Archive for the ‘Uncategorized’ Category

Nearly 1.4 million patients each year undergo Lasik surgery, which is now a $2 billion industry.  Last week, however, the FDA recognized that it had little to no information about adverse life events from people who are undergoing Lasik surgery.  The reason is not the lack of events, but most likely because the adverse events are not reported.  The FDA, the Defense Department and the National Eye Institute are teaming up to run a three-year program to gauge how many Lasik surgery patients suffer from post-Lasik operation problems.  The FDA’s press relase regarding the FDA’s Quality of Life Project can be found here along with information about how to report Lasik related probelms and side effects.

At the same time as the FDA announcement last week about the quality of life program, the FDA issued warning letters to 17 Lasik sugery centers who accept walk-in patients reminding them of their obligation to report poor outcomes and any surgery-related medical complaints from patients who have Lasik surgery at their facilities.  The letters were issued after FDA inspections of the facilities found that they had no system for collecting and transmitting to the FDA data on patients’ reports of post surgical “adverse events.”

The FDA website provides a number of helpful resources about Lasik surgery, including a Lasik surgery checklist (which should help patients avoid Lasik malpractice), which includes various tips and other advice for those considering Lasik surgery, such as:

Know what makes you a poor candidate

Career impact - does your job prohibit refractive surgery?
Cost - can you really afford this procedure?
Medical conditions - e.g., do you have an autoimmune disease or other major illness? Do you have a chronic illness that might slow or alter healing?
Eye conditions - do you have or have you ever had any problems with your eyes other than needing glasses or contacts?
Medications - do you take steroids or other drugs that might prevent healing?
Stable refraction - has your prescription changed in the last year?
High or Low refractive error - do you use glasses/contacts only some of the time? Do you need an unusually strong prescription?
Pupil size - are your pupils extra large in dim conditions?
Corneal thickness - do you have thin corneas?
Tear production - do you have dry eyes?

Know all the risks and procedure limitations

Over-treatment or under-treatment - are you willing and able to have more than one surgery to get the desired result?
May still need reading glasses - do you have presbyopia?
Results may not be lasting - do you think this is the last correction you will ever need? Do you realize that long-term results are not known?
May permanently lose vision - do you know some patients may lose some vision or experience blindness?
Dry eyes – do you know that if you have dry eyes they could become worse, or if you don’t have dry eyes before you could develop chronic dry eyes as a result of surgery?
Development of visual symptoms - do you know about glare, halos, starbursts, etc. and that night driving might be difficult?
Contrast sensitivity - do you know your vision could be significantly reduced in dim light conditions?
Bilateral treatment - do you know the additional risks of having both eyes treated at the same time?
Patient information - have you read the patient information booklet about the laser being used for your procedure?

Know how to find the right doctor

Experienced - how many eyes has your doctor performed LASIK surgery on with the same laser?
Equipment - does your doctor use an FDA-approved laser for the procedure you need? Does your doctor use each microkeratome blade only once?
Informative - is your doctor willing to spend the time to answer all your questions?
Long-term care - does your doctor encourage follow-up and management of you as a patient?  Your preop and postop care may be provided by a doctor other than the surgeon.
Be comfortable - do you feel you know your doctor and are comfortable with an equal exchange of information?

Know preoperative, operative, and postoperative expectations

No contact lenses prior to evaluation and surgery - can you go for an extended period of time without wearing contact lenses?
Have a thorough exam - have you arranged not to drive or work after the exam?
Read and understand the informed consent - has your doctor given you an informed consent form to take home and answered all your questions?
No makeup before surgery - can you go 24-36 hours without makeup prior to surgery?
Arrange for transportation - can someone drive you home after surgery?
Plan to take a few days to recover - can you take time off to take it easy for a couple of days if necessary?
Expect not to see clearly for a few days - do you know you will not see clearly immediately?
Know sights, smells, sounds of surgery - has your doctor made you feel comfortable with the actual steps of the procedure?
Be prepared to take drops/medications - are you willing and able to put drops in your eyes at regular intervals?
Be prepared to wear an eye shield - do you know you need to protect the eye for a period of time after surgery to avoid injury?
Expect some pain/discomfort - do you know how much pain to expect?
Know when to seek help - do you understand what problems could occur and when to seek medical intervention?
Know when to expect your vision to stop changing - are you aware that final results could take months?
Make sure your refraction is stable before any further surgery - if you don’t get the desired result, do you know not to have an enhancement until the prescription stops changing?

If you have undergone Lasik surgery and believe that you may be a victim of Lasik malpractice, contact a Lasik malpractice lawyer today for a free and confidential legal evaluation at info@consumerinjurylawyers.com or (877) 779-1414.

Various lawsuits have been filed in state and federal courts around the country on behalf of women who used Yasmin or Yaz birth control and suffered a stroke, heart attack or gall bladder damage.    Yaz and Yasmin both contain a combination of ethinyl estradiol, which is used in many oral contraceptives, and drospirenone, a new type of progestin that is unique to Yaz and Yasmin.  Soon, a panel of federal judges is scheduled to hear arguments about whether to consolidate and centralize all Yasmin and Yaz litigation pending in various federal courts throughout the United States.

