Breaking Legal News Archive
November 12, 2008
Ethex Corp. and the Food and Drug Administration (FDA) announced a voluntary recall of the following five generic medications: Propafenone HCl Tablets – 150 mg, 225 mg, and 300 mg; Isosorbide Mononitrate Extended Release Tablets – 30 mg and 60 mg; Morphine Sulfate Extended Release Tablets – 15 mg; Morphine Sulfate Immediate Release Tablets – 15 mg and 30 mg; Dextroamphetamine Sulfate Tablets – 10 mg.
November 10, 2008
In a step rarely taken, the U.S. Food and Drug Administration (FDA) today sent U.S. Marshals to seize 11 lots of heparin from a Cincinnati-based medical products manufacturer that twice refused to obey orders to recall the contaminated blood-thinning drug.
November 10, 2008
A newly-released report from the Agency for Toxic Substances and Disease Registry (ATSDR) has concluded that employees, their families, and people living near one of 28 so called “exfoliation sites”? may have been exposed to amphibole asbestos from vermiculite mined in Libby, Montana between the 1920s and early 1990s.
November 6, 2008
The U.S. Food and Drug Administration (FDA) now offers consumers valuable information about over-the-counter medicine through its consumer education website. Over-the-counter medicine, also known as OTC or nonprescription medicine, refers to medicine that can be bought without a prescription.
November 6, 2008
An expert panel of outside scientists appointed by the Food and Drug Administration (FDA) Science Board has determined that the FDA ignored evidence when it concluded that a chemical found in baby bottles is safe. The chemical at issue is bisphenol A (BPA), a chemical that makes plastic hard and shatterproof and is used in thousands of consumer products, from baby bottles to CDs. Some studies suggest that BPA, which mimics that hormone estrogen, may be associated with problems such as early onset of puberty in women and behavioral problems, while other studies suggest BPA is safe.
November 5, 2008
An article published on the front page of today’s Wall Street Journal states that federal safety regulators are investigating the Yamaha Rhino following reports of some 30 deaths involving it, including the deaths of two young girls last month. The Yamaha Rhino, a popular off-road vehicle, has been criticized as being too high off the ground with its wheels too close together, making it prone to tip over, causing serious injury and death.
November 3, 2008
Bayer HealthCare today received warning letters from the U.S. Food and Drug Administration (FDA) concerning two illegal, over-the-counter (OTC) aspirin products the drug company is marketing: Bayer Women’s Low Dose Aspirin + Calcium (Bayer Women’s) and Bayer Aspirin with Heart Advantage (Bayer Heart Advantage).
November 3, 2008
On October 30, 2008, the consumer group Public Citizen asked the U.S. Food and Drug Administration to ban the formerly popular diabetes drug Avandia, claiming the drug’s life-threatening risks greatly outweigh its benefits. In addition to the risk of heart attack, which is already cited in a “black box” warning on Avandia’s label, Public Citizen said it identified 14 cases of liver failure associated with Avandia. The consumer advocacy group also said that a review of adverse-event reports filed with the FDA indicated that 12 of the 14 cases resulted in liver-related deaths.
October 31, 2008
Lawyers for Mentor Corporation, the company that manufactured the OB Tape vaginal sling, have filed a motion to establish a multidistrict litigation (MDL), which will allow all OB Tape vaginal sling lawsuits to be coordinated and centralized during pretrial litigation. In their motion, the Mentor’s lawyers argued that this will help avoid duplicative discovery and depositions, inconsistent rulings and conserve the resources of the parties.
October 23, 2008
Source: Wall Street Journal – A recent rise in the number of reported traffic accidents and seizures involving people taking Chantix has prompted the Food and Drug Administration (FDA) to consider upgrading warnings on the Pfizer Inc. antismoking drug.
October 21, 2008
The Consumer Product Safety Commission (CPSC) announced today that Delta Enterprise Corp. of New York is recalling nearly 1.6 million drop side baby cribs after two babies suffocated when the cribs’ drop side detached.
October 13, 2008
Amylin Pharmaceuticals, the maker of Byetta, is trying to boost the reputation of its diabetes drug by flaunting a new study that shows Byetta to be more effective than another popular diabetes medication. At least one drug industry analyst, however, has characterized the research, which compares Byetta to Januvia, as a ploy meant to focus attention away from Byetta’s association with pancreatitis.
October 6, 2008
The New York State Agriculture Commissioner, Patrick Hooker, announced on October 6 that consumers should not eat “Frozen Salted Croaker”? distributed by YS Trading Corp of 38-21 23rd Street, Long Island City, New York 11101 because the product was uneviscerated. The “Frozen Salted Croaker” was sold in Hicksville, New York, Flushing, New York, and New Jersey in un-coded, unlabeled plastic bags.
