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Litigation Against Pharmaceutical Companies

Pharmaceutical Lawyer Advocating for Injured Victims

Pictured: Brenda Fulmer & Cal Warriner, Shareholders leading our firm’s Mass Tort division.

Searcy Denney: Leading Pharmaceutical Lawyers for Every Aspect of Litigation 

The pharmaceutical industry never stops booming. With countless television commercials revealing new drugs and medical device manufacturers developing new products each year, it should come as no surprise that Big Pharma is a lucrative business. Despite making billions annually, pharmaceutical companies continue to rush products to the market. In doing so, many pharmaceutical drugs and medical devices are not adequately tested, revealing dangers and defects that pose a serious and unreasonable risk of harm to patients. When choosing to take a prescription medication, patients rely on their doctors’ assurances that the drug is safe for its intended use. Each pharmaceutical lawyer and drug injury attorney at Searcy Denney has extensive experience and is well prepared to fight some of the largest pharmaceutical manufacturers in the world. From Bayer to Johnson & Johnson to Pfizer, the legal team of Searcy Denney has the manpower, know-how, and reputation to fight for every client’s rights.

Patients seeking to undergo medical procedures also rely on their surgeons’ assurances that any implantable medical devices to be used in the procedure are safe for their intended use. Although the United States Food and Drug Administration (FDA) regulates the pharmaceutical drug and medical device industry, pharmaceutical companies must take responsibility when their products cause harm to patients.

The Importance of Strong Legal Counsel for Injured Plaintiffs

Whether in the pharmaceutical industry or not, large corporations spend millions of dollars hiring aggressive defense counsel who will fight tooth and nail to ensure injured plaintiffs do not receive the compensation they deserve for suffering personal injuries.

Pharmaceutical drug and medical device manufacturers often hire the largest defense firms in the country, which provide a significant team of lawyers and support staff that work round-the-clock. Because Big Pharma has tremendous resources to fight legal claims, injured plaintiffs must also have a solid legal team to advocate on their behalf.

In the context of pharmaceutical drugs and medical devices, mass torts involve thousands of plaintiffs alleging they have been injured by the same drugs and medical devices. While class actions are similar, they are not the same as mass torts.

Unlike class actions, where ONE lawsuit involves a large group of plaintiffs, a mass tort is one large litigation that involves thousands of individually filed lawsuits. Because of the large number of legal claims concerning the same drug or medical device, mass tort litigations are typically consolidated in one court for administrative purposes. These cases can get large and complex, thus requiring the assistance of an experienced pharmaceutical lawyer. 

Understanding the Pharmaceutical Litigation Process 

Once an injured person contacts a law firm to discuss potential legal options concerning a dangerous drug or medical device, which is the subject of a mass tort litigation, the law firm or lawyer will take the following steps when evaluating the injured person’s potential legal claim:

  • Identify the nature of the injury
  • Identify the name and manufacturer of the product (drug or medical device) that caused the individual’s injuries
  • Identify the date the injury was sustained or when the injured person became aware that a drug or medical device has caused his/her injuries
  • Ensure the statute of limitations period has not expired (i.e., the deadline to file a lawsuit per state law has not passed)
  • Obtain all necessary medical records to document injuries
  • File the lawsuit in state or federal court or seek to settle the claim out of court 
  • Litigate the case with the goal of going to trial and obtaining a winning verdict or reaching a favorable settlement before trial

Given that mass tort litigation involves so many injured plaintiffs, the entire process from the time an injured person contacts a pharmaceutical lawyer to the time the injured person receives compensation (if the case is successful) can take a long time. Injured plaintiffs should be prepared to wait well over one or two years, but the long wait is worth it to truly hold Big Pharma accountable.

Pharmaceutical Drugs and Medical Devices Involve Product Liability Law

Mass tort litigations involving dangerous and/or defective drugs and medical devices involve allegations of product liability along with some negligence claims. The following claims are the most common product liability claims alleged by injured plaintiffs:

  • Design Defects – the nature of the product itself is defective and inherently dangerous based on poor or unsafe design;
  • Manufacturing Defect – the drug or medical device sustained a defect at the manufacturing level, such as contamination or human error that renders a drug or medical device unsafe; and
  • Failure to Warn – when dangerous drug and medical device manufacturers fail to warn of known dangers or defects.

Within each of these three categories, patients and families can potentially pursue claims based on several specific legal theories. To pursue a successful claim, a plaintiff must be able to pinpoint the precise cause of his or her injury or loved one’s death. Some examples of possible theories of liability in pharmaceutical litigation include:

Unreasonably Dangerous Side Effects

While many drugs have side effects, some side effects are more dangerous than others. In fact, some side effects are so dangerous that they outweigh the benefits of taking the medication. If a pharmaceutical manufacturer releases a drug that has unreasonably dangerous side effects, this can entitle harmed patients and their families to financial compensation.

Inadequate, Faulty or Biased Clinical Testing

All pharmaceuticals sold in the United States are subject to FDA approval, and obtaining FDA approval requires clinical testing. Unfortunately, while this testing is supposed to prevent dangerous drugs from hitting the market, experience shows that this does not always happen.

There are several reasons why clinical testing results might not reveal the dangers associated with a drug. In some cases, testing may simply be inadequate. While the FDA’s standard approval process calls for extensive testing, the FDA also has a “fast track” program with significantly reduced testing requirements. Faulty testing is an issue as well, and pharmaceutical manufacturers have a huge financial incentive to present biased testing results in order to obtain FDA approval and bring their drugs to market as quickly as possible.

