Archive for the ‘Product Liability’ Category

Respiratory Depression and Death Caused by Duragesic (Fentanyl) Patches

Thursday, May 9th, 2013

Duragesic fentanyl patch are extended relief patches that dispense a very powerful opiod over (usually) 72 hours. They are only indicated for patients who have chronic and unrelenting pain that is not relived by other, shorter acting painkillers, like Lorcet or Percocet. Although opiod drugs are frequently prescribed for lesser ailments that, in good medical practice, should be treated with non-opiod painkiller, some physicians prescribe opiods far too freely.

Drugs like fentanyl are particularly indicated for severe and long-last pain, like that of cancer with bone metastases. Fentanyl is 100 times more potent then morphine. However, some doctors will prescribe a fentanyl patch for patients with chronic back pain or even fibromyalgia. This is not only inappropriate, but it is very dangerous, as some of these patients are not tolerant of opiods and may overdose on the stronger drug, leading to respiratory depression and death.

In fact, death by opiod overdose is caused by the depression of respirations by the drug, the main adverse effect. Coupled with the sedation of the central nervous system, the patient may fall asleep or pass out, and while asleep, with a decreased respiratory drive, the patient will simply stop breathing.

A particularly dangerous situation occurs when patients are prescribed a fentanyl patch and given other opiods for “breakthrough pain.” The addition of other opiods makes fentanyl patches even more dangerous.  Lethal levels of opiods will cause overdose and death.

Despite 5 recalls of Fentanyl patches for such reasons as leaking and faulty manufacturing, the patches are still available and their use by physicians remains widespread. Problems with leakage from faulty manufacturing of fentanyl patches has resulted in many deaths as a result of large doses of fentanyl gel leakage on to the skin, where it is absorbed in such a large dose at once that is causes overdose. Manufacturers such as Ortho-McNeil, Watson Pharmaceuticals, and Pricara, a division of Johnson and Johnson, have recalled leaking Fentanyl patches. There are multiple generic manufacturers of the patches. Johnson and Johnson alone has recalled almost 40 million fentanyl patches.

Some signs of opiod overdose include constricted pupils, fatigue, clammy skin, nausea and vomiting, confusion, dizziness, slowed breathing, seizures, loss of conscious or coma.

Another side effect of the patches, and of any opiod prescribed on a regular basis, is dependence, which means that the patient will suffer severe side effects when stopping the drug. In some patients, this dependence leads to addiction. Inn 2005, the FDA issued a Public Health Advisory for healthcare professionals and the public to warn of the dangers of fentanyl (Duragesic) patches, significantly mentioning that they should be used only in patients already tolerant of opiods, and that they could result in repiratory depression and interactions with alcohol and other drugs of abuse.

There have been multiple lawsuits against the manufacturers of fentanyl patches, some resulting in multi-million dollar verdicts or settlements to the families of the deceased patients.

If you or a family member has experienced an overdose, addiction or dependence, drug interactions, or death as a result of use of a fentanyl (Duragesic) patch, you may have a claim against the manufacturer and possibly against your prescribing physician. You should consult a personal injury or medical malpractice attorney for a thorough evaluation of your case.

Fresenius Dialysis Lawsuits

Monday, April 15th, 2013

GranuFlo Naturalyte Lawsuit 300x199 Fresenius Dialysis LawsuitsFresenius Medical Care operates 2,100  dialysis clinics in the United States, and they are also the nation’s leading supplier of dialysis machines and supplies. The company makes two products used during dialysis, GranuFlo® and NaturaLyte®. Most patients are unaware of the name of their dialysate, or the fluid used during dialysis. However, GranuFlo® and NaturaLyte® have been implicated by the Food and Drug Administration for contributing to elevated levels of bicarbonate in the blood.

Patients who receive excessive doses of these products may become victims of cardiac arrest, sudden myocardial infarction (heart attack), stroke, sudden death, or irregular heart beats (arrhythmias) that may be fatal.

In addition to these potential consequences, Fresenius patients may have suffered changes in their mental status, or confusion; very low blood pressure has also been linked to excessive amounts of these products. Extremely low blood pressure can lead to blackouts, or even stroke.

The underlying cause of these adverse effects is a dangerous swing in the body’s pH balance. During dialysis, toxic waste that would otherwise be eliminated from the body through the kidney is removed from the blood of people with renal (kidney) failure. Bicarbonate is an alkaline substance, and is administered during dialysis to neutralize the hydrogen ions, or acids, that have built up in the blood.

