September 15, 2009

-A. Tse

Last month the FDA announced that it was reviewing a number of adverse event reports of liver injury in patients taking orlistat, the active pharmaceutical ingredient in the prescription weight loss drug Xenical and the over-the-counter Alli. Xenical, marketed by Roche, was approved by the FDA in 1999 and Alli, marketed by GlaxoSmithKline was approved in 2007 as an over-the-counter weight loss aid for adults.  In 2008, Xenical generated sales of $30million and Alli generated sales of $131 million during its first full year on the market.

Orlistat is not an appetite suppressant and is intended for use together with a reduced –calorie diet. It works by inhibiting the activities of enzymes in the gastrointestinal tract by preventing those enzymes from converting dietary fat and triglycerides into absorbable free fatty acids and monoglycerides.  Undigested dietary fat are not absorbed and are released from the body through bowel movements, therefore the prevention of absorption of fats reduces calorie intake and produces weight loss.

Between 1999 and October, 2008, the FDA received 32 reports of serious liver injury in patients taking orlistat including 27 cases requiring hospitalization and 6 cases of liver failure. The FDA is examining additional data submitted by oristat makers relating to suspected cases of liver injury.  This issue concerning orlistat and liver injuries, specifically hepatoxicity, was also discussed in April, 2009 at the FDA’s Center for Drug Evaluation and Research Drug Safety Oversight Board. Hepatoxicity is chemically induced liver damage, usually caused by drugs. The liver is the body’s main mechanism in metabolizing drugs; therefore it is more susceptible to chemically induced damage.  Hepatoxicity can manifest as hepatitis, inflammation of the liver, vascular lesions and acute liver failure.

As of yet, the FDA has not recommended any prescribing changes for orlistat, Xenical or Alli.  However, any individual who has used orlistat and experienced symptoms associated with the development of liver complications such as:

• Weakness or fatigue
• Fever
• Jaundice
• Brown urine
• Abdominal pain
• Nausea
• Vomiting
• Light-colored stools, and
• Loss of appetite

should contact his or her health care professional immediately.

Unfortunately, these drugs have the serious and debilitating side effect of causing severe movement disorders. Though Reglan and similar drugs are meant to be used for less than 3 months, over 20% of all prescriptions are written for a longer duration of drug use. This extended use of Reglan has been linked to an increased risk in movement disorders such as tardive dyskinesia.

Because of these risks the FDA has issued a black box warning–the strongest warning issued by the FDA short of recalling a drug– in February 2009. This Reglan black box warning cautions patients and health care professionals of the increased risk of tardive dyskinesia, a debilitating and irreversible neurological disease characterized by involuntary and repetitive movements of the limbs, facial muscles, and head. This Reglan side effect risk increases with extended use and with higher doses of this medication.
Symptoms of tardive dyskinesia include uncontrolled and repetitive movements such as:

• grimacing
• lip smacking
• pursing and puckering the lips
• rapid eye movements
• rapid blinking
• impaired finger movement
• tongue protrusion

Sadly, treatment is not yet available to allay the symptoms of tardive dyskinesia. Furthermore, once this condition develops, due to Reglan use or otherwise, its symptoms do not commonly reverse, even when Reglan use is terminated.

Due to this serious side effect risk, a wave of Reglan lawsuits has been filed by patients who have suffered the socially and physically disabling disease tardive dyskinesia. This Reglan cases allege that the makers of this drug failed to provide adequate warnings about the drug’s risks, placing profit before patient safety. Furthermore, these Reglan lawsuits accuse the maker of failing to address the broad over-prescribing of this medication, often for much greater durations than safe.

As Reglan attorneys continue to evaluate the cases of other patients who have developed tardive dyskinesia due to Reglan use, the United States Judicial Panel on Multidistrict Litigation is preparing to hear oral arguments next month on a motion filed by 15 plaintiffs requesting that all federal Reglan lawsuits be consolidated and sent to one court who can coordinate pretrial proceedings.

If you or a loved one has suffered zinc poisoning, hypocupremia (copper deficiency), hyperzincemia (excess zinc), or neuropathy (peripheral nerve damage) while using denture creams, such as Poligrip or Fixodent, you may wish to contact attorney who can determine your legal rights and options. Read on to learn more about the problems with denture creams.

