Posts Tagged ‘Hospitals’

Zimmer Hip Implant Recipients Be On Alert

Thursday, March 26th, 2009

Since 2006, 12,000 plus people received the Durom Cup hip implant by Zimmer. At the onset, the Durom Cup appeared to provide relief for those struggling with damage to the hip bone and cartilage. In fact, hip replacement surgery is the final treatment plan when all other methods fail. Yet, the treatment plan with the Durom Cup hasn’t ended for many due to the disabilities that have resulted from its use. The Durom Cup was recalled after multiple violations cited by the FDA. In addition, there are several other makers that have faced with recalls due to excessive pain and suffering for people that have underwent hip replacement surgery. In fact the lack of consumer awareness is another cause for concern. As Jackie Quinton, Attorney at Law of The Garrett Law Office in Oklahoma City and surrounding areas explains, “People with the recalled Zimmer Hip Implant often initially believe that the persistent pain and/or dislocation they are experiencing is a natural component of surgery and not attributed to a defective product. In fact, they may go to the emergency room and have subsequent surgeries without knowing the root cause of their disability. Some doctors may not be aware of the defect as well.” The affected hip implants date back to 1998. Over 150,000 hip replacement surgeries are performed each year, according to FDA Talk.

Hip replacement surgery may be performed through a variety of techniques. The techniques for total hip replacement involves the use of artificial implant designed to help mimic the function of the hip joint.

Zimmer Hip Implant Issues
Though initial patient reports of the Durom Cup held promise, the failure rate appeared high in the years following surgery. Patient complaints have included: 1) loose implant 2) inability of the cup to bond with the bone 3) implant migration from initial positioning 4) immobility 5) severe pain. The contentions surrounding the hip implants are, as follows:

• Some personal injury attorneys contend that Durom Cup implants should never have been on the market because the company never proved that their product was superior to others. Also, it is suspected that there is a failure in the design of the implant cup.
• Others contend that the doctors were not adequately trained in Durom Cup placement by the maker.
• The process of bonding implants to bone is highly skill dependent. For example, dentists have been using the process of osteointegration (bonding bone to artificial material) for over ten years. Osteointegration is critical for the success of a dental implant. Yet, the skills used in the bonding technique have required many years of time. Osteointegration techniques are used in other medical applications such as head and neck.
• The FDA cited multiple reasons why the Durom Cup implant was a cause for concern, including: 1) failure to deliver adequate quality control information about the product 2) failure to implement preventative and corrective procedures, 3) failure to deliver complaint handling and trend reporting for side effect cases in a timely fashion.

Though the company did suspend sales and ultimately reported the high failure rate, the problems associated with the implant may produce debilitating pain and the need for revision surgery. In fact, surgeons performing revision surgery may require additional expertise to remove and replace the implant. Revision surgeries also have their own set of risks.
Lawsuits involving hip implants have been filed in behalf of victims suffering from hip replacement. There are a select number of personal injury attorneys that handle hip implant lawsuits.

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Body Tissue Linked to HIV, Syphilis and Hepatitis B & C

Tuesday, March 17th, 2009

The tissue transplant industry is under legal fire. Dating back to at least five years ago, bone skin and ligament from cadavers used in transplantation has been an area of concern for the public at large. It has been estimated that hundreds of body parts used for surgeries like knee surgery, back fusion and neurosurgery may not be sterile and inadequately processed. Companies such as Allosource, Biomedical Tissue Services, and Medtronic are under scrutiny for their suspected role in the ill-prepared and un-screened tissue. As R. Helm, Attorney at Law, of Anchorage Alaska explains, “The greatest concern is that no one knows if the people receiving the cadavers have been exposed to medical conditions nor do we know what occurs in the body should the cadaver dissolve.”

Tissue Transplant Watchdogs
Tissue is procured and sent on to manufacturers such as LifeCell Corporation, Blood and Tissue Center of Central Texas, and Regeneration Technologies. However, tissue banks are not required to obtain membership in organizations such as the American Association of Tissue Banks (AATB) which serve to guard against the infiltration of defective tissue to the public. The AATB has set standards for operation and an accreditation process which includes inspections of facilities that procure and process human tissue from cadavers. The inspectors’ analysis includes record-keeping, quality control, quality assurance, donor screening, testing and suitability determinations. The process of tissue procurement is comprised of donor and tissue suitability determination, tissue retrieval, decontamination techniques, quality control, product testing, and clinical application of allografts. The FDA has issued recalls over the years and some companies have come forward to issue their own recalls over the years. Yet, the check and balance system is not refined, placing hundreds of people requiring tissue transplantation at risk.

