August 4, 2016

Woman Died After Medical Procedure Went Wrong

by Levin & Perconti

When we are sick we often require treatments and procedures that assist in the diagnosis of our medical problem. In one recent case, a woman died after a medical testing procedure was allegedly administered improperly. The woman’s estate administrator filed a lawsuit stating that the hospital and doctors were negligent by failing to provide proper care to the woman and thereby causing or contributing to her death.

Endoscopic Procedures

Endoscopies are generally safe procedures that are completed to view and diagnose internal medical problems throughout the digestive tract. In this case, the woman underwent an esophagogastroduodenoscopy, EGD. The procedure is exploratory and is performed using a scope with a camera which is used to view the inside of the esophagus and stomach. The procedure is not supposed to be invasive. The procedure may be completed as outpatient surgery or can be completed in the ICU or emergency room using special portable equipment.

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Woman Died After Medical Procedure Went Wrong

by Levin & Perconti

When we are sick we often require treatments and procedures that assist in the diagnosis of our medical problem. In one recent case, a woman died after a medical testing procedure was allegedly administered improperly. The woman’s estate administrator filed a lawsuit stating that the hospital and doctors were negligent by failing to provide proper care to the woman and thereby causing or contributing to her death.

Endoscopic Procedures

Endoscopies are generally safe procedures that are completed to view and diagnose internal medical problems throughout the digestive tract. In this case, the woman underwent an esophagogastroduodenoscopy, EGD. The procedure is exploratory and is performed using a scope with a camera which is used to view the inside of the esophagus and stomach. The procedure is not supposed to be invasive. The procedure may be completed as outpatient surgery or can be completed in the ICU or emergency room using special portable equipment.

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July 22, 2016

Surgical Mistakes Blamed for Woman’s Injuries

by Levin & Perconti

A woman has filed a medical malpractice lawsuit in Cook County against a hospital, medical group, and two doctors alleging negligence during surgery caused serious injuries. The woman was a patient at St. Alexius Medical Center where she underwent a surgical procedure. The procedure was not performed properly, according to the woman, and she was injured as a result. The lawsuit seeks damages of more than $50,000.

Failure to Properly Perform Procedure

The lawsuit indicates that the woman underwent a surgical procedure through Suburban Surgical Care Specialists, S.C. although the exact operation was not disclosed. After the procedure, the woman complained of extreme physical pain and also suffered from vomiting. The woman claims that the doctors did not perform the procedure properly and that caused her to suffer injuries along with pain.


Negligence occurs when a responsible party fails to provide proper care or take proper precautions to keep someone safe. Particularly, in the case of a doctor, negligence may happen due to a mistake or the failure to do something that should have been done to prevent injuries. Negligence by a doctor is often the same as medical malpractice. Doctors and other medical professionals must provide a high standard of care. Failure to do so could result in medical malpractice if the patient suffers a serious injury or dies as a result.

Surgical Procedures

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December 18, 2015

Negligent Care in Hospital Caused Death, Lawsuit

by Levin & Perconti

A malpractice lawsuit filed in Cook County alleges that negligent care at a Chicago hospital caused the death of a man in 2013. According to the lawsuit, the man underwent triple bypass surgery at the University of Chicago Medical Center. After surgery, the man was utilizing an extracorporeal membrane oxygenation machine (EMCO) which supplies oxygen directly into the femoral artery. In order to prevent bedsores, the man required regular turning which was performed by hospital staff. The EMCO became dislodged due to turning the man, causing him to suffer massive blood loss and ultimately death.

Negligent Care at Hospitals
Negligent care by a doctor or medical professional is also called medical malpractice. Proper care is expected when someone is a patient at a hospital. In this case, the care providers were negligent because they did not use proper care when turning the man and did not ensure that the EMCO device was still in place after moving him. Further, the lawsuit in this case indicates that the providers did not observe the man’s vital signs, and they were not notated on the man’s chart. Had the caregivers noticed that the man was bleeding medical action could have prevented his death. The man’s death in this instance was clearly caused directly by the substantial blood loss.