October 2, 2008
The industrial chemical melamine, which is blamed for sickening thousands of infants in China, has been found in candy on American shelves. Specifically, tests done in Connecticut on White Rabbit Creamy Candy found the toxic chemical in candy being sold at several Connecticut stores.
October 2, 2008
The FDA ordered Bayer to remove Trasylol (aprotinin) from the market after studies linked Trasylol to tens of thousands of deaths. A study looked at more than 78,000 patients from January 2003 to January 2006 and concluded that Trasylol users have a 64% higher death risk than those that took an alternative drug. The increased death risk was due to Trasylol dangerous side effects including kidney failure, heart attack, and stroke.
September 26, 2008
The U.S. Food and Drug Administration (FDA) today announced that seven Mr. Brown instant coffee and milk tea products are being recalled by the Taiwanese company, King Car Food Industrial Co. Ltd., due to possible melamine contamination. The Mr. Brown coffee and milk tea products were made with a non-dairy creamer manufactured by Shandong Duqing Inc., China, which was found to be contaminated with the toxic industrial chemical melamine.
September 19, 2008
With the recent string of taint ed products produced in China, there has been growing concern in the United States over the issue of importation. And in light of the recent contaminated Heparin tragedy, the concern pertains to the importation of prescription drugs as well as drug components manufactured overseas and imported into the United States.
September 19, 2008
Chinese health officials yesterday reported the death of a fourth baby linked to the country’s unfolding scandal involving contaminated baby formula. The tainted baby formula has already sickened 6,244 babies, with more than 1,300 babies, mostly newborns, remaining hospitalized and 158 suffering from acute kidney failure.
September 5, 2008
According to an article recently published by MSN Health & Fitness, some common over-the-counter and prescription drugs are so dangerous doctors say they would never take them. Do you have deadly medications in your medicine cabinet? Here is a list of eight drugs doctors say they would never take.
September 4, 2008
The Food and Drug Administration (FDA) today ordered stronger warnings on the labels of four popular drugs for arthritis and Crohn’s disease to notify patients about the risk of serious fungal infections. The four drugs now required to carry stronger warnings include: Johnson & Johnson’s Remicade; Abbott Laboratories’ Humira; UCB SA’s Cimzia; and Amgen’s and Wyeth’s co-marketed drug Enbrel.
September 3, 2008
The Department of Health and Human Services today released a final report on the safety of bisphenol-A, or BPA, which is a chemical used in plastic baby bottles. The report says government experts have “some concern” that BPA is linked to health and developmental problems. Although the government report released today does not say BPA should be banned, it says more research is necessary to understand how the chemical affects human health.
September 2, 2008
Merck and Schering-Plough, the makers of the popular cholesterol drugs Zetia and Vytorin, were dealt a huge blow in the world’s most prestigious medical journal today.
August 23, 2008
In response to growing safety concerns, the FDA yesterday announced plans to revise standards for over-the-counter children’s cough and cold medicines. If the FDA finds that these products are ineffective and/or unsafe, over-the-counter children’s cold medicines could be permanently removed from the market.
August 21, 2008
According to a new study, undergoing hemodialysis following exposure to gadolinium contrast dyes during an MRI may reduce some kidney patients’ risk of developing nephrogenic systemic fibrosis. The study, conducted by researchers at Weill Medical College of Cornell University and Columbia University’s College of Physicians and Surgeons in New York, was recently published in the journal Radiology.
August 20, 2008
Lawyers yesterday filed what is believed to be the first personal injury lawsuit stemming from injuries associated with the type 2 diabetes drug Byetta. Lawyers filed the lawsuit in San Diego Superior Court on behalf of a Virginia man who claims that Byetta’s manufacturer, Amylin Pharmaceuticals, Inc., and Byetta’s co-marketer, Eli Lilly and Company, failed to adequately test and monitor the side effects of Byetta. The plaintiff’s lawyers also allege that Byetta’s co-marketers failed to warn doctors or patients of the risk of developing pancreatitis.
August 19, 2008
A federal appeals court in Atlanta today heard arguments over whether a U.S. District Court Judge in Florida correctly dismissed testimony from an expert witness who would have testified that Accutane, an anti-acne drug, is linked to medical problems.
August 18, 2008
After receiving two reports of deaths and four other hospitalizations in Byetta users, the FDA today announced its plans to update Byetta’s warning label to include warnings about life-threatening pancreas problems linked to the type 2 diabetes drug.
