Georgia Injury Lawyer Blog

Elderly nursing home patients have been routinely receiving costly antipsychotic drugs which increase their risk of death and are not approved for their treatment.

According to a report from the Health and Human Services Department’s inspector general, 88 percent of the antipsychotic drugs administered in nursing homes were prescribed for uses that the Food and Drug Administration hasn’t approved.

Nearly one in seven elderly nursing home residents, nearly all of them with dementia, are given powerful atypical antipsychotic drugs even though the medicines increase the risks of death and are not approved for such treatments, the government audit found.

More than half of the antipsychotics paid for by the federal Medicare program in the first half of 2007 were “erroneous,” the study found, costing the program $116 million for those six months.

Sens. Chuck Grassley (R-Iowa) and Herb Kohl (D-Wis.) want Medicare to explain why it wrongly paid millions of dollars in claims for drugs that were given to seniors for these unapproved uses.

Medicare provides coverage for some unapproved uses, but the senators suggested that the report’s findings might indicate a flawed decision-making system.

The Medicare agency said in its response to the inspector general’s report that it should have denied more than half the claims it paid for the use of antipsychotics in nursing homes.

The inspector general of the Department of Health and Human Services went so far as to state that “government, taxpayers, nursing home residents as well as their families and caregivers should be outraged and seek solutions.”

According to the audit, some of the drugs such as Risperdal, Zyprexa, Seroquel, Abilify and Geodon are potentially lethal to many of the patients getting them and that some drug manufacturers illegally marketed their medicines for these uses.

In response to the audit, the Centers for Medicare and Medicaid Services said that some of the inappropriate use of antipsychotics in elderly nursing home patients is a result of drug makers’ paying kickbacks to nursing homes to increase prescriptions for the medicines.

Omnicare Inc., a pharmacy chain for nursing homes, paid $98 million in November 2009 to settle accusations that it received kickbacks from Johnson & Johnson and other drug makers for antipsychotic prescriptions.

The government auditors found that of the 2.1 million elderly patients in nursing homes during the first six months of 2007, 304,983 had at least one Medicare claim for an antipsychotic medicine. Nursing home residents received 20 percent of the 8.5 million claims for antipsychotic medicines for all Medicare beneficiaries at a cost of $309 million during those six months.

Federal rules require that any drugs that are paid for by the government be given only for uses that are approved either by the government or one of three independent drug usage encyclopedias. Auditors found that 51 percent, or 726,000 of 1.4 million claims, for antipsychotic medicines did not meet this criterion and were thus paid for by the government improperly.

In a novel, yet sensible approach designed to reduce medical errors, increase the quality of care, and reduce costs, the Obama administration issued a final regulation to reward hospitals that provide high-quality care. This step is the first in a series of planned steps that are designed to fundamentally transform the way that the federal government pays for healthcare.

Under the initiative, one of several authorized in the new healthcare law the president signed last year, Medicare will pay more to institutions that score well on a series of measures that gauge patient care and pay less to those that don't meet quality benchmarks.

Though commonplaces in many industries, setting quality benchmarks and tying them to compensation will be new for many of the nation's hospitals. It is a strategy that Medicare has never used before on a systematic basis.

But many experts and consumer advocates said Friday that they saw these kinds of quality initiatives as crucial not only to improving medical care but also to controlling costs.

Hospitals that fall short of the new benchmarks could lose as much as 1% of what Medicare would pay them in 2013.

That's a relatively smallt penalty for an industry that receives more than $150 billion a year from Medicare, but the stakes could become significant as more quality initiatives are implemented.

Medicare provides insurance to nearly 50 million elderly and disabled Americans, paying for 12.4 million hospitalizations in 2009, according to the Centers for Medicare and Medicaid Services.

One recent study published in the journal Health Affairs estimated that 1 in 3 hospital patients experienced an "adverse event" such as being given the wrong medication, acquiring an infection or receiving the wrong surgical procedure.

The Obama administration sees improving quality as the best strategy for saving cash-strapped public healthcare programs like Medicare and Medicaid rather than requiring beneficiaries to pay more for their care.

In the first year, hospitals will be graded on 12 process measures, which track things like how quickly heart attack victims are given anti-clotting medicines and how quickly surgical patients receive antibiotics after surgery to cut down on infections

In 2014, the Obama administration plans to expand the report card to include outcome measures, including mortality rates for patients after they leave the hospital and the prevalence of hospital-acquired conditions such as infections and bedsores.

