Tampa Bay Personal Injury Lawyer

FDA Seeks to Limit Acetaminophen Products Tylenol, Excedrin

Joe Saunders — Wed, 01 Jul 2009 10:32:14 GMT

The FDA will seek to lower the dosages of such acetaminophen products as Tylenol and Excedrin, long been considered to cause liver damage. In its panel vote, the FDA recommended lowering the maximum single and daily doses of acetaminophen.

In a related move, the FDA panel voted to eliminate such narcotics as Vicodin and Percocet, which combine narcotics with acetominophen.

According to a St. Pete Times article on the subject, acetaminophen products are the leading cause of liver damage and overdoses send an approximate 56,000 patients to the emergency room.

According to one local doctor, the panel vote is a long time in coming. "Hopefully, this will bring awareness to the population that Tylenol isn't as safe as people think," said Bryon Petersen, an associate professor at the University of Florida who specializes in liver regeneration, repair and disease. "It is a very nasty drug if used improperly."

Originally posted at InjuryBoard by Joe Saunders

Dirty Little Secret in the Health Care Insurance World Is Exposed

Jim Clark — Tue, 23 Jun 2009 08:00:00 GMT

Health insurance policy holders would expect to be paying an insurance premium so that they are protected in the event of serious illness. But that’s not always the case when the insurance company no longer sees the policy holder as profitable.

A greedy, unethical, and downright sleazy practice held by some of the world’s largest insurance underwriters has been the practice of rescinding policies of its customers using the contract technicalities. Desperate to drop policy holders who become seriously ill (many of whom have been paying their insurance premiums for years), insurance companies have encouraged its employees to find ways to terminate the policy, saving the insurance company millions of dollars in health care cost a year.

In one case, a nurse diagnosed with breast cancer was dropped because she failed to disclose a visit to a dermatologist for acne. In another, a man was denied coverage when diagnosed with lymphoma for failure to report a possible aneurysm and gallstones that his physician noted in his chart but did not discuss with him.

This has been ongoing for years, but only recently has it come to light. One day after President Obama outlined his proposals for reforming America’s health care system, a congressional subcommittee convened to tackle the issue of insurance policy rescission. They called upon top executives and took turns grilling them, from both sides of the aisle. When asked the question, “Would your company stop the practice of rescinding policies absent intentional fraud?” The answer given by three industry leaders was “no.”

Rep. Joe Barton (R-Tex.) stated “if a citizen acts in good faith, we should expect the insurance company that takes their money to act in good faith also." Rep. Bart Stupak (D-Mich.) was more aggressive, saying “when times are good, the insurance company is happy to sign you up and take your money in the form of premiums, but when times are bad . . . some insurance companies use a technicality to justify breaking its promise, at a time when most patients are too weak to fight back." Stupak also used this opportunity to support a public choice option in health care, saying such an option would help keep health insurance agencies honest, since customers would have other reasonable options.

Clearly, the insurance companies aren’t willing to limit policy rescissions to intentional fraud, so the government needs to step in to protect its people. California has already proposed legislature, but a problem as universal as this requires federal legislation. It will not be surprising to see a proposal coming out of the ongoing subcommittee meetings, and everyone – those for health care reform and those against – should support it. It’s not a matter of politics. It’s a matter of ethics.

Originally posted at InjuryBoard by Jim Clark

Medtronic Class I Recall of Kappa and Sigma Series Devices

C. Todd Alley — Mon, 22 Jun 2009 12:51:35 GMT

Medtronic, in conjunction with the FDA, has issued Class I recall – the most serious type of recall classification reserved for products whose continued use could lead to serious illness or death - of the following lines of pacemakers:

· Medtronic Kappa Series 600/700/900

· Medtronic Sigma Series 100/200/300

The recall has been issued because of a serious risk of operational failure. These devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components, such as the battery. Patients with malfunctioning pacemakers may experience a return of symptoms associated with abnormal heart rate, such as fainting or lightheadedness. Pacemaker-dependent patients may experience serious injury or even death. Most of the pacemakers affected by this recall have been implanted in patients for five years or longer.

