Illinois Plaintiff's Lawyer Personal Injury Blog- Legal News and Insights from Champaign Urbana Attorneys Koester & Bradley, LLP

Does FDA Clearance Mean a Medical Device is Safe? No!

4/23/2019

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The process by which the FDA approves of drugs and medical devices has recently come under fire.  At Koester & Bradley, we have seen these problems first-hand. --Ryan Bradley, Partner, Koester & Bradley LLP

 

If a medical device or a drug is "cleared" by the FDA, is the device or drug safe?  Surprisingly, the answer is No.

With the premiere of the Netflix Documentary, "The Bleeding Edge," Illinois residents and those across the United States are finally becoming aware of a startling fact that Illinois defective product attorneys at Koester & Bradley have been monitoring for over a decade.  Namely, that FDA approval does not make a medical device safe.

Pharmaceutical companies and medical device manufacturers are in business to make money.  Many companies put profits over safety in order to keep shareholders happy.  This attitude has dramatic and catastrophic impact on residents of Illinois who are victims of bad medical devices.  Although the FDA and other regulatory entities have to approve these goods, defective products still reach the market.  This is because drug and medical device companies do not always disclose all of the potential risks of the products they sell.

Our experienced products liability attorneys based in Champaign Illinois investigate claims related to defective drugs such as Uloric, Pradaxa, Xarelto, and Actos, and defective devices such as vaginal mesh, IVC Filters, knee implants, metal hips and other devices.

Koester & Bradley, LLP has decades of experience representing patients who have been harmed by defective medical devices and dangerous drugs.  We have represented injured victims in Illinois and across the country.  


Consumers should be educated about the risks associated with defective drugs and medical devices.   An educated consumer, whether in Central Illinois or another state must do their research before filling a new prescription or agree to have a medical device implanted.  Medical care providers are ready to help.  Ask your doctor about the risks including side effects and history of recalls and poor performance.  If you or a loved one has been injured by a defective device or drug, contact your doctor and Koester & Bradley, LLP.

Again, it is important to understand that a drug or medical device that has received approval by the Food and Drug Administration (FDA) does not necessarily mean it is safe for all uses for all people or that it is not defectively designed or manufactured.  Drug companies are often known for marketing drugs for uses for which they were not originally approved.  Medical device manufacturers know all of the loop holes in the federal approval process that can be used to bring a dangerous device to market faster.  This is known as the 510(k) process.

At Koester & Bradley, LLP we have a team of attorneys, located at home in Champaign-Urbana, Illinois, dedicated to holding the medical device and drug industry accountable.  We are constantly staying apprised with up-to-date information about dangerous products and continually updating our online resources.  If you or a loved one has been injured from a defective medical device or drug, call Koester & Bradley, LLP or submit a claim-- we have the experience to help.

By: Ryan Bradley and Tom Koester, Partners, Koester & Bradley, LLP

Opioids: Are Doctors Liable?

1/15/2019

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In the United States, Opioids officially kill more Americans automobile accidents.  It is safe to say that Opioids have reached epidemic proportions.
-Ryan Bradley, Partner, Koester & Bradley LLP

Drug Manufacturers and Distributors share the Greatest Amount of Blame for the Opioid Epidemic

 

In the United States, opioid abuse runs rampant, and in truth large drug companies such as Purdue Pharma and distributors such as Cardinal shoulder the bulk of the blame.  Still, in certain circumstances, doctors have some responsibility as well.

Despite knowing that opioid pain relievers are addicting, the companies responsible for making and marketing the drugs continued to supply them liberally for years.  During this time, these companies told doctors that the powerful narcotics were not addictive.  Thus, many doctors were victims as well and this resulted in huge amounts of dependency.

However, the country is just starting to acknowledge our massive opioid problem and they are looking for someone to blame. If you have a loved one that got wrapped up in opioid addiction after being legitimately injured, can the doctor be held to blame?

It is a doctor's duty to take the best possible route of care for all their patients, and if they breach this duty, then it can be considered a medical malpractice case. There have been cases in other states where doctors, and more specifically their insurance companies, have had to pay millions of dollars in damages for the over-prescription of opioids. These cases often take a long time and a lot of evidence, investigation and money to fund.  Additionally, it is incredibly rare that only one doctor was prescribing opioids.  Most individuals who are seeking narcotics visit many doctors and even cross state lines to do so before turning to illicit drugs and heroin purchased on the street.  Most of the time the individual doctors are actually unaware for the amount of opioids that the addicted patient is actually taking.