Institutions with high rates of hospital-acquired conditions, as well as those with high readmission rates, stand to be penalized a second time because of another quality initiative still under development.

Some hospital officials have criticized the imposition of two penalties for hospital-acquired conditions. The American Hospital Association raised concerns about relying too heavily on surveys of patient opinion, which they said could penalize hospitals that care for sicker patients.

Children can and do unbuckle seatbelts in car seats exposing themselves to extreme dangers.

A new study finds that children often unbuckle the seatbelts on their own, putting themselves at risk in a car accident.

A team of researchers at the department of pediatrics at Yale School of Medicine, surveyed 378 parents and found that just over half reported that at least one of their children had managed to unbuckle a seatbelt in a car seat at some point.

Of the children who unbuckled their seatbelts, 75 percent were aged 3 or younger; some were as old as 78 months, or over six years. Some unbuckled their seatbelts as young as 12 months. Boys were more likely to do so than girls (59 percent vs. 42 percent).

More than 40 percent of the children who unbuckled their seatbelts did so while the car was moving, increasing the risk of serious injury by 3.5-fold. The most common response that parents reported was pulling the car over, reprimanding the child and rebuckling the car seat.

Car accidents are the leading cause of death in kids aged 4-8. All parents should be aware of this potentially deadly situation.

Women under 50 who follow the advice of a U.S. panel to forgo annual mammograms may be at risk for more severe forms of breast cancer

Three recent studies led by radiologists suggest that failing to get regular breast screenings left women more likely to discover cancer at an advanced stage. The delay resulted in larger tumors and a worse prognosis once the cancer was uncovered, the data found.

The U.S. Preventative Services Task Force said in 2009 that most women ages 40 to 49 do not need mammograms, recommending the screening for those with a disease history or who had a greater risk due to another factor.

The American Cancer Society disputed the advice, and insurers still cover annual screenings.

However, a study in Colorado suggests 62 percent of doctors changed their advice to match the U.S. guideline and 16 percent fewer women got the test.

The three studies were presented at separate medical meetings held recently by the American Society of Breast Surgeons in Washington D.C., and the American Roentgen Ray Society in Chicago.

Breast cancer killed an estimated 40,000 women last year and is the second leading cause of death among women, exceeded only by lung cancer. The American Cancer Society estimated that about 207,090 new cases of invasive breast cancer were diagnosed in 2010.

In issuing its recommendations, the federal task force said women in their 40s are more likely to get false-positive tests that lead to unnecessary biopsies and anxiety than to discover cancer through a mammogram.

The guideline was challenged by the cancer society, which urged doctors to advise women of that age to continue routine annual screenings.

The independent task force under the U.S. Agency for Healthcare Research and Quality, was first formed in the 1980s to give advice on screening, counseling and preventive medicines based on an assessment of scientific

Academic and practicing doctors and nurses make up the group. They have published guidelines on more than 100 topics and are reviewing 30 more, involving cervical cancer tests, dementia and glaucoma screening and the use of electrocardiographs for detection of coronary heart disease.

One of the studies analyzed breast cancer cases in women younger than 50 from 1998 to 2008. The study showed that 94 percent of the women ages 40 to 49 diagnosed through a mammogram were considered disease free after five years compared with 78 percent of those who didn’t receive the screening exams.

Another study studied biopsy results from Jan. 1, 2008, to Dec. 31, 2009. Seventy-one of 108 diagnosed breast cancer cases were detected by a mammogram and 37 resulted from discovery of a lump or other symptom. Twenty-two cases were non-invasive cancer in the tested group compared with one among those who were not.

None of the cancers in the mammogram group had progressed to latest stage form of the disease compared with 17 among those who weren’t screened.
More than half of the women who had a mammogram showed no evidence of cancer in their lymph nodes compared with 39 percent in the group that hadn’t been screened, The study also showed the size of the tumors to be on average smaller among the women whose cancer was discovered in a mammogram.

Each year, according to the most recent Centers for Disease Control and Prevention estimates, 48 million people, that is one in six Americans, are sickened by food-borne illnesses. Of those, 180,000 are hospitalized and 3,000 die.

The first major overhaul of the nation's food-safety infrastructure since 1938 was signed into law yesterday by President Obama.

