Racine Drug Recall & Drug Injury Lawyers & Racine Medical Device Lawyers
Racine Drug Injury Lawsuits
As a nation, we rely upon pills to "fix" whatever it is that ails us--from heartburn to allergies, high blood pressure to arthritis, and insomnia to restless leg syndrome. The drug companies invest billions of dollars into research each year, developing and marketing drugs for consumer use. Last year alone, the pharmaceutical industry invested some $12.6 billion in new drug development. And, historically, the amount invested in drug development has doubled every five years.
This can be a good thing. Sometimes, however, the "push" by the manufacturer to get a drug onto the market can cause health problems for unknowing consumers, often much more serious than the ailment the drug was being used to treat in the first place. Racine residents take prescription and over-the-counter drugs each day and suffer from a variety of unnecessary, drug-related side effects. It is in these situations that a Racine drug recall attorney can help you.
Dangerous and defective drugs are rampant on the market, primarily due to the large pharmaceutical companies that release risky drugs in the hopes of turning a profit. Over the past two decades, these companies have put increasing pressure on the Food and Drug Administration (FDA) to grant approvals faster and to implement less stringent testing processes. Of course, there are official channels and federal regulations that these companies must comply with in order to release their drugs, but the FDA will still approve a drug as long as its dangerous side effects are relatively rare.
Unfortunately, sometimes when the FDA approves a drug it is later discovered that it causes many more medical problems and harmful side effects than initially projected. In fact, the FDA itself has admitted that not all serious adverse reactions to prescription drugs are documented when drugs it approves hit the market. Consumer Reports found that one out of every six Americans has experienced a prescription drug related side effect serious enough to require medical treatment in a hospital. Imagine if one out of every six of your friends or family members in Racine were hospitalized due to adverse reactions to their medications!
Occasionally, pharmaceutical companies end up recalling drugs when the side effects and complications are too dangerous. Other times, however, the drugs are never recalled at all. The result is that injuries and ailments both in Wisconsin and across the country are commonplace and Racine dangerous drug injuries are often overlooked. If you are a victim of a dangerous drug or medical device, contact a Racine drug injury attorney or Racine medical device lawyer today for a consultation regarding your legal rights.
What is the process for the Food & Drug Administration (FDA) for Allowing a Drug to be Sold? Is there a similar process for medical device approval?
The FDA approval process occurs toward the end of the drug development process. This means that the drug manufacturer has already invested a lot of money before the FDA ever sees the potential drug and, if it is not approved, the manufacturer will lose a significant amount of money. These companies are "for profit" companies and they will do almost anything to get their drugs approved. Finally, the FDA, like all governmental units, is always under-funded. Thus, the FDA actually looks to the drug manufacturing companies to provide money and research assistance to reach its conclusion on the safety of the drug. This poses a very real conflict of interest that can ultimately prove harmful--even lethal--for Racine area consumers.
For a medical device to be marketed to consumers, it must first be approved by a division of the FDA known as the Center for Devices and Radiological Health (CDRH). This agency is responsible for testing and approving every medical device to ensure that it will be safe and effective for consumers to use. The FDA may request a voluntary recall by the manufacturer or issue one itself if the device is found to be unreasonably dangerous or defective; however, as with dangerous drugs, many devices are introduced into the market that end up causing excruciating pain and suffering, or even death, to consumers.
Who brings Racine, WI drug injury lawsuits and medical device cases?
Racine County drug injury lawsuits and medical device cases are brought by persons when a dangerous drug causes them injury. Usually, the product is known to be potentially dangerous and is sold without a proper warning to the consumer. It does not matter if the drug is received via prescription or over-the-counter in a local Racine area drugstore. If you or a loved one has suffered injury and you believe that a dangerous drug or medical device is to blame, contact a Racine drug recall attorney today.
Additionally, in Wisconsin, the spouse of a person injured by a dangerous drug or medical device may bring a loss of consortium claim for any damages to their marital relationship resulting from the dangerous drug or device. A loss of consortium claim encompasses a broad spectrum of damages, including loss of love, affection, support, companionship and sexual relations. Thus, spouses may also wish to speak with a Racine drug recall lawyer if their loved one was injured or died as the result of a dangerous drug or device.
If you would like to report a problem regarding an FDA-regulated product or device directly to the FDA, please visit and follow the reporting procedure at this website. Also make sure to contact an experienced Racine drug injury attorney regarding your legal rights.
What are the duties of a drug manufacturer or pharmaceutical company regarding the safety of their products?
The obligation of a drug manufacturer is to make a safe product. This includes the obligation to design, manufacture, inspect, and label a drug or medical device product appropriately. They must provide patients and physicians complete safety information about their product. If a drug manufacturer fails to warn the public about any serious side effects associated with taking its drugs, the company can be held liable for medical expenses, therapy and treatment, lost income, and non-economic damages, such as pain and suffering, if the drug is responsible for causing the harm.
