The FDA recently warned of rare, but serious side effects associated with the anti-seizure drug Onfi (clobazam). Onfi is a medication from the benzodiazepine family that is used to treat seizures associated with a severe form of epilepsy. It is [...]
A few days later, when the terror caused by the executions had died down, some of the animals remembered — or thought they remembered — that the Sixth Commandment decreed “No animal shall kill any other animal.” And though [...]
This is my second post in a series about the pending amendments to the FRCP. I began with commentary on the proposed amendment to FRCP 26(b)(1), which would narrow the scope of discovery. On to FRCP 37(e). First, the text [...]
The U.S. Food and Drug Administration recently issued proposed rules that would allow generic drug manufacturers to independently and promptly revise drug safety information by updating product labeling. Generic drugs are bioequivalent versions of brand name drugs. The former are [...]
On November 4, 2011, the U.S. Department of Justice (DOJ) announced that Johnson & Johnson (J&J) and some of its subsidiaries will pay over $2.2 billion due to allegations regarding several prescription drugs. On November 7, 2013, as part of [...]
“The only thing necessary for the triumph of evil is for good men [and women] to do nothing.” While the origin of the saying is muddled, the message should be clear and familiar. It speaks of our responsibility to bind [...]
The U.S. Department of Justice (DOJ) recently announced that Johnson & Johnson (J&J) and some of its subsidiaries will pay over $2.2 billion due to allegations regarding several prescription drugs. The claims include promotion of the drugs for unapproved uses [...]
By Kaiser Gornick LLP posted in Class Action on Monday, November 4, 2013 Ford Motor Co. recently reached a settlement over claims that it sold defective diesel engines. In particular, the settlement affects the now discontinued 6-liter PowerStroke diesel engines [...]
The FDA recently warned of a recall affecting LifeStent Solo Vascular Stent distributed between November 2011 and June 2012. The maker of this defective medical device, Bard Peripheral Vascular Inc., recalled the device and issued an Urgent Medical Device Recall [...]
The FDA recently warned of a possible link between OxyElite Pro and some 29 cases of acute non-viral hepatitis in Hawaii. OxyElite Pro is a dietary supplement advertised as aiding weight loss and distributed by USPlabs throughout the U.S. Some [...]
The FDA recently posted a press release regarding a voluntary global correction of Samaritan® 300/300P PAD public access defibrillators made by HeartSine Technologies, Ltd. According to the press release, issues with power management in defibrillators made prior to December 2010 [...]
The FDA recently posted a press release regarding a voluntary global correction of Samaritan® 300/300P PAD public access defibrillators made by HeartSine Technologies, Ltd. According to the press release, issues with power management in defibrillators made prior to December 2010 [...]
The FDA recently announced a recall initiated by McNeil Consumer Healthcare that affects three lots of MOTRIN Infant's Drops (active ingredient: ibuprofen). The recall was prompted by the presence of "tiny plastic particles" identified during manufacturing. The particles were found [...]
The FDA recently announced a recall initiated by Cubist Pharmaceuticals, Inc. that affects four lots of Cubicin (daptomycin for injection). Cubicin is an antibiotic indicated for the treatment of certain types of infections. The recall was prompted by "the presence [...]
The FDA recently announced a recall initiated by Stryker that affects all lots of OASYS Midline Occiput Plate distributed between April 23, 2010 and February 12, 2013. The Plate is used during spinal implant surgery and helps stabilize the junction [...]
The FDA recently issued a safety communication requiring label changes for all antibacterial drugs that contain fluoroquinolone and are taken orally or by injection. The label updates were prompted by FDA's recent evaluation of reports from its Adverse Event Reporting [...]
The FDA recently warned that consumers should not use Baczol Antigripal and Baczol Expectorante containing sulfamethoxazole, trimethoprim, or dipirona. The drugs in question are "labeled in Spanish and marketed as antibiotics for bronchitis, pneumonia, and other respiratory infections". Sulfamethoxazole and [...]
A recent article in Digital Journal warns of the risk of serious injury from "wires springing from collapsible cloth laundry hampers." The article cites a July 2013 publication in Pediatrics - the official journal of the American Academy of Pediatrics [...]
Australia's Therapeutic Goods Administration (TGA) reports that Medtronic Australasia issued a hazard alert on July 15, 2013 regarding its Consulta Cardiac Resynchronization Therapy Pacemaker. This implantable medical device is used to treat heart failure. The alert warns of a manufacturing [...]
A recent CBS News article reports on the first "bellwether" trial involving liability for the so-called "sudden unintended acceleration" affecting certain Toyota vehicles. The case deals with a 2006 Toyota Camry that plaintiffs allege unexpectedly and uncontrollably accelerated to speeds [...]
