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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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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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Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

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Transvaginal Mesh a Nightmare for Thousands of Women

Transvaginal Mesh a Nightmare for Thousands of Women

Thousands of women who have received transvaginal mesh surgical implants to treat stress urinary incontinence (SUI) and pelvic organ prolapse (POP) are now living a nightmare, thanks to debilitating pain, bleeding, infection and other serious complications. According to the Sun-Sentinel, many of the women injured by transvaginal mesh claim ...

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

Another Metal-on-Metal Hip Replacement Lawsuit Filed in DePuy ASR Hip Implant Litigation

A vital food safety program was saved from budget cuts this week, enabling the country’s largest—although considered by experts to be far too small—produce-safety testing program to continue.

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Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Another lawsuit has been filed over adverse Plavix side effects. The lawsuit, filed by national law firm Parker Waichman LLP, alleges that the blood thinner, Plavix (clopidogrel), caused an Oklahoma man to suffer from multiple stomach bleeds.

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FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

FDA Metal-On-Metal Hip Replacement Investigation Is Flawed, Researchers Say

The U.S. Food & Drug Administration’s (FDA) metal-on-metal hip replacement investigation is flawed, according to researchers.

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Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis Leads Vulnerable to Fracture after ICD Switch

Medtronic Sprint Fidelis leads are vulnerable to fracture following ICD switch, says a new study published in the June issue of the journal Heart Rhythm.

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

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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Older COPD Patients May Suffer from More Breathing Problems when taking Certain Sedatives, Study Shows

Older adults who suffer from chronic obstructive pulmonary disease (COPD) may be more likely to suffer from serious breathing problems if they take certain sedatives, new research suggests. According to a study published on Thursday in the European Respiratory Journal,benzodiazepines such as lorazepam (Ativan) or alprazolam (Xanax) are associated with a 45 percent increased risk of breathing problems that require outpatient treatment in older COPD patients. These patients were also 92 percent more likely go to the emergency room for pneumonia or COPD, and had a higher risk of being hospitalized for breathing problems. Continue reading

Posted in Legal News |

Class I Recall: Spacelabs Healthcare Ltd., ARKON Anesthesia Delivery System

The U.S Food and Drug Administration (FDA) just announced that Spacelabs Healthcare Ltd. has recalled its ARKON Anesthesia Delivery System with Version 2.0 Software. A software defect may cause the system to cease working. The FDA has deemed the recall a Class I, its most serious designation, which is reserved for situations in which there exists a reasonable probability that use of the recalled product will cause serious adverse health consequences or death.

The recalled ARKON Anesthesia Delivery Systems were manufactured and distributed from March 18, 2013 through June 17, 2013; 16 units were distributed to hospitals in North Carolina and South Carolina. The ARKON Anesthesia Delivery System with Version 2.0 Software includes the following serial numbers of units distributed in the United States: Continue reading

Posted in Defective Medical Devices, Product Recalls, Recalled Medical Devices |

Alarming Rate of Use of Antipsychotic Drugs in Nursing Homes

A Canadian newspaper’s investigative report reveals an alarming increase in the use of powerful antipsychotic drugs in nursing homes, despite warnings that these medications are dangerous – even lethal – for elderly patients with dementia.

The Toronto Star (thestar.com) found that some long-term care facilities, often short staffed, routinely use these drugs to calm and “restrain” wandering, agitated and sometimes aggressive patients. The Star found that as many as one half of residents at some facilities are on antipsychotics. Continue reading

Posted in Health Concerns, Nursing Home Abuse |

FDA Warns of Cancer Risk with Fibroid Removal Procedure

On Thursday, the U.S. Food and Drug Administration (FDA) cautioned doctors about the use of a procedure in hysterectomy and uterine fibroid tumor removal that could unexpectedly spread cancerous tissue into the patient’s abdomen.

