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New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability

A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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Louisiana Whistleblower Lawsuit Revived

Louisiana Whistleblower Lawsuit Revived

A state appeals court in Louisiana has ruled that a former employee of Rapides Parish Coliseum can proceed with a whistleblower lawsuit against the Coliseum Authority.

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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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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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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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Research Suggest Fracking Chemicals Can Pollute Aquifers

A new study suggests fluids used during the hydraulic fracturing (fracking) process could migrate through underground fractures and contaminate water aquifers.

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Exposure to Common Pesticide May Increase ADHD Risk

Exposure to Common Pesticide May Increase ADHD Risk

A new study has found that exposure to a common household pesticide may increase the risk of attention deficit hyperactivity disorder (ADHD) in children.

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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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Cough-and-Cold Medicine Containing Codeine May Lead to Breathing Problems in Kids

Cough and cold medicines that contain codeine are being investigated by the U.S. Food and Drug Administration (FDA) for serious side effects in children, including breathing troubles. The agency stated in a safety alert that it was investigating the opioid because it may be released to slowed or difficult breathing in children under the age of 18. Children may be more at risk for these side effects, especially if they are already predisposed to breathing problems.

Codeine is an opioid that is often found in combination with other drugs in over-the-counter (OTC) cough-and-cold medicines. It is used to reduce coughing and mild to moderate pain. The FDA said it “will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.” according to the July 1st safety alert. Continue reading

Posted in Legal News |

Open Payments Database Details Payments made between Industry and Doctors for 2014

On Tuesday, the federal Center for Medicare and Medicaid Services published the federal Open Payments database for 2014 detailing payments between medical device companies and doctors and hospitals. According to Star Tribune, this is the second year that such data has been published. The data was released under the Open Payments program, which was created by the Sunshine Act provisions of the Affordable Care Act in an effort to create transparency and prevent large companies like Medtronic from using financial incentive to influence medicine.

According to Star Tribune, data looking at payments $1 million or greater showed that Medtronic PLC and St. Jude Medical paid a combined $81 million to eight doctors across the country. The database indicates that Minnesota device makers paid over $211 million to doctors and hospitals for reasons not related to research. For the first time, data revealed 99 percent of submitted payment information. Last year’s data redacted more than a third of the information. Continue reading

Posted in Legal News |

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

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 , , , , |

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