West Palm Beach Personal Injury Lawyer

A Power Grab in Florida -- Special Interests and Political Power

Patrick Quinlan — Fri, 11 May 2012 11:23:51 GMT

We Floridians are faced with a threat that is all too real. Something is quietly sneaking up on us, which before we know it could change our great State of Florida forever and not for the better.

The people who founded our country, and those who then wrote the Florida Constitution, were very afraid of some small group of people gaining too much power and using that power to control our government and the fate of We the People.

So our state and federal constitutions include what we call the “balance of power” or “separation of powers” – structures and systems that prevent a single group from gaining exclusive power over our government. As you can imagine, there are those who want to consolidate and grab an exclusive hold upon that power.

So what is it that prevents an imbalance of power?

There are checks and balances built into the constitutions. Think, for example, about how laws are passed and applied. The legislature can write and pass bills, but the executive branch (the President in Washington or the Governor in Tallahassee) must sign it into law – or he may “veto” a bill, which means he refuses to make it law. If a bill is signed into law, it then becomes the job of the judicial branch to interpret that law and apply it fairly to parties involved in lawsuits. Judges must make sure that a law complies with the constitution and with other laws and prior court decisions. In this job, judges are supposed to act as neutral arbitrators – referees – to make sure that the system operates fairly.

Under our Florida Constitution, we do not elect our Supreme Court justices. They are appointed by a governor and then serve for six years before they must appear before voters for what is called “merit retention.” There is no opponent running against the justice. The voters simply decide whether a given justice should be allowed to remain on the bench or not. Traditionally, if a Supreme Court justice has served faithfully, has not committed any crimes, and is of good moral character, voters have retained him or her on the bench.

So our Supreme Court justices do not run for office like politicians. By the rules of judicial conduct, they are not permitted to discuss why they rendered certain decisions and cannot talk about upcoming cases. Most judges feel it is unseemly to campaign like politicians running for the legislature or for governor. Politics and political agendas really have no place in our system of justice.

Why?

Let’s look at a “what if.”

What if politics were allowed to influence the outcome of our most important cases, such as Brown v. Board of Education? In that case, the United States Supreme Court held that it was unconstitutional to segregate public schools into white-only and black-only schools. At that time –1954 – the Supreme Court’s decision was very unpopular. Politicians, especially in the South, railed against the decision to desegregate the school system. Had politics been allowed to play a role in the court’s decision-making process, the outcome of Brown v. Board of Education – and the entire civil rights movement in this country -- may have been very different. That’s what can happen if political parties are able to influence the judicial branch of government for their own benefit.

And that is what people are trying to do, here in Florida, as we speak. Special interests are beginning a political campaign to unseat three prominent and very competent justices from our Florida Supreme Court.

Why? Is it because these justices are incompetent or lack the legal training or intelligence to serve on the Florida Supreme Court? No. These three justices – Justice Barbara Pariente, Justice Fred Lewis, and Justice Peggy Quince -- were outstanding lawyers who made a mark in the legal profession and earned their places on the court. And since being appointed to the Florida Supreme Court, Justices Pariente, Lewis, and Quince have distinguished themselves as three of the most competent, ethical, and thoughtful justices who have ever sat on our Supreme Court.

So, why do special interest groups like Restore Justice 2012, or political activists like The Tea Party, want to convince voters to not retain these fine justices?

It is about power and influence. It is that simple. If these three qualified Justices are removed from the court, Rick Scott, a Tea Party Republican, will be permitted to appoint three people of his choosing as replacements. This would secure for Mr. Scott’s party, a single political party, control of every branch of Florida government. The executive, the legislative and now the judicial branches would all be controlled by Republicans and Tea Partiers.

But here’s the thing: it does not matter whether you are Republican, Democrat, or Independent. Putting politics in the judicial branch, and upsetting the balance of power upon which our government is based, hurts every citizen. It is exactly what our founding fathers did not want to see happen.

Do not allow yourself to be swayed by the propaganda and misleading ads that will be produced by special interests with big money behind them.

Before you go to the polls in November, I encourage you to read about Justices Pariente, Lewis, and Quince. Educate yourself about the background, the character, and the work ethic of each of them. I am confident you will decide all three should be retained on the Florida Supreme Court.

If nothing else, you can call me. I would be happy to answer your questions, and my firm can provide you with sources of information.

Originally posted at InjuryBoard by Patrick Quinlan

Groups Targeting the Florida Supreme Court Just Like the Iowa Supreme Court

John Hopkins — Fri, 27 Apr 2012 16:04:11 GMT

It is certainly a lesson in new politics for Floridians. Iowans are already familiar with the tactics or else they are the group of Iowans who were victimized without realizing it.

