Tennessee Law Blog

FDA officials announced a nationwide recall of the heart drug Digitek (digoxin), last week. Nashville patients with heart problems were made safer by the recall of these generic heart drug tablets used to treat abnormal heart rhythms and heart failure.

Digitek is distributed by Mylan Pharmaceuticals, Inc. under the Bertek label.

On April 28, 2008, the corporation responsible for this dangerous heart drug, Actavis Totowa, LLC, announced along with FDA officials this nationwide Type I Drug Recall after tablets were found to have double the thickness in size. This increased heart pill size poses a significant health risk of poisoning the heart patient from Digitalis toxicity.

Poisoning by this recalled heart medicine causes various unpleasant reactions. Digitalis toxicity causes in heart patients taking the dangerous medicine:

• vomiting


• nausea


• dizziness


• low blood pressure


• cardiac instability

other dangerous and potentially fatal reactions.

The heart medication dangers were caused by irregular manufacturing practices (much like the imported and dangerous heparin drugs reported in this earlier Dangerous Drug Tennessee Law Blog). Digitek’s dangerous side effects pose the highest health dangers to heart patients with renal failure and low blood pressure.

Digitek is widely distributed through mail-order medication business and large retail pharmacies like those at Nashville-area Wal-Mart and Target. The Class I Drug Recall requires Digitek not be sold and requires heart drug patients return their remaining supplies of the dangerous drug tablet.

While only 11 persons have been reported as sick, many of the symptoms may have been hidden by doctors who attributed injuries to old age instead of the dangerous heart medication.

If you believe you or a loved one has suffered injury from this dangerous, recalled heart drug and believe you would like to pursue legal action against those responsible for this Digitek injury or death, call HHP at (615) 353-0930 or fill out our drug injury initial response form for a free consultation with myself or one of our other qualified, Nashville drug injury lawyers.

For years the medical and insurance lobby in Tennessee has been trying to place financial caps on medical malpractice cases. In attempting to sell this legislation the lobbyist argued that it would stop "frivolous" lawsuits. Our legislature, however, realised that a cap would do nothing to prevent frivolous cases. It would just give the medical community and insurance companies a privileged status in society to avoid responsibility for their actions. Large verdicts are not given for frivolous lawsuits. However, large verdicts only correspond with large damages and reckless conduct.

The Tennessee legislature now has passed legislation that will help prevent frivolous medical malpractice suits. At the same time it will not put artificial limits on valid medical malpractice suits. The bill requires attorneys to give all medical providers who may be named in a malpractice suit at least 60 days notice before filing a lawsuit, and to file a "certificate of good faith" that the claim has merit. The certificate is to be filed within 90 days after the lawsuit is filed. It is based on an evaluation by an independent medical expert. Judges could sanction plaintiffs and their attorneys who they feel have acted in bad faith.

As a lawyer that represents medical malpractice victims, I applaud this legislation. Any responsible lawyer will gladly comply with this new law.

Nursing homes in Tennessee are regulated by the Tennessee Department of Health (TDOH). TDOH takes an active role in investigating complaints made by nursing homes residents and the friends and families of residents. TDOH also performs annual surveys on nursing home facilities to ensure that proper care is being given to residents and to attempt to reduce the risk that residents will suffer from neglect or abusive behavior from staff members at the facility or from other residents within the facility. The surveys also deal with nursing home staffing levels, administration of the facility, nursing services, resident assessments and social services standards at the facility. The evaluation of these important elements is used to determine the overall level of care that the residents receive. By using these surveys and corrective measures following the surveys, including fines, limiting admissions, and even suspending admissions, the TDOH takes proactive steps to force nursing homes to provide the level of care that the residents need and deserve.