The Food Safety Modernization Act moves the Food and Drug Administration (FDA) away from its early-20th-century role of responding to adulterated food to a more modern one of requiring companies to stop contamination before it happens by looking for the places where things can go wrong and fixing them.

It also allows the FDA to issue mandatory recalls and hire more food-safety inspectors.

The FDA oversees most of the nation's food supply, except for meat, poultry and processed eggs, which are the purview of the Department of Agriculture.

Much of the food industry had supported the new rules, saying they would raise the bar for the entire food industry in the words of a statement signed by 20 organizations, including the Grocery Manufacturers Association and the National Restaurant Association.

But, Georgia Congressman Jack Kingston, the incoming Republican chairman of the agriculture subcommittee of the Appropriations Committee has said he may not allow funding of the new system, thereby scuttling the entire program.

Republicans will control the House of Representatives when Congress reconvenes today.

Rep. Rosa DeLAuro, who most recently chaired the committee, called the new law "a significant step forward in modernizing our country's antiquated food-safety systems."

DeLauro, who first proposed food-safety legislation in 1999, noted the food system still makes people sick. At the same time as Kingston is questioning the money for the FDA's enhanced food-safety oversight, the FDA announced "that a salmonella outbreak involving alfalfa sprouts had sickened nearly 100 people in at least 15 states," she said.

Food safety isn't a partisan issue, said Carol Tucker-Foreman, with the Consumer Federation of America.

Today, the United States approved the biggest overhaul to the nation's food safety laws since the 1930s. By a bipartisan vote of 73-to-25 the new law would gives new authorities to the Food and Drug Administration, places new responsibilities on farmers and food companies to prevent contamination, and for the first time, sets safety standards for imported foods.

The Senate vote was one of the few pieces of legislation to receive bipartisan approval in years. The House of Representatives approved a more stringent version of the bill more than a year ago.

The legislation comes after a number of national outbreaks of food poisoning involving products such as eggs, peanuts and spinach in which thousands of people were sickened and more than a dozen died.

Leaders in the House of representatives have indicated that they would accept the Senate version of the bill. This would avoid the time consuming conference process and send the legislation to the President quickly.

Despite the strong bipartisan support among lawmakers and a coalition of major business and consumer groups, the legislation still drew sharp opposition.

Some tea party activists attacked the legislation as governmental overreaching. On his television program this month, talk show host Glenn Beck suggested that the measure was a government ruse to raise the price of meat and convert more consumers to vegetarianism.

The bill has also revealed a divide between local-food movements and major agriculture businesses. Small farmers concerned about the cost of new federal regulation initially opposed the bill and argued that since most cases of national illness are caused by large companies, small producers should be exempted from the standards.

In an effort to assuage these concerns, Sen Jon Tester, a Montana farmer, added an amendment that would exempt small farmers and those who sell directly to consumers at farmers markets and farm stands.

It is estimated that food borne illnesses affect one in four Americans and kill 5,000 each year. In addition, tainted food products have cost the food industry billions of dollars in recalls, lost sales and legal expenses.

The bill places greater responsibility on manufacturers and farmers to prevent contamination, which is a departure from the current system, which relies on government inspectors to catch contamination after the fact.

The measure also gives the FDA authority to recall food. As the law now stands, the FDA must rely on food companies to voluntarily pull products off the shelves.

Millions of consumer may be unwittingly revealing health information which is shared with drug companies.

QualityHealth is a popular health website with more than 20 million registered users. It offers online medical information and e-mail newsletters on a variety of topics, including diabetes, asthma, and other diseases.

But according to a complaint filed last week with the Federal Trade Commission, visitors who provide personal details about themselves might not be aware that QualityHealth collects information about people’s medical conditions, preferred medicines and treatment plans and uses it to profile its users for prescription drug marketing.

QualityHealth is one of a number of companies cited in the complaint to the F.T.C. filed by four nonprofit privacy and consumer advocacy groups. The complaint alleges that online marketing of medications, products and medical services posed fundamental new risks to consumer privacy and health because of sophisticated data collection and patient-profiling techniques.

Asserting that such techniques are unfair and deceptive, the groups asked the F.T.C. to investigate the health marketing used by popular sites including Google HealthCentral, Everyday Health, and WebMD.

According to U.S. PIRG, one of the groups joining in the complaint, the danger is not limited to data mining and marketing that could influence patients to seek drugs they do not need or to spend more money on branded drugs rather than generics. But, more concerning is the potential for employers or health insurers to gain access to the individuals’ data profiles, leading to potential problems or penalties against the consumer.