Groups within and, interestingly from outside, Florida are targeting Supreme Court Justices who stand for a retention vote this election period. The obvious question has to be are these groups are targeting them because they are bad justices and have not done their jobs?

Not so fast. Although groups like "Restore Justice 2012" are throwing around the conservative words like, "legislating from the bench" and "activist judges", not a one of them have levied any crticism of Justice Parient, Quince and Lewsi that are of a substantive basis. That is because they can not. These justices have been good public servants who have followed the law, even when they knew that they would be made targets by people like House Representative Scott Plakon and groups like Restore Justice 2012.

These groups have now thrown stones at these justices claiming they violated the law when they filed their papers in order to qualify for retention. Scott Plakon is spending a great deal of time and has even written to the governor demnding that the justices be investigated.

Why?

Because the justices had employees in the clerk's office notarize their filing papers. Now, understand that the clerk's office has clearly stated they notarize for any Florida citizen. That, however, has not stopped groups like Jesse Phillips' Restore Justice or career politicians like Scott Plakon.

We can only hope that voters will read and educate themselves about Justices Pariente, Lewis and Quince before being swayed by groups who clearly have political and business interests in trying to remove these justices form the bench.

Originally posted at InjuryBoard by John Hopkins

Prescription Drug Consumers Flying Without a Net

Cal Warriner — Wed, 11 Apr 2012 16:14:50 GMT

Most consumers of drugs and medical devices fill their prescriptions trusting that a virtual mass of protection is built in to the drug approval process. While everyone knows that no drug is perfectly safe one should be able to assume that the serious risks and side effects have been identified by the manufacturer, disclosed to the FDA and are contained in the labeling information so that information is passed along to doctors, pharmacists and patients.

In reality, nothing could be farther from the truth.

In yet another example of a new “wonder drug” being “outed” for causing serious, undisclosed side effects, the diabetes drug Actos has now been linked to both bladder cancer and an increased risk of causing heart failure and heart attack. When the drug went on the market a decade ago, neither risk was disclosed to the FDA or physicians. The drug’s label contained no such warning leaving doctors, pharmacists and patients in the dark.

The belief that the FDA has the resources and power to insure that all drugs are safe and effective thereby providing the ultimate safety net is purely myth. Most consumers believe the FDA has thousands of employees running around a labyrinth of labs testing drugs. In fact, they don’t. In reality the FDA relies on the laboratory and clinical testing performed by manufacturers. That data is then supplied by the manufacturer as part of the drug application process.

The FDA does not test drugs.

If the FDA doesn’t test drugs, what does FDA approval mean? When the FDA approves a drug, it is saying no more than the manufacturer has complied with the FDA’s checklist and submitted data that seems to show a drug is safe and effective. Instead of providing a safety net, the FDA is more of a hall monitor enforcing an honor system. With hundreds of new drugs being rushed through the regulatory process, bad drugs will get in the hands of consumers.

When the FDA fails to catch a manufacturer who proposes sale of a dangerous drug the consumer’s entire safety net comes crashing down. Doctors, like patients, believe that drugs have been tested and dangers identified. When they are not, it is easy to succumb to the manufacturers’ marketing pitch that this new drug is better than the old drug. Likewise, consumers respond to direct to consumer advertising that promises new advancements.

When these drugs reach the market, patients are being unwittingly used as human guinea pigs for large-scale clinical trials.

Time and again, we see drugs causing serious, sometimes fatal events that the manufacturer failed to identify or warn against. Your doctor and pharmacist, the second lines of defense, are powerless to pass along solid, reliable information to patients. Often, hundreds of thousands of patients end up consuming bad drugs. Those who experience catastrophic complications are left to fend for themselves.

At the regulatory level, the offending manufacturer may get a slap on the wrist and after banking billions, they are off to the next drug. Perhaps the drug will be recalled. However, in today’s high stakes, high profit pharmaceutical world that frequently comes only after the company has banked a healthy profit. Some examples such as Vioxx, Avandia and PremPro come to mind. Each of these drugs generated billions for the manufacturer before falling into disrepute.

The diabetes drug Actos is another to join the billion-dollar Big Pharma hall of shame. First, in 2007 FDA made the manufacturer of Actos include a black box warning that it increased the risk of serious heart complications. Next in 2011, the FDA demanded that another black box warning be included that taking Actos increases the risk of developing bladder cancer. Both of these complications can be fatal.

Even more shameful, the manufacturer of Actos took advantage of Avandia’s 2007 downfall and launched a media blitz, which focused on Actos’ superior safety profile when compared to Avandia. The message of its direct to consumer pitch was “switch from Avandia to Actos if you want to be safe”. The pitch worked and Actos sales surged. That was before studies revealed that Actos causes bladder cancer and, in the meantime, new Actos takers were developing bladder cancer.

