Do You Understand The Pharmaceutical Approval Process?

May 10, 2020 / 11:34 am

The award-winning product liability attorneys at Colson Hicks Eidson have a long and proud history of helping clients who have been injured due to negligent prescription drug companies. We recently filed a lawsuit on behalf of a client who has taken Elmiron for the treatment of interstitial cystitis and has subsequently sustained permanent eye damage. However, we realize that many people may not realize how prescription drugs are approved before they are allowed to be sold to consumers. Here, we want to discuss the approval process and what you can do if you think you have been harmed by a defective prescription drug.

How do prescription drugs get approved?

Every prescription drug sold in the United States must be approved by the US Food and Drug Administration (FDA). The FDA’s Center for Drug Evaluation and Research (CDER) ensures that both brand name and generic drugs work correctly and that their health benefits outweigh the known risks.

Before any drug company can sell a drug in the United States, the medication must be tested first. The pharmaceutical companies will then send the CDER evidence from their tests to prove the drug is safe and effective. At the CDER, A team of physicians, pharmacologists, chemists, statisticians, and other scientists will review the company’s data and the proposed labeling. If these experts establish that the drug’s benefits outweigh the risks, the drug will be approved for sale.

Before a prescription drug can be tested in people, the company must perform laboratory tests and animal tests to discover how the drug works and whether it is likely to be safe and work well in humans. After those tests, a series of trials in people begin which will determine whether the drug is safe when used to treat the intended disease or health condition.

How do faulty drugs get through the cracks?

Please note that the FDA does not do any testing of their own of the drugs or medical devices that they approve. They rely 100% on the data provided by the manufacturers to determine whether or not that prescription drug will be approved. There are several ways that faulty prescription drugs may make it to the market. In the past, pharmaceutical companies have:

  • Falsified and manipulated studies
  • Misled the FDA into thinking that the drug is similar to previously approved drugs when it is not
  • Discovered defects or dangerous side effects after a drug is released and failing to warn the FDA or take any other action
  • Improperly manufactured a drug or allowed contaminants to enter into the product
  • Failed to properly instruct consumers of how to use or administer the drug
  • Failed to provide proper warnings of the side effects of the drug
  • Used false advertising to promote the drug

Let us get to work on your behalf

If you or somebody you love has been injured or become ill due to defective prescription medication, the nationally recognized product liability attorneys at Colson Hicks Eidson are ready to get to work on your behalf. Our goal is to secure the compensation victims in these cases deserve. This can include coverage of their medical expenses, lost wages, and benefits, pain and suffering damages, as well as punitive damages. Whether you are in Florida or anywhere in the United States, we are ready to help. You can contact us for a free consultation by clicking here or by calling us at 305-476-7400.

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The lawyers at Colson Hicks Eidson are dedicated to delivering outstanding results for our clients. We are honored that Lawdragon recognizes this commitment and are pleased to announce that seven of our partners have been named to the 2026 Lawdragon 500 Leading Litigators in America guide. Congratulations to Stephanie A. Casey, Dean C. Colson, Lewis S. “Mike” Eidson, Joseph J. Kalbac, Jr., Julie Braman Kane, Roberto Martinez, and Curtis Miner.

This guide is based on a record number of submissions, combined with journalistic research and vetting with the nation’s leading trial lawyers.

Click here to read the full guide.

About Colson Hicks Eidson

Colson Hicks Eidson is a renowned law firm based in Miami, Florida, that is recognized as one of the top trial firms in the United States. Built on a foundation of over 50 years of dedication forging strong client relationships, Colson Hicks Eidson handles local, national, and international litigation, with cases spanning from Miami, Florida, and throughout the United States, to matters in the Caribbean, Central America, South America, and Europe. Learn more at: www.colson.com.

Colson Hicks Eidson is proud to share that ten of its attorneys—more than half of the firm—have been recognized in the 2026 edition of The Best Lawyers in America®. 

