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Toyota Recalls 4.26 Million Vehicles for Accelerator Defect

Joe Saunders — Mon, 30 Nov 2009 09:45:45 GMT

Toyota has recalled more than 4 million vehicles due to a defect with the car's accelerator. The defects involve accelerators that are jammed open by floor mats. The dangerous defects have led to auto deaths including the death of a California Highway Patrol officer and three family members. Since 2002, the sudden acceleration defects have claimed the lives of at least 19 motorists who've experienced such Toyota accelerator defects.

Toyota has received strong criticism for their inaction and failure to warn motorists of the problem. "They knew something was wrong way before that San Diego accident happened," said Rebecca Lindland, an auto industry analyst for consulting firm IHS Global Insight. "That was just the catalyst to get them to finally do something."

Originally posted at InjuryBoard by Joe Saunders

Deadline for Chinese Drywall Class Action Lawsuit

Joe Saunders — Mon, 16 Nov 2009 10:08:37 GMT

Now that one of the major manufacturers of the contaminated Chinese drywall has agreed to accept service of a class action lawsuit, the time to act is now. If your home has been contaminated by Chinese drywall and you're contemplating a lawsuit, you must contact a lawyer so that your home can be inspected. The inspection will determine if the Chinese drywall in your home comes from Knauf. If the inspection proves positive for Knauf Chinese drywall, your claim has to be submitted to the class by December 2, 2009. There will be no extensions for this deadline so the time to act is now!

Originally posted at InjuryBoard by Joe Saunders

FDA’s Oversight of Post-Marketing Studies Inadequate

C. Todd Alley — Tue, 10 Nov 2009 11:05:08 GMT

The Government Accountability Office (GAO) has released a new report about the FDA’s lack of post-marketing oversight in a number of the drugs which it conditionally approved.

The FDA normally makes a decision to approve a drug based on clinical trials. If the clinical trials yielded favorable results, the FDA would then likely approve the drug and sales of the drug can be introduced to the U.S. market. The downside to this traditional route, though, is that the clinical trials can take years to complete, and cost the pharmaceutical company millions of dollars. With this in mind, in 1992 the FDA instituted an optional route to approval: surrogate end-points. Surrogate end-points are the end-results yielded by a drug in a laboratory setting which tend to show positive health benefits. For example, HIV-related drugs are often approved based on its virus-lowering power, a major factor in increased survival for HIV-infected patients. A cholesterol drug could be approved to prevent heart disease, an end-point, by showing that the drug lowers cholesterol – since there is a connection between high cholesterol and heart disease. Utilizing this approval route means that manufacturers can get their drugs to the market faster and patients in need have faster access to the drug.

Unfortunately with surrogate end-point approval there are often many factors unknown, namely long-term effects of the drug’s usage. Long term clinical studies provide this information, but drugs using surrogate end-point trials are often approved so quickly that long-term effects are not known until the drug is on the market - which means that adverse effects may not be known until after the drug’s approval. As such, the FDA approves these drugs conditionally. This means that the FDA will require the manufacturer to conduct ongoing research beyond the drug’s approval, or else the drug’s approval will be revoked.

Despite all of these conditionally approved drugs requiring the conduction of post-marketing studies, the GAO found only 52% of these drugs actually have adequately completed them. 18% haven’t even started, 7% were still ongoing, and 2% were delayed. The remaining 21% were either not yet reviewed or found no longer necessary.

The GAO also noted the FDA’s inability to provide accurate record keeping of post-marketing research. Additionally, the GAO found that no drug approved under the surrogate-endpoint system has ever been unapproved, despite a large number of delinquent manufacturers.

