Author: AboutLawsuits

The prominent consumer group Public Citizen has petitioned the FDA to initiate a recall for Savella, saying that the fibromyalgia drug’s heart and suicide risks outweigh its benefits.

The Savella recall petition was sent to the agency on January 20, calling for the drug’s immediate removal from the market. Public Citizen claims that the benefits of the drug are highly questionable, and note that side effects of Savella could increase the risk of hypertension, heart problems and has been linked to suicidal tendencies.

Savella (milnacipran) is produced by Cypress Bioscience, Inc. and Forest Laboratories, Inc. It is a selective serotonin and norepinephrine reuptake inhibitor (SNRI) and is similar to many antidepressants currently on the market. The drug is contraindicated for people taking monoamine oxidase inhibitors (MAOIs) and those who have uncontrolled narrow-angle glaucoma.

It was approved by the FDA for treatment of fibromyalgia in adults on January 14, 2009. While the drug is used as an antidepressant in Europe, the European Medicines Agency (EMEA) refused to approve Savella for fibromyalgia treatment in July 2009, saying that the drug had marginal benefits that failed to outweigh the health risks from Savella side effects.

Fibromyalgia, or fibromyalgia syndrome, is a condition that manifests as widespread chronic pain and is estimated to affect between 2-4% of the population. However, much of the medical community disputes how to diagnose the syndrome, and many do not believe it is an actual disease because of a lack of objective diagnostic tests and physical abnormalities on examination. While some say it may be a neurological condition, possibly brought on by stress and resulting in oversensitive pain receptors, others say it may be a “non-disease.”

According to Public Citizen, two randomized clinical trials with Savella found that the drug increased blood pressure, heart rate and suicidal thoughts. Nearly 20 percent of the trial’s participants who were given Savella developed hypertension, compared to 7.2 percent who were given a placebo. Public Citizen said that FDA’s own reviewers determined that Savella could increase the risk of heart problems, such as strokes, heart attacks and sudden death, by as much as 50 percent.

The group claims that studies have shown Savella increases the risk of seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma, nausea and vomiting. They also indicate that the drug can put fetuses, newborns and nursing infants at risk when used by pregnant mothers, and can cause reproductive problems in men.

In addition, Public Citizen says that there is evidence that the drug does not work. Public Citizen claims the director of FDA’s Division of Anesthesia, Analgesia and Rheumatology Products has said that Savella did not relieve pain, the main symptom of fibromyalgia, in clinical trials.

“Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months,” Public Citizen said in a press release. “And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.”

About 1.5 million Graco strollers have been recalled after at least five children had their fingertips cut off by strollers’ hinges.

The Graco stroller recall was announced on Wednesday by the U.S. Consumer Product Safety Commission (CPSC). The stroller recall came after Graco Children’s Products Inc. of Atlanta, Ga., received at least five reports of child fingertip amputations and two reports of fingertip lacerations.

The strollers have a hinge on the canopy which can cut off a child’s fingertip when the canopy is being opened or closed. Only models with the specific hinge mechanism are affected, including the Graco Passage, Alano and Spree Strollers and Travel Systems. All of the recalled strollers have a plastic, jointed hinge mechanism with indented canopy positioning notches.

A complete list of model numbers is available in the CPSC Graco stroller recall notice. The strollers were manufactured between October 2004 and February 2008. The model number and manufacture date are located just above the wheels on the lower inside portion of the rear frame.

The strollers, made in China, were sold at AAFES, Burlington Coat Factory, Babies “R” Us, Toys “R” Us, K-Mart, Fred Meyer, Meijers, Navy Exchange, Sears, Target, Wal-Mart and other retailers nationwide from October 2004 and December 2009.

The Graco recall is similar to a Maclaren stroller recall announced in November. About one million Maclaren strollers were also pulled after Maclaren USA, Inc. received reports of at least 12 children having their fingertips amputated in the stroller’s hinges after it was being opened or closed.

