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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Division to End Sales of Gynecare Prolift, Three Other Transvaginal Mesh Devices

Johnson & Johnson’s Ethicon Inc. division revealed yesterday that it will end sales of its Gynecare Prolift device and three other transvaginal mesh products. The plan to stop selling the four products was set forth in a letter filed by the company in the Ethicon transvaginal mesh multidistrict litigation ...

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New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions

Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...

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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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Fracking Boom Changing Way of Life in Pennsylvania’s Northern Tier

Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier

In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...

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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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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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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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Study Identifies Greater Cancer Risks for Surgical Device

A 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 |

Deadline Approaches for World Trade Center Cancer Compensation Claims

Zadroga-Deadlines-Approaching-QuicklyFor police officers and others who took part in World Trade Center rescue and recovery efforts and now suffer cancer caused by toxic exposure, a deadline to register for compensation through the James Zadroga September 11th Victim Compensation Fund (VCF) is less than three months away.

The New York City Patrolmen’s Benevolent Association has alerted its members that those who were diagnosed on or before October 12, 2012 with one of the cancers first recognized by the VCF on that date must register by October 12, 2014, according to The PBA Beat. The newsletter says that members diagnosed on or before October 21, 2013 with prostate cancer must register by October 21, 2015. Members who were diagnosed on or before February 18, 2014 with a “rare cancer” as defined by the WTC Health Program must register by February 18, 2016, and members diagnosed with any of the recognized cancers after the relevant cut-off date above may register up to two years after the date they became ill, but no later than October 3, 2016. Continue reading

Posted in Health Concerns, Legal News, Toxic Substances, Zadroga Act Claims |