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Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims

The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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FDA Gives 7 Companies Go Ahead To Market Generic Plavix

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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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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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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Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits

Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits

A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...

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Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

Federal Judge Certifies Medtronic Infuse Shareholder Class Action Lawsuit

A shareholder lawsuit alleging Medtronic Inc. illegally promoted the off-label use of its Infuse bone growth product has been granted class action status by U.S. District Judge Paul Magnuson of Minnesota. According to a report from Law360.com, the Medtronic Infuse off-label promotion lawsuit was filed by several institutional investors on ...

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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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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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Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits

Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits

An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.

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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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