Are you suffering vision problems from retinal detachment? Were you taking an antibiotic when the retinal detachment occurred? There may be a link. A 2012 Canadian study found that patients who take antibiotics called fluoroquinolones are more likely to suffer a serious eye condition called retinal detachment.

Researchers at the Child and Family Research Institute of British Columbia in Vancouver analyzed the medical records of almost one million patients who saw an ophthalmologist between January 2000 and December 2007. They found that taking antibiotics such as levofloxacin (Levaquin), ciprofloxacin (Cipro), moxifloxacin (Avelox), norfloxacin (Noroxin), ofloxacin (Floxin), and gemifloxacin (Factive) caused a five-fold increase in retinal detachment, an eye condition that can lead to blindness. The drugs, which are used to treat urinary tract infections, respiratory illnesses, and hospital-acquired infections, are already known to increase the risk of less serious eye problems, including corneal perforations, optic neuropathy, and retinal hemorrhages.

The scientists suggest that the drugs only be used in patients who really need them and that doctors warn patients to see an ophthalmologist if they experience any changes in vision, including floaters or flashes of light.

The increased risk was only present in patients who were taking the antibiotics at the time of the retinal detachment. There was no extra risk among patients who had taken the fluoroquinolones recently or among those who had taken them in the past.

It is important to remember that the risk is small. About one in every 2,500 (.04 percent) patients who use fluoroquinolones will develop a retinal detachment. This may not seem like a big deal; however, four million prescriptions are written for fluoroquinolones in the US each year. This means that about 1,600 patients will experience retinal detachments. If you are one of the 1,600 who have experienced a retinal detachment while taking a fluoroquinolones antibiotic, it is a significant problem. Retinal detachment can cause permanent vision problems and blindness.

If you suffered retinal detachment while taking Avelox, Cipro, Factive, Floxin, Levaquin, or another antibiotic, we urge you to contact a Salt Lake City pharmaceutical injury attorney. You may qualify to file a Utah pharmaceutical injury claim. To discuss your antibiotic-related retinal detachment, contact the James Esparza Law Firm at 800-745-4050. There is no charge for the consultation.

What Are the Eon and Eon Mini Implantable Pulse Generators?

St. Jude Medical’s Eon and Eon Mini implantable pulse generators (IPGs) are battery-powered medical devices that are surgically implanted to treat neurological disorders and pain. The miniature medical device is surgically placed near the spine. The device works by delivering an electrical pulse to the brain, nerves, or spinal cord. The nerve stimulation helps to control severe pain. The device uses a battery that is recharged every 24 hours. It must be replaced when the battery runs out, about every ten years.

St. Jude Recalls Eon and Eon Mini Implantable Pulse Generators

On July 26, 2012, St. Jude alerted physicians that the batteries in the Eon and Eon Mini could fail and overheat during charging, causing serious burns. The FDA recalled 70,638 IPG devices after two reports of first-degree burns and one report of second-degree burns in patients implanted with the medical device. St. Jude also received 127 patient complaints of heating during charging for the St. Jude Eon IPG and 198 complaints of heating during charging for the Eon Mini IPG. In some cases, there was enough heat to cause discomfort, pain, and injury. Patients also complained that the IPGs would not recharge, did not fully charge, or would suddenly lose power, resulting in a loss of pain relief.

St. Jude warned that patients who experience warmth or heating while the Eon or Eon mini IPG is charging may be at risk of serious burns that could cause pain, scarring, and other complications. The medical device manufacturer recommended that any device that overheats should be surgically removed.

St. Jude claims that the company is working with the battery supplier to correct the problem. Any un-implanted devices should be returned to St. Jude for a free replacement. Patients who have implanted devices should be monitored for signs of battery failure including:

• Warmth at the implant site
• Heat at the implant site
• Redness or swelling at the implant site
• Burns

This Is Not St. Jude’s first recall

This is not the first time that a defect in a St. Jude medical device has caused injury to patients. The St. Jude Riata and Riata ST defibrillator leads were recalled because the electric wires could work through the insulation, causing injury.