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December 12, 2015

Surgical Procedure Caused Serious Burn, Lawsuit Alleges

by Levin & Perconti

When we go under the knife we trust that our surgeon and medical team will provide the best possible care during the procedures. That wasn’t the case for a Vernon Hills woman. The woman underwent a surgical procedure at Hoffman Estates Surgery Center in 2014. According to the lawsuit, during the surgery a Bovie cautery pad was placed onto the woman’s leg causing a third-degree burn on her thigh. The burn was serious and purportedly left her with a scar and permanent disfigurement. The lawsuit was filed in Cook County court, alleging medical negligence.

Surgical Procedures

Many tools and various types of equipment and implements are utilized during surgery. These must be properly accounted for and taken care of throughout the procedure. Many incidents involving misuse of surgical implements have resulted in injuries or death to patients. Common problems include leaving sponges and other items inside the patient, improper sterilization of implements, and general mistakes made during the procedure. These issues are preventable and are generally considered medical malpractice.

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October 6, 2015

Understanding Standard of Care in Medical Malpractice Cases

by Levin & Perconti

Medical malpractice is a common occurrence in today’s world. Doctors and other medical professionals often make mistakes that cause harm to their patients. Of course, not every error results in a medical malpractice lawsuit. The laws regarding malpractice are complex and require the expertise of a skilled malpractice attorney. When a doctor or nurse has provided inappropriate treatment, the patient likely suffers both physically and emotionally. The result can range from minor medical problems that are quickly resolved, to long-term physical problems, and even could cause death.

Standard of Care

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July 27, 2015

Doctors and Hospitals Still Wary of Power Morcellator

by Levin & Perconti

Power morcellators are essentially small power tools that can be used to remove fibroids in the uterus by cutting uterine tissue during surgery. They are manufactured by several companies, including Olympus, Karl Storz, Blue Endo, and Ethicon (a subsidiary of Johnson & Johnson).

However, there is a concern that, in the process of cutting the tissue, they could end up spreading tumor parts to other areas of the body if that tissue contains cancerous cells, resulting in leiomyosarcoma, myelosarcoma, and uterine sarcoma.

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June 10, 2015

More News on Dangerous Medical Device

by Levin & Perconti

Usually when one thinks of medical malpractice, he or she thinks of an error by a doctor or nurse that leads to a serious medical complication. Sometimes, however, the problem is not with the medical staff. Instead it is with the medical device. One such medical device has been making news ever since the FDA warned the public about it last year. This device is used for a treatment called laparoscopic power morcellation and the problem with it is that it appears to be causing cancer to spread throughout the body. Called a ¨power morcellator," this device has been made by companies like Johnson & Johnson. The FDA warned doctors about the dangers of the device last year, but the FBI is investigating whether Johnson & Johnson knew about the problem long before that warning.

FDA Warned Doctors About the Device Last Year

Over a year ago, in April 2014, the Food and Drug Administration (FDA) issued a warning about laparoscopic power morcellation. The procedure involves using a power tool to chop up the tissue of fibroids or, in the case of a hysterectomy, to chop up the uterus itself. Tissue fragments are then removed from the body using tiny incisions. The problem is that roughly one out of every 350 women undergoing fibroid removal or a hysterectomy has a type of cancer called uterine sarcoma.

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November 6, 2014

Surgical Gowns Fail to Protect Against Ebola

by Levin & Perconti

Again and again in the news we have heard that Ebola is only transmittable through contact with the bodily fluids of an infected person, and that if proper safety protocols are handled it is an extremely difficult illness to transmit from person to person. And experts all seem to agree that this is true. But when the makers of equipment designed to protect medical professionals from disease exposure fails, the story changes. Just like medical device failures, these failures could be deadly.

