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Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Smith & Nephew Recalls Metal-on-Metal Hip Implant Component

Medical device maker, Smith & Nephew, just issued a recall for a metal-on-metal hip implant component, a part of one of its all-metal hip replacement systems.

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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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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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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Zadroga Act Cancer Decision Expected This Week

Zadroga Act Cancer Decision Expected This Week

The federal official tasked with determining what ailments should be covered by the federal Zadroga Act is expected to decide by Saturday if certain cancers will be eligible for compensation. The decision is being eagerly awaited by thousands of first responders who believe they developed cancer due to exposure ...

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Metal-on-Metal Hip Replacement Concerns Grow in Canada

Metal-on-Metal Hip Replacement Concerns Grow in Canada

Canadian patients and doctors are voicing more concerns about metal-on-metal hip replacements, as health regulators around the world continue to investigate the safety of the devices. According to a report from the CBC, four companies have recently either recalled or suspended sales of metal-on-metal hip replacement devices, while a number ...

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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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Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.

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First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

First DePuy ASR Hip Implant Lawsuits Head to Trial in December, January

The first trials involving lawsuits filed against DePuy Orthopaedics by recipients of its recalled ASR Hip Implants will begin later this year, and early next year. The first is slated to start on December 3, 2012 in state court in Las Vegas, Nevada. A second DePuy ASR hip implant lawsuit ...

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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 |

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 |

Acetaminophen Not Effective at Treating Back Pain, Study Suggests

Acetaminophen Not Effective at Treating Back PainAcetaminophen is a common pain reliever and fever reducer commonly used to treat back pain, but a newly published study in The Lancet has found that it is no better than a placebo for this purpose. Acetaminophen is sold under brand names such as Tylenol, Anacin and Panadol.

The study involved 1,643 people who suffered from acute lower back pain. The researchers randomly assigned these participants into one of three groups who received two boxes; one box was labeled “regular” and the other “as-needed”. The first group received two boxes, with 500-milligram acetaminophen tablets in the “regular” box as well as acetaminophen in the second “as-needed” box. The second group received one regular box of acetaminophen and an as-needed box containing a placebo. The third group received two boxes of placebo. Continue reading

Posted in Legal News |