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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

FDA Gives 7 Companies Go Ahead To Market Generic Plavix

The U.S. Food & Drug Administration (FDA) just gave seven companies the go-ahead to market generic Plavix. Plavix is a blood thinner prescribed for the prevention of blood clots, heart attacks, and which has been linked to serious side effects such as the heart attacks and strokes it is supposed to ...

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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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Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Western Pennsylvania Familes File Suit Over Alleged Fracking Pollution

Three families in western Pennsylvania believe a leading hydraulic fracturing (fracking) company and two water testing labs are conspiring to produce false results that show natural gas drilling is not contaminating their private water wells.

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Actos Whistleblower Lawsuit Questions Avandia Researcher’s Financial Ties to Takeda

Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda

A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...

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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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Smokers More Vulnerable to Joint Replacement Failures

Smokers More Vulnerable to Joint Replacement Failures

People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.

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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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Transvaginal Mesh a Nightmare for Thousands of Women

Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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

General 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

The 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 tissue uterine 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 |

Unfavorable Study Result Tied to Intuitive Surgical’s da Vinci Robot System

Unfavorable-Study-Surgicals-da-Vinci-Robot-SystemA new study has revealed that, based on insurance claim information, bladder cancer patients may not benefit from robotic surgery for their bladder removal procedures.

In fact, according to Fierce Medical Device, patients experienced similar complication rates and hospital stay lengths regardless of if their bladders were removed by robot or the more traditional open procedure. The study involved 118 patients from Memorial Sloan Kettering Cancer Center from 2010 and 2013 and the participants were randomly chosen for open or robotic surgery. The Sloan Kettering researchers’ data was peer-reviewed, a New England Journal of Medicine (NEJM) spokeswoman wrote in an email, according to The Wall Street Journal. Continue reading

Posted in da Vinci Surgical Robot, Defective Medical Devices |