Most recently, a new lawsuit was filed in St. Clair County, Illinois over the birth control pill Yaz by a woman who claims the drug caused a blood clot in her lung, also known as a pulmonary embolism.
According to a local newspaper, the St. Clair record, Kerry Sims filed the The Yaz blood clot lawsuit on August 18, 2009.  The defendant in the Sims Yaz lawsuit is Bayer, which is the maker of both Yaz and Yasmin birth control pills.  Ms. Sims also sued Walgreens pharmacy, where she purchased the medication. Ms. Sims’ Yaz lawsuit alleges that Bayer misrepresented the benefits and safety of the birth control pill.  Her Yaz lawsuit further claims that she would not have used Yaz birth control had she been fully informed of the health risks.

Sims alleges that she began taking the Yaz birth control pill when it was known as Yasmin. Bayer reformulated the pill and renamed it Yaz after acquiring Yasmin’s original manufacturer, Berlex, in 2006. As a side effect of Yaz, Sims alleges that she suffered a pulminary embolism, which is a blood clot in her lung and an infection of the area surrounding the blood clot.

For more information about a Yaz lawsuit or a Yasmin lawsuit, contact one of Bernstein Liebhard’s Yasmin lawyers or Yaz lawyers for a confidential and free case evaluation.

In December 2008, the Ecri Institute released it second annual report on the top 10 technology hazards that should be on every hospital’s list of safety concerns for medical-device use.  The Ecri Institute conducts patient-safety research and investigates medical-device incidents.   Five of the hazards on the list are new. However, all of the five hazards dropped from the list are still seen as “significant concerns.”  The five new hazards just caused more problems in the past year, including retained devices and air embolism from contrast media injectors, causing them to placed on the list. 

The top 10 technology hazards are listed in order as follows:

1.  Alarm hazards
2. Injuries from needle sticks and other sharp objects
3. Air embolism from contrast media injectors
4. Retained devices and unretrieved fragments left in patients
5. Surgical fires
6. Anesthesia hazards due to inadequate pre-use inspection
7. Misleading displays
8. CT radiation dose
9. MR imaging burns
10. Fiberoptic light-source burns
     

While some problems involve a defective medical device, it tends to be inexperience and/or lack of knowledge on the user’s part that causes these devices to be hazardous.  Few people read the manual. If devices are used safely, fewer incidents would occur.  Every participant in the chain during the process has a responsibility to prevent a problem from arising. If you have been a victim of one of these technology hazards or any other technology, you may have a medical malpractice or hospital negligence lawsuit and may be entitled to a medical malpractice settlement.  You should contact a medical malpractice lawyer today for more information.

Many studies are done on the side effects of drugs before they are released to the market to properly inform patients of the potential side effects.  However, these studies often do not incorporate studies on drug-drug interactions, which are the effect of using a particular medication in combination with several other drugs that a patient is already taking.  Not only can these medications cause their own side effects, they can have additional and sometimes irregular side effects when taken with other drugs.

In the United Kingdom, fifteen percent of its residents over 75 years of age take five or more drugs on a daily basis.  People in nursing homes take an average of six to eight medicines a day.  In the United States, forty percent of people over the age of 65 take five or more drugs on a daily basis.  The number of drugs prescribed to people is on a rise, especially in western European countries.  While the reasons for prescribing more drugs are done to effectively treat older people, there are sometimes other less respectable reasons, such as more drug marketing by drug companies disguised as “disease awareness” campaigns.  Often, drugs are not needed to treat these “diseases” and prescriptions written for these purpose are unnecessary and can even lead to dangerous interactions with other necessary drugs patients are taking.

Various studies show that about five percent of hospital admissions in Europe and the U.S. are due to adverse reactions caused by two or more drugs patients are taking.  In addition, five to ten percent of hospital patients have additional drug reactions when being hospitalized, resulting in prolonged stays and inevitably higher hospital bills.  Another unfortunate reality is that even with drugs that do not have any drug-drug interactions, the patient might stop taking a drug without informing the doctor, because all of the drugs they are taking have cumulative side effects that the patient wants to avoid.  Doctors may prescribe even higher and often unnecessary doses because they think the lower doses are not working.  In addition, doctors themselves are often not aware of the cumulative side effects that patients can have by taking multiple drugs, causing the patients to suffer any unnecessary side effects.

In short, some patient advocates argue that compliance with prescribed doses is a precursor to effective treatment but if you have adverse reactions or are concerned about them, consult your doctor or pharmacist.  If you are injured by a dangerous drug or think you are the victim of medical negligence, contact a medical malpractice lawyer.

Source: http://www.ft.com/cms/s/0/34019120-498b-11de-9e19-00144feabdc0.html

The JPML has denied the request by a number of plaintiffs counsel in the Reglan litigation to centralize the federal cases before a single district court judge for pretrial litigation purposes.  This means that at least for now, the cases will continue to be litigated in various courts around the country.  During oral argument before the JPML in Louisville, Kentucky in late May, moving counsel argued that a flood gate of Reglan (and generic version) cases were coming.  The court apparently decided to wait to centralize the cases to see if that claim proves true.  Click here to view the order.