August 14, 2008
On August 14, 2008, Bernstein Liebhard LLP (“BL”) filed an amicus curiae (friend-of-the-court) brief with the United States Supreme Court in Wyeth v. Levine, supporting the plaintiff-respondent Diana Levine, on behalf of healthcare amici, including Anju Budhwani, M.D., Arthur Levin, MPH, Curt D. Furberg, M.D., Ph.D., Rahul Sharma, MD, MBA, and on behalf of third party payor amici, including the Health and Welfare Fund and Retiree Health and Welfare Fund of the Detectives Endowment Association, Police Department, City of New York, Canton Electrical Welfare Fund of the International Brotherhood of Electrical Workers Local 540, and the Ohio Carpenters Health Fund.
August 4, 2008
An article published in today’s Pediatrics raises additional concerns about the dangers of giving cough and cold medicines to babies. According to the article, a “surprising”? number of young children taken to the emergency room after they stop breathing or lose consciousness have over-the-counter cold medications in their systems.
August 1, 2008
Cipro has been linked to toxic epidermal necrosis, which is a rare and potentially fatal medical disorder involving the skin and mucous membranes. Toxic epidermal necrosis is an immune-complex-mediated hypersensitivity condition, which basically means it occurs due to an allergic reaction. While toxic epidermal necrosis is usually caused by an allergic reaction to medication, such as Cipro, it can also be caused by a reaction to an infection or illness.
July 30, 2008
Last month, about a dozen Bayview-Hunters Point, California residents filed a lawsuit against Lennar, a well-known developer, as well as its environmental consultant, CH2M Hill, and Sacramento-based engineering consultant Gordon N. Ball, on behalf of their young children.
July 30, 2008
The FDA, for the first time, has conclusively linked the deaths of three patients to contaminated lots of Heparin, a widely-used blood thinner manufactured by Deerfield-based Baxter International Inc.
July 21, 2008
An unnamed mesothelioma victim and his family have reached a confidential settlement with several home heating and air conditioning (HVAC) equipment manufacturers in a personal injury lawsuit filed in Oakland, California. The HVAC manufacturers involved in the settlement include industry leaders such as Lennox, Trane, and Carrier.
July 15, 2008
Fosamax, a popular drug for treating osteoporosis, has been linked to a rare type of leg fracture that cuts straight across the upper thighbone after little or no trauma. Typically, fractures in this strong part of the bone result from car accidents, or occur in the elderly and frail. But a recent series of case reports show the unusual fracture pattern in people who have used bisphosphonates, such as Fosamax, for five years or more.
July 8, 2008
The U.S. Food and Drug Administration (FDA) today ordered the makers of certain antibiotics to add a black box warning to their labels alerting patients of possible tendon ruptures and tendonitis. Additionally, the FDA announced it will ask the same drug makers to create a Medication Guide which will be given to patients and will alert them about possible side effects.
July 8, 2008
On July 8, 2008, the FDA imposed the government’s most urgent safety warning on Cipro and similar antibiotics, citing evidence that they may lead to tendon ruptures, a serious injury that can leave patients incapacitated, needing extensive surgery and months of rehabilitation. Specifically, the FDA ordered makers of flouroquinolones, a potent class of antibacterial drugs, to add a prominent “black box” warning to their products and develop new literature for patients emphasizing the risks.
June 27, 2008
A mesothelioma patient and his wife were awarded $16.25 million today in yet another asbestos lawsuit to end with a huge jury verdict. The plaintiff, 71 year old Marvin Penn, was diagnosed with the asbestos-caused cancer mesothelioma after being exposed to asbestos in the 1960s. The jury attributed 20 percent of the liability to the sole defendant at trial, Kerr Corp., a dental supply company.
June 5, 2008
Seven patients at two Virginia hospitals were mistakenly implanted with recalled Bard Composix Kugel Mesh Hernia Patches during the first half of 2007. The accidental implants occurred at Sentara Virginia Beach General Hospital and Sentara Leigh Hospital, both of which are owned by Sentara Health Systems.
May 20, 2008
To date, Bayer HealthCare Pharmaceuticals Inc. has been hit with 78 lawsuits over its drug Trasylol, which is given during heart surgery to control bleeding. The Trasylol lawsuits allege that Bayer ignored studies showing that Trasylol is unsafe and failed to warn consumers about the severe side effects associated with the drug. Among Trasylol’s potential side effects are: kidney failure, heart attacks, stroke, and death.