This is not the first time the FDA has come under fire from the GAO. In 2006, the GAO chastised the FDA for its lack of a clear oversight process, and inability to quickly evaluate post-marketing data. Clearly, the FDA has a responsibility to demand post-marketing studies be completed and submitted to prove a drug’s long-term safety and efficacy

Originally posted at InjuryBoard by C. Todd Alley

Chinese Drywall Defendant Agrees to Accept Service of Class Action Lawsuit

Joe Saunders — Wed, 04 Nov 2009 11:51:46 GMT

Chinese drywall defendant Knauf Plasterboard Tianjin Co. Ltd. has agreed to accept service of process concerning a Chinese drywall class action lawsuit in which Knauf is being sued for manufacturing and importing the contaminated Chinese drywall into the United States.

This is a major victory for the thousands of homeowners who've had their homes contaminated with the drywall. The agreement means that all the drywall lawsuits can be consolidated into a class action and the homeowners won't have to pay the $15,000 fee for each lawsuit filed in the court.

However, Chinese drywall homeowners must submit proof that their home has been contaminated with the drywall and secure a lawyer to represent them by December 2, 2009.

Originally posted at InjuryBoard by Joe Saunders

The FDA Must Improve Communication to Patients

C. Todd Alley — Thu, 29 Oct 2009 15:36:27 GMT

The American Recovery and Reinvestment Act allocated $1.1 billion dollars to coordinate research and guide investments in comparative research funded by the Act. Some critics suggest that a whole lot of money could have been saved just by looking to the FDA.

Dr. Lisa Schwartz and Dr. Steven Woloshin have co-authored a New England Journal of Medicine article titled Lost in Transmission – FDA Drug Information That Never Reaches Clinicians, in which they talk about the fallacies of the current system, and possible ways to correct it. Primarily, on the journey from clinical trials to FDA approval to the production of a drug label, potentially vital information is lost. For example, the FDA approved the drug Rozerem in 2005 to treat chronic insomnia, but in one phase 3 clinical trial, the drug failed to provide any benefit at all for this condition. In fact, a memo created by the FDA’s own medical review team debated whether to even approve the drug since the insignificant benefits provided by the drug may be outweighed by its potential side effects, but Rozerem was eventually approved. Obviously, knowing this background information would certainly appear to have an effect on a doctor’s enthusiasm to prescribe the drug, and a patient’s willingness to take the drug. Unfortunately, though, this type of important information is not placed on the FDA’s approved drug label, so none of it is clearly communicated to the public.

To its credit, the FDA has issued new guidelines about drug labeling, such as including phase 3 trial results and other effectiveness data, but this information is not mandated as it should be. In the case of Rozerem, the effectiveness data is still absent even after the label was updated. Bottom line - more needs to be done.

The FDA is currently undergoing a pilot test of a “drug fact boxes” which would include a succinct table of effectiveness data such as reviews and labels. This would give doctors more pertinent information about drugs and also allow patients to make a more educated decision before they take a new medication. The FDA is still debating internally how to use these “drug fact boxes.”

There are other potential alternatives, but the authors concisely (and correctly) conclude, “Whatever approach the agency adopts, it needs a better way ofcommunicating drug information to clinicians. We don’t needto wait for new comparative-effectiveness results in order toimprove practice. We need to better disseminate what is alreadyknown.”

Originally posted at InjuryBoard by C. Todd Alley

Injectable Pain Drug Recall Expanded

Joe Saunders — Fri, 23 Oct 2009 11:40:58 GMT

The manufacturer of an injectable pain medicine is expanding its recall due to possible contamination. The recalled drug Ketorolac Tromethamine Injection USP 30 mg/ml, is used to treat moderate to severe pain. The contamination may cause blockage in blood vessels which can lead to pulmonary emboli or thrombosis. The drug had been distributed nationwide to wholesalers and hospitals, surgical centers, and pharmacies have been notified of the product recall.

Originally posted at InjuryBoard by Joe Saunders

New Change to HIPAA Protects Patient’s Genetic Information

C. Todd Alley — Tue, 13 Oct 2009 09:24:56 GMT

On October 1^st, the U.S. Department of Health and Human Services (HHS) issued new interim rules protecting patient’s genetic information from being used against them. The new rules come as the department interprets and implements the Genetic Information Nondiscrimination Act of 2008 (GINA), and serve to amend the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule.

