A study released on Tuesday shows that the number of cases where serious health issues (including personal injury and wrongful death) were caused by prescription medication has increased dramatically between 1998 and 2007.

In 1998, the Food and Drug Administration (FDA) reported 34,966 incidents where someone experienced adverse reactions to drugs. This year, the figure was 89,842. The study can be found in the Archives of Internal Medicine.

The FDA defines serious side effects to drugs as including resulting birth defect, wrongful death, hospitalization, or disability. The study results come from reports made by drug makers to the FDA.

Close to 1500 drugs were named for causing serious health injuries to users. Painkillers was responsible for a large number of health problems. The drug ranked number one as a cause of death over the eight-year time frame was Oxycodone, which was held responsible for 5,548 fatalities. The study can be found in the latest issue of the Archives of Internal Medicine.

Every year, millions of people in the U.S. take prescription drugs and over the counter medicines to treat different health problems and medical conditions or to stay healthy. It is unfortunate that the use of certain medications have lead to serious injuries, health problems, and the death of many users.

Here is a list of some of the potentially serious and deadly side effects that can occur from a “dangerous” drug:

• Vomiting
• Stroke
• Heart attack
• Insomnia
• Kidney failure
• Birth defect
• Memory loss
• Hypertension
• Stomach aches
• Death

It is frequently not until after many victims are injured or killed because of a particular pharmaceutical drug that a drug recall is issued.

Over the years, victims of the following defective drugs have filed dangerous drug claims and lawsuits against manufacturers or other liable parties:

• Celebrex
• ReNu
• Trileptal
• Ortho Evra
• Fosamax
• Vioxx
• Bextra
• Fen Phen
• HRT
• PPA

Bad reactions to prescription drugs soar, The Washington Times, September 11, 2007

Related Web Resources:

Archives of Internal Medicine

Dangerous Prescription, PBS.org

Although a Food and Drug advisory panel is recommending that labels on bisphosphonate drugs clarify how long a patient should take them for, the panel refrained from specifying any actual time limits. The panel met because of growing concerns that using a bisphosphonate drug long-term—more than three to five years—can cause jaw bone death and thigh bone and femur fractures in women. Please contact our Charlotte, North Carolina Fosamax law firm if you are someone who has been taking bisphosphonates and developed Osteonecrosis of the jaw or suffered a bone fracture.

Bisphosphonates are often prescribed to treat osteoporosis. Fosamax, Aclasta, Reclast, Actonel, Boniva, and Altevia are examples of bisphosphonate drugs. While the FDA advisory panel acknowledged the unusually high rate of thigh fractures in women who had been taking Fosamax and other bisphosphonates for a number of years was unusually high, it also noted that there isn’t enough data available for it to make specific recommendations.

Osteonecrosis of the jaw
Also known as dead jaw, ONJ involves the death of jawbone tissue. This can lead to exposed bone, teeth loss, swelling, infection, and pain in the gum and jaw, jaw numbness, loss of sensation, gum loss, and the eventual collapse of the bone area. More than 125 ONJ cases have been linked with bisphosphonate drug use. Some researchers say that bisphosphonates stop new blood vessels from forming in the jawbone tissue.

Fractures
Considering that bisphosphonates are supposed to make bones stronger, if they are in fact actually weakening the bones, then the drug is causing damage. A number of women have come forward claiming that their femur bones snapped suddenly while they were walking. In some instances, the damage to the bones was more severe than one would typically see from this type of incident. Symptoms of a possible femur fracture can include:

• Serious pain
• Deformation in the leg area
• Tissue swelling
• Leg immobility
• Bone fragments coming through the skin

Esophageal Cancer
There is also concern that bisphosphonates increase the chance of a user developing esophageal cancer, which hits the channel in the body through which food travels to the stomach. However, there is conflicting information about that at this time. There is usually no cure for esophageal cancer.

Over 1600 Fosamax fracture complaints have already been filed.

North Carolina Dangerous Drugs
Drug makers must warn of any serious side effects that taking their medication can cause. Failure to warn of side effects or dangerous that result in serious health complications can be grounds for a North Carolina products liability lawsuit.

Our Charlotte, North Carolina defective products law firm can help you determine if your bone condition is a result of taking Fosamax or another bisphosphonate. If so, you may be entitled to North Carolina personal injury compensation from Merck, which makes Fosamax, or the manufacturer of any other bisphosphonate drugs that you may have been taking.

