The da Vinci surgical robot has been used in operating rooms around the U.S. for more than a decade. But after hundreds of complications – some fatal – the U.S. Food and Drug Administration is now investigating.
Surgical Robot Complications
- Five deaths have been linked to the robotic surgical system.
- Reports of the robot’s hand not letting go of tissue grasped during surgery have been documented.
- One patient got hit in the face by the robot’s arm while she was lying on the operating table.
- More than 500 da Vinci incidents have been reported by the FDA since January 2012.
The Huffington Post reports the following incidents filled just this year:
- A woman who died during a 2012 hysterectomy when the surgeon-controlled robot accidentally nicked a blood vessel.
- A Chicago man who died in 2007 after spleen surgery.
- A New York man whose colon was allegedly perforated during prostate surgery. Da Vinci's maker filed that report after seeing a newspaper article about it and said the doctor's office declined to provide additional information.
- A robotic arm that wouldn't let go of tissue grasped during colorectal surgery on Jan. 14. "We had to do a total system shutdown to get the grasper to open its jaws," said the report filed by the hospital. The report said the patient was not injured.
- A robotic arm hit a patient in the face during a hysterectomy. The company filed that report, and said it is unknown if the patient was injured but that the surgeon decided to switch to an open, more invasive operation instead.
Nearly 400,000 Da Vinci Surgeries Preformed Last Year
The da Vinci robot is often beloved by surgeons for its ability to perform precise and complex operations in a minimally invasive way. Nearly 1 out of 4 U.S. hospitals have at least one da Vinci system. That is almost 1,400 hospitals.
According to da Vinci’s maker, Intuitive Surgical Inc., the number of robotic surgeries has risen from 114,000 in 2008 to 367,000 in 2012. That is triple the number in just four years.
Most often this type of high tech surgical system is used for prostatectomies (prostate removals) and hysterectomies. However, it is increasingly being used other operations such as:
- Gastric bypasses
- Gall bladder removal
- Thyroid cancer surgeries
- Cardiac operations
- Head and neck procedures
FDA Investigates Da Vinci
Earlier this year, the FDA decided it would conduct a survey of surgeons using the robotic equipment to hopefully be able to answer growing concerns.
The reason for the study now “is the increase in number of reports received” about Da Vinci, said FDA spokeswoman Synim Rivers.
Surgeons Only Required One Day of Robotic Training
A surgeon is required a relatively minimal amount of training to operate this state-of-the-art technology.
This is partly because when da Vinci was first approved by the FDA in 2000 it was done so through a process called “premarket notification,” often used to permit medical devices to be used without the typical rigorous testing required of new drugs.
Before da Vinci was cleared for market, the FDA asked Intuitive twice for more details into how surgeons would be trained to use the technology. The robot makers informed them of their 70-item exam and three-day hands-on training protocol.
Only a couple years later, in 2002, Intuitive decided to decrease the amount of required training by replacing the 70-item exam with a 10-question online quiz. The company also reduced the amount of hands-on training from three days to only one.
Questions for your Surgeon
There are always risks involved with surgery, but you can be better prepared by asking your doctor the following questions.
- How were you trained?
- When did you do your first da Vinci procedure?
- How many robot assisted operations have you done?
- How often do you do them?
- What will you do if the robot malfunctions during the operation?
- Will you be training another surgeon during the procedure? If so, will he or she be performing any portion of the surgery?
Contact an Experienced Product Liability Attorney
Thomas J. Henry Injury Attorneys are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/ or defective pharmaceuticals.
If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or pharmaceuticals, contact Thomas J. Henry Injury Attorneys immediately. We represent clients/victims all over the country. We are available 24/7, nights and weekends.
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On January 25, 2013 the U.S. Food and Drug Administration (FDA) sounded an alarm linking the drug Samsca to increased liver enzymes which can lead to potentially deadly liver damage. This warning came a few days after Samsca’s manufacturer, Otsuka America Pharmaceutical, wrote a letter to healthcare providers warning of the same risks.
What is Samsca (Tolvaptan)?
Samsca is a medication approved by the FDA to treat Hyponatremia, the most common electrolyte disorder in the U.S.
Samsca and Hyponatremia
- Approximately 6 million patients were diagnosed with Hyponatremia in 2006.
- This electrolyte deficiency disorder occurs when the sodium level in the blood falls below 135 millequivalents per liter (mEq/L).
