Everyone makes mistakes -- even hospitals

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.

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.

Boston Scientific Issues Warning About Malfunctioning Defibrillators

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.

Defective Medical DevicesBoston 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

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.

Possible FDA Split Could Mean Safer Drugs, Fewer Medical Injuries

Critics of the U.S. Food and Drug Administration (FDA) have long believed that the agency should be split into two parts to ensure adequate safety processes for drug approvals and, in turn, fewer medical injuries. If President Obama’s recent actions are any indication of whats to come, these critics will soon have their wish.

Last month, President Obama appointed two health experts to top positions at the FDA. Former New York City health commissioner, Margaret Hamper, is the President's choice for the agency's commissioner; while pediatrician and child safety expert, Joshua Sharfstein, is the President's choice for deputy commissioner. Experts believe that the President's choice of two experts is an indication that he is in favor of splitting the FDA into two separate units.

Medical Injury AttorneyFDA critics have long argued that the agency is overworked and simply unable to monitor the safety of the vast amounts of pharmaceutical drugs, medical products, and medical devices that come through its doors. The agency suffers from under staffing and a shortage of resources necessary to ensure drug safety. FDA officials, themselves, admit that the agency is unable to meet the changing demands of a globalized world, where pharmaceutical drugs are frequently sourced from foreign plants. In 2005, the FDA approved close to 3,200 applications for marketing of new medical devices. Yet, the agency has only a fraction of the scientist and researchers necessary to process so many applications. Because of this the FDA often has no other option, but to rely on the device makers themselves to disclose the risks of their products.

FDA Division Supporters

The drug industry has been quietly supporting a possible division of the agency, because it could result in faster approvals of pharmaceutical drugs. The FDA experiences frequent delays in its approval and review processes for pharmaceutical drugs due to its shortage of staff. However, medical injury lawyers would welcome an FDA split due to the possibility of more stringent monitoring of review processes and, therefore, enhanced safety of drugs and devices approved for promotion.  

Medical Injury AttorneyIn recent years the FDA has battled several food safety crises. Every time there is a contaminated batch of peanut butter or pistachios, the agency is forced to turn its attention to food safety. It has become increasingly clear that we cannot continue to expect the agency, responsible for making sure tomatoes and peppers are free of pathogens, to also be responsible for monitoring the safety of bone graft products, implantable cardioverter defibrillators and drug eluting stents.

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

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.

Zencore Plus Recalled; Poses Life-threatening Risk

Bodee LLC is conducting a voluntary nationwide recall of the male enhancement drug Zencore Plus. Due to a combination of ingredients, the drug can cause a sudden, life-threatening drop in blood pressure.

Zencore Plus RecallAfter being alerted by the U.S. Food and Drug Administration (FDA) of its danger, Bodee LLC recalled Zencore Plus on March 11, 2009. The drug contains benzamidenafil, which, when mixed with organic nitrates, can cause serious health risks. According the the FDA, "The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure". One user reported that the drug caused nausea, excessive sweating, and caused their vision to go "white". The probability of these health risks is unknown; anyone with this drug in their possession should stop use immediately.

Zencore Plus is sold in health food stores and over the internet. It comes in 2-capsule packs, five packs at a time or in a single 10-capsule pack. The drug is supplied by Hi-Tech Pharmaceuticals, Inc. in Norcross, GA.

Dangerous Pharmaceuticals

If you have been negatively affected by this drug or experienced any of the above mentioned side effects, an experienced medical injury lawyer can help you get the compensation you deserve.

If you have this drug do not take it. If you have taken it and it caused any adverse effects please contact the FDA at 1-800-FDA-1088 or a medical injury attorney 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.

Psoriasis Drug Raptiva Linked to Brain Infection Injury

The Food and Drug Administration (FDA) has issued a health advisory warning, about a reported link between the use of the psoriasis drug Raptiva and the occurrence of a rare brain infection injury.

FDA regulators received 3 reports of progressive multifocal leukoencephalopathy (PML) in patients using Raptiva, a psoriasis drug manufactured by Genentech. The agency was also informed of at least one "possible" case of infection. Two of the confirmed PML patients as well as the sole possible patient died. All 4 patients had been taking the psoriasis drug for more than 3 years. The agency is reviewing the incidence of PML in patients using Raptiva and has announced that it will take steps to ensure that patients taking the medication are not placed at excessive risk.