Lawsuit Alleges Kleenex-Maker Falsely Claimed its Surgical Gowns Protect Against Ebola

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September 17, 2014

Some Hospitals are Failing to Sterilize Surgical Instruments

by Levin & Perconti

Failing to sterilize surgical instruments is one type of medical malpractice. This sort of health care provider error can result in serious infections, and sometimes, even death. The severe consequences of a failure to sterilize hospital equipment have lead to hospitals putting strict measures into place to insure that only proper equipment is used on patients. However, despite there being universal agreement on the importance of sterilization of instruments, two different news agencies are reporting this month on two different hospitals in two different cities that used unsterilized equipment on patients.

Hospital Used Unsterilized Surgical Equipment

NBC News Channel 11 KARE reports that Abbott Northwestern hospital in Minneapolis, Minnesota used unsterilized equipment in surgeries earlier this month. A hospital employee who spoke to KARE said, “This is … incredibly unacceptable and dangerous.” Fourteen unsterilized instrument sets were released into service. Four of them were actually used on patients. Those four patients have all been contacted by the hospital and have been offered testing for infections. So far no information has been released to the public about how this happened or how the problem was eventually discovered.

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July 31, 2014

FDA Announces it will Start Regulating Medical Laboratory Testing

by Levin & Perconti

Whether a patient is simply finding out whether or not she's pregnant, or is undergoing serious life-or-death surgery, lab tests are a large part of the hospital experience. If something goes wrong with those lab tests the result can be a delayed diagnosis which in the worst cases, can result in a wrongful death. While one might assume that the Food and Drug Administration (FDA) already regulated these tests, that is not the case for all tests. However, that is about to change.

New Process

The New York Times reports that the FDA announced on Thursday that it will start regulating medical laboratory testing. This move has been opposed by both some laboratories and some pathologists who claim that regulation is unnecessary and will hurt innovation when it comes to creating tests for rare diseases. The FDA has attempted to address these concerns by saying it will phase in the regulations of the tests over nine years. It will also focus primarily on regulating tests that pose a high level of risk to patients if the test result is incorrect.

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June 6, 2014

Inaccurate Alere Clotting Time Test Strips Recalled by FDA

by Levin & Perconti

Patients are in many ways at the mercy of their doctors. Doctors have training and skills the average person lacks, and are licensed professionals. Those doctors rely on the manufacturers of their tools and equipment. If the equipment malfunctions, the doctor can’t do her job, and the patient suffers. Unfortunately, sometimes the manufacturers of the doctors’ tools commit serious errors, and the tools don’t work. This has recently happened with an important tool used by doctors on patients requiring blood thinners. The U.S. Food and Drug Administration has issued a recall for certain Alere clotting time test strips. According to the recall notice, there have been nine reports of the strips malfunctioning. Six of those malfunctions resulted in injury, and three others resulted in death.

These strips are used by medical professionals to determine how long it takes a patient’s blood to clot. This information is very important to doctors making the decision as when a blood thinner, like warfarin, is being administered to a patient. If the test results are inaccurate, then the doctor will order an incorrect dosage of warfarin. This can lead to excessive bleeding and wind up being fatal.

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May 20, 2014

Datascope Corp/MAQUET Issues Worldwide Recall of Intra-Aortic Balloon Pumps

by Levin & Perconti

Surgery can be a terrifying experience. Whenever a patient goes to a hospital he or she has to rely on medical professionals to do what is best for him or her. But in the case of surgery, the patient is usually not even away or aware during the procedure. So there is no way of knowing what is going on. The patient has to trust completely in the doctors, nurses, and other medical support staff. But the patient also has to trust completely in the people who design and manufacture the tools the medical professionals use. Unfortunately, sometimes the tools fail, leaving the patient suffering from personal injury.

The Food and Drug Administration (FDA) announced that Datascope Corp/MAQUET issued a worldwide recall of intra-aortic balloon pumps. Specifically, the pumps being recalled are the 98/98 XT, the CS100, the CS100i, and the CS300. They are being recalled due to potential mechanical failure of the power supply fan assembly. Approximately 12,360 affected units have been sold globally. This is another case of what is called “medical device error.”