The CPSC recommends that consumers immediately stop using the recalled Graco strollers and contact Graco to receive a free protective cover repair kit.

An Illinois woman has named Wal-Mart as a defendant in a wrongful death lawsuit filed over her husband’s fatal fentanyl overdose caused by a pain patch he received after a slip and fall at one of the company’s stores.

The complaint was filed on January 6 in Madison County Circuit Court by Kara S. Manley over the death of her husband, Gary Manley, who died from fentanyl toxicity on June 11, 2008. According to a report in The Madison Record, Manley named Wal-Mart, as well as Dr. Oscar F. Florendo and Osbec Medical of Southern Illinois, as defendants.

The wrongful death lawsuit alleges that Gary Manley slipped on an oily substance in a Wal-Mart in O’Fallon, Illinois on Feb. 22, 2008, resulting in a back injury. Gary Manley then saw Dr. Florendo, who gave him a prescription for the fentanyl pain patch in June 2008. A month later, Gary Manley was dead from a fentanyl overdose caused by the pain patch.

Fentanyl is a powerful opioid pain killer that is often prescribed to patients suffering from chronic, severe pain. It is considered 100 times more powerful than heroine and over-exposure to the fentanyl gel contained in the patch can cause a fatal overdose.

Problems with the fentanyl patch have been linked to hundreds of deaths since the brand name Duragesic patch was first introduced by Johnson & Johnson in 1994. The deaths have mostly occurred among those who either used the drug incorrectly or never should have received the powerful painkiller, but there have also been a number of fentanyl patch recalls issued due to various manufacturing defects which allowed the fentanyl gel to leak out of the patch and come into direct contact with the skin.

The FDA has issued several warnings to the medical community about the dangers associated with the fentanyl patch, which is only supposed to be used to treat severe, chronic pain among those who are already tolerant of opioid therapy.

A number of product liability lawsuits have been filed against manufacturers of the fentanyl patch alleging design defects, manufacturing problems and inadequate warnings contributed to fatal overdoses. Of the first four fenrtanyl patch lawsuits to go to trial, plaintiffs won every case and juries returned verdicts that combined to exceed $36 million.

A young man whose legs were partially amputated as the result of a necrotizing fasciitis infection, which involves a flesh-eating bacteria, has filed medical malpractice lawsuits against a number of doctors and two hospitals, alleging that the infection was mistreated.

The Ohio malpractice lawsuits were filed in the Ohio Court of Claims and Franklin County Common Please Court on behalf of 19 year-old Steven Haxton, whose legs were amputated above the knee last year. According to a report in The Columbus Dispatch, the lawsuit alleges that the injuries resulted from the negligent medical care of more than 15 doctors employed by Ohio Health Corp, Riverside Methodist Hospital and Ohio State University Medical Center.

Haxton alleges that he went to the Riverside Methodist emergency room for pain in his calf in March 2009, where he was diagnosed with necrotizing fasciitis. Several days later he was placed on life support and sent to Ohio State University Medical Center for further treatment. He eventually had his legs amputated and had to undergo 20 surgeries to save his life.

Necrotizing fasciitis, better known as flesh-eating bacteria, is usually a form of streptococcus that infects the deeper layers of skin and subcutaneous tissues. Early symptoms include intense pain, swelling, and gastrointestinal distress. Eventually, the bacteria begins to kill tissue, causes fever and illness and in most cases will cause death if left untreated. Even when treated, the infections often require amputation of limbs in order to prevent spread throughout the body.

The infections are most often treated with surgery and antibiotics. However, some cases of flesh-eating bacteria have been caused by methicillin-resistant Staphylococcus aureus (MRSA), which resists many forms of antibiotic treatment.

Haxton’s necrotizing fasciitis lawsuits allege that the care provided at Riverside failed to meet accepted medical standards. Ohio State University Medical Center is named as part of the lawsuit because it employed one of the doctors at Riverside, not because of care that occurred at that OSU, which Haxton and his parents credit with saving his life.