Progressive multifocal luekoencephalopathy (PML), which usually occurs in people with weakened immune systems, can result in a decline in nerve function and is usually fatal. The infection is marked by an inflammation of the white matter of the brain. It is seen very often in patients suffering from AIDS or other immune deficiency disorders. Symptoms may include:

  • muscle weakness
  • loss of coordination
  • speaking difficulties
  • vision problems
  • personality changes

Individuals often become progressively clumsy and are, ultimately, left with serious disability. People who suffer from PML have a grim prognosis. Approximately 80% of PML patients can die within 6 months of contracting the infection. Defective Pharmaceutical DrugThose who do survive may find themselves with severe neurological difficulties. People with AIDS who suffer from PML may find that the anti-HIV drugs they take can help alleviate the symptoms of PML. People taking medications that suppress immunity are especially at risk for PML. Of the 4 Raptiva users who contracted PML, no one was taking any other immune-suppressive medications.  The FDA has confirmed that it will take steps to make sure that patients taking Raptiva are informed of PML symptoms and that these patients are monitored by healthcare professionals for any sign of the infection.

Almost all pharmaceutical drugs come with a set of side effects or adverse reactions. Therefore, testing pharmaceuticals is very important – the benefits of the drug should be weighed against its risks and it should be prescribed accordingly. If a drug is proved to cause a risk of a potentially fatal and debilitating disease, its generally safe to say that the benefits of the drug are not worth the risk of serious illness. Unfortunately, very often, inadequate testing and rushed approval processes cause adverse reactions to come to light only after illnesses and injuries have resulted from the use of the drug.  

Medical Injury Lawyers

People injured by the use of a defective pharmaceutical drug often need the help of a medical injury lawyer to recover damages for their injuries.

If you have been injured by a dangerous drug, contact a medical injury attorney at Arnold & Itkin LLP for a free evaluation of your case.

Digitek Medical Injury Lawsuits Filed in Orange County, Texas

Four medical injury lawsuits have been filed in Orange County, Texas against Mylan Pharmaceuticals over the cardiac drug, Digitek. The lawsuits relate to injuries caused by Digitek tablets that contained a double strength dose of the active ingredient, Digoxin.

The double strength Digitek tablets were the subject of a massive recall in April 2008. The Food and Drug Administration (FDA) announced a Class I nationwide recall of all lots of Digitek, manufactured by Mylan Bertek Pharmaceutical Inc. and UDL Laboratories that year. Earlier, the FDA issued warnings to Mylan and UDL for failure to file regular safety reports at their New Jersey manufacturing facility. In February 2007, the FDA issued a second warning claiming that there were faulty manufacturing practices at the company. The medical injury lawsuit claims damages for “physical pain” the plaintiffs suffered after taking the double dose tablets.

Digitek Lawsuits

Digoxin, which is the main active ingredient in Digitek tablets, improves the heart's ability to pump blood, in case of heart failure. It is used to treat a range of cardiac problems, including accelerated or irregular heartbeat, heart failure, dizziness or palpitations. Pharmaceutical LawyerWhile it is very effective in the treatment of atrial flutter and other heart conditions, an overdose of Digoxin can have serious consequences on a person's health. Digoxin overdose can quickly lead to digitalis toxicity, whose symptoms include dizziness, blurred vision and other medical issues. In extreme cases, the victim can suffer from a decreased heart rate, pulse irregularities and palpitations. Digitalis toxicity can also impact the functioning of the kidneys. It is therefore an especially dangerous condition in patients who already suffer from kidney and renal disorders. Patients who took the double dose Digitek tablets were at risk of an overdose. The companies involved in producing the double dose tablets including Mylan Bertek Pharmaceuticals Inc, UDL Laboratories Inc., and Actavis Totowa have yet to provide solid explanations for why so many lots of these tablets contained twice the recommended dosage.

Medical Injury Lawyers

Pharmaceutical negligence can leave patients at risk for adverse reactions, side effects, and as in the Digitek case, over-dosage. Pursuing claims against these big name companies requires access to financial and medico-legal resources. Often, only specialized medical injury attorneys have access to these resources.

If you have been by the use of a defective pharmaceutical drug, contact a Texas medical injury attorney at Arnold & Itkin LLP for a free consultation. 

