Video Highlight: Personal Injury Attorneys - Arnold & Itkin LLP

The medical injury lawyers of Arnold & Itkin LLP released a new video on LawyerForYou.com that addresses the importance choosing the right lawyer if you or a loved one has suffered a serious injury or death as the result of medical malpractice or using a defective medical device or dangerous pharmaceutical drug. Medical attorneys Jason Itkin, Kurt Arnold and Lisa Sechelski discuss what attributes you should look for when choosing a medial injury lawyer and how Arnold & Itkin LLP goes the extra mile to provide true full-service care for their clients. In the video, you'll also hear from actual clients and learn why they chose Arnold & Itkin LLP.

The medical attorneys at Arnold & Itkin LLP help people injured by medical malpractice, defective medical devices and pharmaceutical drugs.

Bayer Settles Gadolinium Contrast Agent Injury Lawsuits

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 AG Medical Injury LawsuitBayer’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

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:

  1. ProSlim Plus
  2. 3 DAYS fit
  3. EIGHT FACTOR DIET
  4. 24hours Diet
  5. Slim 3 in1 M-18 ROYAL DIET
  6. 3X SLIMMING POWER
  7. Extrim Plus 24hours Re-BURN Formula
  8. Slim 3in1 EXTRA SLIM FORMULA
  9. Slim 3in1 SLIM WAIST FORMULA
  10. SLIM EXPRESS 360 C
  11. SLIM EXPRESS 4in1
  12. ROYAL SLIMMING FORMULA
  13. BODY CREATOR
  14. Slim Waistline
  15. BODY SHAPING
  16. PERFECT SLIM
  17. Perfect Slim 100% Natural Herbal Essence
  18. IMELDA Perfect Slim
  19. Slim Waist Formula
  20. Super Slimming
  21. 2 DAY DIET
  22. Powerful Slim
  23. BODY SHAPING
  24. SUPER FAT BURNER
  25. SLIMMING FORMULA
  26. SLIM FAST 2
  27. SLIM FAST
  28. Slim up
  29. 7 DAYS DIET
  30. Perfect Slim Up
  31. JM Fat Reducer
  32. SlimBurn
  33. 21 Double SLIM
  34. TRIM PLUS 2

Medical Recall Includes SlimfastThere 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

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.

FDAThe 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.

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

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.

Quest Diagnostics Mis-brandingEarlier 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

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 AttorneyMedical 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.

Avandia and Other Glitazones Could Increase Risk of Eye Disorder

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.

Medical Injury AttorneyThe 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

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.

Medical Malpractice AttorneyAttorneys 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

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.

Defective Medical DeviceThe 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

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.

Medical Injury AttorneyThe 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

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. Medical Injury AttorneyThere 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

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

Medical Injury AttorneyAlthough 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

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). Medical Injury AttorneyIt 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.

FDA Issues Class I Recall for Baxter Colleague Infusion Pumps

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.

Medical Injury AttorneyIn 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.

Medical Device Maker Lobbied for FDA Approval

Supporters of the 2008 Supreme Court ruling that granted device makers immunity from medical injury lawsuits brought on by FDA approved devices, should rethink their position. According to the Wall Street Journal, a knee device maker engaged in unethical lobbying to obtain U.S. Food and Drug Administration (FDA) approval for its new device.

The approval for Menaflex implants, which are used to help knee injury patients, was given overriding objections by FDA scientists. According to FDA correspondents, several senior staff members of the agency complained that ReGen Biologics Inc., the company that manufactures Menaflex, pressured the agency to approve the device. Lawmakers have since gotten involved in the controversy with Senator Chuck Grassley sending letters to the agency as well as the device maker, calling for more information about interactions between the two. According to Senator Grassley, his investigation is based on emails that suggest the agency was overenthusiastic in its readiness to ‘’accommodate the company.’’ Menaflex received approval under the agency's fast track rules, in which clinical trials are not necessary.

Medical Injury LawyerIt is not only ReGen Biologics Inc. and the safety, or lack of it, of Menaflex in question here. At the crux of the matter are the reliability and integrity of FDA approval processes. Email correspondence between staff members at the agency indicate that they removed certain lines from emails that could indicate ‘’special treatment for the device maker.’’ FDA critics are concerned about what they call the agency’s tendency to bow to device companies. The fast track process, in particular, has come under intense scrutiny. The process allows scientists to bypass clinical trials only when reviewing devices similar to existing ones. There is no explanation forthcoming about why Menaflex was approved under the fast track process considering it is the only device of its kind in the market. With the FDA behaving more like a corrupt government than the country's premier drug safety agency, it is fair to assume that medical injury lawyers will be kept busy for a while.

