Georgia Injury Law Blog

Published on: January 30, 2009

FDA Reviewing Drug Labeling Charges

Product and pharmaceutical liability lawyers have been seriously worried about the impending outcome of Wyeth vs. Levine and the preemption doctrine.

In December, this blog discussed the case of Wyeth and Levine and federal/state preemption issues. We await the United States Supreme Court’s decision on this issue. Meanwhile, the FDA is having to answer to these problems.

The New York Times is reporting that the U.S Food and Drug Administration may be launching criminal investigations into complaints made by several scientists against agency officials. The complaints go back to November of 2008 when the House Energy and Commerce Committee received a letter from scientists at the FDAs Center for Devices and Radiological Health division. The letter made serious allegations that management at the CDRH had been interfering with the process of approving medical devices. The scientists complained that they were being "forced" into rushing ahead to approve devices, bypassing standard procedures. The letter galvanized the ECC committee to launch an enquiry. Now, nine scientists who had made that complaint have written a letter to President Obama alleging that FDA officials may launch criminal investigations into those complaints. The letter states that it is "an outrage that our agency would step up the retaliation to such a level because we have reported their wrongdoing to the United States Congress."

Published on: January 28, 2009

Seatbelt Laws, Accident Rates, and a $4 Million Grant for Georgia

by Robert N. Katz, Esq.

Georgia’s ongoing budget crisis may actually be a blessing in disguise for the state’s motorists – the state has an incentive for passing seatbelt laws that come in the welcome form of a $4 million federal grant, which would not only add to the state’s depleted coffers, but also reduce the number of accident-related fatalities in the state.

The state is the last one in the country that continues to allow pick up truck drivers to drive without seatbelts.All minors and adults are required to buckle up on other vehicles, however. This pick up truck exemption has come in the way of a fund of $4 million which the federal government has tied to a state’s enactment of seatbelt laws.Georgia however has stubbornly refused to make it mandatory for pick up drivers to snap on their seat belts, and has lost out on the funding, thus far.

Now however, the situation is markedly different, and cries for mandatory seat belt laws that can help save thousands of lives a year, are getting louder. One of the weapons in the armor of proponents of making seat belts mandatory on all vehicles without exception, is of course the $4 million grant that the state would receive if it passed these laws.The state currently faces a budget deficit that is set to exceed $2 billion, and with the economy in the shape it’s in, there’s no telling how deep the deficit could go.

Published on: January 27, 2009

Georgia Supreme Court Hearings in Medical Malpractice Case Soon to Begin

by Robert N. Katz, Esq.

Medical malpractice lawyers in Georgia will be looking with interest at the outcome of a civil case that’s due to begin hearings this week.The judgment in the case that involves four doctors who were cleared of negligence by a jury, has lasting repercussions for medical malpractice lawsuits in the state.

In 2003, 13-year-old Justin Smith was sickened with a rare tick-borne condition called Rocky Mountain spotted fever.The disease is spread by tick bites, and as symptoms worsen, can quickly lead to flat, pink rashes, severe abdominal pain, diarrhea and joint pain. It can be a potentially life threatening illness. Justin was first taken to pediatric doctors, and then transferred to Children’s Healthcare of Atlanta at Egleston, where he finally recovered from his illness. By then however, he had already suffered some amount of brain damage.His parents, in their medical malpractice lawsuit against the four doctors, alleged that the doctors had been negligent in falling to diagnose the illness.The doctors claimed that the condition itself is so rare that it’s difficult to diagnose. In 2006, the four doctors were cleared of any wrongdoing by the jury.

Now, the Georgia Supreme Court will consider whether instructions given by the judge to the jurors regarding hindsight could have been inaccurate or confusing.Plaintiff’s attorneys claim that the hindsight instruction should only be given in case of a claim of negligence where the defendants had no knowledge of certain information.Here, the doctors were aware of the tick bite.The defendant’s attorney argue that Justin’s rashes, which are a symptom of the fever, only became evident when the child was taken to the Egleston facility, and therefore, the doctors were not aware of the symptomatic rashes.