Alley, Clark & Greiwe has been involved with Medtronic litigation for years, and our attorneys have been directly involved with other Medtronic recalls (including Medtronic Sprint Fidelis Leads and Medtronic Implantable Cardioverter Defibrillators (ICD) devices). While it’s unfortunate that another model line has been recalled, it is not particularly surprising. Please contact our office and we will help you determine if a particular pacemaker is part of this recall.

Originally posted at InjuryBoard by C. Todd Alley

Health Care Industry Funds Trips for Military Doctors

Don Greiwe — Mon, 22 Jun 2009 09:36:41 GMT

Numerous health care industry corporations have been paying for the travel of top U.S. military doctors in order to influence their prescription drug medication and medical device decisions, says a disturbing new Pentagon Travel report.

In one case, medical device manufacturer Cardinal Health paid Dr. John Szabo, former chief of the pharmacy service at a U.S. Army Health Clinic in Hawaii, $5,000 to attend a “leadership conference” in 2002. Just a year prior, Dr. Szabo was given over $1,000 by GlaxoSmithKline to attend a diabetes conference. And this is just one example. The investigation found 8,700 trips by Department of Defense officials paid for by the health care industry, totaling more than $10 million, from 1998 to 2007. Top medical industry sponsors include Johnson & Johnson ($215,221), GlaxoSmithKline ($120,690), and Hologic Company ($102, 876).

Companies have been using these tactics for years. Shahram Ahari, a former sales representative for the drug company Eli Lilly & Company, bluntly explained the strategy behind the free trips: “If it costs them a thousand dollars for a dinner, that’s a [patient’s drug] payment for one month. If they fly you on the Concord to Paris for five grand, even if they get one patient out of it, it’s a lifetime of cash.”

Studies in the Journal of the American Medical Association and CHEST, a medical specialty journal, have found a link between perks bestowed on doctors and an increased likelihood that physicians would prescribe a company’s drugs. And it’s no surprise that the health care industry is taking aim at the doctors and decision makers within the Department of Defense. The DoD prescription drug budget has quadrupled since the turn of the century to $6 billion a year.

Further, a recent article published in the St. Petersburg Times on June 19, 2009, reported that Medtronic, the world’s largest medical device firm, admitting to paying $850,000 to a former Army surgeon who was later accused of forging signatures and falsifying data for a study touting the benefits of one of the company’s implants.

Washington politicians have reacted in seemingly bipartisan fashion to curb the program. Senators Chuck Grassley [R – Iowa] and Herb Kohl [D – Wisconson] proposed legislation this year that would require drug companies and medical device manufacturers to publicly disclose all gifts given to doctors valued at more than $100. The bill will also require disclosure of physician ownership in private companies.

The bill doesn’t go so far as to outlaw the program, and maybe it should. But for now, the bill is a positive step towards health care transparency.

Originally posted at InjuryBoard by Don Greiwe

Bisphenol A (BPA) California Ban Prompts FDA to Reinvestigate

Don Greiwe — Thu, 18 Jun 2009 16:10:47 GMT

Bisphenol A, or BPA, is an organic compound used in the production of plastics around the world. BPA is found in plastics used in numerous industries. Some uses include children’s food and drink containers, water bottles, reusable food containers, CDs, DVDs, household electronic equipment, and much more. BPA has come under fire politically in the recent years, and an outright ban of its use in certain products across the nation may potentially be imminent. The FDA has recently agreed to revisit the safety issues concerning BPA at the urging of Democratic lawmakers.

The safety of BPA use has been in controversy for decades, but only recently have major reports began to study its effects on animals and humans. With an LD₅₀ of 3.25 gm/kg, BPA has a relatively low acute toxicity rating. What is a concern, though, is that even low doses of BPA can mimic the body’s own hormones, causing a disruption in hormone production. Because of this, chronic toxicity (danger posed by continual exposure of low doses of BPA) is potentially a serious health risk. Earlier this month the California Senate approved a bill that would limit the use of BPA, and outright ban its use in infant products, such as baby bottles. Retailers, including industry giant Wal-Mart, indicated it will no longer carry infant bottles made from BPA. Many companies now advertise their non-use of BPA and have even removed BPA-containing products from store shelves.

