Author: AboutLawsuits

AstraZeneca has agreed to pay the U.S. government $520 million to settle charges over Seroquel, resolving a federal probe that accused the drug maker of illegally promoting their popular antipsychotic medication for non-approved uses.  

The settlement over Seroquel is expected to be announced Wednesday by the U.S. Department of Justice (DOJ), according to a report by the New York Times. AstraZeneca will not admit to wrongdoing in the settlement, and will enter into a corporate integrity agreement with DOJ.

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. Originally approved by the FDA in 1997 for the treatment of schizophrenia, it has been frequently prescribed off-label for uses that were not approved as safe and effective at the time, such as anxiety, obsessive dementia, compulsive disorders and autism.

While doctors are free to prescribe approved medications for non-approved uses, drug makers are barred from promoting or encouraging such “off-label” use. Since it was approved, Seroquel has been used by more than 19 million people worldwide, and some people have estimated that at one time as much as 70% of all seroquel prescriptions were for unapproved uses.

According to internal company documents uncovered through Seroquel litigation, off-label promotion of the drug has been a key marketing strategy for AstraZenca since at least 2000. During pretrial proceedings in lawsuits over Seroquel filed by consumers who developed diabetes and other health problems after using the drugs, company papers were released that had the stated objective to “continue to encourage off-label use of Seroquel for the treatment of bipolar disorders through publications presented at major congresses,” even though treatment of bipolar disorders was not approved at the time.

The company first announced it had reached an agreement in principle to settle the Seroquel case with the DOJ in a November filing with the U.S. Security Exchange Commission (SEC).

In addition to the federal probe, AstraZeneca faces an estimated 26,000 Seroquel lawsuits in state and federal courts throughout the United States involving allegations that the drug maker failed to adequately warn about the risk of serious side effects. In November 2009, a federal judge presiding over thousands of cases ordered both sides to meet with a mediator to see if there is any possibility for a settlement of Seroquel injury cases before individual trial dates are scheduled in federal district courts throughout the United States.

A new study has found that certain types of hospital patients are far more likely to carry colonies of antibiotic-resistant bacteria in their noses than others, placing them at higher risk of contracting virulent hospital infections or passing it on to other patients. 

The study, published online in the medical journal Infection Control and Hospital Epidemiology, was led by researchers from Rhode Island Hospital along with researchers from the Cleveland Clinic, Johns Hopkins Medical Institutions and other medical centers and universities.

The study found that, overall, one in three individuals had colonies of methicillin-resistant Staphylococcus aureus (MRSA) in their nose, but certain groups, such as elderly nursing home residents, HIV patients and those undergoing kidney dialysis, were far more likely to carry the potentially deadly bacteria. Rhode Island Hospital announced the results of the study in a press release earlier this month.

MRSA infections, also known as “superbug” infections, have been steadily growing in the U.S. over the last decade. According to the U.S. Centers for Disease Control and Prevention (CDC), there are more than 2 million hospital infections acquired each year, resulting in about 90,000 deaths annually. Another 1.5 million long term care and nursing home infections occur every year. MRSA, which resists treatment by many antibiotics, has accounted for more than 60 percent of hospital staph infections in recent years.

In the most recent study, researchers took nose cultures from 2,055 patients at 13 different enrollment centers. About 444 of those cultures resulted in the growth of MRSA. Researchers found that 20% of long-term elder care patients carried MRSA colonies, as well as 16% of patients infected with HIV, and 14% and 15% of inpatient and outpatient hemodialysis patients, respectively.

“Hospitals performing active surveillance for MRSA should consider such patient populations for screening cultures,” said Dr. Leonard Mermel, of Rhode Island Hospital. Mermel was the study’s lead author.

Researchers also discovered that a variety of MRSA strains were found across different patient populations, including some strains which had not previously been detected in the United States.

The findings of this latest study follow the release of the results earlier this month of another study conducted by Johns Hopkins that found that 6% of  children admitted to pediatric intensive care units (PICU) carry MRSA as well.

Shareholders have filed a lawsuit against Goldman Sachs over fraud involving their Abacus products, alleging that the bank misled investors about securities and the financial health of the bank itself.

The Goldman Sachs class action lawsuit was filed on Monday in U.S. District Court for the Southern District of New York by investor Ilene Richman on behalf of any investor who bought shares in the company from October 15 of last year until April 16, when the U.S. Securities and Exchange Commission (SEC) filed a fraud lawsuit against Goldman Sachs. The class action complaint names Goldman Sachs, and Chief Executive Officer Lloyd C. Blankfein, Chief Financial Officer David A. Viniar and President Gary D. Cohn as defendants.

Two other investors sued the company’s officers on April 22 in state court, and another derivative lawsuit was filed against the company’s officers and directors on Monday in Manhattan as well, Bloomberg News reports.

