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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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Knee Replacement Patients Should Consider Nickel Allergies before Surgery

Individuals considering undergoing knee replacement surgery should ask their doctors to run a test to determine if they have a nickel allergy. Determining if a patient suffers from a nickel allergy will ensure the right knee implant is chosen for their surgery, and possibly save them from considerable pain and ...

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Cancer Groups Issue Statement for Regulation of E-cigarettes

Cancer Groups Issue Statement Calling for Research and Regulation of E-cigarettes

The American Society of Clinical Oncology & the American Association for Cancer Research are calling on the government to regulate e-cigarettes.

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Study Finds Plavix May Only Benefit Smokers

An emerging study finds that blood thinner Plavix may only benefit smokers. Plavix (clopidogrel) is prescribed for the prevention of blood clots and heart attacks, and has been linked to serious side effects, including the heart attacks and strokes it is supposed to prevent, gastrointestinal and cerebral bleeding, bleeding ulcers, ...

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FDA Urged to Ban Powdered Caffeine

FDA Urged to Ban Powdered Caffeine

Pennsylvania Senator Robert Casey has written to the Food and Drug Administration (FDA) to urge the agency to ban powdered caffeine, a dietary supplement.

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Study Finds Metal-on-Metal Hip Implants Associated with High Incidence of Pseudotumors

Yet another study is adding to concerns about the potential dangers associated with metal-on-metal hip implants. The study, published in the Journal of Bone and Joint Surgery, found that large diameter metal-on-metal total hip replacement may be associated with a substantially higher incidence of pseudotumor formation.

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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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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.

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Study Suggests Hormonal Contraceptives Linked to Brain Tumor

Study Suggests Hormonal Contraceptives Linked to Increased Brain Tumor Risk

A study of Danish women of reproductive age suggests that long-term use of hormonal contraceptives is associated with an increased risk of brain tumors.

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Scientist Calls for Federal Regulations for Fracking Pollution

Hydraulic fracturing (fracking) drilling should be governed by federal regulations because its pollution has no awareness of state boundaries.

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Oklahoma Court Rules Homeowners Can Sue Oil and Gas Companies Over Earthquake Damage

In a 7-to-0 ruling last week, the Oklahoma State Supreme Court is allowing homeowners who have sustained injuries or property damage from earthquakes blamed on oil and gas company drilling operations to sue for damages in state courts.

This ruling is the first in which the court has specifically addressed whether homeowners could sue for damage believed to be caused by the massive amounts of wastewater injected into the ground by oil and gas drilling in the hydraulic fracturing—fracking—process, the New York Times reports. Continue reading

Posted in Hydraulic Fracturing / Fracking, Legal News |

Cough-and-Cold Medicine Containing Codeine May Lead to Breathing Problems in Kids

Cough/Cold Medicine with Codeine Lead to Breathing Problems

Cough/Cold Medicine with Codeine Lead to Breathing Problems


Cough and cold medicines that contain codeine are being investigated by the U.S. Food and Drug Administration (FDA) for serious side effects in children, including breathing troubles. The agency stated in a safety alert that it was investigating the opioid because it may be released to slowed or difficult breathing in children under the age of 18. Children may be more at risk for these side effects, especially if they are already predisposed to breathing problems.

Codeine is an opioid that is often found in combination with other drugs in over-the-counter (OTC) cough-and-cold medicines. It is used to reduce coughing and mild to moderate pain. The FDA said it “will continue to evaluate this safety issue and will consider the EMA recommendations. Final conclusions and recommendations will be communicated when the FDA review is complete.” according to the July 1st safety alert. Continue reading

Posted in Legal News | Tagged , , , , |

Open Payments Database Details Payments made between Industry and Doctors for 2014

Open Payments Database Details published

Open Payments Database Details published


On Tuesday, the federal Center for Medicare and Medicaid Services published the federal Open Payments database for 2014 detailing payments between medical device companies and doctors and hospitals. According to Star Tribune, this is the second year that such data has been published. The data was released under the Open Payments program, which was created by the Sunshine Act provisions of the Affordable Care Act in an effort to create transparency and prevent large companies like Medtronic from using financial incentive to influence medicine.

According to Star Tribune, data looking at payments $1 million or greater showed that Medtronic PLC and St. Jude Medical paid a combined $81 million to eight doctors across the country. The database indicates that Minnesota device makers paid over $211 million to doctors and hospitals for reasons not related to research. For the first time, data revealed 99 percent of submitted payment information. Last year’s data redacted more than a third of the information. Continue reading

Posted in Legal News | Tagged , , , |

Doctor Urges FDA not to Loosen Restrictions on Drug Company Marketing

Doctor Urges FDA not to Loosen Restrictions on Marketing

Doctor Urges FDA not to Loosen Restrictions on Marketing


A Harvard medical professor has urged the Food and Drug Administration (FDA) against easing the restrictions on drug companies marketing their drugs for uses for which they have not been approved—so-called off-label use.

