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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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Warning for Medtronic InterStim Neurostimulation Devices

Australian Health Agency Issues Warning for Battery Problem with Medtronic InterStim Neurostimulation Devices

Warning for Medtronic InterStim Neurostimulation DevicesTGA has issued a safety warning for InterStim and InterStim II neurostimulation devices, because of possible early depletion of the battery.

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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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Do Vitamin Drinks Pose Health Risks?Do Vitamin Drinks Pose Health Risks?

Do Vitamin Drinks Pose Health Risks?

Scientists are concerned vitamin drinks are contributing to levels of vitamins and other nutrients that are not only unnecessary, but potentially harmful.

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Post -Tonsillectomy Morphine Life-Threatening in Children

Post -Tonsillectomy Morphine can be Life-Threatening in Children, Study Finds

A new study published in Pediatrics suggests that morphine can result in life-threatening respiratory problems when given to children after a tonsillectomy.

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Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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Two Men Found Dead of Carbon Monoxide Poisoning

Two Men Found Dead of Carbon Monoxide Poisoning at Long Island, New York Auto Shop

Two men were found dead of apparent carbon monoxide poisoning in a Holbrook, New York, auto-detailing shop Thursday night, Suffolk County police say.

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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Judge Issues Order in Conserve Hip Implant Bellwether Case

The first of the consolidated multidistrict litigation (MDL) cases over Wright Medical Conserve metal-on-metal hip implants continues to move forward. United States District Judge William S. Duffrey, Jr. issued a 123-page order in the case on August 31. Wright Medical had claimed that the design-defect claims were preempted by the Medical Device Amendment to the Food Drug & Cosmetic Act, but this argument was rejected by the Court. The Court also denied motion for summary judgement related to the plaintiff’s claims for defective design, fraudulent misrepresentation, concealment and punitive damages.

Plaintiffs in the MDL allege that Wright’s Conserve hip implant caused serious injuries as a result of its metal-on-metal design. All-metal hip implants have come under increased scrutiny in recent years in light of multiple recalls and high failure rates. The devices were first marketed as being more suitable for younger, more active patients. However, the implants have a risk of shedding or fretting metal particles into the bloodstream and nearby tissues when the surfaces of the implant rub together. This can lead to a host of complications, including metal poisoning. In some patients, it was necessary to perform a revision surgery to remove and replace the implant. Continue reading

Posted in Legal News |

Knee or Hip Replacement Increases Risk of Heart Attack and Blood Clots

A team of researchers based in Boston found that osteoarthritis patients who had total knee or hip joint replacement surgery (arthroplasty) were at increased risk of heart attack (myocardial infarction) in the early post-operative period.

The findings, published this week in Arthritis & Rheumatology, a journal of the American College of Rheumatology (ACR), indicate that long-term risk of heart attack did not persist, but the risk for venous thromboembolism—blood clot in veins and lungs—remained years after the procedure, News-Medical.net reports. Continue reading

Posted in Defective Medical Devices, Health Concerns |

FDA Renews Warnings of the Dangers of Pure Powdered Caffeine

Because pure powdered caffeine products “are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the Food and Drug Administration (FDA) issued warning letters to five distributors of pure powdered caffeine and the agency has renewed warnings to consumers about this substance.

A teaspoon of pure caffeine is roughly equal to 28 cups of coffee. A tablespoon of pure caffeine can be lethal. A 100-gram package (which is about 3.5 ounces) can have as much caffeine as 400 “tall” cups of Starbucks coffee, 1,250 cans of Red Bull or 3,000 cans of Coke, the New York Times reports. In 2014, two otherwise healthy young men died after using too much pure caffeine, prompting the FDA to issue a safety warning. Continue reading

Posted in Health Concerns |

FDA Allows Sales of 700 Generic Medicines Banned by European Medicines Agency

FDA Allows Sales of 700 Generic Medicines Banned by Europe

FDA Allows Sales of 700 Generic Medicines Banned by Europe


The European Medicines Agency (EMA) instituted a ban on about 700 generic medicines that were approved based in part on what were said to be flawed clinical studies conducted at GVK BioSciences, a contract research organization based in Hyderabad, India.

The U.S. Food and Drug Administration (FDA) said it found no systemic issues affecting the safety or efficacy of generic drugs tested at GVK BioSciences, but the FDA said it supports Europe’s ban, according to Outsourcing-Pharma.com. The banned medicines include different formulations and strengths. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , , |

FDA Warns of Diabetes Drugs that Can Cause Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain

FDA Warns of Diabetes Drug that Causes Disabling Joint Pain


On Friday, the Food and Drug Administration (FDA) warned diabetes patients that an entire class of diabetes drugs can cause severe and disabling joint pain.

