June 27, 2008

Medical Device Safety Act

A new tort reform bill proposed in the House of Representatives may bring justice to those who face medical device defects and have pharmaceutical liability claims. The bill, titled the Medical Device Safety Act would allow those to bring product liability suits even on products approved by the FDA. This bill would allow those who suffered personal injuries from medical device defects and defective drugs to have a cause of action against the makers of such products. To read more about this tort reform that allows this nation to head in a positive direction click here.

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June 26, 2008

Paxil linked to Birth Defects

Following revelations that GlaxoSmithKline misrepresented the suicide risk associated with Paxil, an antidepressant, a recent study has concluded that the drug may also double the risk of congenital malformations in newborns. This study follows the release of information that taking Paxil may lead to an 8 times greater risk of suicide. The company had previously artificially reduced the risk of suicide by improperly counting patients who took placebos.

Similarly, women who took Paxil while pregnant and gave birth to babies with severe birth defects are outraged believing that GlaxoSmithKline may once again have misrepresented the dangers of their drug. Many of these women argue that if they had been properly informed about the risk of birth defects, they likely would not have taken Paxil during their first trimester.

For more information, click here:

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Mega Health Supplement Faces Mega Recall

A product recall has been issued for Total Body Formula and Total Body Mega Formula products. The products which are suppose to help with overall fitness have instead lead to serious personal injuries to the users of the recalled product. The nutrition supplement recall follows after the products were determined to contain toxic levels of some chemicals. Product liability lawsuits have already been filed by users of the recalled product who have suffered personal injuries from hair loss to pain in their legs. Product manufacturer lawsuits and lawsuits against the distributor of the recalled pharmaceutical and health product may be forthcoming. To read the full article click here.

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June 12, 2008

Dialysis Takes a Near Deadly Turn After Tainted Heparin is Administered

A pharmaceutical lawsuit has been filed against Baxter after an individual received tainted heparin. The tainted product given to the 38 year old man lead him to suffer from serious personal injuries, pain and suffering and emotional trauma. There is likely a medical malpractice suit to be alleged against the dialysis clinic where the individual received the tainted medication from. To see the full story click here.

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June 2, 2008

Chantix Anti-Smoking Drug Up in Flames

Chantix drug problems arise as the popular drug used to quit smoking comes under scrutiny. The Chantix drug adverse effects include serious personal injuries, skin reactions, seizures, aggression and suicide. Nearly 1000 FDA personal injury reports have been made since the drug received its May 2006 approval, 28 of those injuries included serious car accident injuries. Sales of the drug continue nationwide, even in Chicago, Illinois. To read the full story on Chantix click here.

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May 13, 2008

AMA Encourages Tighter Restrictions on Prescription Drug Advertising

The American Medical Association has encouraged the Food and Drug Administration (FDA) to add restrictions and regulations of prescription drug advertising. Often, prescription drug advertisements tout the benefits of the product without explaining or even indicating all of the risks and side effects of prescription drugs. Advertising can also be misleading for consumers and patients and lead to situations where the doctor and patient do not agree about the medication and improper medication is prescribed. Advertising his highly important because, as recent studies have shown, 45% of patients ask their doctors about a medication or prescription drug they have seen on television.

Read the full article here.

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May 5, 2008

Woman Sues Walgreen’s After Pharmacy Error Causes Miscarriage

A woman is suing Deerfield-based Walgreen’s in a wrongful death and medical malpractice lawsuit after losing her child. The Walgreen’s Pharmacy filled her prescription for prenatal vitamins with a drug intended for chemotherapy use. After using the drug for an extended period of time, the woman lost her baby. The drug, not intended for prenatal use, interferes with cell production, DNA development, and cell growth. Additionally the drug may increase the woman’s risk of developing tumors and other complications. The drug could make it difficult for the woman to conceive in the future.

Read more about the lawsuit here.