With the drug manufacturer and the FDA having failed consumers, the last and only remaining piece of the safety net is the trial bar. The only chance for any semblance of justice or retribution is for the injured party to bring an action against the manufacturer for not having adequately tested the drug prior to sale to determine the true risk associated with taking Actos.

Of course virtually all of those who developed bladder cancer while taking Actos would far rather have avoided that risk. Unfortunately, that opportunity is past.

Originally posted at InjuryBoard by Cal Warriner

UK Tells Surgeons: Stop Using Stryker/ J&J Metal Hips

Cal Warriner — Fri, 06 Apr 2012 13:26:52 GMT

Hip replacement patients and their surgeons in the U.S. need to be made aware of a government warning out of the U.K. about a metal-on-metal hip (MoM) replacement combination with a high failure rate.

The agency is the United Kingdom’s (UK) version of our Food and Drug Administration (FDA). The Medicines and Healthcare products Regulatory Agency (MHRA) tells surgeons to stop using this metal-on-metal (MoM) total hip replacement (THR) combination - the Mitch THR cup/head (made by Finsbury Orthopedics, a division of J & J), in combination with the Stryker Corp. Accolade Femoral Stems.

Specifically, data from the MHRA found the THR systems had a failure rate of 10.7 percent within four years after implantation.

The agency says patients should be monitored for signs of complications which can include pain, revision surgery, cancer, loss of mobility, tissue and joint damage, swelling, and metal toxicity or metallosis.

Unlike the U.S., the U.K. actually follows patients after they are implanted with a medical device and the high failure or revision rate was noted in data coming from the England and Wales National Joint Registry. It’s believed 271 people in those countries have this combination of hip replacements.

The MHRA suggests all patients be monitored annually whether or not they are experiencing symptoms. One month ago the MHRA advised all patients implanted with the large (36mm or more) diameter metal-on-metal hip joints be checked annually for metal debris specifically chromium and cobalt that may have leeched into their bloodstream.

In the old days a combination of plastic and ceramic components were used in THR surgery. MoM was introduced in recent years as an ‘improvement,’ but studies show that they appear to be failing well in advance of their 15 year life span.

The British Medical Journal (BMJ), along with the BBC, issued an investigation into MOM hips in February which served to warn thousands of people around the world that metallosis is not uncommon in hip implant patients along with high levels of cancer-causing metal debris in the bloodstream. Even though industry has understood these risks for decades, patients have largely been kept in the dark about the downsides, that is, until they experience long-term, painful disability.

Metal-on-metal (MOM) total hip replacement patients have sought representation by our law firm after being implanted with the DePuy Orthopaedics’s recalled ASR Acetabular Hip Implant System as well as the Acetabular Cup System. The ASR hip was recalled in August 2010 due to a defective design.

Lawsuits that name the medical device are currently consolidated in multidistrict litigation in the Northern District of Ohio U.S. District Court in MDL #2197. Lawsuits against the DePuy Pinnacle artificial hips have been consolidated in U.S. District Court for the Northern District of Texas in MDL # 2244, even though the Pinnacle remains on the market.

Originally posted at InjuryBoard by Cal Warriner

Caveat Emptor -- Do You KNow Where Your Drugs Come From?

Cal Warriner — Fri, 06 Apr 2012 07:55:29 GMT

Forget the ongoing debate about whether FDA oversight of new drugs and medical devices provides consumers that “safety net” we all depend upon. Once a drug is approved, where is it made and who oversees adherence to good manufacturing practices? A new report, commissioned by the FDA and conducted by the Institute of Medicine should send chills down the spine of anyone who swallows an “FDA approved” drug.

Surprisingly, more than 40% of finished drugs consumed in this country are manufactured in foreign plants. Many of those are in developing countries where labor is cheap and regulatory oversight lacking. Anyone who’s taken a relatively new shirt out of the laundry and found the seams falling out, inspected the tag and found, “Made in China or India” should ask themselves whether they want to consume drugs made by the same people.

Even more concerning, for drugs manufactured in this country, more than 80% of the active ingredients that make up our drugs are imported from foreign manufacturers. The equivalent would be buying a Ford Explorer only to find the engine and transmission were made in China.

The bottom line is the vast majority of drugs consumed in this country contain ingredients that were manufactured overseas. The FDA has little to no regulatory oversight over the facilities, processes, procedures or quality control. The report pointed out that these countries lag far behind the United States in the technology and advanced systems to insure the quality of both active ingredients and finished drugs.

Congress has issued recent directives for FDA to inspect more foreign facilities however; the report says that FDA cannot meet those requirements given the agencies’ resources. The solution offered by the Institute of Medicine is to form of a consortium of developed nations to share resources and inspect facilities in the developing world. Countries such as Japan, Canada and those in the European Union could share each other’s inspection reports to avoid duplication of effort and expense.

