New Mexico Injury Attorney Blog

There have been numerous Actos lawsuits filed throughout the country. Due to the large and growing number of Actos claims, those claims filed in federal court have been consolidated to the Western District of Louisiana. Due to the large number of users of the drug, the number of legal claims is likely to grow exponentially in the coming months and years.

Actos is prescribed for the treatment of Type 2 Diabetes. Actos has been hugely successful financially for its manufacturers. Both the root of the success of the drug and the coming wave of lawsuits is evident from a quick look at the numbers on Diabetes in the United States.

The 2011 National Diabetes Fact Sheet issued by the Centers for Disease Control and Prevention (CDC) provides some remarkable data portending the future of the Actos lawsuits. Unfortunately, the data would suggest a rather bleak outlook for the scope of the potential harm to the public caused by this blockbuster drug.

The National Diabetes Fact Sheet suggests that over 25 million Americans suffer from diabetes. This represents over 8% of the United States population. There are a number of states whose rates are above 15%. These states and their people are likely suffer the greatest harm associated with Actos use.

Of the 25 million suffering from diabetes, over 18 million have been formally diagnosed according the CDC. These numbers suggest the basis for the huge market success of Actos. They also point to the many unsuspecting users of Actos from a potential market of 18 million diagnosed patients who were unaware of the dangers of prolonged Actos use.

It is alleged that Actos causes bladder cancer. In fact, studies have suggested that the risk of bladder cancer may increase by up to 40% for those using Actos for more than one year. The risk appears to be directly related to dosage levels and duration of use. In other words, those that used it the longest and at the greatest dosages will have the greatest risk of Actos induced bladder cancer.

If you or a loved one has been on Actos for over one year, a checkup with the doctor is surely in order to review your medication. Diabetes is a horrible and life-threatening disease and Actos is in fact it appears effective at treating diabetes. However, the risk of cancer may outweigh the risk of the diabetes in light of alternative treatments.

This risk assessment is between you and your doctor and you have an absolute right to understand these risks. And this failure to inform patients, and doctors for that matter, of the risks associated with extended Actos use lies at the heart of the Actos litigation.

If you have any signs of bladder cancer, then you should get to your doctor immediately. As with all cancer, early detection and treatment is key to survival. In the unfortunate event that you have used Actos for over a year and do learn from your medical professionals that you have bladder cancer, you should contact a personal injury attorney right away to insure that you, your claims and your family are protected.

Collins & Collins, P.C.
Albuquerque Attorneys

It has long been a practice of the pharmaceutical industry pay doctors for a variety of purported purposes such as consulting research and speaking. As often as not, these payments are intended to and do effectively influence the doctors in the prescription of the drug companies' products.

There are many doctors that make significant income off these arrangements. It is not unheard of for the doctor to make more from the drug companies than from his or her medical practice. The potential for conflicts of interests hardly needs stating.

A new law when passed will require pharmaceutical companies to disclose all payments to doctors. This will include research money, speaking engagements, travel, meals and even according to the New York Times, bagels and coffee brought for the doctor's office staff on visits from the pharmaceutical sales representative.

Research has shown that these pharmaceutical practices, until now somewhat in the dark, do in fact influence doctors' prescription habits. Among the more troubling findings is that doctors often will prescribe the medicines off label for unapproved purposes despite obvious dangers of such off label prescription practices.

It is hoped that the new law and disclosure requirements will increase the chances that doctors are making drug prescription decisions based entirely on the well-being of their patients. In addition to the light that these financial disclosures will shed on current and future practices, they may also reveal possible issues related to past practices of both drug companies and doctors.

There has been significant evidence that these payments influence treatment decisions. Of particular interest will be the financial incentives given to doctors for the prescription of known dangerous drugs such as Actos which has been shown to cause bladder cancer. It will also be interesting to understand doctors' incentives in prescribing drugs off label.

