Ethex Corp. Voluntarily Recalls 5 Generic Drugs Due to Overdose Risk

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.

FDA Sends Federal Marshals to Seize Contaminated Heparin

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.

ATSDR Report Presents New Asbestos Exposure Concerns from Vermiculite Mined in Libby, Montana

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.

FDA Website Offers Over the Counter Medicine Information for Consumers

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.

Expert Panel Says FDA Ignored Evidence when Calling BPA Safe

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.

Federal Safety Regulators Investigating Yamaha Rhino after 30 Reported Deaths

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.

Bayer HealthCare Receives FDA Warning Letters for Illegally Marketing Two Unapproved Drugs

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).

Watchdog Group Petitions FDA to Ban the Diabetes Drug Avandia

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.

Mentor Files Motion to Consolidate OB Tape Sling Lawsuits

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.

FDA May Strengthen Warnings on Antismoking Drug Chantix

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.

Delta Recalls 1.6 Million Baby Cribs after 2 Infant Deaths

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.

Amylin Releases Byetta Study To Distract Patients From Pancreatitis Side Effect

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.

Consumers are Alerted to Possible Botulism Contamination in “Frozen Salted Croaker” Distributed by YS Trading Corp. in New York

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.

Melamine Tainted Candy from China Found in United States Stores

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.

Information About Trasylol (Aprotinin) Being Linked to Tens of Thousands of Deaths

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.

FDA Recalls 7 Mr. Brown Coffee & Milk Tea Products Due to Potential Melamine Contamination

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.

FDA Bans Generic Drug Imports From Ranbaxy Laboratories in India

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.

Death Toll Rises to 4 in China’s Melamine Tainted Baby Formula Scandal

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.

Medications Your Own Doctor Won’t Take

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.

FDA Strengthens Warnings on Four Drugs: Remicade, Humira, Cimzia, & Enbrel

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.

Concerns Linger Over BPA Contaminated Baby Bottles

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.

Zetia & Vytorin Makers Criticized in New England Journal of Medicine Editorial

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.

FDA to Revise Regulations for OTC Children’s Cold Medicines

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.

Hemodialysis after MRI with Gadolinium Could Help Prevent NSF

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.

First Byetta Lawsuit Filed

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.

Accutane Lawsuit Heard in Federal Appeals Court

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.

Byetta to Receive New Pancreatitis FDA Warning

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.

Bernstein Liebhard Files Amicus Curiae Brief in U.S. Supreme Court on Behalf of Healthcare Advocates and Union Health & Welfare Funds In Wyeth v. Levine

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.

Study Reveals Cold Medicine Can Kill Babies

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.

Cipro Linked to Fatal Skin Disease

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.

Developer Denies Blame for Asbestos Dust at Hunters Point Shipyard in CA

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.

FDA: Contaminated Heparin Directly Linked to 3 Deaths

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. 

HVAC Manufacturers Settle Asbestos Lawsuit

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.

Osteoporosis Drug Fosamax May Actually Weaken Bones

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.

FDA Recommends Black Box Warning for Levaquin and Cipro

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.

FDA Orders Cipro to Carry Black Box Warning

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.

NY Jury Awards $16.25M to Mesothelioma Cancer Victim

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. 

Recalled Bard Composix Kugel Mesh Hernia Patch Given to Patients at Virginia Hospitals

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.

Trasylol Named in 78 Lawsuits

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.

Recently Recalled Trasylol Blamed for 1,000 Deaths a Month

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.

Class Action Lawsuit Filed against Digitek’s Maker

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.

More Heparin Products Recalled

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.

Fosamax May Double Risk of Heart Condition

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.

Urgent Digitek Recall

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.

Jury Awards Accutane Victim $10.5 Million

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).

Ketek Probe Reveals FDA Chief May Have Committed Perjury

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.

Litigation over Kugel Mesh Hernia Patch Expands

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.

Gadolinium Based Contrast Agents Now Carry Black Box Warning

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.

Georgia Pacific Corp Ordered to Pay Mesothelioma Victim Part of $20M Jury Award

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.

FDA Orders Black Box Warning for Ketek

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.

Bethlehem Steel Shipyard Worker Awarded $15.3M in Mesothelioma Lawsuit

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.

Published November 17, 2011 by