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April 29, 2008

The Double Lesson of the Heparin Case; More Deaths Reported

The case of Heparin contaminated with unknown toxins and imported from China continues to claim lives. To date, more than 81 deaths are linked to contaminated Heparin in the US and more may be discovered soon. The FDA says that the deaths from contaminated Heparin are a direct result of an allergic reaction to the toxin in some patients. The Chinese government denies that the contamination caused any deaths, though they do acknowledge that large batches of Heparin were contaminated. The Double lesson here is not just that drugs can be easily contaminated from foreign sources, but that two congressional hearings have highlighted just how under-funded and under-prepared the FDA is currently.

Read more on this story here.

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April 8, 2008

FDA Cites 62 Possible Deaths Linked to Heparin

The FDA has received 62 reports of deaths over the past 15 months of patients who were treated with heparin, made by Chicago-area Baxter International. In Cook county, Dennis Quaid, a popular actor, has filed suit against Baxter for the wrongful death of his twin daughters after they received excessive doses of heparin. Baxter recalled most of its heparin products in February.

For the full story please click here.

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FDA’s Role in Prescription Drug Labeling Unclear to Jurors

According to a recent industry newsletter, jurors often misconceive the role of the Food and Drug Administration (FDA) in approving new drugs and how pharmaceutical manufacturers create their prescription drug labels. Jurors often believe that the FDA is responsible for pharmaceutical research. In fact it is just the opposite: private drug companies produce their own studies for FDA approval. Additionally, many jurors believe that the pharmaceutical companies have sole control of warning label contents. Though the FDA has some oversight of label contents, a recent article shows that drug companies can hide information from the FDA to prevent certain risks and side effects from appearing on warning labels. Questions and misconceptions about the FDA’s role will continue with increased litigation on the FDA liability shield issue currently pending before the Supreme Court.

To read the full newsletter, please click here.

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April 7, 2008

Supreme Court Will Decide if Drug Companies Can Hide Behind FDA

The Supreme Court will hear a case next term that could decide whether drug companies may escape liability for harm caused by their products and hide behind FDA approval. The issue in the case involves Johnson & Johnson’s prescription birth control patch, Ortho Evra, which delivered much more estrogen than the company originally disclosed. The Ortho Evra patch was a popular form of birth control as an alternative to the birth control pill. For women, medication dosing errors of estrogen may cause an increased risk of blood clots and strokes and has been linked to one death.

Read the full text of the original article here.

Continue reading "Supreme Court Will Decide if Drug Companies Can Hide Behind FDA" »

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January 15, 2008

Recent study shows Medicare & Medicaid fraud out of control

There are many factors that contribute to why Medicare & Medicaid fraud is becoming out of control in America. Two serious contributors are overpriced prescriptions for medications, devices and treatments in addition to overspending by largely unregulated hospitals. Billions of Americans' tax dollars are not going to where they are intended.

Doctors have many incentives for prescribing the most expensive drugs and medical devices mainly including rewards from drug companies. This type of fraud is estimated to account for about 15% of Medicare & Medicaid over-billings. It is difficult to restrict the ability of the drug companies to manipulate doctors because according to the study, the corporations have too much influence in the US Government.

Additionally, "boutique hospitals," those owned by investor groups and not-for-profit hospitals are also cited as a large source of Medicare & Medicaid fraud. According to the study, these hospitals are less regulated by the government and can, as a result, over-bill the federal government.

Medicare & Medicaid fraud was also shown to be extensive in nursing homes, rehab centers, and long term care facilities. Click here to learn more.

Click here for the full article

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January 8, 2008

Wrongful death lawsuit brought against doctor who negligently prescribed drugs to driver who killed a child in auto accident

If physicians do not warn patients of the risks medications have on driving ability, they now can be held liable in an automobile accident lawsuit. In a recent suit, a boy was killed in a car accident by a man prescribed eight different medications by his doctor and was not warned of their side effects. The doctor now faces a wrongful death lawsuit based on his medical negligence. According to the mother of the victim's attorney, the doctor should have warned his patient that the medications he was prescribed are known to have certain side effects such as drowsiness, dizziness and fainting. The doctor should also have warned his patient not to drive. The doctor claimed that this medical mistake was too far removed from the car accident tragedy, but the court ruled that a possible consequence of that negligence could be harm to others.

