Dangerous Drugs

Mass tort cases stem from a defective drug or device on the market that harms a large number of people. Some of these cases are well-publicized, while many others never make headlines, but cause just as much pain to the people whose lives are affected.

Mass tort claims can include different complaints against the same defendant(s), and often involve injuries from dangerous drugs and medical products.  For instance, patients can sue the maker of a defective medical implant for different types of injuries. In a mass tort case, they would file individual lawsuits, which are grouped together only for pretrial proceedings, and then they may be tried later in their original state jurisdiction.

Prescription drug and medical device makers are legally responsible for ensuring that their products are safe
and must:

• Conduct adequate clinical trials and other testing as the FDA requires
• Clearly explain the risks and benefits of their products to healthcare providers and consumers
• Continue to test their products for safety

When corporations fail to satisfy any of these or other requirements, they can be held liable to the people they harm. Dangerous drug and medical device lawsuits involve complex medical and legal issues and are expensive to pursue.

There are a number of reasons why medications can be dangerous, including:

• Drug companies sometimes fail to conduct the studies needed to identify risks that emerge after approval.
• Failure by a drug manufacturer to properly warn the medical community and consumers about risks.
• Marketing of medication for uses not approved by the United States Food and Drug Administration (FDA)

More than 30 dangerous drugs have been approved and later taken off the market because of serious health risks since the 1970s. These drugs have killed or seriously injured thousands of Americans. Dozens of other dangerous drugs remain available. Some of them come with warnings from the FDA, but those warnings are not always clear or
well communicated.

All of these failures come back to the basic principle of accountability. Drug manufacturers can and should be
held legally accountable if they put consumers at risk.

Mass tort categories typically fall into three types:

• Prescription drugs
• Product liability, which includes medical devices: Claims typically fall into three categories: 1) defective manufacture, 2) defective design, 3) failure to provide adequate warnings or instructions concerning the proper use of a product.
• Toxic contamination: Also known as “toxic torts,” these cases involve hazardous pollutants or chemicals that have poisoned people.

Mass tort cases require extraordinary resources and highly sophisticated knowledge. It takes an understanding and mastery of varied and complex subject matter and theories of liability and damages, the time necessary to review and process thousands of case documents, and the ability to work with many witnesses and experts. Our lawyers have the skills and tenacity to prepare a mass tort case no matter how complex.

Complications from dangerous drugs can vary in severity. Because of this, it’s difficult to determine if a tort claim is feasible. To get a fair and accurate assessment of your potential case, contact our attorneys at Berman & Simmons. We handle many cases involving dangerous drugs and medical devices and can let you know if we can help you with a tort claim.

According to the FDA, generic drugs are required to have the same active ingredient, strength, dosage form, and route of administration as the original brand-name drug. All manufacturing, packaging, and testing sites must also pass the same quality standards as the brand-name drug.

The Supreme Court has determined that generic drug makers are not liable for any negative side effects; the original manufacturer is. (See PLIVA, Inc. v. Mensing, 564 U.S. 604 and Mutual Pharmaceutical Co. v. Bartless, 570 U.S. 2468.)

These are the basic steps:

• Review records – We examine statements from claimants and their medical records to identify the device or drug and injuries.
• Injury consistency – We check for similarity of injuries among those harmed by drugs or devices as evidence for the claim and categorize the cases to understand any shared characteristics.
• Federal court filing – Individual cases are consolidated to speed up processing and information gathering.
• Bellwether trials – A small group of lawsuits, chosen from a larger group of similar cases, are tried first. The results can determine the potential outcomes of future cases. As an example, C.R. Bard, the maker of the inferior vena cava (IVC) filter G2, will pay plaintiff Sherr-Una Booker $3.6 million for injuries she suffered from the device and for failure to warn about its dangers in the first IVC “bellwether” case to go to trial.
• Settlement – This occurs when both parties enter negotiations to settle the claims, and any proposed agreements are presented to claimants to decide whether they will accept them or proceed to a trial.

Because mass tort claims can involve multiple plaintiffs, they can take longer than  typical personal injury cases. Generally, these cases take years before resolution.

There are statutes of limitations in medical device and dangerous drug cases, so it’s important to contact a lawyer as soon as possible if you believe you have a claim.

Under state and federal law, victims of dangerous drugs have the right to recover financial damages for various categories of loss, including:

• Current and future medical bills
• Lost work time related to your injury
• Disability and disfigurement
• Pain and suffering
• Mental and emotional damages

If you have been harmed by a dangerous drug or a defective medical device, we are prepared to stand up for you and your family. Our team of experienced lawyers will hold companies accountable and make sure you receive full compensation for the harm done to you.