Fosamax Scare: Those With Osteopenia Gauge Risk, ABC News, March 10, 2010

FDA panel unclear on osteoporosis drug labels, CBS News, September 12, 2011

Related Web Resources:
Bisphosphonates, FDA

ONJ, Rheumatology.org

More Blog Posts:
North Carolina Dangerous Drug: Wrongful Death Lawsuit Blames Yasmin and Ocella Contraceptives for Daughter’s Fatal Pulmonary Embolism, North Carolina Injury Lawyer Blog, June 21, 2011

Yaz Lawsuit Seeks Damages for Wrongful Death Teen Who Went into Cardiac Arrest While Attending Elon University in North Carolina, North Carolina Injury Lawyer Blog, May 16, 2011

Another Dangerous Drug?: Woman Claims Humira Caused Permanent Nerve Damage, North Carolina Injury Lawyer Blog, April 30, 2011

Scott Prewitt is seeking North Carolina wrongful death and products liability damages from Bayer, Teva Pharmaceuticals, and Intendis. He is also suing Dr. William Bryan III, Asheville Children’s Medical Center, and Kelly Klaaren for North Carolina medical negligence. Prewitt’s 15-year-old daughter, Brittany Nicole died from a pulmonary embolism while taking birth control pills to treat her acne. A doctor had prescribed the medication to her.

Brittany Nicole was just 13 when she started taking Yasmin. The following year, the same dermatologist who had prescribed that birth control pill started prescribing Ocella, which is a generic form of Yasmin, instead.

Although the USDA has approved Yasmin for contraception, the pill is not approved for treating acne. While doctors are allowed to prescribe the medication for off-label purposes, the drugs’ manufacturers are not supposed to promote the drug for these uses. Prewitt claims that Bayer did just that when marketing Yaz to dermatologists and ignored the risks involved. He also says that he and his family read and watched media that led them to conclude that it would be safe for Brittany Nicole to use Yasmin and its sister contraceptive Yaz.

Prewitt is also claiming North Carolina medical negligence against Dr. Bryan, who saw his daughter after her knee became red and swollen on June 4, 2009. The doctor diagnosed her symptoms as “superficial cellulitis.” About two weeks later, physician assistant Kelly Klaaren looked at Brittany’s rash and diagnosed her with dermatitis. The teenager collapsed nine days later and was pronounced dead.

Drug manufacturers must follow FDA regulations. They also must make sure that they market the medications in a way that doesn’t prove dangerous and let consumers and medical providers know if there are any risks involved. Failure to do either of this can be grounds for a North Carolina products liability case.

Taking the Pill for Acne Was Fatal, Dad Says, Courthouse News, June 20, 2011

Related Web Resources:
US Food and Drug Administration

Yasmin

More Blog Posts:
Yaz Lawsuit Seeks Damages for Wrongful Death Teen Who Went into Cardiac Arrest While Attending Elon University in North Carolina, North Carolina Injury Lawyer Blog, May 16, 2011

Another Dangerous Drug?: Woman Claims Humira Caused Permanent Nerve Damage, North Carolina Injury Lawyer Blog, April 30, 2011

Republicans Propose Bill Protecting Drug Makers from North Carolina Products Liability Lawsuits, North Carolina Injury Lawyer Blog, March 29, 2011

The family of Michelle Pfleger has filed a products liability lawsuit against Bayer over her wrongful death. The 18-year-old was attending Elon University in North Carolina when she a blood clot went into her lungs, causing her to go into cardiac arrest and die. The plaintiffs contend that the incident was triggered by Plfeger’s use of the Yaz birth control pills for her acne.

In their Yaz lawsuit, Plfeger’s family claims that the pill doesn’t come with adequate warnings about the risks involved with taking it. It was just recently that two studies in the British Medical Journal reported a link between oral contraceptives that contain the hormone drospirenone and a higher risk of blood clots in women compared to those taking birth control pills with the hormone levonorgestrel. Yaz contains drospirenone, as does the Yasmin birth control bill. Both drugs are from Bayer. The drug manufacturer has dismissed these findings.

Some 7,000 products liability lawsuits have been filed by women accusing Bayer of failing to properly warn about the risks of certain serious side effects. Over 50 deaths linked to Yaz and Yasmin were reported to the Food and Drug Administration between 2004 and the third quarter of 2008.

Other side effects linked to Yaz and Yasmin:
• Stroke
• Pulmonary embolism
• Heart attack
• Gallbladder disease
• Liver damage
• Deep vein thrombosis
• Anaphylactic shock
• Migraines
• Weight gain
• Higher level of potassium in the blood
• Hair loss

A North Carolina dangerous drug lawsuit can allow you to hold a drug manufacturer liable for personal injury or wrongful death.