According to the SEC, Goldman Sachs created a synthetic collateralized debt obligation (CDO), called Abacus 2007-AC1, which was backed by subprime mortgage securities. The SEC claims that Goldman Sachs said that the securities were selected by a third party called ACA. However, the SEC says that Paulson & Co., a hedge fund that was betting on the failure of subprime mortgage securities, heavily influenced which securities went into the portfolio.

The charges claim that Paulson picked securities doomed to fail, and Goldman Sachs packaged them and sold them to unwitting investors. Paulson bet on the securities failing and made $1 billion. Those who bought into Abacus on the belief that it was a sound investment lost about $1 billion.

The company has denied the charges, saying that it lost money as well and made full disclosures about the selection of the securities.

The class action fraud lawsuit accuses the bank of misleading investors about its financial condition after it became aware that it was under investigation for the Abacus CDO. Following the SEC’s announcement that it had filed a lawsuit against Goldman Sachs on April 16, the company’s shares fell 13 percent.

The lawsuit says that the company initiated an advertising campaign last October heralding that it adhered to responsible business practices, at the same time that it knew it was under investigation, in order to counteract negative media about the $16 billion in bonuses it was preparing to dole out to employees.

The drug maker Pfizer gave at least 13 children overdoses of its antipsychotic drug Geodon during clinical trials, according to federal investigators. 

The FDA issued a warning letter to Pfizer earlier this month, accusing the company of failing to properly monitor a clinical trial that resulted in “widespread overdosing” of children with the powerful antipsychotic drug. The children suffered tremors and restless legs, but have not suffered any apparent long-term injuries as a result of the overdoses, investigators say.

Late last week, Pfizer responded to the charges, with a statement on its clinical trial procedures. The company has promised to provide an outline of processes aimed at preventing similar problems from occurring during its clinical trials in the future.

The agency blasted the company in its warning letter for failing to correct or detect Geodon overdoses being given to children in a timely manner. According to the letter, adults and children alike received significant drug overdoses daily on consecutive days, with some being subjected to overdoses of the drugs for 16 consecutive days. One subject received 30 days of total overdosing and experienced sleep problems, facial tics and chemical imbalances.

“The final Clinical Study Report submitted to the FDA lists 40 total subjects reported to have had a protocol deviation related to dosing error, including 20 subjects who exceeded the maximum protocol dose,” the warning letter states. Nine site visits by a Pfizer data management team failed to detect the overdoses, the FDA found.

Geodon (ziprasidone) was approved by FDA in 2001 for the treatment of bipolar disorder and schizophrenia in adults. It is an atypical antipsychotic. The clinical trials, which took place in 2006 and 2007, were part of an ongoing effort by Pfizer to gain approval to market Geodon for use by children.

FDA staff members have said that the side effects of Seroquel, Geodon and other antipsychotics need to be further studied due to the possible weight gain and diabetes effects on children.

Last year, Pfizer plead guilty to charges that it illegally promoted Geodon and several other drugs for off-label uses not approved by FDA. Pfizer paid $2.3 billion to the U.S. Department of Justice in a settlement that included a corporate integrity agreement.

Federal regulators have issued new draft guidance aimed at increasing the quality and safety of drug infusion pumps, which have been plagued by defects and recalls in recent years that have resulted in more than 500 deaths. 

The new infusion pump safety initiative, announced by the FDA on April 23, will require manufacturers to undergo more risk assessments before gaining approval for new or modified devices, and they will be expected to submit additional design and engineering information for premarket approval.

Infusion pumps are small medical devices that deliver drugs into the body. They are increasingly worn by Type 1 diabetics as an alternative to daily injections of insulin by syringe or an insulin pen. However, hospitals also use infusion pumps to deliver a wide variety of drugs, such as antibiotics, chemotherapy and anesthesia drugs.

The new guidance comes following an FDA advisory panel meeting in March which was called by regulatory agency due to a disturbing trend in the quality of infusion pumps. According to FDA, there have been 56,000 adverse event reports from people reporting problems with infusion sets in the last five years. In addition, there were 87 infusion pump recalls announced between 2005 and 2009.

Last summer, a recall was issued for Medtronic Paradigm insulin pump Quick Sets after the company determined that about 60,000 infusion sets used with the pumps were defective and could give too much insulin to users due to an air pressure problem.

A number of Medtronic insulin pump lawsuits have been filed over diabetic-related injuries resulting from the defective infusion sets. The FDA issued a warning letter to the company over its manufacturing processes, noting that it had quality assurance problems and that the on-site medical professional hired to determine if there was a medical problem with the devices had only a high school diploma.

