Archive for June, 2009

Medication adherence, which is really the extent to which patients take medication as prescribed by their doctors, is important to the medication’s effectiveness to cure and treat the particular illness.  Poor medication adherence can have a particularly negative impact on the medication’s ability to treat many diseases, causing more severe complications from the illness and decreased quality of life for patients.   Many factors cause poor adherence; the most common ones being the inability to pay for medications, lack of belief that the treatment is necessary or helping, busy schedules, forgetfulness, and confusion about how and when to take the medication.

The Food Drug Administration recently published an article on its website, which discusses the importance of medication adherence and provides tips on how to take different types of medication correctly.  For example, when taking antibiotics, the FDA warns strict medication adherence is vital.  If antibiotics are not taken as prescribed by the doctor, a small number of bacteria is likely to survive and continue to replicate and become resistant to the antibiotics.  The same reasoning goes for the HIV virus.  When patients with AIDS skip or stop taking their prescribed medication, they might develop strains of HIV that are more resistant to the prescribed medication and even some medications that patients aren’t currently on.

The FDA advises people to communicate with their doctors or pharmacists if they are experiencing side effects of their prescribed medication and understand how long they need to take the medication.  Setting a daily routine to take medication, keeping medications in noticeable places, using daily dosing containers, and keeping written or computerized schedules are all good ways to help people remember to take their medication.

Ultimately, if there is ever an issue of negligence, consumers want to make sure it is medical negligence outside of their control and not negligence of their own.  Making sure you properly take medications, at least according to the FDA, is an important consumer health issue.

Advanced Medical Optics (AMO), a manufacturer of contact-lens solution, concealed complaints it received about the Complete MoisturePlus solutions causing eye infections and blindness. Government documents show AMO received complaints about the solution more than a year before it was recalled, and failed to report the complaints to the FDA as compelled by law. AMO recalled Complete MoisturePlus after the Centers for Disease Control and Prevention identified a link between the solutions and dozens of cases of serious infections called Acanthamoeba keratitis.

Acanthamoeba is a microscopic organism found in water or soil that can cause severe harm when it enters the eye. It usually enters the eye by attaching to a contact lens. Once it enters the eye, it is very difficult to kill, because it seals itself in a protective coating when faced with antibacterial drugs and protects itself from being killed for weeks or even months. If Acantheamoeba is not killed, it damages the eye and may cause blindness. In rare cases, it can even lead to a deadly infection of the brain and spinal cord. Acanthamoeba infections generally occur in, at most, two contact lens wearer per million. With 30 million contact lens user in the U.S., one would expect only 60 people to be infected. However, the figure exploded to more than 100 in 2007 alone.

Beginning in February 2006 and continuing through November of that year, AMO received a number of complaints about people diagnosed with the Acantheamoeba infections after using Complete MoisturePlus contact-lens solutions. However, these reports were not disclosed until June 2007, when the FDA went to investigate AMO’s headquarters regarding the recall. The FDA and CDC insisted that AMO recall the product after finding that contact lens wearers who had the infection were at least seven times more likely to use Complete MoisturePlus than those who did not contact the amoeba. The link between Complete MoisturePlus and Acanthamoeba keratitis is unknown, but AMO surmised it was due to improper handling and shipping of the contact-lens solutions.

Paige Reichardt was a victim of AMO’s misconduct. She became infected in 2005 and had to undergo a series of surgeries to remove her cataract lens, iris, and cornea. Ultimately, her whole eye had to be removed and replaced with a glass prosthetic. In an editorial, she described the pain as a feeling that someone had stabbed her eye with knives. Over 220 other plaintiffs had filed lawsuits against AMO, which is now part of Abbot Laboratories.

AMO’s negligence is a prime example of the devastating results that could occur when a manufacturer fails to take proper precautions in ensuring the safety of its product and properly warn people of the product’s dangers. If you are injured by a dangerous drug or defective medical device, contact a dangerous drug lawyer today.

Christine Golden, a Pennsylvanian woman, was recently awarded a $1.88 million judgment by a Pennsylvanian jury in a medical malpractice lawsuit.  Her husband, Terrence Golden, died after two doctors failed to diagnose his bladder cancer during a time when he could have been potentially saved with proper medical treatment.  Terrence died in January 2009 from the bladder cancer, which Christine alleged could have been treated if doctors had diagnosed it correctly.  It took nearly two years and several visits to a urologist and a pathologist before the bladder cancer was discovered.  The jury found that this medical misdiagnosis led to the death of Terrence.

With cancer, medical misdiagnosis is extremely fatal, because it can deprive a patient of important early treatments, which are less effective when the cancer is at later stages.  Bladder cancer is invasive and often spreads to other organs, as it did in Terrence, when not discovered in its early stages.  If caught early, bladder cancer can even be cured.