Bayer faces US lawsuit over contraceptive, AFP, May 11, 2011

Mother of Elon student sues Bayer over daughter’s death, The Business Journal, May 11, 2011

Related Web Resources:
Bayer

Yaz

Warning: Letter, FDA

British Medical Journal


More Blog Posts:
Another Dangerous Drug?: Woman Claims Humira Caused Permanent Nerve Damage, North Carolina Injury Lawyer Blog, April 30, 2011

Topamax as a Dangerous Drug?: FDA Warns of Possible Birth Defect Risk, North Carolina Injury Lawyer Blog, March 26, 2011

GlaxoSmithKline Settles Dangerous Drug Lawsuit Over North Carolina Wrongful Death of Man from Taking Avandia, North Carolina Injury Lawyer Blog, January 31, 2011

A woman is suing Abbot Laboratories for products liability because of personal injuries she says she sustained from Taking Humira. She claims that the drug, which she took for Crohn’s disease, caused permanent nerve damage in her feet.

The plaintiff, Kara Mae Pletan said that she began to develop small fiber peripheral neuropathy three months after she started taking Humira injections. Because of the “stabbing pains and hypersensitivity” in the 32-year-old’s feet, she had to sell her family’s retail furniture store because she could no longer do her job. She also is now unable to take part in outdoor activities.

Pletan contends that even before Abbott started marketing the drug to Crohn’s disease patients, the drug manufacturer knew that the medication could cause peripheral neuropathy. Her lawyer says that Abbott has downplayed Humira’s serious side effects.

Peripheral Neuropathy
• Can cause pain and numbness in the feet and hands
• Typically creates a painful sensation that feels like burning or tingling
• Loss of sensation may cause the person to feel like he/she is wearing a glove or stocking

Initially sold as a drug for rheumatoid arthritis, Humira is now approved by the US Food and Drug Administration for five autoimmune diseases, including Crohn’s diseases. Last year, worldwide sales of Humira was $6.5 billion

Pletan is not the only person to sue Abbott over Humira. In January, plaintiff Gayathri Murthy blamed her lymphoma on the drug, which she took for arthritis. Another plaintiff who has arthritis, Maureen Calisi, also has said Humira caused her cancer.

North Carolina Dangerous Drug Lawsuits
If you believe that taking Humira caused you or your loved one to develop health complications, you should find out about your legal options for filing a North Carolina dangerous drug lawsuit.

Abbott Labs Sued on Claim Humira Caused Lasting Nerve Damage, Bloomberg, April 26, 2011

Arthritis ‘Miracle’ Drug Caused Breast Cancer, Suit Charges, Consumer Affairs, April 19, 2011

Related Web Resources:
Peripheral neuropathy, Mayo Clinic

Humira, NIH.gov

Humira

Related Web Resources:
Republicans Propose Bill Protecting Drug Makers from North Carolina Products Liability Lawsuits, North Carolina Injury Lawyer Blog, March 29, 2011

Topamax as a Dangerous Drug?: FDA Warns of Possible Birth Defect Risk, North Carolina Injury Lawyer Blog, March 26, 2011

GlaxoSmithKline Settles Dangerous Drug Lawsuit Over North Carolina Wrongful Death of Man from Taking Avandia, North Carolina Injury Lawyer Blog, January 31, 2011

Under the House version of a North Carolina medical malpractice reform bill, a person injured by a drug that had been approved by government regulators would not be able to file a North Carolina dangerous drug lawsuit against manufacturer. The bill is part of a larger tort reform package that wants to cap noneconomic damages at $250,000 and for the amount that is awarded to be adjusted every three years to reflect the Consumer Price Index. Our Charlotte, North Carolina injury lawyers will continue to monitor the developments surrounding this issue, which will have an effect on medical malpractice victims.

Exempt from the proposed immunity would be drug makers that continued selling a medication even after the government ordered that it be taken off the market, as well as those that bribed a government official to get the drug approved or misrepresented/purposely kept information so that the government would approve the drug. Also, as with Senate Bill 33, the House bill only allows emergency room doctors to be held liable for North Carolina medical malpractice if he/she acted in grossly negligent manner.

North Carolina House Republicans are also pushing for the state to be able to take 3/4ths of any punitive damages over $100,000 awarded by a jury. The money would be placed in a state fund supporting public schools.

Dangerous Drug Lawsuit
Our Charlotte, North Carolina dangerous drug lawyers are well aware of the serious injuries and health issues that can result because a patient took a dangerous or defective medication. Drug manufacturers have a responsibility to make sure that their products are safe for use. They must also provide adequate warning of dangerous side effects and possible adverse reactions. If their drug contributed to causing North Carolina personal injury or wrongful death, then they should be held liable.