FDA reviewers found that the most common cause of death and injury from the use of either defective insulin pumps or from using them incorrectly was hypoglycemia; lower than normal blood glucose. However, the FDA also has identified a growing number of insulin pump-related automobile accidents.

Between 2006 and 2009, there were at least 29 adverse event reports of motor vehicle accidents associated with insulin pumps. In some cases, drivers wearing insulin pumps and suffering from low glucose levels lost consciousness or died while driving and crashed into other vehicles, drove off the road, into lakes, and even slammed into buildings at high speed.

European Union drug regulators have approved an extended release version of AstraZeneca’s antipsychotic medication, Seroquel, for use by some patients suffering from depression.

The approval of Seroquel XR was announced last week by the European Medicines Agency, which overturned an earlier rejection of the drug by The Netherlands. The EU approval follows a similar green light for the drug by FDA in the U.S. in December. The approvals come despite concerns over the risk of problems from Seroquel, which some believe may outweigh the benefits of using the drug to treat depression

The new version, Seroquel XR, is an extended release formula which European regulators have agreed to allow as an add-on treatment for depression. The Dutch originally reviewed, and rejected, the drug while acting as a reference state for the rest of the EU under mutual recognition procedures in May 2009. AstraZeneca protested the decision and sent a new application to the European Medicines Agency, which reviews drugs for use across the EU.  

Seroquel (quetiapine fumarate) is an atypical-antipsychotic that is a top selling drug for AstraZeneca, generating nearly $5 billion a year in sales. More than 19 million people worldwide have used the medication for both approved and non-approved uses. However, side effects of Seroquel have been linked to an increased risk of weight gain, hyperglycemia and diabetes.

Last month, the UK charged AstraZeneca with ethics violation charges, saying that the company made misleading statements about Seroquel weight gain side effects.

AstraZeneca currently faces thousands of Seroquel lawsuits in the United States that allege the company failed to adequately warn about the risk of weight gain and other metabolic side effects, which allegedly caused users to develop diabetes and other Seroquel health problems.

Covidien is recalling a number of tracheostomy tubes, used to help people breathe on ventilators, due to issues with the tubes leaking. The trach tube problem has resulted in at least 1,200 reported incidents, including at least three deaths. 

The FDA announced the tracheostomy tube recall on April 23, warning that the cuff of the tubes do not always hold in air as they should. If the cuffs leak, it could adversely affect ventilation, decreasing the amount of oxygen being received by patients. This could lead to serious injury or death under some circumstances.

Covidien sent a letter to customers (pdf) on April 13, alerting them that it had received reports of “serious adverse health consequences” due to problems with some versions of its cuffed Shiley tracheostomy tubes, as well as some custom and specialty tracheostomy tubes. Covidien has told FDA that it has received reports of at least three deaths and 1,200 incidents connected with the recalled trach tubes, according to FDA officials.

In the affected units, the cuff does not hold air due to leaks in the pilot balloon inflation assembly. This can cause the ventilation system to lose the ability to create positive pressure in the airway, leading to a sudden decrease in the amount of oxygen being received by the patient, or a sudden increase in the amount of carbon dioxide in their blood.

The medical device recall affects 62 product codes and their associated lot numbers for Shiley Tracheostomy Products and Custom Shiley Tracheostomy Products, commonly referred to as “trach tubes”. All of the recalled devices were manufactured between November 2008 and December 2009. A complete list of the affected product codes and lot numbers is available in the FDA and Covidien press releases.

The FDA and Covidien are recommending that customers return any products affected by the recall. They can contact the company’s technical services department at 1-800-635-5267. Any healthcare professionals or patients who have experienced adverse events associated with this product should contact the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch/report.htm.

About 13,000 Lexus GX 460 vehicles are being recalled by Toyota Motor Corp. due to a high risk that the SUVs may rollover going around sharp turns. 

The Lexus recall was announced last week shortly after Consumer Reports gave the vehicle a “Don’t Buy” recommendation for safety reasons. Test drivers at Consumer Reports say that under certain conditions, the rear of the vehicle may slide going around turns, increasing the chances of a Lexus rollover accident.

The Lexus GX 460 recall affects the 2010 model year, including 9.400 vehicles in the United States and about 3,600 more vehicles worldwide.

Problems with the Lexus GX 460 are known as trailing throttle or lift-throttle oversteer. According to test drivers at Consumer Reports, if the driver takes his foot off the gas while the vehicle is driving through a sharp turn, the rear end of the vehicle may begin to slide. On most vehicles, the electronic stability control system would detect the slide and stop it from happening, but it does not seem to be responsive enough to the problem on the Lexus SUV.

Test drivers said that it is a common maneuver for drivers, which may occur when they take an off-ramp too fast, or realize they are in a sharper turn than they expected. Testers at Consumer Reports said they wouldn’t allow their families to ride or drive in the vehicles in their current condition. Consumer Reports said that the problem could cause a driver to lose control and pose a risk of serious personal injury or death.

