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DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds

A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).

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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 ...
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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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 Associated with more Complications than Warfarin, According to Early Study Findings

Pradaxa Associated with more Complications than Warfarin, According to Early Study Findings

Early results from the largest study to date to compare Pradaxa and warfarin indicate that in a real-world setting, Pradaxa causes more complications than decades-old warfarin. The preliminary study results were announced last week, during the 2012 Thrombosis and Hemostasis Summit of North America.

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Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Failing DePuy ASR Hip Implants Sending Hundreds of Australians Back to the OR

Roughly 1,000 people in Australia have had to undergo revision surgeries because of failed DePuy ASR hip implants. According to TheAge.com, DePuy Orthopaedics has heard from more than 4,000 people in Australia and New Zealand seeking help with the recalled metal-on-metal hip replacement devices.

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Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage

A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...

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Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

Parker Waichman Representing Another Louisiana Plaintiff in Actos Bladder Cancer Lawsuit

A Louisiana man has become the latest to claim that his taking the type 2 diabetes drug Actos resulted in developing bladder cancer. He has filed a lawsuit against the Japanese manufacturer of the drug and the marketer of it in the U.S., claiming they failed to warn about this ...

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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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Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer Yaz, Yasmin Blood Clot Lawsuit Settlements Stand at $147 Million

Bayer AG reported yesterday that it continues to settle Yaz and Yasmin birth control pill lawsuits. According to a report from Bloomberg News, the company said in its latest Stockholder Newsletter that it has settled 651 Yaz and Yasmin blood clot lawsuits for a total of $147 million. The average ...

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Study: Artificial Sweeteners May Raise Blood Sugar, Promote Obesity

Artificial-Sweeteners-May-Raise-Your-Blood-SugarA new study involving artificial sweeteners has found that the additives may be making Americans fatter.

The study revealed that artificial sweeteners may trigger “dramatic” blood sugar disturbances in people and mice. This appears to happen because of the way in which the sweetening additives alter the gut’s bacterial populations, or microbiota, according to the National Post. The microbiota are an intricate ecosystem of bacteria and microorganisms that live in the gut.

The study, conducted by scientists in Israel, was released Wednesday by the journal, Nature. The research calls for a reassessment of the use of artificial sweeteners, which are one of the most widely used food additives globally, wrote the National Post. Continue reading

Posted in Defective Products, Food Products |

Study Finds No Evidence of Effectiveness and Safety of Newer Joint Replacement Devices

Joint-Replacement-DevicesIn light of the failure of articular surface replacement and large head size metal-on-metal joint replacement devices, scientists, doctors, and health policy professionals have highlighted the need for a more thorough and evidence-based introduction of joint replacement devices and for the development of an infrastructure for timely evaluation of these devices.

In a recently published study in the BMJ, a group of researchers, led by Dr. Marc J. Nieuwenhuijse, systematically evaluated the evidence concerning the introduction of five innovative, relatively recent, and already widely implemented devices used in total joint replacement. The research team evaluated comparative data from clinical trials, observational studies, and large national arthroplasty registries to study effectiveness and safety of the new devices versus existing, well proven, comparable devices. The five technologies reviewed are ceramic-on-ceramic bearings, modular femoral necks, and uncemented monoblock (not metal-on-metal) acetabular cups in total hip replacement, and high flexion implants and gender-specific implants in total knee replacement. Continue reading

Posted in Defective Medical Devices, Metal Hip Implants |

Expert Witness in Chantix Case Seeks Pfizer Documents

Chantix-CaseAn expert witness in the multidistrict litigation over Chantix (varenicline), a smoking cessation drug, has moved to unseal court records in advance of a Food and Drug Administration (FDA) meeting to consider whether the drug should carry a warning about suicide risk.

Dr. Joseph Glenmullen, an expert causation witness for the plaintiffs, and Thomas Moore, a drug-safety researcher, called for the unsealing of thousands of Pfizer Inc. internal documents, National Law Journal reports. Both wrote about how smoking cessation treatments like Chantix are associated with a higher incidence of depression, suicide and violence toward other people. The two experts “want to ensure the public debate about the psychiatric side effects of Chantix includes a balanced scientific record, which was examined in depth in the Chantix litigation,” according to court documents.  The FDA meeting is scheduled for Oct. 16. Continue reading

Posted in Chantix, Pharmaceuticals |

Exxon’s Attempt to De-Certify Class Action Lawsuit is Countered

Exxons-Attempt-to-De-Certify-Class-Action-LawsuitExxon Mobil’s attempt to de-certify the class action status of a couple’s lawsuit should be denied, the couple’s attorney argued. According to Arkansas Democrat Gazette, a federal judge granted class action status to the lawsuit, which was filed over an oil spill in Mayflower. Exxon Mobil has petitioned to appeal this decision. Continue reading

Posted in Legal News |

FDA Continues to Express Concern Regarding e-Cigarettes

electronic-cigaretteThe U.S. Food and Drug Administration (FDA) has stated that the exact health effects of e-cigarettes remain unknown. E-cigarettes provide a different nicotine delivery system that, instead of providing smoke, provides vapor.