Defective Medical Device Lawsuits

Medical devices that are rushed through approval processes or approved through lobbying efforts may come with risks that can pose potential dangers to patients. These devices may not have had stringent review guidelines applied to them, which means their safety may not be thoroughly verified.

If you've been injured by the use of a defective medical device, and want to know if you are eligible for compensation, contact an experienced medical injury lawyer at Arnold & Itkin LLP.

Michigan Moving to Reverse Medical Injury Lawsuit Immunity for Drug Makers

Michigan has the somewhat dubious distinction of being the only state in the country to grant pharmaceutical companies immunity from medical injury lawsuits. That may soon change - on March 26th, the Michigan House of Representatives approved a set of three bills aimed at reversing that immunity.

This is the second time the Michigan House of Representatives has passed the bill granting pharmaceutical companies immunity. Of the three bills, the third aims to allow medical injury lawsuits retroactive to 1996, when then-Governor John Angler signed the law that gave the pharmaceutical industry immunity from lawsuits brought by patients harmed by U.S. Food and Drug Administration (FDA) approved products.

The law has been criticized by medical injury lawyers and patient rights advocates, and has been detrimental for thousands of medical injury victims unable to take action against these, often, negligent pharmaceutical companies. These people are victims of a range of defective drugs, such as:

What the law has done, essentially, is give pharmaceutical companies a free pass to market and promote their drugs (in the state) without any fear of consequences in the event of the drugs causing injuries or deaths. Medical Injury AttorneyPatients injured by the drugs are currently helpless in the face of the law. At the time the bill was passed, proponents insisted that it would attract pharmaceutical investment in the state; that theory has since been disproved. Pharmaceutical investments and companies have moved out of Michigan in recent years, taking valuable jobs with them.

Georgia has since tried to emulate Michigan's example. Governor Sonny Perdue introduced a tort reform bill earlier this year that sought to prohibit medical injury lawsuits against pharmaceutical companies for products approved by the FDA. Better sense seems to have prevailed there; that bill was rejected in the Georgia Senate Economic Development Committee.

These instances of states attempting to block patients' right to file medical injury lawsuits against companies signify a dangerous trend. Michigan has one of the highest unemployment rates in the country and their drug immunity laws have done nothing to revitalize it. Other states should take note.

Medical Injury Lawsuits Hold Companies Accountable

The prospect of being held liable in a medical injury lawsuit is probably the biggest factor motivating drug companies to ensure that their products are safe for use. In the absence of such accountability, companies are encouraged to rush through drug approvals. The only people who suffer from this carelessness are unfortunate consumers.

If you've been injured by the use of a defective drug, contact a medical injury lawyer at Arnold & Itkin LLP to discuss your case.

AstraZeneca Accused of Suppressing Unfavorable Seroquel Studies, Faces Medical Injury Lawsuits

According to many, recently filed medical injury lawsuits, AstraZeneca neglected to release findings of a study that linked its anti-psychotic drug Seroquel to diabetes and sudden weight gain.

The results of the study, named Study 15, were available in 1997, but company executives conveniently chose to file away the results rather than notifying doctors. The company used other studies that painted a more favorable picture of the drug to promote it. Medical Injury LawsuitLater that year, the U.S. Food and Drug Administration (FDA) approved the use of Seroquel. Since then, Seroquel has become one of the company's best selling drugs with billions of dollars in sales, including a whopping $12 billion in the last three years. Meanwhile, thousands of patients who were prescribed Seroquel developed diabetes and suffered extreme weight gain.

More than 9000 patients have developed hyperglycemia, diabetes, and weight gain after using the drug and have filed medical injury lawsuits against the company. Plaintiffs called for the unsealing of confidential company documents that prove the company was aware of the link between the use of Seroquel and diabetes and weight gain. As the contents of these documents are revealed, it is  apparent that, not only was the company aware of Seroquel's potential side effects, but the company also ordered its sales representatives in the U.S. to tell doctors that the drug did not cause diabetes. This order was mandated after one of AstraZeneca's own physicians told a client such a link was indeed possible.

