Defective Drugs Law - Drug Products Liability Law



Defective Drugs Law falls under Product Liability law, is closely related to Pharmaceutical law and often overlaps with Medical Malpractice law.

As in all product liability claims, defective drug claims are based on three defect categories:

- Manufacturing defects – the pharmaceutical drug is manufactured improperly or the drug has become contaminated during the process and causes harm to the end user.

- Design defects (Dangerous side effects) – the pharmaceutical drug was manufactured correctly, but the side effects caused by the drug cause harm or injury.

- Failure to Warn (Defective marketing) – a failure to provide sufficient or appropriate instructions, warnings, or recommendations for the use of the drug.

Defective drug claims can result in a great many different defendants: the manufacturer; testing laboratory; pharmaceutical sales representative; prescribing physician; clinic or hospital; and the pharmacy. When suing a hospital or physician for a drug product liability claim, the plaintiff may also have a medical malpractice claim.

It’s important to note that drugs generally have known side effects and hazards; therefore, in order to prove a defective drug claim due to a its side effects, it is necessary to demonstrate that the plaintiff was improperly or inadequately advised regarding these side effects and their potential dangers.

Defective drugs claims can often be dealt with in class action lawsuits. A plaintiff can join a large group of people that have already been injured or harmed by the drug and have filed a single lawsuit, although they can also choose to maintain their own suit instead. See Mass Tort law.

Copyright HG.org

Articles on HG.org Related to Defective Drugs Law

Defective Drugs Law - US

  • Center for Drug Evaluation and Research

    The Center for Drug Evaluation and Research (CDER) performs an essential public health task by making sure that safe and effective drugs are available to improve the health of people in the United States. As part of the U.S. Food and Drug Administration (FDA), CDER regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

  • DEA - Office of Diversion Control - Prescription Drugs

    Of all the major drugs of abuse, only marijuana is available as a natural, harvested product. The others, whether they are illicit drugs such as cocaine, heroin, methamphetamine, or legitimately produced pharmaceuticals, must be manufactured. . Many problems associated with drug abuse are the result of legitimately made controlled substances being diverted from their lawful purpose into illicit drug traffic. The mission of DEA's Office of Diversion Control is to prevent, detect, and investigate the diversion of controlled pharmaceuticals and listed chemicals from legitimate sources while ensuring an adequate and uninterrupted supply for legitimate medical, commercial, and scientific needs.

  • Federal Food, Drug, and Cosmetic Act

    The FDA's online reference edition of the Federal Food, Drug and Cosmetic Act is based on the publication Compilation of Selected Acts Within the Jurisdiction of the Committee on Energy and Commerce; Food, Drug, and Related Law, As Amended Through December 31, 2004, prepared for the use of the Committee on Energy and Commerce, U.S. House of Representatives, March 2005.

  • Food and Drug Administration Amendments Act (FDAAA)

    On September 27, 2007, President George W. Bush signed into law H.R. 3580, the Food and Drug Administration Amendments Act of 2007. This new law represents a very significant addition to FDA authority. Among the many components of the law, the Prescription Drug User Fee Act (PDUFA) and the Medical Device User Fee and Modernization Act (MDUFMA) have been reauthorized and expanded.

  • Prescription Drug Marketing Act of 1987

    The Prescription Drug Marketing Act of 1987 (PDMA) was signed into law by the President on April 22, 1988. The PDMA was enacted (1) to ensure that drug products purchased by consumers are safe and effective, and (2) to avoid the unacceptable risk to American consumers from counterfeit, adulterated, misbranded, subpotent, or expired drugs.

  • Regulatory Guidance Drug Registration and Listing

    Section 510 of the Federal Food, Drug, and Cosmetic Act requires manufacturers, repackers, and relabelers that engage in the manufacture, preparation, propagation, compounding, or processing of human or veterinary drugs and human biological products to register their establishment(s) and submit a listing of every product in commercial distribution with the FDA. This information helps FDA maintain a catalog of all human and veterinary drugs and biologics in commercial distribution in the United States.

  • Title 21: Food and Drugs - Part 610 - General Biological Products Standards

    No lot of any licensed product shall be released by the manufacturer prior to the completion of tests for conformity with standards applicable to such product. Each applicable test shall be made on each lot after completion of all processes of manufacture which may affect compliance with the standard to which the test applies. The results of all tests performed shall be considered in determining whether or not the test results meet the test objective, except that a test result may be disregarded when it is established that the test is invalid due to causes unrelated to the product.

Organizations Related to Defective Drugs Law

  • A Drug Recall

    At ADrugRecall.com, we’re committed to providing our readers with the latest news and information about defective and harmful drugs. We cover breaking news stories, offer tips for consumer safety, provide information on alternative therapies, and more. Our goal is to empower you—our reader—by giving you the knowledge you need when you need it most. If you have a legal issue involving a defective drug, we can direct you to a respected and experienced attorney near you who can inform you of your legal rights and options.

  • Agency for Toxic Substances and Disease Registry (ATSDR)

    The Agency for Toxic Substances and Disease Registry (ATSDR), based in Atlanta, Georgia, is a federal public health agency of the U.S. Department of Health and Human Services. ATSDR serves the public by using the best science, taking responsive public health actions, and providing trusted health information to prevent harmful exposures and diseases related to toxic substances.