Christine sued Terrence’s urologist, Milan J. Smolko, who saw him numerous times between September 2002 and January 2004.  Terrence had complained about urinary problems during those visits.  Smolko had misdiagnosed him with only an inflamed and enlarged prostate without doing any further investigations until July 2003.  At that time, Smolko sent a bladder biopsy to pathologist, Lillian Longendofer, who also failed to identify the problem.  Eventually, Terrence went to another doctor in June 2004, who discovered the bladder cancer, but it was too late.  By that time, the cancer had metastasized to Terrence’s prostate and portions of his urethra.  The doctor removed the affected areas, but the cancer was too advanced to treat completely and as a result, Terrence died in January 2009.

Medical misdiagnosis can lead to serious, even fatal, consequences.  Careless oversights made by doctors can claim lives and deprive people of the chance to live their lives to the fullest.  If you or a loved one has been a victim of medical misdiagnosis or a doctor’s failure to diagnose, contact a medical malpractice lawyer today.

People taking propylthiouracil (PTU) should be aware that the Food and Drug Administration issued a PTU warning about possible liver damage as a side effect of using the drug. PTU is an anti-thyroid medication used primarily for the treatment of Graves’ disease, an autoimmune disorder that leads to hyperthyroidism. The condition can cause increased heartbeat, muscle weakness, disturbed sleep, and eye problems. While methimazole, which has fewer side effects, is generally the preferred drug for treating Graves’, PTU is often used for patients that are allergic to methimazole or are in the first trimester of pregnancy.

Between 1969, when the FDA first established its Adverse Event Reporting System, and October 2008, there have been 32 reported cases of serious liver injury in patients taking PTU. Of those, 13 patients died and 11 required liver transplants. The FDA PTU warning recommends that doctors prescribing patients PTU closely monitor the patients for signs of liver damage, particularly during the first six months of treatment. Read more about drug side effects and complications or dangerous drugs.

Several skin care products, marketed under various brand names, have been recalled after inspections revealed high levels of bacterial contamination. Clarcon Biological Chemistry Lab Inc., of Roy, Utah, recalled several of its skin sanitizer and skin protectant products which were discovered to contain bacteria capable of causing opportunistic infections of the skin and underlying tissue. On June 8, the U.S. Food and Drug Administration issued a Clarcon warning to all consumers to refrain from using any Clarcon products.

The results of the inspection contradict what Clarcon Labs promises its consumers.  The company promises its users skin care products that will safely protect and enhance the skin. Even more alarming, results of the inspection proved the existence of high levels of bacteria within products marketed as antimicrobial agents that claim “to treat open wounds, damaged skin, and protect against various infectious diseases,” the FDA’s statement reported. Use of these products should be discontinued and the products thrown away. Read more for a list of Clarcon products affected by the recall.

Six weeks after the US Food and Drug Administration recalled units of Hydroxycut products, the UK’s Food Standards Agency (FSA) issued warnings against use of the weight loss supplements. The US recall brought to light the loose standards applied to the dietary supplements industry, an industry often accused of being unregulated and providing unsafe products for consumers. Hydroxycut, a highly popular and commercialized weight loss product within the US, was recalled after studies showed ingredients within the supplement cause severe liver damage and other potentially fatal health complications.

The ingredient directly responsible for these adverse effects is still unknown. The UK delay on issuing warnings on the product was a result of investigations of the two different formulas sold in the US and the UK.  However, concerns about the Hydroxycut products increased since both formulas are available for sale in the UK. Retailers contacted Tropicana Health & Fitness, distributor of Hydroxycut within the UK, concerning the adverse side effects associated with use of the product once the US warning was issued. Tropicana, however, did not directly address these concerns and said it was in talks with Iovate Health Sciences, the North American distributor. Although Tropicana does not sell the US formula, it eventually acknowledged customer confusion among the two products and voluntarily agreed to suspend sales after the FSA issued its warning.

The FSA ultimately decided to take precautionary action and issued warnings against the use of 14 products in the Hydroxycut line.  The FSA warning covers the same 14 products recalled in the US, Finland, Canada, and Ireland. Read more for Hydroxycut lawsuits.

     Matrixx Initiatives Inc., manufacturer of Zicam brand cold remedies, failed to turn over 800 consumer complaints of serious side effects to the Food and Drug Administration (“FDA”) over a period of two years.  The FDA recently issued a Zicam warning after it received 130 complaints directly from doctors and consumers linking Zicam swabs and nasal sprays to anosmia, or loss of smell.  The FDA does not know whether these Zicam side effects are permanent, and the side effects can occur after just one use of Zicam products.
     A 2007 mandate from the FDA required all companies to turn over any consumer complaints linking food or drug products to serious side effects.  However, Matrixx maintains that the 2007 regulation does not apply to it because Zicam is a cold remedy, not a drug, and therefore not subject to FDA regulation.  FDA spokespeople have asserted that Matrixx was bound by the 2007 government directive.
     Several Zicam lawsuits have already been filed, and that number is expected to grow in the upcoming months.  If you or someone you love has suffered a loss of smell after using Zicam nasal sprays or swabs, you may be entitled to compensation.  Contact an experienced Zicam lawyer.

