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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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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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Lawsuits over DePuy ASR Metal-on-Metal Hip Implants Continue to Mount

Lawsuits over DePuy ASR Metal-on-Metal Hip Implants Continue to Mount

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be hit with lawsuits over recalled metal-on-metal DePuy ASR hip implants. Just yesterday, the national law firm of Parker Waichman LLP announced it had filed yet another DePuy ASR hip implant lawsuit, this time on behalf of a Virginia resident ...

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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...

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

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

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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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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“National Whistleblower Appreciation Day” Founded by Senate

National-Whistleblower-Appreciation-DayThe United States Senate declared July 30, 2013 as “National Whistleblower Appreciation Day” in an effort to support and commend the actions of individuals refused to accept fraud, misconduct and other wrongdoing. According to National Whistleblowers Center, a non-profit organization, the decision to establish “National Whistleblower Appreciation Day” was a unanimous one made by the Senate on July 31, 2013. Continue reading

Posted in Legal News |

GM’s Best Selling Pickup Trucks Recalled Six Times this Year

GM-Best-Selling-Pickup-Trucks-RecalledGeneral Motors (GM) has recalled its 2014 Chevrolet Silverado and GMC Sierra six times this year so far, making them the most frequently recalled vehicles. And unfortunately for GM, that is not the end of the pickups’ recall history, they have been recalled a total of nine times since they were introduced one year ago, according to CNNMoney. Continue reading

Posted in Legal News |

FDA Rejects Public Citizen’s Call for Ban on Transvaginal Mesh Devices

Transvaginal-mesh-fdaThe Food and Drug Administration (FDA) has decided not to institute a total ban on transvaginal mesh devices, despite a call to do so from the consumer advocacy group Public Citizen.

In a 2011 petition, Public Citizen asked the FDA to halt the marketing of surgical mesh products for pelvic organ prolapse repair, to recall devices currently in distribution, and to reclassify the products as Class III devices, Med Device Online reports. Class III devices, the highest risk devices, are subject to the greatest regulatory control and  typically require approval they are marketed, according to the FDA. Continue reading

Posted in Defective Medical Devices, Transvaginal mesh |

Study Identifies Greater Cancer Risks for Surgical Device

Cancer-Risks-for-Surgical-DeviceA newly published study shows that the power morcellator, a surgical device commonly used in hysterectomies, has greater potential to spread cancers in a woman’s body than previously thought.

The power morcellator, used in hysterectomies and fibroid removal, slices uterine tissue into pieces that can be removed through small laparoscopic incisions, The Wall Street Journal reports. In April, the Food and Drug Administration (FDA) advised doctors to stop using morcellators because of the risk of spreading previously undetected cancerous tissue inside the body, significantly worsening the patient’s odds of survival. The new report in the Journal of the American Medical Association reinforces the risks pointed put by the FDA. Continue reading

Posted in Defective Medical Devices, Health Concerns |

Lawsuit Filed in Canada Over Delatestryl Testosterone Injection

Lawsuit-Filed-in-Canada-Over-Delatestryl-Testosterone-InjectionA testosterone lawsuit has been filed in Canada against the manufacturer of the testosterone injectable, Delatestryl (Testosterone Enanthate), over allegations that include that the consumers were not sufficiently advised of the risks associated with the so-called “Low T” medication. The lawsuit also alleges that use of Low T treatment is tied to the increased likelihood of cardiovascular reactions, such as heart attack, stroke, deep vein thrombosis (DVT), pulmonary embolism, and death.

The U.S. Food and Drug Administration (FDA) posted a notice on its website indicating that, on September 17, 2014, it would be convening a joint meeting with the Reproductive and Urologic Drugs Advisory and the Drug Safety and Risk Management Advisory committees. Recommendations regarding cardiac reactions tied to Low T drugs and what issues should be considered when prescribing low testosterone therapy are expected to be among the covered topics. Continue reading

Posted in Health Concerns, Pharmaceuticals |

Jury Issues $55 Million Verdict in Defective Seat Belt Lawsuit

55-Million-Verdict-in-Defective-Seat-Belt-LawsuitA Philadelphia jury has awarded $55.3 million to a man who sued Honda over an allegedly defective seat belt after a car crash left him paralyzed. The Plaintiff, 57-year old Carlos Martinez, was driving his Acura Integra to work in 2010. Martinez lost control of the car when one of the tires blew out. As the car rolled over, his head hit the roof and he suffered injuries that permanently left him in a wheelchair. Continue reading

Posted in Legal News |

New York City Settling Civil-Rights and Police-Brutality Cases More Quickly

Civil-Rights-and-Police-Brutality-CasesIn what appears to be a policy shift on fighting wrongful conviction and police-brutality cases, New York City is settling cases more quickly, without the protracted fighting seen during the Bloomberg administration.

