Featured Stories

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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Pennsylvania Health System Proposes Comprehensive Fracking Study

A proposed study would examine the health effects of hydraulic fracturing (fracking) drilling on the people living closest to active natural gas wells.

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Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today

The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.

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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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Bronx Teenager Killed in Hit-and-Run, Second Teen Injured

A Port Jefferson Station man was killed on Wednesday in a single-vehicle crash on the Northern State Pkwy in Dix Hills west of Exit 42. He was driving a Nissan Altima.

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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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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

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FDA Warning for Bone Graft Products in Patients Under 18

FDA Safety Warning for Bone Graft Products in Patients Under 18

FDA issued safety alerts to patients, parents & guardians, bone graft devices w/recombinant proteins or synthetic peptides not to be the first treatment for 18 & under.

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Advocacy Groups Sue for Release of Clinical Trial Data for Hepatitis C Drugs

Two public health advocacy organizations have filed a lawsuit against the Food and Drug Administration (FDA) for release of clinical trial data for Gilead Sciences hepatitis C treatments.

Researchers and patient advocates have long fought with drug makers and regulators over access to such information, the Wall Street Journal reports. Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals |

Study Shows Energy Drinks Can Lead to Caffeine Intoxication

Energy Drinks Can Lead to Caffeine Intoxication

Energy Drinks Can Lead to Caffeine Intoxication


The fact that energy drinks contain excessive amounts of caffeine comes as no surprise. But what are the chances that these popular beverages present real health risks? A study published in the journal Drug and Alcohol Dependence investigated this; the authors found that energy drinks may lead to caffeine intoxication, a clinical condition that could lead to death in rare instances. Signs of caffeine intoxication include nervousness, anxiety, insomnia restlessness, tremor, rapid heartbeat, pacing and gastrointestinal distress.

Caffeine is regulated by the U.S. Food and Drug Administration (FDA), but only for food products. A regular 12-ounce soda is allowed to contain a maximum of 71 milligrams of caffeine, but only has about 35 milligrams. Energy drinks manage to circumvent rules because they are considered dietary supplements, which fall outside of the agency’s jurisdiction. Furthermore, these beverages do not have to have warning labels as required of over-the-counter products. Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , , |

ADHD Treatment May Cause Permanent Skin Discoloration, FDA Warns

ADHD Treatment May Cause Permanent Skin Discoloration

ADHD Treatment May Cause Permanent Skin Discoloration


The Daytrana patch, a daily treatment for attention deficit hyperactivity disorder (ADHD), may cause permanent skin color changes, the Food and Drug Administration (FDA) warns.

The FDA added a new warning to the drug label to describe this skin condition, known as chemical leukoderma. The agency says patients and caregivers should watch for areas of lighter skin, especially under the drug patch, and immediately report changes to a health care professional. Patients should not stop using the Daytrana patch without first talking to a doctor. Continue reading

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

UK Regulators Issue Updated Guidance for Smith & Nephew Metal-on-Metal Hip Implants

UK Regulators Issue Updated for Smith & Nephew Hip Implants

UK Regulators Issue Updated for Smith & Nephew Hip Implants


The United Kingdom’s Medicines and Healthcare Products Regulatory Agency has issued updated guidance for Smith & Nephew Orthopaedics Birmingham Hip Resurfacing (BHR) system due to a higher than expected failure rate. According to a medical device alert posted on the regulators’ website on June 25th, the device should not be implanted in women or patients who need a femoral head sized 46 mm or less. The notification also states to “Only use 48mm BHR heads in the specific circumstance of intra-operative downsizing from a pre-operatively templated 50mm to a measured 48mm at the time of surgery”.

The notification instructs customers to return all devices that have femoral head sizes 46 mm and smaller. The respective acetabular and dysplasia cups should also be returned. The alert affects patients who are symptomatic, female, or patients with head sizes 46 mm or smaller. Smith & Nephew used recent data from the National Joint Registry (NJR) for England, Wales and Northern Ireland to identify these groups of high-risk patients. The device alert also gave recommendations for affected patients, including the need for blood metal ion testing. Continue reading

Posted in Defective Medical Devices, Legal News, Product Recalls | Tagged , , , |

Thousands of Complaints Prompt FDA Panel Meeting about Essure Birth Control

Complaints Prompt FDA Panel Meeting about Essure

Complaints Prompt FDA Panel Meeting about Essure


In response to more than 5,000 reports of adverse events and side effects of the Essure birth control implant, the Food and Drug Administration (FDA) has scheduled a hearing for September 24 to evaluate the safety and effectiveness device.