During the summer of 2015 the FDA will hold a public meeting to discuss whether restrictions on what claims drug manufacturers can make about their products improperly infringes the liberty of those companies, HealthNewsReview reports. Dr. Jerry Avorn, chief of the Division of Pharmacoepidemiology and Pharmacoeconomics at Boston’s Brigham and Women’s Hospital, writing in the Annals of Internal Medicine, argues that patients and doctors need the “sovereign” power of the FDA to regulate what claims drug makers can make. Continue reading

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

After Analyzing Data on Liquid Nicotine Poisoning, FDA Proposes Warnings and Child-Proof Packaging

FDA Proposes Child-Proof Packaging on Liquid Nicotine

FDA Proposes Child-Proof Packaging on Liquid Nicotine


The U.S. Food and Drug Administration (FDA) is looking to take regulatory action over liquid nicotine, which is used in electronic cigarettes. On Tuesday, the agency “issued an Advance Notice of Proposed Rulemaking (ANPRM) seeking comments, data, research, and/or other information related to nicotine exposure warnings and child-resistant packaging for liquid nicotine, nicotine-containing e-liquid(s), and potentially for other tobacco products including, but not limited to novel tobacco products such as dissolvables, lotions, gels, and drinks.”

The proposal is open to public commentary for 60 days. The FDA has evaluated data on liquid nicotine and its risks, particularly for accidental exposure among infants and children. The agency notes that as e-cigarettes have become more popular, the number of calls to poison control centers and emergency room visits related to liquid nicotine have increased. Based on this data, the FDA wants more input as to whether it should place warnings about nicotine exposure or require some tobacco products to be sold in child-resistant packaging. Continue reading

Posted in Legal News, Toxic Substances | Tagged , , , , |

Class I Recall Issued for Zimmer Hip Replacement Parts

Recall Issued for Zimmer Hip Replacement Parts

Recall Issued for Zimmer Hip Replacement Parts


A Class I recall has been issued for certain Zimmer M/L Taper with Kinectiv Technology Femoral Stems and Necks, the U.S. Food and Drug Administration (FDA) announced recently. The agency said the recall was issued because the parts may have “unexpected amounts of manufacturing residues”. The Class I designation is reserved for recalled devices that present a reasonable risk of serious injury or death.

According to the FDA notification, the recalled devices contain higher than expected amounts of residue due to a a process monitoring failure. “These residues can cause serious adverse health issues including allergic reactions, pain, infections, or death. Use of these products may require the need for a revision surgery to replace the affected implant.” Continue reading

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

OtisMed CEO Receives Prison Sentence in Distribution of Defective Knee Devices Scheme

OtisMed CEO Receives Prison Sentence

OtisMed CEO Receives Prison Sentence


The U.S. District Court of the District of New Jersey sentenced former OtisMed Corporation chief executive officer, Charlie Chi, to 24 months in prison for his involvement in the distribution of “adulterated” medical devices.

In December 2014, OtisMed agreed to pay more than $80 million to resolve criminal and civil liability related to distributing adulterated medical devices with intent to defraud and mislead. At that time, Chi pleaded guilty to introducing adulterated medical devices into interstate commerce. Chi will also serve one year of supervised release and pay a $75,000 fine, the Imperial Valley News reports. Continue reading

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

Fireworks Safety Tips and Spray Sunscreen Warning Offered for 4th of July

Fireworks Safety Tips & Spray Sunscreen Warning

Fireworks Safety Tips & Spray Sunscreen Warning


As families prepare to enjoy 4th of July festivities, federal agencies have issued safety alerts about spray-on sunscreens and fireworks.

The Consumer Product Safety Commission (CPSC) issued its annual list of tips for safe use of fireworks and the Food and Drug Administration (FDA) was warned about spray-on sunscreens. Continue reading

Posted in Accident, Health Concerns | Tagged , , , , |

Drug Dispenser have 4 More Months to Comply with DSCSA Regulations

Drug Dispenser have 4 Months to Comply with DSCSA

Drug Dispenser have 4 Months to Comply with DSCSA


Pharmacies have an additional four months to meet track and trace requirements under the Drug Supply Chain Security Act (DSCSA), Regulatory Affairs Professionals Society (RAPS) reports. The DSCSA is under the Drug Quality and Security Act (DQSA) signed into law in 2013 and seeks to keep track of drug products in the supply chain nationwide. The U.S. Food and Drug Administration (FDA) has extended the deadline from July 2, 2015 to November 1, 2015 in response drug dispensers’ requests. The agency said it would use its “enforcement discretion” to allow more time even though the statutory date of compliance remains the same.

The DSCA requires drug packages to carry a unique serial number so that they can easily be tracked by federal regulators. This allows the FDA to more easily pinpoint the source of a problem and reduce the risk of counterfeit products. Every entity in the supply chain must keep track of the packages through this system. Continue reading

Posted in Legal News | Tagged , , , |

In DaVita Whistleblower Case, Doctor and Nurse May Receive Over $110 Million

DaVita Whistleblower Doctor & Nurse to Receive Over $110M

DaVita Whistleblower Doctor & Nurse to Receive Over $110M


Two whistleblowers, a doctor and nurse in Atlanta, could receive more than $110 million for exposing alleged fraud by DaVita Healthcare Partners, the largest dialysis provider in the country. According to their lawsuit, the company intentionally wasted drugs in order to receive reimbursements from the federal government. Before 2011, the Centers for Medicare and Medicaid Services reimbursed dialysis providers for drug wastage from single-use vials. The whistleblowers alleged that DaVita instructed staff to use unnecessarily large vials of the vitamin D supplement Zemplar and the iron drug Vanofer. The scheme allegedly cost taxpayers hundreds of millions.

According to a Department of Justice (DOJ) press release dated June 24th, DaVita paid $450 million to resolve the allegations. The release noted that DaVita reduced its wastage substantially after the Centers for Medicare and Medicaid Services changed its reimbursement policy in 2011 and “wastage derived from single-use vials was no longer profitable “ Continue reading

Posted in Legal News | Tagged , , , |

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