Know Your rights

Patients who have experienced warmth, heating, or burning sensations associated with the Eon or Eon Mini spinal cord stimulators may be eligible for compensation for the cost of surgery, a new IPG implant, and related medical expenses. You may also qualify for compensation for your lost wages and other expenses. To learn more, contact a Salt Lake City defective medical device attorney.

The James Esparza Law Firm is currently investigating patient injuries caused by the Eon and Eon Mini IPGs. Contact our office at 800-745-4050 to learn if you have a case.

Last week, we posted an article about the link between fluoroquinolones antibiotics and a serious eye condition called retinal detachment. Retinal detachment can lead to permanent eye damage, vision loss, or blindness, but it is not the most serious side effect associated with fluoroquinolones. Fluoroquinolones may also cause a serious form of nerve damage called peripheral neuropathy.

Fluoroquinolones are a class of antibiotics used to treat respiratory tract infections and urinary tract infections. Fluoroquinolone antibiotics include moxifloxacin (Avelox), ciprofloxacin (Cipro), gemifloxacin (Factive), levofloxacin (Levaquin), norfloxacin (Noroxin), and ofloxacin (Floxin). More than 23 million prescriptions were written for fluoroquinolones in 2011.

Peripheral neuropathy is damage to the nerves that send information to and from the brain and spinal cord and the rest of the body. Damage interrupts this connection, and the symptoms depend on which nerves are affected. In general, the symptoms are in the arms and legs and include numbness, tingling, burning, or shooting pain.

Peripheral neuropathy has been known to be a side effect of fluoroquinolones for many years and has been listed on the label since 2004. In August 2013, the US Food and Drug Administration (FDA) determined that existing warnings on fluoroquinolones drugs were inadequate. The FDA told drug manufacturers that labels must better emphasize the risk for potentially irreversible peripheral neuropathy.

Peripheral neuropathy is a form of nerve damage that affects the hands and feet. The symptoms of fluoroquinolones peripheral neuropathy usually begin within a few days of starting the drugs. The nerve damage may last for several months. In some cases, it is permanent.

Warning signs of Fluoroquinolone Peripheral Neuropathy:

• Numbness in the hands or feet
• Tingling in the hands or feet
• Muscle weakness in the hands or feet
• Burning in the hands or feet
• Shooting pains in the hands or feet
• Paralysis in the hands or feet
• Lack of coordination

Contact your doctor if you experience any symptoms of peripheral neuropathy while taking fluoroquinolones antibiotics. The FDA is asking patients who develop fluoroquinolones peripheral neuropathy to file an adverse event report.

If you are suffering permanent peripheral neuropathy after taking fluoroquinolone antibiotics, consider contacting a Salt Lake City pharmaceutical injury lawyer. You may be eligible for compensation through a Utah medication injury lawsuit. To learn more, contact the James Esparza Law Firm at 800-745-4050.

If you suffer from a rotator cuff injury, shoulder instability, shoulder bursitis, biceps tendinitis, frozen shoulder, or AC joint arthritis, your doctor may recommend arthroscopic shoulder surgery in order to relieve your pain and restore movement in your shoulder.

Arthroscopic shoulder surgery is supposed to speed healing and reduce the risk of surgical complications. Instead of cutting open your shoulder, the doctor makes several small incisions. He inserts a mini camera through one incision and uses it to direct small instruments inserted through the other incisions.

After the surgery, the doctor will usually insert a pain pump catheter. Pain pumps, like the Stryker Pain Pump or I-Flow On-Q Pump, direct an anesthetic medication directly into the shoulder for the first two or three days after surgery. This significantly reduces post-surgery pain without the unpleasant side effects associated with narcotics. The catheter is easily removed by the patient when he removes the dressings. Sounds simple, right?

However, pain pumps may cause a serious shoulder injury. Recent studies have linked pain pump use to a condition called postarthroscopic glenohumeral chondrolysis, or PAGCL.

The long name is a description of the injury:

• Postarthroscopic: after arthroscopic surgery
• Glenohumeral: shoulder joint
• Chondrolysis: damage to the joint cartilage

PAGCL refers to damage to the cartilage in the shoulder joint after arthroscopic surgery. Symptoms include shoulder pain, stiffness, clicking, and decreased range of motion. In some cases, patients with PAGCL have needed complete joint replacement surgery.