Published on: January 24, 2009

Worst Toys of 2008 – Will 2009 Be Any Better?

by Robert N. Katz, Esq.

The year 2000 was the year of several dangerous toy recalls, many of which were the focus of product liability lawsuits around the country.This list of the 10 most dangerous toys of 2008 includes toys that pose hazards of choking and aspiration, lead contaminated toys as well as those that are prone to fire and burn hazards.

It isn’t clear if the list is in any particular order of danger or number of injuries caused, but it kicks off with Air Hogs RC Helicopters that came with the danger of exploding lithium-powered batteries.Many of the toy related scares of 2008 – and there were plenty of them – were linked to children being able to remove the detachable magnets from toys, and swallow these. Several dozen children were rushed to emergency rooms with perforated intestines, after swallowing magnets that later began to stick to each other through intestinal walls. Most of these injuries required surgery.The toys that came with magnets attached included earrings that contained a small magnet inside, and these make it to the list too. Other noteworthy defective playthings include backpacks containing off-the-chart levels of lead contamination, balloon sets, Dora the Explorer Lamps (which are actually electrical items and not really play things, but try explaining that to kids who see their favorite Dora on the lamp, and want to play with her), and high decibel High School Musical Rockerz.

Also on the list are children’s toys containing phthalates, a chemical compound that is often mixed with plastic to make it softer. These have been found connected to reproductive problems in male children, including a drop in testosterone levels, as well as genital abnormalities.Linking phthalates to these disorders has been the easy part – the challenge lies in finding out what products contain these chemicals, present as they are in a variety of consumer products, from air fresheners to teething rings.Phthalates are never mentioned in the list of ingredients, which means that most of us who use these cosmetics, perfumes, cleaners, and toys risk being exposed to them every day.Expect to hear more reports of injuries and illnesses associated with phthalates use in toys in 2009.

Published on: January 23, 2009

Atlanta Residents Continue to be in Danger of Escalator Accidents

by Robert N. Katz, Esq.

Even after new safety standards were introduced and added to building codes in the country, children in Atlanta continue to be in danger of escalator injuries caused when their shoes or clothing get snagged in the gaps at the sides of the escalator.

A report last month highlights some of the most dangerous areas in Atlanta that have escalators concealing a high risk for accidents and injuries to children.These include Hartsfield-Jackson International Airport, and the Metropolitan Atlanta Rapid Transit Authority (“MARTA”), as well as numerous malls where a number of these injuries occur every week. It’s not just children who have been at risk for injuries caused by escalators.Teenagers and adults have had their shoes and clothing snagged in the gaps.People have been dragged down when the edges of their coats were caught in these gaps, ending in a dislocation of the shoulder, and in other cases, have lost their balance and fallen over. Toes and feet have been badly mangled when their shoes have been caught in these gaps.

Many of these accidents have involved children’s shoes, especially Crocs. The problem has been severe enough for the Consumer Product Safety Commission to even warn about these, and confirm that these shoes had been worn by an overwhelming majority of people involved in escalator accidents.The shoes now come with a safety tag warning for such injuries.

Published on: January 22, 2009

FDA Continues to Sleep Over Food Safety

by Robert N. Katz, Esq.

Seattlepi.com has an interesting story about how well we can expect our federal agencies to ensure that the food that makes it to our tables is safe to eat. The focus of the story is but naturally, the salmonella food poisoning crisis that has engulfed the country with 6 deaths connected to the epidemic so far.

The biggest source of concern to American consumers in this latest crisis, the report says is the manner in which the Food and Drug Administration dragged its feet for more than three months before confirming an outbreak. The latest crisis that has involved the agency’s food safety protocol has had consumer safety advocates, food poisoning lawyers as well as the public, wondering how the FDA which found out weeks ago that the Georgia plant of Peanut Corporation of America was the source of the particular strain of Salmonella found in the contaminated peanut butter, could have waited so long before they even confirmed the source. The FDA continued to mouth the same line – that the peanut butter in question was only sold to restaurants, nursing homes and food companies, but they still have not released a list of all Peanut Corporation of America clients who may have received the contaminated butter. The FDA’s outdated practices mean that manufacturers are rarely forced to recall their products. The agency prefers to rely on voluntary recalls by companies, and in many cases, these are too late to prevent severe illnesses.