In order to recover damages for a medical malpractice case of this nature, you would need to prove that the doctor prescribed a gross amount of opioids over a period of time and that the prescription kept being filled for longer than the injury needed. In cases where the doctors have been held responsible for opioid addiction, it was discovered that they fed the addiction for years without pursuing other, less addictive means of treatment.  These cases represent only a small portion of the problem as the federal government and local law enforcement has worked tirelessly to shut down so-called "pill mills."  THis means that most of the time the prescribing doctor has to rely on an accurate medical history from the compromised patient and other objective forms of determination such as drug testing.  This has put a great deal of strain on the system and made it very difficult for doctors, most of which are honest and diligent, to treat pain.

At Koester & Bradley, we believe that the manufacturers and distributors of opioids are truly the responsible parties in this epidemic.  This is why we are representing counties and municipalities in Illinois along with our co-counsel firms.  However, we are here to provide guidance to the families of opioid victims as well in every way we can.

Do you or a loved one need help?  If you believe that it was your doctor's fault that the addiction got so bad because they continued to wantonly prescribe you pills, then contact us today. We may be able to help you pursue a case of medical malpractice against your physician or provide some insight and closure about the issue.  If you are a member of a county board, or part of the law enforcement community in an Illinois County or municipality, also feel free to reach out and we will meet with you about the pending litigation. This can help you recover damages so you or your loved one can get the treatment that they need.

By: Ryan Bradley, Partner, Koester & Bradley, LLP

Hidden Dangers in Popular Do-It-Yourself Products

11/13/2018

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All across Illinois every weekend, thousands of unsuspecting home improvement enthusiasts unwittingly put themselves and their families at risk by using common solvents and products.
-Tom Koester, Partner, Koester & Bradley LLP

Methylene Chloride: When DIY Leads to RIP 

You are spending a Saturday afternoon finally stripping the paint off the bedroom floor.  Little do you know that the product you are using to strip those stubborn layers of old paint could kill you.  There lurking on the storeroom shelves are products containing a highly-toxic chemical known as methylene chloride, also called Dichloromethane (DCM).  Methylene chloride identified by its Chemical Abstract Number:  75-09-2 is a volatile, colorless liquid with a sweet-smelling odor.  If the Occupational Safety and Health Administration (OSHA) is advising its workers to avoid products containing methylene chloride, then why does the general public still have access to these products? 

USES OF METHYLENE CHLORIDE

Methylene chloride is a chlorinated solvent used in a variety of industries and applications.  It is primarily used in paint removers but also is used in aerosol formulations, in the manufacture of pharmaceuticals, as a degreasing agent, in metal cleaning, in electronics manufacturing and as an ethane foam blowing agent.  The Environmental Protection Agency states that paint and coating removal poses some of the highest exposures among the various uses of methylene chloride.

KNOWN HAZARDS OF METHYLENE CHLORIDE PER OSHA

  • Short-term airborne exposure without proper safety equipment can cause headaches, dizziness, nausea, a “feeling of intoxication, and eye, nose and throat irritation
  • Prolonged skin contact without proper safety equipment may cause irritation and even chemical burns
  • Increased airborne exposure without proper safety equipment can cause suffocation, loss of consciousness, coma and sudden death.
  • Animal studies have shown that long-term exposure to methylene chloride may lead to liver and lung cancer, as well as tumors in the breast and salivary glands
  • May lead to early onset heart attacks and arrhythmias in workers with heart disease due to an increase in carbon monoxide.

The Occupational Safety and Health Administration (OSHA) warns that if a worker smells methylene chloride, then he/she has already been overexposed because methylene chloride cannot be smelled until the level in the air is higher than OSHA’s permissible exposure limits (25 ppm (parts per million) in an 8-hour time-weighted average or 125 ppm in a period of 15 minutes (short-term exposure limit)). 

WARNING ON PRODUCTS CONTAINING METHYLENE CHLORIDE

Current warning on the product, Goof Off Semi-Paste Pro Stripper

WARNING:  Contains Methylene Chloride.  INHALATION OF VAPOR CAN KILL YOU.  DO NOT USE IN ENCLOSED AREAS such as basements, bathrooms or closets.  SYMPTOMS MAY NOT BE NOTICEABLE.  Avoid contact with eyes or skin, as severe irritation can occur.

DANGER!  POISON.  VAPOR EXTREMELY HARMFUL.  MAY BE FATAL IF USED IN ENCLOSED AND UNVENTILATED AREAS.  USE ONLY WITH ADEQUATE VENTILATION TO PREVENT BUILDUP OF VAPORS. MAY BE FATAL OR CAUSE BLINDNESS IF SWALLOWED.  EYE & SKIN IRRITANT.  Do not use in areas where vapors can accumulate and concentrate such as basements, bathrooms, bathtubs, closets or other small enclosed areas.  Whenever possible use outdoors in an open air area.  If using indoors open all windows and doors and maintain a cross ventilation of moving fresh air across the work area and across floor.  IF STRONG ODOR IS NOTICED OR YOU EXPERIENCE DIZZINESS, EYE-WATERING, OR HEADACHE – STOP! VENTILATION IS INADEQUATE.  LEAVE AREA IMMEDIATELY, AND GET FRESH AIR.  IF THE WORK AREA IS NOT WELL-VENTILATED, DO NOT USE THIS PRODUCT.  IF used properly, a respirator may offer additional protection.  Obtain professional advice before using.  Cannot be made non-poisonous. 

