In 2014, the US Food and Drug Administration (FDA) issued a warning about the potential risks of using laparoscopic power morcellators in hysterectomies or myomectomies. Since the announcement, there was a decrease in the utilization of minimally invasive hysterectomies, based on a retrospective cohort study conducted by the faculty from the University of Michigan Department of Obstetrics and Gynecology.
In the review, the utilization of power morcellators has significantly decreased, but cases in which a practitioner still opts to use major surgical non-transfusion, complications have increased by 27 percent and occurrences of 30-day hospital re-admissions have increased by 25 percent. Although the cause of the shift in practice patterns has yet to be determined, the study suggests that it has something to do with the FDA announcement discouraging the use of the medical device.
If you or someone you know has developed an undetected cancer following a hysterectomy or myomectomy involving a power morcellator, you may be entitled to a financial compensation. Our lawyers at Williams Hart have worked closely with these lawsuits and can properly represent you in court. Get in touch with us at (888) 220-0640 to learn more about your legal options.
At least fifteen hospitals across the United States failed to comply with the medical device reporting requirements, according to the FDA.
The FDA issued a Form FDA 483 to some prominent hospitals, including Massachusetts General Hospital and New York Presbyterian Hospital, for not promptly reporting deaths and injuries related to medical devices pursuant to 21 CFR Part 803. Under the federal regulation, user facilities, such as hospitals and health centers, have only ten days to submit reports about deaths of patients and serious injuries linked to medical devices to its manufacturer and the FDA. The rule also states that a user facility should maintain a medical device event filing system, which can be inspected by FDA. Out of 17 hospitals, 15 medical centers reportedly demonstrated failures to comply with the federal rule following FDA nationwide inspections. The inspection was initiated last December 2015.
If you or your loved one has been physically injured due to an accident involving a power morcellator, you may be entitled to a monetary claim. Our lawyers at Williams Hart have the experience and skills to properly represent you in court. Get in touch with us at (888) 220-0640.
A power morcellator is an electronic surgical device that has been used by doctors to minimize how invasive several abdominal procedures can be. However, in 2014, the usage of the device was put under criticism following the announcement of the US Food and Drug Administration (FDA) against the device, citing evidence that morcellators could spread cancer cells throughout a patient’s body. Here are some things you need to know about the device:
- Morcellators had been introduced to the public 20 years ago – The US Government Accountability Office (GOA) is investigating the case to determine why FDA cleared morcellators for use despite its potential risks.
- Risks of using morcellators are often overlooked – A recent study in South Korea shows that morcellating tumors is more dangerous than removing them with more invasive measures, as this is more likely to spread cancer.
- Warning led to changes in surgeries – After the morcellator issue had been spilled into the public sphere, US gynecologists changed the way they perform hysterectomies, preferring other options with fewer complications.
If you have developed cancer following a procedure involving a power morcellator, we might be able to help you. Contact our lawyers from Williams Hart at (888) 220-0640.
On January 20, 2015 our client broke his leg when he was hit by an SUV while he was attempting to purchase an automobile at an auto auction. The driver of the SUV was a worker sent over by Pacesetter to drive cars at the Manheim Big H auction center. Our client was safely crossing the road when he was struck by a Ford Explorer being driven by the defendant.
Our client was back to work in just 9 months. He turned to Jim Hart and Steve Kherkher to handle his case and handle the case they did.
Steve and Jim spent many long nights strategizing and prepping for trial. After a rigorous trial before Harris County 55th District Court Judge Shadwick, the jury came back with a UNANIMOUS decision in favor of the plaintiff. They awarded the client $750,000 for pain and suffering as well as $750,000 for physical impairment for a whopping total of $1.5 million dollars.
Here at Williams Hart, we are so proud of Jim and Steve and the work they put in on behalf of their client and know they will do the same for you or your family members.
The U.S. Food and Drug Administration issued a warning about the potential risk of teething tablets and gels to infants and children.
Specifically, the agency urged consumers to temporarily stop using homeopathic tablets and gels after numerous deaths related to the tablets occurred. The products included in the recall were tested by the FDA and found to contain belladonna.
Recently, Hyland’s, a manufacturer of homeopathic teething products, announced it will stop distributing teething tablets and gels in the U.S. following the precautionary warning by the FDA. In a statement released by the company, the manufacturer insisted the products were safe for use because they contained only a tiny amount of belladona, a toxin derived from a poisonous plant. The FDA is urging its consumers to consult with a physician before using any medicine. For a full description of the products included in the recall, you can visit the FDA website.
If your child was affected by Hyland’s homeopathic teething products, we at Williams Hart can help you draft a legal case against them. Get in touch with us at (888) 220-0640 to discuss your situation.
The US Food and Drug Administration pushes hospitals to streamline their process of reporting problems related to medical devices.
