Kentucky Injury Lawyers

Fluroquinolones: An Overprescribed and Potentially Dangerous Treatment for Common Infections

Published on Mar 18, 2016 at 2:25 am in Dangerous Drugs.

Recently a 21- member panel for the Food and Administration met to discuss the overprescribing of a specific class of antibiotics called fluroquinolones.  More than 30 people came forward during the open public hearing about the severe, life-altering side effects they have experienced from taking these antibiotics in potentially unnecessary situations.  As a result, the FDA has decided to strengthen label warnings and clarify when the drugs should and should not be used. 

Thomas Law Offices works with Kentucky Attorney General to resolve $15.5 million Risperdal case

Published on Dec 30, 2015 at 1:14 pm in Dangerous Drugs.

The end of 2015 brought with it the successful end to Risperdal litigation filed by Thomas Law Offices, the Office of the Kentucky Attorney General and the Houston Law Firm of Bailey Peavy Bailey Cowan and Heckman.  The lawsuit, which alleged the drug company violated the Kentucky Consumer Protection Act, sought penalties against the company and its parent, Johnson & Johnson.

A Drug Price Increases by 5,000 Percent Overnight and Doctors Demand to Know Why

Published on Nov 19, 2015 at 11:13 am in Dangerous Drugs.

Infectious disease physicians and advocates are in outrage as the decades-old drug Daraprim increases in price overnight from $13.50 per tablet to $750.00 per tablet.  Daraprim, the common name for the drug pyrimethamine, is the only medication for treating toxoplasmosis, an infection contracted from cat parasites that can cause birth defects.  It is also a co-treatment for HIV infections, some cancers, and malaria.

The rights to Daraprim were recently purchased in August by a company named Turing Pharmaceuticals.  Doctors and advocates wrote a letter to the drug company urging them to reconsider their price increase, as it raises the cost of treatment to as much as $634,500 annually.  “This cost is unjustifiable for the medically vulnerable patient in need of this medication, “the letter said, “and unsustainable for the health care system.”  Turing Pharmaceuticals claims the drug is not overpriced compared to its peers was unprofitable at the former price.  They stated that the drug will now return what they consider to be a reasonable profit, not excessive at all, and the additional money will allow them to develop newer, better drugs.

Daraprim is part of recent trend in increasing costs among older pharmaceuticals where drug companies purchase the rights to an older, neglected drug and attempt to turn it into a high priced specialty drug. This is a frequent occurrence in the cost of drugs for rare diseases because competition in the particular field is so small.  Drug companies often reset the prices when they purchase these drugs because they now have a monopoly on the most common treatment for a given disease.

Companies like Turing Pharmaceuticals attempt to appear understanding and offer discount programs to patients who struggle to pay the new increased price.  However, these programs are often very complicated to register for and are not a sustainable source of assistance for patients who require taking the medication long term.  Research for generic drugs that require a lesser out-of-pocket expense has been growing in recent years, but mainly in drugs that are taken for more common, widespread illnesses like heart disease, high cholesterol, and blood pressure regulation.  The cost necessary to research generic drug options for rare diseases is not something drug companies are interested in paying, especially when little to no competition exists for their current, brand-name product.

Pharmaceutical companies who control drugs for rare diseases claim that the patients who need their products are their highest priority.  But dramatic price increases in Daraprim and uncommon drugs like it leave physicians and patients alike questioning the true motive behind the action.  To learn more about the increasing cost of pharmaceuticals and the likelihood of this action to continue in the future, contact Thomas Law Offices for more information.

Billions of Dollars Paid to Settle Cases Involving Use of the Drug Risperdal

Published on Oct 14, 2015 at 5:16 am in Dangerous Drugs.

Johnson & Johnson recently paid $2.2 billion to settle a decade-long investigation into the company’s illegal promotion of the drug Risperdal.  The settlement was split between the federal government and multiple states and was the largest of its kind in U.S. history.  The company also failed to disclose certain possible health risks from taking the drug, leading to millions of dollars in private settlements paid to individuals who experienced severe side effects.

Risperdal, the name used for the drug risperidone, is an antipsychotic medication prescribed to treat patients with schizophrenia and certain problems caused by bipolar disorder.  Johnson & Johnson aggressively marketed the drug from 1999-2005 for use in elderly patients with dementia and children with disabilities, despite not receiving approval for childhood use until 2006.  The government investigations revealed that Johnson & Johnson offered sales representatives incentives to promote unapproved uses to doctors, paid kickbacks to nursing home pharmacies, and offered doctors trips and monetary reward if they prescribed Risperdal to more patients.  Onmicare, the leading long term care pharmacy in the U.S., paid $98 million to settle charges that it received compensation for pushing physicians to prescribe Risperdal to nursing home patients.

In the first personal injury lawsuit to go to trial, a 21-year-old male claimed that Risperdal caused him to develop gynecomastia, a condition were boys or men experience swelling of the breast tissue, caused by an imbalance of the hormones estrogen and testosterone.  He was prescribed Risperdal at age 9 even though it was not approved for use by children at the time.  He claimed the drug caused pain, rapid weight gain, damage to his endocrine system, and emotional trauma.  Johnson & Johnson agreed to settle his case on the first day of trial, and later that same month paid settlements in five other personal injury cases involving Risperdal.  Under the agreements, the settlement amounts for each case were kept confidential and Johnson & Johnson was not required to admit any wrongdoing.  The company continues to deny liability for Risperdal injuries.

In an attempt to expose potential conflicts of interest in healthcare, the Affordable Care Act requires full disclosure of financial relationships between drug makers and physicians.  Patients who develop gynecomastia following Risperdal use continue to seek compensation for physical and emotional injuries.  Settlements typically include financial compensation, medical treatment, and counseling services.