Consumers are powerless to protect themselves. Pull a medicine bottle out of the cabinet and try to determine where it’s made. It’s impossible. Read the labelling when the drug is delivered to you at the pharmacy. Still, where the drug is made can’t be determined. I guess we are all left to swallow and hope.

Caveat emptor -- Buyers beware.

Originally posted at InjuryBoard by Cal Warriner

FDA Revamps Metal-on-Metal Hip Implant Recommendations

Brenda Fulmer — Thu, 05 Apr 2012 09:47:17 GMT

The FDA has issued some new guidelines for patients and orthopedic surgeons who are contemplating or have been implanted with metal-on-metal (“MoM”) hip implants. This information is terribly important to patients who have long been told that metal-on-metal hip implants provided far greater benefits than hip implants, which utilize older designs made with polyethylene (plastic), or ceramic liners. Once again, as is so often the case with drugs and medical devices, conventional wisdom as well as patient counseling has changed dramatically over the past two years, as surgeons are learning first-hand that the device manufacturers’ promises of a superior product have, once again, fallen short.

Unfortunately, tens of thousands of patients are also paying the price for this orthopedic implant “puffery.” Patients were promised a hip implant that would last for at least 15 years and enhance their active lifestyles. Instead, they have been burdened with faulty devices that fail after only a few years, multiple unnecessary surgical procedures, painful and difficult rehabilitation, and systemic metal poisoning and tissue damage that may prevent them from ever regaining their former selves.

So what is the latest advice from the Food & Drug Administration?

For surgeons, the FDA has made recommendations about not using metal-on-metal implants in patients with certain pre-existing conditions, including:

Current use of high dose steroids;

Kidney disease;

Known metal allergies;

Suppressed immune systems; and

Women who are of childbearing age.

The FDA also alerted surgeons that they must be certain that they are adequately trained with regard to the special surgical techniques required for proper implantation of these devices, and need to take extra precautions to ensure that products are implanted with proper angles for inclination and anteversion of the acetabular cup (as malpositioning of the cup may accelerate improper wear and failure of the implants). This recommendation is somewhat controversial in that surgeons are frustrated because orthopedic device manufacturers are so quick to point the finger at poor surgical technique rather than admit that their devices are defectively designed, which has occurred with regard to a number of defective MoM hip implants. The reality is that some of the metal-on-metal hip implants may have been so poorly designed, even the best-trained orthopedic surgeons cannot consistently install them at the perfect angle. The FDA also warned doctors that they should not mix hip implant components from different manufacturers.

Most importantly, recommendations were made to increase the amount of time counseling patients prior implantation of these devices to ensure that patients are aware of all of the risks versus benefits of metal-on-metal devices as well as the pros and cons of alternative hip implant designs. This heightened discussion of risks associated with metal-on-metal hip implants should include information about metallosis (elevated metal ion levels, especially cobalt and chromium, in the bloodstream and joint space), the risks of pseudotumor or soft tissue mass formation, likelihood of local inflammatory reactions, the incidence of tissue necrosis, and the possibility of systemic disease due to metallosis. Device manufacturers share responsibility here as well, especially in light of the aggressive direct-to-consumer marketing that has occurred over the past few years with regard to implantable medical devices.

Despite the fact that metal-on-metal implants have been in use for years, very little is known at this time regarding the long-term risks of metallosis or treatment options for patients who have elevated levels of cobalt and chromium in their blood. Systemic symptoms of metallosis or cobalt and chromium poisoning include:

Cardiac – arrhythmia and cardiomyopathy (enlarged heart);
Endocrine – hypothyroidism, anemia, abnormal lymphocyte function, chemokine secretion, and other blood abnormalities;
Neurological – hand tremor, lack of coordination, cognitive dysfunction or memory loss, tinnitus, vertigo, hearing loss, headaches, peripheral neuropathy, and visual disturbances; and
Skin – rashes.

Patients with failing metal-on-metal implants or a local adverse reaction to metal debris from the implant will often experience hip or groin pain, severe inflammation or fluid around the hip implant, evidence of tissue necrosis or bone loss, nerve palsy, palpable masses, localized swelling, and x-ray or other radiographic evidence of loosening of the implant. The FDA also recommended that patients who were at risk for metallosis and implant failure be more closely monitored after their implant surgeries. Factors that may identify patients who face the highest risk for implant failure and other MoM-related complications include those with poor alignment of the implants, bilateral prostheses, increased activity levels, severely overweight, females, those with renal insufficiency, and patients who underwent resurfacing procedures with implantation of small femoral heads.