On April 17, 2013, Bryan Medical, Inc. recalled a single lot of its Tracoe Mini 3.0mm Tracheostomy Tube due to mislabeled packaging. The tube is used "to provide safe airway access and to remove discharge from the lungs... in neonatal [...]
A news article published online on July 5, 2013 in The Lancet discusses the carcinogenic potential of Actos (pioglitazone), a drug used for the treatment of Type 2 diabetes. Specifically, the article summarizes the assessments made in a recent expert [...]
The Center for Defensive Driving, a California nonprofit educator, filed a proposed consumer class action lawsuit against the Ford Motor Company in the U.S. District Court for the Central District of California. The lawsuit concerns Ford, Lincoln and Mercury vehicles [...]
On June 7, 2013, Medtronic MiniMed recalled its medical devices known as the Paradigm Insulin Infusion Sets. The recall was prompted by "a potential safety issue" due to "too much or too little insulin being delivered resulting in hypoglycemia or [...]
A recent posting by the FDA informs that Sandoz, a Division of the Novartis group, has issued a voluntary recall of a batch of Estarylla tablets. Estarylla (norgestimate and ethinyl estradiol) is a combination oral contraceptive. The recall was prompted [...]
A Committee of the European Medicines Agency recently concluded that diclofenac is associated with an increased risk of heart attacks compared to other non-steroidal anti-inflammatory drugs (NSAIDs). The conclusion, based on robust evidence, further states that increased vascular risks are [...]
A recent publication by BBC News reports that "SSRIs can double the risk of a child being born with a heart defect." According to Prof. Stephen Pilling, an expert adviser to UK's National Institute for Health and Care Excellence (NICE), [...]
A recent investigation led by the British Medical Journal (BMJ) and UK's Channel 4 Dispatches raises concerns about the safety of several popular drugs used to treat type-2 diabetes. In particular, the investigation uncovered evidence that exenatide (marketed in the [...]
A recent study published in the Journal of Hospital Medicine (abstract at http://onlinelibrary.wiley.com/doi/10.1002/jhm.2058/abstract) shows that complications caused by medical devices are relatively common in children receiving treatment in tertiary care children's hospitals. According to the study, vascular access and nervous [...]
Indian drug maker Ranbaxy Laboratories recently resumed supplying its cholesterol lowering drugs to the U.S. market. The company was shut down by the FDA in January after glass particles were found in some lots of its drugs. Last January, the [...]
Several compounding pharmacies across the country were recently forced to recall their products after federal inspectors found sanitation issues at their facilities. Compounding pharmacies mix sterile specialty drugs for patients who had specific prescriptions. Last year, filthy conditions at a [...]
Medical device manufacturer Medtronic recently recalled two of its drug infusion pumps after receiving numerous device failure complaints. Medtronic says that it has received at least 560 complaints regarding motors stalling on its SynchroMed II and SynchroMed EL pumps. The [...]
Drugmaker Amgen is set to pay a $762 million fine for illegally marketing its anemia drug Aranesp for off-label uses that the U.S. Food and Drug Administration specifically ruled out. The New York Times reports that the biotech company agreed [...]
Medtronic's Infuse Bone Graft has been associated with some of the most extensive medical device liability cases of the past few years. The Medtronic Infuse Bone Graft is a medical device that is used to replace damaged spinal disks and [...]
Regulators around the world are taking a closer look at birth control pills that may expose women to an increased risk of blood clots and strokes. Many product liability lawsuits have arisen out of the newer forms of birth control [...]
An internal study done by Johnson & Johnson estimates that the company's all-metal implants have a 37 percent five-year failure rate, according to court documents recently made public. This means that all-metal hip implants are more than seven times more [...]
Health care experts in the United States and abroad are reconsidering the safety and efficacy of the blood thinner Pradaxa. The U.S. Food and Drug Administration recently issued a warning that Pradaxa, or dabigatran etexilate mesylate, was not safe to [...]
The U.S. Food and Drug Administration recently issued an urgent warning to 350 medical practices that they may have bought counterfeit Botox from a network of wholesalers operated by CanadaDrugs. The company has also been linked to a series of [...]
Federal regulators recently announced plans to tighten restrictions on the sale of all-metal hip implants which have been shown to fail at alarming rates sometimes within years of implantation. The U.S. Food and Drug Administration's new proposal would halt the [...]
Drugmaker Eli Lilly & Co. recently agreed to pay $29.9 million to settle a foreign bribery case with the U.S. Securities and Exchange Commission. The SEC alleged that the drugmaker allowed its subsidiaries to bribe officials of foreign countries to [...]
