West Palm Beach Personal Injury Lawyer - Miscellaneous

Loser Pays -- Tort Reform Hypocrisy

Patrick Quinlan — Fri, 13 Nov 2009 15:06:08 GMT

I just read another anti-lawyer diatribe by John Stossel. Mr. Stossel is one of the great many Tort Reform Hypocrites: people who scream in public about evil trial lawyers filing frivolous lawsuits for pain and suffering damages, but then run to a trial lawyer the moment that they feel that their rights have been violated. Mr. Stossel has said:

“We all have pain and suffering in our lives. And if each time we hang onto it until we get some kind of compensation, society can’t work.”

Yet when a pro wrestler slapped him in 1986, what did Mr. Stossel do? He sued for -- you guessed it -- pain and suffering damages.

Mr. Stossel ends his latest attack on plaintiffs’ lawyers with this suggestion:

"America needs “loser pays." Lawyers marginalize "loser pays" by calling it “the English Rule," as if it’s some peculiar British rule. But it’s not. "Loser pays" is the "Rest-of-the-World Rule."

To Mr. Stossel and all of his tort reform warriors, I say “be careful what you wish for.” By no means do plaintiffs’ lawyers win every lawsuit. But, according to a Bureau of Justice Statistics report, plaintiffs won 59% of state court civil trials in 2005. Interestingly, that number is up from 55% in 2001, and plaintiffs won a higher percentage of bench trials than jury trials, but those are both subjects for another day. Moreover, the 59% figure does not account for the great many valid claims that get settled before trial. Suffice it to say that every plaintiffs’ lawyer I know would be thrilled to see a prevailing party fee provision (or, as Mr. Stossel puts it, “loser pays”) become the law of the land.

Originally posted at InjuryBoard by Patrick Quinlan

The Substance of Water

Jack Scarola — Tue, 10 Nov 2009 11:42:19 GMT

There have been a lot of heated debates surrounding the creation of a state water commission that could route water from North Florida to the overpopulated and overdeveloped South Florida region. Poor developmental planning and a lack of sensitivity to our valuable land and water resources are to blame. We now have to consider routing water to areas that developers have recently built with no concern to the environmental impact it would have on our resources.

In 2003, at the height of the land boom, Florida business leaders came up with a plan to create a state water commission to route water to newly built developments in South Florida. Developers continued to build home and business with no foresight for the repercussions of that growth on our environment and resources. Now it is the taxpayers who are dealing with the implications of their actions.

As a society, we give little thought to where our water resources come from. We turn on the sink, and water comes out. We turn on our sprinklers and water is available. We never give a second thought to where this valuable resource comes from or how it gets there. Now is the time to focus on the conversation of water and planning on how to use less, rather than how we can use more.

The Florida Hometown Democracy Land Use Initiative, or amendment 4, will be brought to the voters on November 2, 2010. This amendment gives voters more say over development, and if passed, any land-use decisions will require voter approval for all changes to local comprehensive land-use plans. In 2008, a lack of signatures kept the initiative off the ballot, but this year it has enough supporters to win a chance to be approved by Florida voters.

Supporter and Florida Hometown Democracy Land Use president Lesley Blackner says “Mismanaged growth destroys communities.” Amendment 4 has gained support from groups such as Clean Water Action Network of Florida, Alliance to Protect Water Resources, the Audubon Society, Save Our Wetlands Coalition, the Sierra Club, and hundreds of other environmental groups throughout Florida.

Those opposing Amendment 4, such as The Florida Chamber of Commerce and other industry groups, say they “strongly oppose” the initiative and argue that the bill would “put us in a permanent recession for Florida’s economy.”

Bottom line is this: we either conserve our natural resources, or we will run out. We can make efforts to pull water from other areas in Florida to accommodate our thirst for water in overdeveloped areas, but ultimately, that will also run out; not to mention the millions of dollars it will take to build the infrastructure for it. Our best bet is to truly make an effort to conserve our natural resources and become forward-thinking in our planning for land and development. We have overindulged for too long and developers have overbuilt and sucked the water dry. Now we must live with the consequences.

Can we afford NOT to do something to try and correct past poor judgment?

