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:
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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.

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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?

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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.

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Settlement in Wrongful Death Lawsuit Against Oral Surgeon

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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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March 15, 2013

Important New U.S. Supreme Court on Liability Following Harm Caused by Generic Drugs

by Levin & Perconti

As reported recently in the New York Times, the U.S. Supreme Court is set to hear a new case that will further clarify legal liability rules as they relate to drug errors and pharmaceutical companies. At the heart of the case is whether a generic drug manufacturer can be held liable for the harm caused by a defectively designed drug.

The original case was filed by a woman who was given a prescription for the pain pill known as sulindac by her doctor. The mild medication was intended to provide some relief for her shoulder pain. In reality, it totally changed the woman’s life--and not for the better. The patient suffered from a reaction to the drug which caused severe burning. Here skin literally “sloughed” off. Ultimately she needed to spend months in a burn unit and was in a coma for even longer. By the end of it all the woman was legally blind and had suffered permanent damage to her lungs and esophagus.

Defective Drug Legal Case
The patient filed a lawsuit against the manufacturer of the generic drug. At trial the woman was awarded $25 million which was upheld by a federal appeals court. However, the defendant pharmaceutical business--Mutual Pharmaceutical Company--appealed again to the U.S. Supreme Court. The high court agreed to take the case and will hear arguments soon.

Liability for generic drugs is one of the most hot-button legal issues being discussed these days. Considering that 80% of all prescribed medications are generic, determining who is responsible when the medication causes harm will have ramifications on many patients. The liability may ultimately rest on the exact legal arguments made.

For one thing, the Supreme Court already found in a previous cases that generic drug makers can not be held liable for harm when insufficient warning labels are argued. In that case, the Court found that the generic drug manufacturer is not responsible for the warning label on these products and so cannot be held liable when those labels are inadequate.

However, claiming that a warning label did not address a particular risk is not the only way that an injured patient may seek accountability. In this most recent case, the plaintiff is instead arguing that the drug itself was defectively designed. For their part, the defendant company is claiming that the logic in the warning label case is the same here: they have no control over the design and therefore cannot be held liable when it is defective.

Yet, there is good reason for the court to see things otherwise. Lower courts reasoned that even if the actual design was not under its control, the company was still not required to sell the product. If it was defective, it should have been pulled from the shelves, regardless of whether they or someone else designed it. If the court’s find otherwise, then many are wondering if the generic drug industry will essentially be immune from liability, and patients will have next to no recourse when harmed by these products.

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January 27, 2013

Joint Commission Proposes Hospital Alarm Management Goals

by Levin & Perconti

If you enter a hospital even once you will recognize it: the beeps, buzzing, hums, and ringing that make-up the hospital safety alarm system. These sounds are used for safety, set to make noise and alert caregivers when something might be amiss with a patient. When used properly, alarms are clearly a critical tool that can ensure fast action in the response to changes in conditions that might save lives.

But managing alarms is not necessarily a straight forward process. Identifying where alarms should be added or where some need to be taken away requires careful thought and planning. Too few alarms might mean that doctors and nurses do not react quickly enough to help a struggling patient. On the other hand, too many alarms could result in alarm fatigue such that there are so many sounds that no alert actually seems urgent. Alarm overload must be considered closely to understand the exact balance that is best for patients.

Goals for Future Years
It is in that vein that the Joint Commission is seeking information and feedback from involved parties before setting its 2014 Patient Safety Goal on Alarm Management. For the next month interested parties can answer a 15 question survey and questionnaire to provide guidance for dealing with these issues. The survey and more information about the Joint Commission’s goal can be found here. It can be completed online or sent via email.

The Commission noted that properly managing these alarms is critical, but there are as of yet no national guidelines or best practices for the management. The goal is to develop a “systematic, coordinated approach to alarms.”

A Becker’s ASC story on the proposed guidelines notes how the guidelines list five general elements which will hopefully be a part of the final 2014 goals. First, there is a need to establish alarm management as a safety priority that needs to be addressed. Until it is an agenda item on the lists of hospitals and clinics, then nothing will actually be done to improve and save lives. Next, an inventory of alarms and alarm settings need to be identified. This provides a “lay of the land” to begin to understand what does or does not need to change. Third, the most important alarms need to be identified. What alerts matter most and why? Fourth, perhaps most importantly, the actual policies for managing these alarms need to be established. The response to these sounds should not be ad hoc. Clear protocols need to be established that can be applied in all settings. Finally, staff members need to be educated about that policies and understand when and how to apply them. Clear rules are of little value if they are disregarded in practices or not understood by those needing to apply them.

Alarm management is just one of many different issues that all combine to influence patient safety at hospitals. While it may seem tedious to deal with these issues so intricately, considering the costs of medical errors in this regard, there is little excuse for failing to act prudently to develop logical rules for managing medical alarms.