Abbott Laboratories has filed a lawsuit against the Department of Justice (“DOJ”), alleging that the DOJ has abused secrecy provisions in the False Claims Act (“FCA”).  The FCA is a law that governs the filing of whistleblower lawsuits, under which private individuals bring claims on behalf of the federal government to report fraud and misconduct.  Under a qui tam provision of the FCA, whistleblowers are entitled to between 15-30% of the damages awarded to the government by courts.
In a 1995 federal lawsuit ultimately filed in Boston, Ven-A-Care pharmacy in Florida sued multiple pharmaceutical corporations, including Abbott Laboratories, in a whistleblower lawsuit. That lawsuit alleged that Abbott had fraudulently inflated prices.
FCA lawsuits are filed under a seal, meaning that only the whistleblower, the DOJ, and the court have access to information regarding the lawsuit.  As a result, pharmaceutical corporations claim that they are at a disadvantage.  The DOJ can obtain documents without informing the corporation that the documents relate to pending litigation.  Also, although the seal only lasts for 60 days under the FCA, the court can extend the seal if the court deems the extension necessary.
Abbott alleges that the DOJ extended the seal for the Ven-A-Care lawsuit for more than 11 years, and did not preserve the evidence that it obtained under seal.  Because this evidence allegedly was not preserved, there are now evidentiary gaps that could harm the company during trial.  Abbott wants the court to bar damages on claims where there’s missing payment data; order the government to provide state-by-state evidence of fraud; consider missing evidence in Abbott’s favor and order the government to prove that it didn’t knowingly pay claims on terms it now calls false and fraudulent.
Previously, the American Civil Liberties Union (“ACLU”) sued DOJ over the FCA seal.  The ACLU believed that the seal prevents the press and public from learning about the serious fraud allegations that underlie most whistleblower lawsuits.
For more information on the False Claims Act or whistleblower lawsuits, contact a whistleblower lawyer.

A recent Wall Street Journal article reported that lawyers and financial advisors across the nation are seeing a rise in elder abuse cases, particularly in the form of financial exploitation.  Senior citizens who have become too fragile mentally or physically are being taken advantage of, being coerced into making decisions regarding their financial assets that may not be in their best interests.  Shockingly, the opportunistic culprits of these wrongful acts increasingly tend to be the victims’ own adult children or grandchildren.

According to MetLife Mature Market Institute, more than half of all elderly financial abuse cases involve family members or caregivers.  Elder-law attorneys often represent seniors in lawsuits brought against family members.  One attorney said he has litigated seven elder abuse cases in the past year, including one suit where a granddaughter allegedly convinced her terminally ill grandmother, who was on morphine at the time, to cut out a brother from a half-interest in the grandmother’s house, allowing the granddaughter to immediately sell the grandmother’s house upon her death to pay off $100,000 in debts.  In other cases, adult children who are taking care of their parents and have access to their bank accounts are often tempted to dip into these funds.  Some may have every intention of repaying the money, but often find they are later unable to.

While it might seem unfathomable that family members or caregivers could take such advantage, experts recommend that it may be in seniors’ best interests to have bank, credit care and investment statements regularly reviewed by a known and trusted independent party.  Though it may cause some awkward tension at the dinner table, it will help ensure the protection of the parents’ money as they grow older.

Read more about issues impacting the elderly, including denture cream zinc poisoning.

There have been recent reports that bisphenol A (“BPA”), a chemical used to harden plastics and found in hundreds of household products, may cause serious health problems. Now Connecticut Attorney General Richard Blumenthal has initiated an investigation into a planned marketing campaign to promote BPA by packaging, food, and beverage manufacturers.

At a recent meeting of major companies like Alcoa, Del Monte Foods, and The Coca-Cola Company, industry executives discussed tactics for reducing public concerns about the side effects of BPA. According to industry meeting notes obtained by The Washington Post, industry executives were especially concerned about the opinions of young mothers, who are likely to be focused on health concerns and often make purchasing decisions for their households. Representatives discussed a range of approaches, including using fear tactics, to convince consumers to opt for packaging that uses BPA. The notes also say that the ideal spokesperson for such a public relations campaign would be a “pregnant young mother who would be willing to speak around the country about the benefits of BPA.”

Blumenthal wrote a letter to the companies involved in the meeting and their trade associations, asking them to provide details about the planned BPA campaign. He also expressed concern that the companies planned on using misleading advertising to influence consumers and legislators about BPA, and hinted that such tactics might cause legal problems for the companies. Blumenthal previously led efforts to curb the use of BPA, which led to a Connecticut law restricting the use of BPA. Minnesota, Chicago, and New York’s Suffolk County have passed similar laws, and legislation restricting the use of BPA is under consideration in other states. BPA has been linked to cancer, heart disease, diabetes, and birth defects, and may be especially harmful to children’s health. Read more about other potentially dangerous products.