Medical Injury Lawyer Blog

ev3, Inc. issues a Class 1 medical recall of Trailblazer Support Catheters

Medical Attorney — Thu, 07 Jan 2010 10:36:36 -0600

Recently, ev3, Inc. of Plymouth, Minn., announced a Class 1 medical recall of their Trailblazer Support Catheters.

Trailblazer Support Catheters are used provide access through the skin to veins and arteries. From there, the catheter is used to provide a support channel for guide wires during access of blood vessels and to allow wire exchanges. The catheter is also used to provide a passage for the delivery of solutions to diagnose or treat patients.

The catheters were recalled because the medical device may crack near the catheter’s radiopaque marker band. A radiopaque band is a marking on the device used so that the catheter will show up clearly on an X-ray.

If the device were to crack and shards of broken catheter where left inside the patient’s body, it could result in serious medical injury, including insufficient oxygen supply to tissues, damage to blood vessels, heart attack, limb amputation, unplanned surgery or even death.

The recalled medical devices include product manufactured from September 11-29, 2009.

Recalled Catheter Model Numbers
SC-014-135
SC-018-090
SC-035-065
SC-035-135
SC-014-150
SC-018-150
SC-035-090
SC-035-150

Effected Lot Numbers
7828282, 7792290, 7792584, 7805570, 7805797, 7806392, 7820252, 7790666, 7791887, 7803307, 7835331, 7822400, 7822593, 7800446, 7800555, 7800756, 7800779, 7800809, 7801822, 7801875, 7803305, 7803306, 7820273, 7834779, 7834845, 7824905, 7832205

For more information, please contact ev3, Inc. at 1-800-716-6700, Monday - Friday, 8:00 AM - 5:00 PM, Central Time. All affected product should be returned to the firm.

Class 1 is the most serious of all medical recalls and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

If a defective medical device has injured you or a loved one, it is critical to contact an experience medical attorney as soon as possible. The medical attorneys at Arnold & Itkin LLP help those who have suffered serious medical injuries as the result of defective medical devices get the care they need and the compensation they deserve. For a Free consultation concerning your medical injury, please fill out the FREE Case Review form on this page or call 866-222-2606 today.

McNeil Consumer Healthcare recalls all 100 count TYLENOL® Arthritis Pain Caplet bottles

Medical Attorney — Thu, 31 Dec 2009 13:06:08 -0600

McNeil Consumer Healthcare and the FDA are notifying consumers that McNeil is expanding its recent drug recall of TYLENOL Arthritis Pain Caplets to include all lots of 100 count bottles with the red EZ-OPEN CAP.

Last month, five lots of the product were recalled after consumers reported unusual moldy, musty, or mildew-like odors associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the chemical 2,4,6-tribromoanisole, which is believed to be created through the breakdown of a chemical used to treat wooden pallets that were used for transporting and storing packaging materials.

The health effects of 2,4,6-tribromoanisole have not been thoroughly studied, and to date all cases of exposure that have been reported to McNeil were temporary and not serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with a red EZ-OPEN CAP from the following lots should stop using the product immediately and contact McNeil at 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions for obtaining a refund or replacement.

07CMC011, 07DMC022, 07DMC024, 07FMC032, 07FMC033, 07GMC038, 07GMC039, 07HMC045, 07HMC051, 07HMC053, 07JMC064, 07JMC069, 07JMC070, 07JMC071, 07XMC055, 07XMC058, 07XMC062, 08AMC002, 08AMC005, 08CMC026, 08DMC029, 08EMC037, 08EMC039, 08FMC044, 08FMC045, 08GMC050, 08GMC053, 08GMC063, 08GMC065, 08JMC103, 08JMC109, 08JMC110, 08JMC111, 08KMC124, 08KMC127, 08KMC131, 08KMC132, 08XMC093, 08XMC094, 08XMC095, 09AMC010, 09CMC041, 09EMC075, 09EMC079, 09EMC076, 09GMC096, 09GMC097, 09GMC099, 09JMC118, 09JMC126, 09KMC133, 09KMC134, 09XMC114, 09XMC116

Consumers who have medical concerns or questions should contact their healthcare provider. Any adverse reactions to product exposure should be reported to the FDA’s MedWatch Program by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or via the MedWatch website at www.fda.gov/medwatch. 

If you became ill or feel you may have suffered a medical injury due to exposure to contaminated TYLENOL, it is important for you to contact a qualified medical attorney as soon as possible to help ensure you receive the best medical care possible and full compensation for illness or injury.

McNeil Consumer Healthcare will reintroduce the TYLENOL® Arthritis Pain Caplet 100 count bottle by January 2010 after moving production to a new facility.

Arnold & Itkin announces lawsuits against makers of defective pain pumps

Medical Attorney — Wed, 11 Nov 2009 13:01:48 -0600

The Houston trial law firm Arnold & Itkin LLP has filed five lawsuits against the makers of defective pain pumps and related medications based on claims that many of the company’s defective medical devices are causing irreversible shoulder damage among patients. Currently, medical attorneys at Arnold & Itkin LLP represent 28 people who received pain pumps to manage pain following shoulder surgery. The pumps utilize a catheter to deliver continuous doses of medication directly into the shoulder. According to the lawsuits, pain pump manufacturers were denied approval by the U.S. Food and Drug Administration to use the pumps to mitigate pain in shoulder joints, but the companies continued to promote their use in that way. Many former pain pump users say the companies were negligent in designing, researching and selling pain pumps that they should have known were dangerous. The legal filings include claims of fraud, breach of warranty and products liability against the defendant manufacturers.

