Archive for June, 2009

On June 22, lawyers filed a Zicam lawsuit in Arizona on behalf of 117 people who suffered adverse reactions to Zicam cold remedies, including Zicam nasal spray and Zicam swabs.  Zicam was recently recalled after the Food and Drug Administration warned that the cold remedy could lead to anosmia, or loss of smell, and that the side effects could be permanent.  The lawsuit was filed against Matrixx Initiatives, and among those suing the company is an upscale Las Vegas chef who can no longer smell or taste food.
     Matrixx has already settled 340 Zicam lawsuits for $12 million dollars to avoid the cost of defending each individual lawsuit.  While Matrixx maintains that Zicam does not cause anosmia, William Hemelt, Matrixx’s active president, recognized that the company is particularly vulnerable to lawsuits.
     If you or someone you love has suffered a loss of smell after using Zicam, you may be entitled to file a Zicam lawsuit.  Contact a Bernstein Liebhard Zicam lawyer for a free claim evaluation.

The U.S. Supreme Court has found that a 1986 ruling by a bankruptcy judge prevents plaintiffs from initiating new claims against insurers of Johns-Manville, once of the largest producers of asbestos in the world. The June 18 holding overturns a Second Circuit Court of Appeals decision which found that the bankruptcy judge had exceeded his jurisdiction.

The bankruptcy court’s 1986 ruling prevented future lawsuits against Manville and its insurers for asbestos-related claims, provided that the company sets up a trust to settle such claims. However, a few years later, plaintiffs began filing lawsuits against Travelers for its role as one of Manville’s main insurers, saying that the suits were allowed because they were for Travelers’ violations of consumer protection laws, not Manville’s actions. In 2004, the insurance company reached an agreement that would settle then-existing cases under this new theory for approximately $440 million. In return, the original bankruptcy judge issued a “clarifying statement” saying that such suits were enjoined by the 1986 ruling. The case before the Supreme Court challenged this agreement.

The effect of the Court’s decision is to bar future lawsuits against Travelers for any claims related to exposure to Manville asbestos. However, the majority opinion emphasized that the ruling had a very narrow application, and was not intended to address bankruptcy court jurisdiction in general. Justices Stevens and Ginsburg dissented, saying that the 1986 order should only bar asbestos-related claims for Manville’s actions, not the actions of Manville’s insurance companies. Read more about asbestos exposure.

From conception to childbirth, pregnant women are challenged with managing their own health while worrying about the welfare of their unborn child. Every year, approximately 500,000 pregnant women in the U.S. battle conditions that require medical treatment, such as cancer, psychiatric illness, autoimmune disease, and influenza. Numerous warnings exist about the use of any type of medication whether prescription or over the counter. These battles leave a pregnant mother and her doctor carefully considering the proper dosage necessary to maintain health without harming the child.

Pregnancy Presents Unique Prescription Rules

Determining what is appropriate for a pregnant mother has not been easy. Shifts in the metabolism of a pregnant woman are substantial compared to a woman who is not pregnant, and, therefore, require changes in treatment. To what extent change is necessary has become difficult to determine. Conducting scientific studies on a pregnant woman to make these determinations raises both ethical and legal issues. 

Better Information About Pregnant Women About the Impact of Medications
 
The Second Wave, a movement begun this spring in Washington and composed of 30 doctors, ethicists, scientists, and government officials, aims at providing better information regarding how drugs affect pregnant women. Only in the 90’s did studies begin to include women, and, as recent as twenty years ago, members of the medical community were still using the male body as their research models and adapting those results to women. A recent 2003 law made it possible for not only women, but in some cases, children to be included in these scientific studies.

Second Wave encourages doctors and agencies to gather data on pregnant women and eases any fears by emphasizing that a lot can be done on a less dramatic level. Blood samples can be drawn and analyses conducted on pregnant women who are already taking medication out of necessity. Unfortunately, chronic illnesses that many women have do not disappear during pregnancy. It is inevitable that pregnant women will be taking medication, and studies show that two thirds of women take up to five drugs over the course of their pregnancy and labor. It is these women that can be used for the study.

While the Second Wave program looks for pregnant women willing to participate, the U.S. Food and Drug Administration is proposing to revamp its system for notifying pregnant women about adverse effects of drugs. Strikingly, only a dozen prescription drugs are approved for use by the FDA and most of these are all pregnancy related, leaving mothers with other common conditions in the dark as to effects of most medications on their unborn child.