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November 5, 2007

Antibleeding drug Trasylol pulled from shelves in US

Foreign drug company Bayer AG, has pulled Trasylol from U.S. shelves. Trasylol has been used to reduce blood loss for patients undergoing by-pass surgery and avoid transfusions. The drug was pulled amid concerns that it may be linked to a higher risk of death than other drugs. So far, no major lawsuits have been filed.

The FDA announced it would review Trasylol last month after a clinical experiment was halted when the drug appeared to be linked to a higher risk of death. There was also a study published in the New England Journal of Medicine in January of last year which advised against continued use of the drug because of the risk of kidney failure, and increased risk of heart attacks, heart failure and strokes.

Click here for the full article

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September 13, 2007

FDA advisory committee votes to keep Aprotinin on the market

After a 15-1 vote, an FDA advisory committee composed of experts in the field has recommended that sales of the blood loss prevention drug be permitted to continue. The drug, sold by Bayer AG under the name Trasylol, was initially approved by the FDA in 1993 to prevent the need for blood transfusions during bypass surgeries. The safety of the drug recently came into question when two studies released in 2006 linked the pharmaceutical to kidney problems, heart attacks, strokes, and even an increased risk of death. Although the committee recommended keeping the drug on the market, it did state that the concerns over the drug’s safety warranted further research.

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September 12, 2007

New research questions FDA’s decision to keep Avandia on the market

A new study published in the Journal of the American Medical Association has confirmed and corroborated the results of an earlier study that first connected Avandia to an increased risk of heart attack. This new study used a different methodology than the earlier study published in the New England Journal of Medicine, and it reached the same conclusion – a patient’s risk of heart attack increases by over forty percent when taking the diabetes medication, Avandia. This statistic is further exacerbated by the fact that diabetes sufferers are already at a higher risk of heart attack. In fact, the leading cause of death for diabetes sufferers is heart attack. It is this heightened risk to heart attack that has the researchers behind the new study to state that the FDA should reconsider its latest decision to keep the drug on the market.

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August 17, 2007

Another occurrence of product liability for pharmaceuticals: Reglan

Pharmaceuticals are continuing to put patients at risk. There have been instances of bad reaction to a common drug, Reglan, used to prevent post-operative nausea and vomiting. A woman has recently come forward alleging an instance of product liability, claiming that after she was injected with Reglan, she immediately began experiencing tremors. Her surgery was canceled, but the tremors have continued. Tardive Dyskinesia, a condition that causes involuntary movements, is one of the adverse effects of Reglan.

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August 14, 2007

Experimental drugs not allowed for terminally ill patients

A federal court has ruled that terminally ill patients do not have a right to experimental drugs that have not been FDA approved. The plaintiff asked that the FDA approve experimental medications that have passed safety trials but have not been sufficiently proven safe and effective. The plaintiffs based this inquiry off of what they believe to be the constitutional right of self preservation. Terminally ill patients might have no FDA approved treatment options and experimental medications could be their only chance at survival. The FDA said that the risks of harm of unapproved drugs is too great, even in cases of the terminally ill. The appeals court ruled in the FDA's favor and suggested that advocates of experimental drugs approach the legislature.

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July 30, 2007

Avandia should be pulled from the market

Today, a federal scientist announced that diabetes drug Avandia should be pulled from the market. Avandia drug maker Glaxo Smith Kline of course disputes these recommendations.

The expert maintains that Avandia should be pulled from the market because of heart risks associated with consuming the drug and the drug’s lack of any unique short-term benefits in maintaining blood-sugar levels for diabetics.

The FDA is currently meeting to determine whether Avandia should be restricted or completely pulled from the market. The FDA was alerted to the dangers of Avandia by a New England Journal of Medicine study that showed a 43% higher risk of heart attack by those taking Avandia compared with patients taking alternative diabetes medication.

Patients who have endured heart attacks or heart problems and who have taken Avandia may be entitled to compensation for these injuries.

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