Indiana Injury And Family Lawyer Blog

Medical device recalls do occur so it is important to know that if you are in need of a medical procedure, it’s not a bad idea to ask the physician the following questions:

1) How long the technology been available?

2) Have there been any recalls associated with the technology?

3) Are there any complications that may result from using the technology or complications risks associated with the procedure?

All medical procedures do have some level of risk. When a physician proposes a medical procedure in a treatment plan, they review the risks, benefits and alternatives.  They also inform you of the ways you can reduce the risks.  Physicians also consider the level of risk compared to the benefits and review this information with you. Yet, since you may be ill and your primary focus is managing through the illness, you may forget to note information about the technology.  Thus, it is advised to inquire about technology or research the technology online before undergoing a medical procedure.

Medical device recalls are sent out to physicians when a defect in the technology is discovered by the manufacturer or the Food and Drug Administration. When manufacturers receive information about physicians, who have discovered defects or injuries resulting to patients due to technology defects, they are obliged to report the defect or injury to the FDA. At this time, the FDA and the manufacturer usually work together to inform physicians about the defect, the risk of injury, and the need to remove it from the physician office or hospital for return to the manufacturer.  Class One Recalls are the most serious.

If you are need of a lawyer due to personal injury, please contact attorney Burton A. Padove at Padove Law at (219) 836 2200.

Tractor trailer accidents in Indiana and Illinois are commonplace and can be very harmful to the driver, as well as, any other drivers or passengers in surrounding vehicles. It is not uncommon for the end result to be a severe life changing event for affected families members, let alone those who are injured.

Tractor trailer regulations are governed by the state. While regulations are stringent regarding vehicle maintenance, load limits and other safety precaution policies, enforcement of the regulations is difficult in light of the shortage of regulators, inspectors and troopers on the road. This leaves the safety in the hands of trucking company owners. Trucking company owners are obligated to meet safety standards with every load that leaves their driveways. Trucking company manufacturers are responsible to ensure that all vehicle parts are completely in an operational order. Yet, sometimes, there are defective auto parts and other times, trucking company owner employees may be inclined to cut corners when deadlines to hit the road and deliver goods in a timely fashion are the highest priority.

Personal injury attorneys who manage tractor trailer accident cases know how to access experts who can evaluate all factors that go into to tractor trailer accidents, including: load limit, breaking capacity, operational parts, and weather condition factors that may have impacted the course of the driver.

Whether you were a driver, passenger in a vehicle struck by a semi-truck or the semi trucker driver, you may be entitled to have your legal rights protected through a personal injury attorney. So, it is vital to seek out medical attention immediately following an accident and contact a personal injury attorney about your legal rights as soon as possible after the accident.

If you are need of a lawyer due to personal injury, please contact attorney Burton A. Padove at Padove Law at  (219) 836 2200.

Medical device recalls do occur so it is important to know that if you are in need of a medical procedure, it’s not a bad idea to ask the physician the following questions:

1) How long the technology been available?

2) Have there been any recalls associated with the technology?

3) Are there any complications that may result from using the technology or complications risks associated with the procedure?

All medical procedures do have some level of risk. When a physician proposes a medical procedure in a treatment plan, they review the risks, benefits and alternatives.  They also inform you of the ways you can reduce the risks.  Physicians also consider the level of risk compared to the benefits and they review this information with you. Yet, since you may be ill and your primary focus is managing through the illness, you may forget to note information about the technology.  Thus, it is advised to inquire about technology or research the technology online before undergoing a medical procedure.

Medical device recalls are sent out to physicians when a defect in the technology is discovered by the manufacturer or the Food and Drug Administration. When manufacturers receive information about physicians, who have discovered defects or injuries resulting to patients due to technology defects, they are obliged to report the defect or injury to the FDA. At this time, the FDA and the manufacturer usually work together to inform physicians about the defect, the risk of injury, and the need to remove it from the physician office or hospital for return to the manufacturer.  Class One Recalls are the most serious.