You believe your surgery is going to fix your shoulder problem. Now you have a shoulder condition that’s even more painful. What can you do?

Victims of post-surgical shoulder pain pump injuries have the right to seek monetary compensation for their medical expenses, lost wages, disability, pain and suffering, emotional trauma, and other losses related to their injury. If you or a loved one is suffering from PAGCL and would like more information about Utah pain pump injury claims, contact a Salt Lake City personal injury attorney who specializes in defective medical device cases. The lawyer will be able to advise you of your rights and let you know if you have a case. To schedule a free consultation, please contact the James Esparza Law Firm at 800-745-4050.

There are many reasons why Utah teens use oral contraceptives like Yaz. Some teens use the pill to prevent pregnancy. Others are prescribed the pill to help with severe menstrual cramps and period-related mood swings and nausea. Others take the pill to clear up acne.

Yaz, and other birth control pills containing the hormone Drospirenone, are supposed to go “Beyond Birth Control” and do all three. Yaz is approved by the FDA to treat moderate acne, which may be why Yaz is the most popular birth control pill among teenagers age 13 to 18. Unfortunately, Yaz and similar pills can be very dangerous.

Drospirenone is linked to dangerous side effects including blood clots, stroke, pulmonary embolism, deep vein thrombosis, cardiac arrest, and heart attack. In 2012, the FDA required that Yaz and other pills containing drospirenone to change the label to warn of these risks.

Birth Control Pills that Contain Drospirenone

• Yaz
• Yasmin
• Beyaz
• Giani
• Loryna
• Ocella
• Safyral
• Syeda
• Zarah

However, by 2012, thousands of teens had taken the drugs without knowing the risks. Now some must spend their lives with the side effects of Yaz injury.

Lynsey Lee is one of these teens. We heard Ms. Lee’s story on MSNBC in December 2011.

Ms. Lee began taking Yaz as a 16-year-old to treat severe menstrual cramps and pelvic pain. Her pain didn’t get better. She started having mood swings and nausea and was told she was adjusting to the medicine. She went to the doctor again when she started having chest pains that made it difficult to breathe. The doctors found a blood clot in her left lung.

The clot could not be removed, so Ms. Lee takes blood thinners in the hopes that it will one day dissolve and move through her system. She suffers from chronic pain and fatigue and feels she has missed out on her youth.

If you or your loved one has a story like Lynsey Lee’s, you deserve accountability. To learn more about Utah Yaz injury lawsuits, contact a Salt Lake City pharmaceutical injury lawyer. To schedule an appointment, call the James Esparza Law Firm at 800-745-4050.

Requiring a surgical implant can be a very scary experience. Many unknown factors can make you second-guess your decision to go through with it at all. However, at the urging of your doctor and the reassurances that these types of procedures are safe, you are persuaded to have the surgery. However, what if the medical device your doctor implanted isn’t as safe as you’ve been told? Many manufacturers of medical devices such as surgical mesh, hip replacements, lap bands and numerous others, do not require adequate testing for their products. This means that the device you are now relying on and have inside of you, could not only suddenly fail to work, but it could also cause you serious harm.

Like all businesses, medical device manufacturers want to make money. Therefore, if they can produce a product cheaply and then sell it at a high cost, they’re happy. Currently, the Food and Drug Administration, who regulates medical devices, does not require rigorous testing for a device to be approved for sale. For a device to be approved, it merely has to pass an investigation, known as the 510(k) clearance. This clearance requires the manufacturer to inform the FDA, 90 days in advance, of their plan to market a device. This window then allows the FDA to classify the device by comparing it to similar devices already in production. The basic theory is that if it is similar to a preexisting device, then it can be classified within the same safety standards.

This process is good for the manufacturer because it doesn’t require trials to test their devices; they merely need to show how it is similar to an already working device. As you can imagine, this saves the manufacturer a lot of time and money and can allow their devices to be put into production that much faster. The problem that this process causes doesn’t really affect the manufacturer, it affects you. If you receive one of these devices, are assured that it is up to FDA standards, but has an untested flaw, you are the one who suffers.

