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Hopkins

Risperdal and Diabetes — Another Tale of Marketing Over Disclosure

Published by John Hopkins in Mass Torts, Product Defect, Uncategorized

Johnson & Johnson has been ordered by a South Carolina court to pay $327 million for minimizing the links between its antipsychotic drug, Risperdal, and diabetes.

The case centers on allegations that Johnson & Johnson marketed Risperdal in a way that was misleading in product labels, “Dear Doctor letters” and in personal sales calls to physicians.

In 2004, the Food & Drug Administration sent Janssen Pharmaceuticals (the division of Johnson & Johnson responsible for Risperdal) a warning letter. The FDA had received post-marketing reports of diabetes mellitus developing in patients who were prescribed Risperdal. The FDA had previously demanded that Jannsen send a warning letter to physicians and it its 2004 correspondence sets forth that Johnson & Johnson minimized the “…risks associated with Risperdal and claims that Risperdal is safer than other atypical antipsychotics, when this has not been demonstrated by substantial evidence or substantial clinical experience”.

In the South Carolina case, the state sued Johnson & Johnson and alleged that deceptive information was disseminated about the dangers of Risperdal and, in particular, that the company downplayed the significant dangers of diabetes secondary to taking the drug. In the ruling, the judge, Judge Roger Couch, wrote a 17 page decision that the drug maker’s executives had “allowed the profit-at-all-costs mentality to cloud” good judgment that would have resulted in a clear warning about Risperdal.

Risperdal was a very big seller for Johnson & Johnson until it lost its patent on the drug. Sales in 2007 were $4.5 billion and declined to $527 million last year. The drug maker still made over $8 billion in the years 2007 to 2010 in sales of the drug.

Judge Couch found that Johnson & Johnson had marketed the drug using labels with deceptive information, marketing letters to physicians and sales calls to doctors’ offices. He fined the drug manufacturer in hundereds of thousands of individual instances for violation of South Carolina’s state consumer protection laws.

Similar cases have been heard in Pennsylvania, Louisiana, and West Virginia.

Johnson & Johnson has indicated they will appeal Judge Couch’s decision.

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Deborah Knapp

A Double Play for Insurance Companies — Governor and the Florida Legislature

Published by Deborah Knapp in Uncategorized

Homeowners Insurance in the State of Florida is already out of reach financially for many Floridians who own homes and are struggling in this economy to makes ends meet.

We have gone several years without hurricanes and when we had a few in 2005 homeowners insurance rates went through the roof.  What happened to all the profits that the insurance industry made for all the years that Florida did not experience any storm damage?

To make matters worse, on May 17, 2011 Governor Rick Scott signed into law SB 408.  This law is for the benefit of the insurance industry and certainly not for the people of the State of Florida.

Senate bill 408 does a number of things in favor of insurers and one of the primary gifts is to  allow insurance companies to raise rates up to 15 percent without filing for approval with the Office of Insurance Regulation.

The law also makes it harder for Floridians to collect on claims.  Insurance companies will be permitted to withhold a percentage of the loss payment until repairs are made and, understandably, contractors are going to insist on payment in order to affect repairs. How many people in the State of Florida can afford to pay for repairs and then get reimbursed from your insurance company?  To pay out of your own pocket for repairs defeats the purpose of having insurance.

For articles further explaining the problems created by this new law, click here.

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Brenda Fulmer

What Risks of Ibuprofen Should Have Been Disclosed?

Published by Brenda Fulmer in Uncategorized

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.

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Hopkins

Are Legislators Drafting Laws… or Insurance Industry?

Published by John Hopkins in Uncategorized

“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)

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Hopkins

Do we have a “government by the people for the people”?

Published by John Hopkins in Miscellaneous, Uncategorized

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.

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Hopkins

What does “by the people, for the people” actually mean?

Published by John Hopkins in Miscellaneous, Uncategorized

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”.

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Hopkins

What does my mom or dad do?

Published by John Hopkins in Uncategorized

Our Firm had fun yesterday by welcoming the children of our employees to share “Bring Your Kids to Work” day.

Our Human Resources Director, Renee Govig, organized an educational and fun experience for all our future leaders. She was joined by her assistant, Lindsay Radziwon, and many others here at the firm in delivering the experience, including: Partner, Jack Scarola; Dave True, our Firm Administrator; Dave’s assistant, Erica Matthews; Joan Williams, our Marketing Director; and Robin Kriberney, our Community Relations Director.