If you are need of a lawyer due to personal injury, please contact attorney Burton A. Padove at Padove Law at  (219) 836 2200.

Pain pumps used during and/or following surgery for medical procedures are generally safe. In fact, advancements in pain pumps have taken the fear, anxiety and discomfort out of surgery for many people throughout the U.S.

At Padove Law, we like to keep you informed about recalls that may occur with many types of medical devices over time. Such is the case for a recent CLASS I RECALL announced by the Food and Drug Administration for Moog Medical pumps, including: Curlin 6000 CMS, Curlin 6000 CMS IOD, PainSmart, and PainSmart IOD.

Not all of the company’s medical devices were recalled, but a specific group that was distributed from May 2007 to February 2011. A CLASS I RECALL signifies the need for healthcare professionals to take immediate action to return affected models to the manufacture due to the discovered risk of serious injury or death that may result with the advent of an uncovered defect in the medical device.

The risk becomes evident when this medical device pump is triggered to signal an error message, denoted by, Error Code 45 (EC45). Error Code 45 is truly a message that indicates the pump is shutting down.   The Food and Drug Administration has reason to believe that the shutdown may pose a risk for serious injury or death. So, this is way that a recall is rated CLASS I.

To date, there have not been any reports of injury or death. So, the early detection of this defect may have saved lives.

If you, your family or a friend need to protect their legal rights, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.

A Class I recall is the most serious type of recall, typically announcing the risk of a life threatening illness due to a defect in a product. Cardiologists and Risk Managers recently received notice that components in the Arstasis One Access System may fracture and/or separate which could result in an emergent life threatening situation.

The Arstasis One Access System is used to support a diagnostic test during upper leg catheterization procedures. The device supports the diagnostic test by providing access to the vascular system so the cardiologist can identify abnormalities in the vascular system.   The Arstasis One Access System also offers a means to help halt bleeding from the upper leg artery that is being tested.  Cardiologists and Risk Managers will be reporting any emergent situations, health issues or side effects that relate to the malfunction of the component sin the Arstasis One Access System to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

The Arstasis One Access Systems involved in this recall include: Models: AAD100, AAD101; Part Numbers: FG-02279, FG-03010; Lot Numbers: 09I10268, 1OC26337, 09J06281, 10C12334. These products were distributed for five months beginning May 14, 2010.

Cardiologists are not liable for defective products that cause harm to patients. Of course, all physicians take precautions by examining technology before use. However, physicians are not engineers and cannot be responsible for identifying defects in products. By the same token, sometimes physicians do discover defects, either by viewing an abnormality in the product or seeing a patient with an unusually expected complication following use of the product.

Medical device manufacturers are responsible and can be held liable for any defective product that causes serious injury or death to an individual.  So, there are lawyers who specifically handle cases involving defective medical devices.

If you, your family or a friend have suffered serious inury and need assistance in asserting your legal rights for compensation, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.

Neuro Resource Group, Inc. manufacturers a variety of medical devices that are sold to people throughout the world. The devices are co-packaged with a variety of accessories, such as, alcohol prep pads, alcohol swabs, and alcohol swab sticks that are manufactured by Triad located in the United States. However, a recall of these accessories was recently announced because of an identified risk that the accessories have been contaminated by Bacillus cereus which is a form of bacteria.

This is especially a concern for people who have had surgery, those with weakened immune systems and those who are frail which elevates the risk of developing a life threatening infection from the bacteria.

There are several ways that the affected lots could be labeled, including the terms “Select”, “Select Medical Products”; “PSS Select”, or “PSS World Medical, Inc”. Consumers are being advised to immediately discard the alcohol wipes, known as Triad Group's Alcohol Prep Pads, associated with the affected lots. Consumers should go directly to the manufacturer’s website to see lot   numbers that are part of the recall or contact the manufacturer directly.  Consumers who must discard their alcohol wipes can visit a local pharmacy and can ask the pharmacist about an appropriate replacement so that the consumers can still use Neuro Resource Group’s devices.    Consumers may also call Neuro Resource Group direct for replacement wipes at 1-877-314-6500.