Denture Cream and Zinc

Many denture creams contain zinc, which acts as an odor blocker and bonding agent. This ingredient, however, is not typically listed on denture cream labeling, as the Food and Drug Administration does not require this disclosure on “low-risk Class 1” products.
Unfortunately, exposure to too much zinc can cause serious health problems. In addition to being swallowed by denture wearers, the zinc in denture creams can also be absorbed through the skin and the gums. With long term use of denture cream, zinc can build up in the system, which is thought to pose the threat of nervous system injury.

Side Effect Risks

The zinc poisoning associated with denture cream use is associated with a type of nervous system disorder known as neuropathy. Neuropathy affects the peripheral nerves in the body (those not found in the brain and spinal cord), and can have debilitating effects.

Symptoms of neuropathy that may develop in patients who suffer the side effects of denture cream use may include:

Motor nerve damage symptoms

• Muscle weakness, cramps and spasms
• Loss of balance and coordination

Sensory nerve damage symptoms

• Tingling
• Numbness
• Pain often described as burning, freezing, electric,
• High sensitivity to touch
• Feeling of wearing a glove or sock over affected part

Autonomic nerve damage symptoms

• Abnormal blood pressure and heart rate
• Changes in perspiration
• Constipation
• Sexual dysfunction
• Bladder incontinence

Denture Cream Lawsuits

Several denture wearers have come forward in recent months to file a claim against the makers of denture cream. Through a denture cream lawsuit, these injured consumers are able to seek compensation for their medical costs and other losses from the makers of these dangerous products.

For example, a man using Super Poligrip for more than 8 years has filed a denture cream lawsuit against the product’s makers, GlaxoSmithKline. In this case, the injured man claims that the manufacture failed to disclose the inclusion of zinc in the cream and that the product poisoned him, resulting in permanent damage of his nervous system.

The grieving family of late sergeant Cindy Wilson received a second devastating emotional blow after learning that they were unable to seek legal damages against the negligent medical team responsible for Cindy’s death. Laboring to deliver her first child, a son, 37-year old Wilson underwent a cesarean section that went horribly wrong. During this surgery, the doctors severed a major uterine artery, which caused massive bleeding leading to Ms. Wilson’s death just 12 hours later. Furthermore, a medical investigation found that the doctors had left two medical sponges inside Ms. Wilson before stitching her up, a ghastly medical mistake that often results in infection and death.

Despite clear evidence that Ms. Wilson’s death was the direct result of gross medical malpractice, her widowed husband, now-motherless child and grieving parents are unable to sue for wrongful death because of a federal legal statute that prevents service members and their families from collecting damages for personal injuries, wrongful death, and loss of consortium from other members of the military. To make matters worse, another federal law mandating confidentiality of medical quality assurance records has prevented Cindy’s grieving family from access to the medical investigation findings pertaining to her death. Further adding insult to injury, the lead obstetrician during Cindy’s c-section continues to practice and received no professional disciplinary action.

Sadly, Ms. Wilson’s case is not the only instance of gross military medical malpractice for which the aggrieved have been able to see compensation. The following are just some recent cases of military medical malpractice that have not had their day in court due to the Feres Doctrine.

• A naval officer died after his cancer was diagnosed as eczema.
• An air force sergeant suffered irreparable brain damage after doctors failed to diagnose his appendicitis.
• A sailor was rendered infertile when military surgeons left five sponges and a plastic device in her stomach during surgery.
• A marine sergeant died of undiagnosed and untreated cancer, despite having several medical exams by military personnel.
• A navy petty officer suffered permanent brain damage after doctors failed to treat him for an uncomplicated case of pneumonia.

In all of these cases, the injured and their grieving family were unable to seek damages due to the Feres Doctrine.

What is the Feres Doctrine?

The Feres Doctrine is a federal statute established during a series of court cases including a landmark Supreme Court case in 1950 (Feres v. United States) involving a member of the armed services who died after an Army doctor left a 30 by 18 inch towel in his body during surgery. In this case, the Supreme Court ruled that the US and members of its armed services cannot be held liable under the Federal Tort Claims Act for injuries to other military members during active duty.

Originally the federal law was meant to bar medical malpractice lawsuits only in cases of combat-related injuries, but the Feres Doctrine broadened the US government’s protection from liability to all cases of military medical malpractice.