According to the complaint, a notice at the bottom of QualityHealth’s registration form provides a link to the site’s privacy policy. The policy explains that information that may or may not identify someone may be used for ads aimed at consumers.
But according to the complaint, QualityHealth advertises to business clients how the site uses tailored messages, informed by patient profiling, to prompt members to seek prescriptions for specific brands from their doctors.

The groups stated that they decided to file their complaint with the F.T.C, because it oversees consumer privacy issues and because, the groups believed that the F.D.A., which has long overseen traditional marketing of drugs in print, radio and television, lacked the staff and the expertise to oversee online and social media drug marketing. An F.D.A. spokeswoman said the agency planned to review the complaint.

The U.S. Public Interest Research Group, a private consumer advocacy group, recently released its 25th annual study of toy safety. It reported that only a small fraction of children's toys tested for toxic substances and choking risks have been found to violate federal safety regulations.

The group’s public health advocate commented that while the study did not find perfection in toy safety, it did indicate progress.

PIRG credited a 2008 law that set stronger limits and standards for children's products for helping to make many of the products on store shelves safer for youngsters. The law was passed in the wake of a wave of recalls of lead tainted toys.

PIRG had 260 toys and other children's products from major retailers and dollar stores tested for toxic substances such as lead and antimony as well as for the risk of choking presented by small parts. Only four of the items tested violated federal safety regulations for children's toys.

In its annual "Trouble in Toyland" report on hazardous playthings, the organization focused on three hazards: lead or other metal-tainted toys, soft plastic toys that contain chemicals called phthalates, and toys with small parts that can choke young children.

Higher than permissible levels of lead or antimony were found in four toys. These are a stuffed animal, a baby book, plastic toy handcuffs and a toy gun. The toys were sold at stores including Toys "R'' Us and Family Dollar.

Lead can cause irreversible brain damage, and antimony has been linked to fertility problems in animals.

While none of the products tested violated federal limits for small parts, PIRG said several toys were still hazardous for children under 3 because the size was not that much bigger than allowed by law.

The toys identified in the group's report as potential dangers were:

—A stuffed animal monkey made by Play Pets that contained lead just slightly above the limit.

—The red handle of a baby book sold at Toys "R'' Us that contained antimony that was about twice the limit.

—The surface coating of toy plastic handcuffs sold at Toys "R'' Us that had excess antimony, many times higher than allowed.

—The surface coating of a wild ranger toy gun sold at Family Dollar with slightly higher levels of antimony than allowed.

The executive summary of the report is reproduced below.

Continue reading "Toy Safety Report Released" »

For decades, the Consumer Product Safety Commission, a government agency, has gathered complaints about potentially dangerous products, from cribs to Chinese-made drywall. However, most of this information is not available to the public because of a federal law that requires a manufacturer’s approval before it can be released.

On Wednesday, the commission is scheduled to vote to create a new, publicly accessible database of safety complaints that is intended to make it easier for consumers to learn about problems with a product.

But, what seems like a common sense proposal is the subject of partisan politics among the five members of the commission.

The CPSC’s two Republican commissioners are attempting to modify the database in ways they say would be more fair to manufacturers. But, at least one Democratic commissioner and consumer advocacy allege that the modifications will significantly weaken the database.

Last week, the Republicans blocked a final vote on the database and proposed an alternative that would restrict who could register a complaint, among other things.
One of the commission’s three Democratic members, said opponents are trying to shield manufacturers from greater public scrutiny.

With Democrats outnumbering Republicans 3 to 2 on the commission, the proposal is expected to pass.

As proposed, the database would go live in March. It would allow the public access to safety complaints about various products. It would also give manufacturers the ability to post replies and, have a complaint removed if they can prove it is inaccurate.
Parents, for instance, could scroll through the database before purchasing strollers, cribs or toys to see if others have reported problems with them.

The database was authorized by Congress as part of a 2008 law intended to give the Consumer Product Safety Commission more oversight abilities.

The National Highway Traffic Safety Administration has a similar database, called SaferCar.gov where consumers can file and review safety complaints about automobiles.