Stephanie A. Casey, Dean C. Colson, Lewis S. “Mike” Eidson, Joseph J. Kalbac, Jr., Julie Braman Kane, Roberto Martinez, and Curtis Miner are listed in The Best Lawyers in America®. Eleni I. Constant, Zachary A. Lipshultz, and Sabrina S. Saieh are recognized in Best Lawyers: Ones to Watch.

Best Lawyers’ lists of outstanding lawyers are developed through peer review surveys where tens of thousands of lawyers evaluate their professional peers. Best Lawyers recognized attorneys in all of the firm’s core practice areas. 

Stephanie A. Casey

Commercial Litigation

Mass Tort Litigation / Class Actions – Plaintiffs

Dean C. Colson

Bet-the-Company Litigation

Commercial Litigation

Personal Injury Litigation – Plaintiffs

Product Liability Litigation – Plaintiffs

Professional Malpractice Law – Defendants

Professional Malpractice Law – Plaintiffs

Lewis S. “Mike” Eidson

Mass Tort Litigation / Class Actions – Plaintiffs

Product Liability Litigation – Plaintiffs

Joseph J. Kalbac, Jr. 

Commercial Litigation

Insurance Law

Mass Tort Litigation / Class Actions – Plaintiffs

Personal Injury Litigation – Plaintiffs

Product Liability Litigation – Plaintiffs

Julie Braman Kane – “Lawyer of the Year”

Commercial Litigation

Medical Malpractice Law – Plaintiffs

Personal Injury Litigation – Plaintiffs

Roberto Martinez

Bet-the-Company Litigation

Commercial Litigation

Criminal Defense: White-Collar

Curtis Miner

Commercial Litigation

Criminal Defense: White-Collar

Mass Tort Litigation / Class Actions – Plaintiffs

Personal Injury Litigation –  Plaintiffs

Eleni I. Constant

Personal Injury Litigation – Plaintiffs

Zachary A. Lipshultz

Commercial Litigation

Mass Tort Litigation/ Class Actions – Plaintiffs

Personal Injury Litigation – Plaintiffs

Sabrina S. Saieh

Mass Tort Litigation/ Class Actions – Plaintiffs

Personal Injury – Plaintiffs

Product Liability Litigation – Plaintiffs

About Colson Hicks Eidson

Colson Hicks Eidson is a renowned law firm based in Miami, Florida, that is recognized as one of the top trial firms in the United States. Built on a foundation of over 50 years of dedication forging strong client relationships, Colson Hicks Eidson handles local, national, and international litigation, with cases spanning from Miami, Florida, and throughout the United States, to matters in the Caribbean, Central America, South America, and Europe. Learn more at: www.colson.com.

Colson Hicks Eidson is proud to celebrate two of our attorneys for receiving prestigious awards at the 2025 American Association for Justice Annual Convention in San Francisco.

President and Senior Partner Lewis S. “Mike” Eidson was awarded the Leonard M. Ring Champion of Justice Award, which recognizes outstanding integrity and overall character demonstrating Leonard M. Ring’s devotion to human and civil rights. Mike is a past AAJ president and long-respected national trial lawyer. He has spent his career advancing justice, defending the right to trial by jury, and shaping the future of the profession through his leadership and unwavering commitment to mentorship.

Partner Julie Braman Kane, also a past AAJ President, delivered powerful remarks on Mike’s behalf, celebrating his legacy and the profound impact he’s made on the legal community and beyond. Julie has spent her entire career at Colson Hicks Eidson, a testament to the inspiration Mike has provided to generations of trial lawyers. 

Partner Curtis Miner was also awarded with the Steven J. Sharp Public Service Award, which recognizes plaintiffs and the attorneys of plaintiffs whose cases help tell the story of the American civil justice system. Curt was recognized for his role as one of the court-appointed leaders in the Champlain Towers Condominium Collapse litigation, where he worked alongside a dedicated team of lawyers to change laws to make condominiums safer and helped secure $1.2 billion in settlements for the families and victims.

