According to new studies, the latest generation of birth control pills, including Yaz, Yasmin, and Ocella, put women at a higher risk of blood clots than other types of birth control pills.  These fourth-generation birth control pills carry a two-to-three times greater risk of venous thrombosis, also known as blood clotting, than previous generations of birth control.  The symptoms of venous thrombosis include pain, swelling, and redness in the extremity where the blood clot is located, which is often in the calves, a condition also known as deep vein thrombosis (or DVT).  Venous thrombosis can also lead to blood clots in the lungs, a life-threatening condition known as pulmonary embolism, which is characterized by shortness of breath, chest pain, and anxiety. Yaz, Yasmin, and Ocella have also been shown to cause heart attacks, strokes, and gallbladder disease.

Drospirenone is the progestin ingredient found in this fourth generation of birth control. Pills that were introduced years ago, known as second generation oral contraceptives, contain an older form of progestin called levonorgestrel, which is considered much safer than newer drugs, and lower doses of estrogen than are contained within the original birth control products first marketed decades ago.  The third generation birth control pills, which were introduced during the 1990s, contain progestins such as desogestrel and gestodene, and are perceived as also being less safe than the older second generation formulations.

Drospirenone causes venous thrombosis by increasing potassium which in turn disrupts heart rhythms and slows blood flow, leading to clotting.  According to the FDA, this latest generation of birth control pills does not possess any added benefit as compared to earlier formulations, but do subject patients to substantially higher risks.

Yaz and Yasmin both became popular very quickly after  they were introduced to the market and made Bayer, the company that produces Yaz and Yasmin, billions of dollars.  In order for a drug to become popular so quickly, there must be something that sets it apart from other drugs on the market.  But there was nothing that made Yaz or Yasmin better than second generation birth control pills, but, rather, the success of the pills stemmed solely from aggressive marketing, including marketing that was found by the FDA to be in violation of federal law as it promoted the drugs for unapproved uses.

(more…)

On May 20, 2011, a jury ruled that Johnson & Johnson’s McNeil Consumer Products, the producer of Motrin, must pay damages of $10 million to the family of a 13-year-old who suffered severe injuries resulting from Stevens Johnson Syndrome after taking Children’s Motrin.

After taking Children’s Motrin to treat a fever when she was three and a half years old, Brianna Maya was left blind in one eye and burns covered 84 percent of her body.  The jury found McNeil negligent in failing to warn of the serious risks associated with Children’s Motrin and that the failure to warn was a “factual cause” of Maya’s injuries.

Stevens Johnson Syndrome is a serious skin disease in which a person’s mucous membranes react violently to a medication.  This complication is almost always a medical emergency and develops rapidly causing severe and debilitating injuries. The onset of the disease is usually marked by flu-like symptoms, followed by a rash and blistering which causes the top layer of the skin to shed.

The lesson that should be learned? The duty of pharmaceutical companies to clearly warn consumers of potential risks.

Even where there is a small chance for the occurrence of these risks, consumers still have the right to know and pharmaceutical companies have the clear duty to set forth warnings in a way consumers can understand.  A portion of the population may have an adverse reaction to Motrin and other products containing ibuprofen.  Even though no changes are being made to those products, consumers should still be made aware of these risks.

Johnson & Johnson has begun to include warnings that that ibuprofen, Motrin’s active ingredient, could trigger “a severe allergic reaction.” Consumers are also urging the FDA to require labels warning of the risk of Steven Johnsons Syndrome associated with other drugs containing ibuprofen.

Keeping the public informed about the potential risks associated with drugs is a part of the duty owed by those who wish to profit from the sale of drugs and is the best way to prevent injury to otherwise unsuspecting consumers.

Thank you Florida Legislators. Thank you Governor Rick Scott.

That gratitude is undoubtedly spilling forth throughout the hallowed halls of every insurance company writing property insurance in the State of Florida.

The Florida legislature passed Senate Bill 408 after a similar bill had been previously vetoed by Governor Charlie Crist. With a super majority, the legislature wasted no time in pushing something through to make insurance companies and the Chamber of Commerce feel, well, real warm and fuzzy. On May 17, 2011, Governor Rick Scott quickly made it happen by signing the bill into law.