Serious side effects related to the use of dangerous prescription drugs include:
- Heart attack
- Bone fractures
- Psychological imbalances
- Birth defects
- Kidney failure
- Cardiovascular problems
- Stevens Johnson Syndrome
- Sleepwalking, sleepdriving, and amnesia
- Multiple Sclerosis
If you or a loved one has experienced a serious side effect, such as one of those listed above, as a result of an unreasonably dangerous drug or medical device, you are entitled to compensation from the manufacturer. Contact a local Racine products liability attorney today.
The following is a list of dangerous drugs that may have harmed you or a loved one:
The following dangerous or defective medical devices are also responsible for Racine injuries and deaths:
These lists are by no means exclusive. If you or a family member has suffered a serious reaction or death due to a dangerous drug or medical device, you might be entitled to compensation from the company that markets and manufactures the drug. Contact a Racine drug recall attorney or Racine County drug recall attorney today to help you protect your rights.
What are some causes of drug related injuries?
Although there are many potential causes of drug related injuries, some common ones include:
(1) Drugs sold without warnings as to the hazards of use with certain other drugs;
(2) Drugs sold with side effects; and
(3) Drugs sold that tend to cause long term use, or withdrawal symptoms that occur when trying to reduce the dosage or quit the use of a drug altogether.
Types of Drug Labels and "Black Box" Warnings
A black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. It means that medical studies indicate that the drug carries a significant risk of serious or even life-threatening adverse effects. The FDA can require a pharmaceutical company to place a black box warning on the labeling of a prescription drug, or in literature describing it. It is the strongest warning that the FDA requires. These so-called "black box" warnings have even been placed on anti-depressants for children, since many children have committed suicide while taking anti-depressants.
Also, the FDA has supplied guidance on what should be included as to drug reactions, and how adverse reactions should be presented in drug warnings. A Racine, WI drug recall lawyer can advise you on whether a proper warning is present on a drug you have taken and whether you may have a claim against the manufacturer.
What are the ways Racine, Wisconsin residents can bring lawsuits for Defective Drugs or Medical Devices?
Racine drug injury lawsuits may be brought in three different ways:
(1) individually, in Racine County Civil Circuit Court;
(2) as a group, through Drug Injury Class Action lawsuits; or
(3) as a group, through Multi-District Litigation
See below for more information on Racine, Wisconsin class action lawsuits and multi-district litigation suits involving dangerous drugs and devices. Racine drug recall attorneys are some of the best in the nation and are able to bring mutli-district or class action lawsuits in defective drugs cases.
Racine Drug Class Actions
While every citizen of Wisconsin has the right to collectively file a complaint on behalf of similarly harmed citizens since the U.S. Congress, under President Bush, enacted the Class Action Fairness Act of 2005, the ability to form national Class Actions has been severely tightened. However, in certain cases, a judge may certify a class action lawsuit and this happens occasionally with defective drug lawsuits. If you believe a defective drug has injured you, contact a Racine drug recall attorney today.
Multi-District Litigation (MDL) Drug Lawsuits
Often, drug manufacturers will try to consolidate many individual lawsuits that are filed in various areas of the country into one central region of the country. This request is made under 28 U.S.C. Section 1447. Examples of drugs for which MDLs have been instituted include:
(1) Bayer Aspirin
(2) Epogen & Aranesp
(3) Vytorin & Zetia
If an MDL has been formed pertaining to your particular drug, it is essential that you retain a lawyer that actively practices in Federal Court and is familiar with the very specialized practice in MDL. Racine products liability attorneys are experienced in handling MDL and complex class actions lawsuits.
Who may be Liable for a Drug Injury or Medical Device Injury?
The designer, manufacturer, and others involved in the chain of commerce, including the distribution of the products that caused the injury or illness, can be held liable for injuries and illnesses caused by the defective drug or medical device product. Racine drug injury lawyers will identify and pursue claims against all potentially liable parties.
What are the requirements to make a claim for Racine defective drug injuries & Racine defective medical device injuries?
(1) You must be able to prove that you took the drug. If it was purchased over-the-counter, then a receipt or a credit card statement would do. Sometimes it can take years to discover that a medication could be dangerous or otherwise defective, and this typically occurs after several people have already suffered debilitating injuries or wrongful death due to their use of such products. Obviously, if it was a prescription medication, proving that you took it is much simpler;
(2) You need to show that the drug or device caused a physical injury or illness (including psychological and/or mental illness) to a person as the result of a defect in the medication or its labeling;
(3) If you or a loved one has been injured or has fallen ill due to what you believe is a defective drug product or device, do not delay in seeking immediate medical attention, as prompt diagnosis and treatment may help to avoid irreparable damage. It is also important to take immediate legal action, as restrictive statutes of limitations can prevent you from collecting the compensation to which you are entitled. Successful defective drug litigation sends a clear message to the pharmaceutical industry about accountability and consumer safety. For more information, contact one of the skilled defective drug litigation attorneys listed at the top of this page.
Is Product Liability Law governed by Wisconsin Law or Federal Law?