House bill would shield drug makers, NewsObserver, March 24, 2011

North Carolina Bill To Restrict Product Liability Suits, Pharmalot, March 24, 2011

Related Web Resources:
Read the Tort Reform Draft Bill, Representatives Rhyne and McComas (PDF)

Food and Drug Administration

Following new data indicating that babies born to women who were pregnant when Topamax are at higher risk of developing a cleft palate, the U.S. Food and Drug Administration has decided to strengthen the warning labels that come with the drug. Topamax’s generic equivalents will also get new labels. If you think there is a possibility that your child may have developed a birth defect or another serious health injury or issue from taking Topamax, you should contact our Charlotte, North Carolina dangerous drug law firm right away.

Per the new data, from the North American Antiepileptic Drug Pregnancy Registry, topiramate, which is the main ingredient in Topamax, can increase the risk of oral clefts in babies during the first trimester of a woman’s pregnancy by more than 20 times.

Other possible serious side effects:

• Other types of craniofacial defects affecting the oral cavity
• Genital birth defects
• Limb malformation
• Greater risk of spina bifida
• Persistent pulmonary hypertension
• Hypospadias
• Genital birth defects
• Congenital birth defects

Johnson & Johnson (JNJ) is the parent company of Ortho-McNeil Pharmaceutical LLC, which makes this anti-seizure/anti-migraine drug. It was just last year that two subsidiaries of Johnson & Johnson consented to paying over $81 million to settle claims by the Justice Department that they had illegally marketed Topamax to facilitate weight loss and treat bipolar disorder, alcohol dependency, and other off-label conditions that the FDA had not yet approved. A number of whistleblower complaints had also been filed accusing doctors of receiving payments to push Topamax for off-label purposes.

The FDA wants doctors and other medical professionals to make sure that they warn women of childbearing age about the risks associated with taking Topamax when prescribing it.

UPDATE: FDA Strengthens Topamax Warning On Evidence Of Birth Defects, The Wall Street Journal, March 4, 2011

Moms-to-Be: Are You Taking This Dangerous Drug?, HuffPost, March 14, 2011

Related Web Resources:
Topamax

FDA

Cleft Palate Foundation

According to a report in the Archives of Internal Medicine, there are questions as to whether the Food and Drug Administration is doing a good enough job of protecting Americans from defective medical devices. This is obviously an issue of concern for patients, as well as for our Charlotte, North Carolina defective medical devices attorneys who are familiar with how dangerous faulty/malfunctioning devices can be for patients.

Researchers looked at 113 devices that the FDA recalled between 2005 and 2009. The recalls were issued because of the health risks the devices posed. It now appears that 71% of these devices were approved without ever being tested on people—primarily because they were considered similar enough to at least one other product already in the marketplace. Just 19% of the products had to go through tougher review.

The FDA’s less strict approval process, which attempts to get medical devices out there sooner rather than later, is hurting patients. Yet, according to the Washington Post, seeing as over 19,000 medical devices were approved during those four years, there really weren’t that many recalls issued. FDA spokeswoman Karen Riley noted that many people have benefited from the approval of many of these medical devices. She did also say, however, that the researchers’ findings show a need for better safeguards. The agency is making 25 changes to ensure this.

While it is true that medical devices can save lives, defective ones have also been a source of serious injury and death. It is important that manufacturers make sure their products are safe before releasing them into the market and that the government does its job by checking to make sure a medical device is safe before placing its stamp of approval on it.

Examples of defective medical devices:

• DePuy Hip Replacement Systems
• Guidant Cardiac Defibrillator
• Medtronic Defibrillators
• Duragesic Pan Patch
• Nuvaring
• Knee Implants
• Guidant Pacemakers

Study of recalled medical devices faults lax FDA testing methods, The Washington Post, February 15, 2011

Medical Device Recalls and the FDA Approval Process, Archive of Internal Medicine, February 14, 2011

Related Web Resource:
US Food and Drug Administration

Related Blog Posts:
Banning Defective Medical Devices: Report Raises Questions About Whether FDA is Doing Enough to Protect People, North Carolina Injury Lawyer Blog, November 24, 2010

Medical Device-Related Complications Send Over 70,000 Children to the ER Every Year, North Carolina Injury Lawyer Blog, November 24, 2010

Supreme Court Places New Limits on Products Liability Lawsuits Filed Against Medical Device Manufacturers, North Carolina Injury Lawyer Blog, February 20, 2008

GlaxoSmithKline and the family of James Burford have reached an out of court settlement over his wrongful death. The North Carolina man died in 2006. The dangerous drug agreement was reached right before the jury trial, which was set to open today. By settling, GSK avoided what could have been a large verdict amount that may have included punitive damages.