Originally posted at InjuryBoard by Jack Scarola

Tort Reform, Lies, and Lady Justice

John Hopkins — Thu, 05 Nov 2009 16:37:17 GMT

It is all about reforming our tort system, right? I mean fixing the health insurance problem for millions of uninsured people is all about preventing the filing of lawsuits against negligent doctors and hospitals, right? We need to limit or eliminate the constitutional right to jury try for a certain class of citizen to provide health insurance for our citizens, right? We need to provide special immunities to certain professionals to fix the health insurance problem?

Who has a “problem” that any of this fixes? One class of “people” has a problem that this will fix: insurance companies. The insurance industry wants tort reform so the insurance industry can increase profits. It is, in fact, that simple.

No one has ever been able to provide me with objective evidence that contradicts any of the following:

There are not an abundance of frivolous malpractice suits being filed now and there has not been in recent memory.
Malpractice claims do not, watch my lips, do not drive up insurance costs. In fact, under oath, many insurance executives have repeatedly testified as such.
Doctors are not fleeing states because of malpractice claims. In fact it is the very, very small minority of doctors who are sued for malpractice.
Malpractice claims do not drive up insurance premiums across the whole population of physicians. Empirical evidence demonstrates that little correlation exists between malpractice claims and increased premiums. Insurance executives have, under oath, also testified to that fact.
Tort reform will never lower insurance costs. The insurance industry simply does not have a track record for doing that.

All of this is a distraction from accomplishing a solution to the real problem. How do we provide health insurance to millions of citizens who are without it? Legislators indebted to the insurance industry need to throw up road blocks and provide distraction they can trump up to be popular with many people in this country.

When 98,000 people die every year and many more are injured from medical malpractice. I must wonder if the tort reformers would be making statements they know are not true if medical negligence killed their wife, their husband, their mother, or their child. Of course they would not. In the height of absolute indifference to the suffering of victims, tort reformers fabricate, invent, and misrepresent; all to benefit an industry who is dumping big dollars into their pockets.

So, if they are successful with roadblocks and propaganda campaigns, the victim will include justice herself.

Originally posted at InjuryBoard by John Hopkins

Dragons, Tort Reform and Other Myths

John Hopkins — Tue, 20 Oct 2009 10:47:26 GMT

I am not just picking on Jay Hancock at the Baltimore Sun and his comments about tort reform. Actually, Mr. Hancock’s comments, although containing the typical unsubstantiated statements that sound like fact, are actually sane in comparison to some of the pundits out there shouting for tort reform to “fix the civil lawsuit system”.

I think it was in George Orwell’s book, 1984, that politicians grasped the repeat-it-to-fact approach to things. This is where you get enough people to say the same thing over and over; the media latches on to the notion and repeats it; and it does not matter that no real substantial evidence to support the notion exists, people begin to spout the notion as if it is fact. That is exactly what has happened to tort reform.

So, let me use a column by Mr. Hancock to address some of the myths made to sound like fact.

“…doctors over-scan and over-treat patients to fend off lawsuits, costs billions of dollars a year.” I am not sure anyone can fairly assess whether claimed over treating is defensive medicine or simply good, cautious medicine. I am sure that no reliable basis exists for this claim except based upon the anecdotal evidence from the subjects of the alleged over treatment, doctors themselves. “

Trial lawyers bring dubious cases…juries deliver nonsensical verdicts.” Are their cases brought by attorneys that I “hear about” and I think, “what in the world was the lawyer thinking?” Yes, there are cases I “hear about” and conclude that very thing; but they are rare, once I learn the details of the case.

That is exactly the problem. People “hear about” cases, have no objective or informed information about the cases, and conclude they were “dubious”. I have been involved with jury trials for over 30 years and it is rare that a jury reaches a “nonsensical verdict”; if you actually knew about the case, heard the evidence that the jury received, and were present in the courtroom during the entire trial. Politicians and journalists do not inform themselves to this extent because it is not practical to sit through an entire three week trial. Instead, we “hear about” a trial and we are told “dubious and nonsensical” conclusions, because the politician or journalist could not possibly have reached a well informed conclusion.

Yes, I know, you are reading this and thinking: “McDonald’s coffee case”! Do us all a favor and really learn the details of that case, along with what the courts finally did with it before you decide it was “dubious” or the jury reached a “nonsensical” verdict. There was much more than sufficient evidence for the jury to conclude what they did in that case.