The tissue transplant scare could have been sparked by the New Jersey case involving stolen body parts that were sent to Medtronic for processing. Or perhaps, the funeral director in North Carolina that conducted tissue recovery in the embalming room of the funeral home has been more provoking. Assuredly, the tissue transplantation industry is under scrutiny now. Select personal injury attorneys are accepting cases involving people that have been injured by questionable tissue transplantation.

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MRI’s Are Not All Made The Same: FDA Alerts About Burn Risk

Wednesday, March 11th, 2009

Magnetic Resonance System may have sounded like the greatest medical invention sweeping the nation twenty years ago. Radio wave signals able to penetrate the body using a magnetic field to transform the images of the body’s soft tissue. Sounds impressive, right? It is. Yet, problems associated with MRI testing may be enough for one to question the procedure and the methodology.

Recently, there was the outbreak of Steven Johnson’s Syndrome. This outbreak was associated with Gadolinium Dye that was used during some MRI procedures. Some MRI patients are required to receive injectible contrast dye to identify changes in non-bony matter of the body. Some of these patients received   gadolinium dye. There are numerous types of contrast dyes to select from for MRI’S, none traditionally associated with life changing risks. However, the gadolinium dye produced long term debilitating effects for many, including: orange peel like skin that sloughs off the body over time, joint disabilities, and pain.

Transdermal drug patches used in some MRI procedures have been the latest safety risk identified by the FDA. Some patients are required to use transdermal patches for the delivery of medication during an MRI. Both brand and generic over-the-counter transdermal patches are identified risks, according to the FDA.
Transdermal patches from certain makers contain metal such as Aluminum. Metals typically do not affect the magnetic field of the MRI, but can conduct electricity. During the procedure, the transdermal patch can ignite and cause skin burns.

The brand and generic patches may not have a warning on the box to alert consumers of the risk. Product manufacturers must warn the public about risks that may be associated with their products. Product manufacturers must guard against risks in the design of their products. If they are not able to design out the risk, then they must warn fl the risk. Until warning labels are on transdermal patches, check with the manufacturer about their products risk of producing a burn.

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Personal Injury: Med Mal & Nursing Home (3 out 3)

Friday, February 13th, 2009

Medical Malpractice Legal Responsibility:

Medical malpractice
state laws have been rewritten over the years which have led to restricted rights for injured consumers due to medical negligence. Severity in harm and supporting documentation are crucial elements to establish validity in claims. As Manuel L. Dobrinsky,Attorney at Law, of Miami Florida, adds, “Doctors today have many more patients to manage than they had in the past. Thus, the risk of a medical error is more likely than years ago. For this reason, it is important for consumers to take a vested interest in their healthcare by being inquisitive about their diagnosis, medications, treatment, and follow up. In doing so, patients can reduce the risk of potential life threatening illness that may otherwise result in a failure to diagnose or misdiagnose an illness. “
Connected Topics:Medical Malpractice

Nursing Home Abuse Accountability:

Nursing home liability refers to emotional, physical or neglectful acts against an elder by a nursing home employee(s). This may include: malnutrition, dehydration, bed sores, wandering off premises, falls, sexual assault, battery, and wrongful death. Skilled nursing and intermediate care facilities must meet criteria set by Medicare and Medicaid should they serve Medicare or Medicaid recipients. Other facilities that wish to accept Medicare patients must meet standards set by the Federal Medicare Health Insurance Program for the Aged. There are also nursing homes that do not accept Medicare patients which allow them to not fall under federal guidelines. State requirements vary among the states. In fact, certain attorneys are creating movements through state
legislature to improve nursing home abuse accountability. As John J. Perconti, Attorney at Law, Chicago, Illinois, explains, “Nursing home abuse has become more common in recent years. Yet, the laws do not reflect upon the needs of today. For example, nursing homes are not required to carry liability insurance. All nursing home residents and their families need to be informed that the nursing home facility does not have insurance. If there is no financial accountability for negligence, these residents will continue to be neglected and abused.  The rights of abused victims are restricted under the current system.” Currently, Illinois is in the process of passing a bill that would require liability insurance in nursing homes.
Connected Topics: Nursing Home Abuse

Premise Liability:

Property damage or bodily harm that occurs on a homeowner’s property maybe the responsibility of the homeowner where the
damage took place. Homeowner’s insurance policies are designed to provide compensation for damages associated with accidents, negligence, and other forms of harm. A government agency may be liable in some instances whereby the accident occurs on the property of the government. An example of this would be slip and fall that occur because of cracks in sidewalks, faulty curbs, potholes, defective crosswalks, flawed stairs on buses and the like.

