Video originally created by FDA -- posted by Lawsuit.com on December 14, 2009
An important FDA program called “MedWatch” allows health care professionals and consumers to report serious problems that they believe may be associated with the medical products they prescribe, dispense, or use. These reports, along with follow-up investigations, can help to identify important safety concerns.
Take the case where over 100,000 vials of the long-acting insulin Levemir were stolen and may not have been stored or handled properly. That could have made it dangerous for patients to use. After learning about a diabetic patient who suffered a serious side effect from poor blood glucose control, FDA and the drug’s manufacturer were able to determine that the stolen Levemir was being sold, and to warn the public not to use it.
Even one report can make a difference. For example, a family member of an MS patient sent FDA a report about the patient suffering heart failure after being treated with a relatively low dose of Novantrone. This led FDA to further investigate the potential for cardiotoxicity from lower doses of Novantrone, and that resulted in updated recommendations for closer monitoring of cardiac function in patients being treated with the drug.
Reporting can also help detect problems with medical products other than drugs. For example, FDA received several reports stating that a company’s drug-eluting coronary stents had been implanted in patients who were supposed to receive that company’s bare metal stents, and vice-versa. The two stents shared part of a trade name -- Liberte -- and that contributed to the potential for confusion.
FDA then worked with the company, which changed the name of the bare metal stent from Liberte to VeriFLEX in order to better distinguish the two products.
Of course, MedWatch reports alone rarely confirm a causal relationship between an adverse event and a medical product. It may take a formal epidemiologic study or a controlled clinical trial to do that. Still, MedWatch reports are vital in helping to make sure that medical products are safe, because they provide a rapid signal to FDA that problems may be occurring.
It is important to keep the MedWatch system working, and FDA cannot do that without your help. Here are the kinds of reports we need from you:
• Serious adverse event that might be associated with a drug, biologic, medical device, dietary supplement or cosmetic product. We’re particularly interested in serious adverse events that are not listed in the product labeling. “Serious” means fatalities, hospitalizations, and medically significant events.
• Therapeutic failures — cases where the drug or device failed to work as it should (e.g., if a patient has to switch from one brand of a drug to another because the original one was ineffective).
• Use errors with medications or devices. That includes situations where the error may have been due to poor communication, or to ambiguities in product names, directions for use, or packaging.
• Product quality issues, such as suspected counterfeit products, defective components, potential contamination, device malfunctions and poor packaging.
Report these problems to MedWatch even if you are not sure that the product was the cause. You can find information about how to report at the “Additional Information” link below.
Ethex Corporation announced multiple recalls of numerous drugs, including morphine, iron and prenatal vitamins. The string of recalls began to commence last year due to double dose tablets of morphine and other potential concerns. There have been recent reports that the FDA is questioning adequate quality control at the manufacturing facility where the morphine tablets were made. As Richard Schulte, Attorney at Law of Dayton, Ohio explains, “This is a clear case of manufacturer defect. The problem we are faced with now is we do not yet know the extent of defective pills on the market and how great of harm they caused to consumers.”
Signs of Overdose
The long term effects of the prenatal vitamins are unknown. Iron supplement overdose side effects usually occur shortly after intake. Iron poisoning side effects may include, vomiting diarrhea, liver dysfunction, jaundice, internal bleeding, and seizures.-1- The initial signs of overdose in morphine are clear and can be life threatening, but may not be fully apparent to the person using the drug. Opioid overdose includes:
• Rapid Heart Beat
• Hypertension
• Tremors
• Bluish Lips
• Headache
• Insomnia
• Dizziness and Fainting
• Blurred vision
• Upset stomach
• Fainting
• Low Blood Pressure
The List of Ethex Recalls
Isosorbide mononitrate: 30mg and 60mg
Propafenone HCI: 150mg, 225mg, and 300 mg
Dextroamphetamine sulfate tablets: 5mg and 10mg
Morphine sulfate ER: 15mg, 30mg, 60mg, 100mg 200mg
Morphine IR: 15mg and 30mg
Prenatal Vitamin Recalls
Advanced NatalCare® Tablets and Advanced-RF NatalCare® Tablets
Cal-Nate™ Tablets
CareNatal™ DHA Tablets
ComBgen Tablets
ComBiRx™Tablets
NataCaps Capsules
NatalCare Gloss, PIC, PIC Forte, Plus, Rx, Three Tablets
NataTab FA Tablets
NataTab RX Tablets
NutriNate® Chewable Tablets
NutriSpire™ Tablets
Prenatal MR 90 FE and MTR w/Selinium Tablets
Prenatal Rx 1 Tablets
Prenatal Z, Advanced Formula Tablets
Ultra NatalCare Tablets
Iron Supplement Recalls
Anemagen Caplets
Anemagen Forte Caplets
Conison™ Capsules
Fe-Tinic™ 150 Forte Capsules
As John C. Wunsch, Attorney at Law, Chicago, IL explains, “Product liability cases can be brought forward under various theories, including negligence, strict liability, and breach of warranty. The validity of a product liability case depends upon a thorough factual investigation of the case which includes the forseeability of the risk of harm, the cost and feasibility of correcting the risk, and the extent to which the risk could be reasonably appreciated by an ordinary user of the product. In addition, there are various defenses to a product liability case, including misuse, assumption of risk, as well as federal preemption. Typically, expert testimony is required to establish whether a particular product was defective and unreasonably dangerous in accordance with the guidelines set forth in the Restatement (Third) of Torts.”
