Glendale Personal Injury Lawyer - Defective Drugs

FDA Warns Singulair Users and Physicians

Greg Owen — Fri, 28 Mar 2008 17:45:37 GMT

The Food and Drug Administration (FDA) informed healthcare professionals and patients alike of their findings regarding the possible links between the use of Singulair and changes in mood and behavior. Their concerns pertain to suicidal thinking, changed behavior and indeed suicide.

Merck, the manufacturer of Singulair, is stressing that this warning is based on a small number of studies. (Still cause for concern, I'd say). Singulair is a leukotriene receptor antagonist. It is used to prevent exercise-induced asthma and to treat asthma and the symptoms of allergic rhinitis.
Last year Merck's Singulair reached $4.3 billion in sales. Their Singulair labeling does not current mention risk of possible mood/behavior changes and/or suicidal thoughts.

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Originally posted at InjuryBoard by Greg Owen

Deaths and Injuries Linked to Heparin

Greg Owen — Wed, 19 Mar 2008 13:36:37 GMT

The Food and Drug Administration (FDA) is working to identify the contaminant that has been found in Heparin, which may be linked to as many as 19 deaths. Although, at this time, the FDA has not established a direct causal link. The drug Heparin is used in dialysis and heart procedures to stave off blood clots. Baxter sells somewhere in the range of 35 million units of heparin sodium injection multi and single dose vials per year in the U.S. alone. Those sales amount to approximately $30 million annually.

Initially, there were nine lot of heparin recalled by Baxter Healthcare corporation. The January 17, 2008, recall was initiated due to reports of a sudden increase in adverse effects from consumers of the product. A host of health problems were reported including, vomiting, abdominal pain and decreased blood pressure.

Baxter released a recall update on February 11, 2008. The company announced that the recall would be expanded due to the fact that they had received reports that consumers were experiencing adverse effects from additional heparin products. It was at that time that Baxter decided to suspend further production of heparin. Although, the vials of heparin that were on the market remained on the market due to a concern pertaining to a diminished supply of heparin to consumers. Baxter also noted, at that time, that adverse effects from the drug could actually be life-threatening.

Shortly after the February 11, 2008 expanded recall, it was reported by The Wall Street Journal that the active ingredient in heparin came from none other than China. At this time, the FDA is inspecting the Chinese facility, but have yet to make an announcement as to their findings. As recently as February 28, 2008, it was announced by Baxter that it would recall all sizes and lots of heparin. By the last week in February the only heparin product that was still on the market was the Haparin IV bags. On the heels of the expanded recall in late February, it was reported by the FDA during the first week of March that a molecule very similar to heparin had been found in the heparin ingredients sent to Baxter by Scientific Protein Laboratories (SPL).

The FDA has reported that up to 21 deaths and 448 allergic reactions may be linked to Heparin. The reports continue to come in and the exact numbers of people adversely effected by this drug are currently unknown, but the numbers continue to grow. Stay tuned for further updates.

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Originally posted at InjuryBoard by Greg Owen

Actavis Recalls Remaining Patches as a Precaution

Greg Owen — Fri, 07 Mar 2008 16:53:45 GMT

Actavis Inc., announced that its subsidiary Actavis South Atlantic LLC is moving forward with the recall of all of the Fentanyl transdermal system CII patches that were sold in the U. S.

The concern pertains to a possible defect that could cause a leakage of the fentanyl gel. Initally, 14 lots of the patches were recalled. However, it is unknown if the defect is present in patches that are still available to the public. Accordingly, Actavis Inc. has expanded its original recall. The patches in question were manufactured by Corium International Inc. The recall does not include Fentanyl patches sold in Europe. Fentanyl is a potent opioid medication. Using the defect patch could cause respiratory depression and possible overdose, which could be fatal. If you have purchased this product, please go to the link provided for additional information.

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Originally posted at InjuryBoard by Greg Owen

FDA Issues a Recall on Class of Bone Drugs

Greg Owen — Fri, 11 Jan 2008 17:24:51 GMT

Although a defective drug recall has not been issued at this time, the FDA has issued an alert regarding a class of bone-density drugs known as bisphosphonates. It appears the drugs can cause severe bone, joint and/or muscle pain.

Severe pain may occur soon after taking the drug, or it may take years to occur. It is currently unknown exactly what the risk of severe musculoskeletal pain is for an individual taking this class of drugs. Please see the full article to see exactly which bone drugs are named.

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Originally posted at InjuryBoard by Greg Owen

Making a Difference - A Medical Malpractice Story

Greg Owen — Fri, 04 Jan 2008 17:54:03 GMT

As a result of the death of their beloved son Michael, due to what is believed to have been medical malpractice, David and Patty Skolnik helped push through House Bill 1331 better known as The Michael Skolnik Medical Transparency Act.

"The Michael Skolnik Medical Transparency Act will make public, via a Web site, information about doctors' license status and medical malpractice settlements." Initially, all doctors will not have to provide updated information. However, when licensed doctors wish to renew their license they must provide information regarding their malpractice convictions, if any.

The bill came about when the Skolniks' only son, Michael, 22, received what the Skolniks describe as unnecessary surgery from an inexperienced doctor who jostled Michael's brain. After the surgery, Michael was half-blind, partly paralyzed, was psychotic and had the reasoning ability of a third-grader. On June 4, 2004 Michael died, after what the Skolniks describe as two years of hell and $4.8 million in medical expenses. Subsequent to the surgery, David and Patty found out that the doctor who preformed the surgery on their son, not only had a malpractice claim and settlement in Georgia, he had only done the procedure once before. Now, when someone is in the position of needing to choose a surgeon they can make an educated decision instead of a stab in the dark. Each doctor's records will be open for all to see. The disclosure will cover the doctors' records in all states. Patty Skolnik said "I'm really pleased that it became law, and I'm pleased it went through with Michael's name on it."

