Latest News

Lead shocks send patient to psychiatrist

A patient affected by Medtronic’s 2007 recall of defibrillator leads is suing the company, claiming unnecessary shocks led to post-traumatic stress syndrome that required psychiatric treatment. Plaintiff Donald Jackson received an implantable cardioverter defibrillator containing a Sprint Fidelis lead in 2006, which he says gave him unexpected and medically unnecessary shocks, causing excruciating pain. The shocks caused “great physical, emotional and psychological suffering and extreme anxiety,” placing Jackson in “imminent apprehension of death,” the complaint says. It adds that Jackson is now prescribed mood-stabilizing drugs. And, as a result of problems with the lead, he has an increased risk of ... Read More

Ortho Evra birth control patch label change

The FDA approved a label change to Johnson & Johnson’s Ortho Evra birth control patch on January 18, 2008. The patch has been known to cause blood clots which can lead to pulmonary embolism and death. The label change comes after testing revealed women on the patch between the ages of 15-44 are at a higher risk for pulmonary embolism. Currently there is litigation pending throughout the United States, including in Chicago, relating to the use of the Ortho Evra patch. Plaintiffs have filed claims after suffering from blood clots, pulmonary embolisms and in some cases death. The side effects ... Read More

NSF study finds link between Gadolinium used in MRI and debilitating disease

Another Nephrogenic Systemic Fibrosis (NSF) study has tied the debilitating condition to Gadolinium contrast agents used in Magnetic Resonance Imaging (MRI). This latest NSF research was conducted by the Centers for Disease Control (CDC), which examined a cluster of NSF patients at one unidentified St. Louis Missouri Hospital. The CDC found that the exposure to Gadolinium contrast dyes during MRI was independently associated with the development of NSF. NSF (sometimes called Nephrogenic Fibrosing Dermopathy or NFD) was first seen in patients in 1997, and it wasn’t mentioned in medical literature until 2000. NSF leads to excessive formation of connective tissue ... Read More

GSK Sent Avandia meta analysis before publication

GlaxoSmithKline’s Avandia is once again making the headlines after it was revealed that the peer reviewer looking at the now-notorious meta-analysis on the diabetes drug’s safety profile leaked a confidential copy of the article to the firm before it was published in the New England Journal of Medicine Details of this strange turn of events were about to be published in the journal Nature before US Senator Charles Grassley broke its embargo and issued a letter written to GSK asking the firm what action it had taken on receiving the article from Steven Haffner of the University of Texas Health ... Read More

Pharmaceutical industry focus on ‘blockbuster’ medications

The Los Angeles Times on Sunday examined how the business “strategy that has made the pharmaceutical industry one of the wealthiest and most powerful on Earth” might have begun to “betray it.” Pharmaceutical companies for 25 years have “imitated the basic business model of Hollywood” and have “focused on creating blockbusters,” which they “hope will appeal to masses” and “promote like mad,” according to the Times. Pharmaceutical companies must spend as much as $1 billion to promote new medications in their first two years on the market to make the products into a “mega-brand” with at least $1 billion in ... Read More

Poor FDA scrutiny of Medtronic Sprint Fidelis lead

The 2007 Medtronic Sprint Fidelis Defibrillator Lead Recall could just be the tip of the iceberg when it comes to defective implantable medical devices. That’s because the number of medical devices meant to be implanted in patients’ bodies is rapidly rising. Unfortunately, despite their rising numbers, as the case of the Sprint Fidelis Lead recall illustrates, the Food & Drug Administration (FDA) is doing a poor job of regulating implantable devices, and often ignores reports of device failures until someone dies. Medtronic suspended sales of the Sprint Fidelis Leads in October, after receiving reports of 5 fatalities linked to lead ... Read More

Avandia study shows increased heart risks or death

Older patients who took Avandia had a higher risk of heart attacks, congestive heart failure and death than those on other diabetes pills, according to a study of nearly 160,000 Canadians. For four years, the study followed patients over age 65, who have the highest rate of type 2 diabetes but aren’t well represented in clinical trials, says lead author Lorraine Lipscombe, a Toronto endocrinologist and researcher at the Institute for Clinical Evaluative Science, funded by the Ontario government. Lipscombe’s team looked at how patients fared on Avandia or Actos, the only two drugs in their class, compared with those ... Read More

Avandia a big risk to your heart

Montgomery, AL: Joyce A. says she did not know that Avandia could cause so many health problems, at least she did not know until her doctor took her off Avandia and put her on another drug. Unfortunately, this happened after she was hospitalized two times with severe chest pains. Although she has started to recover since being taken off Avandia, she says she still experiences some pain. “I was having severe chest pains and I was hospitalized and told at a later time that taking Avandia could cause the severe pain I was having,” Joyce says. “I thought that I ... Read More

Medtronic settles defective defibrillator lawsuits for $114 Million

Medtronic Inc., the maker of the defective Sprint Fidelis Defibrillator Lead, announced last week that it had reached a settlement agreement regarding another of its faulty medical devices. The company has agreed to pay out $114 million to settle product liability lawsuits filed as the result of injuries cased by its malfunctioning Marquis line of implanted cardiac defibrillators. Despite the huge settlement agreement, Medtronic said it does not admit liability in the litigation. Implantable cardioverter defibrillators, or ICDs, provide shocks to stop hearts from potentially dangerous rapid beating. They treat patients at risk for sudden cardiac death, which is the ... Read More

Ohio Supreme Court upholds law that puts cap on personal injury damages

In a 5-2 decision, the Ohio Supreme Court Thursday morning upheld the constitutionality of a 2004 law capping damages for pain, suffering, and other non-economic claims in personal injury and other lawsuits. In a response to a question posed by U.S. District Court in Toledo, which is considering a federal lawsuit stemming from Johnson & Johnson’s Ortho Evra birth-control patch, the court’s majority found that the General Assembly had the authority to enact the law. “Some may think limitations on certain damages to be unwise legislative policy-making, but it is beyond the authority of any court to write into the ... Read More