Under the commission’s proposal, the public could use the database to quickly report and find complaints about unsafe products. The agency’s current rules make it difficult to obtain such information without a manufacturer’s consent and typically require filing a Freedom of Information Act request, a process that can take months, even years.

http://www.serious-injury-litigation.com/lawyer-attorney-1259787.htmlGeorgia injury lawyers know that dangerous products can cause serious injury or death to innocent consumers. For example, the U.S. Consumer Product Safety Commission announced the voluntary recall of Gold Star and Comfort-Aire portable dehumidifiers due to a fire hazard. The Commission said the recall involved 98,000 dehumidifiers exported from China by LG Electronics Tianjin Appliance Co. Of China. According to the Commission, the dehumidifiers have power connectors that can short circuit, posing a fire risk. The company has received four reports of fires involving dehumidifiers including Gold Star model # GHD30Y7, which were sold at Home Depot outlets, model # DH305Y7, sold at Walmart stores, and Comfort-Aire model # BHD-301-C dehumidifiers, sold at Heat Controller.

Defective and dangerous products coming into the United States from China are increasing at an alarming rate. In 2008, 80% of all product recalls in the U.S. involved imported products from China. Other dangerous recalled products include dog food, toys with lead paint, drywall and even pharmaceuticals.

Continue reading "Defective Dehumidifiers Recalled " »

Mandatory arbitration clauses are contained in almost every consumer transaction agreement, and financial and employment contracts. We have previously written about the fact that these mandatory arbitration clauses benefit only big business. As a result of the unfair nature of these clauses, there has been a movement within the United States to prohibit their inclusion in many consumer, financial, and employment contracts.

The increasingly conservative United States Supreme Court has recently been upholding a wide range of mandatory arbitration clauses. Just recently, the Supreme Court agreed to decide during the next term whether a class-action ban in a cell phone arbitration agreement is unconscionable. This is one of the most controversial issues in arbitration.

The Supreme Court has agreed to hear a steady stream of arbitration cases during the past decade or so. The decisions have generally been pro-arbitration., even though lower courts appear to be increasingly skeptical of claims that arbitrations offer greater efficiency and lessen costs of court litigation.

The most important case pending before the Supreme Court is AT&T v. Concepcion, which is the cell phone class-action ban case.

Also pending before the Supreme Court is the case of Rent A Center v. Jackson. In that case, Jackson, the plaintiff sued his employer for race discrimination and retaliation. The trial court granted the employer's motion to dismiss and to compel arbitration according to a clause in Jackson's employment contract.

Jackson appealed, arguing that the arbitration agreement was unconscionable and that the issue of unconscionability must be decided by a court, not an arbitrator. The United States Court of Appeals for the Ninth Circuit agreed that the threshold issue of unconscionability is for a court to decide.

While these cases are pending , Congress has begun to address the arbitration problem. Currently pending is a bill, the Arbitration Fairness Act of 2009, which would ban pre-dispute arbitration agreements in employment, consumer and franchise contracts. This legislation has been introduced by Rep. Hank Johnson of Georgia and Sen. Russell Feingold of Wisconsin. The legislation has garnered substantial support, but other issues such as health care reform and financial reform have placed it on a back burner.

This is very important legislation as the Supreme Court seems intent on upholding these patently unfair and unconscionable clauses.

Medical errors kill and maim thousands of citizens every year. Now, under the new health care reform legislation, something is finally being done to protect innocent potential victims of medical errors.

The new healthcare legislation, which was so vehemently opposed by many as being the destruction of healthcare, puts hospitals on notice that they must improve the safety and quality of care for patients or risk large fines.

The health care reform statute contains dozens of provisions designed to protect patients. These include including fining hospitals in an effort to reduce medical errors, hospital-borne infections and costly preventable readmissions. It is estimated that these three problems alone cost billions of dollars annually.

When considered individually the costs and extent of these problems is staggering.
Preventable readmissions cost the health care system about $25 billion every year, according to accounting firm PricewaterhouseCoopers.

In an effort to alleviate this problem, beginning in 2012, the Department of Health and Human Services will publish each hospital's readmission track record. A “readmission” is defined as a patient returning within 30 days of discharge. High readmission rates tend to indicate hospitals are ignoring patient issues or engaging in premature discharges.

In an effort to stem this issue, beginning in 2012, Medicare will stop paying hospitals for preventable readmissions tied to certain health conditions such as heart failure or pneumonia. In 2014, the policy will be expanded even farther.

The second penalty for hospitals addresses hospital-acquired conditions stemming from medical errors or infections.

