Monthly Archives: August 2017

Featured Stories

National Law Firms Calls for More FDA Action on Actos Bladder Cancer Threat

A national law firm is not satisfied with the way the U.S. Food & Drug Administration (FDA) has handled warnings regarding Actos (pioglitazone) bladder cancer risks. In a statement published today, Parker Waichman LLP called on the FDA to compel Takeda Pharmaceuticals, the maker of the type 2 diabetes drug, ...

Read More

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 ...

Read More

Cancer Groups Call for E-cigarettes Regulation/Research

Two-Leading-Cancer-Groups-Issue-Call-for-Regulation-of-E-cigarettes-and-Research-on-Health-Risks

The American Society of Clinical Oncology & the American Association for Cancer Research called for government regulation & research of e-cigarettes on health effects.

Read More

Metal-on-Metal Hip Replacement Device

Smith & Nephew’s Birmingham Metal-on-Metal Hip Replacement Device

Wright Medical Inc. took steps in to 2006 to convince the U.S. Food & Drug Administration (FDA) to reject pre-market approval of rival Smith & Nephew’s Birmingham metal-on-metal hip implant. Wright Medical, which makes two metal-on-metal hip replacement devices, the Conserve and the Lieneage device, filed a citizen petition ...

Read More

Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

Health Canada has become the most recent national drug regulator to issue a warning about Actos and bladder cancer. Last month, the agency warned that interim results from a 10-year-study indicated that patients taking Actos for more than a year faced an increased risk of bladder cancer. Health Canada also ...

Read More

What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

Read More

Government Penalizes 721 Hospitals for High Rates of Infections, Injuries

Medicare is reducing payments to 721 hospitals, one out of every seven hospitals in the nation, for having high rates of “hospital-acquired” conditions (HAC.

Read More

Actos, Avandia May Up Risk for Diabetic Macular Edema

A newly published study is raising concerns that patients who take Actos or Avandia may face an increased risk of developing diabetic macular edema, an eye disorder that can result in vision loss. The study, published in the Archives of Internal Medicine, found that type 2 diabetics who use thiazolidinediones, ...

Read More

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 ...

Read More

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.

Read More

Thousands of Propane Cylinders Recalled Because of Fire Risk

On July 13, 2017, the U.S. Consumer Product Safety Commission (CPSC) in conjunction with Health Canada announced the recall of certain refillable propane cylinders that pose a risk of explosion and fire. YSN Imports, of Gardena, California, which distributes the … Continue reading

Posted in Product Recalls |

Samsung Galaxy Note 4 Recall due to Potentially Hazardous Batteries

The most recent unfortunate news for Samsung’s beleaguered line of Galaxy Note smartphones is that over 10,000 refurbished batteries for the Note 4, a three-year-old phone, are being recalled due to a risk of overheating, with the potential of fires … Continue reading

Posted in Cellular Phone, Defective Products, Product Recalls |

Cook Medical Recalls Medical Device due to Blood Clot Risk

The U.S. Food and Drug Administration (FDA) has identified the Cook Medical Zenith Alpha Thoracic Endovascular Graft as a Class I recall, the most serious type of recall where there is a “reasonable probability that the use of or exposure … Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns, Legal News, Product Recalls, Recalled Medical Devices |

Papaya Salmonella Victims Increase to 141 with More Possible

As of August 11, 2017, the Centers for Disease Control (CDC) is reporting that 141 people in nineteen states have confirmed cases of strains of salmonella traced back to papayas imported from Mexico. Victims range in age from 1 to … Continue reading

Posted in E. Coli, Food Poisoning, Food Products, Health Concerns, Listeria, Recalled Food Products, Salmonella |

Increased Risk of Bone Fractures with Invokana and Invokamet XR

Despite a multitude of warnings for a drug taken for treatment of type 2 diabetes, the U.S. Food and Drug Administration (FDA) has expanded indications for Invokamet (canagliflozin and metformin). Invokamet along with Invokana (canagliflozin), carry warnings for adverse reactions … Continue reading

Posted in Health Concerns, Pharmaceuticals |

Endo Agrees to Additional $775M Settlement for a Total of $2.6B

As of August 7, 2017, Endo International has agreed to set aside an additional $775 million to resolve the company’s remaining mesh lawsuits’ allegations related to the Transvaginal Mesh (TVM) Multidistrict (MDL) Litigation pending in the U.S. district Court of … Continue reading

Posted in Defective Medical Devices, Defective Products, Health Concerns, Product Recalls, Recalled Vehicles, Transvaginal mesh |

General Motors Recalls 800,000 Trucks due to Power Steering Defects

Nearly 800,000 pickup trucks are being recalled by General Motors because they may suddenly lose power steering while the truck is being driven, and the sudden steering jolt may cause drivers to lose control of the vehicle, reports Fortune. About … Continue reading

Posted in Defective Products, Motor Vehicles, Product Recalls, Recalled Vehicles |

Mixed Metals are Focus of Stryker LFIT V40 Hip Implant Litigation

The Stryker Corporation is facing parallel litigations in Boston and New Jersey defending its LFIT Anatomic CoCr V40 Femoral Head (Cobalt Chromium V40) with allegations that the metal-on-metal ball and joint hip implant has a design defect causing it to … Continue reading

Posted in Defective Medical Devices, Depuy, Health Concerns, Metal Hip Implants, Recalled Medical Devices |

Popular Heartburn Medications Linked to Increased Risk of Death

Drugs to relieve heartburn and acid-reflux are among the best selling drugs in the country, used by millions of Americans annually in both prescription and non-prescription strength. Excess acid can cause stomach ulcers and damage to the esophagus. A reduction … Continue reading

Posted in Health Concerns, Pharmaceuticals, Proton Pump Inhibitors |

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.