In what could be a landmark case, six patients in California are suing one of the world’s largest stem-cell companies for allegedly misleading them about the effectiveness of its stem-cell treatments.
The six patients all live in Los Angeles or Orange County and share the last name Lee. Some of them are related, according to their lawyer, the unrelated Sang I Lee. They are suing Human Biostar based in Sugar Land, Texas; Jin Han Hong, the company’s chief operating officer; and Jeong Chan Ra, a Korean citizen and chairman of the board of Seoul-based RNL Bio, the parent company of Human Biostar.
Although the US Food and Drug Administration (FDA) and Federal Bureau of Investigation have taken action against stem-cell traders and clinicians, this seems to be the first case in which patients are bringing a suit against a prominent company. Whatever way this case goes, it will probably clue aggressive lawyers in to the mismatch between what stem-cell companies are promising and what they are delivering, says Bernard Siegel, director of Genetics Policy Institute, a non-profit stem-cell lobby group based in Palm Beach, Florida. Siegel predicts a new specialty: “cell therapy malpractice.”
The six patients claim they were sold the procedures by Hong when he was president RNL Life Science, another subsidiary of RNL Bio, based in Los Angeles. The procedure consists of taking fat from a patient, removing stem cells from the sample, processing and expanding them in RNL’s Seoul laboratory, and then sending them to one of RNL’s clinics to inject them into patients to treat a variety of diseases.
One patient says that he was given an injection in South Korea, where the treatment is not approved, and then told to keep it a secret. All other injections were at clinics either in China or Tijuana. At the Tijuana clinic, five of the six received an injection on the same day in September 2010.
The patients claim that at RNL workshops they were misled into believing that treatments, still in the experimental stage, had already been proved effective. They allege that Hong told them stem cells would cure all ailments from which they suffered, including diabetes, arthritis, high blood pressure, back pain and insomnia, and “reverse aging, restore health and virility including sex drive, and rejuvenate their body functions to that of their twenties and thirties”. They all say they have received no benefit from the treatments.
They also question whether the stem cells were transported under suitable conditions and by qualified people during their trip from South Korea to China and through Los Angeles to Mexico, and whether the doctors who performed the procedures were qualified.
Altogether there are seven legal complaints, including intentional misrepresentation of fact, negligent misrepresentation of fact, false advertising, unfair competition, negligence and breach of implied covenant of good faith and fair dealing. The seventh claim is “financial elder abuse”, a special clause in California’s Welfare and Institutions Code meant to protect the elderly from being defrauded.
The plantiffs’ lawyer says that all of the plaintiffs are elderly, although he would not give their ages.
The plaintiffs want their money back (they spent US$75,000 between them) “in addition to damages for physical ailments, disgorgement of profits, contractual attorney’s fees and punitive damages”. One of the six had already settled out of court with RNL, but the new case says that the “settlement is unfair, unduly oppressive, unreasonable and unconscionable” and based on an agreement in English that the plaintiff was “hurried into executing… without fully understanding its terms”.
The defendants’ lawyer could not be reached for comment.
The case makes a stem-cell mess in Texas even messier. The FDA has recently audited Celltex, a stem-cell company also based in Sugar Land, and found that the company failed, on 79 counts, to ensure the quality of the cells. Celltex blamed that on communication problems with “RNL Bio (dba Human Biostar)”. Meanwhile, David Eller, the chairman and chief executive of Celltex has been denying that Celltex treats patients, even when a doctor says Celltex gives him $500 every time he injects Celltex cells.
The case could bring closer scrutiny to stem-cell treatments throughout the United States. Until now, clinics advertising or selling unproven and unapproved stem cell treatments to patients had to worry only about the FDA, which monitors the clinical use of stem cells to ensure safety and efficacy — but moves slowly and bureaucratically.
The California case, which has been brought to the United States District Court of the Central District of California, could alert nimbler lawyers to the potential lawsuits from hyped-but-unproven stem-cell treatments, says Siegel. Siegel, himself a lawyer, famously used state laws in Florida to help debunk a cult’s claim to have cloned a human. “The laws are out there, you just have to look for them,” he says. “This case is blood-in-the-water, and any clinician dabbling in unproven autologous stem cells as treatments is placing his or her professional career, their licence to practice medicine and their fortune in jeopardy,” he says. All those connected with the advertising of unproven stem-cell schemes are potential defendants, he adds.
Siegel concludes that “the hand-wringing on the part medical and scientific societies, that has done little to impede purveyors of unproven stem-cell treatments and their unconscionable deceptive advertising” is giving way to the professional trial lawyers. “They certainly know a good lawsuit when they see it.”