Possible Conflict of Interest Could Reverse Dismissal of Medtronic Injury Cases

Earlier this year, a Minnesota judge dismissed hundreds of Medtronic injury cases, citing federal preemption over state law in medical injury lawsuits. It now appears that the judge failed to disclose that Medtronic has been a longstanding client of the law firm his son works for.

This provides a shocking and controversial twist to the litigation and offers a spark of hope to plaintiffs who's cases were dismissed. Judge Richard H. Kyle was appointed to preside over the lawsuit that included nearly 700 Medtronic injury lawsuits, brought by patients who suffered injuries from Medtronic Sprint Fidelis defibrillator leads. Defective Medtronic LeadsIn January, Judge Kyle dismissed all Sprint Fidelis injury lawsuits citing a Supreme Court opinion that establishes the preemption of federal regulations over state law. Now, attorneys for the plaintiffs intend to cite potential conflict of interest because Kyle's son works for the law firm Frederickson & Byron, which has represented Medtronic for years. Judge Kyle insists that he did not see the need to reveal that fact, because his son's work involves criminal law and would, likely, not have had much to do with Medtronic. Plaintiffs' medical injury lawyers have made clear their intention to have Kyle disqualified from the case for his failure to reveal the relationship his son's law firm had with Medtronic. Meanwhile Medtronic, in an effort at damage control, has released a statement claiming that Judge Kyle’s son has never represented Medtronic, the world's largest medical device maker. It seams like this is not the last we will hear of the Minnesota Medtronic lawsuits.

Medtronic Sprint Fidelis Lead Injuries

Medtronic Sprint Fidelis defibrillator leads were the subject of a recall in 2007 when it became apparent that the defective leads could fracture, causing an electric shock to the heart. These lead fractures could also result in the failure of the defibrillator device to function properly and administer a life saving shock to the heart in case of an abnormal heart rhythm. At least 5 people have died from these injuries and hundreds have been injured.

If you have been injured by the Medtronic defibrillator leads or any other defective medical device, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your claim. 

Georgia Set to Limit Liability for Pharmaceutical Drug and Medical Device Companies

Georgia has introduced legislation aimed at protecting manufacturers of pharmaceutical drugs and medical devices from injury liability in a misplaced effort to attract these companies to the state.  If it becomes a law, the bill may have dangerous implications for Georgia residents who could have their options for liability claims severely limited.

Senate Bill 101 was introduced last week by Senator Bill Cowsert (R- Athens). The bill, which has the approval of Governor Sonny Perdue, aims to amend existing liability codes. Promoters are hoping Defective Medical Products to pass it before Atlanta becomes the venue for the world's largest biotechnology conference in May. Earlier this year, Governor Perdue unveiled the legislation at a meeting of the Georgia Chamber of Commerce, outlining his intention of making it harder for victims to pursue civil liability claims against pharmaceutical companies. Basically, the bill grants immunity to drug and medical device manufacturers from any medical injury lawsuits if the drug or device has already been approved by the Food and Drug Administration (FDA). It is no secret that the legislation is aimed at making the state's investment climate attractive to pharmaceutical companies who may consider setting up business there. As a spokesman for the governor confirms, the state wishes to pursue these companies aggressively to set up base in Georgia, and so, has dangled the civil liability immunity carrot in front of them.

Not surprisingly, civil justice proponents, patients' rights advocates and medical injury lawyers have been vocal in opposing any bill that grants immunity to pharmaceutical companies and medical device makers based purely on FDA approval of drugs or devices. As we have seen in recent years, many drugs and devices have been hastily pulled off the market after the dangers of using them came to light. All of these products had FDA approval. There are critics both within the FDA and outside the organization who claim its inspection standards and oversight procedures are far from adequate. In a scenario like this, passing legislation that relies purely on FDA approval to decide the validity of medical injury lawsuits is extremely harsh and unfair to patients. Beside, dangling the immunity carrot in front of pharmaceutical companies may actually prove counterproductive. The only other state that grants immunity to these companies is Michigan, which, contrary to being flooded with investment after the immunity law was passed, has actually found thousands of pharmaceutical jobs leaving the state.

Medical Injury Lawyers

Any time a state attempts to interfere with patients' rights to hold companies responsible for their injuries is a bad sign for civil justice in the country. Granting these companies immunity at the cost of patients' rights to protect themselves is a serious mistake, and one we hope Georgia won't make.

If you have been injured by the use of a defective pharmaceutical drug or medical device, contact a medical injury attorney at Arnold & Itkin LLP for a free evaluation of your claim.