Burford, 49, took Avandia for about 15 months for his diabetes before he died from a heart attack. While the drug maker argued that Burford’s diabetes increased his risk of heart attack regardless of what drug he was taking, the family’s dangerous drug lawyers claimed that Glaxo officials kept studies showing the increased health risks linked to Avandia from regulators.

GSK is facing some 2,000 lawsuits over Avandia and has put aside about $3.4 billion to settle the cases. Bloomberg reports that thousands of lawsuits accusing Glaxo of concealing Avandia’s heart at attack risks were settled last summer for about $460 million.

In September, the Food and Drug Administration decided it was limiting use of Avandia to patients suffering from Type 2 diabetes that cannot manage this condition with other drugs. Users have to be notified of the risks Avandia poses to the heart.

Unfortunately, many people have suffered injuries or had heart attacks from using Avandia and sister drugs Avandaryl and Avandamet, which both contain Avandia. It is unfortunate when a drug that is supposed to help people causes fatal injury instead.

Dangerous Drug Lawsuits
It is negligence on the part of a drug manufacturer that fails to notify regulators and users of possible risks involved with taking a particular medication. As the plaintiff of a North Carolina dangerous drug lawsuit, you may be entitled to financial compensation for mental anguish, pain and suffering, permanent disability, medical costs, future medical bills, present and future lost wages, physical therapy expenses, and prescription costs. If your loved one has died, you may have grounds for North Carolina wrongful death recovery.

Glaxo Suit on Avandia Heart Attack Death Settled on Trial’s Eve, Bloomberg, January 31, 2011

GSK settles Avandia suit involving death of NC man before trial, WRALTechwire, January 31, 2011

Related Web Resources:
Avandia

GlaxoSmithKline

Dangerous Drug Lawsuit: Man Claims Diabetes Drug Avandia Caused Heart Attack, North Carolina Injury Lawyer, November 19, 2009

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

Zometa

Aredia

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

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
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, DrugAlert.org, August 6, 2010

Levaquin, Drugs.com

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

US Food and Drug Administration

A federal jury has awarded Karen Bartlett a $21 million products liability award against Mutual Pharmaceutical Company. The 51-year-old woman developed Stevens-Johnson syndrome (SJS) after taking Sulindac, an anti-inflammatory medication that is the generic version of Clinoril.

Bartlett took Sulindac in 2005 for her shoulder pain. Two weeks later, she developed a reaction on her face. She would go on to be diagnosed with SJS and Toxic Epidermal Necrolysis (TEN). Because 65% of her skin was damaged, Bartlett spent 112 days in a hospital burn unit. She is now blind and has sustained permanent injuries to her stomach, throat, and lungs. In her dangerous drug lawsuit, Bartlett accused the pharmaceutical company of failing to adequately warn about the potential side effects that Sulindac can have on her skin.

Stevens Johnson Syndrome
SJS is a rare, sometimes deadly autoimmune disease that can occur because of drug reactions and allergies. The disease can cause serious skin burns, rashes, loss of skin, and the skin condition Toxic Epidermal Necrolysis. SJS can also cause damage to mucus membranes—affecting areas such as the mouth, eyes, nose, or vagina—and internal organs. A person suffering from SJS can develop deadly infections, such as bacteremia or sepsis.

Recovery from SJS is a long and painful process. Patients usually end up in the ICU or a Burn Unit for a time.

SJS is usually a result of an adverse drug reaction. Bacterial infections and over-the-counter drugs are also possible causes of SJS.

The Food and Drug Administration now requires that non-steroidal anti-inflammatory drugs (NSAIDs) come with a “black box” warning listing serious side effects, such as Stevens-Johnson syndrome.

SJS Lawsuit Garners Victim $21 Million, Salient News, September 20, 2010

Related Web Resources:
Sulindac Side Effects, Drugs.com

Stevens-Johnson Syndrome, MayoClinic

Toxic Epidermal Necrolysis

Michael A. DeMayo, a Charlotte, North Carolina personal injury lawyer, is now a member of the Multi-Million Dollar Advocates Forum, one of the most prestigious groups of trial lawyers in the country. Members must have won multi-million dollar verdicts, settlements, and awards for their clients. Attorney DeMayo, who is founder and president of the Law Offices of Michael A. DeMayo, is also a Life Member of the Million Dollar Advocates Forum. Less than 1% of US attorneys belong to this group, known for its excellence in advocacy and for having obtained for at least one client an award, settlement, or verdict of $1 million or greater.