The new rules also define genetic information, genetic services, genetic testing, and related terms and phrases. Genetic information is defined as "information about the individual's genetic tests or the genetic tests of family members… [and] family medical history." This definition also clarifies that "genetic information" does not cover information about an individual's sex or age.

Under the new rule, group health plans and issuers in the group market cannot:

Increase premiums for the group based on the results of one enrollee’s genetic information;
Deny enrollment;
Impose pre-existing condition exclusions; or
Do other forms of underwriting based on genetic information.

In the individual health insurance market, GINA similarly prohibits issuers from using genetic information to deny coverage, raise premiums, or impose pre-existing condition exclusions. Additionally, insurance companies are prohibited from asking individuals or family members to undergo a genetic test. A violation of any of the above prohibitions can lead to fines from $100 to up to $50,000 per offense.

HHS Secretary Kathleen Sabelius supported the new rule, saying “consumer confidence in genetic testing can now grow and help researchers get a better handle on the genetic basis of diseases.” This comes after stories of patients too afraid of having genetic testing done, for fear of becoming unable to obtain insurance.

Sebelius added, “Genetic testing will encourage the early diagnosis and treatment of certain diseases while allowing scientists to develop new medicines, treatments, and therapies.”

Some insurance industry representatives don’t see GINA as necessary. “It’s an anecdotal fear,” said Mohit M. Ghose, a spokesman for America’s Health Insurance Plans, whose members provide benefits for 200 million Americans. Nonetheless, the fear can compromise the health of patients too afraid of losing health insurance by undergoing genetic testing. GINA and the new interim rule looks to alleviate the patients’ fears, and doctors can now more efficiently diagnose and treat certain diseases early.

The new interim rule is open to public comment for 60 days. The rule will then become final, barring any setback.

Originally posted at InjuryBoard by C. Todd Alley

Troubling Ghostwriting Survey Prompts New Medical Journal Policies

Don Greiwe — Tue, 06 Oct 2009 08:48:02 GMT

A survey released by The Journal of the American Medical Association (JAMA) concludes that six of the top medical journals in the U.S. published a “significant number” of ghostwritten articles in recent years, reports the NY Times. Ghostwriting in the medical profession generally means that the research or conclusions were not written by the credited author. A dangerously common practice in the medical industry is for a pharmaceutical company to pay a group of professional writers to produce papers, and then pay scientists or physicians to attach their names to these articles. Ghostwriting has been common for years, but has received harsh media attention, especially recently. In late July, a federal judge ordered the unsealing of confidential court documents revealing that the pharmaceutical giant Wyeth orchestrated dozens of ghostwritten articles to promote their line of hormone replacement drugs.

According to the anonymous survey of 630 published medical papers, 11% of the articles in the New England Journal of Medicine were ghostwritten. Likewise, 7.9% of the articles in JAMA, 5% of the articles in The Annals of Internal Medicine, and 2% of the articles in Nature Medicine were ghostwritten. In reality, these statistics may actually be much higher, because ghostwriting is difficult to track due to its covert nature.

Many are calling for medical journals to step up enforcement of anti-ghostwriting policies. In an article written in response to the survey, PLoS Medicine editors have made a call to the industry to institute a zero tolerance policy – identifying and retracting any ghostwritten articles and banning those authors from future publications. There’s been swift congressional support too, with Senator Chuck Grassley (R – IA) telling reporters “objective research is really at the heart of public trust in medicine.” Senator Grassley has led the Congressional charge against ghostwriting in Congress, and strongly encourages medical journals to adopt strong anti-ghostwriting policies.

Supporters of ghostwriting say that it allows articles to be released much sooner than otherwise, thus potentially getting medically sound data to the public as soon as possible. However, this data cannot, and should not, be relied upon to make medical decisions if there is a fundamental conflict of interest. The only way medical journals can protect their integrity is to take a very firm stance against ghostwriting, and institute strict policies to identify and combat it.