FDA Guidelines on Off-Label Drug Use May Lead to Injuries

As the Bush administration prepared to vacate office, the Food and Drug Administration (FDA) issued new guidelines that ease restrictions on promotion of off-label drug use by pharmaceutical companies. The rule has been severely criticized because it may lead to more dangers when pharmaceutical drugs are used in ways not approved by the FDA.

It is illegal for pharmaceutical companies to promote off-label use of their drugs, although physicians are allowed to prescribe drugs for purposes not approved by the FDA. Doctors are allowed and often do rely on published medical research to prescribe drugs for unapproved uses to their patients. In its new rule, the FDA allows pharmaceutical companies to cite medical journal research supporting off-label uses of a drug. The biggest problem with relying on medical journal articles is that such research does not go through a strict screening process. It is hardly meant to be used as a substitute for the rigorous approval procedures conducted by the FDA.  Plus, there is also the risk that pharmaceutical companies may pay medical researchers and scientists for articles that recommend promotion of the drug for off-label use, which clearly would not be genuine, in-depth research articles.Pharmaceutical Drugs

The new guideline has been criticized from both within and outside the Bush administration. The Department of Veterans Affairs, patient advocacy groups, state prosecutors and medical injury lawyers around the country stand adamant that the new guidelines will weaken an already unstable FDA and expose patients to the omnipresent dangers of off-label drug use.

Off-label drug use continues to be a major danger to patients at risk of side effects from such drugs. Recently, Eli Lilly and Company agreed to a mammoth settlement over civil and criminal lawsuits arising from off-label drug use promotion. Also, Medtronic currently faces a lawsuit arising from the same unethical practices related to its Infuse Bone Graft. The threat of massive civil and criminal liability is the only thing preventing mass off-label promotion by drug manufacturers.  In the absence of rules completely prohibiting such promotion, drug manufacturers will have the freedom to place patients at risk in order to multiply their profits.

Promotion of off-label drug use by pharmaceutical companies can expose patients to unknown side effects simply because off-label uses are not researched as extensively as approved uses and, therefore, have little research to provide help in the case of adverse effects. In such cases, patients who have been injured can file a medical injury lawsuit against the company with the help of a medical injury lawyer.

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

 
 
 

 

 
 

Defective Pharmaceuticals Could cause Terrorism Risk

If the prospect of contaminated Heparin and injuries from Avandia were not disturbing enough, an eminent cardiologist has now warned of the danger of a biological threat if the FDA does not get its act together, and fast.

Dr. Steven Nissen, a prominent Cleveland Clinic cardiologist and medical researcher, was one of the first to bring the risk of Avandia injuries caused by Glaxo's anti-diabetes drug into the spotlight. This man has a reputation for being straight forward and honest and has never shied away from calling out pharmaceutical companies and the FDA for their negligence.  He has also been named a possible contender for FDA chief.  Big pharmaceutical companies have always been wary of his announcements and the FDA has frequently been the target of Dr. Nissen's criticism. 

So, when Dr. Nissen raises concerns that terrorist organizations, like Al-Qaeda, could use the FDA's scant oversight of foreign pharmaceutical plants to mount a biological attack on the U.S., we are inclined to pay attention. Dr. Nissen insists that he is not trying to stir up paranoia. Recent instances of the FDA’s somnambular conduct of its drug safety processes, especially at foreign plants, do raise concerns that the facilities could be used by those who seek to harm Americans. China, for instance, is growing to be a significant source of drugs manufactured for Americans. Last year's heparin scandal was traced to batches of contaminated Heparin injections manufactured in China. The Heparin contamination, it is believed, came from adding a synthetic, cheaper compound in place of the original ingredient in a possible effort to cut costs. Since then, we have found that the FDA has not conducted a single inspection of the Chinese plant since it received approval several years ago. The FDA now has an inspection office in China to handle inspections of food and drug plants supplying the U.S. It seems like a reassuring first step, until you realize that the total staff strength at the Chinese FDA office is 8.

The FDA admitted that it has been unable to adapt to growing changes brought about by globalization. In a scenario where a growing number of drugs are sourced from Chinese plants, there may be reason to worry about whether a lack of FDA inspections, combined with poor regulatory standards in China could lead to the first major biological terrorist attack on the U.S. Of course, the chances of terrorists infiltrating a Chinese pharmaceutical plant and contaminating drugs meant for American consumers may seem far fetched now, but we never imagined that a group of zealots would drive aircrafts into the heart of New York City either. 

