November 2010

North Carolina Dangerous Drug Lawsuit Involving Zometa and Aredia Results in $12.8M Verdict Against Novartis AG

November 29, 2010, by Michael A. DeMayo

A jury has awarded the family of Rita Fussman $12.8 million in their Winston-Salem, North Carolina dangerous drug lawsuit against Novartis AG. Fussman died of breast cancer in 2009. However, her family contends that prior to her passing she experienced more discomfort than she should have because the chemotherapy drugs Aredia and Zometa caused her to develop osteonecrosis of the jaw (ONJ), which involves the decaying of the jaw bone.

After three days of deliberations, the Winston-Salem jury found that Novartis did not adequately warn Fussman about the risks associated with taking the drugs. Her family’s North Carolina products liability case is the third one involving Zometa and ONJ to go to trial. A $3.2 million jury verdict was awarded in one case last year. A second trial ended with a jury verdict.

Currently, there are about 600 to 700 dangerous drug lawsuits filed against Novartis over its bone strengthening medicines and the increased ONJ risk that they allegedly create. ONJ can lead to decay, may require jaw removal surgery, and can also cause the patient’s death. Although Novartis started warning doctors in 2005 that these drugs can cause bone damage, the Fussman family contends that the drug maker knew about the dangerous as far back as the 1980’s. Fussman started taking Zometa in 2001.

Out of the $12.8 million Winston-Salem dangerous drug award, $12.6 million is for punitive damages and $287,009 is for compensatory damages. However, because the state has a punitive damages cap, Novartis will pay the plaintiffs about $1.1 million.

Jury awards $12.8M in bone-drug lawsuit, Winston-Salem Journal, November 25, 2010

Novartis Hid Risks to Protect Sales, Lawyer Says, Bloomberg, November 19, 2010

Related Web Resources:
Novartis AG

Osteonecrosis of the jaw



Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People

November 24, 2010, by Michael A. DeMayo

A new report published in BMJ, a British medical journal, is questioning the US Food and Drug Administration’s ability to keep defective and dangerous medical devices out of the market. The paper contends that inadequate manpower, an insufficient budget, lack of authority, and the agency’s co-opting by special interests, medical devices makers, and political forces are rendering the FDA unable to do its job to protect the public.

The authors of the study, Dartmouth Institute for Health Policy and Clinical Practice instructor Shannon Brownlee and medical investigative journalist Jeanne Lenzer, talk about the deficiencies in the FDA’s post-approval surveillance process. For example, since the agency approved the vagus nerve stimulator (VNS) by Cyberonics 13 years ago, there have been reports of approximately 900 deaths involving people that used the medical device. The FDA still does not know what caused these fatalities or if a VNS even was a cause of death. Some 60,000 people are currently using a VNS, which is designed for treating epilepsy and is also approved treating depression. Cyberonics is seeking to widen the approval for VNS so that it can be used for treating traumatic brain injury, stroke, and obesity.

Recently, the FDA took back its approval of the Menaflex Collagen scaffold knee replacement device. The agency admitted that it approved the medical device without properly researching it because of political pressure and the flexible requirements that exist to fast-track certain devices. Under the 510(k) program, new medical devices can be approved quickly if their makers can show that the product works in the same that other medical devices currently in the market do.

In August, DePuy Orthopaedics recalled about 93,000 artificial hips over concerns that the medical devices had a 12 – 13% failure rate. Metal particles from the implants have also been known to cause cobalt toxicity.

Our Charlotte, North Carolina defective medical device lawyers know that it can be very upsetting to discover that you or your loved one developed health issues or now have to undergo yet another medical procedure because the manufacturer of your medical device was negligent.

Is the FDA doing its job?, Washington Post, November 3, 2010

Why the FDA can’t protect the public, BMJ, November 2010

FDA Determines Knee Device Should Not Have Been Cleared for Marketing, FDA, October 14, 2010

DePuy ASR Hip Replacement Products Recalled, North Carolina Injury Lawyer Blog, September 16, 2010

Related Web Resources:
US Food and Drug Administration

VNS Therapy, Cyberonics

Dangerous Drug Lawsuit Involving Levaquin and Ruptured Tendons Will Go to Trial

November 22, 2010, by Michael A. DeMayo

Edward Karkoska’s dangerous drug lawsuit against Johnson & Johnson, the makers of Levaquin, will go to trial, ruled a federal judge—despite efforts by the manufacturer and subsidiary Ortho-McNeil Pharmaceutical Inc. to have the case dismissed. Karkoska maintains that if there had been more information available about the side effects linked to the antibiotic, his doctor would have prescribed a different medication.

Karkoska is not the only person to sue Johnson & Johnson over claims of injuries sustained from taking Levaquin. He is also not the first to claim that he ruptured his tendon because of the drug. The plaintiffs have contended that if the drug manufacturer had taken greater pains to let people know about the dangerous side effects that could result from taking Levaquin, their injuries would not have happened.

Levaquin was approved by the Food and Drug Administration in 1996. The drug is used to prevent bacterial infections of the kidneys, skin, bladder, sinuses, prostate, as well as infections related to pneumonia and bronchitis. Over the years, evidence has mounted that the medication can also damage the body’s tendons. A black box warning was issued for the antibiotic in 2008, yet many doctors are still not aware that ruptured tendons is a possible side effect.

Other serious Levaquin side effects:
• Diarrhea
• Seizures
• Dizziness
• Joint pain or swelling
• Dark urine
• Yellow or pale skin
• Easy bleeding or bruising
• Skin rash
• Fever

Our Charlotte, North Carolina dangerous drug lawyers are committed to fighting for our clients’ right to injury recovery from a negligent drug manufacturer. Unfortunately, even medications that have been FDA-approved can be dangerous to ingest.