The kidneys, when functioning, maintain the body’s pH at 7.4. This balance is necessary for the proper functioning of body systems. A higher or lower pH is called wither alkalosis or acidosis, respectively. When cells operate in an environment of inappropriate pH, they are unable to perform their cellular functions, which depend upon complex balances of electrolytes within and outside of the cell. The heart is especially sensitive to pH, and derangements in the acid-base balance may cause irregular heart rhythms, which sometimes deteriorate quickly, leading to disorganized pumping of the heart, and cardiac arrest or circulatory shock.

Both GranuFlo® and NaturaLyte® are widely used in not only Fresenius Dialysis Centers, but in multiple clinics for dialysis throughout the country. Fresenius has long publicized that these products were among the most prescribed dialysis products in the country.

Multiple lawsuits have been filed against Fresenius since the FDA’s announcement. Some of these lawsuits allege that Fresenius was long aware of the risk associated with their 2 top-selling products. Boston attorneys uncovered an internal memo to its own network of clinics, reporting 947 cardiac deaths among only a third of the clinics they operate in the United States. However, although Fresenius sold GranuFlo® and NaturaLyte® to multiple independent clinics, they failed to notify those dialysis clinics until months later.

Many clinics owned by Fresenius are operated under local names. Even if you or a family member undergoes dialysis at an independent clinic, if you have experienced any of the above adverse events after dialysis, you may have been dialyzed with one of the Fresenius products. Many Americans are on dialysis as a result of end-stage renal disease. It is believed that thousands of kidney patients have been affected adversely.

If you have reason to think you may have suffered an adverse event or have knowledge of the death of a family member due to sudden cardiac arrest or stroke, you may have a case against Fresenius Medical Care North America. It is important to consider consulting a medical malpractice attorney to see if you have legal recourse to recovery of damages.

Call Passen Law Group at 312-527-4500 for a Free Consultation.

Study Finds Brain Imaging Can Predict Pain Intensity

Thursday, April 11th, 2013

fMRI Detect Pain 300x194 Study Finds Brain Imaging Can Predict Pain IntensityPain and suffering is often difficult to measure, even by the most experienced pain specialists.  Patients are typically asked to rate their own pain on a scale of 1-10.  Although there are objective ways to confirm physical and psychological injuries consistent with pain, the nature and extent of pain is typically measured by the patient’s own subjective self-reporting.

A new study published in the New England Journal of Medicine finds that brain imaging can be used to objectively assess pain — both physical and emotional pain.

The study involved a total of 114 patients who underwent functional magnetic resonance imaging (fMRI) — a unique and new form of neuroimaging — while being stimulated with heat-induced pain, as well as “social pain.”

What is Functional Magnetic Resonance Imaging (fMRI)?

fMRI is a relatively new form of neuroimaging used to measure brain activity by detecting changes in blood flow that occur in response to certain stimuli. fMRI can identify the parts of the brain that are involved in certain mental processes.

fMRI use is controversial, because it is a relatively new neruoimaging technique.  However, fMRI can be extremely beneficial to identifying a brain injury in patients who are symptomatic of neurologic dysfunction, yet have “normal” brain scans using typical imaging techniques.

As the above-mentioned study demonstrates, fMRI can also be extremely helpful in identifying pain.

fMRI to Identify Physical and Emotional Pain

The study found that in those patients who were subjected to heat-induced pain while being imaged with fMRI, a “nerologic signature” emerged:  increased brain activity in the thalamus, posterior and anterior insulae, secondary somatosensory cortex, anterior cingulate cortex, periaqueductal gray matter, and other regions of the brain.

Even more interesting, the study found that fMRI was helpful in identifying emotional-related pain — related to depression, post-traumatic stress disorder (PTSD), or other events that cause emotional pain.  When subjecting such patients to “social pain,” the fMRI showed that many of the same brain regions were activated as with physical pain.

In general, the study found fMRI to be over 90% sensitive (or accurate) in identifying physical and emotional pain.

This is a huge breakthrough for pain research and treatment for those with chronic and acute pain — both physical and emotional.  Based on this research, new treatment may be developed to focus on these specific areas of the brain that are triggered, rather than on the conventional approach to attempting to block pain impulses from getting into the spinal cord and the brain.

