Federal Food and Drug Violations: FDA Criminal Cases.

The FDA’s enforcement capability goes far beyond what many companies and individuals might expect. While the FDA has a variety of enforcement mechanisms available to it, the OCI plays a central role when the allegations involve what the FDA considers to be “serious violations of the FDCA.” The OCI has conducted investigations that lead to administrative, civil, and criminal referrals. Many companies and individuals find out that the FDA is pursuing an investigation through an FDA Warning Letter. This is the FDA’s most public administrative advisory tool and contains a summary of the FDA’s inspection of a facility or review of records and findings of alleged violations. The FDA may also require companies to take corrective action to address alleged noncompliance, such as corrective action plans. However, even if a company complies with the FDA’s requests, it does not necessarily mean that the company is off the hook. In fact, FDA’s OCI may be able to continue its investigations with the goal of criminal prosecution in a DOJ enforcement proceeding. The FDA may also request records in order to develop its investigative or enforcement files. In some cases, the FDA will share the records it obtains with other agencies for further investigation and possible criminal prosecution. The FDA’s interagency referrals can be just as dangerous as an OCI referral, and in some cases may be more so because they often lead to additional charges. When FDA investigators seek to pursue alleged violations of the FDCA, they can seek administrative or civil enforcement, or they may seek criminal enforcement through the U.S. Department of Justice. While the vast majority of FDA matters remain at the administrative or civil level, any FDA investigation has the potential to escalate into a criminal case.

What can defense counsel do before OCI seeks charges?

If you need to engage FDA-related defense counsel for an OCI case, you will want to determine why you need to hire someone immediately. Some people and companies make the mistake of waiting to hire counsel until the OCI seeks criminal charges. This is simply too late, as a significant portion of the investigative process can be mitigated if your attorney gets involved early.

Our attorneys can:

• Coordinate the production of records and serve as your liaison with the FDA;
• Participate in the regulatory interview process to ensure that the government does not take anything out of context or overreach;
• Negotiate corrective compliance measures so that the FDA may find a civil resolution that helps avoid criminal prosecution;
• Seek resolutions for premarket approval issues and product recalls; and
• Offer pertinent insight into the likely outcome of your case while helping to develop a strategic and cohesive defense plan.

When choosing an attorney for an FDA-related case, you will want to ensure that your attorney has some federal trial-procedure experience. Even if your case is not yet at the trial stage, your attorney will need to know what the eventual goal of the prosecution may be so that he or she can work to prevent that from happening.

At the end of the day, the most important thing is that your attorney has relevant experience handling federal subpoenas, negotiating with federal prosecutors, and making use of the applicable civil-procedure rules. While federal food and drug matters are very complex in nature, a skilled attorney can still assist with mitigating the legal consequences. If you need to hire defense counsel due to an FDA-related investigation or charges, you will want to engage our law firm as soon as possible so that we can help you move forward.

Which Alleged Conduct Triggers FDA Investigations and Criminal Prosecutions?

The FDA has a very broad scope of oversight, and as a result, its OCI investigates alleged violations involving any number of products and practices and refers cases to the Department of Justice for prosecution. The OCI investigates matters ranging from prescription drugs, medical devices, food, and dietary supplements to medical foods, biologicals, cosmetics, and a wide variety of other consumer and medical products. Federal law enforcement in these cases is primarily focused on protecting public health, but cases involving the FDA can also include allegations of fraud and other crimes when they present risks to the federal regulatory system and the American public.

As a result of the OCI’s scope of oversight, a broad spectrum of individuals and business entities can face allegations of food and drug law violations. This includes, but is not limited to:

• Providers, pharmacists, and medical suppliers;
• Laboratories, medical clinics, nursing homes, and other medical-related business entities;
• Drug, medical device, and food manufacturers and distributors; and
• Individual healthcare professionals.

The same is true of the specific allegations that the OCI handles. We represent clients in cases involving allegations including, but not limited to:

• False statements made during FDA regulatory investigations, premarket applications, and other FDA-related matters;
• Marketing, distributing, or selling unapproved, counterfeit, substandard, adulterated, or misbranded medical products, including prescription drugs and medical devices;
• Off-label promotion of medical products, including drugs, medical devices, and biologicals;
• Fraudulent treatments or medical applications, fraudulent clinical investigations, and other forms of FDA-related fraud;
• Fraudulent or improper billing and reimbursement practices;
• Failure to report significant safety data, and failure to comply with FDA’s postmarket surveillance and other reporting requirements; and
• Other matters that rise to the level of criminal violations under the FDCA.