According to the FDA, intra-aortic balloon pumps are electromechanical systems used to inflate and deflate an intra-aortic balloon to provide temporary support to the left ventricle of the heart. The devices rely on the principle of “counterpulsation.” Counterpulsation is defined by MedicineNet as:

A technique that synchronizes the external pumping of blood with the heart's cycle to assist the circulation and decreasing the work of the heart. Counterpulsation pumps when the heart is resting to increase blood flow and oxygen to the heart. Counterpulsation stops pumping when the heart is working to decrease the heart's workload and lessen oxygen demand.

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May 3, 2014

FDA Proposes to Shorten the Approval Process for Medical Devices

by Levin & Perconti

Reuters reports that the FDA proposed a new plan to speed up medical device approvals. The program is called the Expedited Premarket Approval Application Program, and it is in theory designed for patients who have exhausted all other available treatment options. It is not a new pathway to market, but instead a “change in approach.”

The reason the FDA gives for the program to respond to criticisms that the already existing process for device approval is too slow, and that it delays patients’ access to potentially life-saving products. Delays in treatment are certainly a legitimate concern, and properly tested medical devices that are safe and can save lives absolutely should be used in medical treatment. The goal here is a noble one. But there are also serious risks involved that will have to be addressed as the program is rolled out.

Medical Device Reporting
The FDA admits that it receives hundreds of thousands of reports each year of suspected medical device malfunctions, sometimes resulting in serious personal injury or even death. The program that tracks these malfunctions is called “Medical Device Reporting” or “MDR.” Manufacturer, device user facilities, and importers of medical devices are required to report malfunctions, but other malfunctions are only reported on a volunteer basis. In other words, there are likely more malfunctions than the reported numbers. These malfunctions happen under the old, slower approval process for these products.

Increase in Medical Device Death and Injury
In 2012 The Telegraph reported that deaths and serious injuries involving medical devices were up 29% in the United Kingdom. The number of fatalities reported had increased 50% in just two years. Investigations showed that 1 out of 3 of malfunctions turned out to be the fault of the manufacturers of the devices, and that one 1 out of 4 of the malfunctions involved what they call “active and inactive implants.” Active and inactive implants include extremely common devices like pacemakers, replacement hips, gastric bands, and contact lenses. Fifteen percent of the malfunctions involved surgical equipment, and another fifteen percent involved devices like life support machines and incubators.

Medical Device Recalls Up in the United States
The FDA recently released a report detailing medical device recalls between 2003 and 2012. The results are staggering. It shows that the number of annual recalls of such devices increased by a full 97% during the studied time frame. So the number of recalls nearly doubled in a decade. The report also showed that the “most frequent causes for recalls are related to device design, software, and non-conforming material or component issues.”

What this means is that there is a serious problem. While the purpose of medical devices is to prevent injury and save lives, all too often mistakes are made and people wind up hurt. This has been going on for years. A push now to speed up an approval process that already lets flawed devices slip through could lead to more dangerous devices being used on ill patients. The FDA needs to be cautious going forward so as to not allow haste to hurt more patients than it helps.

Related Blog Posts:
Tracheal Tubes Recalled By FDA -Patients At Risk
Medical Device Company Hospira Warned by FDA Over IV Pump Concerns

March 12, 2014

Medication Reconciliation and Health Care Accountability

by Levin & Perconti

Take only as directed. It’s a warning that’s easy to follow. But what happens when physicians transfer a patient’s care to another provider without knowing what medications that patient has already been prescribed? Serious injury and even death can occur when transitions in care leads to uninformed medication orders. To combat these complications, the medical community has been implementing Medical Reconciliation, a process to compare a patient’s medications across caregivers and pharmacies in order to identify duplications, interactions between medications, and whether patients should continue taking current medications.