More companies meanwhile are queuing up to announce recalls of their products that contain peanut butter. General Mills has recalled 2 varieties of snack bars because butter used in the snacks came from the Peanut Corporation of America. Other companies including Perry’s Ice cream Company, Food Lion Cookie, Hy-Vee Inc, have all removed their products containing peanut butter from store shelves as a precautionary measure because of the fear that these could contain traces of the contaminated butter.

Published on: January 16, 2009

Eli Lilly Agrees To $1.42 Billion Fine to Settle Zyprexa Litigation

by Robert N. Katz, Esq.

Eli Lilly & Co. has agreed to a settlement with federal regulators that will include a fine of $615 million to settle criminal lawsuits, and a further $800 million to resolve civil litigation related to injuries caused by its anti psychotic drug Zyprexa.That makes the total fine amount to close to $1.5 billion, said to be the largest criminal fine for an American company. The company will plead guilty to one misdemeanor charge, and will not plead guilty to wrongdoing in any civil case.

The punishment is for the company’s indulgence of off-label use of its Zyprexa medication. Off-label use is the promotion of a drug by a company for purposes other than that for which it has been approved.It’s not prohibited for doctors to prescribe drugs for purposes other than that for which it was specified, but pharmaceutical companies are expressly forbidden from promoting such off label use of the drug.

Zyprexa is an anti psychotic drug that is meant for use by patients who suffer from schizophrenia or bipolar mania, but that didn’t stop Eli Lily from promoting the product as a sleep medication for elderly dementia patients. Between 1999 and 2003, thousands of Eli Lilly representatives were urged to promote use of Zyprexa for use in dementia patients.Documents produced in court have shown that the company greedily pushed Zyprexa to treat a variety of disorders that it was never approved for, including aggression, dementia and dementia related to Alzheimer’s Disease.The company began promoting the medication in assisted living facilities and long term care nursing homes. Effects of the medication like weight gain were already becoming evident, but Eli Lilly’s representatives pooh poohed these, saying these were part of the benefits of taking the medication.Representatives were urged to market the drug for symptomatic treatment, even in cases where the drug had not been approved. Incidences of patients dying from heart attacks and infections after using the drug began to surface, and finally in 2006, the FDA ordered the company to have strong warning labels that cautioned patients of the drug’s risk for elderly patients. Since then, the company has paid out $1.2 billion in settlement of at least 32,000 injury claims that were brought against it.This new settlement is in addition to the previous one.

Published on: January 15, 2009

SATETY GROUP CALLS FOR NATIONWIDE CELL PHONE BAN WHILE DRIVING

by Robert N. Katz, Esq.

The National Safety Council is calling for a ban on all kinds of cell phone usage behind the wheel to prevent traffic accidents, but Georgia’s state authorities still don’t seem to have received the message that driving and cell phone use just don’t go well together.

Cell phone use while driving is rampant and clear to see on Atlanta’s streets, where only school bus drivers are banned from using cell phone devices while driving.Now, the National Safety Council has called for a nationwide ban on all cell phone usage behind the wheel, including hand held and hands free devices, to prevent the growing number of accidents that can be traced to drivers distracted using their cell phones.Currently, no state completely bans cell phone usage while driving, but California, New Jersey, New York, Washington, Connecticut and Utah enforce a ban on hand held cell phone usage. National Safety Council president Janet Froetscher isn’t impressed with such measures – she says that the issue isn’t whether your hands are free to drive, but that your head is engaged in the conversation you’re having on the cell pone. That is what causes accidents, and not the actual act of holding the phone.

