November 30, 2010

Senate Passes Bill To Help Prevent Food Borne Illnesses

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.

November 30, 2010

Suing State Government In Georgia: Exceptions to Sovereign Immunity

There is a State Tort Claims Act found at O.C.G.A. § 50-21-20, et. seq. The Act resulted from an amendment to the Georgia Constitution and became law in April of 1992. It was intended to provide a remedy for torts committed by State officers and employees and establishes a procedure to waive sovereign immunity under certain circumstances to allow suits against the State for tortious acts of state agents, employees and/or officers. Individual State officers and/or employees may not be named as a party to a lawsuit. Under the State Tort Claims Act, the exclusive remedy for a tort committed by a State employee is an action against the state agency involved and not against the employee personally.

It must be noted that if someone has a claim against a state agency or employee they must file an ante-litem notice with the State. The law is very specific in this regard. Notice must be given in writing by certified mail, return receipt requested or a personal delivery letter to the Risk Management Division of the Department of Administrative Services. Additionally, a copy shall be delivered personally to or mailed by First Class Mail to the State government entity involved in the tort. The Notice also must include certain information in order to be valid. It must state the extent of the claimant’s knowledge and belief as to the basis for liability, the time and place of the transaction or the occurrence out of which the loss arose, the nature of the loss suffered and the amount of loss claimed. Once an ante-litem notice is properly filed with all this information, a claimant cannot file suit against the State of Georgia until either the Department of Administrative Services has denied the claim or more than ninety (90) days has elapsed after presentation of the claim, whichever occurs first.
There are twelve (12) areas of State activity specifically excluded from the State’s waiver of its sovereign immunity which include as follows: Losses resulting from any exercise or performance of a discretionary function; acts or omissions in the execution of statutes, regulations or rules; assessment of tax or detention by law enforcement officers; legislative judicial or prosecutorial actions; civil disturbance or riots; assault, battery, false imprisonment, false arrest, malicious prosecution, abusive process, liable, slander or interference with contractual rights; inspection powers or functions; licensing powers or functions; highway and other public work designs when prepared in substantial compliance with generally accepted engineering standards.

As is clear from this list of items excluded from the waiver of the State’s sovereign immunity, all cases are factually specific and must be discussed with counsel. It is also clear that the ante-litem notice provisions must be strictly observed otherwise the claim could be forfeited for failure to properly notify the State in advance of filing a claim. In addition, the waiver of sovereign immunity if it is found to exist in a particular case is limited to $1 million per person with the State’s aggregate liability per occurrence not to exceed $3 million regardless of the number of those injured or killed. An example of this is the case against the Georgia DOT involving a bus of baseball players. Even though there were over 30 claims, the total waiver was capped at $1 million for any one player and $3 million for all the claims.

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November 29, 2010

Nursing Homes Hide Behind Confusing Ownership

Our Atlanta based attorneys frequently pursue cases against nursing homes involving horrible neglect and abuse of elderly and disabled persons.

In most of these cases our attorneys must sort through a maze of companies and entities designed to hide the true ownership of these offending entities and thereby avoid responsibility.

It is encouraging to see that several national lawmakers in the health policy world now want want nursing homes to be more open about who's running them.

Sens. Max Baucus (D-Mont.), Chuck Grassley (R-Iowa) and Rep. Pete Stark (D-Calif.) recently issued a joint statement saying that tangled layers of ownership information, complicated by buy-ups from private investment firms, make it almost impossible for consumers or government regulators to determine who's operating many facilities and who should be responsible if problems arise.

"Nursing home residents and their families deserve to know the full story about who is ultimately responsible for their care,” Baucus, chairman of the Finance Committee, said in a statement. “Federal health care officials need full and detailed information so they can properly oversee these nursing homes and hold the correct parties accountable for keeping patients safe and well-cared for."

The concerns are in response to a new report from the Government Accountability Office (GAO), which found that private investment firms have snatched up more than 1,800 nursing homes since 1998, but current reporting requirements make it difficult to track those ownership changes. The GAO found that ten large firms accounted for 89 percent of the purchases.