In 2008, FDA determined that the possibility of chronic toxicity did not pose a significant health risk to Americans. The problem with this report, though, is that it was based off two industry-funded studies by the American Plastics Council. According an Environment California study, the chemical industry has funded 12 studies relating to BPA, and all 12 studies concluded that BPA had no adverse effects. In a collection of 139 independent government funded reports relating to BPA, 128 (92%) found adverse effects of low-dose BPA.

Clearly, the FDA should base its regulation of BPA on an independent study. And thanks to recently appointed FDA Commissioner Margaret Hamburg, they will. The American Chemistry Council is opposed to any further research, obviously in an interest to protect the manufacturers currently utilizing BPA. ACC has stated previously that BPA in contact with food products “has been and continues to be recognized as safe by the U.S. Food and Drug Administration.” So, the ACC uses FDA in making its case to the public that it is a safe product, yet it is opposed to the FDA revisiting the issue again.

Ironically, ACC has called the FDA’s recent call for independent research a product of “pressure from vocal special interest groups.” You have to wonder if ACC is really worried about a ban of BPA-infused infant products, which most major retailers won’t carry anyway, or if it’s worried a greater health risk will be discovered in the new studies, results of which will be released later this year by the FDA’s acting chief scientist.

Originally posted at InjuryBoard by Don Greiwe

Zicam Sales Suspended by FDA

Joe Saunders — Wed, 17 Jun 2009 11:01:15 GMT

Matrixx Initiatives, Inc., a Scottsdale AZ healthcare company, has suspended sales of its highly popular nasal sprays Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Swabs, and Zicam Cold Remedy Swabs, kid's size because of its link with anosmia, a loss of the sense of smell. While the FDA can not order a product recall due to a lack of regulatory authority, the federal agency has taken the most aggressive action possible by ordering a sales suspension.

Matrixx officials have stated in a press release they'll comply with the FDA directive but would like an opportunity to meet with FDA officials to discuss the homeopathic over-the-counter remedy. Hundreds of consumer lawsuits have already been filed as a result of the product's link to anosmia with many more expected as a result of the FDA action.

Originally posted at InjuryBoard by Joe Saunders

FDA Proposes Stricter Guidelines in Drug Advertisements

Don Greiwe — Tue, 16 Jun 2009 14:13:01 GMT

Televisions advertisements which drug manufacturers use to target potential customers, also known as Direct-To-Consumer (DTC) ads, are commonplace in the industry. In fact, according to a Public Library of Science report, the industry spent $57.5 billion on advertising in 2004, and only $31.5 billion in research and development in the same year. While not every drug’s development costs are dwarfed by advertising costs, these numbers show just how competitive the drug industry has become.

With sophisticated spending comes sophisticated advertisements. Manufacturers have utilized unique methods of promoting their products’ benefits without fairly conveying the side effects. A common technique has become creating a busy on-screen image while side effects are being described, distracting the average viewer. Schering-Plough drew criticism from a congressional hearing for its Nasonex ad featuring a bee that flew around during a description of side effects but simply hovered while benefits were explained.

The FDA already has guidelines in place, but they are fairly basic and do not address some of the newer tactics used by drug manufacturers. Representatives of the drug industry have stated they have adopted their own stricter “standards” for advertising, but certainly this is a situation where FDA needs to revise its standards.

In response to the manipulation of the rules set in place, the FDA has drafted a set of guidelines which go into particularity, even giving examples of do’s and don’ts in DTC advertising. The proposed guidelines are found in a draft report titled “Presenting Risk Information in Prescription Drug and Medical Device Promotion.”

This looks to be a big leap forward in regulating the drug industry’s DTC ads, and hopefully will be finalized without major change in the near future.

Originally posted at InjuryBoard by Don Greiwe

Empowered at Home Act Returns to the Congressional Floor

C. Todd Alley — Tue, 16 Jun 2009 10:19:37 GMT

The Empowered Home Act is common sense. The bill looks to solve a serious health care concern by ensuring America’s senior citizens are given simple and potentially cost-saving alternatives to nursing home care.

More than one million senior citizens in America live in nursing homes, and it’s no surprise that many of them would prefer to remain at home. In fact, 89% of people 50+ want to remain in their homes as they age, according to AARP's Public Policy Institute. However, under the current Social Security Act, nursing home coverage under Medicaid is required, while home and community-based health services are optional. These optional services are often far cheaper than nursing home care – but since they’re optional, they are the first on the chopping block in a poor economy nonetheless.