Everyone makes mistakes -- even hospitals

Medical Attorney — Tue, 20 Oct 2009 13:33:20 -0600

Everyone has heard the clichés: “We’re all human.” “Everyone makes mistakes.” “Nobody’s perfect.”
Those answers are just fine when they come from a waiter explaining an overcooked filet or a child offering a reason behind a less-than-perfect spelling test. But when it’s your doctor?

The fact is that those go-to answers actually are valid, even for doctors … who are human … and therefore are not perfect … and sure enough, make mistakes, many of which fall under the umbrella of medical malpractice. But none of those answers does anything to appease the feelings of patients (and their families) who bear the brunt of errors ranging from the improper administration of medications to sponges (or other items) being left inside a body during surgery to surgery performed on the wrong part of the body.

Hospitals have not always been required to release the frequency of such errors; rules are now changing, and in many states, it is mandatory that hospitals report errors that cause death and/or serious harm, and patients – and more significantly, insurance companies – are using this information to try to ensure that these mistakes happen with far less frequency. In years past, such an error would result in the insurance company being billed not only for the treatment of the original injury or illness, but also for whatever procedure is needed to correct the mistake. But as the costs incurred by the insurance companies rose into the hundreds of millions of dollars (in many individual states), many insurance companies began to refuse to pay when conditions and/or injuries can be shown to be the fault of the hospital or doctor(s).

While nobody claims that financial compensation can make up for the injuries or fatalities caused by medical malpractice, that doesn’t mean a medical attorney won’t file a claim, or multiple claims, when a doctor’s or hospital’s apparent negligence injures – or worse yet, kills – a patient. A successful medical malpractice lawyer can be instrumental in proving negligence that led to either injury or death, thereby increasing the chance of earning some measure of compensation for the injured patient or his or her family.

Bayer Settles Gadolinium Contrast Agent Injury Lawsuits

Medical Attorney — Tue, 28 Apr 2009 15:05:37 -0600

Bayer AG has begun the process of settling medical injury lawsuits regarding its Magnevist contrast agent; Magnevist contains gadolinium.

The company is one among several, including General Electric Company and Tyco International Limited, being sued over complaints that the gadolinium-containing contrast agent was responsible for causing a potentially fatal organ hardening disease, called Nephrogenic Systemic Fibrosis (NSF). Since May 2007, the U.S. Food and Drug Administration (FDA) has required that gadolinium-containing contrast agents carry a black box warning.

Bayer’s Magnevist is used during magnetic resonance imaging scans to define tissues clearly. Gadolinium was approved for use in imaging scans in 1999, but the compound was found to increase the risk of NSF in patients who have weak kidneys. NSF is a rare debilitating disease that affects the skin, eyes, joints, and internal organs, causing them to harden. The disease can be fatal. Symptoms of NSF, include:

Burning or swelling
Tightening of skin
Changes in skin texture
Muscle weakness
Stiffness in the joints

Since the link between NSF and gadolinium became clear, many patients seriously injured by the drug have hired medical injury lawyers to recover compensation for their injuries.

Bayer has begun negotiating approximately 40 cases that linked Magnevist contrast agents with NSF. Apart from Magnevist, there are 4 other contrast agents containing gadolinium - Ominiscan, OptiMARK, MultiHance, and Prohance.

Universal ABC Beauty Supply Recalls Weight Loss Pills After FDA Warning

Medical Attorney — Mon, 27 Apr 2009 15:57:17 -0600

New York-based company, Universal ABC Beauty Supply International Inc., recalled 34 weight loss products after the U.S. Food and Drug Administration (FDA) warned of risks from consuming the products.

The FDA informed the company that the diet pills and supplements contain Sibutramine, a drug that can lead to a substantial increase in blood pressure and an accelerated heart rate. This could cause health risks in people with a history of cardiac problems. None of the products have been approved by the FDA, although, Sibutramine has been approved by the agency for use as a weight loss drug. Because these weight loss products have not received FDA approval, there can be no guarantees of the safety and effectiveness of the products.

The list of weight loss products, includes:

ProSlim Plus
3 DAYS fit
EIGHT FACTOR DIET
24hours Diet
Slim 3 in1 M-18 ROYAL DIET
3X SLIMMING POWER
Extrim Plus 24hours Re-BURN Formula
Slim 3in1 EXTRA SLIM FORMULA
Slim 3in1 SLIM WAIST FORMULA
SLIM EXPRESS 360 C
SLIM EXPRESS 4in1
ROYAL SLIMMING FORMULA
BODY CREATOR
Slim Waistline
BODY SHAPING
PERFECT SLIM
Perfect Slim 100% Natural Herbal Essence
IMELDA Perfect Slim
Slim Waist Formula
Super Slimming
2 DAY DIET
Powerful Slim
BODY SHAPING
SUPER FAT BURNER
SLIMMING FORMULA
SLIM FAST 2
SLIM FAST
Slim up
7 DAYS DIET
Perfect Slim Up
JM Fat Reducer
SlimBurn
21 Double SLIM
TRIM PLUS 2

There have been no reports of illness or injury related to these products; the company said it will discontinue the recalled defective drugs. The company is offering refunds on unused pills. If you have any of these weight loss supplements in your home, discontinue use and contact the company.

