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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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Whistleblower Wins Retaliation - Canaveral National Seashore

Whistleblower Wins Retaliation Lawsuit

A whistleblower who reported misconduct at Canaveral National Seashore has won a retaliation ruling against the U.S. Department of Interior, Florida Today reports.

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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

Victims of alleged Pradaxa injuries are awaiting word on whether their lawsuits will be consolidated in a multidistrict litigation. According to a report from The Madison Record, so far just over two dozen Pradaxa bleeding lawsuits have been filed in federal courts throughout the U.S.

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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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64 More Plavix Patients File Suit Over Bleeding Side Effects

Another Plavix lawsuit has been filed on behalf of 64 Plavix patients who allege bleeding side effects. Plavix (clopidogrel) is a blood thinner prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, such as the heart attacks and strokes it is ...

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Study Links Liquid in E-Cigarette to Viral Infections

Study Links Liquid in Electronic Cigarette to Increased Risk of Viral Infections

The National Jewish Health study, links the liquid used in e-cigarettes to a higher risk of respiratory viral infections, whether the liquid contains nicotine or not.

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Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

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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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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Doctor Urges FDA not to Loosen Restrictions on Drug Company Marketing

Doctor Urges FDA not to Loosen Restrictions on Marketing

Doctor Urges FDA not to Loosen Restrictions on Marketing


A Harvard medical professor has urged the Food and Drug Administration (FDA) against easing the restrictions on drug companies marketing their drugs for uses for which they have not been approved—so-called off-label use.

During the summer of 2015 the FDA will hold a public meeting to discuss whether restrictions on what claims drug manufacturers can make about their products improperly infringes the liberty of those companies, HealthNewsReview reports. Dr. Jerry Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Boston’s Brigham and Women’s Hospital, writing in the Annals of Internal Medicine, argues that patients and doctors need the “sovereign” power of the FDA to regulate what claims drug makers can make. Continue reading

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

After Analyzing Data on Liquid Nicotine Poisoning, FDA Proposes Warnings and Child-Proof Packaging

FDA Proposes Child-Proof Packaging on Liquid Nicotine

FDA Proposes Child-Proof Packaging on Liquid Nicotine


The U.S. Food and Drug Administration (FDA) is looking to take regulatory action over liquid nicotine, which is used in electronic cigarettes. On Tuesday, the agency “issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.”

The proposal is open to public commentary for 60 days. The FDA has evaluated data on liquid nicotine and its risks, particularly for accidental exposure among infants and children. The agency notes that as e-cigarettes have become more popular, the number of calls to poison control centers and emergency room visits related to liquid nicotine have increased. Based on this data, the FDA wants more input as to whether it should place warnings about nicotine exposure or require some tobacco products to be sold in child-resistant packaging. Continue reading

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

Class I Recall Issued for Zimmer Hip Replacement Parts

Recall Issued for Zimmer Hip Replacement Parts

Recall Issued for Zimmer Hip Replacement Parts


A Class I recall has been issued for certain Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks, the U.S. Food and Drug Administration (FDA) announced recently. The agency said the recall was issued because the parts may have “unexpected amounts of manufacturing residues”. The Class I designation is reserved for recalled devices that present a reasonable risk of serious injury or death.

According to the FDA notification, the recalled devices contain higher than expected amounts of residue due to a a process monitoring failure. “These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.” Continue reading

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

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

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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 , , , , , |

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