Medical Injury Lawyers

The FDA's poor oversight of drug makers and poor regulatory practices, combined with pharmaceutical companies' negligence, have time and again placed American consumers at risk of tainted or defective pharmaceutical drugs. If you have been injured as a result of using a dangerous drug or defective medical device, you will need the help of a medical injury lawyer to recover the compensation you deserve.

To get the help you need contact a medical injury lawyer at Arnold & Itkin LLP for a free consultation.

Medtronic Paid University Researcher $19 Million For Development of Spinal Products

Already facing heat for its Medtronic lead and defibrillator injury scandals, the medical device major now faces new issues. An eminent researcher and spine surgeon at the University of Wisconsin admitted that he received payments from the company to the tune of $19 million to develop and promote the Infuse Bone Graft, among other things.

The researcher, Thomas Zdeblick, received payments over a 5 year period and, according to the Wall Street Journal, the payments were made to help in the development and promotion of spinal products, including the Infuse Bone Graft. These facts were revealed in a letter written by Senator Charles Grassley to the University, as part of his investigation in the conflict of interest arising from pharmaceutical companies' payments to doctors. The University of Wisconsin policies require doctors to reveal payments of up to $20,000, but does not require specification of payments beyond $20,000. The University policies on this matter are in line with the policies enforced by other universities and medical research centers. The University admitted that its medical disclosure requirements are inadequate and officials said they will be changing the rules to require doctors to specify exact payment amounts received from companies.

Technically, there is nothing wrong with Zdeblick's failure to reveal the $19 million he received over the years.  Zdeblick claims that he disclosed his financial relations with Medtronic to his patients and always has. However, this is Medtronic we are talking about, a company that has recently come under suspicion of encouraging off-label use, which is illegal. Just a few weeks ago, the family of a California woman who died after Infuse was inserted in her neck against FDA approved uses, filed a medical injury lawsuit against Medtronic for pressuring the doctor to use the bone growth product in an unapproved manner. The nexus between pharmaceutical companies and medical researchers is well known. However, it has increasingly been scrutinized by lawmakers and medical injury lawyers who would like to see scientists and researchers given more independence from the influence of pharmaceutical companies.

There are several ways in which a monetary relationship between a researcher and a drug company can impact the safety of medical products. First, there is always the risk of drugs and devices being pushed for approval simply for financial gain.  A conflict of interest also exists when a doctor is paid by a company for developing a product and then goes on to promote the same product to patients; no one can argue that there is bias in a situation like this. The only party that suffers when unethical things like this happen are the patients injured by defective products and drugs and their families.

Medical Injury Litigation

Taking on big name companies like Medtronic Inc. requires the expertise of an experienced medical injury lawyer who has the resources necessary to handle your case. Here at Arnold & Itkin LLP we have successfully resolved many medical injury and defective medical product cases.

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

Ethex Corporation Issues Large Scale Recall of Defective Drugs

Generic drug manufacturer, Ethex Corporation, has suspended the manufacturing and sales of dozens of defective pharmaceutical drugs from its line, including several brands of isosorbide mononitrate, amlodipine and nitroglycerin, among others.

The company, which is a subsidiary of St. Louis-based KV Pharmaceuticals, took the step after inspections of the company's facilities by the U.S. Food and Drug Administration. This second massive recall comes just a few months after the company announced a recall of some of its products in 2008. The earlier recalls were the result of several anomalies in the manufacturing of drugs, including oversized tablets that contained twice the required amount of the drug. The extra sized tablets included Morphine Sulphate Extended Release, Morphine Sulphate Immediate Release, Propafenone HCI, Isosorbide Mononitrate Extended Release, Hydromorphone HCI tablets, and Dextroamphetamine Sulphate. There have been several medical injury lawsuits already filed against the company related to morphine over-dosage, due to the oversized morphine tablets. Morphine over-dosage can lead to decelerated heart beat, disorientation, confusion, lightheadedness, fainting and convulsions.

The new recall by Ethex includes almost the entire line of drugs manufactured by the company. The products recalled include generic versions of the pain killer OxyContin, anti-depressant medication Toprol XL and cough medicines.  Most of the drugs have been recalled from wholesale agencies, while some have also been recalled from retailers.  A press release issued by the company asks patients who are using the medications to continue using them due to the health risks of suddenly stopping the medication. The company has also asked patients to consult with their doctors and be observant for any side effects; any side effects noticed should be reported through the FDA's MedWatch program.