Diet pill and supplement companies make up a billion dollar industry. However, some pills may have side effects, including nervousness, diarrhea, accelerated heart rate, tremors, increase in blood pressure, and cardiac arrest. Just because pills promise to give you a slim figure does not mean they are completely harmless and contain no side effects. Medical injury lawyers advise people who use these drugs to follow all dosage instructions carefully and consult their physician before they begin taking them.

FDA Looking at Ways to Improve Medical Device Safety

Medical Attorney — Sat, 25 Apr 2009 13:12:48 -0600

Last week, U.S. Food and Drug Administration (FDA) officials held what the New York Times called a “rare” meeting to discuss the many controversies surrounding the agency's device safety record; medical attorneys think the meeting is past due.

The director of the FDA’s Office of Device Evaluation, Dr. Donna-Bea Tillman, called for an “all hands meeting,” to include all scientists in the device evaluation section. Shockingly, a meeting like this has not been held at the FDA in years. Then again, when you consider the agency's medical device safety record, it really is not very surprising.

The meeting is the most recent in a series of developments surrounding the FDA's record in approving devices. At least 9 scientists this year wrote to Principal Deputy Commissioner, Dr. Joshua Sharfstein, alleging that approval procedures in the device section were being "severely distorted." The letter also alleged that scientists at the agency, who were raising their voice against such unethical practices, were facing retaliation by FDA higher-ups. The matter has been serious enough to warrant a Congressional investigation. Soon, the Institute of Medicine could also begin probing these serious concerns about the device section.

Things seem to be heating up at the medical device section of the FDA. Two things are apparent at this point:

There are serious failures in the medical device division of the FDA.
These problems are not going to be solved by mere patch-up work. Rather, the section needs a complete overhaul to root out unethical practices, and make approval processes corruption-proof.

Any changes that come about at the medical device division cannot be a day too soon.

Defective Medical Devices

It is the FDA's responsibility to protect American consumers from dangerous medical devices. If they fall down on the job and let corrupt individuals get in the way of important safety evaluations, we are all at risk.

If you or a loved one has been injured by a defective medical device, a medical injury attorney can help you recover physically, emotionally, and financially.

Contact a medical injury lawyer, at Arnold & Itkin LLP for a free consultation and to find the answers to any questions you might have.

Contaminated Medical Equipment Cases Keeping Malpractice Lawyers Busy

Medical Attorney — Sat, 25 Apr 2009 12:11:13 -0600

On the heels of the Hepatitis B contamination crisis at a New Jersey clinic and the Nevada clinic Hepatitis C scandal, comes another incidence of medical malpractice at a South Dakota urology clinic that could have exposed patients to Hepatitis B, C, and HIV.

This month, the Siouxland Urology Center sent a letter to patients asking them to visit the clinic for free testing of HIV, Hepatitis B, Hepatitis C, and other infectious diseases that could have been contracted by the use of contaminated medical equipment at the center. Now, five residents of Iowa have filed a class action lawsuit against the Siouxland Urology Center and its owners. The clinic is in Dakota Dunes, on the South Dakota - Iowa border.

Last week, the South Dakota Department of Health stated that it identified a possible risk for infection from cystoscopy procedures performed at the facility. A survey of the center revealed that staff used saline solution bags and other single use products on more than one patient before discarding them. According to the Health Department, it has not identified any blood borne infections due to the lack of safe medical practices at the facility.

What is frightening is that the center admitted that since it opened in 2002, more than 5,000 cystoscopy procedures have been performed at the facility.

Inviting patients who you could have exposed to dangerous, possibly deadly diseases by your own negligence, for "free testing" is a like closing the stable gates after the horses are out. These infectious diseases have no known and permanent cure. Patients who contract these diseases can only maintain a lifestyle that keeps symptoms under control. It is appalling that the six doctors who owned the Siouxland Urology Center failed to stop the negligent medical practice of reusing disposable medical equipment. That is the kind of negligence you might expect from a jungle clinic in a Third World country, not from a specialty medical center in the U.S.

Siouxland Urology Center has challenged the health department's statement that using bladder exam equipment on more than one patient can expose them to the risk of disease.

Medical Malpractice

Medical injury attorneys often come across instances in which health care professionals who have been accused of malpractice, continue to remain in a state of denial even when their negligence has been exposed.

If you or a loved one has been infected with a dangerous disease or injured by the negligence of a doctor or clinic, a medical injury attorney can help you find the resources you need to recover.

Contact a medical malpractice attorney, at Arnold & Itkin LLP for a free evaluation of your case.

