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So your probably holding this Civil Investigative Demand about pharmaceutical fraud and your entire pharma business is collapsing. Maybe a sales rep promoted off-label uses. Maybe you provided kickbacks disguised as speaker fees. Or maybe your just caught up in there latest crackdown on drug companies. Look, we get it. Your ABSOLUTELY TERRIFIED. And you should be! Because pharmaceutical companies routinely pay HUNDREDS OF MILLIONS and executives face 5 YEARS in federal prison for Anti-Kickback violations!
Let me explain the healthcare nightmare your facing. The Anti-Kickback Statute makes ANY payment to induce referrals a federal crime – and DOJ interprets this so broadly that normal pharma marketing becomes criminal!
Did your sales rep mention an off-label use that doctors asked about? FRAUD! Provided educational grants to medical institutions? Kickback! Sponsored a doctor’s conference attendance? CRIMINAL KICKBACK! We’ve seen pharma executives imprisoned for marketing practices every company does!
The False Claims Act turns every prescription influenced by your marketing into a false claim to Medicare/Medicaid. One improper detail to one doctor can trigger liability for THOUSANDS of prescriptions over years! Each prescription is a separate violation carrying up to $27,894 in penalties!
Sit down before reading because these numbers will destroy your entire company! Recent pharma settlements show the catastrophic scale:
QOL Medical paid $47 MILLION for providing free testing services! Teva Pharmaceuticals paid $450 million for copay assistance programs! Assertio Therapeutics paid $3.6 million just for marketing one fentanyl product! These aren’t outliers – there typical!
But here’s what’s worse – PERSONAL LIABILITY! CEOs face criminal prosecution! Anti-Kickback violations carry 5 years prison and $25,000 fines PER KICKBACK! Had 100 speaker programs? That’s 500 years potential prison time! Obviously nobody gets that, but prosecutors use it to force guilty pleas!
Your probably wondering “Who turned us in?” Let me tell you what destroys pharma companies:
Whistleblowers are your BIGGEST threat! Qui tam relators get 15-30% of recoveries! That fired sales rep who knows about your marketing practices? They could make $50 million by reporting you! We’ve seen entire sales forces become whistleblowers after layoffs!
Data analytics expose patterns! CMS analyzes prescribing data looking for statistical anomalies. Spike in off-label use after your conference? Red flag! Doctors who attend your programs prescribe more? KICKBACK EVIDENCE! Even legitimate medical education gets twisted into criminal conspiracy!
Off-label marketing is the DEADLIEST trap in pharma! DOJ aggressively pursues off-label promotion under False Claims Act!
FDA approval for one indication doesn’t allow promoting other uses – even if doctors routinely prescribe off-label! Mentioning published studies about off-label use? Illegal promotion! Answering doctor questions about off-label? FRAUD if not done “properly”! We’ve seen companies pay billions for sales reps truthfully discussing medical literature!
The worst part? “Intended use” doctrine means FDA can claim your marketing changed the drug’s intended use, making it “misbranded” and every prescription illegal! Your approved drug becomes unapproved overnight based on sales presentations!
ABSOLUTELY! And executives are increasingly prosecuted personally! The Anti-Kickback Statute has both criminal and civil penalties!
Park Doctrine holds executives criminally liable for corporate violations they “should have prevented”! CEO didn’t know about improper marketing? Doesn’t matter! VP of Sales tried to ensure compliance? STILL GUILTY! We’ve seen pharma executives imprisoned for violations by contractors they never supervised!
Recent prosecutions are terrifying – Insys executives got PRISON TIME for speaker programs! Purdue Pharma executives became felons! Even mid-level managers face indictment! One regional sales director got 3 years federal prison for approving speaker fees!
The scope is absolutley crushing! DOJ demands EVERYTHING about your marketing and sales:
Every email mentioning ANY product use, all sales force communications and call notes, speaker program contracts and attendee lists, grant applications and funding decisions, clinical trial data and publications, pricing strategies and discount programs, interactions with patient assistance foundations!
But here’s the trap – they demand documents showing “compliance” with vague FDA guidance! How do you prove every sales conversation was compliant? How do you show no improper influence on prescribers? Its impossible! They know you can’t produce perfect evidence!
Speaker programs are PROSECUTION MAGNETS! DOJ views most speaker fees as disguised kickbacks!
