anyone who has the recalled Duragesic patches should call 800-547-6446 for instructions on how to return them. Those who have the recalled Sandoz fentanyl patches should call 800-901-7236.
The second recall affects over a dozen lots of Actavis fentanyl patches in all strengths. Note that the pouch containing the fentanyl patch may have an Abrika Pharmaceuticals label, whereas the outer carton has the Actavis logo. Lot numbers can be found under “Additional Information” below. Anyone who has Actavis patches from the recalled lots should call 1-877-422-7452 for information on how to return them.
If you have a defective patch, dispose of it immediately by flushing it down the toilet, but be sure not to handle it directly. Anyone who comes in contact with fentanyl gel should rinse the exposed skin thoroughly with water. Do not use soap, because this could increase the drug’s absorption through the skin.
Signs or symptoms of fentanyl overdose include respiratory distress, shallow breathing, fatigue, sleepiness, confusion, dizziness and fainting.