  • ClinicalTrials

    ClinicalTrials.gov is a registry of federally and privately supported clinical trials conducted in the United States and around the world. ClinicalTrials.gov gives you information about a trial's purpose, who may participate, locations, and phone numbers for more details. This information should be used in conjunction with advice from health care professionals.

  • DEA National Forensic Laboratory Information System (NFLIS)

    The DEA National Forensic Laboratory Information System (NFLIS) systematically collects results from drug chemistry analyses conducted by state and local forensic laboratories across the country. As a national drug forensic laboratory reporting system, NFLIS provides timely and detailed analytical results of drugs seized by law enforcement. It is a unique source of information for monitoring and understanding drug abuse and trafficking in the United States, including the diversion of legally manufactured drugs into illegal markets. Findings from NFLIS can also supplement existing drug data sources, including information from drug demand surveys and drug testing programs.

  • DrugInfo

    Drug databases are the best source of information on pharmaceuticals. They provide detailed information about the use and side effects of drugs. Many governmental, industry, and university sites offer carefully selected pharmaceutical and health resources. DrugInfo is a free guide intended to provide an easy access to the resources for locating the most relevant information on medications on the Web.

  • Food and Drug Administration

    FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. FDA is also responsible for advancing the public health by helping to speed innovations that make medicines more effective, safer, and more affordable and by helping the public get the accurate, science-based information they need to use medicines and foods to maintain and improve their health.

  • Good Medicine, Bad Behavior

    For as long as there have been medicines and products aimed to heal injuries, cure diseases and relieve pain, there has been experimentation with overusing and abusing those products. From the rise of the patent medicine industry in the middle and late 1800s through to modern day scientifically-engineered prescription drugs, there have been good medicines, that because of bad behavior, have caused many negative results.

  • International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH)

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) is unique in bringing together the regulatory authorities and pharmaceutical industry of Europe, Japan and the US to discuss scientific and technical aspects of drug registration. Since its inception in 1990, ICH has evolved, through its ICH Global Cooperation Group, to respond to the increasingly global face of drug development, so that the benefits of international harmonisation for better global health can be realised worldwide. ICH's mission is to achieve greater harmonisation to ensure that safe, effective, and high quality medicines are developed and registered in the most resource-efficient manner.

  • MedWatch - FDA Safety Information and Adverse Event Reporting Program

    Product problems should be reported to the FDA when there is a concern about the quality, authenticity, performance, or safety of any medication or device. Problems with product quality may occur during manufacturing, shipping, or storage.

  • National Association of Boards of Pharmacy

    The National Association of Boards of Pharmacy is an impartial professional organization that supports the state boards of pharmacy in creating uniform regulations to protect public health. Founded in 1904, the National Association of Boards of Pharmacy (NABP) is the impartial professional organization that supports the state boards of pharmacy in protecting public health.

  • National Institutes of Health (NIH)

    The National Institutes of Health (NIH), a part of the U.S. Department of Health and Human Services, is the nation’s medical research agency—making important medical discoveries that improve health and save lives.

Publications Related to Defective Drugs Law

  • About Lawsuits - Defective Drugs

    AboutLawsuits.com is an information website providing legal news, warnings and recalls about potentially dangerous products and an index of different types of personal injury lawsuits which could impact the safety and health of you and your family.

  • Drug and Device Law

    Drug and Device Law, recognized as the most widely read product liability blog on the internet, offers Dechert counsel James Beck's personal take on various topics that arise in the defense of pharmaceutical and medical device product liability litigation. The blog also features regular contributions by Dechert attorneys Stephen McConnell, Will Sachse and David Walk.

  • FDA Drug Review Process - Ensuring Drugs Are Safe and Effective

    The path a drug travels from a lab to your medicine cabinet is usually long, and every drug takes a unique route. Often, a drug is developed to treat a specific disease. An important use of a drug may also be discovered by accident Most drugs that undergo preclinical (animal) testing never even make it to human testing and review by the FDA. The drugs that do must undergo the agency's rigorous evaluation process, which scrutinizes everything about the drug--from the design of clinical trials to the severity of side effects to the conditions under which the drug is manufactured.

  • Fen Phen Lawsuit News

    The Food and Drug Administration, acting on new evidence about significant side-effects associated with fenfluramine and dexfenfluramine, has asked the manufacturers to voluntarily withdraw both treatments for obesity from the market. Dexfenfluramine is manufactured for Interneuron Pharmaceuticals and marketed under the name of Redux by Wyeth-Ayerst Laboratories, a subsidiary of American Home Products Corp. of Madison, N.J., which also manufactures and markets fenfluramine under the brand name Pondimin. Both companies have agreed to voluntarily withdraw their drugs.

  • Laws, Regulations, Policies and Procedures for Drug Applications

    The mission of FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook. The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments, it is the most extensive law of its kind in the world.

  • Recalls, Market Withdrawals and Safety Alerts

    This section includes the most significant product actions over the last five years based on the extent of distribution and the degree of health risk. In this section, you will find a listing of FDA and industry press releases regarding the product recalls.




Find a Lawyer

Find a Local Lawyer