So, what are some of the facts about tort reform do we have? (In fairness, cited by Mr. Hancock)

"Tort reform as discussed in the United States would probably have very little impact," says Gerard Anderson, a professor at the Johns Hopkins Bloomberg School of Public Health. "The states that have enforced tort reform have about the same amount of litigation - and the awards are comparable - as states that don't."

A more drastic malpractice makeover would deliver substantial gains - but only once. New Zealand has a no-fault medical injury system in which lawsuits are essentially banned and experts decide how much to award victims. But even such a system, which nobody is talking about in the United States, would cut health care costs by maybe 7 percent at the most, Anderson said.

The nonpartisan Congressional Budget Office, as usual the best source for this kind of analysis, says malpractice costs make up only 2 percent of health care spending. "The evidence available to date does not make a strong case that restricting malpractice liability would have a significant effect," the CBO says.

Before draconian tort reform was passed in Florida, insurance executives testified, under oath, that tort reform would have no effect on insurance premiums; the executives did not believe a medical malpractice lawsuit crisis existed; and the executives did not believe frivolous lawsuits were really a problem, at least in medical malpractice. If these executives would benefit from tort reform, you must wonder why they would testify in this way. It is simply because the insurance industry and their minions of politicians have done such a great job of creating the mythical need for tort reform, they knew they could tell the truth and still have tort reform passed.

Please do us all a favor. Before all of you politicians decide to take away or severely limit my constitutional rights, please be sure you are doing it for reasons that are not dubious and base it on real, objective evidence. If you do, you will sensibly conclude that tort reform is a myth and practicing defensive medicine might simply be practicing careful medicine.

Originally posted at InjuryBoard by John Hopkins

A Website By Any Other Name

John Hopkins — Thu, 27 Aug 2009 09:50:45 GMT

I am outraged and I have had just about enough. Before I get started, let me get the preliminaries out of the way: 1) this is most certainly a tirade; and 2) this is entirely my opinion.

OK, let’s just get it out there: www.WhoCanISue.com . Now maybe it is because I have seen not one, not two, but at least six of their billboard advertisements in the last week that has sent me over the edge. The mythical reputation of trial attorneys is not bad enough; someone feels it is necessary to launch a website with a name that cannot avoid offending the majority of people I know, both lawyers and non-lawyers.

I am not going to engage in trying to explain that trial attorneys are the last safeguards of citizens with no hope of controlling reckless defendants without them. No, I am not going to explain the constitution or the part about having access to the court system. And, I am certainly not going to try and discuss how, without trial attorneys, people are going to be victimized by defendants more interested in profit than safety. Nope, I am not going to go into any of those things.

I am going to tell you that I am personally offended by a website that seems to trivialize something as serious as the suffering of real injured victims. I am offended by a website that, at least in terms of its name, seems to infer that exercising your legal rights is somehow tantamount to a lottery. I am insulted by a website that encourages people to think about a lawsuit; almost in terms of a game show.

In conclusion, I would also encourage attorneys and law firms who have not undertaken to do business with this website to check the site and verify whether their firm’s name or the names of any of your attorneys are on the site. Our firm accidentally discovered the inclusion of most of our attorney’s names on the site without any knowledge or permission on the part of our firm. We have been assured that any reference to our firm or its attorneys have been removed from the site, but we have no idea how long our names were being exploited without our permission or how much damage may have been done to our reputation, which we have worked long to establish and maintain.

Thanks. I feel a little better.

Originally posted at InjuryBoard by John Hopkins

Taking Time to Care

Brenda Fulmer — Thu, 13 Aug 2009 09:39:09 GMT

The law firm of Searcy Denney Scarola Barnhart & Shipley recently donated a Wii gaming system to Seagull Industries for the Disabled, Inc. This donation was part of a coordinated giving program through InjuryBoard, a growing community of attorneys, media professionals, safety industry experts, and local activists committed to making a difference by helping families stay safe and avoid injury, and helping those who are injured receive the assistance they need to seek justice and move on with their lives after an accident or injury.

