Orlando Medical Device AttorneysDrug and medical device litigation typically takes place when one or more patients are harmed from the use of certain pharmaceutical drugs or medical devices. In a number of cases, drug and medical device litigation against a single defendant is filed by a number of plaintiffs through mass lawsuits such as multi-district litigation and class action. Drug and medical device litigation has been an often-discussed topic among state and federal courts.

Drug and Medical Device Litigation Examples

Drug and medical device litigation examples may include products such as:

  • Diet drugs that cause irregular heart rhythms
  • Cholesterol drugs with side effects such as type 2 diabetes
  • Sleeping pills that cause addiction, cancer, or death
  • Osteoporosis drugs that cause interactions or bone fractures
  • Acne medications that cause digestive diseases
  • Antidepressants that cause birth defects when taken during pregnancy
  • Anti-psychotic drugs that cause white blood cell disorders
  • Type 2 medications that cause bladder cancer or heart failure
  • Birth control pills that cause blood clots or stroke
  • Implanted birth control devices that cause blood clots or organ perforation
  • Hip or knee replacement devices that cause blood toxicity or osteoporosis

Types of Drug and Medical Device Litigation

Drug and medical device litigation primarily falls under a category of law known as product liability. In product liability lawsuits, the law holds responsible the manufacturers, retailers, distributors, and other parties involved with delivering dangerous or defective drugs or medical devices to consumers. There are three main types of product liability in drug and medical device litigation: manufacturing defects, design defects, and marketing defects.

Manufacturing Defects

Manufacturing defects occur when the product in question is being manufactured. Manufacturing defects are often caused by factors such as low-quality manufacturing materials, tainting due to contamination or other issues, and poor workmanship on the part of the parties responsible for manufacturing the product.

Design Defects

Design defects are alleged when the product itself is considered inherently dangerous or defective. Design defects may occur despite a product being properly manufactured. In certain design defect lawsuits, the plaintiff may allege that the manufacturer was aware or should have been aware of the dangers, yet failed to prevent them or caution consumers against them.

Marketing Defects

Marketing defects are also referred to as “failure to warn.” Marketing defects occur when a product’s labeling, instructions, safety information, and other marketing materials fail to adequately warn consumers that a danger is present. This may mean that the manufacturer failed to point out a danger, or failed to provide proper safety and use instructions to avoid a danger.

Orlando Medical Device Attorneys

In order to win a lawsuit, the plaintiff holds the burden of proof. The burden of proof is the responsibility to provide sufficient evidence to prove that the defending party is legally at fault. When proving a drug and medical device litigation claim, the plaintiff must prove three main conditions.

Drug and medical device litigation plaintiffs must prove that:

  • The plaintiff sustained an injury.
  • The drug or medical device used by the plaintiff was defective in terms of manufacturing, design, or marketing. In other words, the product had unreasonably dangerous hazards or side effects of which the plaintiff was not properly warned.
  • The plaintiff’s injury was caused by the drug or medical device’s defect.

Past U.S. Supreme Court Rulings

In recent years, the United States Supreme Court has often addressed whether or not state-filed tort law claims against FDA-approved drug and medical device manufacturers are valid under federal law. As a result, a number of varying decisions have been made.

Federal law has invalidated some claims against vaccines, generic prescription drugs, claims that allege FDA fraud, and Class III medical devices. Class III is a federal classification given to medical devices that provide inadequate information on effectiveness and safety based on Class I and Class II guidelines.

Valid Drug and Medical Device Claims

However, federal laws often have not invalidated claims against brand name prescription drugs and Section 510(k) medical devices. Section 510(k) is an approval process used to approve new medical devices for introduction to the market.

Through the Section 510(k) process, a medical device manufacturer may receive FDA approval without providing substantial market research to prove efficacy and safety. This can be done if the manufacturer can prove that the medical device is significantly similar to an existing FDA-approved device.



Field, Robert I. “When Can Patients Sue Drug Companies?.”Pharmacy and Therapeutics. 34.5 (2009): 243-244. Print.

Ghosh, Shubha, and Tamsen Valoir. “FDA preemption of drug and device labeling: who should decide what goes on a drug label?” Health Matrix Spring 2011: 555+. Academic OneFile. Web. 25 Sept. 2013.

Lasker, Eric, and Rebecca A. Womeldorf. “Preemption of Punitive Damages in Prescription Drug Litigation.”Federalist Society. 14.1 (2013): n. page. Print. <http://www.fed-soc.org/publications/detail/preemption-of-punitive-damages-in-prescription-drug-litigation>.

Rostron, Allen. “Prescription for fairness: a new approach to tort liability of brand-name and generic drug manufacturers.” Duke Law Journal Feb. 2011: 1123+. Academic OneFile. Web. 25 Sept. 2013.