Medical Reconciliation should be implemented whenever there is a transition in care where new medications are ordered or existing orders are rewritten. A care transition may include changes in setting, service, practitioner, or level of care. For example, a patient’s daily medication may be suspended during a hospital stay, and the need to restart the medication upon discharge may be overlooked. Or a dosage has been mis-transcribed and when a new physician assumed care, the patient was overdosed and seriously injured. Medical Reconciliation attempts to prevent discrepancies like this.

The process of Medical Reconciliation includes

· Developing a list of current medications
· Developing a list of medications to be prescribed
· Comparing the medications on the two lists
· Making clinical decisions based on the comparison; and
· Communicating the new list to appropriate caregivers and the patient.

For newly hospitalized patients, care providers should obtain and verify the patient’s medication history, documenting that medication history, writing orders for the hospital medication regimen, and creating a medication administration record. Once a patient is discharged, care providers should determine the post-discharge medication regimen, develop discharge instructions for the patient for home medications, educate the patient, and transmit the medication list to the follow-up physician. For patients who aren’t in hospital care, the care provider should document a complete list of current medications and update that list whenever medications are added or changed. The Joint Commission requires that any accredited institution treating patients should have a process in place for Medication Reconciliation.

Medication Reconciliation and Tort Law
Even though most facilities have incorporated a Medical Reconciliation process, caregivers may not adhere fully to that policy. There is still a risk for miscommunication during the transfer process, transcription errors, and incorrect medication histories. When a patient is harmed by errors like these, lawsuits can be a particularly powerful way to hold caregivers accountable.

In some states, laws prevent patients who are harmed from filing lawsuits in certain instances. In Virginia, for example, legislation established a state fund to compensate babies born with brain injuries and prevents families from seeking damages in courts. But lawsuits require explanations from negligent health care providers and help to keep them accountable.

Filing lawsuits against negligent physicians can have a bad rap. Sometimes these suits are seen as frivolous. But in reality, only 6% of incoming civil cases are tort cases, and on average, medical malpractice cases represent only 0.6% of all incoming civil cases. In comparison, 70% of civil cases are contracts-based.

If you or someone you know has been injured due to a physician’s negligence, you don’t need to feel like filing a lawsuit makes you a “sue-happy” person. Rather, lawsuits are vital to both compensating you for your injuries and holding physicians and other caregivers accountable for their actions. The malpractice lawyers at Levin and Perconti are experienced in representing people who have been injured by negligent healthcare providers.

See Related Posts
Dangerous Medication Errors Exist in Many Forms

CJ&D Briefing Book: The Truth About Medical Malpractice Lawsuits

March 2, 2014

Tracheal Tubes Recalled By FDA -Patients At Risk

by Levin & Perconti

When medical patients go into the hospital to receive care they rely on the expertise and professionalism of all those working on their behalf--doctors, nurses, aides, and others. Not only that, but patients also rely on the products those professionals use. From the high-tech medical beds to immensely complex surgical robots, medical care today is dependent on the sophistication of many different medical devices.

Unfortunately, at times these products are designed dangerously or there are manufacturing mistakes that put patients at risk.

FDA Catheter Recall
For example, consider a recent recall of certain tracheal tubes by Smiths Medical. The FDA announced the recall in a press released posted to their website last week.

Tracheal tubes are a type of catheter inserted into the trachea (throat) to help a patient breath. There are different types of these tubes, including: endrotracheal tubes (inserted through the mouth), tracheostomy tubes, and tracheal buttons. These tubes can be used in different ways for different patients. In addition to maintaining airways, they can also help deliver medication.

According to the press release announcing the most recent recall, the manufacturing company Smith Medical voluntarily decided to recall a specific type of catheter known as the Portext Uncuffed Pediatrio-Sized Tracheal Tube. The recall affects three different sizes of tubes--2.5mm, 3.0mm, and 3.5mm--manufactured several years ago (before September 2009).

