Toledo Personal Injury Lawyer - FDA & Prescription Drugs

Toledoans speak up on heparin in Washington, DC

Anneke Kurt — Fri, 02 May 2008 17:10:53 GMT

From January 2007 until February 2008, at least 81 wrongful deaths have been linked to heparin, as well as 785 personal injuries from allergic reactions. The Toledo Blade reports that 62 of the 81 heparin deaths occurred between November 2007 and February 2008.

Two Toledoans testified Tuesday in front of the House Energy and Commerce Subcommittee on Oversight and Investigations in Washington on the government’s need for safer U.S. drug supplies, specifically referring to heparin, a popular blood thinner used during dialysis and open-heart surgery.

Both people who testified lost family members to complications caused by the drug, which were administered in local Toledo health care facilities.

According to the New York Times, controversy surrounds heparin that the drug was intentionally contaminated, as found in the written testimony Janet Woodcock, director of the FDA's drug center. That is why stricter laws requiring more inspections of overseas companies may help the problem of unsafe drugs.

Our Toledo, Ohio personal injury attorneys urge patients to ask questions before taking any medication, in order to prevent personal injury. Find out why the drug is being used, if it can interact with any other medications you may be taking, as well as the side effects of the drugs. Avoid being the victim of medical malpractice by staying informed on your healthcare, as well as keeping your doctor informed on all aspects of your health.

Originally posted at InjuryBoard by Anneke Kurt

Merck Scientists Defend Vioxx

Christina Cole — Fri, 16 Mar 2007 23:53:14 GMT

Merck & Co., accused of pointedly selling Vioxx while aware of the health risk and potential to cause heart attacks, started its defense Thursday by calling their top research scientist to testify and explain the vast research the company does.

Merck's director of clinical research and vice president of early research both said the company had preformed dozens of tests on the arthritis dug to discover any potential side effects along with interactions when taking other drugs such as aspirin.

Both scientists testified as the defense in a lawsuit before the Madison County Circuit Court. Frank Schwaller claims the drug caused the heart attack that claimed his wife's life on August 8, 2003. The company is attempting to put into context the studies that the plaintiffs have highlighted in their claims.

A top cardiologist is expected to testify Monday on the effects the arthritis drug may have had on Schwaller, 52, of Granite City, in light of the fact that she had several other risk factors, such as diabetes and being overweight.
Both sides expect the Schwaller case to be closely watched to see for the first time how the legal wrangling over Vioxx plays out in the Midwest.
Merck withdrew Vioxx from the market in 2004 when a study showed it likely raised the risk of heart attacks and strokes.
Merck faces 27,000 lawsuits nationwide and has said it plans to fight every one of them in court.

Originally posted at InjuryBoard by Christina Cole

Celebrex Approved for Children

Christina Cole — Wed, 10 Jan 2007 21:58:49 GMT

Federal approval has been granted to Pfizer Inc. to market the painkiller Celebrex as treatment for thousands of children that suffer with a devastating form of arthritis. The approval allows the New York company to promote the drug for juvenile rheumatoid arthritis in patients that are two years of age and older. The drug is already used off-label by many doctors as the treatment for the disease, which affects as many as 60,000 children in the United States.

Juvenile Rheumatoid Arthritis is often a devastating disease, said Dr. Steven Galson, director of the FDA's Center for Dug Evaluation and Research. While there are other drugs approved for treatment of this disorder, some children may experience intolerable side effects. Celebrex will be needed as an additional treatment option for children.

The decision comes after FDA advisers recommended Nov. 29 the drug as an effective but not necessarily safe treatment for the autoimmune disease, but said that its benefits still outweigh any risks. The FDA said it would require Pfizer to continue studying the safety of the drug in children, including its long-term effect on the kidneys, blood pressure and heart.
Celebrex is the only member of the class of drugs that included Vioxx and Bextra not to have been withdrawn from the market over concerns they elevate the risk of heart attacks and strokes in adults.
An earlier FDA review questioned the cardiovascular risks of long-term use of the drug in children.

Originally posted at InjuryBoard by Christina Cole

Vioxx Decision Upheld, Award Reduced

Christina Cole — Mon, 08 Jan 2007 16:39:32 GMT

Good news for Felicia Garza - a Texas judge certified the ruling of a state jury that held the pharmaceutical company Merck & Co. liable for the Vioxx related death of her husband. The bad news however is the same judge decided the initial damages awarded to Garza in the tune of $32 million, violated state laws and therefore reduced the award to $8.7 million.

Leonel Garza died in 2001 after suffering a heart attack that the plaintiffs believe was caused by him taking the controversial painkiller Vioxx. In April, a Texas jury had ruled against Merck and awarded Garza's family $32 million in damages - $7 million in compensatory damages and $25 million in punitive damages. Judge Alex Gabert ruled that the award was in violation of the 2003 state law that sets strict limits on punitive and compensatory damages.

The big news for other Vioxx plaintiffs was that the original ruling was upheld, meaning that the courts accepted the premise that even short-term use of Vioxx may have led to severe side effects including heart attacks and strokes. Well more than 27,000 lawsuits have been brought against Merck, which pulled Vioxx from the shelves in September of 2004 after a study disclosed that long-term use of the drug could double a patient's risk of a coronary event.
However, a New Orleans federal judge rejected appeals by the plaintiffs to form a class action, saying that each individual case was too distinct to be tried as a group. Merck has emerged victorious in the majority of the cases heard to this point.
A financial relationship between Felicia Garza and one of the jurors in the Texas trial has called the legitimacy of the original verdict into question, and Merck plans to seek a new trial because of the alleged improprieties. The lengthy appeals process may delay payment to the Garzas for many years to come.

Originally posted at InjuryBoard by Christina Cole

Drug In Same Class as Bextra and Vioxx Approved For Use in Children

Staff Writer — Wed, 27 Dec 2006 11:11:54 GMT

Pfizer has received federal approval to market Celebrex, its Cox-2 inhibiting painkiller, as a treatment for Juvenile Rheumatoid Arthritis (JRA). JRA affects tens of thousands of children, and other treatments have seen limited success or resulted in severe side effects.

The decision comes after FDA advisers recommended Nov. 29 the drug as an effective but not necessarily safe treatment for the autoimmune disease, but said that its benefits still outweigh any risks.
The FDA said it would require Pfizer to continue studying the safety of the drug in children, including its long-term effect on the kidneys, blood pressure and heart.

Celebrex is in the same class of drugs as Bextra and Vioxx and remains the only drug in its class still on the market.
Vioxx and Bextra were removed from shelves after they were linked to heart attacks and strokes in adults.

Originally posted at InjuryBoard by Staff Writer