Seagull Industries for the Disabled, Inc. is a private, non-profit organization founded in 1979 and provides educational, vocational, social and residential services to adults with developmental challenges. More than 100 adults participate in the organization’s Work-Make-Cents program located in Riviera Beach in Palm Beach County. These men and women operate a full-service fulfillment house which offers services such as product assembly, bulk mailing, packaging and printing for business clients. Seagull Industries also has farming operations at its Seagull Ranch facility in Indiantown where they operate a hydroponics farm that sells lettuce to local wholesalers and restaurants. This inspiring organization also offers residential programs as well as social, vocational and recreational programs at its Seagull Place assisted living facility on Singer Island in Palm Beach County.

The lawyers and staff of Searcy Denney Scarola Barnhart & Shipley are proud of our longstanding support of Seagull Industries and are thrilled to be able to enrich their program with this donation. The Wii is being installed at the Seagull’s Café Mouette, their lunchroom at the Riviera Beach facilities that is transformed into a French café on Fridays. There volunteers act as servers and the clients enjoy a restaurant experience. Several clients at the facility are preparing for the upcoming Special Olympics and are anxious to incorporate some of the Wii sports games into their training.

If you would like to donate to this very worthy organization, please visit: Make a Difference.

Originally posted at InjuryBoard by Brenda Fulmer

What is next with C. R. Bard’s Urethral Bulking agent, Tegress: Is It Too Technique Sensitive and Unpredictable for Continued Effective Use?

Armand Rossetti — Thu, 30 Oct 2008 17:24:33 GMT

I have been reporting about problems with tension-free vaginal tape, and approval of vaginal mesh products without tracing the history of submissions to ensure that the initial predicate device was not itself dangerous and defective. However while researching about these issues, I found another area of concern; a relatively new urethral bulking agent, C. R. Bard, Inc.’s Tegress Urethral Implant.

An Eerie Feeling About How Tegress Works:

In reading about properties associated with Tegress, the first thing that came to mind that the material acted much like spray foam insulation. While I completely understand that there is no biological comparison between the two materials; that they are not interchangeable in application and not even related chemically, the way that each material works is somewhat similar. I focus on: 1) seamless application; 2) dimensionally stable; 3) Does not shrink or settle; and 4) adds structural strength.

The Use of A Special Penetrating Solution:

Something else caught my attention. The carrier fluid used to make the injection less viscous and to set up the reaction once the Tegress is in place is a chemical named dimethyl sulfoxide (DMSO). Of utmost concern is the fact that DMSO can penetrate tissue because it is a “go-between” solvent, a delivery vehicle that can dissolve and transport chemicals through tissue that otherwise would not be able to pass through. Here is a description:

“This colorless liquid is an important polar aprotic solvent that dissolves both polar and nonpolar compounds and is miscible in a wide range of organic solvents as well as water. It has a distinctive property of penetrating the skin very readily, so that one can taste it soon after it comes into contact with the skin. Its taste has been described as oyster- or garlic-like.

Use of DMSO in medicine dates from around 1963, when a University of Oregon Medical School team, headed by Stanley Jacob, discovered it could penetrate the skin and other membranes without damaging them and could carry other compounds into a biological system.

Because DMSO increases the rate of absorption of some compounds through organic tissues including skin, it can be used as a drug delivery system.”

Because DMSO easily penetrates the skin, substances dissolved in DMSO may be quickly absorbed. For instance, a solution of sodium cyanide in DMSO can cause cyanide poisoning through skin contact. DMSO by itself has low toxicity. Dimethyl sulfoxide can produce an explosive reaction when exposed to acid chlorides; at a low temperature, this reaction produces the oxidant for Swern oxidation.”

Manufacturer’s Warning:

Tegress instructions carry a warning that DMSO “might be a contributing factor in the causes of erosion of the implant into the urethra or vagina and necrosis of the urethra, which is minimized by strict adherence to the Tegress implant injection described herein.” The procedure seems very technique sensitive.

The FDA’s Involvement in Developing the Device:

Review of Urology 2005; 7(Suppl 1): S22-S26 contained a paper entitled Tegress™ Urethral Implant Phase III Clinical Experience and Product Uniqueness (Domochowski, MD, FACS). One statement caught my eye:

“Upon injection of and exposure to the solution (blood or extracellular space) at physiologic temperatures, the DMSO diffuses from the hydrophobic copolymer and causes the EVOH to precipitate into a complex cohesive spongiform mass. This phase change requires diligent separation of agent and body temperature fluids prior to implantation. The phase transformation takes place rapidly, with the spongiform mass developing within 60 seconds post injection. Based on these unique findings and the demonstrated biocompatibility of the agent, the applicability of Tegress as a urethral bulking agent was analyzed in a large-scale new-device trial supervised by the US Food and Drug Administration (FDA).”