May 14, 2008
On May 14, 2008, Bayer HealthCare Pharmaceuticals Inc. announced that it was voluntarily removing Trasylol, a drug given during heart surgery to control bleeding, from the market. Compared to two other drugs used to control bleeding, Trasylol may significantly increase the risk of death.
May 13, 2008
Following the recent Digitek recall, a class action lawsuit was filed in U.S. District Court in New Jersey against Digitek’s foreign maker, Actavis Totowa LLC. One of the lead plaintiffs in that class action is a woman who alleges she experienced changed cardiac symptom episodes, nausea, and dizziness from taking Digitek. In addition, another plaintiff alleges he may have suffered serious personal injuries, including kidney damage, after taking the defective drug.
May 7, 2008
Medtronic, Inc., a maker of medical devices for heart patients, today announced that it is initiating a voluntary and precautionary recall of selected products featuring the Carmeda Bioactive surface. The affected medical devices are disposable products used during heart surgeries for a procedure called cardiopulmonary bypass and include blood oxygenators, reservoirs, pumps, cannulae, and tubing packs. This recall is being issued in response to the FDA’s April 2008 recommendation to device manufacturers that heparin supplies be checked with newly-developed tests, and that affected products be evaluated for possible field corrective action.
April 28, 2008
According to research from Group Health and the University of Washington, the osteoporosis drug Fosamax appears to double women’s chances of developing atrial fibrillation, the most common form of chronic irregular heartbeat. Atrial fibrillation occurs when a problem with the heart’s electrical system causes the atria to quiver, or fibrillate. The quivering interrupts the normal rhythm between the heart’s upper and lower chambers, which may cause the heart to beat fast and irregularly.
April 25, 2008
On April 25, 2008, a nationwide recall was issued for all strengths of Digitek, a prescription drug used to treat heart failure and abnormal heart rhythms. According to Actavis Totowa LLC, Digitek’s maker, a manufacturing defect may have caused double-strength Digitek tablets to be released to the public. The recalled Digitek tablets are distributed by Mylan Pharmaceuticals Inc. under a “Bertek”? label and by UDL Laboratories, Inc. under a “UDL”? label.
April 23, 2008
A jury yesterday awarded $10.5 million to a 24 year old Utah woman who claims Accutane, a drug used to treat severe acne, caused her to develop ulcerative colitis. Out of the approximately 425 existing lawsuits brought by patients who allege Accutane caused them to develop some form of inflammatory bowel disease, this was the third to go to trial. All three trials have resulted in multi-million dollar judgments against Accutane’s maker, Hoffmann-La Roche Inc (Roche).
March 9, 2008
A congressional probe into the safety of Ketek has taken a stunning turn, as it now appears that the head of the Food & Drug Administration (FDA), Andrew von Eschenbach, may have committed perjury when he gave written testimony to a committee investigating the agency’s approval of the defective drug, Ketek.
January 30, 2008
Earlier this month, a Federal Court charged with hearing all lawsuits related to the Kugel Mesh Hernia Patch ruled to expand proceedings to include all claims involving defective Kugel Mesh Hernia Patches, including claims unrelated to the original Kugel Mesh Hernia Patch recall. Davol Inc., the maker of the defective Kugel Mesh Hernia Patch, will now have to face additional lawsuits over its faulty hernia patches.
May 23, 2007
In May 2007, the FDA ordered all manufacturers of gadolinium based contrast agents to include a black box warning on their product labels. A black box warning is the strongest warning that the FDA requires and means that a particular drug carries a significant risk of serious or even life-threatening side effects. Specifically, the gadolinium black box warning states that patients with kidney problems or renal failure are at risk of developing NSF / NFD if injected with gadolinium.
March 18, 2008
A San Francisco jury recently awarded $20 million in damages to a woman who was diagnosed with mesothelioma in 2006. Georgia Pacific Corp., an asbestos manufacturer, was ordered to pay 30 percent of the verdict, or approximately $7 million, for exposing Joan Mahoney, a onetime film actress and singer, to the asbestos fibers that caused her terminal cancer.
February 12, 2007
In May 2006, a study published in Annals of Internal Medicine stated that Ketek, a popular antibiotic drug, caused severe kidney damage to three patients in one hospital. One patient required a liver transplant and another patient died. This prompted the FDA to advise Sanofi-Aventis, Ketek’s manufacturer, to include a black box warning on Ketek’s label detailing the increased liver damage risk.
February 4, 2008
A Baltimore jury has awarded $15.3 million to a 73-year-old Halethorpe man whose terminal cancer was linked to asbestos exposure while working at Bethlehem Steel Corp.’s Key Highway ship repair facility, a South Baltimore shipyard, in the 1950s.