Medical Device Maker to Pay $302 million to Settle Misleading Marketing Allegations

Medical Attorney — Sat, 25 Apr 2009 12:01:12 -0600

Quest Diagnostics has agreed to pay $302 million as part of a settlement in a case involving both civil and criminal charges. The Quest settlement is one of the largest involving a medical device.

The agreement also calls for a Quest subsidiary, Nichols Institute Diagnostics, to plead guilty to criminal mis-branding charges. Both New Jersey-based Quest and Nichols will pay $262 million plus interest, to settle charges against them stating they made misleading product claims under the Federal False Claims Act. Nichols will also pay a fine of $40 million. Also, Quest has agreed to compensate state Medicaid programs with $6.2 million to settle claims of misleading marketing. Nichols, as part of the criminal resolution of the case, pled guilty to felony mis-branding and marketing ”unproven advantages” of the Advantage Chemiluminescence Intact Parathyroid Hormone Immunoassay. As part of the settlement, Quest entered into a no prosecution agreement with the government.

Earlier this year, the company was involved in another medical injury scandal in which defective diagnostic kits used for monitoring vitamin D levels, caused botched test results. Thousands of people were believed to have been impacted by the defective results. A high reading of vitamin D levels could result in patients not taking as high a dose of the vitamin D supplement as they needed, while an erroneous low reading could result in patients taking higher doses of vitamin D supplements than required, ultimately resulting in Vitamin D toxicity. The company issued a massive recall of its lab tests and sent letters to thousands of doctors asking them to get their patients retested. Quest has also faced criticism from medical injury lawyers and patient safety advocates because it waited nearly two years to announce the test recall.

Medical Injury Prevention

Medical companies have a responsibility to keep consumers safe by informing them when there has been a mistake or if they find a defect in one of their products. Failure to do this can result in the company being fine great amounts of money and, more importantly, injuries to innocent patients.

If you or a loved one has been injured due to the neglect of a medical company, a medical injury attorney can help you find the resources you need.

Contact an experienced medical injury attorney at Arnold & Itkin LLP for a free consultation.

FDA Asks Pharmaceutical Companies to Include Drug Injury Risk Information in Google Ads

Medical Attorney — Wed, 22 Apr 2009 15:36:30 -0600

Last month, the Food and Drug Administration (FDA) sent letters to major pharmaceutical companies, warning them that their Google search ads will be removed unless they start including information about the risks of the drugs.

Most of the top pharmaceutical companies received the letter, which included two pieces of information the agency expects pharmaceutical search ads to have:

The full name of the drug
Risk factors associated with the drug

Until now, pharmaceutical marketing companies followed the “One Click" rule. As long as all risk information was provided on the page users were directed to after clicking the ad once, risk information was considered sufficient. Now, the agency is demanding that ads include the risks and explains that, laws for print or television marketing are the same for internet marketing. Many pharmaceutical companies have complied, but argue that the FDA should look further into internet advertising and understand that including the risks of a drug is, not only impossible considering Google's guidelines, but also more confusing for consumers. The FDA set April 9th as the deadline for companies to change their ads.

Medical injury lawyers support the FDA's decision to regulate pharmaceutical companies' internet advertising. After all, if a company has is able to describe a product in glowing terms within the Google character limit, it should have no problem including risk information within the character limit as well. However, what we would like is for Google, the FDA, and pharmaceutical companies to come up with ways in which consumers would have all pertinent information about the drug, including risks, when a search ad catches their attention. Currently, the FDA’s new system has online pharmacies showing up as the top listings in text ad results; this is not very helpful for consumers.

This is one more example of good intentions, but flawed methods. The FDA needs to put a little more effort into defining the rules clearly, and pharmaceutical companies must work with the agency to ensure that customers have all risk information at a glance. This is all new territory for the agency. Clear guidelines will give companies no excuse for disobeying the rules and will provide consumers with all the information they need.

Pharmaceutical Attorney

Pharmaceutical companies are required to disclose the risks of their products. Failure to do so can result in seriously injured consumers and even death. Luckily, the FDA is doing what they think is best to protect American consumers, lets just hope they are not confusing the situation even more.

If you or a loved one has been injured by a defective pharmaceutical drug an experienced medical injury lawyer can help you find the answers and resources you need to recover. For a free evaluation of your case, contact a medical injury attorney at Arnold & Itkin LLP.

Nevada Legislative Panel Approves Bill Raising Medical Malpractice Caps

Medical Attorney — Tue, 21 Apr 2009 14:19:06 -0600

Patients in Nevada who have suffered medical injuries due to malpractice by doctors will now be able to claim unlimited damages for pain and suffering.

Last week, a Nevada assembly judiciary committee voted to approve a bill that lifts the cap on medical malpractice court judgments. The bill, which is supported by medical injury lawyers, will protect patients who have been exposed to medical negligence. Propelling Bill 495 forward was the recent Hepatitis C scandal in the state, in which more than 50,000 patients were believed to have been exposed to the deadly disease as a result of poor standards of hygiene at two Las Vegas clinics. Health officials confirmed that 9 patients who were treated at the Endoscopy Center of Southern Nevada and the Desert Shadow Endoscopic Center, both owned by Doctor Dipak Desai, tested positive for Hepatitis C.