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January 16, 2013

Metal on Metal Hip Implants & The FDA Approval Process

by Levin & Perconti

All medical operations are somewhat delicate procedures. That is why it is obvious that the devices used in those procedures--from medical tools to implants--need to be safe and secure. Most medical patients assume that there are regulations in place so that not just any device is used when they go in for medical treatment or an operation. One assumes that there will be testing and trials for most products so medical professionals know that they are safe before they are used in a way which might harm thousands of patients.

Sadly, many of those assumptions are incorrect. Often is is not until a product causes significant harm that its lack of safety is verified. That was evidenced vividly over the last few years with the recall of thousands of metal-on-metal hip implants which were discovered to cause serious harm to thousands of patients. Readers are likely familiar with the two most high-profile cases, the Stryker hip implant recall and the Depuy recall. Our attorneys work with residents who were harmed by these products. Thousands of medical patients across the country, including in Illinois, were forced to endure painful revision surgeries and deal with other medical complications as a result of receiving these faulty devices.

The 501(k) Approval Process
But how did these devices make it to the marketplace in the first place? A recent New England Journal of Medicine article lays it all out in a comprehensive and readable fashion. As outlined in the story, the approval process has its roots in a law passed in 1976 known as the Medical Device Amendments. This piece of legislation created three classes of medical devices, ranked for their risk of injury. On the lowest end were class I devices, like a toothbrush, with low risk. On the other hand, class III devices, like hip implants, could cause significant harm.

As you might expect, class I items require less rigorous testing before being allowed to enter the marketplace. Class III items were supposed to undergo a far more intense premarket approval (PMA) process to ensure that dangerous items did not make it into the stream of commerce and cause problems.

However, a loophole was formed which has yet to be closed that circumvents what was intended to be a comprehensive safety process. That loophole is known as the 501(k) process which allows an object to avoid the rigorous PMA process if it is “substantially equivalent” to an already-approved object. Originally, class III devices were never supposed to be able to use this loophole. Instead, the ability for devices like hip implants to use the 501(k) process was supposed to be temporary, while the FDA completed its full classification for all devices. The problem is, several decades later, and the FDA classification is still not complete. That means that the 501(k) process is still available to class III devices, allowing dangerous metal-on-metal hip implants to enter the marketplace and be installed in hundreds of thousands of patients without ever going through full clinical trials to prove their safety.

See Other Blog Posts:

Reminder About Stryker Hip Replacement Recall

First Johnson & Johnson DePuy Hip Recall Settlement

November 27, 2012

Bed Rails: The Fine Line Between Medical Devices and Consumer Products

by Levin & Perconti

Our attorneys often explain the difference between medical malpractice (professional negligence) issues and ordinary negligence. While professional negligence refers to mistakes made in specialized medical care, ordinary negligence refers to general safety lapses. For example, while giving a patient an overdose of a medication is professional negligence, failing to properly monitor a wandering patient is ordinary negligence. The difference has legal ramifications, often with different procedural and evidentiary rules.

One similar split exists between products and regulation of those products. There are medical products and regular consumer goods. While all products need to be safe, the rules for use of these devices and the governmental entity that is charged with ensuring their safety differs between them. In many cases, it is easy to differentiate between the two. A Tiffany lamp is obviously a consumer good, while a DePuy hip implant is a medical device. However, at times the line between whether a device is a medical product or an ordinary consumer item is not clear.

Where Do Bed Rails Fit In?
For example, take bed rails. These are usually metal bars that attach to the side of beds to help patients sit up and to prevent someone sleeping from rolling out of the bed. Most have seen different versions of these rails on beds in hosptials and nursing homes. However, the rails are also used on occasion in individual homes, sometimes for seniors or even children.

Are bed rails medical devices or regular consumer goods? Unlike hip implants, they are not obviously used exclusively for actual medical care. In theory they can help anyone who is sick or well, inside or outside the hospital.

This issue was disussed tangentially in a recent New York Times article that delved into the dangers of bed rails. Many patient safety advocates have been calling for years for improvements to limit harm caused by these rails. Hundreds of medical patients and nursing home residents have died and tens of thosuands have been injured in the last decade or so as a result of getting stuck in the metal rails or smothered between the rail and the bed. Seniors with cognitive issues like dementia and Alzhemiers are the most likely to be affected.