If you believe that you are a victim of a faulty medical device or have had to undergo multiple surgeries because of a medical device flaw, you owe it to yourself to call the Utah defective medical device lawyers at the James Esparza Law Firm. We know how scary and upsetting this can be, and we are here to help. Please call us at 800-745-4050 for a free consultation. Let us help you fight back.

The advancements in medications within the last 50 years are an incredible achievement. Millions of people are now surviving with diseases, ailments, and injuries that they may not have otherwise been able to handle without medication. However, some pharmaceutical drugs can cause more harm then help. This is why you should always be cautious of the potential dangers when taking prescription or over-the-counter medication.

Medications are meant to fix a specific problem and either make you feel better by stopping the cause of your ailment or by increasing your body’s ability to fight off the problem. However, several factors may cause medications to damage other areas of your body while it’s fighting. Some of these factors include:

• Using a drug for an amount of time longer than recommended
• Overmedicating – taking more than the recommended dose
• Side effects inherent to the drug itself – blood thinners can result in excessive bleeding, if cut
• Over-performance of drug – dosage is incorrect, causing your ailment to worsen on the flip side (medication for high blood pressure causes you to have low blood pressure)
• Drug incompatibility – when two or more medications do not work well together, causing severe side effects
• Wrongly prescribing – doctor prescribes a medication that attacks the wrong ailment
• Drug manufacturing errors

These factors, as well as human error, can cause a lot of varying health issues such as:

• Kidney and liver problems
• Psychological dependency
• Internal bleeding
• Irregular heartbeat
• Breathing problems
• Death

Medications and prescription drugs have become a necessary part of our lives and, for the most part, are helping millions of people survive. Sometimes you just can’t face the day without an aspirin, while others need medication to keep their hearts beating. Either way, if you use it to keep your body working, or to help a headache, you need to be aware of the dangers associated with that particular medication. Do not hesitate to discuss side effects and potential problems with your doctor.

The Utah pharmaceutical injury lawyers at James Esparza know all too well about the suffering that can come from a medication injury. If you have any questions, concerns, or if you believe that you may have been injured because of your medication, call us for a free consultation at 800-745-4050. Don’t let your questions go unanswered. We’re here to help.

Are you worried about your child using a medical device? You may have just cause, as some pediatric medical devices are not only difficult to use, but can cause serious harm if not used properly. Your child’s health and safety are your most important concerns, and you shouldn’t have to worry that a device that should be helping him, may be harming him. This is why it is important to understand how to properly use, administer, and store your child’s device, as well as how to recognize potential problems it may cause.

Pediatric devices like pacemakers, tubes, or x-ray machines should be administered at a hospital under doctor care and supervision. Although you and/or your child do not need to physically use or administer these devices, you should still be aware of their side effects and dangers. Some self-sustaining devices can cause:

• Internal Bleeding
• Rapid Heart Rate
• Infections
• Radiation Exposure

Devices such as inhalers, braces, or syringes are dependent on the user and require assistance to be effective. This allows for a greater chance of human error, causing dangers such as:

• Breathing Problems
• Infections
• Rashes
• Blood Circulation Problems
• Fatigue
• Over-Medication
• Elevated Heart Rates

When your child depends on a pediatric device, he is also depending upon you and your doctor to know exactly how to use or administer the device, as well as recognize symptoms that the device may be causing injury. Always make sure that you discuss the proper way to operate the equipment with your child’s pediatrician, as well as discuss the necessary steps with your child, in case he needs to handle it on his own. The symptoms you should watch out for, in case of defects or improper use, are:

• Headaches
• Fevers
• Fatigue or lethargy
• Swelling around device area or abdomen
• Excessive sweating
• Changes in urine or stool (frequency, color, shape, smell, or size)
• Increased and excessive pain

Seek medical attention immediately if you notice or your child expresses any of these symptoms.  He could be having an extremely dangerous reaction or suffer severe injury.

If your child has already suffered pain, injury, or an ailment from a pediatric medical device, he may be entitled to medical compensation. The Salt Lake City medical device lawyers at James Esparza, are anxious to fight for you and your child. Our lawyers and staff will help make sure all of your questions, concerns, and worries are taken care of. Don’t allow your child to be a victim; call us today for a free consultation at 800-745-4050.