Personal injury resulting from a product falls under the general category of strict liability. Strict liability refers to injury resulting from products whereby the manufacturer is held responsible because of one or more reasons,
including:
safeguards in the design of the product failed to protect the injured party from harm despite cautious use
failure to design the product through an alternative that would offer better safety mechanisms,
omission of warnings that would otherwise allow for reasonable use of the product.
The types of products that fall under the category of product liability include just about any product available in the U.S. market such as pharmaceutical drugs, industrial or manufacturing component parts, construction equipment, play products, food and drink. Personal injury resulting from products can be extremely detrimental and can extend harm to a great number of people.
Consumer Product Injury
The U.S. Consumer Product Safety Commission was established to help protect the public from unreasonable risks that can result in injury or death for over 15,000 consumer products under their surveillance. While this number represents only a partial list of the number of products that may pose an unreasonable risk of harm, the following statistics reported by The U.S. Consumer Product Safety Commission demonstrate the gravity of a nationwide problem.
Over $800 billion each year is the estimated cost in the U.S. for damage resulting from consumer products.
212,000 emergency room visits resulted from toys in 2002
Approximately 11,000 escalator related injuries, of 90 billion riders occurred in 2007.
4,000 plus recalls of products are listed on the CPSC website, www.cpsc.gov.
In fact, over the past 60 days, the following hazards relating to everyday, household, and recreational products were reported through the Consumer Product Safety Commission website, including:
Chemical Dangers
Fire Hazards
Entrapment Hazards
Choking Risk
Fall Danger
Lead Exposure Vulnerability
Burn Hazard
Gas Leak and Fire Danger
Strangulation Risk
Lead Paint Violations
Property Damage Vulnerability
Explosion and Fire Danger
Emergency Call Cell Phone Hazard
Laceration Vulnerability
Steering Risk
Ejection Hazard
Carbon Monoxide Danger
Drowning Hazard
Accident Danger from Tires
Food Borne Disease Injury
Food borne infection and disease can result from the mishandling of food during preparation through the time that the food is consumed by the public. There are numerous organizations dedicated to overseeing the food industry, including, but not limited to: the CDC (Centers for Disease Control), EPA (Environmental Protection Agency), FDA (Food and Drug Administration), and USDA (U.S. Department of Agriculture). Yet, often the damage resulting from food borne illnesses is not prevented until the product has been introduced to the U.S. market. As Patrick Carreon, Attorney at Law, Irvine, CA, adds, “The greatest challenge in preventing the spread of food borne disease is related to the food producer’s delay in providing its recall announcement. Unfortunately this is usually motivated by profit/profit-loss considerations which ultimately results in a delay in taking the offending food products off the market. There is also an access to information issue in relation to the consumer, not only brought about by delay, but also by the inadequate obligations on the part of the food producer to alert the general public and give specifics as to why there is a recall. Consumers deserve immediate access to information concerning the pathogen they have been exposed to and the potential illnesses related to the pathogen so they can understand what is wrong with them and get proper care.”
In 2007, the Foodborne Disease Active Surveillance Network noted the incidence of bacterial and parasitic infections as well as post diarrheal hymolytic iremic syndrome among Americans. Approximately 45 million people were affected by
the following infections and diseases:
Cryptosporidium
Cyclospora
Listeria
Salmonella
Shigella
STEC0157
STEC non-0157
Vibrio
Yersinia
Construction, Toxic and Work Related Product Injury
The number of productslocated in work related environments that may cause personal injury are substantial. Personal injuries relating to this topic can be very damaging and it is important to be proactive in every
aspect of care surrounding the circumstances of the injury. As John Gomez, Attorney at Law, San Diego CA, explains, “It is critical for consumers to consult a personal injury attorney about any work related injury. Though worker’s compensation provides benefits for occupational injuries, a defective or hazardous product may be responsible for the injury, making a potential third party responsible for the injury.” Construction, toxic materials and other work related injuries may include, but not be limited to:
Allergenic wood
Asphalt
Beriluim Alloy
Bricks
Cadmium Alloy
Cement
Concrete
Drywall, plaster or cement before 1975
Glue Solvents, Sealants and Foams: n-hexane, epoxy, isocyanates, formaldehyde-resin
Industrial Machine Defective Parts
Insulation
Lead Roofing
Lead
Old paint, lead poisoning
Paint, oil and water based
PCB contaminate transformer fluid
Rubber Gloves
Stone
Terazzo
Tiles
Welding materials, solder and braze
Pharmaceutical Drugs and Medical Device Harm
Currently, there have been more than 50 drugs that have caused personal injury to users. Many cases are the result of new drugs and devices that have entered the U.S. market. This is because new drugs and devices have a learning curve associated with them. New drugs and devices are approved by the FDA after research and studies
have been conducted, often by the manufacturer alone. The number of study participants and time threshold provided in the evaluations varies among products. This means that unknown side effects may be uncovered after FDA approval. In essence, new drugs and devices have not passed a test of time. Furthermore, widespread knowledge of uncovered side effects may not exist, making the doctor and patient more responsible when it comes to new drugs and medical devices. For some of the common pharmaceutical drugs known to cause personal injury, click here.