The New York Times found that the doctors that benefit from these pharmaceutical payoffs practice medicine differently from their counterparts who do not. These doctors are more willing to prescribe risky drugs and to prescribe drugs for unapproved uses. Sometimes they do both according to the Times when for example they prescribe powerful antipsychotic drugs to children.

This all sounds good so far. The penalties range from $10,000 to $100,000 per violation. However, the maximum fine is only $1 million per year. When speaking of pharmaceutical companies that bring in billions upon billions of revenue each year, this is a pittance and a small cost of doing business.

Due to the relatively low fines for violations, these practices will likely continue unabated at least from the pharmaceutical industry side of the equation. What is far more interesting and far more likely to effect change is the potential light this will shed on individual doctors and medical providers which may lead to medical malpractice claims. In fact, isn't the discussion that we should be having about a doctor's duty to disclose conflicts of interest that might be detrimental to the health of his or her patients?

Collins & Collins, P.C.
Albuquerque Attorneys

The Food and Drug Administration has unleashed a new tool for ensuring the regulation of foods and drugs. The FDA has begun using the "Park Doctrine" for the imposition of criminal sanctions against pharmaceutical companies for violations of FDA regulations.

The FDA is targeting the illegal promotion of products for unapproved uses. The practice is known as off-label marketing and is fairly widespread. The FDA has brought back the Park Doctrine after years of dormancy with the realization that civil penalties, no matter how steep, seem to have no deterrent effect on the practice.

The 1970's Supreme Court case of United States v. Park ruled that company executives may be held criminally liable for willful violations of FDA regulations. The criminal penalties typically include fines. However, the FDA has expressed the intention to also seek jail time for those executives responsible for the illegal acts.

The FDA recognizes that the profit motive overcomes the threat of fines, whether criminal or civil. The threat of actual prison time is hoped to be more of a deterrent. Off-label marketing is clearly profit driven and until the profit equation is tipped in favor of public safety, the practice will continue.

These practices are both widespread and widely accepted by pharmaceutical companies and doctors alike. There are numerous ongoing lawsuits, criminal cases and criminal investigations related to these practices. It remains to be seen whether the FDA will hold true to its threat of jail time for guilty executives. It also remains to be seen whether even a threat of a little jail time will tip the profit loss calculation sufficiently for these folks to stop skirting the law.

These cases are interesting for a number of reasons. First and foremost these practices risk the health and safety of patients. Related to this is the fact that both medical industry and the pharmaceutical industry are among the strongest proponents of caps on personal liability awards. They argue that it is trial lawyers that harm the public and threaten public health.

Even President Obama has jumped on the Tort Reform bandwagon suggesting support for medical malpractice caps. There is no disputing that medical malpractice is on the rise, while actual successful medical malpractice claims are on the decline. Neither is there a dispute that wrongful prescription of drugs for financial gain is commonplace. Finally, there is absolutely no disputing that medical malpractice and pharmaceutical company off-label marketing harm the public. So why the continued calls for personal injury liability caps?

Let's start over. It has become a widespread practice of pharmaceutical companies to actively market through financial incentives for cooperating doctors the use of their drugs beyond their FDA approved uses. The practice is called off-label marketing...

Collins & Collins, P.C.
Albuquerque Attorneys

The statute of limitations in most personal injury cases is 3 years from the date of the incident that caused the injuries. In cases against state, county and local governmental entities, the statute of limitations is only 2 years.

Failure to file a suit within the statute of limitations bars a lawsuit completely. In other words, if you do not file within the statutory period, then you cannot file the lawsuit at all. The statute of limitations is harsh and a personal injury plaintiff should not flirt with these deadlines.

There are some rare cases where the statute of limitations may be extended or tolled. These are extremely rare and an injured plaintiff would be well advised not to place any reliance on these exceptions to the statutory deadlines.

Perhaps the most common situation where the statute of limitations would be extended is in cases where the injured party is unaware of the injuries. This often arises in cases of medical negligence. After all, for instance, the patient may not know of a surgical sponge left inside them for years following the surgery.