In this case, the FDA actually supervised the large scale new device trial for Tegress involving 15 sites in the United States and Canada, and compared Tegress with Bovine collagen. While the results of the study seemed to indicate success amidst adjustment for delivery technique and area of placement, modified directions for use highlight the fact that investigators reported hundreds of treatment related events. Of the treatment related adverse events, 39% were classified as mild, 58% were classified as moderate, and 3% were classified as severe. The procedural insert for surgical placement contains the following added language (revisions to the original procedural directions are highlighted in green):

“Potential Adverse Events:

Although not reported in the clinical study, other potential adverse events which may occur include erosion, implant extrusion through urethral tissue during injection, necrosis, erythema, embolic phenomena, and vascular occlusion. Erosion, implant extrusion through urethral tissue during injection and necrosis have been observed during post-approval use of Tegress™ Implant in clinical practice. These adverse events have been noted immediately after injection (implant extrusion) or in the period of days to months after injection. Erosion may be an incidental finding during repeat cystoscopy, or patients may complain of urethral pain, dysuria, hesitancy or frequency, usually of mild to moderate but rarely severe intensity.

Urinary tract infection may or may not be present. Bladder neck obstruction by the extruded or eroded material has been reported. Signs and symptoms of eroded material typically resolve within days to 2 weeks. Resolution of the signs and symptoms is typically accompanied by re-epithelialization of the necrotic or eroded urethral mucosa, after elimination by voiding or cystoscopic removal of the extruded/eroded material. Treatment of pain or infection may be required.”

Upon accessing the FDA's Adverse Event Reports (AERs) on the FDA’s Manufacturer and User Facility Device Experience (MAUDE) and entering “Tegress” in the “Brand Name” window, 207 Adverse Events appear. The date range for the reports is from August 30, 2005 to November 21 2007 (post study).

An Outside Opinion Concerning Tegress' Effectiveness:

Recently, a paper appeared in the International Urogynecology Journal(2007) 18:869-873 (Hurtado, E., et al.) entitled The safety and efficacy of ethylene vinyl alcohol copolymer as an intra-urethral bulking agent in women with intrinsic urethral deficiency. The abstract contained the following statement:

“Intra-urethral bulking for the treatment of SID is meant to be minimally invasive and safe with minimal reports of complications. This series of 19 patients show significant percentage of patients experiencing serious complications with Tegress. Additionally, Tegress may be less efficacious than reported in the FDA trials, especially those with prior injections. A long-term prospective study needs to be performed in women with intrinsic sphincter deficiency (ISD) before treatment can be recommended for general use by all gynecologists and urologists.” [Emphasis added}.

GIGNA's Comment:

The following statement appears in the Cigna HealthCare Coverage Position (revised 12/15/2007):

“Based on findings from this multicenter study, the FDA granted the PMA with the following requirements:

• The manufacturer must create and administer a physician training program on the specific injection technique needed for the use of URYX.

• The manufacturer must perform a five-year post-approval study to assess the long-term safety and effectiveness of URYX (e.g., durability of the treatment effect, the impact of re-treatment); and confirm that the incidence of material exposure has been minimized, with modifications to the instructions for use.

• The manufacturer is to conduct a two-year enhanced surveillance program, in which U.S. physicians using URYX will be contacted on a quarterly basis to actively solicit information on adverse events.

In December 2004, the manufacturer submitted their training and post-approval study plans to the FDA.”

Ten Pages of Patient Precautions:

C.R. Bard has also released a 10-page booklet entitled, Tegress for the Treatment of Stress Urinary Incontinence in Women; Information for Patients. The booklet is replete with warnings and contraindications, including a statement that Tegress Implant should only be used by a doctor properly trained in the use of the product.

Hence, the FDA has granted a qualified PMA approval for Tegress, unlike 510(k) approved devices, PMA approved devices are federally preempted.