Right now the FDA’s notification system consists of classifying drugs into one of five pregnancy-related categories, with A being the safest and X being the least necessary. Research on Category C drugs, which the FDA believes covers nearly 70% of all drugs, is much less conclusive in terms of safety for unborn children. Consequently, the FDA is moving towards eliminating these categories in favor of a system that more narrowly defines each individual drug and its effect on pregnant and nursing women. Below is a brief description of each of the five categories:

- Category A: Large number of human studies show no increased risk of birth defects when used by pregnant women. Examples include: Levothyroxine (thyroid hormone), B6, folic acid.

- Category B: Large number of animal studies show no increased risk of birth defects. No well done human studies have been conducted. Examples include: Zofran (antiemetic), amoxicillin (antibiotic).

- Category C: Animal studies suggest an increased risk and there are no large well-done human studies. Drug’s benefits may be worth the potential risk. Examples include: Zoloft, Paxil (antidepressants); Tamiflu (antiviral); Amitiza; any ACE inhibitors.

- Category D: Human studies show an increased risk of birth defects, but drug’s benefits may outweigh that risk. Examples include: tetracycline (antibiotic); Cytoxan (chemotherapy).

- Category X: Human studies show increased rates of birth defects and animal studies suggest an increased risk. The risk usually outweighs the benefits. Examples include: Accutane (acne treatment); Lipitor (cholesterol reducer).

If you or a loved one thinks you have been the victim of medical negligence because you have been wrongly prescribed medication during pregnancy or experienced adverse side effects as a result of being wrongly prescribed medication during pregnancy, you may be entitled to file a lawsuit seeking compensation for your medical expenses, pain and suffering, lost wages and more. Contact a medical malpractice lawyer today for a free and confidential case evaluation.

The United States Justice Department has served Medtronic with a subpoena, requesting information about the company’s ties to Dr. Timothy Kuklo, a former orthopedic surgeon at Walter Reed Army Medical Center. In a June 23 filing with the Securities and Exchange Commission, Medtronic revealed that it had received the subpoena from the U.S. Attorney in Boston on May 21. The Justice Department is interested in the company’s dealings with and financial ties to Kuklo.

The Army has accused Kuklo, who worked at Walter Reed until 2006, of manipulating data in a study about the effectiveness of Medtronic Infuse bone growth products in treating leg injuries in soldiers. Kuklo has also been accused of forging the signatures of several Walter Reed colleagues when submitting the study results to medical journals for publication. Recently, Medtronic revealed that it paid Kuklo a total of about $800,000 in consulting fees, mostly over the past three years. Although the company learned about the allegations against Kuklo at the end of last year, it did not formally suspend his consulting contract until the New York Times published an article on the ongoing Army investigation in May. Along with the Army and the Justice Department, Senator Charles E. Grassley is also investigating whether Medtronic violated federal rules by promoting Infuse for unapproved uses.

From 2002 until mid-2008, doctors at one V.A. hospital in Philadelphia made significant medical mistakes in 92 out of 116 brachytherapy procedures, a less invasive method of treating prostate cancer. Most of the errors involved patients receiving too little radiation to effectively treat their cancer, but about 35 veterans received overdoses of radiation to the wrong parts of their bodies. This often occurred because doctors injected radioactive pellets used in the procedures into the wrong organs. Investigators say that it took so long to uncover the mistakes because of insufficient internal and external oversight.

Fortunately no one has died as a result of these errors, but many patients have suffered painful and unnecessary medical complications because of the hospital’s surgical mistakes. The radioactive material used in cancer treatments is a carcinogen and can damage or destroy healthy tissue in addition to cancerous cells. All of the affected patients have obtained follow-up care, and eight had brachytherapy procedures performed properly at another V.A. hospital. Read more about medical malpractice and hospital negligence.

Last week the Environmental Protection Agency (EPA) declared the first ever public health emergency under the Superfund law, which was passed in 1980 to govern sites that have been contaminated by hazardous materials. The emergency was declared in Libby, a small town in Montana which has been exposed to large amounts of asbestos for decades. The asbestos came from a contaminated vermiculite mine and the waste produced by local vermiculite processing plants. The EPA pledged to spend $125 million on decontamination efforts, in addition to the $250 million promised by the mine’s owner, W.R. Grace & Company.