Levaquin Lawsuit Proceeds To Trial Over Ruptured Tendons,, August 6, 2010


Related Web Resources:
Read Pretrial Order #4 (PDF)

US Food and Drug Administration

North Carolina Nursing Home Negligence?: Facility Investigated Following Five Patient Deaths from Hepatitis B

November 16, 2010, by Michael A. DeMayo

Public health investigators have been looking into whether the use of unclean or shared diabetes testing equipment caused at least eight patients to contract hepatitis B GlenCare Mount Olive center the GlenCare of Mount Olive. Five of the patients passed away last week. The average age of those who developed the virus is 70. This week, the state released its findings.

According to the NC Division of Public Health, certain staff members did not receive proper training on how to take care of diabetic patients and the assisted living facility violated resident rights. The virus was spread because blood monitor meters used for diabetes testing that had come into contact with tainted blood.

During the probe, a medication tech had indicated that adjustable lancing devices had been used on more than one patient and that the devices, as well as glucometers, were not routinely disinfected or cleaned in between uses. Also, nursing home employees reported that they were only allowed to use one box of gloves a shift, which forced them to have to buy their own additional gloves.

Hepatitis B
The Centers for Disease Control says that hepatitis B serious disease can impact the liver, resulting in diarrhea, appetite lose, jaundice, tiredness, vomiting, stomach pain, and joint and muscle aches. People with diabetes have a 15 times greater chance of developing acute hepatitis B.

It is the responsibility of nursing homes to make sure that they provide residents with the proper medical, nursing, and daily care, while protecting them from North Carolina nursing home abuse, neglect, and negligence. This includes making sure that the patients are not exposed to any unsafe or unsanitary conditions that could cause them to become even more ill or die.

Officials Release Findings In GlenCare Investigation,, November 16, 2010

Unclean procedures likely caused 5 hepatitis B deaths at nursing home, NewsObserver, November 12, 2010

Report: Unsafe practices led to fatal NC outbreak, NECN, November 12, 2010

Related Web Resources:
NC Divison of Public Health

Hepatitis B, eMedicineHealth

North Carolina Personal Injury: A Free Step-by-Step Guide for Victims and Their Families

November 11, 2010, by Michael A. DeMayo

Our Charlotte, North Carolina injury lawyers at the Law Offices of Michael A. DeMayo, L.L.P. know how confusing and scared you must feel now that you or a loved one has been involved in an accident. To help you get through this stressful and challenging time, we have written a book called “Carolina Injury Law: A Reference Guide for Accident Victims” that is available for free to all South Carolina and North Carolina residents. This step-by-step guide was created to answer many of your questions about the claims process and provide you with information on how to best pursue your financial recovery from a responsible party.

In the book, Our Monroe, North Carolina personal injury attorneys will walk you through the process, provide you with concise and clear information about your legal rights, and offer valuable insights about a number of topics, including:

• Basic insurance concepts
• Dealing with underinsured and uninsured motorists
• Workers’ compensation
• Understanding your injuries
• Understanding damages
• Choosing a lawyer
• What to expect as a plaintiff
• When to file a lawsuit
• The litigation process
• Settling your case
• Your personal injury trial

The Law Offices of Michael A. DeMayo, LLP has locations in the North Carolina cities of Charlotte, Monroe, Hickory, and Lumberton. We represent clients and their families in North Carolina and South Carolina whose cases involve personal injury, wrongful death, workers’ compensation, nursing home abuse and neglect, and social security disability.

Our Lumberton, North Carolina injury lawyers have worked with 10 other US law firms to provide you with this invaluable public service resource. To receive your free copy, send an e-mail request that includes your name and address to Kristine Woolley at or download a free copy at

$200,000 North Carolina Injury Settlement Reached with Roommate of Teen Who Was Fatally Shot by Sheriff’s Corporal

November 5, 2010, by Michael A. DeMayo

A North Carolina personal injury settlement has been reached between Michael Rhoton and New Hanover County. Rhoton is accusing Sheriff Ed McMahon, ex-Sheriff Sid Causey, other office members, and the county’s insurer of failing to follow proper procedures when a warrant was served to his roommate Peyton Strickland on December 1, 2006. Strickland, a suspect in the robbery of a University of North Carolina Wilmington student’s Sony PlayStation 3 game consoles, was accidentally shot in the head by Cpl. Christopher Long, who didn’t realize that what sounded like gunshots was in fact a battering ram.

Rhoton saw his roommate get shot multiple times. The heavily armed law enforcement team then allegedly held a gun to Rhoton’s head while forcing him to stay on the ground next to Strickland, who was dying. The officers also shot and killed Strickland’s dog.

Rhoton, who was never a suspect in the robbery, was held in custody overnight. His North Carolina injury attorney says that Rhoton has been dealing with trauma, survivor’s guilty, and post-traumatic stress issues. Rhoton’s North Carolina excessive use of force lawsuit against the UNCW’s police department is still pending.

In 2008, Strickland’s family settled their wrongful death case over the deadly shooting with the county for $2.45 million.

North Carolina Excessive Use of Force
It is not acceptable for someone to get hurt or die because a law enforcement official used excessive force when dealing with him/her. There are less violent ways to apprehend or question or hold a suspect. Unfortunately, North Carolina police brutality and excessive use of force do happen.

New Hanover County pays roommate of fatal shooting victim Strickland, StarNewsOnline, November 2, 2010

Sheriff’s department settles with Strickland family, WWAY, February 27, 2008

Related Web Resources:
New Hanover County

University of North Carolina Wilmington Police Department


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