The release of the "hidden" documents has generated a long list of questions about the extent of deceit by the company. The documents reveal that a University of Minnesota psychiatrist, Dr. S. Charles Schulz, came to "questionable" findings regarding the safety of the drug, and still announced that it was "significantly superior" to the then, industry-leading Haldol. In his research, Dr. Schulz used much of the same data that, back in 2000, revealed Seroquel was no more effective than other cheaper alternatives. After using the same data, however, he managed to come to the conclusion that the drug was more effective.

If this all sounds sickeningly familiar, you may have heard about the recent Forest Laboratories Inc. scandal, in which federal prosecutors charged Forest Laboratories Inc. with suppressing studies that showed not-too-favorable results of its Lexapro medication for use in teenagers. 

Medical Injury Lawyers

These all-too-frequent scandals raise questions about how drug companies are managing to spin research to present a favorable picture of their otherwise, questionable drugs. This is an issue the FDA has been battling a lot in recent years, as lawmakers, patients' safety advocates and medical injury lawyers around the country demand to know why companies are allowed to pass off results of company-sponsored studies as proof of their product's safety.

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

Forest Laboratories Inc. Accused of Illegal Marketing of Antidepressants

As the Justice Department charged Forest Laboratories Inc. in February with illegal marketing of its antidepressants Celexa and Lexapro, the U.S. Food and Drug Administration (FDA) approved the use of Lexapro for use in children.

Forest Laboratories Inc. marketed the drugs for use in children and adolescents even though it had no FDA approval for such use. The civil complaint filed against the company alleges that:

  • Executives at Forest promoted favorable results from one clinical trial to purport that the drugs were effective in children. The trial, conveniently enough, was financed by the company. Another study, that did not result in such favorable findings, was concealed and the company failed to share the results of that study.
  • The company awarded pediatricians who prescribed the drugs. There were ski vacations, gift certificates, fishing trips, and spa visits dangled before doctors to coax them into prescribing Celexa and Lexapro.
  • Forest conducted trials that were simply marketing campaigns in the guise of studies. Doctors are not prohibited from prescribing drugs for unapproved uses; drug makers, however, are not allowed to promote off label or unapproved uses of drugs. In recent weeks, Eli Lilly settled an off label use promotion suit and Medtronic had a medical injury lawsuit filed against them for off label promotion of its Infuse bone growth product.

Medical Injury AttorneysThe allegations that Forest Laboratories Inc. concealed studies showing unfavorable results for Lexapro and Celexa seem to have received no attention by the FDA. On March 20th, the agency approved the use of Lexapro for use in adolescents. Lexapro is only the second antidepressant approved for use in younger patients.

Medical Injury Attorneys

Often, pharmaceutical companies indulge in unethical and illegal marketing of products that have not been approved for certain uses. Forest Laboratories' illegal marketing of Lexapro and Celexa for use in younger patients even before they were approved for such use, could have placed children and adolescents at risk of antidepressant abuse. Antidepressant medications, when not used as they are prescribed, can cause suicidal fantasies or worsen symptoms of depression. Unfortunately, we often see pharmaceutical companies ignoring health risks posed by unapproved uses of drugs to increase profits without thought of the risks of medical injuries.

Patients injured by unapproved use of a drug can consult a medical injury lawyer to file a lawsuit against the company, if it was engaged in promoting such off label use.

If you or a loved one has been injured by the use of Celexa or Lexapro, contact a medical injury lawyer at Arnold & Itkin LLP to learn about your options for compensation.

Watson Recalls Propafenone HCL tablets Due to Risk of Injuries from Over Dosage

Watson Pharmaceuticals Inc. announced that it is recalling one lot of Propafenone HCL 225 mg tablets because they may contain a more intense dose of the active ingredient than is needed. The recall affects a single lot of the tablets that was shipped between October 15th and November 26th of 2008.

Propafenone is used in the treatment of cardiac arrhythmias, including conditions associated with accelerated heartbeat, like ventricular and atrial arrhythmias. However, it can be dangerous if not used as prescribed. The drug is believed to increase the risk of dangerous arrhythmias if taken by patients who have an underlying heart disease. Patients who suffer from liver problems, asthma, or bradycardia are also advised to avoid Propafenone. The long term effects of the drug have not been extensively researched. Even minor over-dosage of Propafenone has been found to have serious effects. Patients who take even small quantities of the drug above the prescribed limit could experience a drop in blood pressure and arrhythmias.