Defective Manufacturing Processes

Defective manufacturing processes can cause drugs that might otherwise be safe to become dangerous. Processes that allow for contamination are perhaps the biggest concern, but other defects in the pharmaceutical manufacturing process can cause serious and potentially fatal problems as well.

Inadequate Quality Control

Inadequate quality control processes can allow dangerous and defective drugs to make their way to the hospital, pharmacy and doctor’s office shelves. Pharmaceutical companies must implement adequate processes to check their drugs for potential issues before packaging and shipping them to providers. If they fail to do so, or if they overlook issues identified during quality control inspections, this can establish grounds for liability.  

Improper Pharmaceutical Labeling

Proper labeling of pharmaceuticals is essential for ensuring that doctors, pharmacists and patients understand proper dosages and the risks associated with use. Improper labeling (i.e., printing inaccurate information or omitting necessary information) can be extremely dangerous and can lead to serious or fatal complications for large numbers of patients.

Improper Pharmaceutical Marketing

Improper pharmaceutical marketing is also a major issue. Misrepresentations and omissions are both common, and they can both lead to doctors, pharmacists and patients having an inaccurate understanding of a drug’s benefits, risks or both. In many cases, pharmaceutical manufacturers will make unsubstantiated claims or comparisons in order to make sales.

Failure to Timely Recall Dangerous Pharmaceuticals

Pharmaceutical recalls are far too common. Yet, many of these recalls come too late, and sometimes pharmaceutical companies fail (or refuse) to recall dangerous drugs despite being well aware of the risks they present. When these companies prioritize their profits over patients’ safety, they deserve to be held fully accountable for the consequences of their decision

A Pharmaceutical Lawyer Can Maximize Damages

In addition to having ample resources to fight Big Pharma, the right pharmaceutical attorneys  will know what steps to take to “maximize” a plaintiff’s damages. This means that a lawyer will review a plaintiff’s medical records with a fine-tooth comb to ensure no injury or complaint is overlooked.

Moreover, a qualified pharmaceutical lawyer will hire the best experts to exploit the defendant(s)’s weaknesses and counter the arguments made by defense experts. Such attorneys must be willing to go to trial, using the discovery (fact-gathering) phase of litigation (depositions and exchange of documents) to uncover the true extent of a plaintiff’s injuries and damages.

Along with physical and mental injuries, damages include a plaintiff’s medical bills, lost wages, other identifiable economic damages, and punitive damages, which are awarded at trial to “punish” unruly defendants for their bad conduct. Unfortunately, bad conduct is often the root cause of defective and dangerous pharmaceutical drugs and medical devices injuring thousands of patients.

Pharmaceutical Litigation FAQs

When should I contact a pharmaceutical litigation attorney?

If you have any concerns about serious side effects or other complications linked to a prescription or over-the-counter drug, you should speak with a pharmaceutical litigation attorney about your legal rights. Unfortunately, there are many dangerous drugs on the market, and many patients and families find themselves needing to sue in order to recover just compensation.

Do I need to join a class action to sue a pharmaceutical company?

You don’t necessarily need to join a class action to sue a pharmaceutical company. While there are many pharmaceutical class actions, many patients and families pursue individual claims as well. These are often “mass tort” cases in which hundreds or thousands of plaintiffs sue the same company on the same legal grounds.

What is a “fast track” FDA approval?

The FDA’s “fast track” approval process is “designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.” However, pharmaceutical companies can request fast-tracking for any drug; and, once they submit a request, the FDA must make a decision within 60 days. As a result, many drugs that don’t necessarily merit fast-tracking still receive this special treatment, and this allows pharmaceutical companies to bring these drugs to market without going through the standard clinical testing procedures for new drugs.

How long does it normally take pharmaceutical companies to obtain FDA approval?

Without fast-tracking, it can take several years—if not a decade or longer—for a new drug to go from conception to FDA approval. This underscores the extensive research, development and testing that should go into offering new drugs to patients. However, this also explains why pharmaceutical companies routinely seek to cut corners so that they can start profiting as quickly as possible.

Does FDA approval mean that a pharmaceutical is safe?

No, FDA approval does not necessarily mean that a pharmaceutical is safe. While this should be the case, it isn’t. The FDA simply doesn’t have the resources to thoroughly investigate all newly proposed drugs; and, as a result, dangerous drugs slip through. FDA-approved drugs are routinely subject to recalls, with many recalls coming only after patients have suffered adverse effects due to defects or other issues.

Can I sue a pharmaceutical company for a drug that hasn’t been recalled?

Yes, you can sue a pharmaceutical company for a dangerous or defective drug even if the drug isn’t subject to a recall. While some dangerous and defective drugs get recalled, many do not. Additionally, many pharmaceutical recalls are triggered by patients’ and family members’ complaints. As a result, if you think you may have a claim against a pharmaceutical company related to any prescription or over-the-counter drug, you should schedule an appointment to speak with a lawyer promptly.  

Contact Searcy Denney Right Away

If you or a loved one has sustained pharmaceutical drug or medical device injuries at the hands of Big Pharma, you have very little time to act to discuss your legal rights with a pharmaceutical lawyer.

At Searcy Denney, our nationally recognized pharmaceutical lawyers are standing by to evaluate your injuries and provide you with the advice you need. Contact our office today by calling (800) 780-8607 or completing a case inquiry form on our website to receive a free case evaluation.

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Posted By: Clinton Cimring