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FDA Advisory Panel Wrestling with Metal-on-Metal Hip Replacement Safety

An advisory panel for the U.S. Food & Drug Administration (FDA) began a highly-anticipated meeting yesterday to discuss the safety of metal-on-metal hip implants. Among other things, the panel of outside experts is being asked to make recommendations regarding the best practices for monitoring patients with metal-on-metal hip replacements. ...

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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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Older Patients Face Heart Attack Risk Following Surgery

Older Hip Implant, Knee Replacement Patients Face Heart Attack Risk Following Surgery

An emerging report reveals that older hip implant and knee replacement patients face increased heart attack risks following surgery. The risk for acute myocardial infarction (AMI) was seen in the first two weeks after these surgical procedures.

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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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Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products

Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.

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Toxic Nano-Particles from Failing Metal-on-Metal Hip Replacements May Pose Long-Term Health Risks

According to a new study, failing metal-on-metal hip implants generate toxic nano-particles that release Cobalt 2+ ions, which not only cause inflammation in surrounding tissue, but have the potential to cause long-term damage to the genetic material of cells. According to a report published by Medicalxpress.com, this “genotoxicity” could ...

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First Bard Avaulta Transvaginal Mesh Lawsuit Scheduled for February Trial in MDL

The first test trials in the federal C.R. Bard Avaulta transvaginal mesh litigation will most likely start next year, according to a report from Bloomberg News. About 600 lawsuits involving Bard Avaulta transvaginal mesh products are currently pending in the multidistrict litigation underway Charleston, West Virginia. U.S. District Judge Joseph ...

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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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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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Research Study Confirms Fracking Cause of Ohio Earthquakes

Research Study Confirms Fracking as Cause of Ohio Earthquakes

Fracking operation near Poland Township, Ohio, activated a previously unknown fault in the, causing 77 earthquakes with magnitudes ranging from 1.0 to 3.0 in March 2014.

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Former JCPenney Employee Files Whistleblower Lawsuit

Former JCPenney Employee Files Whistleblower Lawsuit

Former JCPenney Employee Files Whistleblower Lawsuit

A former part-time JCPenney employee has filed a lawsuit claiming retaliation after he reported the retailer was overcharging customers.

The fired employee has filed a claim against the company under Florida’s Private Whistleblower Act, Fortune reports. Former CEO Ron Johnson could be required to give a deposition. Continue reading

Posted in Legal News, Whistleblower | Tagged , , , , |

Zimmer Recalls Knee Replacement Device Following Increased Reports of Loosening

Zimmer Recalls Knee Replacement Device

Zimmer Recalls Knee Replacement Device

Medical device maker Zimmer, Inc. has initiated a voluntary recall of nearly 12,000 Persona Trabecular Metal Tibial knee replacement devices in response to increased complaints of loosening of the device.

The recall covers the Persona Trabecular Metal Tibial Plate/Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer, all lots land sizes, left and right. Research has shown that radiolucent lines (seen on x-rays), which show the gap between the cement and the device component, can be associated with early failure of the device. Some recipients have needed revision surgery to replace the defective component. Continue reading

Posted in Defective Medical Devices, Legal News | Tagged , , , , |

Regulatory Loophole Can Allow Unsafe Devices Onto Market

Regulatory Loophole Can Allow Unsafe Devices Onto Market

Regulatory Loophole Can Allow Unsafe Devices Onto Market

Data from the U.S. Food and Drug Administration (FDA) shows that there are over 100,000 medical devices on the market. Unfortunately, not all of them are safe. In fact, agency data indicates that between 13 and 75 devices are recalled in the United States every day. Motley Fool reports that a regulatory loophole, which allows devices to be sold and implanted into patients without clinical testing, may be a major contributing factor to these statistics.

Manufacturers can submit certain devices for 510(k) approval; this process can allow a device to be sold on the market without clinical testing for safety or efficacy so long as the FDA finds that the product is “substantially equivalent” to an older product. Only Class I and Class II devices are eligible for 510(k) clearance. Class III “high-risk” devices must go through the more stringent premarket approval. Continue reading

Posted in Health Concerns, Legal News, Product Recalls | Tagged , , , , |

Potential Cases to be Selected for Second Mirena IUD Trial

Potential Cases to be Selected for Second Mirena IUD Trial

Potential Cases to be Selected for Second Mirena IUD Trial


A recent court order has directed the parties to select seven cases that may be included in the second Mirena intrauterine device (IUD) trial.

According to a court order filed on March 17, 2015, each side must select seven cases for potential inclusion in the Second Disposition Pool. The case is In Re: Mirena Litigation, Case No. 297 in the Superior Court of New Jersey Law Division: Bergen County. Raymond C. Silverman, partner at Parker Waichman LLP, has been appointed co-lead counsel in the litigation. Continue reading

Posted in Defective Medical Devices, Mirena IUD | Tagged , , , , |

Antipsychotic Medications Linked to Increased Risk of Early Death in Dementia Patients

Antipsychotic Meds Linked to Death in Dementia Patients

Antipsychotic Meds Linked to Death in Dementia Patients


Antipsychotic medications are sometimes used to treat aggressive or violent behavior in patients with dementia, but new research suggests that health care professionals should consider the risks closely before prescribing them. According to study published in JAMA Psychiatry, antipsychotic medications can increase the risk of early death in patients with dementia, including those with Alzheimer’s Disease. The U.S. Food and Drug Administration (FDA) already warns that antipsychotic drugs can have serious side effects in patients with dementia. The findings from this study support the practice of not using these drugs in dementia patients.