Safety advocate urge the ban of these devices in many settings or at least the use of tougher safety protocols and warnings. However, even though the dangers have been known for many years, little has been done to keep those at risk safe. Part of the problem, say those involved, is confusion over which federal agency is responsible for ensuring the safety of the devices. The U.S. Food and Drug Administation (FDA) is charged with monitoring medical devices. Alternatively, the Consumer Product Safety Commission (CPSC) regulates traditional, non-medical consumer goods.
So where do bed rails fit? One one hand, they may include specific instructions from manufacturers on medical uses, such as helping to ensure the safety of patients with dementia and Alzheimers. When unique benefit for those with specific ailments is used, then it tends to be viewed as a medical device. However, if the manufacturer does not make those claims, then it may be a regular consumer good just like other products on a bed--the pillow, sheets, or mattress. According to the NYT story, the CPSC has long-maintainted that bed rails are medical devices outside of their purview, however, FDA officials have noted that the line is not so clear.

See Our Related Blog Posts:
Reminder: Bed Rail Dangers are Real

Consumer Voice on the Dangers of Bed Rails

October 20, 2012

Malpractice Trial Postponed In Collarbone Surgical Error Case

by Levin & Perconti

Surgical errors may be the prototypical form of medical malpractice. That is because they involve the classic scenario of a patient who is in the complete control of the medical professional (often under anesthesia) with complex bodily invasions that often include life and death issues. Of course, attorneys working on these cases appreciate that patients are at their most vulnerable during surgeries, and all medical practitioners must abide by aprropriate standards of care at those times.

A recent story in the Star Exponent is an example of this type of case. According to the reports, a medical professional was sued by a former patient who claimed that problems during surgery left her deformed and with chronic pain in one arm. The problems, the plaintiff alleged, stemmed from inadequate care during a collarbone surgery on the left side of her body. According to the complaint filed with the court that initiated the suit, the defendant-doctor performed a "carpal tunnel release" and an "open reduction internal fixation" on the plaintiff's left clavicle. The idea was that the work would help relieve pressue and pain along the nerve in the wrist. The operation also involved repairing bones in the area with artificial implants.

Unfortunately, instead of improving her situation and relieving pain, according to the patient the operation only made things worse. And she suggests that probems during the operation are the cause. In particular, the complaint explains that, in the middle of the procedure the doctor determined that there was a problem with one of the bones. To correct this he attempted to screw in a six inch metal plate into the left side of the woman's upper body. Unfortunately, because of poor bone condition, he was unable to screw the plate to the clavicle. Instead of recogonzing the lack of feasibility of completing the operation in this case, the doctor plunged ahead. He kept the metal plate in the body and tried to keep it in place with sutures instead of screws.

This decision proved incredibly harmful for the woman. According to the complaint the sutures "acted like a saw" and literally cut one end of the collarbone off inside her body. The doctor acknowledged this in a follow-up visit but explained that the snapped bone was caused by it's poor condition, not the sutures. All of this caused the woman continual extreme pain, and she has lost significant mobility in the arm.

The family eventually filed a medical malpractice lawsuit alleging negligence and seeking accountability for the long-term harm caused by the surgical error. Even though the suit was filed last October, it is only now that a trial date has been set--for September of next year. This is a testament to the lengthy time-frames of many of these cases. Also, it is unclear if the case will actually go to trial, because on many occassions families and medicla professionals are able to come to an agreement on fair compensation without the need to go to trial.

Surgical errors are far too common with far-reaching consequences on the lives of the patients and their families. If you or someone you know may have been harmed by inadequate care during a surgery, please reach out to our lawyers to see how we can help.

See Our Related Blog Posts:
Subbing Out Surgeons

Disclosing Sleep Fatigue Before Surgery

October 6, 2012

New Lawsuits Alleging Defective Medtronic Infuse Spinal Implants

by Levin & Perconti

It goes without saying that there is little room for error when it comes to medical products that are inserted inside a patient body. It is absolutely imperative that all mistakes be avoided when patients agree to have a device surgically installed in their body to treat a certain ailment. Unfortunately, there are many cases of various objects their either do not work as intended or actually cause more harm. In those cases, lawyers often fight hard to ensure the affected families have their legal rights respected.

Spinal Implants Problems
One of the more recent examples of this scenario involves BMP spinal implants--like one known as Infuse. Some “off label” uses of the device may actually cause injuries and harm to patients.

A recent PR web story discusses the situation.

According to the release, the U.S. Food and Drug Administration (FDA) recently issued a public health notification on certain uses of the BMP spinal implant--that includes Medtronic Infuse bone graft in cervical spinal fusions. The release notes that these uses may cause patients to suffer unacceptable injuries. The potential damage includes swelling of the tongue, mouth, neck, and throat. In addition, certain patients may have difficulty breathing, suffer nerve damage, experience compressions of neurological neck structures, and have difficulty swallowing. In the most extreme case, the problems may be fatal.

The main concern is that the Infuse BMP spinal implant was only approved by the FDA for spinal fusion surgeries using approach at the front of the body in the lumbar region of the spine. Even then, some reports have critiqued even this limited approval, noting that there may be problems with the Medtronic Infuse bone graft product that the FDA approved.