Recently, TDOH conducted a complaint investigation and Annual Survey at Palmyra, Tennessee based Palmyra Health Care Center. In response to the report issued following the review, TDOH suspended admissions at the facility and assessed fines against the facility. Specifically, the TDOH report found 18 deficiencies - four of which were deemed as immediate jeopardy to the residents. The immediate jeopardy issues stemmed from the facility's failure to develop and implement a plan to prevent residents from suffering abuse at the hands of other residents that suffer from mental health and psychosocial behavioral problems. Also, the report noted that there was no plan implemented to prevent such residents from harming themselves, staff or others at the facility. The suspension of admissions to the facility and the retroactive fines levied against the facility are significant measures taken on behalf of TDOH to address the problems at this facility.

If you have concerns about the treatment of a loved one in a nursing home facility feel free to call our office. If we can't help we can usually point you in the right direction.

Aluminum manufacturer Aleris International Inc. announced that it will close its alloy facility in Shelbyville, Tenn. Unfortunately, this is just another plant closing in Tennessee.

It is important to note that some of the workers who lost their jobs and have a previous workman's compensation claim may be able to re-open their case. These folks need all the help they can get and this is one area where the work comp law may give some relief.

If you have recently lost your job and had a prior worker's compensation claim in Tennessee feel free to call my office to see if your case get be reopened for more compensation.

This week the Tennessee nursing home industry pushed legislation to give them limited liability for the neglect of residents. It is amazing that the industry has the guts to ask for a special law created just to limit their liability when there has been record fines and citations of inadequate care this year. In fact, just this week the Tennessee Department of Health suspended new admissions of patients to Country Place Health Care Center in Crossville. The Centers for Medicare and Medicaid Services has also put in place temporary management at the facility

It seems that Tennessee Nursing Homes could limit their exposure to lawsuits by making sure homes like Country Place provide quality care. Doesn't this make more sense than trying to have a law passed that protects you from a lawsuit. I have never handled a nursing home negligence case that I believe could not have been avoided if the home had provided adequately trained and a sufficient number of staff. Maybe nursing homes could avoid more lawsuits if they spent more time caring for their patients and less time trying to obtain special protections from the legislature.

After the past few years the state of Tennessee and my office has seen more age discrimination cases. There is some debate as to why. The most commonly given reason I hear for the rise in job related age discrimination is that the work force is simply getting older. Whatever the reason for the rise in claims it is very unfortunate that it is occurring.

Under the law employers may not discriminate against employees in hiring, firing, or other terms and conditions of employment if they are 40 years of age or older. This law applies to all employers with 20 or more employees. Tennessee has some laws that applies to employers with less than 20 employees.

If you feel that you are being treated differently solely on the basis of you age it is important that you take every step necessary to protect yourself. It is not an easy task to prove age discrimination so it is advisable that you contact an attorney, the EEOC or both if you are uncertain as to what you should do.

There are many considerations in determining the value of a workman's compensation claim. One of the most crucial factors is whether the "cap" applies. The is a limit in Tennessee on an award if the employer goes back to work for the same employer. Basically, if an employee returns to work for the same employer, making the same or greater hourly wage as before the injury, then their permanent disability is limited to no more than 1.5 times your medical impairment rating. This was placed as an incentive to have an employer return the employee to work.

It is important to note, however, that there are many situations where a workers compensation case can be reopened if the employee later losses his job. This is know as a right to reconsideration under the TN comp act. There are time limits to the right. The the right to file for reconsideration of the award must be done within 200 or 400 weeks of the return to work, depending on the type of injury. For instance a back injury there is a 400 week time limit but a leg injury is only 200 weeks.

If you have recently lost your job and had a prior workers compensation settlement you need to check your right to re-open your claim. Feel free to call my office to discuss.

Baxter International Inc. has announced the recall of all remaining, potential lethal doses of its heparin products including its possibly defective:

• Sodium injection multi-dose


• Single-dose vials


• HEP-LOCK heparin flush

This completes the series of heparin recallsTennessee Law Blog has been covering.

The first Baxter heparin recall was made in January when it recalled nine lots of heparin sodium injection multi-dose vials. This came after a number of reports of patient reactions and side-effects.

FDA officials refused to take further action at the time out of fear a total recall would create product shortages of the blood thinner, which is need in operating rooms, dialysis centers, and other areas of critical care.