The government currently gives hospitals an incentive payment for reporting their performance in areas such as patient satisfaction and care tied to treatment of conditions such as heart failure, pneumonia and hospital-borne infections.

Under the new statute, beginning in 2012, hospitals will be reimbursed according to their score. Higher scoring hospitals will receive higher payment and vice versa.
In 2015, the government will start reporting each hospital's record for medical errors and infections relating to Medicare patients.

About 15 million injuries result every year in the United States due to inferior medical treatment. These include more than than 30,000 people who die annually from catheter-related blood stream infections.

In 2015, Medicare will reduce its payments by 1% to hospitals with the highest rate of medical errors and infections. The government will also no longer pay hospitals for treatment when a Medicaid patient is harmed during a hospital stay.

It is anticipated that these financial incentives and penalties will greatly reduce injuries to patients and save millions of dollars at the same time.

From a consumer, patient and taxpayer perspective, these new common sense provisions are a big win.

An outbreak of 19 E-coli related illnesses in Michigan, Ohio and New York may be linked to shredded romaine lettuce sold to grocery stores for use in salad bars and delis, according to the Food and Drug Administration (FDA). Yesterday, the FDA announced a recall of the potentially dangerous produce.

Escherichia coli (abbreviated as E. coli) are a large and diverse group of bacteria. Although most strains of E. coli are harmless, others can be extremely harmful. Strains of E. coli can cause diarrhea, urinary tract infections, respiratory illness, pneumonia, and other illnesses.

The lettuce has been recalled by Freshway Foods, a closely held company based in Sidney, Ohio, according to the FDA press release. Twelve of the 19 people with confirmed cases of E. coli have been hospitalized, including three with potentially life-threatening complications.

The recalled lettuce was sold to wholesalers and food- service outlets in 23 states and Washington, D.C., the FDA said. The lettuce also was sold for use in salad bars and delis in supermarkets owned by Kroger, Ingles, Marsh Supermarkets Inc., and Giant Eagle Inc. The states involved are: Alabama, Connecticut, District of Columbia, Florida, Georgia, Illinois, Indiana, Kansas, Kentucky, Maryland, Massachusetts, Michigan, Missouri, New Jersey, New York, North Carolina, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Virginia, West Virginia, and Wisconsin.

The illnesses in the three states were linked to lettuce produced by one processing plant and a New York public health laboratory confirmed E. coli in an unopened bag of lettuce from the same facility, the FDA said in its release

We have recently written about the defective heart defibrillators sold by the Guidant Corporation and the dangers they present. Last week a federal judge in Minnesota rejected a plea agreement between the federal government and the Guidant Corporation, saying that the deal did not hold the company sufficiently accountable.

The plea agreement worked out between federal prosecutors and Guidant requires Guidant to plead guilty to two misdemeanors and pay a $296 million fine.

But, the judge held that the agreement was not in the best interest of justice and failed to adequately serve the public’s interest. He found that it did not adequately address the seriousness of the offenses.

The judge found that prosecutors should have sought probation for Guidant and its parent, Boston Scientific. Probation would have allowed the court to maintain control over Guidant to ensure that agreed upon remedial steps were implemented.
The judge also suggested other provisions that might be suitable in a new plea deal, including charitable activities by Guidant to improve heart device safety and improve medical care among minority patients.

After a hearing last month, several doctors and patients wrote to the judge urging him to reject the deal and arguing that former Guidant executives should be criminally charged in the case.

The case results from disclosures in 2005 that Guidant did not alert doctors and patients that some of its defibrillators had a defect that might cause them to fail. At least six patients died.

Recently, prosecutors charged in court papers that Guidant had knowingly sold potentially flawed defibrillators. But that issue was not addressed in the plea agreement. Instead, the company agreed to plead guilty to two misdemeanor charges that related to the completeness and accuracy of its filings with the FDA.

Dangerous cribs that can injure or kill infants have been recalled. The Consumer Product Safety Commission announced last week that approximately 217,000 Graco cribs have been recalled, due to a malfunction that can entrap, suffocate or strangle infants and toddlers.

The recall includes "drop side" wooden cribs made by LaJobi.

Faulty hardware can cause the drop side to detach from the crib, creating a gap in which infants and toddlers can become wedged or entrapped, posing a risk of suffocation and strangulation.