The Neuro Resource Group’s devices are not contaminated and are still safe to use so the device should not be discarded.

Anyone who feels that they are ill or showing symptoms of an infection should contact their physician immediately.

If you, your family or a friend have suffered serious illness and need assistance in asserting your legal rights for compensation, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.

Indiana law conflicts were suited to reshape the statute of limitations for medical malpractice. According to Indiana statues, a medical malpractice lawsuit must be brought against a party within two years of failure to treat, neglectful injury or wrongful death. Recently, the Indiana Supreme Court weighed in on conflicts for lower court decisions in which the Supreme Court decided that the statue has merit, but cannot be applied in cases when the injured party was not able to learn about the condition until after two year rule. In this exception, injured parties may file a lawsuit within two years after the discovery of the medical malpractice.

This decision served a breast cancer patient well so that she could recoup losses for a physician’s failure to diagnose her breast cancer. Several other medical malpractice victims received proper attention for their complaints under the same exception.

The majority of medical malpractice cases in Indiana fall under the Medical Malpractice Act. However, if the physician does not participate in a state sponsored excess insurance program, other laws may apply. In all medical malpractice cases, there are numerous conditions that just be met in order to qualify for a lawsuit, including, but not limited to:

• The patient must disclose complete medical history information, including the use of medications, over-the-counter drugs, and supplements.
• The patient must follow preoperative and post-operative instructions which reduce the risk of complications.
• Patients must understand that there are risks with all medical procedures, but complications from medical procedures and conditions do not constitute medical malpractice.

Physicians also have responsibilities, including, but not limited to:

The core responsibility of a physician, barring his medical license, is to allow patients to make informed decisions regarding their healthcare. This is called the informed consent process. Physicians may use a variety of tools to be certain that you understand the following:

• what is wrong with you
• what procedure options you have
• what risks are associated with the procedure
• what are the recovery requirements
• how you would contend with an unsatisfactory outcome

You will also sign an informed consent agreement when you are at your physician’s office. It is advised that you take home that informed consent, review it thoroughly, along with any pre or post-operative instructions so that you can make an informed decision.

If you, your family or a friend have suffered damages and need assistance in asserting your rights for justice and compensation, contact PADOVE LAW, toll free at (877) 446 5294 for a free consultation.

Advanced Bionics took swift action to recall the company’s HiRes 90K cochlear implant device and all un-implantable devices that have been distributed. This hearing aid recall was initiated following two reports from users who experienced excessively loud sounds, shocking sensations and a high level of discomfort. These side effects occurred within eight to ten days of initial use of the hearing aid.

At present, Advanced Bionics does not know why the HiRes 90K cochlear implant device and the company’s unimplantable devices are producing such side effects. The company is working with the Food and Drug Administration to determine the root cause that prompted the hearing aid recall. Typically, flaws in the design of the product or in safeguards of the product are the reasons for malfunction in products.

Hearing aids have come a long way from the first ear trumpet style versions of the 1700’s. By the mid 1850’s, a thin metal device was designed to meet specific needs for the hearing impaired. Nearing the 1900’s, ear tubes with speaker connections gained popularity. By the 1940’s, more modern hearing aids were developed and were offered in a variety of sizes to meet the specific needs of individual users. By the end of the 50’s, hearing aid styles were smaller due to advancements in microphone and battery technology.  In the 1990’s, digital processing hearing aids took over the marketplace, which provided greater clarity, a full range of tones and a more discreet appearance.  With the advent of digital technology, designs specifications have changed and hearing aid manufacturers are dedicated to creating advanced design specifications that do not pose risks for consumers.

Hearing aid companies that uncover risks in their products must perform an investigation to determine the reason for the risk. The company must correct the problem in order to sell the product to the public.