Reactions to the Feres Doctrine

Military families, lawyers, and Congress members have long been opposed to the Feres Doctrine, arguing that the law renders service members second-class citizens. They also point to increased cases of military medical malpractice in the absence of any legal consequences for such negligence. According to Jonathan Turley, a law professor at George Washington University, these above-mentioned cases illustrate how the Feres Doctrine has contributed to substandard military medical care. He considers the Doctrine one of the most grotesque rules created in the history of this country and says that it has done untold damage to thousands of military personnel and their loved ones.

Supreme Court judges have hotly contested the Feres Doctrine since its inception. In a 1987 Supreme Court decision Justices John Paul Stevens and Antonio Scalia dissented to a reaffirmation of the Doctrine by declaring it wrongly decided and deserving of the widespread almost universal criticism it has received.

Attempted to repeal this unjust law have surfaced routinely in the last 20 years but without success. One reason cited for this failure is the costs associated with upgrading the military medical system to meet basic civilian medical standards. “Congress simply doesn’t want to spend the money,” says Turley. “Soldiers and sailors are a real bargain to kill and injure in the United States.”

The surveillance tape shows medical staff, security guards and other patients walking past Green as she struggled desperately for her life. According to medical examiners, Ms. Green was suffering from blood clots. It was over an hour after Ms. Green had collapsed in her struggle before a nurse came over to check her pulse and announce her death.

The US Department of Justice cites Ms. Green’s death as part of a larger pattern of medical negligence, inadequate care, violence, and sexual abuse perpetrated against patients at Kings County Medical Hospital in New York City. This federal report went public when the president of New York’s Health and Hospital Corporation, Alan Aviles, announced reforms for the hospital including the replacement of two head administrators and the addition of 200 medical professionals to its 600-person staff. An additional six hospital employees were fired after Ms. Green’s death.

Mr. Aviles hopes that the changes made within the hospital will reduce psychiatric patient’s ER waiting room time to 6 hours from a shocking 27 hours. He added that the settlement awarded to Ms. Green’s family through the wrongful death medical malpractice settlement was not meant to put a value on a person’s life and the suffering of their loved ones. He hoped that this tragedy would compel the hospital to create a national model for patient-based health care and mental health services.
Ms. Green’s family is still awaiting a complete investigation of her case, according to their family lawyer.”What remains most important to this family is the criminal culpability for those responsible for what happened and those who attempted to cover it up,” the personal injury attorney added.

Who is Sonia Sotomayor?

Sonia Sotomayor, born in the New York City borough of the Bronx in 1954, has worked tirelessly in the legal profession for over 30 years. As a former New York City District Attorney prosecutor and private practice attorney, Sotomayor joined the US Federal Court system in 1992 when she became the youngest and first Puerto Rican American to become a judge for the US District Court. She later became a judge for the US Court of Appeals and is now under consideration for a Justice position with the US Supreme Court, the highest court in our nation.

Sotomayor Timeline

June 23, 1954       Sonia Sotomayor is born in the Bronx, New York
1962                         Diagnosed with diabetes at age 8
1976                         Graduates from Princeton University summa cum laude
1979                         Receives her JD at Yale and serves as Editor of Yale Law School
Journal
Early                        1980s serves as a prosecutor for Manhattan District Attorney’s office
1983                         Divorced
1984                         Enters private legal practice
1992                         Became the youngest person and the first Puerto Rican
American to be appointed as a United States District Court
judge for the Southern District of New York
1998                        Began serving as a judge for the United States Court of Appeals for the Second Circuit
May 2009             President Barack Obama nominates Sotomayor for the Supreme Court, to replace retiring judge David H Souter.

Considered neither an extreme liberal nor a crusader, Sotomayor has earned a reputation as an astute, outspoken, fearless, and sometimes sharp-tongued judge who is unswayed by powerful political interests.

With regards to predicting her views on major current issues, it is unclear where Sotomayor may side on matters such as abortion, gay marriage, and big business. Some abortion rights activists feel Sotomayor may not be a reliable vote to assure that Roe v Wade is upheld at this moment when the nation is deeply divided over abortion and its legality. Lawyers and scholars say they are unable to clearly place Sotomayor as either pro or anti-business.