Charlotte, Personal Injury Attorney DeMayo leads a team of dedicated professionals with over 100 years of combined legal experience. They are committed to obtaining the financial recovery that their clients and families are owed by negligent parties. Our North Carolina law firm represents victims and surviving family members with all types of injury cases, including those involving medical malpractice, automobile accidents, truck accidents, slip and fall, products liability, defective medical devices, dangerous drugs, nursing home neglect and abuse, motorcycle accidents, dog bites, pedestrian accidents, and workers’ compensation. The Law Offices of Michael DeMayo is located in Charlotte, Monroe, Hickory, and Lumberton, North Carolina. We also represent clients with South Carolina personal injury cases in the counties of Marlboro, Chesterfield, York and Lancaster.

Charlotte, North Carolina Car Accident Lawyer Michael A. DeMayo is also an active member of the community. Each year, his law firm awards college scholarships to a number of high school seniors for their innovative and creative ideas on ways to stop teens from driving drunk.

Multi-Million Dollar Advocates Forum & Million Dollar Advocates Forum

Michael A. DeMayo, Esq.

Verdicts & Settlements, Law Office of Michael A. DeMayo

A 23-year-old man who is now a quadriplegic has filed a dangerous drug lawsuit against the makers of Rituxan. The defendants of this products liability complaint are Biogen Idec. and Genentech Inc.

Jesse Peetz started taking the immunosuppressant in 2003 to treat thrombotic thrombocytopenia purpura, an autoimmune disorder that he had been suffering from since he was 11. He contends that he was unaware that the drug would make him susceptible to developing untreatable infections. He developed a near-deadly infection in 2005 that resulted in his loss of motor function.

In his dangerous drug complaint, Peetz is accusing the defendants of failing until 2007 to warn users about the risks associated with taking the immunosuppressant. He contends that in 2003, defendants began marketing Rituxan for off-label use to treat the condition that Peetz was suffering from. Off-label means that the Food and Drug Administration had not approved this particular use for the suppressant. In 2007, BIogen Idec and Genentech finally put out a warning that use of the drug could lead to untreatable viral infections, catastrophic injury, and death.

Rituxan is FDA-approved for treatment of rheumatoid arthritis, non-Hodgkin’s lymphoma, and chronic lymphocytic leukemia. The powerful drug gets rid of mature circulating B-cells for close to nine months, which can allow for the deadly viruses. Rituxan has also been linked to several cases of progressive multifocal leukoencephalopathy, a deadly brain and nervous system viral infection.

Peetz took Rituxan for two years before he developed the dangerous viral inflection. Now, he depends heavily on a ventilator.

Charlotte, North Carolina Dangerous Drug Lawsuit
Just because you or your loved one took a drug prescribed by a doctor and made by a pharmaceutical company doesn’t mean that the medication is good for you. Unfortunately, dangerous drugs continue to make it out into the marketplace, posing a serious danger to people. Drug manufacturers must be held accountable for their negligence in making and designing a drug that can hurt or kill you.

Neb. man sues makers of Rituxan after infection, WTOP/AP, August 11, 2010

Lawsuit Says Rituxan Left Man A Quadriplegic, Drug Discovery and Development, August 12, 2010

Related Web Resources:
Rituxan

Genentech Inc.

Biogen Idec.

Last month, a jury ruled against Pfizer in the dangerous drug lawsuit filed by a breast cancer survivor who used the hormone replacement drugs Prempro, Premarin, and Provera. The verdict in favor of plaintiff Donna Kendall: $28 million in punitive damages and $6.3 million in compensatory damages.

The 66-year-old woman was diagnosed with breast cancer after taking Provera and Prempro for 11 years. According to the civil jury, the three drugs contributed to causing Kendall’s breast cancer. Jury members also found that Pfizer failed to adequately warn consumers about the dangers linked to using the hormone replacement medications.

This dangerous drug verdict comes just one month after another jury ordered Wyeth Pharmaceuticals, now owned by Pfizer, to pay $75 million to a woman because she developed breast cancer after taking Prempro. Connie Barton took the hormone drug from 1997 until 2002 when she was diagnosed with breast cancer. Barton underwent a mastectomy to remove her left breast to combat the disease. She says she started taking Prempro because her doctor told her it could prevent dementia and heart disease.

Prempro and Premarin are used to treat menopause. The drugs are used by millions of Americans women who have menopause. They were told that using the HRTs could prevent major illnesses. Provera is used to treat secondary amenorrhea, abnormal uterine bleeding, and endometrial hyperplasia.

However, recent findings have linked Premarin and Prempro to breast cancer, ovarian cancer, stroke, and cardiovascular disease. Plaintiffs have filed some 13,000 products liability lawsuits against Pfizer claiming the hormone replacement drugs caused cancer and other issues.