The CPSC and LaJobi received 99 complaints about the faulty drop side. Children were trapped in two cases and later freed by their caregivers. There were six reports of children falling out of the crib due to the malfunction.

While LaJobi, as the manufacturer, is primarily handling the recall, it marks the third major recall tied to the Graco name this year. Atlanta-based Graco Children's Products recalled 1.5 million strollers in January and 1.2 million high chairs in March.

The cribs were sold, starting in February 2007 at retailers throughout the country for $140 to $200. The crib recall includes Ashleigh Drop Side, Hapton Drop Side, Jason Convertible Drop Side, Kendal Drop Side, Lauren Drop Side, Sarah Drop Side, Shannon Drop Side, and Tifton Drop Side.

Consumers should immediately stop using the cribs and contact LaJobi's recall hotline at (888) 842-2215 to receive a free hardware retrofit kit, the company said.

Yesterday, the Associated Press reported that on Thursday of this week the government recalled thousands of baby cribs manufactured by Simplicity and Graco, after warning that babies could suffocate or strangle in them. Apparently the problem with both types of cribs relates to faulty or defective hardware. According to the article, the Consumer Product Safety Commission said the Simplicity crib recall was linked to at least one death and it involved thousands of cribs. The recall involving Simplicity products is for all full-sized cribs with tubular medal mattress or support frames. Allegedly, those frames can bend or detach, causing the mattress to collapse and creating a space where a child can become trapped and suffocate. The Graco branded wood cribs involve a side that moves up and down, which can break or detach, creating a dangerous gap where a child can become trapped and suffocate.

The Georgia injury lawyers at Finch McCranie, LLP have represented the families of numerous consumers whose loved ones have died as a result of defective products. If you or a loved one have been seriously injured as a result of purchasing and using a dangerous product, call us today for a free consultation. We have been handling product liability cases for over 45 years.

Defective medical devices have been a major source of injury and death for years. During previous administrations device makers have been basically unregulated due to lax enforcement by the Food and Drug Administration. This abdication of responsibility may soon end.

Federal regulators say they are moving to tighten their oversight of medical devices. Specifically included are infusion pumps, one of the most commonly used pieces of medical equipment. These pumps intravenously deliver drugs, food and other solutions to patients, and have been the subject of many failures for years.

Last Friday, the FDA issued preliminary guidelines that will require producers of infusion pumps to supply the agency with more test data on them before they can be approved for sale.

The FDA reports that over the last five years it has received reports of 710 patient deaths linked to problems with infusion pumps. FDA officials say they think the number may be significantly higher. Some of the reported deaths involved patients who suffered drug overdoses accidentally, either because a hospital worker entered incorrect dosage data into a pump or because the device’s software malfunctioned.

The FDA estimates that two million infusion pumps are used in hospital and clinical settings and hundreds of thousands more are used by patients in their homes.
The new initiative by the FDA is the result of the Obama administration trying to reestablish the role of the FDA after years of criticism by lawmakers and others that it was a rubber stamp for medical device industry.

A few years ago several top FDA scientists complained that their superiors had ignored both their recommendations and policy guidelines in approving the sale of infusion pumps. Along with reports of 710 deaths, the center also received more than 10,000 complaints annually about infusion pumps from 2005 to 2009.

A senior FDA official announced that new approach that the agency was taking toward infusion pumps might soon be extended to other types of medical devices.
The biggest makers of infusion pumps include Baxter Healthcare of Deerfield, Ill.; Hospira of Lake Forest, Ill.; and CareFusion of San Diego.

Under the infusion pump proposal, which could be completed by the end of the year, producers would be required to provide additional data to support the procedures they used to determine the effectiveness and safety of their devices. In addition, companies would have to conduct limited clinical trials to ensure their pumps were not susceptible to misuse or had design elements that could create errors.

The pump manufacturers say that most problems occur when a nurse or health care worker enters the wrong software data accidentally. FDA officials found that not to be the case. In the FDA review of pump complaints many more deaths and injuries related to the devices were the result of defective product design and engineering.

Under current FDA rules, life-sustaining devices like heart defibrillators must be subjected to clinical trials before they are approved for sale. But the FDA clears the sale of many other critical devices like pumps without clinical testing based on a manufacturer’s claim that a new device is similar to a product already on the market.

The Food and Drug Administration and Medtronic Inc have announced a recall of some of Medtronic’s Lifepak heart monitor and external defibrillators. The recall was caused by concerns that the devices can unexpectedly turn on and off.