For more information on this subject, please refer to the section on Medical Malpractice and Negligent Care.

Originally posted at InjuryBoard by Greg Owen

Merck Recalls Childrens' Vaccines

Greg Owen — Fri, 21 Dec 2007 16:55:31 GMT

Merck & Co Inc have recalled approximately 1.2 million doses of its popular childrens' vaccines. It is feared that the production equipment was not adequately sterilized. According to the U.S. Centers for Disease Control and Prevention, the recalled vaccine is used to protect against the leading cause of meningitis in children under 5 years old.

The potential for contamination of any individual vaccine is low, and, if present, the level of contamination would be low," a spokesperson for Merck said. Dr. Anne Schuchat, director of the CDC's National Center for Immunization and Respiratory Diseases, advised parents to look for signs of infection at the site of inoculation the first week following the administration of the shot.

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Originally posted at InjuryBoard by Greg Owen

How Close is Too Close

Greg Owen — Fri, 30 Nov 2007 14:55:13 GMT

It has long been believed by many that the Food and Drug Administration (FDA) is much too close to drug companies, which clearly causes a conflict in terms of regulating those companies. To see the extent of the problem, we only need to take a look at Merck's Vioxx catastrophe, were it was revealed by one scientist that he had actually received vailed threats from the FDA regarding the release of his findings, findings which were less than favorable to Merck/Vioxx.

There is a lot more evidence than the issues with Vioxx, not that any more is needed. Take Wyeth and their disastrous drug fen-phen. Wyeth eventually withdrew fen-phen from the market. Although, by the time they did that, eight million prescriptions had been written and the drugs had been linked to thousands with severe heart and lung damage and even some deaths. Where Vioxx and the fen-phen were concerned, there is no doubt that both involved negligence on the part of not only the drug companies but also the FDA. In fact, when lawsuits were filed by consumers of the drugs Pondimin and Redux, thousands of documents became public. Those documents showed that the FDA knew about the health problems related to these drugs, when they knew and that they resisted taking action until they could resist no more. Criticism of the FDA does not end there. The FDA's handling of many other drugs have come under scrutiny i.e., Avandia , which is still on the market; cholesterol drug Baycol; pain reliever Bextra; and the Guidant heart defibrillator. Without a doubt, the reaction time of the FDA and drug companies alike are at a snails pace.

Recently, Congress passed a drug-safety bill in order to promote tracking of drugs and possible adverse reaction. Although, many see that as nothing more than a public-relations move. One other disturbing fact worth noting, is the fact that the office that promotes drug approvals is double the size of the office that deals with drug safety issues, obviously that is a major weakness in the system.

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Originally posted at InjuryBoard by Greg Owen

Vioxx Settles - Merck & Co. to Pay $4.85 Billion

Greg Owen — Fri, 09 Nov 2007 18:09:09 GMT

Merck & Co. have agreed to a $4.85 billion global resolution for claims stemming from claims of heart attacks, strokes and even deaths due to the ingestion of the drug Vioxx. Now these victims can finally be compensated, which will bring an end to the on-going Vioxx litigation.

Vioxx was first marketed by Merck & Co. In 1999 to treat arthritis and other types of pain. The drug was made by the Whitehouse Station, New Jersey company. It is a drug that is non-steroidal and anti-inflammatory. It is also a drug that carries a heart attack risk that is five times higher then people taking other types of painkillers.

Despite having that information Merck waited for two years before warning physicians about the risks of taking Vioxx. It seems money got in the way of their conscience, after all Vioxx was a multi-billion-dollar-a-year drug. It was not until 2004 that the drug manufacturers voluntarily withdrew that drug. And now, the final settlement. It has been a long time coming. For the people who have been permanently damaged by this drug and for those who have lost loved ones, hopefully this settlement will allow closure to some degree so that they can pick up the pieces of their lives and move forward.

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Originally posted at InjuryBoard by Greg Owen

Wyeth Must Pay for their Defective Drugs

Greg Owen — Fri, 19 Oct 2007 18:21:45 GMT

On October 12, Reno jurors decided that Wyeth, the largest maker of hormone-replacement medicines, must pay $134.1 million, including $99 million in punitive damages. This suit was filed due to the mishandling of menopause drugs that helped cause cancer in three women. The punitive damages were levied on Wyeth for concealing the breast-cancer risks of its Prempro and Premarin drugs.

Some six million women took the drugs to treat symptoms of menapause. The company has annual sales of more than $2 billion. While the increase for breast cancer in women taking the drug was a high as 24 percent. Wyeth have promised that they will appeal the verdict.

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Originally posted at InjuryBoard by Greg Owen

N.J. Top Court Rejects Vioxx Class Action

Greg Owen — Fri, 07 Sep 2007 20:32:19 GMT

In what amounts to a huge legal victory for the manufacturer of Vioxx, Merck & Co, the New Jersey Supreme Court rejected a class-action lawsuit. The company currently has close to 27,000 individual claims from users claiming to have suffered heart attacks and strokes after consuming this defective product.

Apparently, the court felt that a class-action suit was not appropriate for this particular lawsuit. The suit was brought on behalf of all insurance plans that paid for Vioxx prescriptions. Given the fact that New Jersey's consumer fraud law allows for triple damages, had this class-action been allowed it could have cost the company in the neighborhood of $15 to $18 billion, which would have put a cramp in their style when it comes to their ability to fight the thousands of individually suits that have been filed against them.

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

Originally posted at InjuryBoard by Greg Owen