Under current rules, nursing homes wishing to participate in Medicare and Medicaid must disclose ownership information to the Centers for Medicare and Medicaid Services (CMS). The agency keeps a database that's supposed to track that data. But the GAO found the database was deficient in clarifying the complex ownership structures and chain affiliations.

Senator Grassley said the findings provide "further evidence of what we already knew: That the federal government needs to do a better job giving nursing home residents — including Medicare beneficiaries — complete, accurate and timely information so they can make the right choices when choosing a nursing home."

The new health reform law addresses the ownership issue head on, requiring skilled nursing facilities (under Medicare) and nursing facilities (under Medicaid) — at the request of state and federal regulators — to provide full and clear ownership information.

November 28, 2010

Children's Benadryl Recalled

Johnson & Johnson, the maker of health care products, has recalled about four million packages of cherry and grape flavored Children’s Benadryl allergy tablets and about 800,000 bottles of junior-strength Motrin caplets.

According to the company, the recall was necessary because of "insufficiencies in the development of the manufacturing process.,The recalls are taking place at wholesale and retail locations.

The company issued a press release advising consumers that they can continue to use the products because the action “is not being taken on the basis of adverse events” or safety issues.

Johnson & Johnson’s McNeil unit withdrew more than 40 types of children’s over-the-counter liquid medicines in April, forcing a suspension of production at a manufacturing plant and reducing 2010 sales by about $600 million.

The United States House of Representatives Oversight and Government Reform Committee has been investigating the company’s handling of the recall and a separate incident involving Motrin tablets.

The products being recalled are Children’s Benadryl allergy Fastmelt tablets, in cherry and grape flavors, and junior-strength Motrin caplets, 24 count, according to the McNeil Web site.

November 28, 2010

Data Mining Concerns On Health Related Web Sites

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.

November 28, 2010

Toy Safety Report Released

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.

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November 28, 2010

Consumers May Get Product Safety Information Under New Proposal

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.

November 21, 2010

Medical Errors Kill 15,000 Medicare Patients Each Month, According to Inspector General

A disturbing Inspector General report from the shows that medical errors are harming and killing our senior citizens at alarming rates.

An estimated 15,000 Medicare patients die each month, and many more are injured, because of usually preventable medical mistakes in hospitals and other facilities.

The report focused on “adverse events,” defined as "harm to a patient as a result of medical care, such as infection associated with use of a catheter," and “never events,” which are specific "serious events, such as surgery on the wrong patient, that the National Quality Forum (NQF) deemed 'should never occur in a health care setting.'”

The Inspector General of the Department of Health and Human Services found:

--An estimated 13.5 percent of hospitalized Medicare beneficiaries experienced adverse events during their hospital stays.

--An additional 13.5 percent of Medicare beneficiaries experienced events during their hospital stays that resulted in temporary harm.

--Physician reviewers determined that 44 percent of adverse and temporary harm events were clearly or likely preventable.

--Hospital care associated with adverse and temporary harm events cost Medicare an estimated $324 million in October 2008.

Significantly, the 2009 loss to taxpayers was "$4.4 billion spent on care associated with events"--which did not even include the cost of followup care.

The cost in lives, health, and taxpayer dollars of preventable medical errors is far too high. Respect for life of our senior citizens requires accountability when harm occurs, and preventive steps to ensure patient safety.

A portion of the Inpsector General's report is reprinted below:

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November 17, 2010

Airplane Crash Wrongful Death Case Is Allowed to Proceed by West Virginia Supreme Court of Appeals

Yesterday afternoon our Canadian clients whose mother was killed in a plane crash near the Virginia-West Virginia border received good news. Their wrongful death case arising from this airplane crash was allowed to proceed by the West Virginia Supreme Court of Appeals.