The scandal resulted in several malpractice lawsuits filed by medical malpractice attorneys against the facilities. There has also been severe criticism of the state board of medical examiners for its failure to correct errant doctors and punish them accordingly.

The experience of these patients, who have been exposed to a potentially fatal infection due to the utter negligence of doctors, has no doubt spurred the committee to move quickly to approve Bill 495. Patients who have filed lawsuits have demanded changes in the law which currently places a $350,000 cap on malpractice lawsuits. However, Bill 495 does not apply retroactively to the Las Vegas Clinic Hepatitis C cases.

Opponents of the bill have been staging protests in the days leading up to the vote. Their argument? The bill would raise doctors' insurance premiums and force doctors to leave Nevada. The bill will be sent to the general assembly this week. We hope law makers will do the right thing and return patients' rights to justice.

Medical Malpractice Attorney

Doctors' failure to keep their facilities cleaned properly and free of dangerous diseases puts, not only their patients at risk, but also the family and friends of those patients and so on. A medical injury attorney can hold negligent physicians accountable for their recklessness.

If you or a loved one has been injured due to a doctor's negligence a medical malpractice attorney can help you recover physically, mentally, and financially. Contact a medical malpractice attorney at Arnold & Itkin LLP for a free evaluation of your case.

Avandia and Other Glitazones Could Increase Risk of Eye Disorder

Medical Attorney — Sat, 18 Apr 2009 09:46:21 -0600

You can add yet another medical injury to the long list of risks associated with Avandia – this time it is the increased likelihood of developing an eye disorder called Diabetic Macular Edema (DME). According to studies, people who take a group of anti-diabetes drugs called glitazones, including Avandia, are at a greater risk of contracting the disorder.

Avandia and DME

The research was conducted at the Southern California Permanente Medical Group, and was published in the April issue of the American Journal of Ophthalmology. The study is not the first one suggesting a link between glitazone use and DME, but has confirmed a "modest" association between the two. DME is linked to the accumulation of fluid in the eye and swelling, and may eventually lead to loss of vision.

The study, which was conducted on a total of 996 DME patients, revealed that people who took glitazone-containing drugs, like Avandia, were up to 2.6 times more likely to develop the disorder than those who were not taking the drugs. In fact, the risk of developing DME for glitazone users was up to 68% higher than for non-glitazone users. Avandia contains rosiglitazone, which belongs to the glitazone family.

According to the authors of the study, the safety of a drug is as important is its efficacy in treating a disease. However, current safety evaluations for drugs do not take into account long-term safety because approvals are based on short term clinical drugs. This lack of intensive study could result in the release of a potentially defective pharmaceutical drug into the market. The authors have found enough of a link between DME and glitazone use to advise ophthalmologists treating DME patients to consider glitazone use during diagnosis.

Dangers of Avandia

Recently, a study by the Canadian Medical Association Journal found a link between Avandia and a higher incidence of bone fractures in women. Previous clinical studies have also linked the anti-diabetes drug to chest pain, heart failure, and other heart problems. Medical attorneys have been pursuing lawsuits against GlaxoSmithKline, the company that markets Avandia, for these injuries.

The list of risks associated with Avandia use continues to grow. Eye problems are one of the effects of uncontrolled diabetes which, ironically enough, Avandia is supposed to keep under control. If you are currently taking Avandia, you should consult your doctor about the risks of DME. Your doctor may be able to prescribe a less risky substitute.

If you or a loved one has been injured by the use of Avandia or any other pharmaceutical drug, contact a medical injury attorney at Arnold & Itkin LLP for a free consultation.

New Jersey Doctor's License Suspended After Hepatitis B Outbreak

Medical Attorney — Thu, 16 Apr 2009 12:51:39 -0600

A New Jersey board of medical examiners temporarily revoked the license of an oncologist whose clinic is suspected to be the source of a Hepatitis B outbreak. At least five of Dr. Parvez Dara's patients contracted Hepatitis B, provoking an investigation and a safety alert by New Jersey health officials.

Health inspectors described seeing unsterilized and unsanitary conditions at the doctor's Toms River clinic. There was blood on the floor of the room where Dr. Dara administered chemotherapy treatments to his patients. Inspectors also found blood inside the bin used to store blood vials. The saline and gauze were unsterilized, and medication vials had been left open. Inspectors also found violations that involved the use of contaminated pens, counter tops, and refrigerators; misuse of antibiotics, and other violations. In March, health officials sent a letter to more than 3,000 patients who were being treated by Dara asking them to get themselves tested for hepatitis B and C, and for HIV. At least five of his patients tested positive for hepatitis B.

Attorneys for the doctor insisted that there is no direct evidence linking the five hepatitis cases to Dr. Dara’s office. They also suggested that the patients could have contracted the disease at a hospital shared by them. The attorney is asking for Dara’s license to be reinstated or, at least, for him to be allowed to conduct examinations and consultations.

Hepatitis B is a highly infectious disease that affects the liver. It is up to one hundred times more infectious than the HIV virus, and can result in liver cirrhosis, inflammation, and liver cancer. It is primarily transmitted through contact with the bodily fluids of an infected person. Common modes of transmission include:

Unprotected sex with a person who has Hepatitis B
Sharing needles
Sharing tooth brushes and razors
Transfusion of infected blood
Perinatal infections in which the disease is transmitted from the mother to a baby at birth

Treatment for chronic hepatitis B can include medications that can be very expensive. People who develop liver cancer as a result of prolonged hepatitis B infection may die within a few months of being diagnosed.