Senate Bill 408 does several things, but one of them stands to create a situation made famous in the novel by John Grisham titled, The Rainmaker. Having worked in the insurance companies at most of the levels and having run claims divisions, I feel confident in predicting where part of the bill is going.

The bill sets forth that if a policyholder submits a claim for sinkhole damage and the insurer denies coverage, the insured must pay 50% of the cost of sinkhole testing, up to $2500, after an insurance company denies the claim. The law does not provide for the insurer having any documented expert basis for denial of a claim.

So, here is how it is going to proceed in some insurance companies:

Mr. Smith has damage to his foundation that he first noticed on his concrete porch. Mr. Smith’s contractor comes out and takes a look at the damage. The contractor, a seasoned general contractor, excavates around the foundation and tells Mr. Smith he has suffered sinkhole damage. Mr. Smith submits a claim to ABC Insurance Company. An unwritten rule developed in the claims department of ABC soon after May 17, 2011, tells adjusters to deny coverage for every sinkhole claim. When Mr. Smith calls to ask about the denial of his claim, ABC’s adjuster may tell him that they will reexamine the damage, but only if Mr. Smith pays half of the first $5000 in costs of an engineer. Mr. Smith asks what the cost will be and the adjuster tells him it will be at least $5000. Mr. Smith needs to come up with $2500 for the costs.

What the insurance company knows is that of all the claims they simply deny, a large percentage of the people will be unwilling or unable to come up with the $2500 for the engineer to “appeal” the denial of their claim. So, the insurance company knows they will win without a fight in most cases and they can always retract their denial if things look like they are getting out of hand otherwise.

The bill also allows for insurance companies to increase premiums up to 15%, of course with approval of the state’s insurance regulator (wink, wink, nod, nod). Net result: expect your insurance premiums for homeowners’ coverage to increase by 15%.

So, from the bottom of the insurance industries’ “heart”: Thank you Mr. Governor, Mr. House Speaker and Mr. Senate President, and all the corporate lobbyists at the Chamber of Commerce for a job well done.

Now, let’s get to work so you can pay for those increases.

“I love insurance companies and want them to make even more profit than they already do. That’s why I am a Florida Legislator!”

This should be the button being worn by most legislators in Florida who permitted an unsubstantiated and unfounded bill to be passed during this most recent business oriented session of the legislature. That bill now sits on the desk of Governor Rick Scott.

The bill provides for a number of things – all of them, every one of them, bad for consumers, but good for insurance companies.

Insurance companies say the legislation will help cut down on fraud. This is fraud that was not documented or proved to even be happening beyond the statements of insurance company advocates like Sam Miller, with the Florida Insurance Council:

“We are paying out hundreds of millions of dollars in fraudulent sinkhole claims and hurricane claims that are filed five years after a hurricane and an awful lot of those are fraudulent.”

That is all that has been seen or heard from insurance company “experts”: shucks, an awful lot of these suckers are fraudulent (we believe or, at least for purposes of getting this bill passed, that is our story and we are sticking to it).

The legislation is like a wish list for the insurance industry:

• Elimination of sink hole coverage
• No full payment of claims until verification of repairs (even if contractors will not finish without the assurance of prompt payments that insurers are not know for)
• A 15% rate hike without state approval

What it seems legislature leaders did is to sit down with property insurers and ask, “so what do you guys want?”

Contact Governor Rick Scott to express your feelings about unregulated insurance company sponsored bills:

Office of Governor Rick Scott

State of Florida

The Capitol

400 S. Monroe St.

Tallahassee, FL 32399-0001

Email: click here to send email

(850) 488-7146

(850) 487-0801 (fax)

“Women Build is a Habitat for Humanity International program that encourages women to make a difference by building homes in their local community.” Women are encouraged and the organization helps to empower women to encouraging groups of women to help with the funding and building of homes.

Saturday May 7, 2011 the Florida Association for Women Lawyers (FAWL) asked its members to participate in this special day and our own ladies of Searcy Denney Scarola Barnhart & Shipley made a strong showing.