Product Liability and Law
Personal injury resulting from unusual hazards associated with products substantiates cause for legal investigation. There are personal injury attorneys who focus specifically on product liability. They serve both individuals and
the public. Their goal is to provide compensation for legitimate cases that meet the requirements of the law and in doing so, help protect the public from further harm. By the same token, their job has become more cumbersome since
1993 with the introduction of new guiding principles such as The Learned Intermediary Risk Doctrine, DUBERT and the recent Supreme Court ruling which bans bringing liability against pharmaceutical companies at the state level.
The Learned Intermediary Risk Doctrine provides governing principles relating to medical devices and pharmaceutical drugs. This doctrine denotes conditions which have limited liability for manufacturers’ from unsafe drugs under two
conditions:
The manufacturer failed to sufficiently educate the prescribing physician about the circumstances that would make the drug or device unsafe for select users with certain medical conditions or risk of producing side effects that
could be harmful to the user that are not part of a warning to the user or the physician.
An insufficient warning to the physician resulted in personal injury to the user.
Because new drugs and medical devices may be associated with side effects that may not be widely known, a point of contention in pharmaceutical and medical device liability against the manufacturer may be raised.
In addition, a Daubert motion does not allow for presentation of evidence that has not passed the test of time through an expert witness unless the following conditions are present:
The theory must have been presented through peer review and publication.
A known or prospective error rate associated with the product or a particular component of a product.
Acceptance of the theory by the related scientific community.
One contention disputing the validity of the Daubert motion that might have a bearing in cases is that there are many scientific communities that present varying view points about products and medical devices, especially new ones.
Again, the test of time is often key in gathering all information so one general consensus can be made regarding particular new drugs and devices.
These two guidelines alone provide two reasons why it is important for personal injury victims to seek out the advice of a personal injury attorney who focuses on the specific product in question. Furthermore, this information cannot
replace the advice of a personal injury attorney nor does it include every type of hazardous product on the market. Personal injury attorneys are best equipped to answer questions about product liability.
Personal injury resulting from a product falls under the category of strict liability. Strict liability refers to injury resulting from products whereby the manufacturer may be held responsible because of one or more reasons, including: 1) safeguards in the design of the product failed to protect the injured party from harm despite cautious use 2) failure to design the product through an alternative that would offer better safety mechanisms, 3) the omission of warnings that would otherwise allow for reasonable use of the product.
Product liability may result from food poisoning (such as ecoli and liceria), pharmaceutical drugs, defective toys, playground equipment, recreational apparatus, dysfunctional components in machinery, motorcycles, ATV’s, cars, trucks, strollers or any other product in the marketplace. This may also refer to products that release harmful chemicals such as PBC’s, mercury, lead, asbestos,benzene, and mold.
Personal injury attorneys can assist individuals and serve the public in several ways, including:
1. Aware of technical bulletins and recalls associated with defective products
2. Report defective products to help create awareness about hazards associated with certain products. Understand how to preserve evidence from tampering or destruction.
3. Advocate for large groups and contribute to keeping the public safe from harm.
As Rich Ruohonen, Attorney at Law, Minneapolis, Minnesota, of Pritzker, Ruohonen & Associates, PA. warns, “Manufacturing companies may not be aware of the hazards associated with their product. Consumers can actually help prevent defective products
from causing injury to others by reporting questionable products to the Public Health Department, the Consumer Product Safety Commission and/or other proper authorities.”
Pharmaceutical Drug Damages:
Liability on pharmaceuticalcompanies occurs when t heir drugs cause harm to individuals taking the drug.In fact, the number of pharmaceutical drugs causing health problems and the types of health issues resulting from certain drugs has risen over recent years. As Steve Fields, Attorney at Law, Minneapolis, MN, explains, “It is wise for consumers to be proactive about their healthcare. This equates to doing your own research about medications which can provide stronger outcomes through better informed decisions. The lesson of Trasydol, which resulted in many preventable deaths, should send a message to all that pharmaceutical drugs require ongoing evaluation.”
Construction Accidents:
Construction accident liability may involve the company hired to perform the construction contract such as a construction firm or general contractor. Accidents can occur to many types of workers and the types of injuries can be life changing in many ways. According to the National Institute of Occupational Safety and Health, 17,000 construction workers were killed because of injuries they received while on the job. Falls are the most common type of injury in construction work. As Michael Gunzberg, Attorney at Law, of New York, New York warns, “Construction workers should verify that appropriate safety equipment is being provided and utilized by the general contractor or construction firm for whom they are employed by. For example, construction workers operating on buildings should be equipped with safety harnesses, safety lines and safety nets. Too often I see less than all three types of equipment being utilized during construction work. This can be extremely detrimental to a worker should a fall occur.”