The last time Consumer Reports issued a “Don’t Buy” warning was 2001, for the 2001 Mitsubishi Montero Limited.

The low rating came at a sensitive time for Toyota, which is still reeling from accusations that they covered up problems with sudden acceleration in many different Toyota and Lexus vehicles. Toyota has recalled about 8 million vehicles due to the gas pedal problems and has paid a fine of $16.4 million to the U.S. Department of Transportation.

Toyota quickly halted sales of the Lexus GC 460 following the negative recommendation by Consumer Reports. Now officials in Toyota’s Lexus division said that they have developed a fix that requires an update of the SUV’s Vehicle Stability Control (VSC) system. All Lexus dealers will have the updated software by the end of April, according to the press release on the Lexus recall (pdf).

Toyota officials urged owners of the vehicles to return them to their dealers to get the update, which should not take much longer than an hour, depending on the dealer’s schedule. Owners of affected vehicles will begin receiving letters in early May alerting them to the problem and the fix.

Any Lexus GX 460 owners with questions can go to www.lexus.com/recall.

Photo Courtesy of: http://www.flickr.com/photos/nadaguides-garage/ / CC BY 2.0

Following an explosion Tuesday night on the British Pretroleum (BP) oil drilling rig known as Deepwater Horizon in the Gulf of Mexico, at least two families have filed lawsuits against BP and the rig’s builders alleging negligence caused the disaster.

Eleven of the 126 crewmembers of the Deepwater Horizon were still missing Friday morning, after the BP drilling platform exploded and caught fire for reasons that are still unknown. The platform burned until Thursday morning, when it collapsed and the massive oil rig plunged into the waters of the Gulf.

There were 115 people on the rig who have been confirmed to have escaped by life boat. At least seventeen of the rescued workers were injured, with three in critical condition. The wounded were flown by air ambulances to hospitals in New Orleans, Louisiana and Mobile, Alabama.

On Thursday, the family of missing worker Shane Roshto filed a lawsuit over the Deepwater Horizon drilling rig explosion against BP and Transocean Ltd. in the U.S. District Court for the Eastern District Court of Louisiana. The lawsuit accuses the companies of negligence and failing to meet federal regulations. Another Deepwater Horizon lawsuit was also filed against the companies on behalf of worker Karl Kelppinger Jr. in state court in Harris County.

Officials have indicated that the explosion and sinking oil rig may unleash a catastrophic oil spill in the already environmentally fragile Gulf of Mexico. Coast Guard officials on the scene say it does not appear that such a spill has occurred yet, but they are monitoring the drill’s wellhead and will continue to do so. The Coast Guard warns that if the wellhead does rupture, it could release up to 8,000 barrels of crude oil a day.

The Coast Guard has detected a sheen of oil on the water across a five mile area, but has determined that the oil was blown out by the explosion.

The Deepwater Horizon platform was constructed and owned by Transocean Ltd., and was under lease to BP. The rig was 50 miles off the coast of Louisiana performing exploratory drilling. Officials from Transocean said that workers who escaped the burning platform feared that the 11 missing workers were too close to the initial blast, and may not have escaped.

The potentially deadly explosion comes a few months after the U.S. Occupational Safety and Health Administration (OSHA) fined BP $77.4 million for safety problems at its Texas oil refinery. A blast in 2005 at the refinery killed 15 people and injured 170 others. OSHA has issued 270 safety notifications in regards to problems at the BP refinery, noting that there were 439 instances of “willful and egregious” safety violations at the facility.

A recall has been issued for the LIFEPAK 15 defibrillator by Physio-Control, Inc. after it was determined that the defibrillators could turn off and on by themselves, potentially resulting in injury or death. 

The FDA issued a Lifepak 15 defibrillator recall alert this week, indicating that the action is a class 1 recall, meaning that there is a reasonable chance that the devices could cause serious injury or death. Class 1 recalls are the most serious type of medical device recall.

Physio-Control, Inc., a division of Medtronic, sent a letter to customers in March informing them that they should keep using the devices, but should test them according to operating instructions. The company also told customers that it was sending local representatives for service visits within 60 days. The company referred to the action as a “voluntary correction.” The FDA classified it as a Class 1 recall.

Physio-Control’s announcement says that the problem involves an internal component in the defibrillators, which could inadvertently contact the power printed circuit board assembly. This can cause the device to turn off and on by itself, or turn itself on and not respond to being turned back off. There have been no reported injuries associated with the defective LIFEPAK defibrillators.

The defibrillator recall affects certain LIFEPAK 15 Monitor/Defibrillators by Physio-Control Inc. that were manufactured between March 26, 2009 and December 15, 2009. The recall is limited to a specific set of serial numbers. Customers can perform a search for their device’s serial number on the company’s defibrillator recall announcement.