We participated in a range of activities which included roofing, exterior painting, land clean-up and other miscellaneous work-site tasks at 3033 Jennings Avenue in Greenacres.

I was pleased to be joined by others at my firm, including fellow attorney Laurie Briggs, marketing director Joan Williams, administrative professionals Suzanne Mabie and Amanda Gauger. Employee spouses and friends also lending a hand for habitat included: Jessica Covey, Annie Bass, Sarah Wojton, Julie Schnee and Candace Majercik.

We worked together with other women in the legal community as well as the recipients of this home and future Habitat for Humanity home owners.  It was a powerful experience to see such a diverse group of women join forces to accomplish so much in just one day.  It really proves that a little sweat equity truly goes a long way.

I speak for all of us with this well known quote, “You make a living by what you get.  You make a life by what you give.”  Volunteering in our community… another great way to “take time to care”!

The recent news about the Food & Drug Administration’s (FDA) actions in connection with hip implant manufacturers demands the question: why wasn’t the action being ordered required before the hip implants were placed on the market?

The answer is that the FDA’s order to 20 device makers to study the effects of heavy metals, like cobalt and chromium, and their effect on humans was something that manufacturers should have done before placing hip implants on the market. The FDA is now ordering the study to involve patients who have already had the hips implanted, but that is simply because “the deed is done”.

The FDA relies heavily, right or wrong, on the representations of medical device manufacturers and the studies they conduct. The FDA examines the data produced by the manufacturers but the FDA has neither the personnel nor the funding to conduct their own independent studies. Instead, the FDA relies on the truthfulness of the manufacturer who, after all, should know and understand the potential risks of the very device they have manufactured.

So, why would medical device manufacturers rush their product to be implanted in unsuspecting patients?

Money.

It is not entirely a pure profit issue. Manufacturers typically have products in development and testing for lengthy periods of time and their investments have a long shelf life even before they can be sold.  Manufacturers are denied the use of the money invested; they earn no return on that money; and they often have independent investors and stockholders to whom they must answer. They are sometimes denied the ability to begin developing the next best “widget” because of funds tied up in product development. So, they sometimes rush to production.

Sometimes it is a profit issue.  Manufacturers see a particular product in development as having significant potential to generate high sales and, thus, large profits. They cut a corner here; they cut a corner there; and, all of a sudden, they have sent a dangerous product into the market.

In the case of hip implants, the FDA spokeswoman, Karen Riley said, “There is not enough scientific data to specify the concentration of metal ions in a patient’s body necessary to produce adverse systemic effects.”

Is heavy metal concentration from leaching of cobalt and chromium ions into the human body something that manufacturers could have and should have anticipated and tested for? Of course they should have. Why didn’t they?

Money. Profit. Shelf life of investments.

Any one of these business motivating factors may have caused it. Did they mean to hurt people? Unlikely. They simply allowed the need to market overcome their need for caution and good judgment.

The FDA action involves 20 manufacturers, including: Johnson & Johnson (Depuy), Biomet Inc., Stryker Corp. (SYK) and Zimmer Holdings Inc. (ZMH).

Perhaps sometimes these manufacturers forget they are not manufacturing “widgets”, they are manufacturing parts of peoples’ lives.

The legislature passed and failed to pass a number of bills during this legislative session. Some have said that the session demonstrated a great deal of work on the part of legislators, while others have said it amounted to a session about cutting business deals.

Some bills of importance:

Bike Safety (SB 118/HB 981): Failed. Legislators do not see as important the requirement that childrens’ bicycle helmets comply with federal safety requirements.

Booster Seats (SB 238/HB 11): Failed. Legislators saw no need to specify safety requirements for children 4 to 7 years old.

Doctors & Guns (SB 155): Passed. Legislators found it necessary to pass a law prohibiting physicians from asking about guns in the household. This often comes up when pediatricians are counseling young parents about household safety for children.

Expansion of Charter School Programs (SB 1546/HB 7195; SB 1388/HB 965; SB 1822/HB 1331): Passed. In one way or another, legislators promoted private charter schools and “demoted” public schools.