An injured person may also be unaware of his or her injuries in cases of product defects. Often these too are associated with a medical malpractice claim. The best example currently in the news are the hip replacement recalls from Depuy . There are many other surgical products that have caused injuries to patients which were apparent only years after the surgery.

The same type arguments hold for numerous pharmaceuticals both past and present that have been found to cause serious personal injury to patients. There are currently recalls with either pending or possible lawsuits involving Yaz, Nuvaring, Accutane, Darvon, Darvocet, Gardasil, Fosamax, and Paxil to name only a few. For each, patients may have taken the drugs for years before realizing the harm that the drugs caused. Some may have ceased using the medications long before knowing of their injuries.

There are certainly other situations where an injured party may not be aware of his or her injuries until months or years after the incident. Keep in mind, however, that ignorance of the injuries alone is not sufficient to toll the statute of limitations. If the injured person should have known of the injuries, then there will be no tolling of the statute of limitations. By way of example, this is true in New Mexico even where there are differing medical opinions regarding the source of the injuries.

The bottom line is the statute of limitations is real and it is rigid. There are very few exceptions. It would be exceedingly unwise to ignore an injury or illness that may have been causes by medical negligence, a product defect or any other cause. It is entirely possible that ignorance of the cause may not be grounds for tolling the statute of limitations.

If you are injured or sick and you believe it was caused by the products or actions of another, then seek a medical opinion immediately. If there is more than one possible cause, then it may unfortunately be necessary to sue them all and sort out the causation through litigation.

Collins & Collins, P.C.
Albuquerque Attorneys

GlaxoSmithKline has paid around $1 billion in Paxil settlements for litigation related to birth defects, suicides, and addiction as well as some non-medical related litigation. There remain 600 birth defect lawsuits pending so that the settlements are likely to grow much larger in the coming months and years.

Bloomberg News reports that Glaxo has spent almost $400 million in suicide related lawsuits, $200 million in addiction and birth defect litigation, and $400 for claims unrelated to antitrust, fraud and design.

Paxil was first approved in 1992 for the treatment of depression. It is among the most frequently prescribed drugs on the market with sales close to $1 billion in 2008. Unfortunately, the drug has many side effects including suicidal ideation, birth defects, and addiction. The drug maker failed to warn users and doctors of these known side effects.

The drug has been clearly linked to suicide. It is reported that there have been 300+ suicide attempts with an average settlement of $300,000. In addition, there have been around 150 wrongful death lawsuits related to suicide related deaths.

Paxil used during pregnancy has been linked to birth defects including persistent pulmonary hyper-tension in newborns along with other congenital heart defects. The average settlement costs for the birth defect cases has been in the range of $4 million. There remain around 600 birth defect related lawsuits outstanding.

Analysts have estimated potential liability of $1.5 billion in damages before it is all over. Glaxo has not disclosed the total numbers. However, the company has disclosed that it set aside $3.09 billion for legal and other non-tax disputes including litigation at year end 2008.

The numbers seem pretty large but pale in comparison to the $21 billion necessary to resolve 200,000 personal injury lawsuits against Pfizer for the diet drug fen-phen. However, the scope of the problems in the Paxil lawsuits is unique with a range of serious side-effects from birth defects to suicide. It is very unusual for one drug to present such a wide range of problems for its users.

It is important to the public that the settlement numbers be disclosed. First, it helps to alert the public to the problems with Paxil. More importantly, it alerts doctors and other medical providers of the risks of the drug. This puts a burden on doctors to both research the drug and to know their patients before routinely prescribing the drug as seems to have been the case in the past.

The sheer volume of the prescriptions of the drug suggests that perhaps some doctors have not given it the proper medical attention. The next wave of lawsuits will likely be against doctors for medical malpractice in the negligent prescription of the drug as they can no longer argue that they were unaware of the dangerous side effects.

www.CollinsAttorneys.com