The company believes it has contacted all customers who purchased the affected devices and is scheduling service visits to repair the problem. Customers who experience the power problems should contact the company’s technical support at 1-800-442-1142.

The FDA requests that any health care professionals or consumers who experience problems with this device report the incident to FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/medwatch.

The results of a new study suggest that individuals who make regular use of tanning beds are more likely to be suffering from substance abuse, raising questions as to whether tanning itself is actually addictive. 

The research, conducted by Catherine Mosher and Sharon Danoff-Burg of the Memorial Sloan-Kettering Cancer Center and the State University of New York, was published in the latest issue of the Archives of Dermatology. The researchers found that people who admitted to other forms of substance abuse were more likely to have made frequent use of tanning beds in the previous year than those who did not show signs of substance abuse.

The scientists interviewed a total of 421 college students from September through December of 2006. They found that, out of 229 students who used indoor tanning facilities, 90 of them met criteria for signs of addiction to indoor tanning. Those same students also were more frequent drinkers of alcohol, marijuana users and were more likely to suffer symptoms of anxiety.

The study’s results were released less than a month after an FDA advisory panel recommended that the government either ban the use of tanning beds for everyone under the age of 18, or require parental consent. The recommendations were aimed at protecting children from the heightened risk of skin cancer from tanning beds.

FDA began to review the use of tanning beds, particularly among young people, after the World Health Organization (WHO) reclassified tanning beds as known carcinogens last year. WHO came to that conclusion after it conducted a study on tanning bed skin cancer risks. WHO’s report determined that the use of tanning beds before the age of 30 increases the risk of skin cancer by 75%.

Some studies have shown that the use of tanning beds by young adults results in eight times the risk of developing melanoma, a deadly form of skin cancer once found mainly in the elderly, but which has increasingly become a problem for younger adults. The American Cancer Society says that melanoma, the most dangerous form of skin cancer, is diagnosed in about 69,000 Americans each year and causes about 8,650 deaths annually. Less dangerous, but more common, basal and squamous cell carcinomas affect more than one million Americans each year and cause about 2,000 deaths annually.

If the process of getting a tan from an indoor tanning bed is itself addictive, it may make it harder to devise effective interventions to reduce skin cancer risk, researchers warned. However, the study does not draw a direct link between tanning and addiction, it only notes that frequent tanning bed users often show signs of an addiction and are more likely to be addicted to other substances.

Officials from the Indoor Tanning Association, which represents the U.S.’s $5 billion indoor tanning industry, was skeptical about the results, saying that there was no definitive proof that tanning was addictive, and that the word addiction was being used to stir up media attention.

Concerns over tanning bed cancer has resulted in bipartisan legislation aimed at lowering tanning bed cancer risks. The Tanning Bed Cancer Control Act, was introduced in late January by U.S. Representatives Carolyn Maloney (D-New York) and Charlie Dent (R-Pennsylvania). The bill would allow federal regulators to set controls on the amount of ultraviolet radiation emitted by tanning beds as well as set limits on the amount of time users can use the devices.

A coalition of groups representing various medical fields has come up with new ethical guidelines that aim to severely limit the influence of industry on medical policy. 

The new code for interactions with companies was released on April 21 by the Council of Medical Specialty Societies (CMSS), which represents 32 major medical professional societies and represents 650,000 physicians across the U.S. Overall, the new codes seek to prevent and disclose conflicts of interest and financial ties, promote more independent program development and promote the rise of medical leadership without industry ties.

The new guidelines include a rule to prevent industry from underwriting the development of medical guidelines, and restrictions on allowing industry to promote and give free gifts at medical conferences. The new code also calls for a ban on consulting deals from top medical society leaders and medical journal editors.

“Physicians and patients count on medical societies to be authoritative, independent voices in science and medicine,” said one of the code’s authors, Dr. Allen Lichter, CEO of the American Society of Clinical Oncology. “By adopting this code, societies demonstrate their commitment to the highest level of ethical standards in their activities and to providing the best possible care for patients and populations.”

The new guidelines come in the wake of a sustained media interest in reports that industry-paid doctors and consultants have frequently ghostwritten articles in medical journals, and researchers have repeatedly failed to disclose ties to companies that could be considered a conflict of interest regarding papers they’ve published.

In March, an editorial in the Journal of the American Medical Association (JAMA) blasted GlaxoSmithKline’s research over the side effects of the diabetes drug Avandia, which some say are responsible for tens of thousands of heart attacks and deaths. The authors called for new, stringent, medical and scientific journal reforms that would ensure integrity and minimize the ability of corporations to obfuscate scientific data.

