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Canadian Study Confirms Actos Bladder Cancer Risk

A new study conducted by Canadian researchers has found that users of the type 2 diabetes drug, Actos (pioglitazone), may face a higher risk of developing bladder cancer than first thought. The study, published in the British Medical Journal, found that taking Actos for two years doubles the likelihood ...

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Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

A West Virginia man fitted with a metal-on-metal version of DePuy Orthopaedics’ Pinnacle Hip Implant System has filed suit against the company and its parent, Johnson & Johnson, alleging the device caused him to suffer pain and elevated cobalt levels. The Plaintiff is being represented by the national law ...

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Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer

National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...

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Geodon the antipsychotic drug can Cause Deadly Skin Reaction

Geodon can Cause Deadly Skin Reaction, FDA Warns

The FDA has required a new warning label for the antipsychotic drug Geodon (ziprasidone) to include the risk of a potentially fatal skin reaction.

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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...

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Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits

A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...

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OtisMed CEO Receives Prison Sentence in Distribution of Defective Knee Devices Scheme

OtisMed CEO Receives Prison Sentence

OtisMed CEO Receives Prison Sentence


The U.S. District Court of the District of New Jersey sentenced former OtisMed Corporation chief executive officer, Charlie Chi, to 24 months in prison for his involvement in the distribution of “adulterated” medical devices.

In December 2014, OtisMed agreed to pay more than $80 million to resolve criminal and civil liability related to distributing adulterated medical devices with intent to defraud and mislead. At that time, Chi pleaded guilty to introducing adulterated medical devices into interstate commerce. Chi will also serve one year of supervised release and pay a $75,000 fine, the Imperial Valley News reports. Continue reading

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

Fireworks Safety Tips and Spray Sunscreen Warning Offered for 4th of July

Fireworks Safety Tips & Spray Sunscreen Warning

Fireworks Safety Tips & Spray Sunscreen Warning


As families prepare to enjoy 4th of July festivities, federal agencies have issued safety alerts about spray-on sunscreens and fireworks.

The Consumer Product Safety Commission (CPSC) issued its annual list of tips for safe use of fireworks and the Food and Drug Administration (FDA) was warned about spray-on sunscreens. Continue reading

Posted in Accident, Health Concerns | Tagged , , , , |

Drug Dispenser have 4 More Months to Comply with DSCSA Regulations

Drug Dispenser have 4 Months to Comply with DSCSA

Drug Dispenser have 4 Months to Comply with DSCSA


Pharmacies have an additional four months to meet track and trace requirements under the Drug Supply Chain Security Act (DSCSA), Regulatory Affairs Professionals Society (RAPS) reports. The DSCSA is under the Drug Quality and Security Act (DQSA) signed into law in 2013 and seeks to keep track of drug products in the supply chain nationwide. The U.S. Food and Drug Administration (FDA) has extended the deadline from July 2, 2015 to November 1, 2015 in response drug dispensers’ requests. The agency said it would use its “enforcement discretion” to allow more time even though the statutory date of compliance remains the same.

The DSCA requires drug packages to carry a unique serial number so that they can easily be tracked by federal regulators. This allows the FDA to more easily pinpoint the source of a problem and reduce the risk of counterfeit products. Every entity in the supply chain must keep track of the packages through this system. Continue reading

Posted in Legal News | Tagged , , , |

In DaVita Whistleblower Case, Doctor and Nurse May Receive Over $110 Million

DaVita Whistleblower Doctor & Nurse to Receive Over $110M

DaVita Whistleblower Doctor & Nurse to Receive Over $110M


Two whistleblowers, a doctor and nurse in Atlanta, could receive more than $110 million for exposing alleged fraud by DaVita Healthcare Partners, the largest dialysis provider in the country. According to their lawsuit, the company intentionally wasted drugs in order to receive reimbursements from the federal government. Before 2011, the Centers for Medicare and Medicaid Services reimbursed dialysis providers for drug wastage from single-use vials. The whistleblowers alleged that DaVita instructed staff to use unnecessarily large vials of the vitamin D supplement Zemplar and the iron drug Vanofer. The scheme allegedly cost taxpayers hundreds of millions.

According to a Department of Justice (DOJ) press release dated June 24th, DaVita paid $450 million to resolve the allegations. The release noted that DaVita reduced its wastage substantially after the Centers for Medicare and Medicaid Services changed its reimbursement policy in 2011 and “wastage derived from single-use vials was no longer profitable “ Continue reading

Posted in Legal News | Tagged , , , |

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

Advocacy Groups Sue for Release of Clinical Trial Data

Advocacy Groups Sue for Release of Clinical Trial Data


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 | Tagged , , , , |

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 , , , |

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