The FDA said it considered the recall of Medtronic's Lifepak 15 emergency heart devices a Class I recall, the most serious possible. It said the defect is serious enough to cause harm or death.

Lifepak devices are used in emergency settings by hospitals, the military and others to help the heart beat normally and to monitor patients.

The recall affects Lifepak 15 devices made before Dec. 16, 2009. No patients have been harmed to date.

The defibrillators were manufactured with an internal component that could cause an electrical short that leads to the device turning off/on by itself or a power loss. A loss of power could delay or prevent delivery of defibrillation therapy.

A study of Medicare patients shows that doctors are increasingly performing costlier, more complex spinal fusion surgeries, sometimes unnecessarily, for stenosis, a common lower back condition caused by aging and arthritis.

Even more disturbing is that the findings suggest these more challenging operations are riskier, leading to more complications and even deaths.

According to surgeons, a simpler and less risky operation could cost $20,000 and the more complex one $80,000 without any good evidence the expensive one is being used appropriately in the majority of cases.

The cost to Medicare, just for the hospital charges for the three types of back surgery reviewed is about $1.65 billion a year, according to the researchers.

All the patients in the study had stenosis in their lower backs, a painful squeezing in the spine that's most common in people over 50. The researchers compared the risks for three different types of surgery for the condition: decompression, simple fusion and complex fusion.

There's little agreement about the best way to treat chronic lower back pain, and much depends on what's causing the pain.

Many times steroid injections and physical therapy provide relief, and a simple decompression procedure is as helpful as a spinal fusion and with less risk.
In a decompression procedure, the simplest method in the Medicare study, a surgeon cuts away part of the bone that's painfully pressing on nerves. It can cost about $30,000 in hospital and surgeon fees.

For a fusion, a surgeon binds two or more vertebrae together using a bone graft, with or without plates and screws. The researchers defined a complex fusion as one involving three or more vertebrae or more than one side of the spine. Fusions cost $60,000 to $90,000.

The researchers analyzed data on more than 32,000 Medicare patients who had one of the three types of surgeries in 2007.

About 5 in 100 patients who had simple or complex fusions suffered major complications such as stroke compared to 2 in 100 with decompressions. The risk of death within 30 days after surgery was different too: 6 in 1,000 for complex fusions compared with 5 in 1,000 for simple fusions and 3 in 1,000 for decompressions.
More than half the patients who had complex fusions had a simple stenosis, which usually calls for decompression alone. They did not have curvature of the spine or a slipped vertebra which might suggest a fusion is needed.

Rates of complex fusions in Medicare patients rose 15-fold from 2002 to 2007, while decompressions and simple fusions declined, the study found. Although the overall procedure rate fell, hospital charges grew 40 percent.

Aggressive marketing of devices used in complex fusions is likely playing a role in the increase according to researchers. The marketing includes ads in medical journals and lectures by surgeons on the payroll of device manufacturers.

Allegations of kickbacks to spine surgeons for using products and questionable financial arrangements to doctors as consultants have abounded in the industry. One company, Medtronic Inc., reached a $40 million settlement with the U.S. Justice Department in a whistleblower case that included allegations the company paid doctors to use its spine surgery products. The company denied any wrongdoing.

A provision in the new health care law requires device makers and others to file annual reports to the government on their financial ties to doctors. Patients will be able to look up possible conflicts in a government database.

General Motors Co. Is recalling 1.3 million Chevrolet and Pontiac compacts cars to repair or replace steering motors which can fail causing the vehicle to be difficult to steer at lower speeds. While this may not be an insurmountable problem for some drivers, the Georgia injury lawyers recognize that it may be a serious problem for older or elderly drivers who may surprised by the loss of the power steering and be physically unable to steer the vehicle. Under those circumstances a power steering failure could cause an automobile accident with devastating consequences.

According to an article published by the Associated Press today, General Motors told the National Highway Traffic Safety Administration about the recall on Monday. NHTSA began an investigation into 905,000 of the models on January 27th after getting 1,100 complaints that the cars lost their power steering. The complaints included 14 crashes and one injury.

If you or a loved one have been injured in an automobile accident involving a recalled vehicle, contact the Georgia injury lawyers at Finch McCranie, LLP .Our firm has been representing injured victims in products liability claims for over 45 years.