Hiring a Medical Injury Lawyer

When it comes to injuries caused by unsafe pharmaceutical drugs, it is important to save the bottles or containers of the medication. We advise you to discontinue use of the medication after consulting with your doctor and talk to a medical injury lawyer. It's important to hire an attorney who has an established record of pursuing and winning claims against major pharmaceutical companies. The medical injury lawyers at Arnold & Itkin LLP have successfully represented dozens of victims of unsafe pharmaceutical drugs. 

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

Minnesota Judge Dismisses Medtronic Defibrillator Lawsuits

A judge in St. Paul, Minnesota has dismissed dozens of lawsuits related to heart injuries caused by Medtronic's Sprint Fidelis defibrillator leads, citing federal preemption of state laws on the matter. 

In October of 2007, Medtronic Inc., stopped sales of its Sprint Fidelis defibrillator lead wires after reports that they failed to function properly in the event of heart attacks. The leads are wires that connect the defibrillator to the heart. When the lead is fractured the defibrillator cannot send a life saving shock to the heart in the event of an impending heart failure. The broken wire can also cause a massive and painful shock to the heart. After reports of patient injuries and deaths resulting from defective leads, Medtronic was forced to withdraw them from the market. At the time of the recall, approximately 257,000 patients had been implanted with the Sprint Fidelis defibrillator lead. Since then the company has faced multiple medical injury lawsuits filed by patients across the nation who sustained injuries caused by the defective leads.

In a separate case in February 2008, the US Supreme Court ruled under a controversial doctrine known as "preemption" that FDA approval of a medical device would supersede any lawsuit filed against a medical device maker under state laws. The Bush administration has pushed for preemption of federal regulations over state laws which has been criticized by consumer rights advocates and medical attorneys for the unwarranted protection it offers makers of medical devices. Under preemption, an injured patient would not be able to file a personal injury lawsuit against a medical device maker if the FDA had already approved the device. This doctrine works on the assumption that the FDA can never be wrong in all its approvals and that patients should have blind faith in the agency's ability to ensure that only the safest products enter the market. Unfortunately, the FDA's record on maintaining safety in drugs and devices introduced into the American market give little cause for comfort. The agency has battled allegations from its own scientists that approval for medical devices is obtained through coercive techniques.

Medtronic Sprint Fidelis Lead Lawsuits

Thousands of people around the country who have been injured as a result of the malfunctioning leads have filed lawsuits against Medtronic Inc.  For the remaining who have yet to suffer injuries from the malfunctioning lead, the prospects for replacing the lead are bleak, as it involves an invasive and potentially dangerous surgery.

As is evident from this lawsuit dismissal in St. Paul, taking on major pharmaceutical companies who enjoy the protection of the government is not an easy task. The medical injury lawyers at Arnold & Itkin LLP have the solid expertise and experience, as well as the considerable resources that pursuing Medtronic defibrillator lawsuits requires. We can answer your questions and help you evaluate your options for possible compensation.

If you have been inured by the Medtronic defibrillator leads, contact a medical injury attorney at Arnold & Itkin LLP. 

 

CDC Report Confirms Heparin Injuries Caused by Synthetic Chemical Contamination

A report titled Outbreak of Adverse Reactions Associated with Contaminated Heparin issued by the Centers for Disease Control and Prevention has confirmed the worst fears of the public – that Heparin injuries and deaths were caused by a synthetic chemical that was added to the drug at a Chinese plant.

According to a followup article published in the Washington Post, the CDC has found strong evidence linking the chemical oversulfated chondroitin sulphate and the symptoms that patients who had been given Heparin, Baxter's blood thinner began to suffer in November last year. Allergic reactions to the product included nausea, breathing difficulties and a rapid drop in blood reassure. In the United States alone, 81 people are confirmed to have died from the contaminated Heparin, and there have been hundreds of reactions to the medical product.  There are fears that more side effects could lie potentially hidden in a patient's system, to erupt later in unrecognizable forms. 

