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Blog Posts in 2013

  • FDA Warns of Serious Skin Reactions with Anti-seizure Drug

    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 manufactured by Lundbeck and has been prescribed to over 31,000 patients in the U.S. since its approval in 2011. Based on evaluation of its own Adverse ...
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  • Down on the Farm, the Rules are Changing

    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 no one cared to mention it in the hearing of the pigs or the dogs, it was felt that the killings which had taken place did not square with this. Clover asked Benjamin to read ...
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  • Proposed FRCP 37(e); "Perverse Incentives and Sloppy Behavior"

    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 of the amendment. Added text, deleted text. Rule 37. Failure to Make Disclosures or to Cooperate in Discovery; Sanctions (e) Failure to Provide Electronically Stored Information. ...
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  • FDA Proposes Rules Enabling Prompt Updates of Generic Drug Product Labeling

    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 usually sold at much lower prices once the patent protection for the brand name counterpart has expired. Currently, ...
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  • Judge Approves Janssen Pharmaceuticals' Guilty Plea of Misbranding

    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 this settlement agreement, Janssen Pharmaceuticals Inc. (a J&J subsidiary) pled guilty to a misdemeanor charge for misbranding a drug that was at one time ...
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  • Proposed FRCP Amendments; The Emperor's New Clothes

    “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 together in furtherance of justice, and the inevitable consequences of complacency; our duty to make our voices heard, rather than sit idly by while liberty is threatened. It is a ...
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  • Johnson & Johnson Fined Over $2.2 Billion for Criminal and Civil Liability

    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 ("off-label" use), as well as kickback payments to physicians and to Omnicare Inc. - the biggest U.S. long-term care pharmacy provider. The ...
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  • Ford Settles Class-Action Lawsuit Over Diesel Engines

    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 installed in 2003-2007 Ford vehicles sold or leased in the Unites States (mostly Super Duty pickups and E-series vans). The components ...
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  • FDA Issues Recall Notice about LifeStent Solo Vascular Stent

    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 Notification to its customers. The device "is an implantable... stent and delivery system used to improve the inner open space of a blood ...
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  • FDA Warns Dietary Supplement Might Cause Acute Hepatitis

    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 of the hepatitis cases required hospitalization, and one person has died. The FDA is inspecting the manufacturing facilities involved with the product. It ...
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  • FDA Requires Design Changes To Fentanyl Patches

    September 23, 2013 - As part of its efforts to regulate dangerous pharmaceuticals, the FDA issued a drug safety communication requiring changes to the design of Duragesic (fentanyl) pain patches so that the patches can be seen more easily. Fentanyl patches are dangerous and prone to cause accidental exposure because they retain potent amounts of the active narcotic ingredient even after use. ...
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  • Heartsine Technologies, Ltd. Issues Global Correction Of Samaritan® 300/300p Pad

    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 may prevent these devices from functioning properly or at all during a cardiac event. The press release includes ...
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  • McNeil Consumer Healthcare Recalls Motrin Infants Drops Due To Contamination

    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 in a lot that was not released on the market, but was part of the same batch as the three recalled lots. The ...
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  • Cubist Pharmaceuticals Recalls An Antibiotic Due To Contamination

    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 of [glass particulates] found in a number of vials" from the four lots. No adverse reactions associated with vials containing glass ...
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  • Stryker Recalls a Spinal Implant Device

    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 between the occipital bone (the bone at the back of the skull through which the spinal cord passes) and the vertebrae in the cervical spine. The recall ...
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