Propafenone RecallWatson Pharmaceuticals Inc. says they are voluntarily recalling the lot of tablets to prevent any risk to patients due to over dosage. The Food and Drug Administration (FDA) has been informed of the recall and the company has asked patients who are in possession of the 225 mg tablets to check the container and see if the tablets belong to the lot being recalled. Consumers should return the recalled tablets by calling the company. Any adverse reactions should be reported to the FDA’s MedWatch program. Patients currently using 225 mg Propafenone HCL tablets have been asked to contact their physician if they have any questions.

Last year, Ethex Corporation announced a recall of over sized morphine Sulphate, Propafenone HCI, and other tablets because they contained twice the necessary amount of the drug. Those over sized tablets caused morphine over dosage injuries and resulted in several medical injury lawsuits filed by medical injury lawyers against Ethex. Also, medical injury lawsuits continue to be filed against Mylan Pharmaceuticals over double strength Digitek tablets that contain extra dosages of the active ingredient Digoxin. 

Injuries Caused by Defective Drugs

Over dosage due to a defective pharmaceutical drug containing a greater amount of the active ingredient than is necessary is entirety preventable by the company if it follows stringent manufacturing and quality control processes. There is no excuse for releasing batches of drugs that expose users to dangerous effects of over dosage because of careless errors made at the manufacturing plant.  

If you've been inured by the use of recalled Propafenone HCL tablets manufactured by Watson Pharmaceuticals Inc., contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

Law Makers Move to Return Patients' Right to File Medical Device Injury Lawsuits

In recent weeks, patients injured by Medtronic defibrillators have watched in pain as judges around the country dismissed their medical injury lawsuits. Law makers' recent plans to reintroduce patients' rights, give them reason to cheer.

Democratic lawmakers are working on plans to reintroduce legislation that would return patients' rights to sue medical device companies for their injuries. In February 2008, the Supreme Court ruled that patients injured by the use of defective medical devices, like Medtronic defibrillators, could not file a lawsuit against the company if the device had received approval from the Food and Drug Administration (FDA). Since then, judges around the country have cited the Supreme Court decision numerous times, using it as an excuse for throwing out hundreds of lawsuits including several against Medtronic. Medical Injury LawyerOn February 17th, a judge in Wisconsin dismissed a lawsuit filed by a 63-year-old man who needed surgery to remove a Medtronic device after the company warned that the batteries may suffer from a sudden depletion of power causing it to malfunction. Earlier this year, a judge in Minnesota dismissed hundreds of Medtronic injury lawsuits brought by injured patients.

With the new administration, however, it seems like patients may have their right to sue companies like Medtronic returned to them. House democrats, Henry A. Waxman of California, who also serves as the chairman of the House Energy & Commerce Committee, and Frank Pallone Jr. of New Jersey, plan to introduce legislation that would nullify the Supreme Court ruling. Senator Edward Kennedy of Massachusetts and Patrick Leahy of Vermont sponsored a similar bill last year which could be reintroduced later this year.

At the crux of the Supreme Court decision last year was the belief that the FDA, as the country's chief drug and medical device safety agency, could be trusted to approve a product only after ensuring it was entirely safe to use. Since then, we have seen evidence of the agency's ineptitude, not only in the number of defective drugs that seem to enter the market like contaminated Heparin and Vioxx, but also through the whistle blowing efforts of its own staff who allege that the agency's approval processes are questionable. In this situation, where companies attempt to push their products through approval processes as quickly as possible and the FDA continues to lurch from one food and drug safety scandal to another, the only losers are patients who end up with no recourse to civil justice after they suffer injuries. Several lawmakers, medical injury lawyers, and patient advocates have strongly voiced their opposition to the 2008 Supreme Court ruling. With a new administration in power, however, it seems like change is finally coming to American civil justice.

Medical Injury Lawsuits

Going up against big medical device manufacturers like Medtronic can be intimidating. In conjunction with laws prohibiting your right to justice, however, it can seem impossible. Our team of medical injury attorneys can help you find the resources you need in such a situation.

If you have been injured by the use of a defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP to learn how you can begin to recover compensation for your suffering.