Oversulfated chondroitin sulphate is a processed form of chondroitin sulphate, an animal sourced product that is used in arthritis medications. Chondroitin sulphate is much cheaper to produce, and it's believed that this is why the Chinese producers added it to the drug to replicate the blood thinning properties of the original ingredient.  The recalled contaminated heparin continued to sit on shelves in hospitals in many states even after a recall was announced in early 2008, and it's entirely possible that there may be more injuries resulting from the contamination that are still under the radar. It's not easy to connect a contaminated drug to symptoms, and for months the FDA was unaware that the allergic reactions that patients were suffering were due to any contaminant in the Heparin.

Baxter's failure to maintain quality control at its Chinese supply plant, combined with the FDA's inadequate inspection procedures ensured that hundreds of people suffered violent reactions to the drug before experts were able to point to the source. An increasing dependence on foreign drug suppliers whose facilities are rarely put through FDA inspections has meant that Americans can hardly use a medication without worrying if it's going to cause extreme reactions or in worst case scenarios, even death. The FDA has had a particularly worrisome couple of years with numerous tainted drugs entering the market, many of them manufactured at overseas plants. It doesn't help that the agency barely has enough resources to inspect facilities at home, let alone plants that are located thousands of miles away.

Heparin Injury Numbers Continue to Rise

Contaminated Heparin has caused serious injuries in patients that may have long term implications, including organ damage, low blood pressure, and even death. There may be other little known effects that manifest themselves weeks and months after the administration of the drug. Across the country, dozens of patients have filed medical injury lawsuits against Baxter to protect their rights and obtain compensation for their suffering.

Pursuing claims for damages against large pharmaceutical companies like Baxter can be a complex and expensive process. Victims benefit from the expertise of a specialized pharmaceutical liability lawyer who has both the experience and the resources to pursue the claim.

If you've suffered adverse reactions to Heparin or another dangerous pharmaceutical drug, contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case. Our lawyers handle most cases on a contingency basis so there is no fee unless we prevail on your behalf.

 

Probe Launched Into Shady Medical Device Approvals at FDA

Pharmalot has a report that's bound to be of special interest not just to medical injury lawyers around the country, but also to millions of Americans who have been implanted with a medical device. According to the report, a group of scientists at the FDA's Center for Devices and Radiological Health division have, in a letter to the House Energy and Commerce Committee, made dramatic charges about the "coercions" and "force" that they have been subjected to in order to speed up or bypass normal procedures before approval of medical devices.

The charges have been shocking enough to galvanize John Dingell, chairman of the Committee and Bart Stupak, Chairman of the Subcommittee on Oversight and Regulations to launch a probe into these allegations. According to the report, scientists were "ordered, intimidated and coerced" by higher-ups into modifying their recommendations for approvals in violation of standard FDA procedural practices. These coercion techniques included, the experts say, being forced to use unreliable evaluation processes, and accept data that was not procured through correct scientific means. All this was done, the letter alleges, to allow the faster approval of certain medical devices and products.

These allegations are deeply concerning to all citizens, but the tragedy is that this isn’t the first time frustrated scientists at CDRH have tried to bring this to the attention of FDA authorities. In May of this year, a similar letter with the same charge was sent to FDA officials, and in response, recommendations were made for the removal of some senior managers at CDRH. In that instance, investigating officers found "compelling evidence" that these charges were true. The fact that such allegations have been made again, this time in a letter sent to the ECC, indicates that the problem is more deep rooted than we think.

Corrupt FDA Practices and the Potential for Medical Injuries

Let's look at the implications of how this coercion of employees to rush through device safety approval procedures affects the ordinary citizen. Depending of course, on whether these latest charges are 100 percent true, and the number of years these unethical practices have been going on at the FDA, it's conceivable that thousands of people are walking around with unsafe, ineffective, or defective medical devices ranging from pacemakers and stents, to breast implants and intraocular lenses. The potential for injury through these devices is staggering, and the consequences for public safety are enormous.  As long as the FDA continues to play with the health of ordinary Americans, we can hope that pharmaceutical companies that benefited from these unethical practices will be kept in check by medical injury lawsuits and other actions brought on the part of injured consumers.

Building a Medical Injury Lawsuit

Medical devices can cause serious injuries not just through faulty design and manufacture, but also because of failure to test these devices properly, or to provide proper instructions for their use. Injuries from a defective product can include adverse reactions to the product and life threatening complications. 

Medical device litigation can be a complex and intensive process. If you have been injured by a defective device, you will need the help of an experienced medical injury lawyer to build your lawsuit. Contact a medical injury lawyer at Arnold & Itkin LLP for a free evaluation of your case.