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Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker Metal Hip Implant Component Recall Bad News for Makers of Metal-on-Metal Hip Replacement Devices

Stryker’s recent recall of two metal hip implant components, the Rejuvenate Modular and ABG II modular-neck hip stems, may have dealt a serious blow to one of the key arguments medical device manufacturers have made to defend their metal-on-metal hip replacements. Facing thousands of lawsuits, the makers of ...

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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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Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

Bisphosphonate Study Confirms Atypical Thigh Fracture Risk

New research has confirmed the link between bisphoshonates, such as Fosamax, and atypical femur fractures, a type of thigh fracture that occurs spontaneously, without any major leg injury. The study, published in the Archives of Internal Medicine, also found that the risk of atypical thigh fractures increases the longer a ...

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West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

West Virginia Man Claims Metal-on-Metal DePuy Pinnacle Hip Replacement Led to Pain, Elevated Cobalt Levels

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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Fracking Boom Changing Way of Life in Pennsylvania’s Northern Tier

Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier

In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...

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Actos, Avandia May Up Risk for Diabetic Macular Edema

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, ...

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Zadroga Act Cancer Decision Expected This Week

Zadroga Act Cancer Decision Expected This Week

The federal official tasked with determining what ailments should be covered by the federal Zadroga Act is expected to decide by Saturday if certain cancers will be eligible for compensation. The decision is being eagerly awaited by thousands of first responders who believe they developed cancer due to exposure ...

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Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Bleeding Side Effects of Pradaxa, Xarelto Have Some Doctors Concerned

Some heart doctors are raising concerns about a new class of heart drugs that include Pradaxa. Recently, a number of doctors interviewed by Reuters said they were hesitant to prescribe Pradaxa, as well as another blood thinner called Xarelto, because of concerns regarding the risk of stroke, serious bleeding ...

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Medtronic Settles Charges Over Kickbacks To Doctors

Medical device giant, Medtronic Inc., is settling charges over kickbacks to doctors. The firms just agreed to pay $23.5 million to settle claims it paid physicians kickbacks in exchange for their use of its pacemakers and defibrillators, according to a U.S. Justice Department announcement yesterday. The company was accused of seeking ...

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Transvaginal Mesh Lawsuit Trial

$5.5 Million Awarded to Plaintiffs in First Transvaginal Mesh Lawsuit Trial

An award of $5.5 million has been made in the first trial over a transvaginal mesh lawsuit. The jury found against medical device maker, C.R. Bard, and its Avaulta Plus transvaginal mesh. The jury agreed that Bard’s Avaulta Plus transvaginal mesh caused numerous and painful injuries in a California woman. ...

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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 |

Sporting Equipment Company STX Recalls Lacrosse Goalie Throat Shield Protector Over Injury Hazard

STX_Recalls_Lacrosse_Goalie_Throat_Shield_ProtectorThe Consumer Product Safety Commission (CPSC) has announced the recall of the STX  Shield Throat Protector because the product can crack or break when struck by a lacrosse ball, posing an injury risk to the user.

The STX Shield throat protector is black and has the letters STX engraved on the outer surface of the protector. The shield attaches to the goalie’s helmet below the chin guard with straps on each side and the bottom. The shield sold for $20 to $25 at specialty sporting goods stores such as Athlete’s Connection, Commonwealth Lacrosse, Lacrosse Unlimited, Play It Again Sports, Sport Stop USA and Universal Lacrosse and online at www.LAX.com from September 2013 through February 2014.

STX has received one report of the throat protector breaking, which reportedly resulted in bruising and lacerations to the user’s neck, according to the CPSC.

The CPSC said consumers should stop using the Shield and return the product to STX for a full refund. Consumers can contact STX toll-free at 888.789.7894, 8:30 a.m. to 5 p.m. ET Monday through Friday or online at www.stx.com.  Click on RECALL–Shield Throat Protector for more information. Continue reading

Posted in Product Recalls |