Conclusion:

UPDATE:

I received an email from Mr. John Uro, alerting me that Bard had withdrawn Tegress from the marketplace (effective January 31, 2007). During my research on Tegress, I had consulted the FDA Recall Archives and found no evidence of an FDA recall concerning Tegress. Evidently (because I can yet find no evidence of an FDA recall regarding Tegress), Bard had made a decision, on its own, to pull Tegress from the marketplace in 2007.

However, please note that there are many patients who received Tegress implantation, and the controversy about the accuracy of peer rreviewed studies remains in the mainstream of concern.

My conclusion remains the same:

Given all of the variables discussed above that are attached to the placement and use of Tegress, it will be interesting to see what develops in the future, regarding this novel, technique sensitive, and somewhat unpredictable implant. Those patients who received Tegress treatment will still be affected by the dangers associated with Tegress.

Originally posted at InjuryBoard by Armand Rossetti

There is a Reason Why the Use of Pain Pumps May Lead to Knee Joint as Well as Shoulder Joint Chondrolysis

Armand Rossetti — Wed, 29 Oct 2008 10:40:55 GMT

Recently, Attorney Calvin Warriner posted two articles on Injuryboard. The first was about pain pumps that cause devastating shoulder injury and the second addressed a 2008 Stanford University study that showed that injectable pain medicine from pain pumps has a devastating effect on tissue. It seems fair to say that there is a common thread connected with certain episodes of pain pump induced chondrolysis; no matter which joint in the body is being treated. The knee joint cartilage is just as susceptible to toxic medication as is the shoulder joint.

The FDA and the press have been focusing most publicity concerning chondrolysis on PAGCL , which involves the shoulder, which is one of the more mobile joint systems in the body. However, when undergoing similar treatment, hinge-type joints such as the knee will sustain similar cartilage injury.

While the complexity of a joint system like the shoulder might explain a higher incidence of post surgical, pain pump induced shoulder chondrolysis, the simpler knee joint should not be overlooked as a problem synovial medication delivery site. In an editorial entitled, The Dislocated Knee, pain pump induced chondrolysis was at the top of Dr. Bernard Bach’s list for possible treatment complications to watch closely. In his editorial, Dr. Bach mentioned the study that Nechleba et al. conducted in 2005, and Dr Bach stated the following:

“What have not been determined are the effects of Marcaine/epinephrine solution on articular cartilage. Recently Beck (personal communication, Herodicus society, July 2005, Sun Valley, Idaho) identified 12 patients who developed chondrolysis after use of an intraarticular pain pump following arthroscopic shoulder stabilizations without use of thermal energy. Nechleba’s study and Beck’s report (unpublished) would give me caution to use an intraarticular pain pump.”

As the 2008 Stanford study on drug induced chondrolysis, mentioned above, has pointed out, “All anesthetics containing epinephrine (pH less than or equal to 4) were chondrotoxic and cannot be advocated for pain pump use. The use of 0.5% bupivicaine for greater than 48 hours is not recommended.” Therefore, Dr. Bach’s caution in 2005 about not using an intraarticular pain pump to palliate surgically induced pain was and continues to remain, a prescient observation.

Episodes of knee chondrolysis after intraarticular pain pump treatment seem to occur less often than like episodes of shoulder chondrolysis, but this discrepancy might be due to the physiology of the joint, itself. Exposing cartilage to specific toxic medications like epinephrine, should be totally contraindicated, as hould bupivicaine in more concentrated dosage. In any event, it seems evident that both drugs will indiscriminately affect chondrocytes found in knee cartilage as well as those found in shoulder cartilage.

Originally posted at InjuryBoard by Armand Rossetti

Thoughts about a Possible Common Thread Running Through Drugs that Cause Devastating Skin Disease

Armand Rossetti — Thu, 02 Oct 2008 10:58:04 GMT

REVLIMID (lenalidomide)is an analogue of Thalidomide that that doctors prescribe to many patients with multiple myeloma. Lenalidomide works within the bone marrow to stop or slow the growth of cancerous myeloma cells. Revlimid is used in combination with Dexamethasone, a synthetic steroid with powerful anti-inflammatory effects.

Between 1957 and 1969, physicians in almost 50 countries prescribed Thalidomide to pregnant women as a sleep aid. However Thalidomide reached market without prior adequate testing to assess its safety. As a result, approximately 10,000 children were born with severe abnormalities.