Many residents of Libby and the surrounding area have suffered serious health problems from asbestos exposure. Hundreds of residents suffer from lung problems and diseases, and asbestos-related illnesses have been blamed for at least 200 deaths since the late 1990s. The town has 40 to 80 times the national average of asbestos-related deaths. Residents were primarily exposed through dust emitted into the air by vermiculite processing plants and mine waste used in construction projects throughout the town, although some individuals were directly exposed when working in the mine or plants. Read more about asbestos work exposure and asbestos-related illness.

Keith Gordon-Smith, a contractor from Rochester, New York, has been indicted by a federal grand jury on 15 counts of violations to the Clean Air Act, submitting false statements, and obstruction of justice.  The Justice Department claims that Gordon-Smith, who owns Gordon-Smith Contracting, conducted illegal asbestos removal on several occasions and hid the removal from several federal agencies.
 The Clean Air Act requires contractors who remove asbestos to follow certain standards to prevent unsafe exposure.  These standards include reporting to the Environmental Protection Agency (EPA) before beginning the removal, and wetting the asbestos during removal to prevent bystanders from inhaling dangerous asbestos particles.  According to the Justice Department, Gordon-Smith allegedly failed to take both of these precautions.
Gordon-Smith allegedly improperly removed asbestos between June 2006 and August 2008 at Genesee Hospital, Roberts Wesleyan College, and Bloomfield Elementary School.  According to Justice Department officials, anyone present at these locations could have suffered asbestos exposure. 
  Once Gordon-Smith is arraigned, the U.S. Attorney’s Office for the Western District of New York will be providing a public notice in the Rochester Democrat and Chronicle to notify potential victims who may have been directly and proximately harmed as a result of the alleged crimes.  If you or someone you love has been exposed to asbestos illegally, you may be entitled to file an asbestos or mesothelioma lawsuit.  For more information on asbestos lawsuits, contact an asbestos lawyer.

The Wall Street Journal and other news outlets are reporting that on June 19, Zicam manufacturer Matrixx Inc. received an informal inquiry from the Securities and Exchange Commission regarding its line of recently recalled Zicam cold remedy products.  As we reported previously, Matrixx recalled Zicam nasal spray and swabs after the Food and Drug Administration (“FDA”) received over 30 reports that the products could lead to anosmia, or loss of smell, and that these side effects could be permanent. 

According to the Wall Street Journal, the SEC is asking for documents related to the FDA warning letter sent on June 16.  This letter contained the FDA’s concerns that Zicam could lead to anosmia.  The product was recalled the next day.  A Matrixx spokesperson says that the company will fully comply with the SEC request.

Zicam lawyers are currently investigating potential Zicam lawsuits and some Zicam lawsuits have already been filed.  Bernstein Liebhard lawyers are available for a free legal consultation about potential Zicam claims.

Millions of children’s heath may be at risk because they do not live close to effective pediatric trauma care. According to a recent study in the Archives of Pediatrics & Adolescent Medicine, more than 17 million children in the United States live further than an hour away from their nearest pediatric trauma center. This figure represents more than a quarter of the population under the age of 15. The problem is more pronounced in rural areas, where more than 75% of children are at least an hour away, compared to only 10% in urban areas. This matters to the children’s health because studies have shown that timely trauma care improves the chances that an injured patient will survive. Read more about child safety.

The Food and Drug Administration took steps to protect consumers from predatory and misleading advertising by manufacturers when it issued its new proposed advertising guidelines for drugs and medical devices. While the guidelines are not binding, they provide information to companies about how to avoid breaking FDA regulations.

According to the FDA, the document was issued in part because of a request from the drug industry for advice on how to comply with the agency’s rules for the marketing of medical products. Of particular concern is the omission or minimization of information about possible risks associated with a product, which compromise the most common violations of FDA regulations.

The guidelines recommend that advertisements be as specific as possible, and describe how small details like font and the amount of white space in printed material can best present information about risks and side effects. The FDA guidelines also discourage companies from sending conflicting messages in advertisements, such as using cheerful music in commercials while the risk information for a drug or device is being listed. Hopefully, if companies follow these guidelines, they will increase awareness in patients and health-care providers about the possible side effects of their drugs and medical devices. Read more about FDA product warnings.