Monthly Archives: October 2015

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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 ...

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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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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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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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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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Metal-on-Metal Hip Implant Lawyer Takes Issue with Statements Made by DePuy Orthpaedics Official During FDA Meeting

An attorney with a national law firm that represents victims of alleged metal-on-metal hip implant injuries has expressed dismay at some statements made last week regarding the regulation of all-metal hip replacement devices by an official with DePuy Orthopaedics. According to Daniel Burke, Senior Litigation Counsel at Parker ...

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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 ...

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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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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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Nursing Home Abuse Lawsuit Filed after Strangulation Death

Nursing Home Abuse Lawsuit Filed after Strangulation Death

There are questions of abuse and neglect surrounding the death of a nursing home resident in North Carolina. According to Star News Online, Mary Bowling was an 89-year-old widow at Carolina Rivers Nursing and Rehabilitation Center. Her death certificate and … Continue reading

Posted in Legal News | Tagged , , , , |

European Medicines Agency Seeks Market Suspension of Medtronic InductOs

Euro Medicines Agency Seeks Suspension of Medtronic InductOs

The European Union’s medical device regulator has recommended suspension of the marketing authorization for Medtronic’s InductOs bone growth device until issues at a U.S. plant that makes a component of the device are resolved. The European Medicines Agency (EMA) launched … Continue reading

Posted in Defective Medical Devices, Medtronic Infuse | Tagged , , , |

Texas Compounding Pharmacy Recalls Possibly Contaminated Sterile Drug Products

Texas Compounding Pharmacy Recalls Contaminated Products

A Dallas, Texas compounding pharmacy that has previously been cited for safety issues by the Food and Drug Administration (FDA), once again faces problems with the federal drug regulator. Downing Labs in Farmers Branch was cited for failing to investigate … Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , |

Device Used During Surgery Linked to 8 Infections, 4 Deaths at PA Hospital

Device Used During Surgery Linked to 8 Infections, 4 Deaths

A device used to heat and cool a patient’s blood during heart surgery has been linked to infections in 8 patients at a Pennsylvania hospital. The New York Times reports that four of those patients have died, but it is … Continue reading

Posted in Defective Medical Devices, Legal News | Tagged , , , , |

Invokana Increases Risk of Bone Fractures, FDA Warns

Invokana Increases Risk of Bone Fractures

The Food and Drug Administration (FDA) issued a safety announcement in September warning patients and health care providers of an increased risk of bone fractures in patients taking the type 2 diabetes drugs Invokana and Invokamet (canagliflozin). The FDA deemed … Continue reading

Posted in Defective Products, Health Concerns, Pharmaceuticals | Tagged , , , , |

FDA Requires Drug Interaction Studies for Kayexalate

FDA Requires Drug Interaction Studies for Kayexalate

The Food and Drug Administration (FDA) is requiring the manufacturer of the potassium-lowering drug Kayexalate to conduct studies to investigate Kayexalate’s potential to affect how other medications work. The approved labeling for Kayexalate (sodium polystyrene sulfonate) describes its potential to … Continue reading

Posted in Legal News, Pharmaceuticals | Tagged , , , |

Popular Acid Reflux Medications Associated with Serious Side Effects

Popular Acid Reflux Medications

Protein pump inhibitors, a class of widely used acid reflux medications that includes Nexium (esomeprazole), Prevacid (lansoprazole), and Prilosec (omeprazole). can have serious side effects. Dr. Shoshana J. Herzig of Harvard Medical School told the New York Times that they … Continue reading

Posted in Health Concerns, Nexium, Pharmaceuticals | Tagged , , , , |

Due to Fire Risk, Toyota Recalls 6.5M Cars

Due to Fire Risk, Toyota Recalls 6.5M Cars

Due to a defect in the driver’s side window that presents a fire hazard, Toyota is recalling 6.5 million vehicles. The recall affects roughly 2 million cars in the US. The problem is that the power-window master switch may have … Continue reading

Posted in Legal News, Product Recalls, Toyota Recall | Tagged , , , , |

Does the Flu Vaccine Carry Risks?

Does the Flu Vaccine Carry Risks?

As flu season is upon us, some may wonder whether there are any risks associated with getting the flu vaccine. This is addressed in a recent New York Times Ask Well blog, which responds to a reader question that asks … Continue reading

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FDA Updates Contraindications for Myrbetriq

FDA Updates Contraindications for Myrbetriq

The U.S. Food and Drug Administration (FDA) has updated the label on Myrebetriq to include a new contraindication and additional information in the Warnings and Precautions section. The revised label now states that the drug, which is used to treat … Continue reading

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