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective products.  He can be reached at (877) 446 5294.

On November 18, 2010, the U.S. Judicial Panel on Multidistrict Litigation will meet in Durham North Carolina to decide if all states’, including Indiana, DePuy ASR Hip Implant lawsuits should be heard in one court.  This outcome is the result of the high number of lawsuits that are being brought against the company, estimated at 4000 to date and thousands more expected because consumers who have this hip implant are still learning about the risks.

The DePuy ASR Hip Implant was recalled by the FDA following a report by the National Joint Registry of England and Wales which demonstrated that 1 out of every 8 patients who received the DePuy ASR Hip Implant had undergone revision surgery within a five year time period after the initial placement of the implant. Typically, a hip implant should be long lasting, at least 15 years.  Revision hip surgery is real surgery that is very invasive, requires a significant recover time period and is associated with risks. There has also been an additional warning about metal on metal hip implants, such as the DePuy ASR Hip Implant, which can cast metal particles into the body, causing soft tissue damage and inflammatory responses that may lead to bone loss.

People who have filed lawsuits are those who have undergone revision hip surgery or are concerned about the increased risks associated with the hip implant. Approximately, 93,000 DePuy ASR Hip Implants were distributed throughout the U.S.

The basis for the lawsuits is that DePuy, a subsidiary of Johnson & Johnson, did not sufficiently test the hip implant and failed to warn the public or issue a recall in a timely fashion.   It is suspected that the DePuy ASR hip implant has a defect in the design of the acetabular cup, which is shallower than acetabular cups made by other medical device companies, making it more likely to fail. .

Burton Padove, Indiana and Illinois lawyer, is available to help those who are injured because of defective medical devices.  He can be reached at (877) 446 5294.

Guidant, LLC, maker of a cardiac defibrillator, pled guilty to criminal violations of the Food and Dug Administration Cosmetic Act which requires that medical device companies disclose risks of serious injury and death that are associated with their products. The Guidant defibrillator was used in cardiac surgery to produce a shock to restart the heart when the device detects that the heart fails.  Guidant apparently was aware that there were short circuit failures in their Ventak Prizm 2 DR (Model 1861) and the Contak Renewal (Models H135 and H155), but failed to disclose this information to the proper authorities or the public.

The FDA’s Office of Criminal Investigations spent four years investigating this case before determining that criminal allegations must be brought against the manufacturer. The affected Guidant defibrillator models were designed to detect and treat irregular heart rhythms, but when they fail due to short circuiting can result in sudden death momentarily. In the end, Guidant admitted to making a false statement about the Ventak Prizm 2DR device and failing to notify the FDA that the company made a correction to the Contak Renewal devices in order to reduce the risk of sudden death.

Guidant, a wholly-owned subsidiary of Boston Scientific Corporation, has now been presented with the largest criminal penalty imposed on a medical device company that failed to meet FDA requirements in the Cosmetic Act.

If you or a loved one has been injured by a cardiac defibrillator or other medical device, contact Burton Padove, a highly experienced lawyer that understands drug litigation. For a free consultation with Burton Padove, call 219-836-2200.

Cardiac patients should be aware of the Class I Recall involving Thomas Medical Products with the company’s Transseptal Sheath Introducer Kit, also known as HeartSpan, CHANNEL FX, and Torflex, Braided Guiding Introducer Kit. This medical device is used in cardiac patients to pass a heart catheter from one side of the heart to the other during cardiac surgery.  It has reported that the tip of the medical device may break off, move through the heart and arteries as well as penetrate vital organs such as the heart or brain. Consequently, cardiac patients that experience this defect may be subject to emergency open heart surgery or suffer from injury such as heart attack, stroke or death.

Cardiac patients should be aware that cardiologists are in the process of being informed. Class I Recalls are the most serious types of recalls. Such recalls are usually generated following reports of life threatening injury and/or death.  It is wise for cardiac patients to be aware of medical device defects. Cardiac patients may inform cardiologists about the defect. Though, it is not the responsibility of cardiac patients to be informed about medical devices or inform physicians. It is the responsibility of the manufacturer to inform cardiologists about medical device defects.