The children inspected vehicles involved in automobile accidents and were taught safety while riding in cars by Dave Gilmore, paralegal-investigator. They visited our technology department and were amazed by our IT guys, Curtis Reynolds and Scott Colburn. They went to a travel agency and were taught about how travel happens for everyone. The kids visited with a graphic artist and a graphics arts company, Above & Beyond Reprographics, as well.

A special thanks to all of our employees I have failed to mention for making this such a great day for the children. We were happy to be able to provide an opportunity for our kids to see what their moms and dads do for a living.

After a day of great fun and learning, all the children were ready for graduation:

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Deborah Knapp

Congratulations to Lake Worth, FL — Protecting Victims Without Voices

Published by Deborah Knapp in Miscellaneous, Uncategorized

I am saddened that all too often I turn on the television or pick up the local newspaper only to read about another horrific incident of animal abuse; once again it has happened, this time in my own back yard.

A Lantana, FL pet shop owner who had 26 cats, dogs, a rabbit, a bird and a hedgehog seized from her and was jailed on unspecified charges. Authorities also found five dead dogs and cats in her freezer.

There are puppy mills in which sometimes dozens of animals are confined to small cages; destined only for breeding. These animals often never feel the kind touch of a caring human being; receive no comforting petting; and no love at all.

Reports have been developing of even pet store owners breeding animals in cages in their homes in deplorable conditions. Unscrupulous breeders over breeding dogs and cats in order to make a buck are becoming more and more common.

For these reasons, I am proud to say that Lake Worth, Florida has become the first city on the East Coast to ban the sale of dogs and cats in pet stores.  The city of Lake Worth, Florida only allows the sale of dogs and cats on the same property where they were bred, which effectively prohibits pet shops from selling animals.

There is no excuse for abusing animals.  We need stricter penalties, fines and jail time so that people will think twice before they abuse an animal for any reason. Sadly, we still consider pets to be chattel and, as long as they remain property, I am afraid we will continue to lag behind in our own humanity.

Perhaps we should be reminded of what a great and peaceful man once said: “The greatness of a nation and its moral progress can be judged by the way its animals are treated.”

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Hopkins

What are the hot investments in Tallahassee?

Published by John Hopkins in Miscellaneous, Uncategorized

What do you want from the people you elect to public office?

Honesty? Candor? Fairness? Intelligence? Independent thinking? To listen to you, the people who voted them into office?

If only things were that simple. The problem is the noise. At least in Florida, legislators have a great many interests whispering in their ears and, so far, no shouting from constituents.

So, as the Florida legislature drafts, proposes and passes legislation for sweeping changes in the very best interests of the lobbyists whispering to them, let us take a look at the various interests gaining representative and senator attention:

$4.2 million – this is the amount of money spent just in 2011 by the top two dozen companies and special interests in order to court lawmakers.

$45 million – this is the amount of money poured into the 2010 elections by the 30 largest contributors to pick the special legislators we have today.

So, what have the special interests put on their shopping list?

  • Walt Disney wants to maintain its tax advantages – bid, $188,010
  • Universal wants tax breaks for its film company – bid, $181,549
  • The Florida Association of Realtors wants a property tax cut – bid, $275, 500
  • Health care and insurance groups want reforms to further improve their already plentiful bottom line – bid, $449,500 from just one of the companies
  • Florida Power & Light, TECO, and Progress Energy want permission to tax customers to pay for solar plants – bid, over $748,000
  • GEO Group, a private prison company wants, well, to run all Florida’s prisons – bid, $106,000
  • Florida Chamber of Commerce wanted to get a very special Senator, John Thrasher, reelected – bid $1.5 million
  • Florida Chamber of Commerce wants to better the bottom line of its corporate members, including Publix, Disney, land developers and other interests. They contributed even more to get our special legislators elected – bid $5.5 million
  • Florida Chamber of Commerce did not want to lag behind in its efforts, so it continues to give in 2011 – bidding has started at $257,000
  • AT&T wants a new phone bill (advantageous legislation) and so they gave and keep on giving – bid, $1.7 million on last year’s lobbyists, $1.4 million on last year’s campaign contributions and $177,847 so far in 2011.

These groups are not letting up either. It is reported that the Florida Chamber of Commerce has 30 lobbyists ram-rodding 65 bills.