When facing criminal enforcement by the OCI, a full-scale defense strategy is a critical part of mitigating the risks. If you or your business are being targeted in an OCI case, it will be important to evaluate your current situation and immediately engage federal food and drug defense counsel.

How Long Can an FDA-Related Investigation Last? When Will it Become a Federal Criminal Case?

Regardless of why the FDA’s OCI is investigating you or your business, you will want to make informed decisions. The OCI is part of the FDA, a federal agency, and the federal government will prioritize the investigations it believes to be the most important. This usually includes cases that allegedly present dangers to public health and cases where the alleged violators are apparently resistant to the normal FDA compliance processes. If your business is under investigation for FDA-related violations, it can take anywhere from a couple of months to several years for the government to decide whether to seek criminal prosecution. The FDA conducts audits and inspections of companies and other regulated entities. It also issues demands for information, interviews, and subpoenas for records. If an investigation becomes criminal in nature, the OCI may issue subpoenas for records as well, in addition to other types of evidence that are sought during federal criminal investigations. Our lawyers can provide early intervention to help protect you and your business in an FDA-related investigation.

How Are FDA Cases Handled in Federal Court?

Federal criminal cases are very different from criminal cases in state court. This is due to both the rules that govern the proceedings and the procedures that are specific to the federal court system. For example, while all criminal cases have the same basic structure, federal cases utilize specialized pretrial procedures to identify key witness testimony and to handle matters related to grand-jury subpoenas and target letters. Even when a federal judge or a magistrate judge is involved, a well-informed and experienced defense attorney is essential to navigating the federal courts.

In federal criminal proceedings, magistrate judges are involved to a greater extent than in state criminal proceedings. Magistrate judges can grant or deny bond hearings, conduct arraignments, handle motions to suppress evidence, and oversee the acceptance of guilty pleas. Along with hearing evidence and guiding the proceedings, the magistrate judge plays a very important role in criminal enforcement cases.

What Are the Penalties in FDA Criminal Prosecutions?

Similar to the penalties in state criminal cases, the penalties for FDA criminal cases can be either criminal or civil. While the most-severe charges carry more serious penalties, even the most-minor charges can carry penalties such as fines, probation, or even a prison sentence for the primary offenders.

What other federal allegations can accompany an FDCA criminal case, and what is at stake in these types of cases?

In many cases, FDA-related matters will also involve allegations related to the False Claims Act (FCA). Because FDA-regulated matters frequently involve questions about reimbursement for patient treatments or medications, the FCA can be an important tool for prosecutors. If the government opens an investigation targeting these entities, it can expose the potential defendants to liability for a wide range of allegations involving FCA violations.

In addition to the FCA, FDA-related cases can involve allegations related to the Anti-Kickback Statute and Stark Law. These laws are designed to prevent conflicts of interest and ensure that patients’ needs, not financial gains, drive medical referrals and prescriptions. The OCI and other law enforcement agents targeting physicians, laboratories, and pharmacy benefit managers often include allegations of violating these laws in their investigations. The OCI often shares information with other agencies that pursue allegations of billing fraud targeting Medicare, TRICARE, the Department of Veterans Affairs, and other federal healthcare programs.

As for the potential penalties in FDCA cases, both civil and criminal penalties can apply in federal criminal prosecutions. While the severity of the penalties depends on various factors including the specific charges involved, some of the possible consequences of facing an FDCA criminal case include:

• Civil money penalties, criminal fines, probation, and imprisonment;
• Loss of professional license (physicians, pharmacists, doctors, etc.);
• Disbarment from participating in federal healthcare benefit programs;
• Reputational harm, financial losses, and other personal and professional losses;
• OCI-related consequences such as drug or medical device recalls, lost licensing authority, lost premarket approval, shut-down operations, bankruptcy, and other similar consequences.

In addition to the consequences for individuals, FDA-related investigations and criminal prosecutions can disrupt the ongoing business activities of medical practices, medical device companies, and pharmaceutical manufacturers as well. If you or your business are currently being targeted in an OCI investigation, it is important to engage defense counsel who can assist in protecting you in all federal criminal matters.

Where to Go From Here

If any of this describes your situation, the next step is a conversation rather than more reading. Spodek Law Group runs a fully online client portal and represents clients coast to coast, with offices in New York, Brooklyn, Queens and Los Angeles. The number is 888 348 8028.