As stated throughout this website, most product liability law is governed by the laws of Wisconsin. However, sometimes state law can be preempted by federal law. In short, federal preemption is the application of the Supremacy Clause of Article VI of the United States Constitution. This Article provides that:"This Constitution, and the Laws of the United States which shall be made in Pursuance thereof; and all Treaties made, or which shall be made, under the Authority of the United States, shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, anything in the Constitution or Laws of any State to the Contrary notwithstanding." What this means is that when Congress has enacted a law, the States cannot then go and enact a contrary law. If they do, then the state's law is deemed preempted and unconstitutional. On occasion, the federal government will move to preempt an entire area of product liability law from state control in order to protect a certain group of manufacturers. This occurred in 1998 when congress enacted the Federal Biomaterials Access Assurance Act 21 U.S.C.A. §§ 1601-1606. The Federal Biomaterials Access Assurance Act was designed to protect the suppliers of materials for implantable medical devices from frivolous or unwarranted lawsuits. Under the Federal Biomaterials Access Assurance Act a biomaterials supplier may only be held liable in three situations: (1) when the supplier is a manufacturer of medical implants under the act; (2) when the supplier is a seller of medical implants; or (3) when the supplier sold materials that did not meet contractual specifications of the manufacturer.
In March of 2009, The Supreme Court of the United States solidified its stance regarding federal preemption in Product Liability law when it announced its decision in Wyeth v. Levine, 129 S. Ct. 1187, (2009). In this case, the Supreme Court held that product liability claims made under state law were NOT preempted by federal law. In a 6-3 decision, the court rejected a pharmaceutical company's argument that state law claims were preempted by federal law because it was impossible for Wyeth Pharmaceutical Inc. to comply with both sets of laws. In particular, the Court made a point of noting that the there was no evidence that the particular risks at issue with this product had actually been considered by the FDA and that the defendant had thus failed to show that there was an actual conflict between FDA regulation and the state law tort suit.
In Wyeth, the pharmaceutical company labeled its product Phenergan, complete with warnings and instructions about use, in compliance with federal standards. However, this was not the same standard that was required under Vermont's state regulations. As a result of using the product, professional musician Diana Levine developed gangrene because of the product's injection and had to have part of her right arm amputated. Levine's suit said the drug's labeling should have forbidden the quicker acting IV injections of Phenergan because of the risk of injury. Had the FDA considered the risks associated with this type of product and injury, the Court may have ruled differently.
Why the Increase in Preemption Arguments?
Simply put, states try to make laws that protect their own citizens. The federal government's standards can often times be less stringest, and if the case went before federal court, chances are the consumer would lose. As one law professor has put it, "The increase in preemption arguments since the early 1990s surely resulted in part from product manufacturers and other litigation targets trying to get out from under the “weight,” perceived or real, of large-scale tort litigation. The occasional tort claim in the face of federal regulation never seemed to generate much preemption interest until truly large-scale tort litigation became the norm after the explosion in asbestos cases in the 1980s and 1990s. Traditional analysis of the preemptive scope of most federal regulation had not resulted in findings of preemption until then; indeed very few such arguments had been made."
A Racine Wisconsin product liability lawyer can help with even the most complicated claims and make sure that a preemption argument doesn't go unchallenged.
When President Obama took office, one of the most important actions that he performed was to reverse eight (8) years of the Bush Administration's assault on the rights of individuals to seek justice from corporations that had placed profits in front of corporate responsibility in decision making. He entered a Presidential Order reversing governmental preemption by almost every department of the federal government.
HELPFUL LINKS & OTHER INFORMATION:
FDA Contact Information
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993
Medwatch is an on-line system whereby consumers can report serious reactions and side effects from medications, dietary supplements, and herbal remedies. The FDA recommends consulting your doctor for help with filling out the forms.
Hospitals in the Racine area
Aurora Health Care Southern Lakes Inc
Wheaton Franciscan Healthcare
Aurora Health Center
United Hospital System, Inc.
Wheaton Franciscan Healthcare
Midwest Orthopedic Specialty Hospital
Midwestern Regional Medical Center
Lakeview NeuroRehab Center Midwest
Wheaton Franciscan Healthcare
Aurora St. Luke's Medical Center
Racine Area Hospitals
Racine Area Pharmacies
Where can you find a Racine Drug Recall Lawyer or Racine Dangerous Medical Device Lawyer to represent you?
Serving clients throughout Southeastern Wisconsin, including Beloit, Brookfield, Brown Deer, Burlington, Caledonia, Delavan, Elkhorn, Fort Atkinson, Franklin, Germantown, Glendale, Greenfield, Janesville, Kenosha, Lake Geneva, Madison, Menomonee Falls, Mequon, Milwaukee, Muskego, New Berlin, Oak Creek, Port Washington, Racine, Richfield, Salem Oaks, Somers, South Milwaukee, Sturtevant, Waterford, Watertown, Waukesha, West Allis, West Bend, Whitewater, Wind Lake, areas in the vicinity of General Mitchell International Airport and John H. Batten Field, and other communities in Milwaukee County, and Racine County.
Call one of the experienced Racine Dangerous Drug Attorneys listed on this page for a free initial consultation and find out your rights.