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EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

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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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Decision on Pradaxa Bleeding Lawsuit Multidistrict Litigation Expected Soon

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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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Issues Voluntary Recall for Rejuvenate Modular and ABG II Hip Implant Components

Stryker Orthopedics is recalling two metal-on-metal hip implant components, its Rejuvenate Modular and ABG II modular-neck hip stems. According to a notice posted on Stryker’s website, risks associated with the Rejuvenate Modular and ABG II modular-neck hip stems include the potential for fretting and/or corrosion at or about ...

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1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

1,000+ Australians Join DePuy ASR Hip Implant Class Action Lawsuit

A class action lawsuit filed in Australia over DePuy Orthopaedics’ recalled metal-on-metal ASR Hip Implants has signed up more than 1,000 plaintiffs. The attorneys representing the Australian ASR Hip Implant lawsuit plaintiffs recently told The Courier-Mail that damages in the lawsuit are expected to be worth more than $200 million. One ...

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

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

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

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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Purdue Pharma Faces Potentially Devastating OxyContin Lawsuit in Kentucky

Purdue Pharma, which makes the best-selling painkiller OxyContin, is accused, in a lawsuit brought by the state of Kentucky, of actions that help create widespread addiction.

The company has never gone to trial on a case of OxyContin abuse, Bloomberg News reports, and has won dismissals of numerous personal-injury lawsuits. Purdue has settled some product-liability cases under secret terms but has also succeeded in fending off more than10 class actions. Purdue has lost a number of procedural decisions in the Kentucky case, which appears to be headed for trial next year. Continue reading

Posted in Health Concerns, Legal News, Pharmaceuticals |

FDA Warns about Counterfeit Decorative Contact Lenses

With Halloween just around the corner, the U.S. Food and Drug Administration (FDA) is warning about the risks associated with counterfeit decorative contact lenses. In a collaborative effort with the U.S. Immigration and Customs Enforcement’s Homeland Security Investigations and U.S. Customs and Border Protection, the FDA’s Office of Criminal Investigations is increasing efforts to seize fake contact lenses. Illegally imported counterfeit contact lenses are not FDA-approved, and can lead to serious injuries and blindness in users.

The ICE-led National Intellectual Property Rights Coordination Center in Washington is coordinating these efforts, which is called “Operation Double Vision.” There have been 74 seizures including a total of over 20,000 pairs of counterfeit and decorative contact lenses this year alone thanks to Operation Double Vision. Continue reading

Posted in Legal News |

Jury Finds Guardrail Maker Cheated Government

This week a Texas jury found that Trinity Industries defrauded the government by deliberately withholding information about changes to its ET-Plus highway guardrail system that potentially made it more dangerous. The company faces a potential liability of $1 billion.

The jury found the guardrail maker cheated the government of $175 million by passing off the product as eligible for federal funding, Insurance Journal reports. The damages awarded will be tripled and a penalty determined by the judge will be added – with total liability possibly reaching $1 billion, according to company attorneys. Continue reading

Posted in Accident, Defective Products |

Takata Air Bag Recall Affects 7.8 Million Vehicles

The owners of 7.8 million Toyota, Honda, Mazda, BMW, Nissan, Mitsubishi, Subaru, Chrysler, Ford and General Motors vehicles have been told to “act immediately” on recall notices to replace faulty air bags supplied by Takata. The parts should be replaced because they can explode, the National Highway Traffic Safety Administration (NHTSA) warned. According to TIME magazine, the faulty air bags have been linked to at least three deaths and over 100 injuries.
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Posted in Legal News |

Motion to Consolidate Xarelto Bleeding Side Effects Cases in Multidistrict Litigation

Xarelto-Bleeding-Side-EffectsPlaintiffs who allege they were injured by the blood thinner Xarelto have filed a motion to have their cases consolidated as part of a multidistrict litigation (MDL).

At least 21 actions pending in 10 judicial districts make similar allegations against the manufacturers of Xarelto (rivaroxaban), a medicine prescribed to prevent or treat blood clots and reduce the risk of stroke. An MDL coordinates proceedings in complex litigation where a large number of lawsuits allege similar injuries associated with a medication or product. The motion requests the U.S. Joint Panel of Multidistrict Litigation (JPML) to assign the MDL to the Southern Illinois District, which handled the recent MDL involving another new anticoagulant, Pradaxa. Continue reading

Posted in Defective Products, Pharmaceuticals, Pradaxa |

Motion Filed to Consolidate Xarelto Lawsuits into MDL

Xarelto_LawsuitsThe anticoagulant Xarelto has raised a number of safety concerns in the short time it has been on the market. A number of lawsuits have been filed alleging that Bayer hid the risks of the drug, including an increased risk of bleeding. Now, a motion has been filed to consolidate the lawsuits into a multidistrict litigation (MDL).

The U.S. Joint Panel of Multidistrict Litigation (JPML) should centralize cases in the Southern District Illinois court, the motion stated. Plaintiffs said that the court is an ideal venue because it has has experience with the recent MDL over Pradaxa, another new bloodthinner. In a hearing that will take place either late this year or early next year, the JPML will hear arguments on the motion. Continue reading

Posted in Legal News |

Toyota Recalls 1.67 Million Vehicles Worldwide

Toyota_Recalls_1.67_Million_VehiclesToyota 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

Medication-Errors-Occur-in-Young-ChildrenAccording 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

Facebook_Ethics_CaseA 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

Medication_Dosage_for_KidsWhen 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 |

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