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Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Colorado Woman Sues American Medical Systems Over Transvaginal Mesh Injuries

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a Colorado woman allegedly injured by transvaginal mesh products manufactured by American Medical Systems, Inc. The suit was filed on May 21, 2012 in the U.S. District Court for the Northern District of California (Case No. ...

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Actos Bladder Cancer Lawsuits Continue, New Complaint Filed by Tennessee Resident

Actos Bladder Cancer Lawsuits Continue, New Complaint Filed by Tennessee Resident

Actos bladder cancer lawsuits continue, with a new complaint filed by a resident of Tennessee. The national law firm, Parker Waichman LLP, represents the Tennessee man who alleges that Actos caused his bladder cancer.

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Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos Bladder Cancer Lawsuit Filed by West Virginia Resident

Actos (pioglitazone) continues to be named in lawsuits alleging long-term use of the type 2 diabetes drug caused patients to develop bladder cancer. Just last week, the national law firm of Parker Waichman LLP filed suit against Takeda Pharmaceuticals on behalf of a West Virginia man who developed bladder cancer ...

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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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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 Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business

Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...

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Canadian Warning Issued for Actos Bladder Cancer Side Effect Risk

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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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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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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FDA Advisors Set to Examine Metal-on-Metal Hip Implant Safety Concerns

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 ...

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Whistleblower to Receive Record $30 Million Award

A foreign whistleblower will receive an award of over $30 million from the Securities and Exchange Commission (SEC), the agency said on Monday. According to the Wall Street Journal, this is the largest award since the SEC program began in 2011, more than double the highest previous award.

The award comes soon after Attorney General Eric Holder said he wanted to increase whistleblower payouts as an incentive. Continue reading

Posted in Legal News |

Nationwide M&Ms Recall: Allergen Concerns

Last week, Mars Chocolate North America announced a voluntary recall of its M&Ms Brand Theater Box, 3.40 oz, UPC #40000294764 because the box may contain peanut butter M&Ms, though peanut butter– an allergen – is not listed on the outside of the box.

The inside package is correctly labeled with ingredients and allergy information, according to the recall notice on the Food and Drug Administration (FDA) web site. People with peanut allergies run the risk of a serious or life-threatening reaction if their theater box contains an M&Ms Brand Peanut Butter bag and they consume the product. No adverse reactions have been reported to date. Continue reading

Posted in Food Products, Health Concerns |

Medtronic Makes Final Payment to Settle Kickbacks Lawsuit over CRM products

Medtronic has made the final payment in an $11.1 million settlement over allegations that it used kickbacks to promote the use of its cardiac rhythm products. According to a press release issued by the office of Eric Schneiderman, the U.S. Attorney General for New York, the company’s final payment of $362,362 will be split among the Medicaid programs in 46 states and the District of Columbia. Continue reading

Posted in Legal News |

Bipartisan Congressional Group Seeks Reauthorization of Zadroga 9/11 Act

A bipartisan group of U.S. senators and representatives has introduced legislation to reauthorize the James Zadroga 9/11 Health and Compensation Act, to continue programs providing medical treatment and compensation to 9/11 responders for another 25 years.

Senators Kirsten Gillibrand and Chuck Schumer and seven other senators introduced the legislation in the Senate. The House bill was introduced by Representatives Carolyn Maloney, Jerrold Nadler, Peter King, and 37 others. New York City’s mayor, Bill de Blasio, along with 9/11 first responders, community survivors, and union leaders joined the effort to reauthorize the programs, 9/11 Health Watch reports. Continue reading

Posted in Health Concerns, Toxic Substances, Zadroga Act Claims |

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 |

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