The editorial was written in response to findings by a Mayo Clinic investigation that found an alarming number scientists and medical experts, who supported Avandia after it was linked to an increased risk of heart attacks, had undeclared financial ties to GlaxoSmithKline. The Mayo Clinic study found that 87% of scientists who downplayed Avandia side effects had links to the drug maker, and about a quarter of them failed to declare the potential conflict of interest.

Adhering to the code is voluntary for medical societies, and not required to stay a part of the CMSS. However, those who do sign are expected to either adhere to the new ethics code or put in place policies that are even more stringent. In addition, medical associations outside of the CMSS organizations are invited to sign on as well.

According to new research, patients may face a higher risk of death from colon surgery if their operation is performed at a teaching hospital. 

The results of the new study are published in this month’s issue of the Archives of Surgery medical journal, and indicate that those who have colon surgery in a teaching hospital are hospitalized longer and face a slightly increased mortality rate. Teaching hospitals were often found to have performed the colon surgery procedures less often.

In the study, U.S. researchers from Johns Hopkins in Baltimore and the University of Michigan in Ann Arbor, looked at more than 115,000 patients in 1,045 hospitals who had colon surgery from 2001 through 2005. They found that the mortality rate for colon surgery patients was 3.9% at teaching hospitals, compared to 3.7% at non-teaching hospitals. In addition, those who had the surgeries performed at teaching hospitals tended to remain hospitalized a half a day longer, on average, when the operations were done at teaching hospitals. The average length of stay, overall, was about 10 days.

Researchers say that, though small, the difference is important. They concluded that how the hospitals handle benign disease among the patients seems to be a “tipping point” that non-teaching hospitals seem to handle slightly better. Researchers said that the findings emphasize that diagnosis of a patient’s conditions before surgery should be considered as important as the procedure itself, particularly when determining where that surgery should be performed.

Researchers say that reputation often trumps the quality of care when it comes to hospital rankings. 

A newly released study published in the Annals of Internal Medicine takes a critical look at the annual U.S. News & World Report’s “Best Hospitals” rankings, which lists the top 50 hospitals in the nation in various fields. Researchers examined data used to compile the rankings and found that the hospitals holding the top slots were there based more on reputation than merit.

Dr. Ashwini R. Sehgal, a professor of medicine at Case Western Reserve in Cleveland, Ohio, found that while the rankings were based in part on objective data, such as death rates, nurse-to-patient ratio and patient safety, it was the reputation scores given by other doctors that were the predominant decider as to which hospitals ranked highest. Dr. Sehgal said reputation trumped factual objective data in 100% of the publication’s top hospital picks for each specialty, and 91% of the time for the top 10 overall hospitals.

Dr. Sehgal explained that the large amount of variation in the reputation scores, which are determined by interviewing top doctors in certain fields, means that the reputation scores have more of an affect on the final outcomes, because the objective data has far less variation.

“The relative standings of the top 50 hospitals largely reflect the subjective reputations of those hospitals,” Dr. Sehgal concluded. “Moreover, little relationship exists between subjective reputation and objective measures of hospital quality among the top 50 hospitals.”

Officials from U.S. News and World Report have said that the rankings have caught flack for giving reputation so much influence, and intend to scale down its effect on future rankings, according to a report by Bloomberg News. However, they say that reputation is an important overall piece of the hospital rankings that will not be removed entirely. The next annual hospital rankings results are due to be released in July. The news magazine has released the rankings for 20 years.

An Illinois mother has reached a $9.5 million medical malpractice settlement with a hospital, doctor and midwife she alleged were responsible for her son’s cerebral palsy birth injury. 

Helen O’Came filed the cerebral palsy lawsuit against Sherman Hospital in Elgin, Dr. Jae Eun Han and Mary Traub, accusing the defendants of negligence during the birth of her son, Patrick, and of not having a doctor available during the delivery when one was needed. Patrick O’Came, now 14, suffers from cerebral palsy as a result of a brain injury suffered during birth when he was deprived of oxygen over the last 15 minutes of delivery.

The birth injury malpractice suit alleges that Traub, a nurse midwife, was allowed to perform the birth alone, but was required to have a sponsoring physician available in case of complications during delivery. However, the physician sponsoring Traub, Dr. Han, was in Korea visiting family, and had arranged for another physician to take his place.

O’Came began experiencing complications during labor and there was a drop in fetal heart rate. Instead of getting a physician, the lawsuit alleged that Traub decided to perform a risky procedure instead of halting the labor and getting help. Patrick’s umbilical cord was compressed, and he was deprived of a significant amount of oxygen.

As a result of the birth injury, Patrick developed cerebral palsy, which is a permanent disability that will require care for the rest of his life. The hospital has agreed to pay $7.5 million, and Traub and Dr. Han will pay $1 million each as part of the cerebral palsy settlement.