The city’s Law Department recently announced a $41 million settlement in the Central Park Five case. The five men convicted in the 1989 rape and beating of a Central Park jogger had their convictions vacated but have fought for more than ten years for monetary damages, The New York Times reports.  Under Bloomberg, the city had vigorously fought the case, but now, six months into de Blasio’s term, the settlement was reached. Mayor de Blasio spoke of the city’s “moral obligation to respond to that injustice.” Continue reading

Posted in Legal News |

BMJ Highlights Flaws with Pradaxa’s Approval Route, Pushes Dose Monitoring

Pradaxas-Approval-Route-Pushes-Dose-MonitoringThe British Medical Journal has published three reports and one editorial criticizing the way Pradaxa (dabigatran) was approved, and is advising drug dosing in the interest of patient safety.

Boehringer Ingelheim’s Pradaxa is prescribed to patients who have nonvalvular atrial fibrillation (AF). The drug was the first new oral anticoagulant to hit the market in an effort to supersede warfarin, an older anticoagulant. One of Pradaxa’s main selling points was that, unlike warfarin, it does not require drug monitoring. The BMJ reports allege that the manufacturer hid information showing that monitoring would significantly benefit the safety profile of the drug in order to maintain this claim. Continue reading

Posted in Legal News |

Some Protein Powder Makers May be Spiking Products with Inferior Ingredients

Protein-Powder-Makers-May-be-Spiking-ProductsSome protein powder makers are reportedly adding less expensive ingredients to their products to can trick a protein-content test into registering a higher protein concentration that the product actually has.

The practice – called “nitrogen spiking” or “amino acid spiking” – yields misleading results on a test that determines the protein content of the product by measuring nitrogen released as ammonia. The American Herbal Products Association (AHPA) says U.S. Food and Drug Administration (FDA) regulations for supplements allow protein to be calculated as a factor of nitrogen content, but the sources of nitrogen do not have to be included. The AHPA feels the industry needs a “defined standard” of what substances should be included in measuring nitrogen content and therefore contribute to the powder’s supposed protein content.

Amino acid spiking increases a product’s nitrogen content and consumers do not receive the full complement of genuine, high-quality, natural protein they are paying for. While isolated amino acids are technically not “protein,” they contribute to the total protein amount.

Companies suspected of amino acid spiking include Body Fortress, ProSupps. MusclePharm Arnold Series, 4 Dimension Nutrition, Designer Whey, Mutant Nutrition, Top Secret Nutrition, Gaspari Nutrition, Giant Sports Nutrition, Infinite LabsL, and Beast Sports Nutrition. Arginine, creatine, glycine, and taurine are among the amino acids used in spiking. While amino acids do offer benefits in the products, they should not be counted in the protein content.

The FDA regulates ingredients in dietary supplements, though they fall under different regulations than conventional foods and drug products. The FDA takes action against adulterated or misbranded dietary supplement products after they reach the market but has no regulatory power before a product is marketed. The FDA has taken action against manufacturers whose supplements contain hidden drug ingredients or do not contain the listed type and amount of an ingredient. Adulterated or misbranded supplements can be dangerous to health, the FDA warns.

 

Posted in Defective Products, Health Concerns, Toxic Substances |

FDA: All Non-Expired Sterile Unique Pharmaceuticals’ Drugs Recalled

Sterile-Unique -Pharmaceutical-Drugs-RecalledThe U.S. Food and Drug Administration (FDA) advised that it is alerting health care professionals and consumers regarding a recall of all non-expired drug products meant for sterile use and sold and distributed by Unique Pharmaceuticals Ltd., located in Temple, Texas.

The recalled products include Lot Number 86513, N-Acetyl Cysteine 20 percent, and all other non-expired, purportedly sterile drug products.

Health care professionals are being advised to immediately check their medical supplies and to quarantine all sterile drug products from Unique Pharmaceuticals. These recalled drugs must not be administered patients as the products may be contaminated. What’s more, administration of a non-sterile drug product that is meant to be sterile may lead to serious and potentially life-threatening infections, and even death. Continue reading

Posted in Pharmaceuticals, Product Recalls, Recalled Drugs |