In addition, there are concerns about the marketing of the product for uses not approved by the FDA. This is a serious problem, and our attorneys know that many
legal battles involving medical devices and medications stem from potential marketing concerns--with manufacturers trying to “sell” the product by suggesting its use in ways not approved by the FDA.

In this case it appears that some suits have already been filed alleging off-label promotion of these BMP spinal implants. News reports on that suit suggest that as much as 85% of all sales of the product were for “off label” purposes. The suit suggested that sales representatives for Medtronic may have actually promoted the product for those off-label reasons. All of this eventually resulted in a settlement in the case amounting to $85 million.

However, that settlement does not end the legal matter. Many other individual patients may have been hurt as a result of these practices. Those individuals may be entitled to recovery for the losses they experienced as a result of these medical devices problems.

If you are in Chicago or throughout Illinois and believe that your may have been harmed by one of these spinal implants, be sure to get in touch with a lawyer working on these cases. The attorney can explain the situation and determine the best way to proceed in your individual case.

See Our Related Blog Posts:

New Resource on Hip Implants

FDA May Implement New Standards for Metal-on-Metal Hip Implants

July 10, 2011

Number Of Injuries From DePuy Hip Replacements Continues To Grow

by Levin & Perconti

In August of 2010, DePuy Orthopedics, a division of Johnson & Johnson, issued a recall for two of its widely used hip replacement products, ASR™ XL Acetabular Hip System and the DePuy ASR™ Hip Resurfacing System, after it was determined that the metal-on-metal design of the prosthetic hip could be harmful to the individual recipients. The metal-on-metal devices have caused issues for thousands of recipients because of the deterioration of the metal once implanted in a patient’s body. The metal-on-metal design can lead to the release of small metal particles into the recipient’s body. This can lead to a slew of health problems including infection, necrosis, allergic problems or even heart and neurological system problems.

The company estimated that between 2003 and 2009 over 90,000 patients received one of the now recalled DePuy hip replacement systems. Research has shown that nearly one in eight recipients of a DePuy Hip Replacement required a revision surgery to correct the issues associated with the faulty hip replacements.

With approximately 90,000 faulty hip replacements used and a one in eight chance of issues occurring, it is safe to assume that well over 11,000 patients will require a revision surgery to correct the problems suffered because of the faulty metal-on-metal design. “Anyone who received a recalled DePuy hip implant may be eligible to receive compensation for these defective products, even if they have not yet experienced pain or symptoms,” said attorney Steven Levin of Levin & Perconti.

With the large number of potential claimants DePuy is expected to face an increased amount of litigation.

The Chicago hip implant attorneys at Levin and Perconti believe that the number of claims already filed against DePuy may only be the tip of the iceberg. It is impossible to know whether the tens of thousands DePuy hip replacement recipients that have not yet incurred problems will in the future.

November 6, 2010

DePuy Hip Implant Recall Spurs Another Lawsuit

by Levin & Perconti

The effects of the massive recall of hip implantation devices made by DePuy Orthopaedics continue as more individuals have filed lawsuits after suffering complications with the defective devices. Our Chicago product liability lawyers at Levin & Perconti are closely following the developments of the situation as many individuals in the Chicagoland area may have been affected by the problematic pieces of medical equipment.

DePuy Orthopaedics, a division of Johnson & Johnson, recalled many of the ASR hip implant systems after data from the National Joint Registry showed that 1 in 8 patients needed corrective surgery within five years following hip implants surgeries with one of those devices. However, information has revealed that the company was aware of the problem long before the joint registry issued its reports—perhaps years earlier. However it waited before issuing the recall, allowing thousands more patients to be fitted with the defective and damaging medical device.

Typically, these hip implant systems are supposed to last 15 years before needing any corrective revision. Over 93,000 patients have received the defective hip implant devices since its creation and prior to the recall. The problem with the device centers on its metal-on-metal ball and socket design. The wear of the system creates microscopic cobalt and chromium debris which causes damage to the bone and tissue it contacts.

The Star Advertiser reported on the latest lawsuit involving a Hawaiian woman who filed suit this week. The victim had hip implant surgery over a year ago, but she began suffering pain in the hip a few months after the surgery. She continues to endure the pain, which causes her to be in constant pain and struggle to get to sleep at night. Following the DePuy recall this August, she is finally scheduled to have replacement surgery next month to help correct the problem.

Tens of thousands of other patients may have been affected by the defective medical device without yet being aware. If you have had a hip implant, be sure to contact your doctor to learn more about the status of your implant. If complications arise or if you experience pain or other problems with the implant, make sure to seek legal advice from an experienced product liability lawyer to ensure your rights are protected.