Originally posted at InjuryBoard by Don Greiwe

Nonprofit Nursing Homes Provide Better Care

Don Greiwe — Thu, 01 Oct 2009 08:01:00 GMT

A group of doctors from around the world have came together to take a hard look at the relationship between nursing homes and profiteering, and the results reaffirm what many of us would have guessed: Nonprofit nursing homes provide better care than for-profit nursing homes.

Dr. Gordon Huyatt, the senior author of the study, stated “the reason patients' quality of care is inferior in for-profit nursing homes is that administrators must spend 10 percent to 15 percent of revenues satisfying shareholders and paying taxes,” and as a result, “For-profit providers cut corners to ensure shareholders achieve their expected return on investment.”

Looking at 82 different statistical studies taken into account, 40 significantly favored nonprofit facilities. This means that in 40 of the 82 reports, it was obvious that patients received better care at the nonprofit facilities compared to for-profit facilities. On the flip side, only 3 of those studies favored for-profit facilities. The remaining 39 studies had inconsistent findings and were not counted either way. The study looked at four major factors in determining quality of care:

More or higher quality staffing;
Lower rates of pressure ulcers;
Less use of physical restraints; and
Fewer deficiencies cited by regulatory agencies.

These findings have significant implications for patients across America. Of the roughly 80,000 patients who have bedsores, 7,000 of those can be attributed to for-profit ownership. Additionally, the study went on to predict that if all the current for-profit nursing homes converted to nonprofit, 500,000 hours a DAY would become available to residents without additional cost.

There are many ways to interpret the study data, but the overall conclusion is clear: nonprofit nursing homes offer better care than for-profit ones. These sorts of studies may be very important in the health care reform debate, as many reformers push for an increase in “evidence-based medical treatment.”

Moving forward, if you or a loved one needs the care of a nursing home, look into whether that home is for-profit or not, because it clearly should be a factor to consider.

Originally posted at InjuryBoard by Don Greiwe

Tobacco Makers Sue U.S. over Free Speech

C. Todd Alley — Tue, 29 Sep 2009 08:37:43 GMT

A group of tobacco manufacturers, including RJ Reynolds, Commonwealth Brands, Inc., National Tobacco Co., and Lorillard, sued the U.S. Government in August claiming the new federal law passed in June called the Family Smoking Prevention and Tobacco Control Act unconstitutionally restricts their ability to communicate with consumers and unfairly limits their ability to promote new tobacco products. The new law gives the FDA broad powers for the first time for approving all new tobacco products (but not products already on the market), requires larger warnings on cigarette packages, and places harsh restrictions on tobacco advertisements. The Plaintiff tobacco companies say the new law goes too far in restricting their commercial free speech rights.

“While the act is purportedly intended to reduce youth tobacco use, a number of its provisions broadly restrict all speech by plaintiffs about tobacco products,” according to the complaint. Plaintiff Tobacco companies called some of the restrictions “egregious,” saying that Americans have “been well-informed of the harms of tobacco use” for decades.

Noticeably absent from the lawsuit was tobacco giant Philip Morris. Interestingly, Philip Morris was a very enthusiastic backer of the new law and has been in favor of FDA regulation. So if not all of Big Tobacco is rallying behind this lawsuit, what’s the true motivation for this suit? The answer’s clear. Philip Morris is the largest tobacco producer in the U.S., holding over 50% of the cigarette market share in the U.S. Meanwhile, RJ Reynolds and Lorillard control 28% and 11% of the market, respectively. And because the law adds new limits on the ways cigarette manufacturers can promote new products, RJ Reynolds and Lorillard adamantly declared that Philip Morris’ dominance will continue.

So is this lawsuit really a question about free speech and the government’s rights to limit advertising harmful products? Is it a question about the government’s role in protecting public health? Or is it just a handful of tobacco companies who see the new advertisement restrictions undercutting their bottom line?

Originally posted at InjuryBoard by C. Todd Alley