Featured Stories
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. ...

Read More

Lawsuit Alleges Plavix Caused Oklahoma Man to Suffer Multiple Stomach Bleeds

Another lawsuit has been filed over adverse Plavix side effects. The lawsuit, filed by national law firm Parker Waichman LLP, alleges that the blood thinner, Plavix (clopidogrel), caused an Oklahoma man to suffer from multiple stomach bleeds.

Read More

Fracking Should be Kept 600m From Aquifers, Study Says

New research on the safety of hydraulic fracturing (fracking) suggests new wells should not be dug within 600 meters of a water aquifer because underground fractures can extend about that far from a dug well. According to a report from UK’s The Guardian newspaper, researchers and geologists at Durham University have ...

Read More

Crash on N.State Pkwy Kills Port Jefferson Station Man

Single-Car Crash on Northern State Parkway Kills Port Jefferson Station Man

A Port Jefferson Station man was killed on Wednesday due to a single-vehicle crash on the Northern State Parkway in Dix Hills. Police are investigating the accident, Newsday reports. According to Newsday, the 81-year-old man was driving a Nissan Altima west in the right lane, west of Exit 42. He ...

Read More

Study Linking Z-Pak to Increased Death Risk Being Reviewed by FDA

The U.S. Food & Drug Administration (FDA) is reviewing a new study that reported an increased risk of sudden, heart-related deaths among people using the antibiotic Zithromax (azithromycin), known popularly as Z-Pak. In a statement issued late yesterday, the FDA said patients being treated with Zithromax should not stop taking ...

Read More

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.

Read More

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.

Read More

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 ...

Read More

U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients

Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...

Read More

Former Executives Accuse Health Technology Firm of Fraud

Former Executives Accuse Health Technology Firm of Fraud

Former NantHealth executives claim that the company made fraudulent claims about the reliability of its system, which links patient information gathered by the devices.

Read More

Jury in Washington State Awards $1 Million to Plaintiff “Perceived” as Whistleblower

Continue reading

Posted in Legal News, Whistleblower |

OriGen VV13F Reinforced Dual Lumen ECMO Catheters Recalled Due to Risk of Tube Separation

OriGen Biomedical recalled one lot of 51 VV13F Reinforced Dual Lumen ECMO Catheters, according to a recall alert posted on the U.S. Food and Drug Administration’s (FDA’s) website. The devices were recalled due to the risk of the clear extension tube separating from the hub in which it is inserted. Intervention may be needed to prevent permanent impairment or damage if this occurs. The recall affects lot N18549, which expires 09/2018. OriGen knows of at least one product failure, which is associated with a serious adverse event that led to a serious patient injury, the recall indicated. Continue reading

Posted in Legal News |

Beech-Nut Recalls Baby Food Over Possible Glass Contamination

On Tuesday, the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) announced that Beech-Nut Nutrition is recalling approximately 1,920 pounds of baby food products that may be contaminated with small pieces of glass.

The recalled baby food was produced on December 12, 2014. The following product is subject to recall:

  • 4-oz. glass jars containing “Stage 2 Beech-Nut CLASSICS sweet potato & chicken”

Continue reading

Posted in Defective Products, Food Products |

9/11 Responders and Workers Release Video Urging Extension of Zadroga Act

An advocacy group for 9/11 responders and clean-up workers, Citizens for the Extension of the James Zadroga Act, has released a video, urging Congress to renew the James Zadroga 9/11 Health and Compensation Act. The Zadroga Act provides treatment and compensation for those who were injured or became ill after exposure to toxins in the aftermath of the 9/11 World Trade Center terrorist attacks.

The World Trade Center Health Program and the September 11th Victim Compensation Fund— key provisions of the act—will expire in October 2015 and October 2016, respectively, unless the Zadroga Act is renewed. U.S. Senator Kirsten Gillibrand is leading the effort for the Zadroga Act renewal. Gillibrand was a sponsor of the original legislation in 2010. Continue reading

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

Concern About Conflicts of Interest in FDA Dietary Supplement Regulators

Concern About Conflicts of Interest in FDA Regulators

Concern About Conflicts of Interest in FDA Regulators

The Food and Drug Administration (FDA) is facing criticism of its regulation of dietary supplements containing a dangerous stimulant. The stimulant is BMPEA, a chemical nearly identical to amphetamine. BPMEA is added to weight-loss and workout products to enhance their effect.