Not unexpectedly, the makers of e-cigarettes argue that their products are safer than traditional cigarettes; however, the FDA has questions concerning the fairly new nicotine products, according to Daily News Journal. “While e-cigarette aerosol may contain fewer toxicants than cigarette smoke, studies evaluating whether e-cigarettes are less harmful than cigarettes are inconclusive,” the FDA indicated in a recent report. The agency also questioned claims that e-cigarettes may be of help in smoking cessation, indicating in the report that, “No e-cigarette has been approved by FDA as a cessation aid.” Continue reading

Posted in Defective Products, Health Concerns |

Portico TAVR Heart Device Implants Halted Over Safety Concerns

Portico-TAVR-Heart-Device-Implants-HaltedDevice maker St. Jude Medical has halted implantation of the Portico transcatheter aortic valve replacement (TAVR) over safety concerns that surfaced in U.S. clinical trials.

The Portico TAVR device is intended for patients with severe aortic stenosis (narrowing) who are at high risk for open-heart valve replacement surgery or who cannot have surgery. In an email to Medscape, the company confirmed that it had halted implantation worldwide while evaluating “recent cases of reduced valve leaflet mobility that were reported from a small number of CT scans performed approximately 30 days after implant in the U.S. IDE [investigational device exemption] study.” Continue reading

Posted in Defective Medical Devices |

DePuy Executive Questioned about Pinnacle Hip Implant Safety Studies in Bellwether Trial

Pinnacle-Hip-Implant-Safety-StudiesOn Monday, a DePuy executive was questioned about whether or not the company properly analyzed the dangers of the metal-on-metal Pinnacle hip implant. According to Reuters, Depuy worldwide vice president of clinical research Pamela Plouhar took the stand in the bellwether trial.

There are over 6,000 Pinnacle lawsuits consolidated in Dallas federal court. The first to go to trial was filed on behalf of a 58-year old Montana woman who received two metal-on-metal versions of the Pinnacle hip implant in 2009. Her lawsuit, filed in 2012, alleges that the defective devices released cobalt into her bloodstream and caused it to jump up to 85 times the normal level. Continue reading

Posted in Legal News |

Newer Joint Replacement Systems May Offer No Benefit

Newer-Joint-Replacement-SystemsAccording to a systematic review published online September 9th in the BMJ, there is no evidence to support the use of 5 newer joint replacement devices compared to analogous products that have been on the market longer. In fact, the risk of undergoing revision surgery is higher with some of the newer systems.

The study was led by Marc J. Nieuwenhuijse, MD, PhD from the Patient Centered Comparative Effectiveness Program and US Food and Drug Administration Medical Device Epidemiology Science and Infrastructure Center, Department of Public Health, Weill Cornell Medical College, New York, City; the Department of Orthopaedics, Leiden University Medical Center, the Netherlands; and the Office of Surveillance and Biometrics, Center for Devices and Radiological Health, US Food and Drug Administration, Silver Spring, MD. He and his colleagues wrote that “[N]ew technologies are being introduced to the commercial market without sufficient high quality evidence for improved benefit over existing, well proven, and safe alternative implant solutions…[T]he status quo regarding the introduction of new device technologies is not acceptable.” Continue reading

Posted in Legal News |

Nineteen Deaths Linked to GM Ignition Switch Defect

gm-ignition-switch-deathsKenneth Feinberg, the attorney overseeing the General Motors compensation fund, has so far linked 19 deaths to a serious flaw with the ignition switches, a higher number than the 13 deaths GM had acknowledged in crashes resulting from the switch problem.

The fund has received 125 death claims and 320 injury claims in the five weeks it has been operating. Feinberg has found 31 claims eligible for compensation, CNN Money reports. Continue reading

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

Fracking Workers Exposed to High Levels of Benzene, Study Finds

fracking_workers_exposed_to_benzeneWorkers at hydraulic fracturing – fracking – oil and gas sites are routinely exposed to high levels of benzene, according to a study by the National Institute for Occupational Safety and Health (NIOSH).

The agency, part of the Centers for Disease Control and Prevention (CDC), recommends that workers limit their benzene exposure to an average of 0.1 of a part per million during their shift. But when the researchers measured airborne benzene workers would be exposed to when they opened hatches on tanks at well sites, 15 of 17 samples exceeded that amount, the Los Angeles Times reports. Benzene levels at the wells “reached concentrations that, depending on the length of exposure, potentially pose health risks for workers,” the researchers wrote in the Journal of Occupational and Environmental Hygiene. Workers must open the hatches one to four times per hour to inspect and measure the contents. Continue reading

Posted in Benzene, Health Concerns, Hydraulic Fracturing / Fracking |

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