Methylene Chloride has been shown to cause cancer in laboratory animals.  Reports have associated repeated and prolonged over-exposure to solvents with neurological and other physiological damage.  The risk to your health depends on the level and duration of exposure.  Intentional misuse of this product by deliberating concentrating and inhaling vapors can be harmful or fatal.  Avoid breathing vapors or mist and contact with skin, eyes and clothing.  Do not swallow.

SAFETY DIRECTIONS:  USE OUTDOORS IN AN OPEN AREA.  It is dangerous to use this product indoors.  If you must use indoors, cross-ventilate work area by opening all windows and doors and circulating fresh air through the work area to reduce vapor accumulations.  Always wear chemical-splash goggles and chemical-resistant gloves when handling this product.  A dust mask does not provide protection against vapors.

OSHA SAFETY REQUIREMENTS FOR METHYLENE CHLORIDE

  • Gloves made of polyethylene vinyl alcohol(PVA)/ethylene vinyl alcohol (EVOH), or other laminate materials that are resistant to methylene chloride (required regardless of methylene chloride levels). LATEX, NITRATE, NEOPRENE AND POLYETHYLENE GLOVES DO NOT PROTECT AGAINST METHYLENE CHLORIDE.  BUTYL RUBBER GLOVES DO NOT MEET THE REQUIREMNET OF THE OSHA METHYLENE CHLORIDE STANDARD BECAUSE THEY DEGRADE IN LESS THAN 1 HOUR.
  • Outer gloves are also recommended to prevent cuts and tears to the inner methylene chloride-resistant gloves
  • Methylene chloride-resistant aprons, sleeves and boots or shoe covers
  • Chemical-resistant goggles or a face shield
  • OSHA requires workers to wear a full-face atmosphere-supplying respirator when engineering and work practice controls cannot decrease methylene chloride levels below OSHA’s permissible exposure limits.

THE EPA AND METHYLENE CHLORIDE

A 2015 study conducted by the Center for Public Integrity determined that methylene chloride exposure was responsible for approximately 56 deaths since 1980.  The Environmental Protection Agency (EPA) conducted its own risk assessment of methylene chloride in paint stripping uses in 2014 and had proposed to ban the consumer and commercial paint stripping uses in January 2017.  However, in June 2017, the EPA announced that it would not re-evaluate the paint stripping uses of methylene chloride.  An EPA News release of May 10, 2018 announced that: (1) The EPA intends to finalize the methylene chloride rulemaking; (2) The EPA is not re-evaluating the paint stripping uses of methylene chloride and is relying on its previous risk assessments and (3) The EPA is working to send the finalized rulemaking to the EPA’S Office of Management and Budget (OMB) shortly. 

Methylene chloride is one of 10 specific chemicals that the EPA  chose to evaluate for changes to the Toxic Substances Control Act of June 2016.  The new rules would require when a chemical poses an unreasonable risk that the EPA be required to take action within two years, with a possible extension of four years.  If the chemical is assessed as unreasonably dangerous, then phaseouts and bans of this chemical must occur within five years of that assessment. 

METHYLENE CHLORIDE BANS OUTSIDE THE UNITED STATES

On May 6, 2009, the European Parliament passed Decision 455/2009/EC which banned the use of methylene chloride in paint strippers by private persons and commercial entities.  Industrial uses are the exceptions to the decision but all products must be labeled accordingly.

RETAILERS AND METHYLENE CHLORIDE

News media have reported that Walmart, Lowes, Home Depot, Sherwin-Williams, Menards, Ace and Truce Value will no longer sell paint strippers made with methylene chloride or N-methyle-2-pyrrolidone (NMP) in its United States, Canada, Mexico and Central America stores and will cease the selling of these products on its e-commerce sites as of February 2019.

By: Thomas Koester, Partner, Koester & Bradley, LLP

Illinois Plaintiffs Lawyer Personal Injury Blog by Koester & Bradley, LLP 

Legal News and safety tips with Illinois Impact from the Accident and Personal Injury Firm Koester & Bradley, LLP

Authors

Ryan R Bradley is a personal injury and litigation lawyer based in Champaign County Illinois focused on representing injured clients and businesses navigate the maze of litigation to financial recovery.  


Tom Koester is a personal injury attorney based in Champaign County in Central Illinois focused on representing the injured and victims of Medical Malpractice and Personal Injuries.