It appears that the staff at Dr. Dara's clinic lacked training in handling sterile medications and surgical products. Such negligence could well have exposed several of his patients to an infectious disease. Patients should not have to worry that being treated in a doctor’s clinic will expose you to a deadly infection.

Medical Malpractice

A medical malpractice lawsuit can help hold a healthcare worker accountable for negligence that results in medical injuries to patients. It is common for people to blame medical malpractice attorneys for a lot of ills, including the rising cost of insurance, and the flight of doctors outside the state, but all too often, unfortunately, it is only the risk of a lawsuit that ensures health care professionals exercise care in the treatment of their patients.

If you've been injured by the negligence of a doctor, nurse, or other healthcare professional, a medical malpractice attorney can help you obtain justice and recover your rightful compensation. The experienced attorneys at Arnold & Itkin LLP have helped thousands of victims of negligence receive justice. Contact a medical malpractice attorney at Arnold & Itkin LLP for a free consultation.

Zoll AED Plus Defibrillators Recalled After Reports of Death

Medical Attorney — Wed, 15 Apr 2009 12:08:23 -0600

Zoll Medical Corporation recalled its AED Plus Defibrillators because of battery defects in some of the units, and malfunction of self testing software that fails to detect faulty batteries. Approximately, 180,000 units have been included in the recall.

The company sent a letter to customers in February warning them that the defibrillators were prone to a malfunction that has already been linked to the deaths of two people.

The Zoll AED Plus Defibrillator is used by emergency personal, medical personnel, and those who have received CPR AED training. The device is used to treat patients having a cardiac arrest. It works by analyzing the heartbeat of an unconscious patient and instructing the user to press a button that can deliver an electrical shock to the heart, and restore a normal cardiac rhythm. The recalled defibrillators failed to deliver an electrical shock to patients' heart.

In the letter it sent to customers in February, the company asked customers to get their batteries replaced every three years. In March, the company sent a follow up letter asking customers to download new testing software to test the devices. According to that letter, the defibrillators could be prone to failure because of defective battery test software that does not detect flawed batteries.

The recalled devices were manufactured from May 2004 to February 2009, and distributed during the same period. The company asked customers not to stop at changing the batteries, as that will not correct the problem, also, the device software must be downloaded for the defect to be corrected. The company also confirmed that it received two reports of death from the failure of the device. The U.S. Food and Drug Administration (FDA) has classified this as a Class I recall, meaning there is a ‘’reasonable probability’’ that using the product could cause injury or death.

Medical Injury Attorney

Complex medical devices like defibrillators have been responsible for saving thousands of lives, but when these are sent out into the market with a defect, the resulting injuries can be extremely serious. Medical injury lawyers can help victims, who have been injured because of these defects, recover compensation.

If you have been injured by the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

FDA To Ask Medical Device Makers to Prove Safety

Medical Attorney — Tue, 14 Apr 2009 10:44:22 -0600

In a step long awaited by medical injury lawyers, the U.S. Food and Drug Administration (FDA) has announced it will ask makers of external defibrillators, pacemakers, and other medical devices to prove the safety and effectiveness of their products.

These devices, among others, were allowed into the market with very little testing in 1976, before the medical device law was passed. After the law was enacted, the FDA was supposed to determine which of the older devices needed retesting before the agency could give approval for new versions. The agency, however, failed to do so and, for years since, has continued to approve such devices without requiring rigorous safety testing. The agency recently began a review of two of its older device categories and will be sending notices to the makers of at least 25 other device types, asking them to submit product safety information to the agency within 120 days.

The device categories include several high risk devices like external defibrillators, pacemaker parts, and others that have been in the news for various medical injury lawsuits. With this, the theory that the FDA has stringent monitoring processes and should, therefore, be the sole arbiter of a device's safety, has been debunked.

Meanwhile, patients across the country who have been implanted with Medtronic's Sprint Fidelis Defibrillator leads, just one example of the FDA's failure to monitor the safety of devices, are living in anxiety that their devices could malfunction, leading to severe injuries. For these patients, every day that goes by could mean further deterioration of the lead that connects the defibrillator to the heart, and even more anxiety. The extraction process is high risk and not recommended; these patients are caught between a rock and a hard place. They cannot undergo surgery because it is risky, and they cannot sue the company because of the Riegel vs. Medtronic Supreme Court ruling, in which the court held that a device maker could not be sued for injuries caused by an FDA-approved medical device.

The FDA and Defective Medical Devices

For those of use who have never fallen for the theory that the FDA's "stringent" review processes can be relied on, and that device makers, therefore, deserve immunity from lawsuits relating to agency-approved devices, this move by the FDA is a welcome first step. However, thousands of patients who have been injured by the use of these minimally tested devices continue their wait to seek justice for their injuries.

