Featured Stories
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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Study Finds Plavix May Only Benefit Smokers

Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

Thousands of people with metal-on-metal hip implant devices could soon get some answers from the U.S. Food & Drug Administration (FDA) about the dangers they face. Tomorrow, the agency will convene a panel of outside medical experts to examine the safety record of metal-on-metal hip replacements, and recommend the ...

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Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Johnson & Johnson Facing More Metal-on-Metal Hip Implant Woes, as DePuy Pinnacle Complaints Rise

Having already spent around $3 billion on its DePuy Orthopaedics ASR hip implant recall, Johnson & Johnson is facing another potential debacle involving a metal-on-metal version of its Pinnacle Hip Replacement System. According to a report from Reuters, Johnson & Johnson and its DePuy unit already face some 1,600 metal-on-metal ...
Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke

The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...

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Scientist Calls for Federal Regulations for Fracking Pollution

Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

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Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries

Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...

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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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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 |