Primer on the Supreme Court

The Supreme Court, the highest judicial body in the US, consists of nine Supreme Court Justices including one Chief Justice. All Justices are nominated by the President, confirmed by a Senate majority, and serve for life. In contemporary times, once a judge has been nominated a Senate Judiciary Committee forms to conduct hearings, question nominees, and determine their suitability. Following their confirmation hearings, the Committee votes on whether the nomination should go to the full Senate with a positive, negative or neutral report. While it is possible for a President to withdrawal his nomination of a candidate if he feels the nominee will not be confirmed, historically the Senate usually confirms a President’s nominee.

Current Supreme Court Justices

The current Supreme Court bench is composed of nine justices:

1. Chief Justice John Roberts (age 54)- nominated by GW Bush
2. Justice John Paul Stevens (89)- nominated by Ford
3. Justice Antonin Scalia (73)- nominated by Reagan
4. Justice Anthony Kennedy (72)- nominated by Reagan
5. Justice Clarence Thomas (60)- nominated by GHW Bush
6. Justice Ruth Bader Ginsburg (76)- nominated by Clinton
7. Justice Stephen Breyer (70)- nominated by Clinton
8. Justice Samuel Alito (59) – nominated by GW Bush
9. Justice David Souter (69) – nominated by GHW Bush

The Sotomayor Nomination

If Sotomayor is confirmed, she will be the first Latina woman to ever serve on the Supreme Court. This fact has Conservative critics in a sticky position as they attempt to weigh the price of aggressive opposition to the first Hispanic Supreme Court nominee at a time when they are trying so desperately to appeal to Hispanic voters.
Furthermore, if confirmed, Sotomayor will be one of two women currently serving on the Supreme Court and the third woman ever two fill this position.

Under this new federal stimulus law, employees and others who report misconduct by business entities receiving federal stimulus money will have broad protections against retaliation by their employers. While whistleblowers are already granted certain protections against employer retaliation, this law broadens these legal protections in response to concerns about the waste and mismanagement of stimulus funding.

Section 1553 of the new Federal Stimulus Plan states that any business entity receiving funds under the act is prohibited from demoting, discharging or otherwise discriminating against any employee when such an individuals makes a reasonable disclosure of information involving any of the following acts on the part of the business or its representatives:

1. gross mismanagement of stimulus funds
2. gross waste of stimulus funds
3. specific and substantial threat to public safety or health related to use of the funds
4. an abuse of authority with relation to the funds
5. and a violation of law, rule, or regulation with relation to the funds.

The protections afforded by this law kick in when disclosure of such information is made by an employee to his or her supervisor, co-workers, investigative authority, state or federal law enforcement or government representatives, courts, and grand juries.

This whistleblower protection provided by the Stimulus Law has two broad intended effects. One, it helps to compel individuals with information about misuse of stimulus funds to come forward and report such action by providing them protection against retaliation. Second, the law deters entities receiving stimulus funds from misuse and waste by providing such legal consequences. This law is also much broader than similar laws, with the former providing whistleblower protection in a greater number of contexts and thus potentially deterring misconduct by fund recipients.

Read on to learn more about the elements of this whistleblower protection statute.

Five elements of the whistleblower protections

To be considered a violation of Section 1553, the following criteria must be met:

1. The employer must have received funds under the act directly or indirectly
2. To receive protection, the employee must disclose information they believe is evidence of wrongful conduct under one of the five aforementioned categories.
3. This disclosure must be made to one of the parties also listed above.
4. The employer must have discharged, demoted, or otherwise discriminated against the “whistleblowing” employee following the disclosure
5. This employer action must be considered a retaliatory response to the employee’s disclosure. (note that the employer action need only be compelled by the disclosure as a contributing, not a sole factor, in the action. This can be proven by circumstantial evidence.)

Filing a claim of whistleblower discrimination

In order to file a complaint of employer discrimination of a whistleblower, the latter must file a complaint with the inspector general of the federal agency that distributed the stimulus funds. This inspector then has to determine if the complaint is warranted, investigate the allegations, and file a report of their findings with the Transparency Board.

In a case where the whistleblower has exhausted this administrative course of action, they have the right to file a private lawsuit against the employer. This may be a beneficial step, particularly in cases where the investigator has declined to conduct or continue an investigation, complete and file a report within a specific timeframe, or some other terminating action.

As the law exists at present, some questions remain unanswered as to its implementation. For example, the statute of limitations for filing a private lawsuit is unclear. It is also unclear as to whether the employee in a whistleblower lawsuit may pursue punitive damages. Other questions remain and will likely play out in future cases involving whistleblowers.