Pradaxa Named in Most FDA Adverse Event Reports for Deaths, Hemorrhage, Kidney Failure and Stroke
The controversial blood thinner, Pradaxa, surpassed all other drugs monitored by the U.S. Food & Drug Administration (FDA) in adverse event reports made to the agency last year. According to the Institute for Safe Medicine Practices’ (ISMP) latest QuarterWatch report, Pradaxa also topped the list for reports of deaths, ...
Smith & Nephew Says Metal-on-Metal Hip Replacement Controversy Slowing Sales of Birmingham Hip Resurfacing System
Medical device maker Smith & Nephew has reported a drop in sales of its metal-on-metal hip implant devices. According to the company, hip implant sales were down 2 percent during the first quarter of 2012, largely because its Birmingham Hip Resurfacing System suffered from an association with other metal-on-metal hip ...
Medtronic Plans Layoffs, as Infuse Bone Graft Controversy Continues to Weigh on Spinal Business
Medtronic’s spinal division continues to take a huge hit thanks to the controversy surrounding its Infuse Bone Graft product. According to a report from MassDevice.com, the company’s latest earnings report stated that the division saw Infuse sales decline 26% in the first quarter of 2012, and now Medtronic is talking ...
Newly-Filed Plavix Lawsuits Claim Drug Caused Gastrointestinal Bleeds, Cerebral Hemorrhage, and TTP
The manufacturer of Plavix continues to be named in lawsuits alleging the blood thinner caused some patients to suffer from serious bleeding side effects. Most recently, the national law firm of Parker Waichman LLP filed nine Plavix bleeding lawsuits in state court in New York.
Tennessee Resident Files Pradaxa Bleeding Lawsuit Following Cerebral Hemorrhage
A man from Tennessee has filed a lawsuit against the maker of Pradaxa, claiming that the blood thinner caused him to suffer a cerebral hemorrhage. The complaint alleges Boehringer Ingelheim Pharmaceuticals, Inc. concealed knowledge that Pradaxa can cause Serious, life-threatening bleeds, and did not warn that Pradaxa bleeding side effects ...
Medtronic Infuse Studies Faulted for Downplaying Side Effects
Medtronic Inc.’s published studies for its Infuse bone graft product may have downplayed serious side effects, according to an analysis published last year in The Spine Journal. The study, which drew on U.S. Food & Drug Administration (FDA) documents and other data sources, suggests that up to half of ...
Tentative Ohio Fracking Regulations Criticized as too Lax
Lawmakers in Ohio have tentatively passed new regulations governing hydraulic fracturing (fracking) drilling but they’ve immediately been criticized for being too favorable to the natural gas and oil industries.
U.K. Regulators Issue Additional Guidance for Metal-on-Metal Hip Implant Recipients
Regulators in the U.K. are once again issuing advice to doctors and other healthcare professionals involved in the follow-up of patients with metal-on-metal hip replacement devices. In an alert issued by the Medicines and Healthcare products Regulatory Agency (MHRA), guidance is provided for four groups of metal-on-metal hip implant ...
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.
Johnson & Johnson Marketing of Gynecare Prolift Transvaginal Mesh Raises More Questions
Johnson & Johnson and its Ethicon unit are again coming under scrutiny for the way it marketed its Gynecare ProLift transvaginal mesh product. According to a new report from Bloomberg News, Johnson & Johnson continued marketing the Gynecare ProLift device for months after it received a warning from the ...Bronchiolitis Obliterans—Popcorn Lung—Cases Continue, Lawsuits Mount
According to researchers, cases of bronchiolitis obliterans continue to be seen in a broad array of areas and involving a number of industries.
We have long followed the issue of bronchiolitis obliterans, a respiratory disease that is casually known as “Popcorn Lung.” The condition received its nickname in 2007 when it was found to be occurring in popcorn plant workers. Bronchiolitis obliterans is a potentially life-threatening, irreversible ailment, for which the only cure is a lung transplant in severe cases. Popcorn Lung inflames the bronchioles—the small lung airway—causing scarring and obliterating appropriate airflow.
The chemical flavoring diacetyl, which was popularly used in microwaveable popcorn, was long deemed the culprit in Popcorn Lung cases. The chemical is used to butter flavor a number of snack foods and also naturally occurs in some foods and drinks, according to Law360. The chemical has led to mounting lawsuits as scientists and regulators find that excessive diactyl exposure may likely lead to bronchiolitis obliterans. Continue reading
Study: Increased Diabetes Risks Seen with Some Statins
Statins, drugs prescribed to reduce blood cholesterol levels, have been associated with an increased risk for Type 2 diabetes, according to a new study.
The researchers in Canada reviewed 1.5 million people over the age of 66 in a report published in the British Medical Journal, according to BBC News Health. The study found that statins could increase risks for developing Type 2 diabetes by 22 percent when compared to less potent options. Lipitor (atorvastatin) was associated with one extra case of Type 2 diabetes for every 160 patients treated. Continue reading
Thalomid Label Updated Over Serious Side Effects
Thalomid (thalidomide) has been associated with an increased risk of second primary malignancies, according to Celgene Inc. and Health Canada. This serious, adverse side effect has been added to the drug’s Product Monograph.
