FDA Panel Takes up Metal-on-Metal Hip Implant Safety Today
The Food and Drug Administration (FDA) is convening a meeting starting today to help decide the future of metal-on-metal hip implants following high-profile recalls and mounting questions about their overall safety.
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 ...
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 ...
Actos Side Effects Lawyers Says Whistleblower Revelations Could Boost Bladder Cancer, Heart Failure Lawsuits
An attorney with a prominent personal injury law firm says an Actos whistleblower lawsuit filed earlier this year could strengthen legal claims alleging the type 2 diabetes medication caused some users to develop bladder cancer and heart failure.
Actos Whistleblower Lawsuit Questions Avandia Researcher's Financial Ties to Takeda
A prominent researcher has been implicated in an alleged cover-up of Actos side effects, according to a report from TheHeart.org. An Actos whistleblower lawsuit unsealed earlier this year has alleged financial connections between the Cleveland Clinic’s Dr Steven Nissen and the maker of Actos “should be considered when analyzing Actos’s ...
New Study Links Metal-on-Metal Hip Replacement Corrosion with Adverse Local Tissue Reactions
Yet another study is pointing to potential dangers posed by metal-on-metal hip implants. This time, an article published in the Journal of Arthroplasty is reporting corrosion in the head taper junction was more likely to occur in patients with 36-mm diameter metal-on-metal hip replacement, compared to those with the same ...
Fracking Boom Changing Way of Life in Pennsylvania's Northern Tier
In just a few years, the impact of hydraulic fracturing (fracking) drilling on northeastern Pennsylvania is hard to miss. Thousands of natural gas wells have been opened in that area specifically in the last five years as companies look to exploit the vast Marcellus shale formation about two miles below the ...
Smokers More Vulnerable to Joint Replacement Failures
People who smoke cigarettes before and after receiving a total joint replacement, such as a hip replacement device or knee implant, are far more likely to endure revision surgeries on those implants than people who don’t smoke.
Indiana Woman Alleges Serious Injuries From Transvaginal Mesh Products
Parker Waichman LLP, a national law firm, just filed a lawsuit on behalf of a woman who suffered injuries after receiving transvaginal mesh implants. The lawsuit suit alleges that the transvaginal mesh created an unreasonable risk and directly caused her injuries.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
Pharmacists Distributed Cheap Drug Substitutes to Kidney Dialysis Patients, Faces Four Years in Prison
A Tennessee pharmacist just pleaded guilty to swapping a cheaper drug substitute for the U.S. Food and Drug Administration (FDA) approved iron sucrose drug for kidney dialysis patients.
The pharmacist, Robert Harshbarger, 53, substituted a cheaper version of the drug from China, which was administered to kidney dialysis patients in Kansas, according to Kansas First News. Harshbarger was conducting business as American Inhalation Medication Specialists, Inc. and pleaded guilty to one count of distributing a misbranded drug and one count of health care fraud. Continue reading