The FDA’s recommendations note the current deficits in understanding the long-term risks of metal implants as well as the differences in opinion for the proper treatment of metallosis patients at this time. The Agency has promised to provide more in-depth recommendations after its upcoming meeting of the FDA’s Orthopaedic and Rehabilitative Devices Panel of the Medical Device Advisory Committee scheduled for June 27-28, 2012.

Originally posted at InjuryBoard by Brenda Fulmer

Zoloft and Propecia: New Coordinated Litigation on the Horizon?

Brenda Fulmer — Fri, 30 Mar 2012 15:20:40 GMT

An important hearing was held on March 29, 2012, before the Judicial Panel on Multidistrict Litigation in San Diego, California.

The Judicial Panel is a select group of federal judges, led by Judge John G. Heyburn II, who meet every two months at federal courthouses around the country to rule on requests for the establishment of multi-district litigation as well as oppositions filed by individual litigants or defendants seeking to prevZoloft and Propeciaent a transfer of specific cases into already-existing MDL proceedings. The March 12, 2012, quarterly report for the Panel indicated that there are currently 295 active MDL dockets involving 55 different district courts and 221 judges. There are approximately 55,397 individual lawsuits or actions pending at this time, which is a substantial decrease from the more than 320,000 claims that were once pending in these 295 MDL dockets. Most of the decline in the number of pending MDL actions is due to large-scale settlements of pharmaceutical cases involving Celebrex and Bextra (MDL No. 1699 in San Francisco); Trayslol (MDL No. 1928 in West Palm Beach); Vioxx (MDL No. 1657 in New Orleans); Baycol (MDL No. 1431 in Minneapolis); Ortho-Evra (MDL No. 1742 in Toledo); Fen Phen and Redux Diet Drugs (MDL No. 1203 in Philadelphia); and Zyprexa (MDL No. 1596 in New York City).

At this latest hearing, the Panel heard arguments from attorneys regarding the establishment of coordinated multi-district proceedings in federal court for nearly 20 new complex litigation efforts, most of which were focused on securities litigation, class actions, consumer fraud, antitrust and other commercial disputes. There were two proposed dockets included, however, that are particularly relevant to mass tort litigators and their clients: Zoloft and Propecia.

Pfizer filed a motion in January of 2012 asking the Judicial Panel to consolidate a number of individual lawsuits involving its popular serotonin-reuptake inhibitor (SSRI) anti-depressant Zoloft (sertraline hydrochloride). The drug manufacturer requested the establishment of MDL No. 2342 in the United States District Court for the Southern District of New York in Manhattan, which is where Pfizer’s global headquarters are located. Alternative venues in federal courts in Mississippi and Ohio were also suggested by the pharmaceutical giant.

In its initial filing, Pfizer indicated that it was facing 59 lawsuits filed by families whose children had suffered birth defects due to in utero exposure to Zoloft. The number of pending lawsuits has since risen to nearly 90 cases. The cases that Pfizer seeks to transfer were originally filed in state or federal courts in Illinois, Mississippi, Missouri, New York, Ohio, and Pennsylvania. The request would have no impact on a number of state court cases that are pending in Philadelphia and elsewhere. There are a number of additional defendants included in these lawsuits, including Wolters Kluwer Health, and MediSpan, companies that publish patient education materials including the limited warnings that are included on pharmacy receipts (and, unfortunately, the only warning labels ever seen by most patients who take prescription drugs).

Zoloft was first approved by the FDA in 1991 for the treatment of depression, obsessive-compulsive disorder, panic disorder, post-traumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). Generic versions of Zoloft have been available since 2006. The plaintiffs claim that the warning label for Zoloft fails to adequately warn prescribing physicians and patients of the risks that a fetus faces from exposure to the drug when ingested by the mother during pregnancy. There were some changes to the warning label in 2006 for all anti-depressants to reflect an increased risk of persistent pulmonary hypertension of the newborn (PPHN), a potentially fatal lung disease, but the warning labels have not been adequately changed to reflect an increased risk of other birth defects. Paxil, another SSRI drug that is similar to Zoloft, carries stronger warnings regarding the risks of the drug to the fetus and has a different FDA pregnancy risk classification than Zoloft and other SSRI drugs (a class which includes Paxil, Celexa, Effexor, Lexapro, Pristiq, Prozac, and Zoloft).

In addition to premenstrual dysphoric disorder, the lawsuits that have been filed so far over Zoloft and other anti-depressants involve a number of serious birth defects:

atrial septal defects
cardiac malformations
autism spectrum disorder
neural tube defects
craniosynostosis
omphalocele
clubfoot
anal atresia
cleft lip
cleft palate
limb defects
premature births

GlaxoSmithKline, the manufacturer of Paxil, has reportedly paid in excess of $1 billion to settle more than 1,000 individual lawsuits over the past two years involving drug-induced birth defects.