Cerebral palsy can be caused by an injury to an infant’s brain before, during or shortly after birth. If the brain of a baby is deprived of oxygen, it can result in irreversible damage that leaves the child with developmental problems, loss of motor functions and other life-long injuries and disabilities associated with cerebral palsy. The condition is also commonly associated with seizures, sensory impairments and cognitive limitation.

Medical malpractice lawsuits for cerebral palsy are often filed when a medical mistake or series of mistakes occur during prenatal care or delivery that result in the child’s brain being deprived of oxygen for an extended amount of time.

A federal judge has rejected a motion to have the several Mentor ObTape vaginal sling lawsuits dismissed, clearing the way for a consolidated trial of three “bellwether” cases to begin on June 1. 

The Mentor ObTape trial was originally scheduled to begin in February, but the start was delayed while the court considered, and ultimately agreed to, the plaintiffs’ request that three of the lawsuits be tried at the same time.

All of the cases involves similar allegations that problems with the Mentor ObTape sling, which is used to treat female stress urinary incontinence, resulted in complications such as vaginal extrusions, urinary tract erosion, severe pain and infection. Some women have required multiple surgeries to remove the sling and have been left with permanent and debilitating injuries.

Mentor Corp. distributed approximately 16,271 ObTape slings between 2003 and 2006, when it was removed from the market. Also known as a bladder hammock, the sling is used to provide support for the vaginal wall, reinforcing the muscles that control the flow of urine. According to the complaints, a defective design of the Mentor ObTape can block oxygen and nutrients, increasing the risk that women may suffer severe and debilitating injuries following bladder surgery.

In December 2008, the U.S. Judicial Panel on Multidistrict Litigation centralized the federal Mentor ObTape litigation in the Middle District of Georgia, before U.S. District Judge Clay D. Land. The lawsuits were made part of a multidistrict litigation (MDL) for pretrial proceedings, and three cases originally filed in Georgia were selected for early trial to gauge how juries are likely to respond to evidence that will be presented throughout the litigation.

According to court documents filed by Mentor in January, seeking to have the initial cases dismissed, approximately 348 lawsuits over the ObTape vaginal sling have been filed by women who have experienced problems.

In a scheduling order issued April 13, Judge Land indicated that Mentor Corp.’s motion for summary judgment will be denied and the three cases will be consolidated for trial beginning on June 1.

A Georgia jury has awarded $1.5 million in compensation for pain and suffering in a medical malpractice suit over an amputated thumb, which is believed to be the first jury award to exceed a recently overturned cap on non-economic damages in the state.

The case was filed by Johnnie Jackson, 47, against a Georgia hospital and several nurses after an alleged medical mistake involving an intravenous needle in his wrist, which was inserted incorrectly and allowed medications to infiltrate the surrounding tissue. The lawsuit alleged that a nurse who checked the IV hours later found that the site was painful and swollen, and removed the needle. However, nine hours allegedly passed before Jackson’s doctor checked on Jackson and found that the drugs had leaked into the rest of his hand, which ultimately resulted in several operations to save his hand. However, they were unable to save his thumb.

Only four days after a $350,000 cap on Georgia malpractice suit damages was struck down by the state supreme court, a Coffee County jury awarded Jackson $53,026 in medical expenses and $1.5 million for pain and suffering. If the cap had still been in place at the time of the award, Jackson’s recovery would have been limited to just over $400,000.

The Georgia medical malpractice damage cap was put in place by the state legislature in 2005. However, the Georgia Supreme Court unanimously struck down the cap last month as being unconstitutional when it was challenged by a plaintiff who sued a plastic surgery office for disfiguring her face.

California was the first state to enact a damage cap in 1975, specifically limiting the non-economic damages in medical malpractice lawsuit. As of 2005, ten states had capped recoveries specifically on medical malpractice cases and another 22 had imposed caps on all injury suits, according to the National Conference of State Legislatures.

The FDA has launched a new web site aimed at making the processes and decision-making rationales for the development of regulations concerning radiation-emitting medical devices more transparent. 

The Center for Devices and Radiological Health (CDRH) Transparency web site is part of a continuing initiative by the agency to increase transparency and public accessibility, but it also comes at a time when the health risks of radiological procedures are under the microscope due to concerns over cancer and over-exposure to radiation.

CT scan procedures across the country are under close scrutiny by the FDA after the discovery that a number of patients have suffered radiation overexposure from CT Scans performed incorrectly. The FDA is currently reviewing CT scan procedures nationwide, and released interim guidance for health care professionals and radiologists in December. The guidance advised them to review procedures and CT scan settings, and to be thorough in checking the amount of dosage prescribed for each CT scan patient.

