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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

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Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions

Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...

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

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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Actos, Avandia May Up Risk for Diabetic Macular Edema

Actos, Avandia May Up Risk for Diabetic Macular Edema

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

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

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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National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

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Canadian Study Confirms Actos Bladder Cancer Risk

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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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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Toyota Recalls 1.67 Million Vehicles Worldwide

Toyota Motor Corp. has announced the recall of 1.67 million vehicles worldwide over safety defects, including faulty brakes and fuel components.

A Toyota representative said the company is not aware of any accidents or injuries related to the defects. The recall involves 1 million vehicles in Japan and 615,000 in other countries, Law360 reports. Fuel delivery pipe problems affect 759,000 vehicles and 802,000 others have brake issues. In addition, 190,000 Corolla Rumion and Auris models in Japan will be recalled because of faulty emission control components. All of the recalled vehicles in the United States are Lexus sedans with potentially leaky fuel pipes, which could cause the cars to catch fire, the Toyota representative said. Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles, Toyota Recall |

Study: Significant Number of Medication Errors Occur in Young Children

According to a study published in the journal Pediatrics, medication mistakes among young children occur more frequently than some would imagine. The study, which was based on calls to poison control hotlines, found that a medication mistake occurred in a child roughly every eight minutes from 2002 through 2012. The authors state that medication mistakes can lead to injury and sometimes death, in addition to increasing healthcare spending.

Researchers saw an increase in the rate of reported medication errors during the 11-year time frame of the study. The exception to this was cough and cold medicines. Henry Spiller, an author of the study and director of the Central Ohio Poison Center at Nationwide Children’s Hospital in Columbus, told Reuters Health that this decrease was preceded by a multipronged campaign to reduce the use of these products in children. The findings suggest that education has been successful in this effort. “We think that multipronged effort had an effect,” said Spiller to Reuters Health. “We can see a drop associated with these efforts.” Continue reading

Posted in Legal News |

New Jersey Appeals Court Considering Facebook Ethics Case

A New Jersey appeals court is considering whether the Office of Attorney Ethics has the power to file ethics grievances against lawyers after district ethics committees have declined to do so, and whether the judges themselves even have the authority to get involved in the dispute.

If the panel decides that the Superior Courts can exercise jurisdiction over ethics matters, it will then have to decide whether OAE Director Charles Centinaro violated the rules governing the disciplinary process when he filed a complaint against two lawyers in Hackensack, after District II-B Ethics Committee secretary Doris Newman concluded their actions did not constitute unethical conduct, New Jersey Law Journal reports. Continue reading

Posted in Legal News |

Limited Data Available on Medication Dosage for Kids

When it comes to prescribing medication for children, there is often little data to support information about dosage, safety or efficiency. According to Scientific American, most clinical trials do not include children so the burden of deciding what treatments to use and how falls on physicians.

Scientific American reports that only 46 percent of drugs used in kids have been approved by the U.S. Food and Drug Administration (FDA) for pediatric use. In the past, that statistic was far worse. Continue reading

Posted in Legal News |

Trinity Industries Accused of Hiding Failed Crash Tests in Whistleblower Trial over Guardrails

In a trial over its guardrails, Trinity Industries was questioned about why they did not tell authorities about five failed crash tests. The New York Times reports that the case was filed under the False Claims Act by a competitor who alleged that the company violated federal rules when it failed to notify the Federal Highway Administration that it modified the design of its ET-Plus rail head in 2005.

These guardrails are the subject of the safety concerns outside of this federal lawsuits, according to The New York Times. Last month, the states of Missouri and Massachusetts banned the design and began their own investigations. Virginia also took issued with Trinity, and said in a letter that it believes the company failed to adequately test the ET-Plus. The state wants further testing. Continue reading

Posted in Legal News |

Jury Problems Not Enough to Reverse No-Cause Verdict

Despite indications that a jury might have misunderstood what evidence it was allowed to consider and that one juror called the plaintiff a liar in a discussion outside the jury room, an appeals court found there were not sufficient grounds to reverse the no-cause verdict.

The appeals court upheld the verdict and the trial judge’s denial of a request for either post-verdict questioning of the jurors or a new trial. The plaintiff had sued over whiplash injuries to her neck allegedly from a 2010 automobile accident, where her car was rear ended and her head slammed into the back of her seat, the New Jersey Law Journal reports. Continue reading

Posted in Accident, Legal News |

Class Action Lawsuit over Infuse Could Complicate Medtronic Acquisition of Covidien

A class action lawsuit over Medtronic’s bone growth product Infuse could complicate the company’s planned acquisition of Dublin-based device maker Covidien.

U.S. District Judge John Tunheim will allow lawyers for Medtronic investors to explore an alleged coverup of Infuse’s side effects by Medtronic officials, the Minneapolis Star Tribune reports. Off-label use of Infuse has allegedly injured thousands of patients. Tunheim said the plaintiffs could pursue their claim that former Medtronic CEO William Hawkins purposely made misstatements to stock analysts to hide the fact that the Food and Drug Administration (FDA) had refused to approve Amplify, the next iteration of Infuse. Continue reading

Posted in Class Action Lawsuits, Defective Medical Devices, Legal News, Medtronic Infuse |

Sugary Sodas may be Linked to Higher Risk of Rheumatoid Arthritis

According to a study recently published in The American Journal of Clinical Nutrition, women are more likely to develop rheumatoid arthritis (RA) if they drink one or more sugar-sweetened sodas a day compared those who drink less than one soda per month or less.

According to the Arthritis Today, RA leads to inflammation and subsequent joint pain and damage, fatigue and other consequences. It is a systemic, autoimmune disease believed to be caused by a combination of genetic and environmental factors. Continue reading

Posted in Legal News |

European Scientific Committee Urges Caution on Metal-on-Metal Hips

SCENHIR, the European Union’s Scientific Committee on Emerging and Newly Identified Health Risks, has issued an opinion on the safety of metal-on-metal (MoM) joint replacement devices, with “particular focus” on hip implants.

The committee examined concerns over possible exposure to cobalt and/or chromium after MoM-hip resurfacing or replacement that can lead to organ toxicity, carcinogenicity and teratogenicity (malformation of the fetus). Continue reading

Posted in Defective Medical Devices, Depuy, Health Concerns, Metal Hip Implants |

Safety Alert Issued for Covidien Defibrillator Electrodes

A Field Safety Alert was issued for some of Covidien’s defibrillator electrodes. According to the alert, certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes will not connect with Philips FR3 and FRx Defibrillators. There are at least two reported incidents “where customers attempted to use a Covidien electrode with a Philips FR3 AED unit. The mismatch of these devices contributed to a delay in resuscitation and may have contributed to the subsequent death of one patient.”

An automated external defibrillator (AED) is a portable device that attempts to correct a life-threatening heart rhythm using electrical shocks. The alert states that the Philips FR3 and FRx AED units are not compatible with certain Medi-Trace Cadence and Kendall Multi-function Defibrillation Electrodes; trying to pair these AEDs with the electrodes will delay therapy that can save a patient’s life. The FRx AED requires the pads to be connected before use, so a continuous chirp alarm will notify the user that the appropriate pads are not connected before the device is used. The FR3, on the other hand, does not require the pads to be connected beforehand; therefore, the users will not realize that the electrodes are incompatible until the unit needs to be used, causing a delay in therapy. Continue reading

Posted in Legal News |

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