The medical injury attorneys at Arnold & Itkin LLP have extensive experience representing victims of injuries. If you have been injured by the use of a defective medical device, contact a medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

FDA Issues Class I Recall of Centurion Trays & Kits

Medical Attorney — Mon, 13 Apr 2009 12:43:11 -0600

The U.S. Food and Drug Administration (FDA) and Tri-State Hospital Supply Corporation have announced a Class I recall of several types of Centurion disposable trays and kits due to of defective packaging, which can lead to these products losing their sterility.

According to the recall notice, the disposable trays and kits have flawed package sealing that could compromise the sterility of the products. The trays and kits, which were distributed between November 2008 and January 2009, were used to insert catheters and ports. Health care professionals have been advised to remove the recalled products from their stocks and hold them until Tri-State Hospital Supply Corporation arranges to take them back. The FDA notice advises health care professionals and consumers to report any adverse reactions resulting from the use of the products. There is no information yet on whether these products have been responsible for any injuries or illnesses. Tri-State Hospital Corporation is a Michigan-based company that manufactures and distributes medical products throughout the country.

Medical products that are not properly sterilized or have a high risk of contamination due to poor or substandard packaging can lead to infections and illnesses. The use of sterilized products ensures that the risk of contamination is kept at a minimum. Defective packaging is usually the result of poorly monitored manufacturing and packaging practices. Tri-State has not yet commented on how the problem occurred, but it is likely that there was a less-than-stringent quality control process in place at the packaging facility.

Defective Medical Products

Lack of sterilization of medical products can expose a patient to infectious illnesses that can exacerbate medical conditions. Pharmaceutical companies are responsible for the quality of their products and any illnesses or injuries that result can place them at fault in a medical injury lawsuit.

If you have been injured by the use of a defective medical product, a medical injury lawyer can help you recover compensation. Contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.

FDA Issues Class-I Recall of Medtronic Brain Catheters

Medical Attorney — Fri, 10 Apr 2009 11:11:01 -0600

The U.S. Food and Drug Administration (FDA) announced a Class I recall of a brain catheter manufactured by Medtronic Inc. due to failures in the device that may result in serious medical injuries.

In February, Medtronic recalled the BioGlide Ventricular Snap Shunt Catheters that are used to drain excess brain fluid into another part of the body. The catheter is often used in the treatment of hydrocephalus, a condition in which excessive fluid forms in the brain. The company received reports that the catheters are prone to disconnecting. According to Medtronic, such failures could cause:

Vomiting
Nausea
Fatigue
Headache
Seizures
Visual problems

Although the company says it has not received reports of death or serious injuries connected to the use of the catheters, the FDA has classified the recall a Class I. Generally, such a recall is issued when there is “a reasonable probability” that the use of a product can result in serious injuries or death. 3,000 catheters, distributed between 2000 & 2009 are affected by the recall.

The company has received nine reports of the catheter disconnecting. In these instances, the catheters disconnected from the snap base assembly, resulting in the need for emergency revision surgery.

The recall involves the following models of the catheter:

Inner Vision Snap Shunt Ventricular Catheter BioGlide (R: 25.44, 1.15, 4.73%) Catalog Number 27782
Snap Shunt Ventricular BioGlide(R: 25.44, 1.15, 4.73%) Catalog Number 27802
Snap Shunt Ventricular Catheter BioGlide (R: 25.44, 1.15, 4.73%) Catalog Number 27708

Patents who have questions have been asked to contact their doctors or the company.

Defective Medical Devices Can Cause Serious Injuries

By the time a medical device is found to have a serious defect, it is often too late for patients who have been injured, sometimes fatally, by their use. It is the job of the FDA and medical device companies to keep patients informed and to protect consumers from dangerous medical products.

If you or a loved one has been injured by the use of a defective medical device, a medical injury lawyer can help you recover compensation for your injuries. Contact an experienced medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

Patients March for Right to Sue Medical Device Makers

Medical Attorney — Thu, 09 Apr 2009 14:40:35 -0600

Across the country, support for the Medical Device Safety Act of 2009 is growing as medical injury lawyers, patients' rights groups, and the New England Journal of Medicine throw their combined weight behind it. The Act, which was introduced in March, aims to overturn the 2008 Supreme Court ruling that granted device makers immunity for injuries caused by U.S. Food and Drug Administration (FDA)-approved devices.

The Act was introduced by U.S. Representatives Frank Pallone Jr. (D-NJ) and Henry Waxman (D- CA), together with a similar bill, introduced by Senator Edward Kennedy (D-MA) and Patrick Leahy (D-VT). It seeks to nullify the Supreme Court's ruling in Riegel v. Medtronic. In that case, the Supreme Court ruled that patients could not file medical injury lawsuits against device makers under state laws, if the device had been approved by federal regulating authorities.

The new Act has spurred action from health and consumer groups, and has received backing from the American Bar Association. The Center of Justice and Democracy released a report, Hazardous Heart Devices and the Importance of Litigation, that offers a chilling look at the way heart device makers have used blatant cover ups to avoid liability for defective products. Even the venerable New England Journal of Medicine has thrown its support behind the bill, arguing in favor of patients' rights to full disclosure of the benefits and risks of a device and their right to hold a company accountable if it fails to disclose all risks associated with a device.