The Panel also heard argument from both sides regarding the establishment of MDL No. 2331, involving the hair loss drug Propecia (also knowzoloft, propecia, n as finasteride) and defendants Merck & Co. and Merck, Sharp & Dohme Corp. The initial petition for transfer and consolidation included approximately 25 cases filed in federal courts in Colorado, Florida, New Jersey, New York, Ohio, Washington, and Illinois. This is a very small number of cases for an MDL, but it is anticipated that a large volume of additional cases will be filed in the future (the petition to establish the MDL indicates that there are at least another 300 known cases that have yet to be filed). If an MDL is granted, it will have little impact on the more than 50 claims pending in state court in New Jersey. The plaintiffs have requested that the Propecia MDL be assigned to a federal judge in the Eastern District of New York or, as a second choice, the Western District of Washington (where three of the lawsuits are already pending).

Most of the claims involving this drug are being filed by young men who ingested Propecia (and/or generic finasteride or Proscar tablets which had been cut into smaller doses) in hopes of stemming early hair loss, and instead experienced permanent sexual side effects. The package insert for Propecia, which is manufactured by Merck, includes a warning that temporary sexual side effects might occur with use of the drug, but fails to accurately reflect the current medical science which indicates that those side effects may be permanent. Patients have reported impotence, erectile dysfunction, and lack of sexual desire occurring within only a few days of ingesting Propecia. This is a particularly devastating injury as most patients taking Propecia for hair loss are in the late teens to early forties.

Merck first introduced Proscar, a stronger version of finasteride, in the United States in 1991. Proscar is used for the treatment of benign prostatic hyperplasia (BPH). It was noted coincidentally that patients taking Proscar were experiencing unexpected growth of their hair. Finasteride interacts with the 5-alpha reductase enzyme and blocks the enzyme from binding to testosterone to form dihydrotestosterone (DHT), which is one of the causes of male pattern baldness (also known as androgenic alopecia).

Merck obtained FDA approval in 1997 to market a lower dose of finasteride for the treatment of baldness, which is the brand name drug Propecia. Since FDA approval of Propecia in 1997, Merck has updated the warning label on eleven different occasions, including 5 changes to the warning label between March of 2010 and June of 2011. It was not until 2011 that Merck finally updated the warning label to reflect what had been known to scientists and Merck for many years – that the sexual side effects caused by the drug can happen within days of first use and can persist long after the drug is discontinued. It is sad that it took so long for Merck to update the warning label, especially since there have been safety concerns raised by European drug safety regulators for years. For instance, the Swedish Medical Products Agency began an investigation into the persistent of Propecia-induced sexual side effects in 2006.

In June of 2008, Merck updated its warning label distributed in Sweden with Propecia to alert patients and prescribing physicians of the possibility of persistent sexual dysfunction after discontinuation of Propecia. There were also changes to the drug’s warning label in Italy and the United Kingdom, yet Merck decided not to share this critical safety information with the medical community and consumers in this country.

Originally posted at InjuryBoard by Brenda Fulmer

Consumer Report Has Concerns About Popular Medical Products

Brenda Fulmer — Thu, 29 Mar 2012 17:29:29 GMT

A recent Consumer Reports article on medical device safety has generated a great deal of buzz (and concern) among patients. Consumer Reports, founded in 1933, is an expert, independent, nonprofit organization that has worked tirelessly for many years to educate consumers about product safety. The organization employs 600 staff members involved in product testing, education, lobbying, and publication of their magazine and other materials, and claims to have 600,000 online activists involved in their consumer safety mission.

The latest medical device safety report from this organization has placed several popular medical products in its cross hairs:

Surgical mesh used in hernia and pelvic organ prolapse surgeries;
Lap-band weight loss device;
Metal-on-metal hip implants; and
Cardiac devices.

Since nearly 17% of all American adults have been implanted with some type of medical device, concerns about the safety of these products has far-reaching political, social, and financial impact. The organization has raised questions about the adequacy of the FDA approval process as well as whether the immunity granted to certain drug and medical device manufacturers against lawsuits for defective products is a policy that is in the best interests of consumers and patients.