Apparently, the problem with the tubes is that some had internal diameters smaller than indicated on the label. In other words, while indicated at 3.0mm, for example, some tubes diameters were actually not that size. This labeling and/or manufacturing error can cause serious problem for patients. Doctors and nurses working with the defective tubes may have “difficulty passing through or withdrawing the suction catheter.”

Ultimately, catheter errors of this nature are incredibly serious. At the recall notification explains, problems may include the build-up of secretions and the blockage of a patient’s airways. This partial or complete airway obstruction can make it hard for the patient to breathe or for caregivers to ventilate the patient. The recall notice specifically indicates that “there is a reasonable probability of serious injury and/or death

Considering the stakes, it is important for all medical professionals to take appropriate steps to prevent harm. Specifically, the recall notice advises all those who may have received these defective tubes to return all unused products. Caregivers should review the specific list with affected products codes available on the FDA webpage for the situation.

Legal Help
If you or someone that you know may have been injured as a result of problems with a tracheal tube, please contact our malpractice lawyers today. We work with families in many different settings, including dangerous medical devices. The civil law specifically provides avenues for those harmed in this way to recover damages for their losses.

See Related Blog Posts:

What is a Standard of Care in Medical Malpractice Claims?

Scary Statistics on Medical Malpractice

January 29, 2014

What is a Standard of Care in Medical Malpractice Claims?

by Levin & Perconti

Doctors, hospitals, and medical providers in general all owe a duty to their patients which must meet a minimum standard of care. A standard of care is the reasonable degree of prudence exercised by a medical provider in tending to a patient. In the medical world, such standards may be measured against treatment and care standards across the medical industry in a particular state or jurisdiction. There may also be published guides to care and treatment that doctor or hospitals commit to abide by.

This standard of care also includes a medical provider’s duty to inform patients of particular risks with a medication or a certain procedure, for example. A failure to disclose the risk could result in malpractice liability if the patient were to get hurt and claims he or she would not have opted for a particular course of treatment if they were aware of the risks. In general, plaintiffs must demonstrate that a standard of care was breached as an element to their overall malpractice claim.

A Case Study
The relatively recent case of Hunter v. Amin provides a distinct example of a medical provider’s standard of care and how the plaintiff believed the provider breached his duty by failing to meet that standard. In Hunter, an inmate, Stanley Bell, who suffered from bipolar disorder was taking anti-depressants and an antihistamine for his anxiety. The defendant doctor was a psychiatrist employed by the jail who took on Bell as a patient. When Bell refused to go on with a particular session until a jail officer left the room, the defendant psychiatrist threatened to withhold his medications unless he participated in the session with the officer present. Bell also refused to sign a waiver requested by the psychiatrist which would release him from any liability for Bell’s refusal to participate in the psychiatry session, but Bell refused to do that as well. Within two days, without his medications, Bell committed suicide.

Bell’s sister sued the psychiatrist for malpractice, alleging he failed to meet the standard of care in treating her brother when he withheld the medications. The trial court found that Bell’s complete refusal to participate in the session effectively excused the psychiatrist from any duty of care since the inmate, as the patient, refused to accept any treatment in the form of his weekly session. The psychiatrist was therefore no longer under any duty of care, and a malpractice suit could not move forward.

An appeals court, however, found that there was in fact a remaining duty between the psychiatrist and Bell during that session. The court found stated there was no evidence to say that engaging in the weekly session was a prerequisite for receiving medications that were previously prescribed to Bell, and that the psychiatrist had previously prescribed medications to him without an actual exam or session. Therefore, the psychiatrist’s discontinuing of the antidepressant medication was in fact a breach of the duty of competent care that did still exist between the doctor and patient. The case was remanded back to the lower court for trial.

The appeals court’s decision stands as an interesting example of how complicated it can be to determine when a duty of care attaches between a medical provider and patient. In bringing forth a malpractice suit, this can often be the most challenging element to prove.