In 1964, Israeli physician Jacob Sheskin used a left over bottle of Thalidomide to treat a critically ill patient suffering with leprosy. In Dr. Sheskin's attempt to help his patient to sleep, he observed that the patient began to make progress. That observation led to a successful clinical trial. In 1991, Dr. Gills Kaplan determined that Thalidomide inhibited tumor necrosis factor, and she partnered with Celgene Corporation to seek further development for Thalidomide. Later, Celgene developed Revlimid, a substantially more powerful analogue, having fewer side effects.

Revlimid gained FDA approval as a new drug application (NDA) on December 27, 2005. Later, the FDA further cleared Revlimid on June 29, 2006 for use in combination with Dexamethasone in patients with multiple myeloma who have received at least one prior therapy. While laboratory tests have suggested that Revlimid is not tetratogenic, Revlimid is categorized as such because it has structural similarities to Thalidomide. Given the uncertainty of this danger, the FDA requires restricted distribution through the RevAssistSM program, which requires that prescribers register with RevAssist, pharmacies contract with RevAssist, and that Patients enroll in RevAssist.

Despite special distribution requirements, the FDA has recently included Revlimid on a list of 20 prescription drugs under investigation for potential safety problems. In addition, the FDA has shed light on a postmarket safety review, linking serious skin reactions, including reports of Stevens Johnson syndrome (SJS) and similar skin conditions.

Revlimid, however, is not alone in this respect. The FDA has warned consumers that carbamazepine (an anti-epileptic drug also known as Tegretol) can also cause SJS. The drug-related skin disease is more prevalent among patients of Asian ancestry. However, it is important to note that patients afflicted with skin diseases as a result of using carbamazepine will show signs of the disease within 90 days of first taking the drug. If skin reactions do not appear within ninety days, there is minimal risk that those diseases will appear thereafter.

The FDA has found the same to be true for Provigil, Trileptal, Dilantin (phenytoin) Injection, and a few other similar drugs.

Just out of curiosity, I took a look at the chemical structures for the drugs under discussion:

lenalidomide; and

Does a reactive commonality exist, somewhere?

Originally posted at InjuryBoard by Armand Rossetti

AIG: The Giant Stumbles

John Hopkins — Wed, 17 Sep 2008 15:58:43 GMT

Everyone has read about or heard newscasts related to the financial problems being experienced by AIG Insurance Group. Insurance companies and financial institutions have failed relatively regularly in the last few years, so why is AIG’s problems causing so much turmoil.

One reason is probably that AIG is one of the giants in international insurance and financial matters. AIG has always brought to mind images such as the giant who is not afraid to walk through the valley of the shadow of death, but fears no evil, because he is the biggest and “baddest” giants in the valley. AIG has always been one of the companies by which all others have been measured. If AIG can be in $75 billion in trouble, what may happen to the rest of these industries?

The other reason is probably just the failure of Lehman Brothers, the save of Merrill Lynch, and the government bail out of Bear Stearns. One could fairly say that these are tremulous times.

So should AIG policyholders panic? Not yet. The feds have agreed to bail AIG out with a two year, short term loan of $75 billion. Furthermore, AIG reports that their assets remain strong and they appear to have reasonable liquidity. The AIG umbrella also includes many different companies; many of which are sufficiently capitalized and have sufficient liquid assets to respond to demands.

In Florida, AIG has 46 subsidiary companies that operate; 34 selling property & Casualty insurance and 12 selling life insurance. Florida’s insurance commissioner, Kevin McCarty advises:

“We have been told the insurance companies are solvent and will be able to pay claims. It is important that policyholders continue to pay their premiums to ensure that their coverage does not lapse,” McCarty said. “I assure you that, if it should become necessary, we will immediately intervene if we feel that any one of the AIG companies operating in Florida will be unable to pay its claims and fulfill the promises made to its policyholders.”

Most individual states have guarantee funds that will stand in the shoes of insolvent insurers, up to a certain limit that is usually $100,000 to $300,000 per policyholder. All of this good news said, should the condition of AIG worsen, it is quite possible that all the guarantee associations together may not have sufficient assets to fill the shoes of this giant.

Originally posted at InjuryBoard by John Hopkins