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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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Tentative Ohio Fracking Regulations Criticized as too Lax

Tentative Ohio Fracking Regulations Criticized as too Lax

Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.

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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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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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New York Property Owners Challenge Binghamton Fracking Ban

New York Property Owners Challenge Binghamton Fracking Ban

According to a Reuters report, the landowners believe the Binghamton, N.Y., city council and Mayor acted against proper protocol when voting to ban fracking drilling the the city. Instead, they feel the city should have consulted with the Broome County Planning Commission before approving the ban.

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Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Infuse Studies Faulted for Downplaying Side Effects

Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...

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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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Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System

Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...

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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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Higher Risk of Gynecomastia in Risperdal Users, New Research Suggests

New research presented at the American Association for Geriatric Psychiatry 2014 Annual Meeting suggests that there is a higher risk of gynecomastia with Risperdal (risperidone) users than non-users. Researchers found that older men taking the antipsychotic drug were 69 percent more likely to have breast enlargement compared to those who did not. The researchers also found evidence that there is a higher risk of gynecomastia with Risperdal compared to other antipsychotics.

“This is the first and largest epidemiologic study on this question using data from 1 million men in the United States,” said lead author Mahyar Etminan, PharmD. Dr. Etminan is a drug safety researcher in the Therapeutic Evaluation Unit at Provincial Health Services Authority of British Columbia and an assistant professor at the University of British Columbia, Vancouver.

The researchers looked at data from the IMS LifeLink Health Plan claims database. Among 1 million men in the United States between the ages of 45 and 80 who made the claims between 2001 and 2011, 8,285 were identified as having gynecomastia. Ten men who did not have the condition were matched to each man who did as a control group. The mean age of both groups was 65.5 years.

“There has been a lot of interest on the risk of gynecosmastia with Risperdal, mainly in adolescent boys but also in older men. There have been reports to the FDA [US Food and Drug Administration] and case reports from academics,”  Dr. Etminan said.  “So we wanted to see if there was actually a risk with Risperdal that is over and beyond the other antipsychotics. We do know that these drugs in general can cause gynecomastia because of the way they change the hormones in the body. But we weren’t really sure whether Risperdal does it more than the others.”

There was a trend in the data suggests that Risperdal increased the risk of gynecomastia compared with paliperidone or quetiapine. Etminan noted that “Statistically, this wasn’t significant, which means we didn’t have enough power or enough people in this study. But the trend was definitely there,”

Although the study was only done on older men, Dr. Etminan emphasized that the condition can occur in younger boys. This factor may be especially important if the drugs are equal in efficacy, he says, because the psychological effects may be more problematic in younger men, say VendorsBay.

There are hundreds of lawsuits alleging that Risperdal caused gynecomastia. In 2012, Johnson & Johnson reached the first settlement; the lawsuit was filed on behalf of a 21-year old man alleging that the drug led to breast enlargement and subsequent surgical removal. Shortly afterwards, five more lawsuits were settled.

Posted in Legal News |

Surgeon General Issues Warnings About Skin Cancer, Tanning Beds

Experts agree that tanning—whether from natural sunlight or from tanning salons—is creating a major health issue in the United States and is increasing risks for certain cancers, some deadly.

The U.S. Surgeon General, Borish Lushniak, just warned that, when outside, people should remain in the shade and should wear sunscreen. Tanning booths, said Lushniak, should be avoided, wrote News Ledge.

The Surgeon General told The Washington Post that, “Right now we’re seeing kind of a bad trend developing when it comes to skin cancers. Skin cancers—melanoma and non-melanoma skin cancer—are increasing. It got to the point for us, right now, to be able to say, ‘We need to have this call to action.’” Continue reading

Posted in Consumer Fraud |

Safety Concerns Prompt FDA to Evaluate OTC Antiseptics

Just months after raising concerns to manufacturers, the U.S. Food and Drug Administration (FDA) will be holding a meeting to discuss whether or not non-prescription antiseptic products are safe and effective, RAPS reports.

Over-the-counter antiseptics are used to reduce the risk of infection during an injection. They are distributed in both single-use form and multiple-use packages; with the latter, the product is available in a package such as a tube that allows users to apply more antiseptic later. Continue reading

Posted in Legal News |

FDA Warns that OTC Acne Products May Cause Dangerous Side Effects

In a recent consumer warning, the Food and Drug Administration (FDA) said over-the-counter acne products that contain benzoyl peroxide or salicylic acid can cause serious and potentially life-threatening allergic reactions or severe irritation.

These products come in a variety of forms: gels, lotions, facial washes, cleansing pads, and facial scrubs. The FDA received 131 reports of serious allergic reactions from these products, according to Health Hub (of the Cleveland Clinic). Consumers and manufacturers made the reports between 1969 and January 2013. Those reports included such severe symptoms as

  • Throat tightness
  • Shortness of breath
  • Wheezing
  • Low blood pressure
  • Fainting
  • Collapse Continue reading
Posted in Pharmaceuticals |

FDA: Unique Pharmaceuticals’ Sterile Drugs Recalled Over Insanitary Conditions

Unique Pharmaceuticals, Ltd. just announced a nationwide recall of all of its sterile compounded preparations within those preparations’ expiry period over a potential lack of sterility assurance, the U.S. Food and Drug Administration (FDA) just revealed.

The sterile drug preparations compounded by the outsourcing facility have not reached the expiration date listed on the products. Unique Pharmaceuticals indicated that it initiated the recall following FDA concerns with Unique Pharmaceuticals’ compounding facilities and processes. According to the agency, the facilities and processes present a lack of sterility assurance and were also observed during recent inspections conducted by the FDA. Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals |

Researchers: Liver Failure, Transplant Tied to Weight-Loss Supplement

A woman who had been taking a weight loss supplement suffered liver failure and needed a liver transplant, according to a recent report of her case.

The woman, 35, had taken three Saba Appetite Control and Energy (ACE) pills in a two-day period. Two weeks later, she developed jaundice, suffered from liver failure and required a liver transplant, according to Live Science, citing a report from researchers at the University of Kentucky in Lexington, who treated her. Continue reading

Posted in Defective Products, Health Concerns |

“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 |