Medical Injury Lawsuits

Medtronic, the company responsible for setting off the preemption debate, is standing firm in its belief that the FDA should be the sole arbiter of a device's safety. Determining safety of a device is the responsibility of the FDA and should not be left to "juries of laypersons," company representatives say. The company has managed to duck numerous medical injury lawsuits related to its defective Sprint Fidelis leads and judges around the country have used the Supreme Court ruling to dismiss many other medical injury lawsuits.

As things currently stand, patients can sue pharmaceutical drug companies for their failure to warn of risks that cause medical injuries, but cannot sue device makers. It is a strange and entirely incompatible state of affairs and the bill's supporters hope patients' right will be soon be reinstated.

If you've been injured by the use of a defective medical device, contact a medical injury attorney at Arnold & Itkin LLP for a free consultation.

Boston Scientific Issues Warning About Malfunctioning Defibrillators

Medical Attorney — Wed, 08 Apr 2009 10:25:56 -0600

Boston Scientific Corp. recently announced, a malfunctioning wire in Cognis and Teligen defibrillators may result in an abnormal or unnecessary shock, causing serious medical injuries to patients.

Boston Scientific introduced the defibrillators last year in an attempt to grab market share from other device makers. The company expected sales from the two defibrillators to fast track growth this year. The safety warning, sent to cardiologists, seems to have put a halt on the company's plans, in addition to causing concern to thousands of patients who are implanted with the Cognis and Teligen defibrillators. The company says about 34,000 units have been sold since their introduction. The problem, however, is restricted to about 8,000 of these devices that come with respiratory sensors. The wires that connect the defibrillator to the heart are prone to malfunction which can result in one of two situations:

The device may fail to operate properly, resulting in failure to emit a lifesaving electrical jolt to the heart when an abnormal cardiac rhythm is detected.
The device may deliver an unnecessary electrical shock to the heart, resulting in severe pain and cardiac injuries.

Wire problems with defibrillators tend to increase as the device gets older. The Cognis and Teligen defibrillators however are a relatively new entrant into the $11 billion defibrillator market. This is why the announcement, which warns of the device's susceptibility to early malfunction, surprised so many defibrillator experts. If these warnings seem all too familiar, it is because medical injury lawyers and patients who suffer from cardiac arrhythmia remember the thousands of injuries and 13 deaths caused by Medtronic’s malfunctioning defibrillators in 2007.

Defective Defibrillators

Considering the number of problems linked to these devices, it is fair to assume that there could potentially be malfunctions in defibrillators manufactured by other companies also. Cardiac defibrillator devices have been a blessing for thousands of patients who suffer from heart problems. However, manufacturing companies have been reluctant to inform the public about problems with the devices. To make matters worse, the U.S. Food and Drug Administration, which is supposed to screen devices thoroughly before approving them for marketing, has been slow to warn patients.

If you've been injured by the use of a defective defibrillator or other medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.

FDA Issues Class I Recall for Baxter Colleague Infusion Pumps

Medical Attorney — Tue, 07 Apr 2009 11:54:29 -0600

The U.S. Food and Drug Administration (FDA) has issued a Class I recall for Baxter International's Colleague infusion pumps, but a prominent consumer advocacy group is criticizing the agency for its delay in issuing the recall.

The recall was made concerning Single and Triple Channel Volumetric Infusion Pumps, which are used to deliver fluids and drugs to patients. There is a malfunction in the battery and software of the device that can cause an interruption in the infusion. This defect is serious enough to cause injury or death, therefore, the recall assigned is a Class I.

In January, Baxter sent a letter to customers informing them of the failures in the pumps. The warning included an alert that the pump could overheat, resulting in fire and smoke if not properly cleaned. The letter also underscored the importance of proper battery care, pointing out that failure to do so could cause the device to malfunction.

Baxter issued a press release announcing the recall on March 11th; the FDA posted a recall notice on its website the same day, a full seven weeks after Baxter sent the letter to customers. The FDA has come under fire by Public Citizen for its delay in issuing the recall of the drug pump. The criticism is not new – medical injury lawyers have insisted that the FDA issue recall notices quickly and on its own, rather than waiting for companies to act first.

Colleague infusion pumps have been linked to safety issues for years. The FDA, in fact, has issued at least 7 Class I recalls for the pumps. The company stopped sales of the pump in the U.S. in 2005, but at least 200,000 of the pumps are currently in use in hospitals and nursing homes across the country. The malfunctioning, which can cause the pumps to stop pumping and overheat, has been blamed for at least 19 deaths. Sidney Wolfe, the director of the Health Research Group of Public Citizen has demanded that all existing Colleague Infusion pumps be removed from the facilities that continue to use them to deliver fluids and medication to patients. Baxter, however, insists that a full withdrawal, including removal of pumps currently in use, would lead to a shortage in the market.

Delayed Recalls Increase Risk of Medical Injuries

Thousands of patients in hospitals and nursing homes around the country are at risk due to defective medical devices like Colleague Infusion pumps that they depend on to receive lifesaving drugs and fluids. It is outrageous that these pumps continue to be used, even after the manufacturer admitted the device has serious flaws.

If you've suffered injuries due to the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim.