Medical Journal Articles Promoting Risky prescription Drugs Were Actually Written by Drug Maker

According to the New York Times, Wyeth, a giant pharmaceutical company, paid ghostwriters to produce medical journal articles favorable to its female hormone replacement therapy Prempro. Wyeth admitted this in response to a Congressional inquiry investigating the company’s involvement in medical ghostwriting. At least one of these articles was published after a federal study found the drug raised the risk of breast cancer.

“Any attempt to manipulate the scientific literature, that can in turn mislead doctors to prescribe drugs that may not work and/or cause harm to their patients, is very troubling,” Mr. Grassley, an Iowa Republican, wrote Friday to Wyeth’s chairman and chief executive, Bernard J. Poussot.

Mr. Grassley’s staff on the Senate Finance Committee released dozens of pages of internal corporate documents gathered from lawsuits showing the central, previously undisclosed connection between Wyeth and DesignWrite in creating articles promoting hormone therapy for menopausal women as far back as 1997.

At the peak of hormone replacement therapy, in 2001, more than 126 million prescriptions for such drugs were written for women in the United States. Sales that year, primarily by Wyeth, were $3 billion. But after the federal findings of cancer risks, sales of the hormone drugs plummeted. The drugs, which contain cancer warnings on the label, are still approved to treat severe symptoms of menopause, but their use is advised at only the lowest possible doses.

The medical journal articles all involved reviews of clinical studies and other research. While such reviews are common in medical publishing, what Mr. Grassley contends happened with the Wyeth-commissioned articles is that those expert authors whose names appear on the articles became involved only after outlines or drafts of the articles were already written.

Two months before the negative findings of the federal study were released, a May 2002 memo to DesignWrite employees said that Michael S. Dey, who was president of Wyeth’s Women Healthcare Business unit, asked a committee to increase the number of positive journal articles related to another of its hormone replacement drugs, Premarin. “Mike would like us to publish at least 1 study per month,” the memo said.

No one deserves to be put at risk because of a dangerous or defective product or medication. If you or a loved one has been injured due to a defective product or medication, contact our experienced Michigan personal injury attorneys immediately for a free confidential legal consultation.

Long-Term Care…Know Your Options.

An accident that results in a permanent disabling injury or the birth of a special needs child can force people to assume a lifelong care giving role. As the number of people with severe disabilities, debilitating chronic diseases and terminal illnesses grows, concern about their care has focused primarily on long-term care facilities, nursing homes, home health aides and hospices. Relatively little official attention has been paid to those who provide the overwhelming amount of services for people, both young and old, who are unable to care for themselves.

Various surveys have found that 20 million to 50 million family members in the United States provide care that was traditionally performed by nurses and social workers. Family caregivers supply about 80 percent of the care for ill or disabled relatives, and the need for their services will only rise as the population ages and modern medicine improves its ability to prolong lives.

Financial burdens can also complicate matters, especially when the family caregiver is forced to quit a job or cut back on outside work for pay. About a third of family caregivers lose most or all of their savings as a result of care giving, studies have shown. Family caregivers provide an estimated $237 billion in unpaid services a year.

Most family caregivers have no training for the physically and emotionally demanding tasks they undertake. And many are struggling themselves with age-related disabilities and chronic ailments. Others are members of the so-called “sandwich generation” who must juggle care giving with paying jobs and the needs of their own family.

It is important family members and caregivers know their options for help. The Michigan Department of Community Health (MDCH) has five programs that offer services to eligible persons in the home:

Home Health provides in-home skilled nursing services and associated personal care from qualified nurses and home health aides.
Home Help provides unskilled personal services such as meal preparation, assistance with eating, grooming, laundry, shopping and moving about the home.
PDS provides assistance in purchasing durable medical equipment and home modifications not otherwise covered by Medicaid.
MI Choice Program provides services such as personal care, transportation, private duty nursing, meal preparation and routine household care to allow an individual to remain in his or her home.
PACE provides comprehensive medical and long-term care services to program enrollees who are 55 years of age or older.

Additional services:

Hospices offer end-of-life care, usually provided in the home. In some cases care may also be provided in a residential facility such as a nursing home. Support is provided for the family through counseling, and for the individual with skilled nursing services, pain management and personal care.
Nursing homes are residences that provide housing, meals, rehabilitative care, skilled nursing services and protective supervision for post--acute and long-term care needs.

Other resources that may help:

MMAP is the Michigan Medicare and Medicaid Assistance Program that offers free counseling and education on Medicare and Medicaid benefits. You can contact MMAP toll-free at 1-800-803-7174.

MISeniors.net is Michigan’s Office of Services to the Aging website. The website lists support services for the elderly, housing options, information on nutrition and health care providers: www.MISeniors.net.

The Department of Human Services- DHS is a State of Michigan agency that provides information on independent living, senior services, adult community placement and medical services. To locate county DHS offices, call 517-373-2035, or select ‘County Offices’ from its website at www.michigan.gov/dhs.

Eligibility for long-term care services is determined by assessing your medical needs and functional abilities, and looking at financial criteria. MI Choice Program, PACE and nursing homes use Michigan’s Medicaid Nursing Facility Level of Care Determination to identify eligibility.

Financial eligibility is determined by your local Department of Human Services (DHS) office. If you are determined eligible for services, you will be informed of program options. If you are determined ineligible, you will be informed of other services in your community that may help you, and your right to appeal a determination of ineligibility. Contact your local Area Agency on Aging or community service organization for more information about all program options.

If you or a loved one has been injured to due to the negligence of a nursing home or long-term care facility, protect your rights. Contact one of our experienced Michigan personal injury attorneys immediately for a free confidential consultation today.

Small Melamine Amounts in Baby Formula Safe?

Public health groups, consumer advocates and members of Congress blasted the Food and Drug Administration on November 26, 2008 for failing to act after discovering trace amounts of the industrial chemical melamine in baby formula sold in the United States.

The FDA began testing infant formula in September and has so far analyzed 74 of the 87 products it has collected. None of the samples contained both melamine and a related compound, cyanuric acid. After reviewing the samples and animal studies, the agency decided that either melamine or cyanuric acid alone is safe formula at 1 part per million or less. Melamine can cause kidney and bladder stones and, in worst cases, kidney failure and death. If melamine and cyanuric acid combine, they can form round yellow crystals that can also damage kidneys and destroy renal function.

Melamine was found In Good Start Supreme Infant Formula with Iron made by Nestle, and cyanuric acid was detected in Enfamil Lipil with Iron infant formula powder made by Mead Johnson. A spokesman for Nestle did not respond to repeated calls and e-mails for comment. Gail Wood, a spokeswoman for Mead Johnson, said the company does not think that cyanuric acid poses a health threat to infants. “Cyanuric acid is approved by the FDA to sanitize processing equipment,” she said. “The risks of not sanitizing equipment are far greater than ultra trace amounts of residual cyanuric acid found in formula.

Agency scientists have maintained they could not set a safe level of melamine exposure for babies because they do not understand the effects of long-term exposure on a baby’s developing kidneys. The problem is exacerbated by the fact that infant formula is a baby’s sole source of food for many months. Premature infants absorb an especially large dose of the chemical, compared with full-term babies.

The FDA spokeswoman said no illnesses have been linked to melamine consumption in the United States. Chinese manufacturers deliberately added the chemical to watered-down formula to make it appear to contain higher levels of protein. More than 50,000 Asian infants were hospitalized, and at least four died.

Critics said the FDA’s reassurance about products carry less weight after the recent controversy over bisphenol-A, a chemical found in plastic baby bottles, dinnerware and the linings of food cans. The FDA dismissed a growing body of scientific evidence that has linked BPA to health problems even as worried consumers stopped buying BPA-containing products. Instead, the FDA relied on two industry-funded studies that concluded the BPA did not pose a health risk. Last month, the agency’s science advisory board said the agency should no longer maintain that BPA is safe.

Your child’s safety is one of our law firm’s main concerns. If you or a loved one is injured due to consumption of a dangerous product, contact our experienced Michigan layers immediately.

Strengthening United States Consumer Product Safety

In recent months, millions of toys have been recalled from stores across America because the products violate basic safety standards. Shopping for young children has become increasingly difficult, because it often is impossible to tell which toys are safe and which are not. Some of the recalled products were covered in lead paint, built with deadly magnets, or coated in a substance similar to the “date rape” drug.

These dangerous toys should never have reached retail store shelves. However, recent Congressional investigations have revealed that the federal Consumer Product Safety Commission (CPSC) is failing to protect the public from defective products.

When children are injured or killed by toxic toys or other products, their families encounter huge legal hurdles if they seek compensation for their losses. Over 70% of all toys now sold in this country were manufactured overseas, mostly in China. These products, although cheaper, receive minimal regulatory oversight. Additionally, foreign manufacturers have argued that they are not subject to jurisdiction in United States courts.

The U. S. Congress is working on legislation to secure the rights of American consumers against foreign manufacturing mistakes. Many lawmakers agree that foreign manufacturer should be legally accountable for non-compliance with U.S. safety standards. Both the House of Representatives and the Senate are boosting the CPSC’s annual budget, as well as increasing the standards of testing and certification before products can be sold.

Marketing defective products is not only dangerous, it is wrong. Injuries sustained by simple toys can be substantial, and in some cases fatal. We encourage the U.S. Congress to continue to put pressure on the CPSC, American importers, and foreign manufacturers to ensure the safety of our families.

At the Bernstein Law Firm, we have been protecting the legal rights of victims injured by defective products for over 40 years. If you or a loved one was injured by a defective product, we recommend that you contact an experienced product liability attorney immediately.

Health Insurance Companies Resort to New Ways of Denying Medical Benefits to Policyholders

Health insurance companies are finding new ways to avoid paying claims of policyholders most in need of medical treatment.

One of the latest insurance company tactics is rescinding policies after individuals file claims, and encouraging them to pursue benefits from Medicare, Medicaid, or other sources.
Another serious problem is “dual-role insurers,” which are companies that not only pay benefits, but also decide who is entitled to receive them. While the federal Employee Retirement Income Security Act allows insurance companies to do this, many argue this dual role presents an inherent conflict of interest.

Some insurers are directing staff to scrutinize each claim, to find any hint of “misrepresentation” that would be an excuse to cancel a policy. For example, a company might try to revoke a policy, if an individual did not identify a previous health problem or medical procedure on his or her initial insurance application.

Increasing public attention has prompted state industry regulators to investigate and fine some health insurers for these unfair and unlawful practices. One recent investigation revealed that an insurer paid employee bonuses, based on the number of policies they cancelled.

In short, these companies increase profits by wrongfully denying claims of their sickest policyholders, and continuing coverage only to those who are healthy.

If you or a loved one has encountered similar problems with your insurance company, you need to protect your legal rights. Contact an experienced attorney who can help you receive the medical benefits and coverage that you deserve.

Ohio Defective Product Law Overview

We believe that in Ohio, companies that make dangerous products that cause injury should be held accountable. The area of Ohio law that covers these types of cases is generally referred to as Ohio product liability law.

Under Ohio law, ORC 2307.711, a product liability action is:

“Product liability claim” means a claim that is asserted in a civil action pursuant to sections 2307.71 to 2307.80 of the [Ohio] Revised Code and that seeks to recover compensatory damages from a manufacturer or supplier for death, physical injury to person, emotional distress, or physical damage to property other than the product in question, that allegedly arose from any of the following:

• The design, formulation, production, construction, creation, assembly, rebuilding, testing, or marketing of that product;
• Any warning or instruction, or lack of warning or instruction, associated with that product;
• Any failure of that product to conform to any relevant representation or warranty.

Ohio Defective Product Law - Causes of Action

Ohio plaintiffs interested in pursuing an Ohio products liability case have three potential causes of action:

1. Negligence
2. Contract
3. Strict liability in tort

To establish actionable negligence, a plaintiff must show the existence of a duty, a breach of the duty, and an injury resulting proximately from this breached duty.

In order for an Ohio plaintiff to recover on the basis of strict liability in tort, he/she must allege and prove the following: that a defect existed in the product manufactured or sold by the defendant; the defect existed at the time the product left the defendant’s hands; the defect was the proximate cause of the of the plaintiff’s injury. This applies to defects in both design and manufacture.

Who May Be Liable under Ohio Defective Product Law

Under Ohio product liability law, an injured party may recover against four types of defendants:

Manufacturers

The Ohio Revised Code defines a “manufacturer” as “a person engaged in a business to design, formulate, produce, create, make, construct, assemble, or rebuild a product or a component of a product” (ORC 2307.71(I))

Suppliers

A “supplier” is defined under the Ohio Revised Code as “a person that, in the course of a business conducted for the purpose, sells, distributes, leases, prepares, blends, packages, labels, or otherwise participates in the placing of a product in the stream of commerce” (ORC 2307.71(O))

Successor Corporations

The general rule, under Ohio product liability law, is that a successor corporation’s amenability to suit depends on the nature of the transaction that gave rise to ownership. If the transfer was accomplished by a merger or consolidation, then the liability of the former corporation will be assumed.

Parent Corporations

Under Ohio law, there is a general presumption that a parent and its subsidiaries are separate entities and entitled to be treated as such. The plaintiff would have to present evidence to overcome this presumption.

Damages in an Ohio Product Liability Claim

Damages available in an Ohio products liability claim based upon negligence may include compensatory damages, pain and suffering damages, and punitive damages where appropriate.

Punitive damages are only recoverable upon a finding of “actual malice” defined as “(1) that state of mind under which a person’s conduct is characterized by hatred, ill will or a spirit of revenge, or (2) a conscious disregard for the rights and safety of other persons that has a great probability of causing substantial harm.”

Theories of Liability Under Ohio Product Liability Law

Under Ohio law, several theories of liability are available to plaintiffs including:

1. Defects in manufacture or construction
   
2. Defects in design or formulation
   
3. Defects due to inadequate warning or instruction
   

Defenses to an Ohio Product Liability Claim

It should be expected that the negligent corporation will vigorously fight a product liability claim. Defenses typically presented by the manufacturer in an Ohio products liability claim include:

• The danger was open and obvious and required no warnings
  
• The product was misused
  
• The user’s negligence contributed to the injury
  
• The injured user assumed the risk of injury
  
• The alleged lack of warning did not cause the injury
  
• There was an intervening cause that cuts off the liability of the manufacturer

Ohio defective product law is complex. Therefore, if you or a loved one was injured by a defective product in Ohio, it is wise to consult a dedicated Ohio product liability lawyer.

How a Social Security Disability Claim Proceeds

Starting a Claim for Social Security Disability Benefits
To make a claim for Social Security Disability benefits, you need to file an application with the Social Security Administration (SSA). The SSA provides an on-line application form on its website www.ssa.gov. You also can file for Social Security Disability benefits by going to a local SSA office. If you have trouble finding a Social Security Administration office close to your home, call the Social Security Administration toll-free hotline number at 1-800-772-1213. (Deaf and hard-impaired individuals can reach Social Security Administration by TTY at 1-800-325-0778.)

Submitting an Application for Social Security Disability Benefits
Take the time to carefully fill out your Social Security Disability application. Remember that the Social Security Administration will use whatever information you provide to decide if you qualify for Social Security Disability benefits.

Give complete answers to every question. This could help the Social Security staff fully understand the severity of your disability, the limitations that it places on your capacity to work, as well as the prospect that your disabling condition or illness might get better or worse in the future. In addition, the Social Security Administration may process your application more quickly, if you include all the required information on your application form.

If you have trouble understanding all the questions on the application, you have a legal right to ask the SSA to help you. To get assistance, call their toll-free number listed above, or visit a local Social Security Administration office.

Getting an Answer from the SSA about Your Social Security Disability Application
After you send in your application, the SSA may take several weeks or months to review your information and tell you its decision.

If your Social Security Disability benefits are approved, the SSA will send letters to let you know the amount of your benefits and your health coverage options. They will also tell you about your responsibility to report changes in your medical condition, employment status, and other factors that could affect your eligibility for benefits.

Be sure to read and follow all the instructions, to help ensure that your benefits continue for as long as you have a right to receive them.

If the Social Security Administration denied your initial application, you have the legal right to challenge the unfavorable decision by filing an appeal.

Appealing a Denial of Your Benefits
Do not give up, if the SSA denies your claim. In fact, the SSA often rejects the initial applications of individuals who meet all the requirements. Many of these people have to go through the appeal process to get their Social Security benefits approved.

To protect your right to appeal, you must act immediately after you find out that the Social Security Administration disapproved your application. You only have 65 days from the date stamped on the denial letter to ask for another review of your claim.

A Social Security Administrative Law Judge conducts this review, after taking another look at all your Social Security claim information, including your application form, medical records, and additional material you submit to support your claim, and after holding a hearing at which you can present evidence to support your case.

Do not delay filing an appeal. If you miss the 65-day deadline, and decide later to seek Social Security Disability benefits, the SSA will make you go back and start the application process all over again.

Presenting Your Social Security Disability Claim at a Social Security Hearing
When you properly file an appeal before the 65-day deadline, the SSA will schedule an Administrative Law Judge hearing. Usually, it takes between 6 months to 18 months to schedule your hearing date.

The Administrative Law Judge who conducts your hearing will evaluate the following factors, to decide if you should get benefits:

• Whether or not you accumulated enough Social Security earnings, or “work credits,” to qualify for benefits.
• If not, whether or not your income and other financial resources are so limited that you may qualify for Supplemental Security Income (SSI).
• Whether or not you have an impairment that has lasted, or is expected to last, for at least 12 months, or is expected to result in death.
• The nature and extent of your impairment.
• Your ability to engage in substantial gainful activity since your impairment began.
• The date that your disability began.

If the Social Security Administration just denied your application for benefits, or if you already filed an appeal and are waiting for your hearing, take the time to contact an experienced Michigan Social Security lawyer immediately. Our Michigan Social Security law firm represents individuals at this level of appeal. We want to help you get the Social Security Disability benefits you deserve.