Featured Stories
What Action Will the FDA Take on E-cigarettes?

What Action Will the FDA Take on E-cigarettes?

As health and quality concerns trouble the e-cigarette industry, experts and the public await the Food and Drug Administration (FDA)’s action to regulate the devices.

Read More

EMA Seeks Stronger Pradaxa Guidance for Bleeding Side Effects

Regulators in Europe have again asked Boehringer Ingelheim, the manufacturer of the blood thinner Pradaxa, to update the drug’s label with additional information regarding Pradaxa bleeding side effects. According to the European Medicines Agency (EMA), the new guidance should include more specific information on when Pradaxa must not be used, ...

Read More

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 ...

Read More

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 ...

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.

Read More

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 ...

Read More

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. ...

Read More

Lawsuit Alleges Bi-Lateral DePuy ASR Hip Implant Resulted in Elevated Chromium and Cobalt Levels, Need for Revision Surgery

DePuy Orthopaedics and its parent, Johnson & Johnson, continue to be named in lawsuits by metal-on-metal hip replacement recipients who suffered severe injuries, including elevated chromium and cobalt levels, allegedly due to recalled ASR hip implant devices. Most recently, the national law firm of Parker Waichman LLP filed suit on ...

Read More

Medtronic Infuse Lawsuit Alleges Off-Label Use Cause Painful Complications

A man in Louisiana has filed suit against Medtronic Inc. over injuries allegedly cause by off-label use of its Infuse Bone Graft product. The plaintiff, who received Infuse during transforaminal spinal lumbar fusion surgery, claims that the bone growth protein caused unwanted bone growth along his spine, worsening the back ...

Read More

New York City Council Calls for Zadroga Act to be Renewed

New York City Council Calls for Zadroga Act to be Renewed

New York City Council members are calling for the Zadroga Act, which provides compensation and medical treatment to 9/11 victims, to be renewed. According to press release issued Jan. 7, a resolution was introduced by Council Member Margaret Chin, Council Speaker Melissa Mark-Viverito and Council Members Paul Vallone and I. ...

Read More

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 , , , |

Advocacy Groups Sue for Release of Clinical Trial Data for Hepatitis C Drugs

Advocacy Groups Sue for Release of Clinical Trial Data

Advocacy Groups Sue for Release of Clinical Trial Data


Two public health advocacy organizations have filed a lawsuit against the Food and Drug Administration (FDA) for release of clinical trial data for Gilead Sciences hepatitis C treatments.

Researchers and patient advocates have long fought with drug makers and regulators over access to such information, the Wall Street Journal reports. Continue reading

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

Study Shows Energy Drinks Can Lead to Caffeine Intoxication

Energy Drinks Can Lead to Caffeine Intoxication

Energy Drinks Can Lead to Caffeine Intoxication


The fact that energy drinks contain excessive amounts of caffeine comes as no surprise. But what are the chances that these popular beverages present real health risks? A study published in the journal Drug and Alcohol Dependence investigated this; the authors found that energy drinks may lead to caffeine intoxication, a clinical condition that could lead to death in rare instances. Signs of caffeine intoxication include nervousness, anxiety, insomnia restlessness, tremor, rapid heartbeat, pacing and gastrointestinal distress.

Caffeine is regulated by the U.S. Food and Drug Administration (FDA), but only for food products. A regular 12-ounce soda is allowed to contain a maximum of 71 milligrams of caffeine, but only has about 35 milligrams. Energy drinks manage to circumvent rules because they are considered dietary supplements, which fall outside of the agency’s jurisdiction. Furthermore, these beverages do not have to have warning labels as required of over-the-counter products. Continue reading

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

ADHD Treatment May Cause Permanent Skin Discoloration, FDA Warns

ADHD Treatment May Cause Permanent Skin Discoloration

ADHD Treatment May Cause Permanent Skin Discoloration


The Daytrana patch, a daily treatment for attention deficit hyperactivity disorder (ADHD), may cause permanent skin color changes, the Food and Drug Administration (FDA) warns.

The FDA added a new warning to the drug label to describe this skin condition, known as chemical leukoderma. The agency says patients and caregivers should watch for areas of lighter skin, especially under the drug patch, and immediately report changes to a health care professional. Patients should not stop using the Daytrana patch without first talking to a doctor. Continue reading

Posted in Defective Products, Pharmaceuticals | Tagged , , , , , |

© 2005-2015 Parker Waichman LLP ®. All Rights Reserved.