FDA officials and Baxter now consider the supply of safe heparin sufficient to remove possibly lethal Baxter heparin from market, including all remaining heparin sodium injection and heparin flush products.

Reported adverse reactions include stomach pain and discomfort, burning sensations, nausea, diarrhea, and faintness/shortness of breath. The defective heparin has also been known to to be entirely ineffective, causing serious side-effects. Confirmed cases also show that the defective Baxter heparin has caused death. Most Baxter heparin deaths have come from allergic reactions and occur within minutes of heparin-initiation.

Note: This recall does not involve Baxter's heparin pre-mix IV solutions in bags: heparin sodium in 5% dextrose injection and heparin sodium in 0.9% sodium chloride injection.

If you or a loved one has been seriously injured by Baxter’s defective heparin, contact HHP today to begin the process of forcing Baxter to take responsibly for the injuries it has caused from its defective drugs.

Click for a free consultation with a Nashville dangerous drug attorney.

This week I was interviewed by a local news station, Fox 17, to discuss the sexual assaults which recently occurred on school buses. Unfortunately, my office has handled several inadequate security cases and school liability cases. These cases never come to my office until the damage has been done. As such, I would like to share a little advice to prevent these tragic events before they happen.

I have found that in almost all my school violence cases ofter, there was a lack of communication between the student, parents and school before the accident occurs. Many times this happens in cases where considerable warning signs existed. As such, if you have a child or friend that is dealing with a bully or aggressive student I would suggest you consider the following advice:

Whenever a serious case of bullying occurs, make a personal visit to the teacher, principal and follow up with certified letters or emails to the principal of the school, school board members, and the superintendent. Include the full names of all of the bullies, what the bully or bullies did, and the date the incident occurred. Request a response and a plan of action.

With any serious bullying you should call the police immediately.

You also want to document everything that happens. Write copious notes about every aspect of the bullying. If there are bruises or injuries, take pictures. Use a notebook to write down any doctors visits, calls to the school, visits to the school, letters sent, and also all responses that you receive.

If you have any questions, feel free to call my office.

Amendments to The False Claims Act in 1986 as well as Tennessee’s own Tennessee Medicaid False Claims Act (TMFCA) allow qualified whistleblowers to earn a portion of the government’s recoveries (called “qui tam provisions”) when whistleblowers, known as “relators,” appropriately report their company’s defrauding the government. Two examples of False Claims Act fraud found settlement in court and received media coverage this week for their substantial moneys awarded their whistleblowers who reported the fraud.

Military Contractor Fraud

A False Claims whistleblower led Justice Department officials to investigate from a company producing inferior-quality Kevlar cloth for our military’s combat helmets for the past 12 years. This military contractor fraud investigation led to a $2 million settlement after whistleblowers’ testimony during the False Claims Act lawsuit revealed that the company under military contract was knowingly producing inferior quality goods that did not meet military specifications. Instead, they wove up to 10% fewer than the minimum safety standard of 35 x 35 strands of Kevlar in order to save on production costs and time, that is, stealing federal tax dollars to provide an unsafe product to our troops.

Defense Department officials have not presented any evidence of troop from these inferior materials, but this could be due to the helmets the cloth was used in being phased out.

The two relators for this case had previously approached management concerned about the lives they were endangering by producing the inferior Kevlar. When that didn’t work, they sued.
From qui tam provisions under the False Claims Act, the two will receive $406,350 of the government’s award.

Health Care Fraud

A district sales manager for Merck finally found completion to her 7 year False Claims lawsuit alleging billing fraud by the drug pharmaceutical maker. But the wait was worth it. Merck, the U.S.’s third largest drug pharmaceutical company, agreed to pay over $400 million in one of the largest sums ever collected by various state and federal governments. The qui tam relator will receive about $68 million.

The relator in the Merck’s lawsuit had inside information about corporate practices--information the government relies on when it contracts with or subsidizes an industry. This is especially true in the health care industries, where whistleblowers have helped recover just under $9 billion (and to the $1.4 billion benefit of the relator).