Cancer is a serious illness. If a pharmaceutical drug caused your cancer, you may be able to obtain dangerous drug compensation from the negligent pharmaceutical company that manufactured the drug and/or failed to tell you about the associated risks.

Pfizer Ordered to Pay $34.3 Million in HRT Lawsuit, MedPage Today, November 24, 2009

Menopause, as Brought to You by Big Pharma, NY Times, December 12, 2009

Related Web Resources:
Pfizer

Hormone Replacement Therapy, Medline Plus

A jury has ordered Allergan to pay a woman $15 million for the personal injuries she sustained from using Botox. The plaintiff, Dr. Sharla Helton, claims that she suffered botulism poisoning after she received Botox injections in 2006 to get rid of her wrinkles.

Jury members found that Allergan was negligent in its labeling of the Botox injections, which, at the time, did not warn that botulism might be a possible side effect. The 48-year-old gynecologist and obstetrician says that because of her health issues she was forced to resign as Lakeside Women’s Hospital’s medical director. She also had to sell her medical practice.

The verdict comes just three months after another jury ruled in Allergan’s favor in the Botox lawsuit filed by a woman seeking products liability compensation for her daughter’s wrongful death in 2007. Kristen Spears received Botox injections to treat her cerebral palsy, but Allergan’s legal team argued that she died from cerebral palsy complications and not from the drug. The jury in that case found that Allergan had provided adequate warning about the possible risks that could arise from using Botox.

Life-threatening side effects from receiving Botox treatments can include heart attacks, serious allergic reaction, arrhythmia, respiratory depression, and botulism poisoning. That said, Helton’s dangerous drug attorneys claim that there are many people out there who don’t realize that the reason they fell ill was because they were injected with Botox.

Botox is now approved for cosmetic use and for treating certain medical conditions, such as strabismus, cervical dystonia, blepharospasms, and hyperhidrosis.

Oklahoma County jury finds Botox maker negligent, awards $15 million, NewsOk, May 12, 2010

Jury Awards Doctor $15M In Lawsuit Against Botox, CBS2, May 12, 2010

F.D.A. Orders Warning Label for Botox, NY Times, April 30, 2009

Related Web Resources:
Botox Cosmetic

Allergan

Food and Drug Administration

A $110 million class action settlement was approved last week against the maker and distributor of E-Ferol. Carter-Glogau Laboratories was E-Ferol’s manufacturer and O’Neal, Jones & Feldman Pharmaceuticals distributed the supplement that was administered briefly during the mid-80′s.

At least 38 baby deaths are linked to E-Ferol, which was supposed to prevent blindness known as retrolental fibroplasias, that can be caused by a vitamin E deficiency. However, The plaintiffs’ lead attorney believes that many more infants died than the ones noted by the Centers for Disease Control and Prevention.

The vitamin E supplement was administered intravenously and marketed as a drug that could help premature babies. E-Ferol had not been approved by the Food and Drug Administration and was recalled after approximately just five months in the market following reports of deaths in hospitals throughout the US.

Plaintiffs have accused the defendants of deceptive marketing practices, such as promoting E-Ferol as a vitamin supplement instead of a drug and giving hospitals and giving doctors the impression that the drug was FDA-approved. Carter-Glogau Laboratories and Jones & Feldman Pharmaceuticals have said that there weren’t many laws regulating vitamins back then. The two companies haven’t been in business for nearly 20 years.

In addition to the babies that died, dozens of infants that were given the drug ended up with kidney damage, blindness, brain damage, and liver damage. The symptoms became known as “E-Ferol syndrome.”

According to the CDC, about 89 hospitals administered E-Ferol to babies. While some of them willingly notified parents that they’d given their children the supplement, others were not as forthcoming and had to be legally forced to disclose this information. Many plaintiffs didn’t even know that their children had received E-Ferol until they found out about the dangerous rug lawsuit.

The class action case was brought on behalf of anyone who was administered E-Ferol between November 1, 1983 and April 30, 1984. Heirs of victims, the estates of those that died, parents of 42 babies who died, and adults that received the vitamin supplement as infants were among the plaintiffs. The defendants’ liability insurance will cover the settlement.

Hundreds of other dangerous drug lawsuits and wrongful death complaints have been filed over the injuries that were sustained by babies who were given E-Ferol.

Dangerous Drugs
Unfortunately, there are drug manufacturers that continue to market and release dangerous drugs into the marketplace. Some of these pharmaceutical companies are trusted names in the industry. You may have grounds for filing a North Carolina dangerous drug lawsuit seeking damages for personal injury, products liability, or wrongful death.