Here are some of the highlights of this important report on how a speedy FDA approval process and manufacturers putting profits over safety have injured numerous patients:

The FDA has been reviewing the safety of a number of transvaginal surgical mesh products that are used to treat stress urinary incontinence and pelvic organ prolapse in women for several years. The devices remain on the market today, but surgeons have been urged to spend more time educating women on the likelihood of product failures, the potential for serious surgical and product-related complications, and the availability of non-surgical treatment options prior to implantation of bladder slings, TVT tape, and other mesh products. The Consumer Report article focuses on the deficient FDA 510K approval process that has permitted a number of mesh manufacturers to introduce their products to the market with little or no testing. In January of 2012, the FDA finally ordered 33 manufacturers of these questionable devices to conduct post-marketing safety studies. Most people involved in patient safety issues relating to mesh products believe that the FDA’s actions are far too little and far too late, but certainly a step in the right direction, and one that was desperately needed, as the manufacturers had failed for many years to investigate looming safety issues despite a moral obligation and legal duty to do so. Currently, there are thousands of individual lawsuits pending around the country involving pelvic mesh devices, with most of the case filings focused on products manufactured by C. R. Bard (Avaulta), Mentor Corporation (ObTape and ARIS), Ethicon (Gynecare Prolift and Gynecare Prolene), American Medical Systems (AMS Elevate), and Boston Scientific (Pinnacle Pelvic Floor Repair Kits).
This report noted a recent study that showed that approximately 25% patients who have undergone weight loss-related surgeries with implantation of Allergan’s Lap-Band had to have the device removed within three years. Removal of the gastric band device was necessitated by complications stemming from the device or a failure of the device to result in weight loss for the patient. This high percentage of failures of the Lap-Band is alarming in light of estimates that more than 650,000 patients have been implanted worldwide. This high percentage of failures of the Lap-Band is alarming in light of estimates that more than 650,000 patients have been implanted worldwide.
The entire class of metal-on-metal hip implant devices has come under scrutiny, as tens thousands of patients have had to undergo repeat surgeries due to premature loosening and failure of the prosthetic implants. Patients are also terribly concerned about whether they have been poisoned by metallic particles that flake off of the components of the hip implants due to excessive friction, a condition known as metallosis that is characterized by elevated blood levels of cobalt and chromium, pseudotumor formation, fluid and inflammation around the implant in the absence of an infection. Recent medical studies have called into question whether these products should have ever been implanted into patients. At this time, only one of the metal-on-metal hip implant products has been recalled (the DePuy ASR implant), but there are safety concerns and ongoing litigation involving other non-recalled, metal-on-metal hip devices manufactured by DePuy, Zimmer, Stryker, Biomet, Smith & Nephew, and Wright Medical.
Heart devices, such as pacemakers, implantable defibrillators, and leads, were also included in the report. More than 29,000 deaths and injuries relating to defective cardiac implants have been reported to the FDA since 2009. It is estimated that more than 500,000 patients are currently implanted with these devices in the United States. The Consumer Report investigation mentioned safety issues stemming from several large recalls involving Medtronic’s Sprint Fidelis leads and St. Jude’s Riata leads, which have been linked to numerous patient deaths and injuries due to lead fracture requiring emergency surgery. The report, however, was focused mostly on the abbreviated 510k approval process, and failed to give enough attention to a far greater threat to the safety of patients implanted with cardiac devices: medical device preemption, which has given virtual immunity from liability to Medtronic, St. Jude, Guidant, and others who have manufactured admittedly defective heart devices that went through the longer FDA Pre-Market Approval (PMA) rather than the abbreviated 510k process. The bottom line is that neither FDA approval process will ensure that patients are implanted with safe devices, especially when so little is asked of the device manufacturers. The reality is that our government has taken huge steps backwards over the past decade in patient safety, as the lack of accountability from the device manufacturers will continue to trump any improvements that are made to increase the effectiveness of the FDA and, ultimately, patients will not be truly safe until federal medical device preemption is eliminated.

The Consumer Reports findings are not surprising to those of us who deal with patient safety issues on a regular basis. Given their reputation and large readership, it is hoped that these important precautionary statements will reach patients who are contemplating implantation of medical devices or who have already been implanted with a medical device.

Originally posted at InjuryBoard by Brenda Fulmer

The Debate Over Pradaxa (Dabigatran) Safety - Follow the Money

Cal Warriner — Tue, 20 Mar 2012 10:19:16 GMT

Boehringer Ingelheim, a German pharmaceutical company beat all competitors to the market with its new wonder drug Pradaxa. The new drug was touted as equal or superior to Coumadin (Warfarin) for preventing strokes in patients suffering from Atrial Fibrillation. In addition, because of its properties, Pradaxa provided the added convenience of not requiring regular blood level monitoring. The study upon which it based those claims was funded by…you guessed it…Boehringer Ingelheim.

Soon after completion of the study, a hoard of doctors began publishing their findings in medical journals such as the New England Journal of Medicine. The main authors of the article have one thing in common. The each disclose at the close of the publication that they all received; consulting fees, lecture fees and grant support from Boehringer Ingelheim.