In Merck’s case, the whistleblower reported that the pharmaceutical company was using unfair pricing practices to overcharge Medicaid (tax funded healthcare for the poor).

Working with a False Claims Attorney

One whistleblower can make all the difference in the immediate lives of soldiers or in the tax dollars available for bona fide health care programs. Relators can earn upwards of 30% of the total government fraud recoveries--just for doing the right thing. As an added bonus, federal and Tennessee law protects False Claims whistleblowers from retaliation, even if their case is not won.

But protections and payoffs only come if you appropriately file your False Claims lawsuit.

To speak with either myself, Attorney Jim Higgins, or of HHP’s Tennessee government fraud specialists, fill out our quick online form or call our Nashville, TN offices at (615) 353-0930.

The Tennessee Legislature is considering a bill that would cap any nursing home neglect or abuse jury award to $300,000.00. Apparently, the legislature does not believe that we as citizens are smart enough to sit on a jury and award a sum that is in proportion to any neglect suffered by a nursing home resident. Even more important is the fact that most nursing home are for profit corporations. The only way to deter a for profit corporation is to be able to hit them where it hurts, in the pocket book. If a nursing home has no real financial responsibility for its actions it will have little incentive to behave responsibly.

I believe we would all agree that we should be responsible for our actions. My children realize that if they misbehave there will be consequences. It may be loss of a toy or to be put in time out but they realize that they are responsible for their own behavior. I do not understand why a nursing home, a place that cares for our most frail and vulnerable citizens, should be place in a privileged class to have a very limited responsibility for their actions. Also, I recognize that $300,000 is a lot of money, however, do you think it is a lot of money do a company that makes hundreds of millions. Do you think that this sum would be a deterrence if a corporation knows it can profit more by taking shortcuts and cutting staff than they would ever have to pay in a lawsuit? Also, do you think the families of residents who were abused and neglected in a home should have a specific dollar amount set by the legislature for their loss or should a jury have the ability to determine what is just? These are all important concerns that will be drastically effected by this legislation.

I will state that however you fell this is an important issue. As such, whether you are for or against this limitation please call your representative and let your voice be heard. You can locate your rep at TN gov. If you would like to discuss the issue or concerns you have with my office feel free to contact me at hhpfirm.com.

FDA recall of Baxter International’s drug heparin made the front page of yesterday’s Wall Street journal after FDA officials confirmed four deaths from the blood-thinner. The culprit appears to be a Chinese plant producing the active ingredient in heparin.

Four deaths and hundreds of allergic reactions and other adverse drug side effects have been reported, including vomiting and diarrhea. More serious injuries from the drug heparin include increased heartbeats, low blood pressure, and fainting. FDA officials state that 40% of patients taking Baxter’s heparin suffered serious adverse reactions.

Heparin, which has been available in the U.S. since the 1930s, is administered by injection to prevent blood clotting during apheresis, heart surgery, and kidney dialysis. Patients undergoing these three treatments suffer the most severe injuries from Baxter's defective heparin.

Baxter, which produces about half of all heparin used in the U.S., announced a temporary halt in production of its generic anti-clotting (blood-thinning) drug. This FDA recall and Baxter's halt is predicted to create a shortage of the heparin blood thinner to hospitals and was the reason this dangerous drug was not pulled from market earlier.

Despite last year’s recalls and public notifications of lead in children’s toys and tainted pet food, the People’s Republic of China remains the world’s largest producer of active ingredients in drug medications. Drug companies seeking cheap labor and questionable safety and work conditions produce their pills and medicines in China, which produces just over 10% of the world's drugs.

If you have been injured by a FDA recalled drug medication or other dangerous prescription drug and would like to recover your losses from hospital bills, doctors’ bills, lost wages, and for your pain and suffering caused by shady business practices of big pharm companies, HHP would like to help. To speak with Attorney Jim Higgins or another one of our local, Nashville, TN dangerous drug medication attorneys, give us a call at (615) 353-0930 or fill our drug injury legal consultation forms.