Maker of E-Ferol ordered to pay $110 million settlement in deaths of babies, Star-Telegram, April 10, 2010

Settlement Reached in E-Ferol Case, Consumer Affairs, April 12, 2010

Related Web Resources:
Three jailed for selling drug that killed 38 babies, FDA Consumer/Findarticles.com, July – August 1989

The Tragic Case History of Intravenous Vitamin E, The New York Times, May 27, 1984

Xanodyne Pharmaceuticals is pulling the painkiller Darvon off the market. The Food and Drug Administration issued the ban over concerns that it causes potentially fatal heart rhythms. The FDA is also banning related brand Darvocet and wants drug manufacturers to stop marketing low-cost drugs that contain propoxyphene, which is the active ingredient in Darvon. Current Darvon users, however, are being directed keep using the drug until a replacement medication can be prescribed.

Darvon is an opioid narcotic that is prescribed for moderate to mild pain. Last year, about 10 million people were given prescriptions for Darvon and related drugs. However, the popular medication has been plagued with safety concerns for decades. Consumer watchdog group Public Citizen, which blames Darvon for several hundred deaths a year, has been pressing the FDA for a ban. Darvon has already been banned in Great Britain and the European Union following numerous suicides and accidental drug overdoses.

In January 2009, the FDA decided to keep the drug in the market but to include a stronger warning label with overdose risks. It wasn’t until a recent study showing that Darvon can cause fatal irregular heart rhythms that the federal agency finally told Xanodyne Pharmaceuticals to stop making the drug.

Dangerous Drugs
Medication prescribed to you by your doctor is not supposed to cause serious injury or death. Any potential side effects and health risks should be included in a warning to users. Unfortunately, some drugs make it into the market with FDA-approval and later prove to be more dangerous than previously thought. You may have grounds for a North Carolina dangerous drug case.

Other common side effects that have been linked to dangerous dugs:
• Birth defects
• Heart attack
• Kidney failure
• Psychological problems
• Stevens Johnson Syndrome
• Death

Our Charlotte, North Carolina dangerous drug lawyers represent clients who have suffered serious health issues or who have lost loved ones because they took a prescription drug or over-the-counter medication that caused serious injury, illness, or death.

Darvon painkiller pulled off market due to heart risks, USA Today, November 21, 2010

Popular painkillers taken off the market, Los Angeles Times, November 19, 2010

Related Web Resources:
Food and Drug Administration

Darvon, National Center for Biotechnology Information

Xanodyne Pharmaceuticals

A Winston-Salem man says he is going to sue GlaxoSmithKline for North Carolina personal injuries that he claims he sustained from using Poligrip. Johnny Howell, 53, says he started exhibiting signs of zinc poisoning in 2004, 15 years after he started using the denture cream.

It wasn’t until last year that Howell found out what was causing his disease. He says that even after receiving treatment for his condition, he has problems walking and experiences weakness and numbness in his legs. Due to a number of fall accidents, Howell broke an ankle and a rib. He must now use a walker and is unable to drive. Howell also lost his job working as a mechanic and receives disability.

While humans need zinc, too much of it can lead to calcium deficiencies, bone loss, anemia, and nerve damage, which can become permanent if excessive consumption of zinc goes on for too long. Howell is not the only person who has sustained injuries from using denture cream. There are dozens of people who say their nerve damage was caused by using Poligrip or Fixodent, which is made by Proctor & Gamble. Considering that about 40 million Americans use adhesives to keep their dentures in place, the health risk link is cause for concern.

Although the American Dental Association says it doesn’t know of any cases confirming that nerve damage is caused by dental glue, an article published in “Neurology” in 2008 linked high levels of zinc in Super Poligrip to “profound neurological disease” in patients that were examined.

GlaxoSmithKline just recently started including a warning with its Super Poligrip denture cream noting that too much zinc may cause health issues. Newsinferno.com reports that there are already scores of people that have been damaged by using denture creams and have filed their dangerous drug lawsuits.

Dangerous Drug Lawsuits
Drug manufacturers are supposed to make products that are safe for people to use. When an over-the-counter product or a prescription drug leads to dangerous side effects that a pharmaceutical company failed to warn against, those who were injured as a result may be able to obtain personal injury damages by filing a North Carolina dangerous drug lawsuit.

Zinc in denture adhesives blamed for nerve damage, Reporter News, January 18, 2010

North Carolina Man Says Poligrip Left Him Disabled, Plans Lawsuit, NewsInferno, February 3, 2010

Related Web Resources:
Poligrip, GlaxoSmithKline

Zinc poisoning, Medline Plus

American Dental Association