As the Supreme Court summarized the background:

The appellant’s claims arise from a crash of the Mooney M20C Ranger on
March 16, 2008, in the State of Virginia, 20 miles from the border of West Virginia. Piloting the airplane was Roy Sanwalka, who possessed a Canadian private pilot’s license. This license did not include an instrument rating. The sole passenger in the airplane at the time of the crash was Margaret O’Brien, Roy Sanwalka’s girlfriend. Both Roy Sanwalka and O’Brien were killed when the airplane crashed in or near the Jefferson National Forest in Atkins, Virginia.

The events leading up to the crash were as follows: On March 14, 2008, Roy Sanwalka and O’Brien left Canada en route to the Bahamas. The airplane stopped in Buffalo, New York. The next day, Roy Sanwalka and O’Brien took off from Buffalo International Airport. While in the air, Roy Sanwalka encountered adverse weather and made an unplanned stop at Yeager Airport, in Kanawha County, West Virginia. Roy Sanwalka and O’Brien stayed overnight in Charleston and returned to Yeager Airport on March 16, 2008. While at the airport, Roy Sanwalka refueled the airplane, and despite not being certified with an instrument rating, filed an Instrument Flight Rules (IFR) plan documenting his intention to travel to Florida on his way to the Bahamas.

The pair took off from Yeager Airport. Eighteen minutes into the trip, while still over West Virginia, Roy Sanwalka contacted air traffic controllers requesting permission to drop to a lower altitude because of airframe icing on his airplane. Eleven minutes after that radio conversation, Roy Sanwalka contacted the air traffic controllers stating his airplane was going down. Shortly after that conversation the airplane in which Roy Sanwalka and O’Brien were traveling crashed in Atkins, Virginia, killing both occupants instantly.

With co-counsel Scott Segal and Mark Staun of The Segal Law Firm in Charleston, West Virginia, our firm filed a lawsuit for personal injuries and wrongful death against the pilot and his employer, the owner of the plane. Frank Tierney of the Terney Stauffer firm in Ottawa is also counsel representing our clients.

The Supreme Court agreed today that the case could proceed in Charleston, West Virginia, where the pilot's negligent acts took place that ultimately caused the plane to crash just over the Virginia border.

We are very pleased for our clients that they will have their day in court.

November 15, 2010

Suing The Government: Exceptions to Sovereign Immunity

Today we received a telephone call from a client who had been injured on some school property. The client was vaguely aware of the doctrine of sovereign immunity and unfortunately for this particular person their claim was completely barred by operation of law. Why: because of the doctrine of Sovereign Immunity?

The law has long been that lawsuits against government official performing their discretionary and official job functions are discouraged. If it were not otherwise there would be litigation every time someone disagreed with what a government official did or how they performed their job, particularly if they claim to have been damaged by unskillful performance. Over the years more and more barriers have arisen with respect to tort claims against governmental entities. The obvious policy reason behind this doctrine is to protect government officials from being sued when performing their official functions on behalf of the public at large. It’s application can sometimes be harsh, but public policy cannot allow government officials to be sued for allegedly unwise decisions. That would surely open the proverbial floodgates as almost everyone at times questions the wisdom of public officials.

In future blogs we are going to talk briefly about how one can sue their government when they are injured by the negligent acts of a government agent or employee. As an example, if the United States Government is involved, one must be familiar with the Federal Tort Claims Act. If the State of Georgia is involved, one must be familiar with the State Tort Claims Act. If a county or municipality is involved, one must be familiar with the legions of cases that spell out the distinction between protected discretionary acts for which there is official immunity and the difference between cases involving a breach of ministerial duties for which there may be the possibility of a viable claim.

In our future blogs we will talk about exceptions to sovereign immunity and how it is still possible in certain limited contexts to obtain compensation for injuries caused by government officials. While sovereign immunity is still a bar to many otherwise valid claims based on public policy in this area, nonetheless, there are ways to obtain compensation for injuries and damages incurred by innocent victims of governmental negligence. The controlling legal issue for lawyers who seek to serve clients with such claims is to find a legal exception to the doctrine of sovereign immunity, to know when exceptions apply and to know how to survive a Motion to Dismiss based on a legal defense of sovereign immunity. As indicated, we will address this topic in future entries.