See Other Blog Posts:

New Malpractice Suit Dubbed “Death by Forceps”

Failure to Diagnose: Parents of Young Doctor File Medical Malpractice Lawsuit

May 22, 2013

Medical Device Company Hospira Warned by FDA Over IV Pump Concerns

by Levin & Perconti

The U.S. Food and Drug Administration (FDA) plays a critical role in keeping consumers safe. There is a reasonable expectation that a product that is bought at a store will be safe for use. That expectation is even more secure when it comes to products that are used by medical professionals in critical health care processes. A patient does not wander through a store to select which medical products are used in their care. From hip implants and needles, to medication and IV pumps, patients rely on the choices of their doctors and care of regulatory agencies like the FDA to ensure that dangerous products are not allowed.

Our entire caregiving process is based on this trust. That is why we must be incredibly vigilant about holding designers and manufacturers accountable when products actually harm patients unnecessarily. In the aftermath of dangerous products, medical device lawsuits are common to ensure that accountability is provided and those affect receive redress.

Yet, ideally the damage would be prevented altogether. That is where regulatory agencies are in control. It is critical that the FDA act aggressively to ensure product manufacturers make choices, if necessary, so that dangerous products are pulled from use in a timely manner.

Dangerous IV Pumps
For example, recently the FDA issued another warned to a company that produces a line of IV pumps. As reported in Chicago Business, Hospira, Inc. received a letter from the Administration two weeks ago which included findings from the FDA’s inspection of the company’s headquarters earlier in the year.

The problems included in the letter mostly relate to serious concerns about the safety of pump designs. On top of that, however, the FDA was concerned about the lack of sufficient protocols in place to take “corrective and preventative” action as part of an overall safety plan. There were also concerns about lack of proper reporting following adverse events related to products that the company makes.

In addition, the findings included some worrisome flaws, including concerns about the company’s planned phase out of IV pumps like the Symbiq, GemStar, and others. The company plans to replace those pump with “remediated Plum A+ pumps.” This entire process will cost upwards of $350 million, and FDA officials are unsure of the ultimate effect on patient safety.

Profits Over Patients - Always Unacceptable
Obviously many varied business decisions factor into choices by companies like Hospira. The business of medical device design and manufacture is quite complex, and it is easy to get lost in the details. However, the underlying principle of patient safety must be prioritized first, above all else. While any consumer product can cause harm, those created specifically for medical care pose an increased risk of serious adverse consequences when they are not designed with safety in mind or manufactured improperly.

We have many examples of dangerous products that are not pulled from the market quickly enough (like DePuy hip implants), allowing more patients to be harmed than necessary. We should never allow that to happen again, and so it is encouraging to see the FDA act with vigilance in mind.

See Other Blog Posts:

Do Negligent Hospitals Actually Profit From Malpractice?

Leading Cause of Litigated Medical Malpractice - Diagnostic Errors

April 10, 2013

FDA Taking Another Look At Safety of Robotic Medical Tools

by Levin & Perconti

There is always a critical balancing act that must be performed with so many technological advances in the medical field. On the one hand, there is a desire to get these new products and procedures in place as soon as possible so as to help as many medical patients as possible. We lose people each and every day who might have been saved by earlier use of advances or specialized tools. Of course, on the flip side, just as these tech tools can save lives, they can also take them away. Medical care is an incredibly delicate process, and any errors, imperfections, or slip ups can literally be the difference of life and death.

This inherent tension is why federal regulators have created various layers of oversight and a formalized approval process for most medical advances--from new devices to drugs. This ensures that medical patients do not unknowingly suffer the consequences of being an unwanted guinea pig for something that doesn’t yet have all the kinks worked out. As those who have followed various mass recalls and medical malpractice cases in the medical field appreciate, even when the approval process is followed, serious harm can still result. One need look no further than the thousands of medical patients suffering as a result of defective DePuy hip implants to understand what can happen when defective products are on the market.