Georgia lags behind most states in the kind of cell phone driving legislation it has in place.Representative Matt Ramsey (R-Peachtree City) is currently working on plans for legislation that will ban cell phone use for drivers under the age of 18.According to Rep Ramsey, the under-18 age group is the most vulnerable because they are still learning the ropes of correct behavior behind the wheel, and also because distractions are a major cause for accidents involving teens. Violators would receive a first time fine of $175 and a $500 fine for additional offenses.

Published on: January 14, 2009

GOVERNOR MULLS TORT REFORM AGAIN

by Robert N. Katz, Esq.

Governor Sonny Purdue is at it again – he has proposed legislation aimed at reducing the number of "frivolous" lawsuits," including measures that are clearly aimed at making it harder for plaintiffs to initiate civil litigation against companies.Purdue’s proposals, which he unveiled at a breakfast meeting of the Georgia Chamber of Commerce, will mean that plaintiffs have to pay the legal fees of the defendant, in case the lawsuit is dismissed at the earliest stages.Even more disturbing, the legislation will virtually grant immunity to biotechnology companies who have a "significant presence" in the state.That’s political speak for giving big name pharmaceutical companies carte blanche, without the drag of accountability to the consumer. Under the proposed laws, a citizen of Georgia cannot sue a company for a defective or dangerous medical device or drug that has received approval of the FDA.

Purdue’s proposals, not surprisingly were cheered by the 2500 members of the Chamber at the meeting.The initiatives, the Governor believes, will make the state "even more attractive" to biotechnology companies.The last time Georgia attempted to introduce tort reform in medical malpractice, the resulting storm was intense.That move resulted in senate Bill 3, which severely limits the amount of compensation thata patient who has been injured due to the fault of doctors, or hospitals to $350,000 even in the event of death of the patient due to negligence.Many of the provisions of the Georgia Tort Reform Act of 2005 have been removed as violations of a citizen’s constitutional rights.That doesn’t seem to have deterred Purdue, who this time around, intends to protect the pharmaceutical industry. Needless to say, the Georgia Trial Lawyers Association has already voiced strong opposition to any such new legislation.

As we’ve seen last week in Minnesota, where a judge has thrown out dozens of lawsuits relating to the Medtronic defibrillator leads, device or drug approval from the FDA cannot and shouldn’t be allowed to come in the way of a person’s right to sue if these approved devices result in injuries.The Sprint Fidelis leads were approved by the FDA, and yet, have caused several deaths and heart injuries, because of fractures or broken wires that caused the defibrillator to malfunction.Now, dozens of injured patients or families of those who died have had their lawsuits dismissed, and their hopes for justice becoming bleaker because of the pre emption doctrine.

Published on: January 13, 2009

GEORGIA AFFECTED BY PEANUT BUTTER SALMONELLA FOOD POISONING OUTBREAK

by Robert N. Katz, Esq.

According to the Department of Public Health, five cases of the salmonella food poisoning that have been reported across the country have been found in Georgia.A few days ago, the Centers for Disease Prevention and Control announced an outbreak of salmonella poisoning in 42 states.The outbreak apparently occurred between October to December, and has sickened close to 400 people.One elderly woman who died during the period had been infected at the time of her death, but it hasn’t been confirmed if she died because of the poisoning.

Now, fresh reports confirm that a brand of peanut butter has been traced as the source of the contamination. Batches of King Nut and Parnell’s Pride peanut butter that were distributed by King Nut Cos, and supplied to schools, nursing homes and restaurants, have been recalled.The batches were only sold to institutions, and were not available directly to the public.The company apparently only distributed the product which is manufactured by Peanut Corporation of America.The link was traced when tests conducted by the Minnesota Department of Agriculture and Health on the peanut butter batches revealed a match with the strain of salmonella Typhirium type that has been responsible for the outbreak.

Symptoms of salmonella poisoning include abdominal cramps, fever and diarrhea. In cases of serious infection, hospitalization may be required. The symptoms are particularly acute in the case of children, elderly or those who have weakened immune systems.In serious cases, the infection may spread to other parts of the body, and death can result.