The drugs include Januvia (sitagliptin), Onglyza (saxagliptin), Tradjenta (linagliptin) and Nesina (alogliptin). They are all in the same class and work by making more insulin available to the body. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , |

FDA is Using Whole Genome Sequencing to Stop Foodborne Illnesses

FDA is Using Whole Genome Sequencing to Stop Illnesses

FDA is Using Whole Genome Sequencing to Stop Illnesses


The U.S. Food and Drug Administration (FDA) is implementing whole genome sequencing to quickly detect and stop the spread of foodborne illnesses, Business Insider reports. The process offers huge advantages over the previous method, where samples from sick patients were tested to see if infections were caused by the same pathogen. Once enough matches appeared, the sick individuals were interviewed by epidemiologists to see if a common food was responsible for the outbreak. This method, however, does not conclusively find the cause and is time-consuming. “While all of this was going on, more contaminated product was getting out into the public,” said Dr. Steven Musser, deputy director for scientific operations at the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition, according to Business Insider.

The FDA is now having state and federal labs map out the exact genome of strains of foodborne pathogens such as Listeria and Salmonella. The National Institutes of Health houses a public database, known as GenomeTrakr where all the sequences are uploaded. Whole genome sequences allows scientists to distinguish a pathogen from related species, as well as slight mutations within the same strain. Continue reading

Posted in Legal News | Tagged , , , , |

FDA Takes Action Against Three Tobacco Companies over “Additive-Free” and “Natural” Marketing Claims

FDA Takes Action Against Three Tobacco Companies

FDA Takes Action Against Three Tobacco Companies

Three tobacco companies—ITG Brands LLC, Santa Fe Natural Tobacco Company Inc., and Sherman’s 1400 Broadway N.Y.C. Ltd.—have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels.

ITG Brands LLC makes Winston cigarettes, labeled additive-free; Santa Fe Natural Tobacco Company’s Natural American Spirit cigarettes are labeled additive-free and natural; and Sherman’s 1400 Broadway N.Y.C. Ltd.’s Nat Sherman cigarettes are labeled natural, WebMD reports. The companies may not represent “implicitly or explicitly . . . that the product presents a lower risk of tobacco-related disease,” the FDA news release says. Continue reading

Posted in Health Concerns | Tagged , , , , |

Stryker Recalls Orthopedic Devices that May Have Been Damaged in Shipping

Stryker Recalls Orthopedic Devices

Stryker Recalls Orthopedic Devices


Medical device maker Stryker Corporation is recalling nearly 17,000 orthopedic implant devices because of potential of damage during shipping.

The Food and Drug Administration (FDA) notice lists five devices included in the recall: the rHead lateral stem and Recon radial implant, both for replacement of the proximal end of the forearm’s radius bone; the uHead ulnar implant and Sigmoid Notch radial plate, both for replacement of the distal radioulnar joint; and the Radio-Capitellum to improve elbow function, Medscape reports. Continue reading

Posted in Defective Medical Devices | Tagged , , , , |

FDA Strengthens Heart Attack and Stoke Warnings for Nonsteroidal Anti-inflammatory Drugs

 FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs

FDA Strengthens Heart Attack & Stoke Warnings for NSAIDs


The Food and Drug Administration (FDA) has strengthened existing warnings on prescription and over-the-counter (OTC) nonsteroidal anti-inflammatory drugs (NSAIDs) Drug Facts labels to indicate that the drugs can increase the risk of a heart attack or stroke, which can lead to death.

These side effects can occur as early as the first weeks of using an NSAID, and the risk might rise the longer people take NSAIDs. (Aspirin is also an NSAID, but the revised warning does not apply to aspirin.) The OTC drugs covered by the revised warning in this group are used for the temporary relief of pain and fever and the prescription drugs are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple medicines with the same active ingredient. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , |

FDA Warns of Danger of Giving Codeine Cough-and-Cold Medicines to Children

FDA Warns of Giving Codeine Medicines to Children

FDA Warns of Giving Codeine Medicines to Children


The Food and Drug Administration (FDA) is investigating the potential risks of using medicines with codeine to treat coughs and colds in children and has issued a Drug Safety Communication about such medicines. There is a potential for serious side effects, including slowed or difficult breathing.

Codeine is a type of opioid used to treat mild to moderate pain and reduce coughing. It is usually combined with other medications in prescription and over-the-counter (OTC) cough-and-cold medicines, according to the FDA. In April, the European Medicines Agency (EMA) announced that codeine must not be used to treat coughs and colds in children younger than 12. The EMA also said codeine is not recommended for children and teens between 12 and 18 who have breathing problems, such as asthma. The FDA will continue to evaluate this safety issue and will consider the EMA recommendations. Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , , , |

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