About Colson Hicks Eidson

Colson Hicks Eidson is a renowned law firm based in Miami, Florida, that is recognized as one of the top trial firms in the United States. Built on a foundation of over 50 years of dedication forging strong client relationships, Colson Hicks Eidson handles local, national, and international litigation, with cases spanning from Miami, Florida, and throughout the United States, to matters in the Caribbean, Central America, South America, and Europe. Learn more at: www.colson.com.

The lawyers at Colson Hicks Eidson are committed to teamwork, professional development, and mentoring our younger lawyers. We are proud to announce that four of our attorneys have been named to the 2025 Lawdragon 500 X – The Next Generation guide. Congratulations to Eleni I. Constant, Aziza F. Elayan, Zachary A. Lipshultz, and Sabrina S. Saieh.

Lawdragon selects lawyers for this guide through independent research, submissions, and peer review, recognizing those who have demonstrated consistent excellence and significant impact, typically within 15 years of graduating law school.

Click here to read the full guide.

About Colson Hicks Eidson

Colson Hicks Eidson is a renowned law firm based in Miami, Florida, that is recognized as one of the top trial firms in the United States. Built on a foundation of over 50 years of dedication forging strong client relationships, Colson Hicks Eidson handles local, national, and international litigation, with cases spanning from Miami, Florida, and throughout the United States, to matters in the Caribbean, Central America, South America, and Europe. Learn more at: www.colson.com.

Colson Hicks Eidson is proud to share that attorneys Zachary A. Lipshultz and Sabrina S. Saieh have been named to the 2025 Florida Super Lawyers Rising Stars list.

Zach’s practice spans all aspects of civil litigation in state, federal, and arbitral forums, at both the trial and appellate levels. He played a key role on the team that recently secured a $3 million damages award for a family of four who suffered significant trauma when a defective lithium-ion battery-powered scooter caused a catastrophic fire that destroyed their home.

Sabrina focuses on product liability, commercial litigation, personal injury, class actions, and multidistrict litigation. She has represented clients in complex matters in federal and state courts, including cases involving defective products, dangerous drugs, catastrophic injuries, and mass torts. She was integral to the Takata Airbag Products Liability MDL—a high-profile class action tied to the largest automotive recall in U.S. history, resulting in settlements exceeding $1 billion.

Rising Stars recognizes top young attorneys who are 40 or under or have been in practice for 10 years or less. Only 2.5% of Florida lawyers earn this honor each year, following the same rigorous selection process used for Super Lawyers.

About Colson Hicks Eidson

Colson Hicks Eidson is a renowned law firm based in Miami, Florida, that is recognized as one of the top trial firms in the United States. Built on a foundation of over 50 years of dedication forging strong client relationships, Colson Hicks Eidson handles local, national, and international litigation, with cases spanning from Miami, Florida, and throughout the United States, to matters in the Caribbean, Central America, South America, and Europe. Learn more at: www.colson.com.

Colson Hicks Eidson is thrilled to announce that seven of its attorneys have been named in the 2025 edition of Florida Super Lawyers. Stephanie Casey, Dean Colson, Joseph J. Kalbac Jr., Julie Braman Kane, and Curtis Miner have been named Super Lawyers. Zachary A. Lipshultz and Sabrina S. Saieh have been recognized as Rising Stars.

Super Lawyers uses a rigorous screening process including independent research, peer nominations, and evaluations to rate lawyers. Only 5 percent of lawyers in Florida are rated by Super Lawyers, and no more than 2.5 percent of lawyers under 40 or with fewer than 10 years of practice are selected as Rising Stars.

About Colson Hicks Eidson

Colson Hicks Eidson is a renowned law firm based in Miami, Florida, that is recognized as one of the top trial firms in the United States. Built on a foundation of over 50 years of dedication forging strong client relationships, Colson Hicks Eidson handles local, national, and international litigation, with cases spanning from Miami, Florida, and throughout the United States, to matters in the Caribbean, Central America, South America, and Europe. Learn more at: www.colson.com.