Paid doctors fair market value for speaking? Doesn’t matter if they prescribed your drug! Held programs at nice restaurants? “Lavish entertainment” kickback! Speakers gave same presentation multiple times? Sham arrangement! We’ve seen companies destroyed for educational programs that actually educated!
Consulting agreements are equally dangerous! Need KOL input on clinical trials? Better have ironclad documentation or its a kickback! Advisory board meetings? DOJ claims there cover for bribes! Even legitimate research collaborations become criminal conspiracies in prosecutions!
Corporate Integrity Agreements (CIAs) are BUSINESS-DESTROYING! Pharma companies under CIAs face crippling restrictions!
Independent monitors review EVERYTHING – every email, every sales call, every marketing piece! Compliance costs explode – companies spend $50+ million annually just on CIA requirements! Sales force effectiveness crashes when every interaction requires legal review!
Exclusion from federal programs is the death sentence! Can’t sell to Medicare/Medicaid? That’s 40% of the market gone! VA and DOD contracts vanished! We’ve seen billion-dollar drugs become worthless because companies got excluded!
Prepare for YEARS of paralysis while DOJ builds there case! Pharma investigations are extraordinarily complex:
Initial CID response (60-90 days of massive document production), DOJ/FDA/OIG coordinated review (12-18 months), statistical analysis of prescribing data (6-12 months), whistleblower depositions and witness interviews (12-18 months), settlement negotiations or prosecution (12-24 months)!
Your looking at 4-6 YEARS of torture! During this time, stock price crashes, partnerships dissolve, clinical trials get scrutinized, new drug approvals delayed! Legal fees? Expect $10-20 MILLION minimum! We’ve seen profitable pharma companies become penny stocks before investigations conclude!
States pile on with there own prosecutions! 30+ states have pharmaceutical fraud statutes!
State AGs coordinate through National Association of Attorneys General (NAAG) to maximize penalties! New York, California, Texas, Florida – they all want there piece! State penalties often EQUAL federal amounts! We’ve seen companies pay $500 million to feds, then another $500 million to states!
State investigations trigger local media coverage destroying reputation! Prescriber confidence vanishes, patient lawsuits explode, insurance companies refuse coverage! One client’s blockbuster drug lost 70% market share just from investigation announcement!
Self-reporting is a DANGEROUS GAMBLE! DOJ claims cooperation brings leniency but look at reality!
Companies that self-report still pay hundreds of millions! Still get CIAs! Executives still prosecuted! “Cooperation credit” might reduce $500 million to $400 million – your still destroyed! We’ve seen companies self-report minor issues only to face decade-long investigations!
But not reporting when you “should have known”? Willful blindness charges! Enhanced penalties! Mandatory exclusion! Its a lose-lose designed to extract maximum penalties while claiming your getting “credit” for cooperation!
Look, we’re not your typical FDA regulatory lawyers who just file applications. We’re criminal defense attorneys who specialize in keeping pharma executives out of federal prison when marketing issues become criminal prosecutions.
We understand the intersection of FDA regulations, Anti-Kickback Statute, and False Claims Act. We know how statistical analyses can be manipulated to show false correlations. We can demonstrate that complex healthcare regulations make perfect compliance impossible. Most importantly, we prevent civil investigations from becoming criminal indictments!
Other firms tell you to cooperate and show good faith. That’s EXACTLY how pharma executives end up in federal prison! DOJ doesn’t care about your patient assistance programs – they want massive settlements and criminal convictions. We fight strategically, challenging there interpretations while protecting you personally!
Call us RIGHT NOW at 212-300-5196
Pharmaceutical CIDs destroy companies overnight!
Former DOJ healthcare prosecutors – Anti-Kickback experts – Available 24/7!
Don’t wait another second! That CID means whistleblowers have been cooperating for months or years! Sales reps are being interviewed! Prescribing data is being analyzed! Criminal prosecutors are preparing indictments! Your competitor is already planning to take your market share!
Remember – pharmaceutical fraud cases routinely exceed $100 million in penalties with executives facing prison time. One speaker program, one sales message, one patient assistance decision can trigger catastrophic liability. You need someone who understands both pharma industry complexity AND criminal defense. Call us NOW before that CID becomes handcuffs!
Very diligent, organized associates; got my case dismissed. Hard working attorneys who can put up with your anxiousness. I was accused of robbing a gemstone dealer. Definitely A law group that lays out all possible options and best alternative routes. Recommended for sure.
- ROBIN, GUN CHARGES ROBIN
NJ CRIMINAL DEFENSE ATTORNEYS