When your doctor prescribes you medication, you generally trust that he knows what he is talking about. So you take the prescription to the pharmacy (again, trusting that the pharmacists know what they’re doing), pick them up, and take them as prescribed on the bottle. But how often do you actually check that the medication prescribed is intended for your ailment, or that the prescription you dropped off is the prescription you picked up, or even if the pills in the bottle match the description of the prescription pills on the warning label? The US has experienced a dramatic rise in medication-related injuries within the last few years, making the need for all three of these checks that much more important.

The amount of emergency room and hospitalizations caused by prescription errors has increased from 1.2 million in 2004 to roughly 2.5 million in 2012, nationwide. These injuries, ranging from rashes and shortness of breath, to heart, liver, and kidney failure, were all a result of prescription drug side effects and overdoses. These effects were related to one or more of the following:

Unintended Overdose:

• Wrongfully Prescribed Dose – Victims followed the dose on the bottle, even though it was wrongfully prescribed
• Dose Miscommunication – Victims were told by their doctor to take one pill twice a day, but the prescription said two pills twice a day. Language barriers may cause problems, as well (“once” means 11 in Spanish)
• Pharmacy Filled Wrong Prescription – The description of the pill prescribed on the label doesn’t match the pill inside the bottle
• Pharmacy Filled Wrong Dose – The dose was supposed to be 25mg but was filled with 75mg
• Label Error – The medication label didn’t accurately inform about drug and side effects of overuse

The development of birth control pills not only allowed women to help prevent against pregnancy, but they can also help regulate menstruation, ease cramping, and help hormonal issues. In recent years, IUDs, or intrauterine devices, have also been developed with great success rates in preventing pregnancies, lessening pain, and regulating menstruation without the need to continuously take pills. However, IUDs can also cause severe damage if inserted improperly or cause serious side effects if defective.

Before getting an IUD, you must be aware of these side effects, as well as how to protect yourself. Some simple precautions you can take are:

• Research the specific IUD you are thinking about getting. Pay special attention to side effects caused by insertion, as well as long-term effects.
• Speak with your doctor about what type of birth control is best for you. IUDs aren’t for everyone.
• If you feel any discomfort after the procedure, make sure you contact your physician. Some pain is normal during insertion and for a short time afterward, but if you feel uneasy about the pain (intensity, frequency, or length), do not keep it to yourself.

Implants of any sort have the potential to cause harm. The decision to voluntarily get one, should not be taken lightly. Medical technology, especially medical devices, have greatly evolved within the last 100 years. Despite that evolution, human error still has a profound effect on the devices. In every stage of the procedure—from the device being made, your decision to have it implanted, your doctor’s advice, all the way to the insertion and the years that follow—accidents can occur. Protect yourself as much as possible by being educated, communicative, and cautious.

If you currently have or have had an IUD that caused you severe pain or injury, you can still protect yourself and your future. The Salt Lake City defective medical device lawyers at James Esparza will help you fight to get the answers and restitution you deserve. Don’t let your injury go unnoticed. Continue to protect yourself by calling us today at 800-745-4050 for a free consultation.

Baldness drug Propecia and enlarged prostate drug Proscar, both manufactured by Merck & Company, will now both carry a new warning linking the two drugs to sexual dysfunction after treatment this according to the Food and Drug Administration. The warning for Propecia will include a warning regarding libido disorders, ejaculation disorders, and orgasm disorders that continue after discontinuation of the drug. A revision to the Proscar label will include a warning about decreased libido that continues after discontinuation of the drug. Finally, a revision to both the Propecia and Proscar labels will include a description of reports of male infertility and/or poor semen quality that normalizes or improves after discontinuation of the drugs.

Proscar was approved in 1992 for treatment of in men with benign prostatic hyperplasia (also referred to as BPH or an enlarged prostate).

Propecia was approved in 1997 for the treatment of men with male pattern hair loss.

Helpful links:

FDA: http://www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm299754.htm?utm_campaign=Google2&utm_source=fdaSearch&utm_medium=website&utm_term=propecia&utm_content=6

Bloomberg Article:

http://www.bloomberg.com/news/2012-04-12/merck-s-baldness-drug-linked-to-sex-concerns-after-use.html

Bloomberg reports that Pfizer has won another lawsuit involving Prempro. The federal jury in West Virginia ruled that Leah Royce Hines’ breast cancer was not caused by her use of the hormone drug – Prempro.