The Empowered Home Act makes these home and community-based services required in state Medicaid programs. AARP President Jennie Chin Hansen put it best, “there's no excuse for a program as critical as Medicaid to force people into more expensive institutions when we could be saving money and improving the quality of life for so many Americans."

According to govtrack.us, the bill was introduced by a bypartisan group of senators in 2008. Then the bill was referred to the Committee on Finance, never to be heard from again.

Now the bill has been reintroduced on both the Senate and House floor. Sponsoring the bill on the House floor is Rep. Frank Pallone [D-NJ] and Rep. Diana DeGette [D-CO]. In the Senate, Sen. John Kerry [D-MA], Sen. Susan Collins [R-ME] and Sen. Charles Grassley [R-IA] are sponsoring the bill.

Clearly, this bill has bipartisan support. And why shouldn’t it? It reduces the overall cost of Medicaid, while giving seniors more options for care and improving their quality of life.

You can track the bill’s progress here. If you see the common sense in this bill, make sure you let your local senator and congress persons know. Click here to easily contact your local U.S. Senators and U.S. Representatives.

Originally posted at InjuryBoard by C. Todd Alley

NY Child Victim Act May Come Up For Vote Today

Joe Saunders — Tue, 16 Jun 2009 10:01:41 GMT

The much antipated Child Victim Act may finally reach a vote in the NY State Legislature today. The bill has been aggressively opposed by the NY State Catholic Conference and Brooklyn Bishop Nicholas DiMarzio and Rockville Centre Bishop William Murphy.

The bill has been amended by its sponsor Rep. Margaret Markey to include both public and private institutions. The measure would allow childhood victims of sexual abuse the opportunity at justice in the courts. Since the statute of limitations has long since passed in many of these tragic cases, the bill would allow those abused by priests, nuns, teachers, and other public officials to bring lawsuits against the perpetrators as well as the institutions who covered up the systemic abuse. One amendment to the bill which is not so good but necessary for passage is the age restriction placed on the measure. Only those who have not reached their 53rd birthday would be eligible.

In sum, here's hoping the bill passes so that thousands of childhood sex abuse victims can seek justice and healing.

Originally posted at InjuryBoard by Joe Saunders

Nearly 50% of Hospitals Don't Report Significant Physician Misconduct

Don Greiwe — Wed, 10 Jun 2009 10:45:42 GMT

Last month, Public Citizen reported a decline in physician discipline among state medical boards. Now Public Citizen has released another disturbing report on the health care industry. The report shows almost 50% of U.S. hospitals have not reported a single disciplinary action to the National Practitioner Data Bank (NPDB). The NPDB was established by the Health Care Quality Improvement Act of 1986 to protect patients from questionable physicians. Reporting physician disciplinary actions to the NPDB for misconduct resulting in a 31+ day revocation or suspension of license is required by law.

In 1991, a year after the NPDB was opened for reporting, there was 830 reports recorded. In 2007, that number was 551 (and that is not even the recent low). While it would be great to assume that this lower reportage is due to less need for physician discipline, Public Citizen has other explanations.

The report noted that some hospitals avoid the legal requirement to report moderate to long term suspensions by a number of means. One such way is changing their bylaws, intentionally making more types of misconduct warrant a suspension less than 31 days. Also, hospitals can ask the physician to take a "leave of absence" in place of a suspension. This means that the hospital would not be required to report the suspension, and thereby avoiding any blemish to their record. Some hospital officials argue that the NPDB creates an adversarial environment between the doctor and the hospital.

“It is impossible to justify the fact that thousands of hospitals, which collectively have granted admitting privileges to hundreds of thousands of doctors, have not reported a single discipline case in 17 years," said Sidney Wolfe, MD., acting president and director of Public Citizen's Health Research Group, which issued the 38-page report.

The failure of hospitals to discipline or report therefore deprives state medical boards of critical information and creates the potential for patient harm. Now is the time to revise the reporting standards of NPDB – and to close loopholes so many hospitals have used to avoid reporting physician discipline.

Originally posted at InjuryBoard by Don Greiwe