BPMEA has never been tested for safety and effectiveness in humans and is not a permissible ingredient in dietary supplements. The FDA was the first agency to suspect that BMPEA had been added to supplements that listed the little-known plant acacia rigidula among the ingredients. Experts say that plant listings like this are often an indication that the manufacturer is trying to disguise a chemical additive as a natural botanical extract, the New York Times reports. Continue reading

Posted in Defective Products, Health Concerns | Tagged , , , |

Tri-Methyl Xtreme Supplements May Lead to Liver Damage, FDA Says

Tri-Methyl Xtreme Supplements May Lead to Liver Damage

Tri-Methyl Xtreme Supplements May Lead to Liver Damage

The U.S. Food and Drug Administration (FDA) is warning that Tri-Methyl Xtreme, a muscle-building supplement sold by Las Vegas company Extreme Products Group, has been linked to liver damage. According to Associated Press, the supplement was linked to three reported injuries in California, New Jersey and Utah. The FDA began investigating the product following these reports.

Tri-Methyl Xtreme claims to contain anabolic steroids, although it is sold as a dietary supplement. Dr. Charles Lee of the FDA drug center’s office of compliance said that anabolic steroids “may have a range of serious adverse effects on many organ systems, and the damage may be irreversible,” according to Wall Street Journal. The FDA warned that these chemicals can also negatively impact cholesterol levels, increase the risk of heart attack and stroke, cause masculinity in women and lead to testicle shrinkage. Continue reading

Posted in Legal News | Tagged , , , , |

FDA Warns Wrinkle Cream Maker About Overstated Claims

FDA Warns Wrinkle Cream Maker About Overstated Claims

FDA Warns Wrinkle Cream Maker About Claims

The Food and Drug Administration (FDA) is warning the beauty industry about some of the claims being made for some of its products. Five warnings letters have gone out to companies since November.

The most recent warning letter went out to StriVectin, whose wrinkle creams are sold by a wide range retailers, including Costco and Nordstrom, the Today show reports. The FDA objects to language in the ads that makes the products seem like drugs, not cosmetics. The language includes Continue reading

Posted in Defective Products | Tagged , , , , |

FDA Should Ban Dietary Supplements, Senator Schumer Says

FDA Should Ban Dietary Supplements, Senator Schumer Says

FDA Should Ban Dietary Supplements, Senator Schumer Says

On Sunday, United States Senator Chuck Schumer called on the U.S. Food and Drug Administration (FDA) to ban dietary supplements, WHEC Rochester reports. Schumer says the ban should be implemented due to evidence showing that popular supplement products contain hidden stimulants. Many products contain an addictive, amphetamine-like chemical that is not listed on the label, Schumer said. The senator emphasized that the unknown ingredient can be dangerous for users, and that the FDA should issue a recall.

A recent study published in the journal Drug Testing and Analysis identified a number of supplements containing BMPEA, a substance similar to amphetamine. Supplements found to contain the substance include Aro Black Series Burn, Black Widow, Dexaprine XR, Fastin-XR, Lipodrene Hardcore, Lipodrene Xtreme, Stimerex-ES and Yellow Scorpion. Researchers conducted the analysis after being unable to get answers from the FDA, who found BMPEA in nine out of 21 samples in a 2013 study but would not name the products. Continue reading

Posted in Defective Products, Health Concerns, Legal News, Pharmaceuticals | Tagged , , , , |

FDA Says Diabetes Drug Onglyza May be Linked to Higher Death Rate

FDA Says Diabetes Drug Onglyza Linked to Higher Death Rate

FDA Says Diabetes Drug Onglyza Linked to Death Rate

After conducting a preliminary review of data, the U.S. Food and Drug Administration (FDA) has issued a report indicating that AstraZeneca’s diabetes drug Onglyza may be linked with an increased rate of death. According to Reuters, an FDA advisory panel will meet on April 14 to discuss he risks of Onglyza and another similar drug.

Previous findings from the SAVOR trial, which was comprised of 16,000 patients taking Onglyza, showed that the drug was associated with an increased risk of hospitalization due to heart failure. The FDA reviewed the data and determined that the risk of heart failure is legitimate. Additionally, the FDA found that Onglyza may be linked to an increased risk of death from all causes. Even though the overall trial results did not point to an increased death risk, the agency’s review found that the drug may pose “a significantly increased risk of all-cause mortality,” upon further analysis. Continue reading

Posted in Legal News | Tagged , , , , |

FDA Says Some Generic ADHD Medications May Not be as Effective

FDA Says Some Generic ADHD Medications Not as Effective

FDA Says Some Generic ADHD Medications Not as Effective

The U,S, Food and Drug Administration (FDA) has raised questions about the effectiveness of two generic medications used to treat attention deficit hyperactivity disorder (ADHD). The agency said in November that generic versions of Concerta, the long-acting version of Ritalin, may not be “therapeutically equivalent” to the brand name and may not have the same benefits,

“Two of these generics, so to speak, were not exactly providing the same rate and extent of absorption of medicine that Concerta had,” said Dr. Andrew Adesman of Steven and Alexandra Cohen Children’s Medical, according to CBS. Continue reading

Posted in Legal News | Tagged , , , , |

© 2005-2014 Parker Waichman LLP ®. All Rights Reserved.