Mrs. Hine’s lawyer, Harry F. Bell Jr. of The Bell Law Firm, said “the verdict is not surprising given the defense’s resources and how restricted the evidence in the case was.” Mr. Bell went on to state:

The defense’s resources also were considerable.

“I wish people could understand the time and resources they put into this case,” he said.

Bell said the company’s attorneys set up a temporary office in downtown Charleston and brought in jury consultants and focus groups.

Then they bombarded the court with motions, he said.

“They just pounded us on every single argument, every single point,” Bell said. “They slammed the court and us with a lot of motions. And I’d say the vast majority of those motions, the defendants won.”

Helpful Links

http://www.wvrecord.com/news/237265-hormone-therapy-drugs-didnt-cause-cancer-jury-rules

http://www.bloomberg.com/news/2011-07-28/pfizer-s-prempro-didn-t-cause-woman-s-cancer-jury-concludes.html

On July 8, 2011, Pfizer filed a pleading in the MDL Proceedings (4:03-cv-1507) asserting that there may be no reason for core discovery to take place in the MDL proceedings thereby permitting many cases to be remanded to the trial court for scheduling orders with trial dates. This development may be significant for the thousands of cases in the MDL proceeding.

Cases ripe for remand will involve those cases where only Wyeth/Upjohn are named as parties and those cases that are not subject to Daubert Motions pending in the MDL.

Attorneys for both sides of this litigation view this development to be significant in moving this slowed litigation forward. As many are aware this litigation started with the release of the Women’s Health Initiative in July, 2002.

For updates on the Prempro litigation check our blog for up-to-date information.

Pfizer’s first-quart report included a charge of $472 million primarily to cover settlements and potential future liabilities in the long-running product liability litigation surrounding Pfizer’s hormone-replacement therapies including Prempro. A spokesman said the company plans to continue its strategy of defending itself against lawsuits and striking settlements when appropriate. Presently, approximately more than 8,000 cases have been filed in this litigation. The vast majority of the claims involve women who developed breast cancer after using combination estrogen and progesterone. Whether the long-running litigation is coming to an end is unclear.

Pradaxa is a prescription medication that is used to reduce the risk of blood clots and stroke in patients with certain irregular heartbeats.. Nearly one million patients in the United States have used the drug. While Pradaxa is very effective at preventing clots, it has been associated with more than 500 bleeding deaths. In fact, the Institute for Safe Medication Practices says it has more reports of adverse events linked to Pradaxa than to any other of the 800 drugs the agency monitors.

Adverse reactions associated with Pradaxa include:

• Unstoppable bleeding in injury patients
• Stomach (gastrointestinal) bleeding
• Brain bleeding (hemorrhaging)
• Bleeding in the kidneys
• Pradaxa bleeding death

All medications that prevent clotting pose a risk of bleeding. In clinical trials, Pradaxa was compared to Warfarin (Coumadin), a blood thinner that has been used for nearly 60 years. Pradaxa, which prevents clotting without thinning the blood, was found to be 35 percent more effective than Warfarin with the same risk of serious bleeding. However, vitamin K can be used to stop bleeding in patients taking Warfarin. There is no antidote to stop Pradaxa bleeding.

Patients at high risk include:

• Patients age 75 or older
• Patients with kidney problems
• Patients who take dronedarone (Multaq®) or ketoconazole tablets (Nizoral®) for kidney disease
• Patients who have had a stomach ulcer
• Patients with recent stomach or intestinal bleeding
• Patients taking other medications that increase the risk of bleeding, including: aspirin, aspirin products, non-steroidal anti-inflammatory drugs (NSAIDs), and other blood thinners

If you or a loved one has suffered life-threatening bleeding while taking Pradaxa, it is important that you contact a Salt Lake City drug injury lawyer  as soon as possible. You may be eligible for compensation for your medical expenses, pain and suffering, lost income and more. To learn if you qualify to file a Utah Pradaxa lawsuit, contact the James Esparza Law Firm at 800-745-4050.