Soon thereafter, doctors began conducting studies and publishing letters to the editor criticizing Pradaxa (Dabigatran) for causing deaths from what appeared to be excessive, uncontrolled bleeding. They pointed out that unlike Coumadin, Pradaxa did not have an effective reversal agent. Since both drugs thin the blood, patients taking them are at significantly increased risk of catastrophic bleeding events if they suffer a trauma or internal bleeding. Coumadin, has an effective reversal agent. So, the blood thinning properties of Coumadin can be emergently reversed. Pradaxa does not. The doctors critical of Pradaxa pointed to reports of bleeding deaths in Pradaxa patients and the physician’s frustration with their inability to intervene as the patients bled to death.

The doctors critical of Pradaxa also had one thing in common. They reported not having received any consulting fees, grants or lecture fees from Boehringer Ingelheim. See the trend? It gets worse.

The two camps have recently squared off in a letter writing campaign that has been published in the New England Journal of Medicine. First, in late 2011, the doctors critical of Pradaxa published a letter to the editor pointing to bleeding deaths in trauma patients taking Pradaxa. They called on the FDA to create stricter guidelines for clinical trials and stronger hemorrhagic and trauma related death post market surveillance. They also pointed out the danger in Pradaxa having no reversal agent.

In March of 2012, one of the lead authors who had touted Pradaxa (and had disclosed having received research support, honoraria, lecture fees, consulting fees and grant support from Boehringer Ingelheim) fired a letter back saying that there was no evidence that the lack of an antidote contributed to the deaths of the Pradaxa takers who had bleed to death. He went on to say that a while a reversal agent was “desirable” and under development, the lack of one should not deter physicians from using the new drug. He even went so far as to suggest the drug was a safe, convenient alternative to Warfarin and more effective at preventing stroke. As support for his statements, he cited an earlier paper he and the other doctors who disclosed receiving payment from Boehringer Ingelheim had published.

That was not the final word. The doctors with no financial ties to the drug’s manufacturer published yet another letter in response. Calling the need for a reversal agent “essential” and not “desirable” the doctors point out the ridiculous nature of that statement. They went on to explain that the excess bleeding deaths in patients taking Pradaxa had been witnessed by a multi-disciplinary team of doctors who were powerless to stop the bleeding. Again highlighting the absurdity of the statement that there was no evidence that the lack of a reversal agent contributed to the observed bleeding deaths. Finally, they said that continuing to prescribe Pradaxa when there is no antidote should only be done with full knowledge of the FDA’s statements regarding this issue and only after a complete and thorough risk-benefit conversation with the patient.

The Debate Over Pradaxa (DabigatranWhat we do know is that this drug thins the blood. If a person on anticoagulant therapy suffers an unexpected bleed from trauma or any source they need emergency medical care. We also know Pradaxa has no antidote or reversal agent. Doctors who have no financial ties to the company have observed people die from uncontrolled bleeding they could not stop. Doctors who do have financial ties to the company are willing to risk their professional reputation by continuing to tout the drug as superior, safe and effective despite these observations and clear knowledge there is no antidote. They even go so far as to say that doctors should not be deterred from prescribing the medicine despite these observations. There exists not a word of caution in the conflicted doctors’ writings. Even with peoples’ lives at stake the old adage, “Follow the money” is in play. Amazing.

Originally posted at InjuryBoard by Cal Warriner

A House Christmas Special

John Hopkins — Wed, 21 Dec 2011 11:53:56 GMT

Whether you are Republican, Tea Partier, Democrat or Independent, the current shenanigans in Congress should make you mad.

Merry Christmas to the middle class citizens of this country.

We have a House Majority Leader who refuses to allow his House members to simply vote; up or down, one way or the other.

So, it is not as if the House members have reached an impasse on the Senate resolution to extend the payroll tax cut for an additional 60 days. That is not the problem. House Majority Leader, John Boehner, simply refuses to allow a vote on that Senate solution.

As former Presidential candidate, John McCain said, "It is harming the Republican Party," McCain said. "It is harming the view, if it's possible any more, of the American people about Congress."

I am not sure it is possible to further tarnish the image of politicians spending more time on politics than on the citizens’ business, but this is certainly something they should consider.

John Boehner laughs and simply insists that he is “still in town ready to work”.

First, this is nothing to laugh about and, second, why would you rush something as important as whether the employment tax break should be renewed permanently or not? Why would you not wait until calmer heads are in attendance and the issue can be given due consideration and time?

While House members play games, citizens may face thousands in lost income. Americans may very well find already stretched budgets strained that much more – Rome burns while Nero fiddles.

Five Republican Senators have called for the House to stop playing politics and start paying attention to the Nation’s business. In fact one, Senator Scott Brown (R) of Massachusetts, said that House Republicans “would rather continue playing politics than find solutions.”

Let us hope that party politics in the Boehner House can be put to bed and Americans are not held up to pay additional taxes simply because House Republicans want to draw dramatic lines in the snow.

Originally posted at InjuryBoard by John Hopkins