Virtual Schools (SB 1620/HB 7197): Passed. This bill is the legislature’s attempt to expand on-line schools and opens the door for the use of tax payer money to go directly to a private corporation, Florida Virtual School, without education professionals’ oversight. Anyone who has taken on-line instruction knows that we are not quite “there” yet, at least for children.

Citizen Challenges (SB 1382/HB 993): Passed. The state and polluters no longer must prove that a project will not harm the environment. The bill shifts the burden to citizens for the very expensive task of proving a project will be environmentally damaging.

Blind Trusts (SB 86): Failed. Would have required the governor and three cabinet members to place personal assets into blind trusts to avoid conflicts of interests when passing legislation, which will directly benefit them.

Elections (SB 2086/HB 1355): Passed. This bill provides for very serious and unnecessary limitations to early voting.

Ethics (SB 2088/HB 1071): Failed. This bill would have prevented lawmakers from voting on legislation that would benefit the lawmaker or an employer or relative of the lawmaker. One would have thought basic good character would prevent this.

Gun Control (HB 45): Passed. Prohibits local government from regulating firearms.

Medicaid (SB 1972/HB 7107, 7109): Passed. All recipients are to be placed into managed care corporations. The bill also places a limited value for the life or injury of Medicaid recipients negligently treated by physicians and hospitals.

Property Insurance (SB 408/HB 803): Passed. Significantly impairs consumers rights in the area of sinkhole insurance coverage and improves insurance companies’ ability to increase cost of coverage if provided. The bill also provides for a shorter time in which consumers can bring claims for damages resulting from hurricanes and windstorms.

Union Dues (SB 830/ HB 1021): Failed. Would have prevented unions from receiving dues through payroll deduction even if employees request them to be paid in this fashion.

Corporate Income Tax (HB 7185): Passed. Provides corporations with additional tax breaks.

Unemployment Compensation (HB 7005): Passed. Cuts state benefits to unemployed Floridians by reducing weekly compensation and limiting the total period in which compensation can be collected.

Leadership Funds (HB 1207): Passed by overriding previous veto. Allows the leaders in the House and the Senate to maintain campaign funds that are permitted to raise and spend unlimited amounts of cash.

Claims Bills: Failed. (5) cases in which awards were given for egregious injuries caused by the negligence of governmental instrumentalities. The bills would have provided for some amount of payment for these individuals; many who have waited over a decade for justice.

You should carefully read the bills and their various outcomes and draw your own conclusions, but, all in all, the legislative session seems to have been particularly good for lawmakers, lobbyists and corporations; but not particularly good for consumers or citizens of Florida.

Consumers are clearly not the focus of the current group that was elected to the legislature. Insurance companies and large corporations seem to be the acknowledged constituents for them.

The Sun Sentinel just reported on some of the bills that look like they could pass and how they stack up against the best interests of consumers (voters):

• Insurance companies can charge as much as they want to charge for coverage of sinkhole damages or they can drop sinkhole coverage altogether. Great news for insurance companies – not so much for consumers living on a sand bar.
• Allow insurance companies to raise rates without any regulatory review whatsoever in order to cover costs of advertising and agent commissions. So, the costs for selling you and me the product are going to be borne by, well, you and me.
• Shorten the time in which policyholders can file claims under insurance contracts. Currently, consumers have (5) years to file a claim or a lawsuit. The new legislation will shorten that time to (3) years for hurricane claims and (2) years for sinkhole damage (assuming your carrier is nice enough to provide that coverage).
• Allow insurance companies who insure both your home and your auto to drop coverage as long as they give you notice 90 days in advance. Legislators say this will invite at least one, as yet undisclosed insurance company, into our state.

Legislators say they are trying to ease the “insurance crisis” and lure insurance companies to Florida. I am not at all sure when we had an “insurance crisis” develop, but I have an idea for legislators:

Why not just pass a bill that unregulates insurance premiums, provides for consumers to pay all overhead costs of the insurance companies and permits insurance companies to deny claims whether they have a valid basis to do so or not.

Should you be concerned about what your legislators are doing to or for you in Tallahassee, visit them at “find your elected officials” and be sure to stop by and see the Governor at “contact Rick Scott”.