After receiving reports about the potential risk of using hysterectomy surgery devices, the FDA is said to be enhancing the agency’s current reporting system by determining how a medical device causes deaths or injuries. They are also looking at the possibility of forcing all hospitals to submit death and injury reports related to the issue.
The FDA is currently targeting laparoscopic morcellators following the death of a 51-year-old woman who died from uterine cancer. According to reports, the Brigham and Women’s Hospital did not report a case in which a power morcellator reportedly triggered the proliferation of cancer cells in the patient’s body. Meanwhile, the U.S. Government Accountability Office is currently conducting an investigation and will be releasing a report in January.
If you or someone you know has developed cancer after undergoing a surgery involving a power morcellator, get in touch with a lawyer from Williams Hart at (888) 220-0640.
Though the list of side effects in regards to the use of power morcellators tends to grow more and more frightening the longer you look at it, many people claim that the chances of such effects are incredibly low and the question about whether people should use morcellation during surgery lingers.
In the case of Amy Reed, a doctor and opponent to the use of the instrument, had personally undergone uterine fibroid removal three years ago. After her surgery, a rare cancer appeared in her uterine wall and she has since undergone four separate surgeries to remove the subsequent tumors.
Furthermore, the FDA has released a public warning against the use of power morcellators, claiming that they spread the same rare cancer that Reed has faced. The use of the tool has decreased from 13.5% of surgeries calling for them to 2.8%. The number of complications in hysterectomy surgeries has since remained about the same, but the spread of cancer has decreased.
Johnson & Johnson, the largest distributor of the tool, did issue a recall fo their devices, but since it was voluntary, the residual effects have not totally bumped the tool from use. There are several active lawsuits that directly address the morcellator misuse, proving that most people understand that the danger is real.
If you developed previously undetected cancer in the uterine wall following morcellator use, or some other side effect in direct conjunction with the tool, contact one of our attorneys of Williams Hart today. Call us at (888) 220-0640 to learn more information.
Williams Hart has been ranked among the best law firms in Houston and the nation by U.S. News – Best Lawyers “Best Law Firms.” We are honored to have received this prestigious distinction.
Our firm received a Tier 1 rating in Texas and a Tier 2 rating nationally for Mass Tort Litigation and Class Actions for plaintiffs.
The rankings were based on numerous factors, including evaluations from clients, other attorneys in our field, and information provided to the rankings administration. A Tier 1 score indicates that a firm scored within a few percentage points of the highest ranking firm. Williams Hart is happy to be included in “Best Law Firms” and we hope to continue doing the work that has earned us our high ratings.
If you have been injured by another person or the negligence of a corporation, call our injury attorneys at (888) 220-0640 to learn about what we can do to help you.
For the past three years, pharmaceutical company Johnson & Johnson has been shelling out huge amounts of money in over 1,500 Risperdal lawsuits.
Risperdal is an antidepressant prescribed by health practitioners for bipolar and schizophrenia disorders. The downside of the drug is that it may cause an increased level of prolactin, which could result in breast enlargement among male patients. The FDA released advisory related to the risk of death in elderly patients, and uncontrollable abnormal movements around the shoulder, face, and limbs of patients.
Among the damages incurred are three trials for not sufficiently cautioning patients about the risks of taking the drug. In November 2013, Johnson & Johnson was fined $2.2 billion because of civil and criminal claims. The company also suffered marketing claims settlements amounting to $158 million, $124 million, and $180 million in Texas, South Carolina, and D.C., respectively.
At Williams Hart, we recognize the dangers of pharmaceuticals, especially Risperdal. Contact us at (888) 220-0640 to learn more about your legal options.
Some of the most common tumors found in the uterus are known as fibroids. Many people faced with needing surgery to remove these tumors are now opting for minimally invasive surgery as opposed to traditional, open surgery, though there is a risk factor.
Hysterectomies, or removals of the uterus, have been performed by gynecologists or obstetricians since 1843. The process was then revolutionized in 1989 when the first laparoscopic hysterectomy was performed.
Open hysterectomies are done through either a large cut in the abdomen or in the vagina, known as an abdominal hysterectomy or a vaginal hysterectomy, respectfully. In laparoscopic hysterectomy, only a small cut is made in the patient’s abdomen to insert a lighted camera called a laparoscope and robotic surgical arms. The result is less pain and a shorter healing time. However, one of the laparoscopic tools, a power morcellator, increase the potential risks of spreading cancerous tissues inside patient’s belly cavity.
The two main types of laparoscopic hysterectomies are total and partial. In a partial laparoscopic hysterectomy, surgeons remove the uterus only. Total laparoscopic hysterectomy involves the removal of both uterus and cervix or the lower part of the uterus that connects to the vagina.
Researchers have highlighted the real danger linked to power morcellators and their risk of spreading undetected cancer. If you underwent a hysterectomy in which your doctor used a morcellator and you experienced adverse effects, contact a Williams Hart attorney at (888) 220-0640 today.