At Passen Law Group, most of our clients have experienced significant pain — both physical and emotional — as a result of serious motor vehicle accidents, medical malpractice, and other contexts which produce pain.  We welcome these new developments addressed at identifying pain, and hopefully leading to beneficial treatment for pain.

For a Free Consultation with one of our attorneys, Call us at 312-527-4500.

Maker of Meningitis-Tainted Injections May Be Prosecuted

Sunday, December 9th, 2012

Meningitis Steroid Injection 300x168 Maker of Meningitis Tainted Injections May Be Prosecuted  Our meningitis injury attorneys have previously written about the outbreak of meningitis found in steroid injections used to treat pain, which sickened scores of people earlier this year.  We have encouraged the victims of this negligently-prepared product to seek legal advice immediately.

Now,  it appears that civil lawsuits may not be all that the makers of this dangerous and deadly product will face.

This week, the Boston Globe reported that the New England Compounding Center, a company that prepared the steroid injections containing meningitis, is under investigation by a federal grand jury.  A grand jury investigation is a preliminary step used to determine whether criminal charges should be filed.

The outbreak occurred this summer and fall, leaving victims sickened nationwide.  The outbreak also killed at least 36 of its victims.

The tainted steroids were particularly dangerous because they were intended for injection directly into the spines of patients.  Meningitis is a bacterial infection of the membranes of the brain and/or spinal cord.  By injecting the tainted materials directly into the spine, physicians inadvertently gave the bacteria access to the location in the body where it could do the most damage, and was the most dangerous.  Our experienced injury and wrongful death lawyers believe that, had the steroids been intended for injection elsewhere, the outbreak would have been far smaller.

The grand jury investigation has only just begun, with subpoenas issued to employees and others working for and connected to the New England Compounding Center.  Although the grand jury proceedings are closed – and secret – sources connected to the company disclosed the subpoenas to the Boston Globe.

Thus far, federal officials have declined to comment on the case.  This includes the U.S. Attorney’s office, which previously raided the pharmacy and was conducting an investigation.  But federal  District Court Judge Dennis Saylor, the judge presiding over numerous lawsuits against the pharmacy filed in Boston, stated during a hearing this week that there “may” be a current grand jury investigation.

We are pleased to see the grand jury investigation, and hope that charges will indeed be filed against this negligent company, and perhaps its leaders.  In the meantime, we urge the victims of this tragedy to continue to place pressure on those responsible by filing lawsuits seeking justice and compensation for the harm they have suffered.

For a free consultation with an experienced Chicago meningitis lawyer at Passen Law Group, call us at (312) 527-4500.

Holiday Shopping and Product Recalls

Friday, December 7th, 2012

Holiday Recalls 300x197 Holiday Shopping and Product Recalls  The holidays are a magical time, particularly for children – music, fun, sweets, and toys, toys, toys!  As parents scurry to create that magical experience for their youngsters, however, our experienced Chicago injury attorneys urge a measure of caution.

Each year, many children are hurt or killed by their holiday presents – dangerous toys which have already been recalled.  These toys come into children’s hands in two ways:  the toy is purchased secondhand, and thus sold despite the recall, or the toy is recalled (or the store learns of the recall) after the toy has already been purchased.  In fact, many toys designed and marketed for the holidays are recalled during the holiday season itself.

For these reasons, our product injury lawyers urge parents and others who are giving toys this year to stay on top of holiday recalls.  The easiest way to do that is to use the website of the United States Consumer Product Safety Commission.

Parents can consult a list of recent recalls at http://www.cpsc.gov/cpscpub/prerel/category/child.html.  Parents can also visit the CPSC’s main page, where they can search by toy type and other categories to ensure that the items they have purchased – particularly secondhand items – are not on a recall list.  Parents can also use this page to sign up for automatic email notifications when a toy or other children’s item is recalled.  The CPSC main page is found at http://www.cpsc.gov/cpscpub/prerel/prerel.html.

Naturally, the CPSC website does not list defective or dangerous toys which have not yet been recalled.  However, armed with these tools, parents can make the holiday safer for their children by protecting them from defective and dangerous toys which have already been recalled.  We urge our readers to use these tools, and wish all a safe and joyful holiday season.

For a free consultation with an experienced injury and wrongful death lawyer at Passen Law Group, call us at (312) 527-4500.