If you wish to learn more about legal options available to those affected by the use of Risperdal or other dangerous and defective drugs, contact the Louisville, Kentucky personal injury lawyers at Thomas Law Offices for more information.

Tracking Down the Silence behind Antibiotic-Related Injuries

Published on Aug 26, 2015 at 1:06 pm in Dangerous Drugs, Multi-district Litigation, Product Liability.

Despite how often antibiotics are prescribed for multitudes of reasons every day, some types of antibiotics have potentially dangerous side effects. The most risky types of antibiotics are generally those belonging to the fluoroquinolone family. Levofloxacin (often referred to as Levaquin) and ciprofloxacin (often referred to as Cipro)—both fluoroquinolones—are two of the drugs most commonly regarded as to having some of the most serious adverse side effects among all drugs. Avelox is the name of another fluoroquinolone that can have dangerous side effects.

Year after year, cases of serious, incurable impairments and even deaths are reported as a result of side effects from taking these three drugs, yet the drugs remain on the market and the FDA remains stubbornly silent regarding the matter. Why is that?

The answer to that question largely lies with that fact that physicians are often unaware of just how dangerous these side effects can be or do not pay close attention to the changes in FDA warnings. According to data accessible at RxISK.org which is an independently-ran research site, reported medical conditions that result from adverse side effects from fluoroquinolones far exceed those reported that result from all other types of antibiotics. Over 79,000 cases have been linked to Cipro alone. This includes over 1,700 deaths during the last 10 years.

The Realities of Warning Labels

In the grand scheme of things, the above numbers still look slight when compared to how many prescriptions physicians write for fluoroquinolones on a regular basis. Millions of prescriptions are handed out every year for these drugs. Many physicians simply feel that antibiotics are a safe, generalized approach to curing many ailments and hand out prescriptions unnecessarily. Many others fail to tell their patients about the array of negative possible side effects.

The vast majority of physicians also rarely take initiative when it comes to reporting side effects to the FDA. This often results in data points that are largely inaccurate and/or difficult to prove. According to this editorial written by health writer Idelle Davidson, there is currently a study starting up at University of California at San Diego which may help researchers gain a better idea of how fluoroquinolone-based side effect symptoms progress and how the FDA can better inform patients and physicians regarding these side effects.

According to the FDA, all warning labels currently placed on both Levaquin and Cipro display all of the information patients need to be aware of. All fluoroquinolones carry a warning with a black border, in fact, which is the FDA’s strongest grade of warning. Problems often arise when physicians don’t inform patients about the seriousness of these warnings and fail to take factors like age and current joint/tendon health into consideration.

One of the largest issues with injuries caused by side effects from taking fluoroquinolones is the fact that many of the injuries related to taking the drugs are permanent. Irreversible tendon ruptures and nerve damage top the list of serious ailments caused by fluoroquinolones and can cause lifelong pain and suffering. Other adverse side effects include disorientation, convulsions, anxiety, cognitive disorders, and difficulty breathing/walking. Many of the cognitive issues caused from adverse side effects are also irreversible.

Ending the Silence

The fact that many of the most serious side effects caused by fluoroquinolones are irreversible should be cause for concern among physicians and patients alike, especially when other families of antibiotics have a safer track record and potentially cause side effects that are easily curable. When Idelle Davidson interviewed Beatrice Golomb, a professor of medicine at UCSD, Golomb said the following:

“It’s true that every antibiotic class has the potential for some problems, but in many cases they are curable. These people seem to be left with a life-altering situation from which many years out they haven’t recovered. The reason we should care is that many of these problems are needless sources of permanent, horrifying, life-altering effects that did not need to happen.”

Quotes like this are why UCSD feels the fluoroquinolone study is so important. Studies can lead to cold, hard facts that will help the FDA and physicians become more informed. This, in turn, will help patients become more informed and may lead to other antibiotics being prescribed more often in place of Levaquin, Cipro, and Avelox. With knowledge comes a possibility of an end to silence on the matter.

One other way to end the silence regarding the dangers of fluoroquinolone-based antibiotics is by taking legal action against the manufacturers of these drugs that fail to make the side effects of their drugs better known. At least 3,400 cases have been filed against Johnson & Johnson, the manufacturer of Levaquin, since 2006. Most cases claimed the company failed to adequately warn physicians regarding the risks of tendon-related injuries.

Currently, there are roughly 60 pending federal cases against Johnson & Johnson as well as against Bayer, the manufacturer of both Cipro and Avelox. The plaintiffs claim the drugs caused irreversible peripheral neuropathy and/or nerve damage and were sold without proper warning labels depicting those risks. All of these cases have now been combined in what is known as an MDL, or Multi-district litigation. The MDL, known as In Re Fluoroquinolone Products Liability Litigation MDL 262, will be heard in front of Judge John Tunheim in the District of Minnesota.  A copy of the transfer Order is attached 2015-8-17 In Re Fluoroquinolone MDL Transfer Order.

Lawsuits like these can’t cure irreversible nerve or tendon damage, unfortunately, and they cannot take away years of pain. But they can help these drug manufacturers realize that their products are causing serious harm and many physicians do not realize how much harm they’re causing. In time, these drugs may even be taken off the market if enough cases are successfully filed.

If you or someone you know has suffered from personal injuries you feel may be related to side effects caused by Levaquin, Cipro, Avelox, or any of the drugs on this list, contact Thomas Law Offices today to see how we can be of assistance. It’s time to put an end to the silence regarding the dangers of antibiotics.