Cardiac patients and their families may not be aware that illness, stroke, heart attack or death may be caused by a defective medical device. This may appear to be an unexpected, but natural occurrence for an individual with heart disease. However, such is not always the case in medical devices that are subject to a Class I recall. Lawyers that focus on illnesses relating to defective medical devices invest in research to identify the true cause for unexpected injuries and death.

If you or a loved one has been seriously injured because of a defective Cardiac medical device, contact Burton Padove for a free consultation at 219-836-2200 or 877-446-5294 for nationwide callers.

Dialysis Systems by Baxter called HomeChoice and HomeChoice PRO are under a medical device recall following reports from physicians that people have experienced serious injury and one known death because of a defect in the product. The specific defect is unknown at this time. What is known is that the Automated PD system which is programmed to repeatedly deliver and remove dialysis solution may produce increased Intraperitoneal Volume (IIPV). Intraperitoneal Volume (IIPV) is described as overfilling of the abdominal cavity.

Intraperitoneal Volume (IIPV) is known to cause serious breathing difficulty, hernias of the abdomen or diaphragm, pulmonary dysfunction, hypertension, hydrothorax, pericardial effusion and peritonitis. Dialysis patients that are children or are seriously ill are at an increased risk of injury from the affected models of Baxter’s Dialysis System.

Some physicians may still be using Baxter’s HomeChoice and HomeChoice PRO. If they are still using Baxter’s Dialysis Systems, they are being advised by the FDA to inform dialysis patients about the risk associated with HomeChoice and HomeChoice PRO.

Nearly 300,000 people undergo dialysis annually. If you undergo dialysis, it is important to inquire about the safety and efficacy of all medical devices involved in your treatment. Risks and benefits are associated with all medical treatments. In the case of a medical device recall, the risk is elevated more than an acceptable standard defined by the Food and Drug Administration and the law. Such situations include:

• When an alternative design would have prevented the risk.
• When an alternative product is equally effective but not associated with elevated risks.
• When a manufacturer fails to warn the consumer of the risks.

Dialysis victims that have been injured because of the defect in Baxter’s system may be entitled to financial compensation for their injuries. The Baxter dialysis system recall is a Class I Recall, denoting the most serious risk of injury or death.

If you or a loved one has been seriously injured because of Baxter’s HomeChoice or HomeChoicePro, contact Burton Padove for a free consultation at 219-836-2200 or 877-446-5294 for nationwide callers.

Millions of Becton, Dickinson and Company catheter systems are involved in a recall because of a defect in the product that may result in injury or death to a user. The direct flaw of the catheter system involves the risk of an air embolism and leakage of blood or therapeutic fluids. These risks pose an additional risk of serious injury or death.

Becton Dickson received reports that air was entering through the septum disk. Catheter system failures were reported on units that were distributed from November 2009 to November 2009.

Catheters are used in hospitals to treat a variety of medical conditions, including, but not limited to:

Urine Drainage: People may require a catheter to drain urine from the bladder. A catheter may be used for this purpose for kidney patients, following surgery or for bedridden patients that cannot get up to go to the bathroom.

Fluid Drainage: People that have medical conditions in whereby fluids gather in the body may require a catheter to remove fluids in the body.

Anesthesia Administration: People that are having surgery often receive a catheter which provides a means to deliver anesthesia.

Medication Administration: People that require subcutaneous delivery of insulin or other medications may do so with catheters.

Heart Pressures Measurement: People may have a catheter to evaluate heart pressures.

Premature Infant Support: Premature infants may require catheters for access to central circulation.

If you or a loved on has been seriously injured because of a medical device, contact Burton Padove for a free consultation at 219-836-2200 or 877-446-5294 for nationwide callers.