Robotic Surgical Tool Injuries
In that same spirit of ensuring medical patients are not unnecessarily exposed to increased risks, reports this week suggest that the U.S. Food and Drug Administration is taking another look at the safety of the armed robotic tool used in surgeries known as “da Vinci.” The extremely complex machine is often said to “wow” physicians, and more and more are deciding to utilize it. Reports suggest that over 400,000 surgeries were performed last year alone with da Vinci.

But now that the initial outburst of support has waned, many are raising red flags about bugs that still need to be worked out. These patient safety advocates point out that there have already been several cases where patients may have died as a result of errors with the equipment. For example, in one case the robotic tool apparently would not let go of one patient’s tissue that it had grasped during the operation. In another case a patient was hit hard directly in the face by one of the tool’s robotic arm.

In fact the FDA noted that they have seen a rise in reports about accidents using da Vinci--that includes at least five reports of deaths within the last year alone.

Illinois Medical Malpractice
A few of the patients who may have been harmed as a result of problems with da Vinci include Illinois residents. For example, in 2007 a Chicago resident died during a spleen surgery when the robot was in use. It is unclear from these reports whether or not that case resulted in any legal liability.

Of course, “some” reports of problems does not mean that da Vinci is an inherently dangerous product or even that changes need to be made to lower risks. However, it is important to remember two points. First, even if an incident is rare, those affected still may have the right to recover for their losses. Second, the only way to fully understand if there are systematic issues with any medical product is for open and complete reporting about those possible errors. That requires all involved parties, from patients to the device maker to be forthright about their concerns and documenting possible adverse events.

See Other Blog Posts:

Settlement in Wrongful Death Lawsuit Against Oral Surgeon

Jury Decision Upheld in False Light Case

April 8, 2013

Tort Cases Making Their Way to Court Following Mirena IUD Injuries

by Levin & Perconti

Defective medical devices pose incredible risks, because the possibility exists that they may harm hundreds or thousands of patients before being pulled from the market. Unlike individual cases of malpractice, when the products used by doctor (or consumers directly) are unsafe, the costs can be staggering. That is why there are clear standards that must be followed by all those who play a role in designing, manufacturing, and using medical products. Failure to act carefully may result in significant legal liability.

Mirena Lawsuits
That seems to be the case with the inter-uterine device known as Mirena. Over two million women have had the device implanted. Multiple sources are reporting on the many women have come forward suggesting that they have suffered serious injury as a result of the device. Considering the significant number of women who use Mirena, tens of thousands may ultimately suffer serious injury as a result of these complications.

The product is a birth control tool that has grown in popularity growing in recent years. It is usually inserted during a doctor’s visit, and can last as long as five years. Mirena works by releasing a daily progestin levonorgestrel shot into the wall of the uterus. This thins the lining of the uterus for birth control purposes.

The product has been used since 2000, but in recent years a chorus of voices is growing claiming the product comes with significant risks of moving while inside the body. Some women have had the device become embedded in the uterus or even puncture organs. Sometimes risky surgery is required to remove the device, and complications, like infections, can result. Obviously, no patient should have to deal with these ramifications merely by a using a product intended to prevent unwanted pregnancies.

Those affected have reached out to attorneys, and well over one hundred cases have already been filed in various states across the country. In fact, a petition was recently filed at the federal level for multi-district litigation. This is a step taken to consolidate many cases for efficiency purposes. It is often uses in cases like this one, when many people are harmed in similar ways by a specific product.

The legal arguments made in these cases are varied. Most include claims of defective design as well as failure to properly warn of risks. A few claimants are even alleging fraud and seeking punitive damage awards from the company which created the product, Bayer.

IUD Injury Attorney
It will be interesting to see how these first cases play out, as it may have ramifications on this device and others like it. Recently, a product similar to this one--known as SKYLA--was approved by federal officials and hit the market earlier this year. Many women may begin using that device as well, and so it will be critical to ensure they do not suffer some of the same harms as is seen with Mirena.

In any event, if you or someone you know is ever harmed by any sort of IUD, consider contacting an attorney who works on these cases for guidance on your legal rights.

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