It is no wonder that many lawmakers have warm feelings for the Florida Chamber of Commerce. As Rep. Mike Horner, a Kissimmee representative said:

“They are an invaluable ally. My door is always open to the Chamber, and they were very helpful during my election. But we ran on creating jobs. So, the idea that it looks like we may have a pro-business session shouldn’t surprise anybody.”

No, Mr. Horner, no one is surprised in the least. Business groups and corporations have paid well for what they have gotten. We voters just really expected legislators would represent Florida citizens, rather than foreign corporations.

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Hopkins

Politics–Don’t we wish for public servants again?

Published by John Hopkins in Uncategorized

In days of old when knights were bold and gentlemen believed in honor…

In those days of old, if you were to wrong me and failed to pay proper recompense, we dueled…often to the death. Today, in our democracy, we have access to the courts for redress of our differences without you and I being forced to duel.

Our “founding fathers” (Washington, Jefferson, Adams) never expected that politics would become a vocation. They saw political service as the duty of gentlemen owed to their country. It was an honor bestowed to be allowed to represent the people in protecting them and in furthering the best interests of the country or state.

Unfortunately, politics has become a vocation and politicians have strayed from representing the people to efforts at garnering power. Today, in addition to the Florida legislature’s apparent need to legislate in the very best interests of their present constituents by passing legislation aimed at maximizing corporate profits, they have decided to take on the “balance of power” as well.

Our form of government is safe as long as the “balance of power” is maintained between the three branches: the executive branch, the legislative branch and the judicial branch. Our system provides for a workable, but delicate, set of checks and balances meant to prevent one branch from gaining too much power over any other branch.

The Florida legislature, or at least the majority in the House, believes they know better than the founding fathers or, perhaps, they are simply living out their political vocation. In any event, the legislature now deems it knows best how to structure the court system and has just passed a bill identified as CS/HJR 7111. In this bill, the legislature has decided to put upon the people of Florida a constitutional amendment to recreate the way in which the Florida Supreme Court is structured, the way in which it operates and, ultimately, the seat of power over the judicial branch.

But why? Legislators have postulated several reasons for why this amendment is needed.

They say that death penalty cases can be moved more quickly to execution. According to former Supreme Court Justice, Raoul Cantero, this is completely untrue:

Mr. Cantero agreed they can take years to navigate the justice system, “but very little of that time is in the Supreme Court,” he said. “It’s just not the case that the Supreme Court is holding them and not deciding them.”

The Tallahassee.com reported one legislator’s and one former Governor’s view on the legislation:

The legislator said he wants to improve the court’s efficiency, including dealing with death-penalty cases. But a bipartisan group of former justices, former and current judges, former U.S. Sen. Bob Graham and Florida Bar leaders spoke out Thursday saying those reasons are without merit.

The legislators also maintain that specialization is important. One House member pointed out that: “The civil side can take away your property and your money. The criminal side can take away your liberty and your life.” Well, yeah, but this ignores the balance the court needs to arrive at many of its decisions. Some decisions find their basis in a mix of civil and criminal law. In addition, the Supreme Court is a court of review. The Supreme Court largely decides cases based on procedural and constitutional history and law; those are their areas of specialization.

The bill passed by the house also provides for additional provisions that would effectively do nothing but allow for “court packing”. They would allow for the party with the most power to pack the court with “their people” and maintain that control for as long as eight years or more at a time. Again, not really keeping with the whole “balance of power” portions of the constitution.

In a time when politicians claim they want less government, lower taxes and less spending, this proposal is an unnecessary expenditure of money; since some have estimated that restructuring the court will likely add many millions of dollars of overhead to an already operating fund starved court system.

Let us look at a couple of issues behind the legislative and executive branch that could be the motivation for this desire to restructure the balance of government power.

Some of the legislators involved in this court restructuring tried to get a couple of constitutional amendments placed on the ballot during the last election season. The Supreme Court found those constitutional amendments did not comply with the law because the summaries did not reflect the full or true nature of what the actual amendment was meant to do.

For all amendments, the Supreme Court is required to approve the amendments to confirm their form is in compliance with the law before they can be placed on the ballot. Every amendment you read on a ballot has gone through this very same vetting by the Court. Each election season, amendments are approved and disapproved by the Supreme Court. The Court quite often finds amendments do not conform to the law and exclude them from the ballot.

So, you decide. Is this an effort at necessary restructuring to solve a real problem or are these efforts simply in search of a problem that really does not exist? Are the real goals for the proponents of this constitutional amendment bill to improve the efficiency and specialization of the Court or to simply improve their own ability to control the Court?

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