The procedure, power morcellation, involves a device to cut tissue into pieces that can be removed through the tiny incisions made during minimally invasive surgery, The New York Times reports. But, according to FDA data, approximately one in every 350 women with fibroids could have a uterine sarcoma and slicing up the cancerous tissue could allow it to spread in the patient’s abdomen, reducing the patient’s long-term survival rate, according to Law360. Though the FDA stopped short of removing power morcellators from the market, it warned doctors to consider other treatment methods for symptomatic fibroids. Surgeons are taught, the Times explains, that cancers or potentially cancerous tissue should be removed whole and not broken up or cut, to avoid spreading the disease. Continue reading

Posted in Defective Medical Devices, Health Concerns |

Study: Misdiagnosis occurs in 1 out of Every 20 Outpatients

outpatient_misdiagnosis_studyA new study suggests that at least 1 in every 20 outpatients-those who receive care without being admitted to a hospital-experience a misdiagnosis. The study, which was published in the journal BMJ Quality & Safety, found that the rate of misdiagnosis in outpatients was about 5 percent. This translates to 1 in 20 adults, 12 million people when applied to the entire US population. Continue reading

Posted in Legal News |

FDA Send Endo Warning Letter Over Vaginal Mesh Facility

FDA_warns_endo_transvaginal_mesh_facilityFollowing an inspection by federal regulators, pharmaceutical firm, Endo International PLC, was sent a warning letter by the U.S. Food and Drug Administration (FDA) over issues discovered at a vaginal mesh facility.

The inspection was conducted at an Endo subsidiary’s Minnesota facility, Endo wrote this week in a regulatory filing with the U.S. Securities and Exchange Commission (SEC), according to Law360. Endo wrote that the April 10 warning letter came after issues were identified by the FDA following an inspection of a Minnetonka, Minnesota facility operated by its subsidiary, American Medical Systems Inc. (AMS). Continue reading

Posted in Defective Medical Devices, Transvaginal mesh |

SSRI Antidepressant Use in Pregnancy Tied to Autism Risk

pregnant_woman_antidepressants_risk_autismA new study reports that boys with autism were three times more likely to have been exposed to SSRI antidepressants (selective serotonin reuptake inhibitors)  in the womb than typically developing children.

Boys whose mothers took SSRIs – including Celexa (citalopram), Lexapro (escitalopram), Paxil (paroxetine), Prozac (fluoxetine), and Zoloft (certaline) – during pregnancy were also more likely to have developmental delays, HealthDay News reports. The study was published online this week in Pediatrics and will appear in May in the print issue. Continue reading

Posted in Health Concerns, Pharmaceuticals, SSRI Antidepressants |

Harm from E-cigarettes Increase as Their Popularity Rises

Harm_from_E-cigarettes_IncreasesReports of injuries and other harm from e-cigarettes – burns, nicotine toxicity, respiratory and cardiovascular problems – have risen in the past year as the devices become more popular, recent data show.

More than 50 e-cigarette complaints were filed with the U.S. Food and Drug Administration (FDA) between March 2013 and March 2014, Reuters reports. This about equals combined numbers for the previous five years. Continue reading

Posted in Health Concerns, Toxic Substances |

Paralysis a Potential Complication of Spine Stimulators

Paralysis_Potential_in_Spine_StimulatorsSome patients who have been implanted with spinal-cord stimulators have ended up with paralysis, Wall Street Journal reports. These devices are manufactured by a number of companies, the biggest of which include Medtronic, St. Jude Medical and Boston Scientific. The devices use stimulation therapy to help manage chronic pain; a small external remote is used to send low currents of electricity to the implanted generator and the electrical current from the leads creates a tingling sensation that it supposed to mask pain signals being sent to the brain, WSJ says. According to a Wall Street Journal analysis of the U.S. Food and Drug Administration’s (FDA) adverse-event reports and a review of medical malpractice lawsuits, more than 100 patients have experienced partial or permanent paralysis after having a spinal-cord stimulator inserted into their backs. Continue reading

Posted in Legal News |

GM Car Owners File Class Action Over Defective Ignition Switches

GM_Ignition_Switch_RecallA federal class action alleges that General Motors Corp. fraudulently concealed a defect in the ignition switches of 2.6 million Chevrolet, Pontiac and Saturn vehicles, and that the defect is linked to at least 13 deaths.

The complaint, Ruff v. General Motors, was filed Monday in Trenton, New Jersey, and it claims company engineers first learned in 2001 that ignition switches in these vehicles can accidentally move from the “run” to the “accessory” or “off” position, shutting off the engine and disabling such systems as power steering, antilock brakes, and air bags, the New Jersey Law Journal (Law.com) reports. Plaintiffs claim the number of deaths may be far higher than the 13 GM has acknowledged. They cite 303, from a study of airbag deployment failures in crashes of Chevrolet Cobalt and Saturn Ion cars. Continue reading

Posted in Accident, Class Action Lawsuits, Defective Products, Legal News, Motor Vehicles, Product Recalls, Recalled Vehicles |