Thalomid is an immunomodulatory agent indicated for the treatment of patients who are 65 years of age or older and with a previously untreated multiple myeloma. Thalomid is prescribed in combination with melphalan and prednisone (MPT).
The Canadian Product Monograph safety information was updated to include that: Continue reading
Catholic Whistleblower Group Seeks Stronger Sex Crime Policies, Legislation
Members of the national advocacy group, Catholic Whistleblowers, comprised of Catholic clergy and nuns, is urging the Church to increase its stand against child sexual abuse.
In its first public action, Catholic Whistleblowers met in New York for a news conference, according to Milwaukee-Wisconsin Journal Sentinel (JS Online). Cardinal Timothy Dolan, head of the U.S. Conference of Catholic Bishops, and considered one of the most powerful American ecclesiastical dignitaries, is located in New York, said JS Online. Continue reading
Judge Orders DePuy Orthopaedics to Produce Compliance Reports in Pinnacle Cases
A federal judge overseeing a multidistrict litigation against Johnson & Johnson subsidiary DePuy Orthopaedics has ordered DePuy to provide the plaintiffs with compliance reports on its metal-on-metal Pinnacle hip implant.
More than 900 individual lawsuits have been consolidated into a multidistrict litigation (MDL) in U.S. District Court for Northern Texas under Judge Ed Kinkeade, MassDevice reports. The lawsuits accuse DePuy Orthopaedics of negligence, fraud, and improper design, manufacture, and marketing of the Pinnacle system. Pinnacle hip implant recipients allege the hip’s faulty design caused problems including severe swelling, pain, bone and tissue damage, and loosening of the implant. Recipients often needed additional surgery to remove and replace the implant. Continue reading
Study: Statins May Reduce Exercise Benefits in Overweight, Obese Adults
A new study has found that statins, used to lower blood cholesterol levels, may reduce exercise benefits for overweight adults.
Statins rank among the best selling drugs in the world and are typically prescribed to people with obesity, diabetes, and metabolic syndrome (a combination of excess body fat and/or high blood pressure, blood sugar, and/or cholesterol), explained Medical News Today. Statins are prescribed to reduce cholesterol as a means of preventing blood clots, heart attack, and stroke that could lead to death.
Drugs in the statin class are known to carry a risk of causing myopathy (severe muscle damage) and should be taken with caution and at the lowest possible effective dose to reduce the risks of these side effects. Now, research conducted at the University of Missouri (MU) revealed that simvastatin—sold under the brand Zocor—stalled any positive effects from exercise in obese and overweight adults, according to Medical News Today. Continue reading
Infuse® Maker, Medtronic, Cutting Staff
Device maker, Medtronic Inc., just announced another scheduled staff cut. We recently wrote that Medtronic was laying off about 4 percent of its spinal business workforce worldwide, which amounted to about 230 of it spinal division’s 5,600 employees,
This is the third year in a row, according to Pioneer Press, that Medtronic has announced cuts. The announcement was made during a conference call and confirmed that the device maker plans on eliminating 2,000 jobs worldwide. About half will impact Medtronic’s workforce in the United States, according to the firm’s chief financial officer, Gary Ellis. Continue reading
da Vinci Robotic Surgery Case With Jury
Jury deliberations are scheduled in the first of some 26 lawsuits brought over Intuitive’s da Vinci robotic surgical system and involve allegations of injuries associated with the controversial robotic system.
Kitsap County Superior Court Judge Jay Roof (Port Orchard, Washington), just handed the case to the 12-member jury after a five-week trial, according to Bloomberg News. Deliberations being this week.
Personal injury lawsuits have alleged that the da Vinci system has caused patients to suffer from a variety of adverse events, including internal injuries. Many of these injuries are the result of burns, tears, and other complications. In some cases, patients have died or suffer from chronic pain, even disability. da Vinci lawsuits fault aggressive Intuitive marketing positioned to induce hospitals to buy the costly system. Lawsuits also allege that a collaboration of design flaws and poor physician training on the da Vinci led to the injuries alleged in the litigation. At last count, some 70 deaths have been tied to the system since 2009. Continue reading
Jurors Told Intuitive Surgical Ran Like a Car Dealership
In a case involving the safety of Intuitive Surgical’s da Vinci robotic system, the jury was told that the company acted “just like a car dealership” in training doctors to use the equipment.
In addition, jurors heard that the plaintiff, Fred Taylor, had died because of the company’s practices, and that Intuitive should pay more than $8 million in damages to his estate. These remarks were part of the plaintiff’s attorney’s closing arguments in a Port Orchard, Washington state court, Bloomberg News reports. Continue reading
End in Sight for Water-Contamination Cleanup at Camp Lejeune
At Camp Lejeune, the North Carolina Marine Corps base, cleanup continues of the decades-long drinking-water contamination problem that began in the 1950s.
More than 600 polluted sites are scattered around the 170-square-mile Marine base, located at the mouth of the New River. About five-dozen sites remain to be cleaned up, according to The Associated Press (AP). The contamination comes from a variety of pollutants – leaking gasoline from the base’s fuel storage farm, and chemicals including carcinogenic pesticides, benzene, and dry-cleaning solvents, some of which were intentionally dumped at Lejeune. Continue reading