The recent FDA investigation was sparked by the discovery of CT scan radiation over-exposure problems that may have affected more than 200 patients at Cedars-Sinai Medical Center in Los Angeles last year. Since then, the FDA has uncovered at least 50 more radiation CT errors.

The new web site will give the public access to premarket submissions for new or improved radiation-emitting medical devices, postmarket performance and safety documents, FDA compliance and enforcement actions, science and research program data, performance metrics and educational resources. In addition, the site will allow visitors to perform a Total Product Life Cycle search, which will pull premarket and postmarket data on a particular medical device from multiple sources and compile them into a single “snapshot.”

CDRH Director Jeffrey Shuren, M.D. said that the web site will give the public a window into the FDA’s regulation of radiation-emitting medical devices. “It provides a closer and clearer look at what we do and why we do it,” Shuren said.

The new site follows an initiative announced earlier this year by the National Institute of Health (NIH), which plans to track radiation exposure in patients’ medical records. Their record-keeping will also not focus on radiation errors, but instead will watch the accumulation of radiation exposure from  a variety of treatments.

Charles Schwab could face close to $1 billion in damages and settlements stemming from securities fraud lawsuits over their Schwab YieldPlus bond fund. 

In an earnings release issued by Charles Schwab Corp. last week, the company announced that it faces at least 194 individual stockbroker arbitration claims for up to $34 million, in addition to a YieldPlus Bond Fund class action lawsuit that looks to recoup $890 million for investors. In addition, other claims may still be filed against the brokerage firm over investment losses allegedly caused by their handling of the bond fund.

The Schwab YieldPlus funds are ultra-short bond funds that were heavily promoted as conservative investment alternatives to money market funds or cash. Despite being advertised to generate income with minimal changes in share price, the fund lost more than 30% of its value between June 2007 and June 2008 due to heavy investments in risky subprime mortgage securities, which some experts indicate violated the prospectus.

The funds lost much of their value when the sub-prime mortgage market crashed in late 2007, leaving investors with substantial losses. The investor claims allege that Schwab misled investors and failed to properly disclose the nature of the risks associated with certain securities held by the bond funds.

In October, Schwab announced that it had received a “Wells notice” from the U.S. Securities and Exchange Commission (SEC) indicating that they plan to recommend that the company be brought up on civil charges. No charges have yet been filed.

Earlier this month, a summary judgment from a federal judge in California determined that the company erred in failing to get investors’ approval before shifting half of the fund’s assets into mortgage-backed bonds. The ruling clears the way for the pending class action lawsuits for three classes of plaintiffs to proceed.

Two classes of plaintiffs are scheduled to go to trial on May 10.

A Texas woman has filed a class action suit over Levaquin, claiming that the popular antibiotic increases the risk of tendon ruptures and other tendon injuries. 

The Levaquin class action lawsuit was filed on April 8 in the Beaumont Division of the Eastern District of Texas by plaintiff Lisa Presley. The complaint names Johnson and Johnson and its subsidiary Ortho-McNeil Pharmaceuticals as defendants, alleging that the Levaquin side effects led to Presley suffering from Achilles tendonitis, which she says led to severe and permanent injuries.

Presley charges the defendants with negligence, strict product liability, failure to warn, breach of warranties, fraud, and violation of consumer protection laws, among others. The Levaquin suit is seeking damages for economic losses, disability, disfigurement, pain, suffering, mental anguish, physical impairment and medical expenses on behalf of Presley and seeks class action status on behalf of other similary situated individuals.

Levaquin (levofloxacin) is part of a class of medications known as fluoroquinolones, which was approved by the FDA in December 1996. It is prescribed to prevent infection by stopping the reproduction of bacteria. However, it has also been found to be toxic to the tendons, leading to an increased risk of tendon damage, including debilitating ruptures of the Achilles tendon.

In July 2008, the FDA required that a “black box” tendon damage warning be added about the side effects of Levaquin and other similar antibiotics. However, consumer advocates called for stronger warnings about the Levaquin tendon rupture problems at least two years earlier, with Public Citizen filing a petition with the FDA in 2006 insisting that consumers and the medical community be provided with clearer warnings about the risk of tendon damage from the class of antibiotics.

There are several hundred individual Levaquin tendon rupture lawsuits already filed in federal courts throughout the country, which have been consolidated and centralized in the U.S. District Court for the District of Minnesota as part of a multidistrict litigation (MDL). There are also more than 100 other cases pending in various state courts throughout the country. All of the lawsuits involve allegations that the drug makers failed to adequately warn about the increased risk of tendon ruptures and other tendon injuries that can occur from the side effects of Levaquin.

In February, U.S. District Judge John Tunheim identified the first six Levaquin suits to go to trial in the federal MDL. The cases will act as “bellwether” trials, helping parties involved in the litigation gauge how juries will respond to evidence and testimony.