The FDA said it has received 5,093 reports of adverse events—including deaths—among women who received the Essure permanent birth control implant. In the twelve years since Essure’s approval, the agency has received reports of four deaths of women who used the device, as well as five reports of deaths of fetuses in women who became pregnant despite the implant, the Wall Street Journal reports. The device has been on the market since 2002. Continue reading

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

FDA Says Partially Hydrogenated Oils, Source of Trans Fat, Must be Removed from Food

FDA Says Hydrogenated Oils Must be Removed

FDA Says Hydrogenated Oils Must be Removed


In a press release issued last Tuesday, the U.S. Food and Drug Administration (FDA) announced that partially hydrogenated oils (PHO), the main source of trans fat in processed foods, must be removed from food products over the next three years. PHOs will no longer be “generally recognized as safe” or GRAS in human food, the agency said. The FDA first made about PHOs not being GRAS in 2013; the agency has just now finalized it.

Trans fat is created when hydrogen is added to vegetable oil, changing the shape of the fat so that it becomes solid at room temperature. The food industry also uses partially hydrogenated oil because it extends the shelf life of a product. However, trans fats are shown to have a detrimental affect on health; these types of fats increases your LDL (bad cholesterol) and lower your LDL (good cholesterol). “This action is expected to reduce coronary heart disease and prevent thousands of fatal heart attacks every year.” said FDA’s Acting Commissioner Stephen Ostroff, M.D. Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , |

Medtronic Recalls Tracheostomy Tubes Because of Injury Reports

Medtronic Recalls Tracheostomy Tubes Because of Reports

Medtronic Recalls Tracheostomy Tubes Because of Reports


Medtronic PLC has announced the voluntary recall of 70,000 tracheostomy tubes for children and babies following reports that some patients have had difficulty breathing while using them.

Hundreds of adverse events involving the Covidien Shiley tube have been reported to regulators since 2012, when the device was altered to give it a wider angle, the Minneapolis StarTribune reports. Continue reading

Posted in Defective Medical Devices, Health Concerns, Product Recalls | Tagged , , , , |

Covidien Agrees to Settlement in 11,000 Transvaginal Mesh Cases

Covidien to Settlement in 11,000 Transvaginal Mesh Cases

Covidien to Settlement in 11,000 Transvaginal Mesh Cases


Device maker Covidien has agreed to a settlement of more than 11,000 claims involving its transvaginal mesh devices, alleged to have caused severe and painful side effects.

A court filing on Tuesday in West Virginia federal court did not disclose the settlement amount or exactly how many cases would be resolved under the confidential agreement, but as of June 1, Covidien mesh products were involved in about 11,300 filed and unfiled claims, Reuters reports. Continue reading

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

Research Indicates Viagra Use Could Increase Melanoma Risk by 20 Percent

Viagra Use Could Increase Melanoma Risk by 20 Percent


Viagra Use Could Increase Melanoma Risk by 20 Percent

A new research study shows that men who use Viagra and similar drugs to treat erectile dysfunction could be at greater risk of developing skin cancer.

The study, published this week in the Journal of the American Medical Association, looked at more than 4,000 men in Sweden and found that those who were prescribed a single course of an erectile dysfunction drug were one third more likely to develop a malignant melanoma. For men who had multiple prescriptions, the risk was raised by 20 percent, the (U.K.) Telegraph reports. Continue reading

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

Study Indicates Popular Sleep Medications Increase Risk of Respiratory Cancers

Sleep Medications Increase Risk of Respiratory Cancers

Sleep Medications Increase Risk of Respiratory Cancers

A new research study reveals that some of the most widely used sleep medications could triple the user’s risk of lung cancer.

The widely used medications—benzodiazepines and “Z-hypnotic” drugs—are carcinogenic, the (U.K.) Daily Mail reports. Taking these drugs on a regular basis is linked to a higher rate of lung cancer and to a greater risk of cancerous growths in the nose, mouth, and windpipe. Continue reading

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

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