WEST PALM BEACH, Fla. (CN) - A prominent Florida doctor implicated in a corruption scandal involving Sen. Robert Menendez is battling civil claims that he injected tainted meds into patients' eyes, permanently damaging their vision.
At least seven putative patients have filed lawsuits against Dr. Salomon Melgen in Palm Beach County, claiming they suffered severe eye infections after receiving injections of bacteria-laden medicine at Melgen's South Florida offices.
The lawsuits allege the bacterial contamination stemmed from Melgen's profit-driven decision to repackage single-use vials of ocular drugs, primarily the macular degeneration drug Lucentis.
According to the complaints, Melgen ordered the repackaging of Lucentis vials into multiple doses, in disregard for manufacturer guidelines, and in defiance of the Centers for Disease Control's warnings to the medical community that compounding the drug could cause it to become tainted with bacteria prior to injection.
Melgen and his medical group, Vitreo-Retinal Consultants, carried out the Lucentis repackaging "for no purpose other than increasing their profits," according to Richard Doyle, a Fort Lauderdale attorney who represents the majority of the plaintiffs.
The plaintiffs developed the infections while Melgen was treating them between the fall of 2013 and early 2014, the lawsuits allege.
In April 2015, Melgen and Menendez, a New Jersey Democrat, were indicted on charges of conspiracy, bribery and honest services fraud in connection with Melgen's alleged profiteering off Lucentis. Melgen was slapped with more than 40 counts of healthcare fraud in a separate indictment.
Federal prosecutors claim Melgen was bringing in "exorbitant and improper" revenue by milking multiple doses from single-use vials of Lucentis and then billing Medicare for each instance where he administered the drug.
Melgen and Vitreo-Retinal Consultants billed Medicare $190 million and received more than $105 million in payments, much of which was obtained through fraudulent invoicing, prosecutors say.
Melgen is also accused of falsely diagnosing patients with wet macular degeneration, so that he could administer his high-priced Lucentis treatments to them.
Menendez meanwhile is charged with accepting exorbitant gifts and campaign contributions from Melgen in exchange for political favors, including lobbying for Melgen in his long-running dispute with Medicare over his use of Lucentis.
Beginning in 2009, when Melgen was hit with a clawback order directing him to refund the government nearly $9 million for his overbilling of Lucentis treatments, the New Jersey senator engaged in pay-to-play efforts to help Melgen justify the medical profiteering, the corruption indictment claims.
In the three following years, Sen. Menendez met with top officials from the Centers for Medicare and Medicaid Services and advocated for Melgen, all the while taking trips on Melgen's private jet and vacationing at the doctor's villa in the Dominican Republic, prosecutors say.
At one point, Menendez purportedly emailed a staffer, saying he wanted "to determine who has the best juice at CMS and Dept. of Health," with regard to Melgen's dispute with Medicare.
In the summer of 2012, shortly after Melgen issued a $300,000 check to a political action committee tied to Sen. Menendez, the senator spoke to the Acting Administrator of Medicare and allegedly tried to convince her that Melgen should not be subjected to the multimillion-dollar clawback. In concert with Melgen's lobbyist, prosecutors say, the senator's staff had prepared a talking-points memo for the conversation, which reads in part: "The [Centers for Disease Control] guidelines, while necessary to ensure patient safety and reduce the number of healthcare-associated infections, has no bearing on Medicare reimbursement policy."
Melgen has defended his handling of Lucentis injections by maintaining that multi-dosing was common practice among doctors in his field.
In preliminary pleadings in the Palm Beach civil cases, Melgen blamed the contamination cluster on Eastern Pharmacy, a company that repackaged Lucentis for him. He alleged that batches of the drug were accidentally contaminated by Eastern Pharmacy during the compounding process, prior to being sent to his office for administration to patients.
According to the FDA, Eastern Pharmacy shut down its sterile-drug production operations in Jan. 2014, after microbially contaminated shipments of Lucentis and Avastin that had been processed at its facility were linked to "adverse events" in more than 30 patients. The FDA inspected the pharmacy and found "significant deficiencies," including a failure to properly use a flow hood and separate sterile drug-production counters from the common pharmacy area.
Eastern Pharmacy was sued alongside Melgen in a subset of the Palm Beach civil cases.
Earlier this year, two of the plaintiffs, Catherine Hoecherl and Louise Constantine, settled their claims: Constantine settled with Eastern Pharmacy, while Hoecherl settled with both Eastern Pharmacy and Melgen.
Melgen's malpractice insurer, Healthcare Underwriters, is maintaining, however, that the pharmacy is solely responsible for the contamination under the Uniform Contribution Among Tortfeasors Act.
In a complaint for equitable subrogation filed last week, Healthcare Underwriters argued that Eastern Pharmacy should shield Melgen from financial liability in Hoecherl's case notwithstanding the settlement agreements.
At least five other plaintiffs still have claims pending against Melgen in Palm Beach County: Helen Pluskot, Mary Katherine Worth, Delphine Metcalf, Sam Belcher and Patricia Curry, all of whom allege that their vision was permanently damaged after receiving tainted eye injections administered by Melgen and Vitreo-Retinal Consultants.
Courthouse News' daily reports have been covering the lawsuits since they started flowing into Florida's Fifteenth Judicial Circuit in 2014.
Menendez and Melgen have pleaded not guilty in the criminal case. Four of the eight bribery counts against them were dismissed by a federal judge last September.
Melgen's South Florida attorney has not responded to a request for comment on the civil cases.
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