Using medical records from over 91,000 veterans over the age of 65, researchers from the University of Michigan’s Medical School and VA Center for Clinical Management Research compared mortality death rates between patients taking antipsychotic drugs for dementia to those who did not. The study found a 3.8 percent increased risk of death in patients taking haloperidol compared to those who did not take any antipsychotic medications. There was a 2.5 percent increased risk of death in patients taking olanzapine. Continue reading

Posted in Legal News | Tagged , , , , , |

Kraft Foods Recalls Macaroni & Cheese Dinner Due to Possible Metal Pieces

Kraft Foods Recalls Macaroni & Cheese Dinner

Kraft Foods Recalls Macaroni & Cheese Dinner


Kraft Foods Group has voluntarily recalled approximately 242,000 cases of Original flavor Kraft Macaroni & Cheese Dinner because some boxes may contain small pieces of metal.

The recall is limited to the 7.25-oz. size of the Original flavor with “Best When Used By” dates of September 18, 2015 through October 11, 2015, with the code “C2” directly below the date on each individual box. The “C2” refers to the production line on which the affected product was made. Continue reading

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

Stryker Hip Settlement Enrollment Deadline Extended

Stryker Hip Settlement Enrollment Deadline Extended

Stryker Hip Settlement Enrollment Deadline Extended

The deadline for hip implant recipients to enroll in the Stryker Orthopaedics Rejuvenate Hip System settlement has been extended to March 30, 2015. Patients who received a recalled ABG II Modular Hip System or Rejuvenate Modular Hip System still have time to register with the settlement.

In June 2012, Stryker voluntarily recalled the ABG II and Rejuvenate Modular Hip Systems because of a high early failure rate and increased risks of metallosis. In November 2014, Stryker announced it had set aside $1.45 billion to compensate patients who received one of its recalled hip devices. Patients who had one hip implant removed prior to November 3, 2014 are eligible for $300,000; patients who had both hips implanted and removed will receive $600,000. Patients with more serious injuries or who required multiple surgeries could receive more than the base amount. The settlement also includes implant patients not able to have the hip(s) removed because a doctor deemed them unable to undergo surgery. Continue reading

Posted in Defective Medical Devices, Health Concerns, Metal Hip Implants, Recalled Medical Devices | Tagged , , , , |

Biomet Probation Extended by a Year in Light of New Bribery Evidence

Biomet Probation Extended by a Year in Light of Evidence

Biomet Probation Extended by a Year in Light of Evidence

The New York Times reports that Biomet’s federal probation was set to expire next week, but new evidence of foreign bribery has extended it by a year. During that time, the Justice Department will investigate the issue.

Additionally, the Justice Department will be looking into whether Biomet was involved in the bribery of government officials in Mexico and Brazil. The company settled a bribery case in 2012 for $17 million, according to NYT. Biomet also entered into a so-called deferred prosecution that withholds criminal charges if the company does not commit any wrongdoing during three years of probation. Continue reading

Posted in Defective Medical Devices, Legal News | Tagged , , , , |

Brilinta May Prevent Heart Attacks But Can Raise Bleeding Risks

Brilinta Prevents Heart Attacks But Can Raise Bleeding

Brilinta Prevents Heart Attacks But Can Raise Bleeding


While clinical trial results for AstraZeneca’s heart drug Brilinta (ticagrelor) are positive, the trail showed bleeding risks with the blood-thinning drug.

A 21,000-patient clinical trial showed Brilinta (ticagrelor) cuts heart attacks and strokes, but caused more bleeding, Reuters reports. Continue reading

Posted in Health Concerns, Pharmaceuticals | Tagged , , , , |

Retired Ground Zero Worker Wins Appeal for Disability Pension

Retired Ground Zero Worker Wins Disability Pension

Retired Ground Zero Worker Wins Disability Pension


A retired police officer has successfully won an appeal for disability pension after years of legal struggle. The Chief reports that last month, a state appeals court ruled in her favor. The offer serviced over 300 hours at Ground Zero and developed fibromyalgia, among other conditions. She is represented by Jeffrey Goldberg, an attorney with the national law firm of Parker Waichman LLP.

The officer was a first responder on September 11th.Court records show that she was assigned to a security post a block away from Ground Zero in October 2001. After  developing shortness of breath, dizziness, nausea and severe chest pains, she was diagnosed with fibromyalgia in March 2002. According to court documents, she filed for disability retirement in 2008 but was denied. The medical board of the Police Pension Fund acknowledged that her fibromyalgia and chronic fatigue syndrome left her unable to work, but asserted that these conditions were not caused by 9/11. She was denied again when reapplying several months later. The officer challenged these decisions by filing an Article 78 petition in State Supreme Court, but did not win. Continue reading

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