Some of the more common injuries that result in premise liability include:dog bites, slip and falls, or any type of property that is termed an attractive nuisance liability which is an item that can harm children regardless of reasonable precautions taken to prevent injury. As Arnold Hernandez, Attorney at Law, of San Diego County, CA explains, “Premise liability is founded on the idea that we all owe a duty of care to our fellow human beings to insure that there are no hidden risks of personal injury on our property and that we have exercised reasonable care in insuring we have removed foreseeable risks. The duty of care is much higher when it comes to children that may come onto our property and we must anticipate how children will behave, including: children’s conduct that to an adult would seem irrational.”
Connected Topics: Dog Bites, Slip and Falls.

Terms for Liability:

Timeliness is important when it comes to liability. Every state has specific rules relating to the number of days that you are permitted to file a claim. It is important to seek the advice of an attorney as soon as you can after injury to provide substantial time necessary to uncover the circumstances surrounding the injury and determine validity for a claim. Once a claim is filed, there will be a select number of days to file a lawsuit. It is important to note that the date of harm may be considered the date of discovery which can sometime occur years after the actual injury. In some cases, both the injured party and the party being held liable are found negligent. This is called comparative negligence. In other cases, negligence may be strictly due to the injured party. Depending
upon the circumstances, personal injury attorneys may refuse to take such cases.

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Potential Problems with Insulin Pens in Hospitals (Aug 2008)

Tuesday, February 10th, 2009

Video originally created by FDA -- posted by Lawsuit.com on August 13, 2008

In a recent article, the Institute for Safe Medication Practices (ISMP) highlighted several potential safety problems when hospitals switch from multiple dose vials of insulin to insulin pens.

ISMP points out that there are certain safety advantages in using the pens. For example, the pens may reduce the chance of drug mix-ups, since each pen is pre-labeled with product name and strength, and the patient’s name can be on the label as well. But ISMP also notes a number of potential safety problems to watch out for when hospitals switch to pens.

One possible problem is needlestick injuries, which could happen because the pen may make it difficult to see the injection site. Also, some needles do not have needle guards, so a needlestick can occur after the injection.

Another difficulty is that part of the insulin in the pen may not be delivered. This can happen because the buttons on some pens are difficult to push down, making it easy to accidentally lift the needle out of the skin during the injection. There can also be leakage around the injection site if the needle is not left in place for at least six seconds after the injection. In addition, uneven dosing of an insulin suspension can occur if the user fails to tip and roll the pen before the injection, causing the suspension to clump.

Sometimes nurses unfamiliar with a particular type of pen will use it as a multiple-dose vial, withdrawing insulin from the pen cartridge with a sterile needle and a conventional insulin syringe. This is not recommended, because aspirating insulin from the cartridge can leave air pockets. When the cartridge is used again, these air pockets can cause dosing errors or air injection.

Another problem is using the same pen for multiple patients, which is potentially hazardous. Attaching a new sterile needle to the pen before using it on another patient cannot solve the problem. That’s because the insulin inside the pen’s cartridge can become contaminated with biological material after the first injection, while the original needle is still on the pen.

Finally, the design of some pens can lead to dosing errors. For example, in some cases the digital display of the dose can be mis-read if a person holds the pen upside down, as a left-hander might do. In that case, a dose of 21 units looks like 12.

How can these problems be avoided? ISMP says that the key is to prepare for the transition to pens. That means understanding and anticipating the risks beforehand, doing a failure mode and effects analysis, educating the staff about using the pens properly, and closely monitoring their use for the first few months of the transition. ISMP recommends that written guidelines be developed for each type of pen used in the hospital, with specific instructions on handling the pens safely, injection techniques, and prohibitions on sharing pens or using them as multiple dose vials.

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