Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims
The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...
Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke
The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...
Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices
Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...
Hip Replacement, Knee Implant Patients with Diabetes, Other Health Problems May Face Difficult Recoveries
Patients receiving hip replacement devices or knee implants may face a more complicated recovery if they are obese, or suffer from diabetes or other health woes. According to a new study published online in the journal Anesthesiology, at least 3% of all total hip or knee replacement patients will ...
EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects
Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...
Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries
Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...
Actos, Avandia May Up Risk for Diabetic Macular Edema
A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...
Pennsylvania Health System Proposes Comprehensive Fracking Study
A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.
FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today
The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.
FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns
Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...MRI Imaging May Spot Meningitis from Tainted Steroids
Results of new research show that a screening MRI may provide early warning of spinal or paraspinal meningitis in patients who received contaminated steroid injections.
The imaging technique showed abnormalities in 21% (36) of 172 patients screened, according to Dr. Anurag Malani of St. Joseph Mercy Hospital in Ann Arbor, Mich., and colleagues, MedPage Today reports. Of the 36 patients screened, all but one met the Centers for Disease Control and Prevention (CDC)’s definition for probable (17 patients) or confirmed (18 patients) fungal spinal or paraspinal infection. The patients had received methylprednisolone injections from a highly contaminated lot of the steroid, but had not sought medical care related to the injection, the research team reported online in the Journal of the American Medical Association (JAMA). Continue reading
Johnson & Johnson Wins $16M in Patent Suit with Globus Medical
Globus Medical was ordered to pay Johnson & Johnson over $16 million in damages after a Delaware jury ruled that medical device maker, Globus Medical, violated three of Johnson & Johnson’s patents.
The three Globus products, which have been discontinued, violated patents held by DePuy Synthes, a segment of health care giant, Johnson and Johnson, according to FierceMedicalDevices. Globus indicated that it continues to work through motions that are aimed at reversing the verdict; the court’s formal judgment is pending. Continue reading
Zyprexa Gets FDA Attention Following Two Patient Deaths
Zyprexa is an antipsychotic medication manufactured by Eli Lilly used to treat disorders such as schizophrenia and bipolar disorder. This drug, however, has caught the attention of the U.S. Food and Drug Administration (FDA) when two patients died after receiving the injections. The FDA is now investigating Zyprexa, which is manufactured by Eli Lilly. Continue reading
Despite Prior Objections, Chrysler to Recall 2.7 Million Jeeps
Despite intense objections last week, Chrysler Group has agreed to recall 2.7 million Jeeps. The announcement was made hours before a government deadline on the issue.
In a rare move, Chrysler had defied a National Highway Traffic Safety Administration (NHTSA) recall request maintaining its Jeeps were safe and challenging the regulator’s collision data analysis. The NHTSA said that the rear-mounted gas tanks in 1993-2004 Jeep Grand Cherokees and 2002-2007 Jeep Liberty vehicles are too vulnerable to leaking and could catch on fire in a rear-end crash, according to ABC News previously. Although the NHTSA can call for a recall, the agency requires a court order to enforce that demand. Continue reading
Class Action Lawsuit: Goodman and Amana Air Conditioners Allegedly Violated Consumer Warranties
Since 2007, Goodman and Amana manufactured and sold central air conditioners that are both defective and breach warranties that were not honored, according to a recently filed class action lawsuit.
The complaint indicates that defective evaporator coils cause the air conditioners to work improperly. In fact, the defective evaporator coils “improperly and prematurely leak refrigerant under normal use.” The complaint also states that, “As the air conditioners leak refrigerant, they are unable to function properly and are thus unfit for their ordinary and intended purpose.” Continue reading
Many Popular Medications Contain Cancer-Causing Compounds, May Increase Cancer Risks
Cancer is devastating, killing about 600,000 people every year. Cancer is, in fact, the second-leading cause of death in the United States. Yet, despite consumers’ proactive measures to avoid cancer-causing products, some pharmaceuticals might contain carcinogens, ameliorating the best consumer efforts.
Medications we routinely take may contain dangerous ingredients. Consider that the U.S. Food and Drug Administration (FDA) does mandate that pharmaceutical companies test their products for so-called “carcinogenicity” in animals, yet even if the drugs test positive for increased tumor risks, that does not automatically get those drugs rejected, according to The Gazette. In fact, those very drugs may end up making their way to market. Continue reading
Supreme Court Decision Allows Regulators to Sue Over Generic-Drug Deals
In a decision handed down on Monday, the U.S. Supreme Court ruled that pharmaceutical companies that pay rivals to keep less-costly generic versions of best-selling drugs off the market can be sued by the Federal Trade Commission (FTC) for potential antitrust violations.
The justices, in a 5 to 3 vote, threw out lower-court rulings that said such agreements, called pay-for-delay agreements, are legal, provided they did not keep a generic drug off the market beyond the term of the brand-name drug’s patent, The New York Times reports. Continue reading
InFuse® Bone Graft No Better than Traditional Graft, Review Finds
An independent, dual review, found that Medtronic’s InFuse® product provided limited benefits. The bone graft product was also found to cause potential harm, including a small increased risk of cancer and works no better than traditional bone grafts, according to the review.
The U.S. Food and Drug Administration (FDA) approved InFuse® in 2002 for use in fusing damaged vertebrae in the lower spine; InFuse® was not approved for use on the upper, or cervical, spine, where it is now widely used, according to Bloomberg Businessweek. In fact, the FDA released a July 1, 2008 notification warning that the InFuse® bone graft had been associated with serious complications, including excessive swelling in the neck, compressed airways, difficulty breathing, problems swallowing, and nerve damage, when used in cervical spinal fusions. Continue reading
Asbestos Continues to Cause Significant Mesothelioma Risks
One case of mesothelioma is proving to be an example of what new generation asbestos lawsuits are looking like.
In one case, the plaintiff suffered from chest pain, traveled nationwide for major surgery, underwent chemotherapy, had to manage debilitating pain, and was dealing with a lawsuit that had not been finalized at the time of his death, according to The Wall Street Journal. His attorneys are suing an array of firms they believe exposed the now-deceased plaintiff to asbestos at some point during his life. Continue reading
European Drug Regulator Urges Caution in Use of Painkiller Diclofenac
The European Medicines Agency (EMA), Europe’s drug regulator, warned on Friday that the painkiller diclofenac, especially in high doses, carries extra heart attack risks, which should be taken into consideration by doctors prescribing the drug.
“Patients who have serious underlying heart or circulatory conditions, such as heart failure, heart disease, circulatory problems or a previous heart attack or stroke, should not use diclofenac,” the EMA said in a statement. The EMA’s warning comes after a large international study showed that long-term, high-dose use of non-steroidal anti-inflammatory (NSAID) painkillers such as diclofenac and ibuprofen increases the risk of a major vascular event—heart attack, stroke, or death from cardiovascular disease—by around a third, Reuters reports. Continue reading