- Normal sodium level is between 135 and 145 mEq/L.
Samsca was approved to treat two types of Hyponatremia
- Hypervolemic Hyponatremia: both sodium and water increase in the body with a greater increase in water.
- Euvolemic Hyponatremia: normal sodium level with increase in total body water.
Studying Samsca’s Treatment of ADPKD
A trial study was conducted for Samsca’s potential to treat Autosomal Dominant Polycstic Kidney Disease (ADPKD). Samsca is not currently approved in the U.S. for ADPKD.
Samsca Clinical Trial Facts:
- The trial was a double-blind placebo controlled study.
- It was conducted over 3 years.
- It included about 1,400 patients with ADPKD.
- 3 Samsca patients developed significant increases in the liver enzyme bilirubin
- Study participants taking Samsca also had 3-times higher than normal level of ALT, which is a liver enzyme that is released when the liver is damaged.
- 42 out of 958 patients taking Samsca had raised ALT compared to only 5 of 484 given a placebo.
Trial Finds Samsca May Cause Fatal Liver Injury
- The maximum dose approved for Hyponatremia is 60 mg per day.
- Samsca’s trial participants were given 120 mg per day: 90 mg in the morning and 30 mg in the afternoon.
These findings indicate that Samsca (tolvaptan) has the potential to cause irreversible and potentially fatal liver injury.” – External Panel of Liver Experts
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Thomas J. Henry Injury Attorneys is a personal injury law firm with offices in Corpus Christi, Texas and Houston, Texasrepresenting accident victims nationwide. Our priority is to provide our clients with the best legal representation. Our experienced trial attorneys are committed to defending your rights in personal injury matters including defective products, recalled drugs, child injuries, and auto accidents.
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Last week the pharmaceutical giant, Novartis International AG, got hit with two lawsuits filed by the U.S. Department of Justice.
- One allegation seeks triple damages and civil penalties for corrupting the dispensing process with multi-million-dollar ‘incentive programs’ thus violating the Federal False Claims Act.
- The other complaint involves kickbacks to at least 20 pharmacies in the form of discounts and rebates if they would switch kidney transplant patients from competing medicines to Novartis’ Myfortic immunosuppressant.
Novartis Turned "Pharmacists into Salespeople"
"Novartis co-opted the independence of certain pharmacists and turned them into salespeople." – U.S. Attorney Preet Bharara, Manhattan
According to news reports, US Attorney Preet Bhararahas said Novartis tried to conceal the scheme by omitting the agreements from rebate and discount contracts with pharmacies. One pharmacist in Los Angeles was allegedly offered a “bonus” rebate of 5% of their pharmacy’s annual Myfortic sales equaling several hundred thousand dollars in exchange for switching at least 1,000 patients to Myfortic.
Another complaint involves an Arkansas pharmacy increasing sales of Myfortic from $100,000 to $1 million over four years, after being compelled by Novartis. Lawsuit filings describe the details of Novartis reps’ “lavish” wining and dining of doctors as well.
Novartis Called a “Repeat Offender”
Shockingly, the drug maker just paid $422.5 million in 2010 and pleaded guilty to a misdemeanor settling criminal and civil liability charges involving their marketing of the epilepsy drug, Trileptal and several other medications.
A 5-year Corporate Integrity Agreement was signed in September 2010 as a result of the settlement. However, both lawsuits accuse the company of a variety of infractions that occurred afterwards.
Novartis Disputes the Allegations
Novartis is "committed to high standards of ethical business conduct and regulatory compliance in the sale and marketing of our products." – Julie Masow, Novartis Spokeswoman
If Novartis is convicted of paying people to buy their treatments, and therefore violating anti-kickback statutes, they could be penalized with exclusion – this term means they would be prohibited from contracts with U.S. federal healthcare programs, such as Medicaid and Medicare.
Novartis Ranks 2nd in World-wide Pharmaceutical Sales
- This multinational drug company had sales figures of 46,806 billion in the U.S. alone in 2010.
- Myfortic sales are up 12% from last year with total net sales of $579 million in 2012.
Thomas J. Henry Personal Injury Attorneys
Thomas J. Henry Injury Attorneys is a personal injury law firm with offices in Corpus Christi, Texas and Houston, Texas representing accident victims nationwide. Our priority is to provide our clients with the best legal representation. Our experienced trial attorneys are committed to defending your rights in personal injury matters including defective products, recalled drugs, child injuries, and auto accidents.
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