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, ...
Study Finds SSRI Antidepressant Side Effects Outweigh Their Benefits
A new study is raising more concerns about the safety of commonly used antidepressants, including selective serotonin reuptake (SSRI) inhibitor antidepressants. Investigators who conducted the study, which is published in the journal Frontiers in Psychology, posit that increased knowledge of the negative effects of SSRIs and other antidepressants could reduce ...
New York Man Claims Biomet Metal-on-Metal Hip Implant Caused Pain, Disability
A New York man claims his metal-on-metal hip implant was defective and required replacement within a year of receiving it. This has left him facing a lifetime of pain, disability, and rising medical costs.
DePuy ASR Hip Implants, Other Faulty Medical Devices Subject to Little FDA Oversight, Investigation Finds
A newly-published investigation from ProPublica has revealed that several questionable types of medical devices, including DePuy Orthopaedic’s recalled ASR hip implant, managed to make it to market without much scrutiny on the part of the U.S. Food & Drug Administration (FDA).
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.
Oklahoma Woman Latest to Head to Court Over Alleged DePuy ASR Hip Implant Injuries
Lawsuits filed by alleged victims of DePuy Orthopaedics’ recalled ASR hip replacement devices continue to pile up in the multidistrict litigation currently underway in U.S. District Court, Northern District of Ohio. Most recently, a woman from Pryor, Oklahoma, filed suit alleging complications caused by a DePuy ASR hip implant ...
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.
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 ...
Pradaxa not Fit for a Dog, Family of Alleged Pradaxa Bleeding Victim Claims
The family of a Texas woman who died just months before her 60th wedding anniversary believes she would be alive today were it not for Pradaxa (dabigatran). According to a report from the Houston Press, Pradaxa patient Loraine Franklin fell and hit her head last December, resulting in an intracranial ...
Estate of Kentucky Man Alleges Wrongful Death Due to Actos Bladder Cancer
National law firm, Parker Waichman LLP, just filed a lawsuit on behalf of the estate of a Kentucky man who developed bladder cancer and subsequently died, allegedly due to the use of diabetes drug, Actos. The lawsuit names Takeda Pharmaceuticals America, Inc., Takeda Pharmaceuticals USA, Inc., Takeda Pharmaceuticals North America, ...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
