Are Amgen Sales Reps Looking At Your Medical Records?

Amgen (AMGN) has been accused by at least three different people of unlawfully trawling through patients' medical records for people who may be suitable for its rheumatoid arthritis and psoriasis drug Enbrel. It is against federal law for non-medical employees to access patient medical records, a fact that Amgen's management was surely aware of.

Yet two of those accusers, former Amgen drug sales reps, say that looking through doctors' files for new patients was part of the company's marketing strategy. If true, there's a fairly simple management lesson here: Make sure your marketing strategy isn't dependent on violations of federal law. The company's alleged violations of patient privacy have also been the subject of federal subpoenas and a grand jury investigation, according to page 17 of this SEC disclosure.

Two former Amgen sales reps, Elena Ferrante and Marc Engelman, have both filed lawsuits against the company claiming they were asked to look through doctors files for prospective Enbrel patients. (This saga has been ably reported by Pharmalot's Ed Silverman, and you can read more about it here and here and here and here.)

BNET reported in October that Amgen is also being sued by a patient, William Moke, who claims he was hoodwinked into entering a clinical trial for Enbrel even though his condition was not severe enough. A side effect of the drug made him lose all his body hair. A recently updated version of his complaint alleges Amgen pharmaceutical sales reps pretended to be employees of his doctor when they encouraged him to join the trial, and that they had access to his medical records without his permission. His allegations dovetail with those of Ferrante and Engelman:

Just before the study began, defendant's representatives gained access to plaintiff's medical information without plaintiff's knowledge or consent. Defendants representatives conspired with plaintiff's heathcare provider, [Dr.] Wilson, to cull information from plaintiff's file to determine whether plaintiff would be a suitable candidate for their study.

... Thereafter, defendant's representatives approached plaintiff and solicited him to particpitate in the study. ... Defendants' representatives were not employed by plaintiff's healthcare propvider, although they initilly held themselves out to be so employed.

Plaintiff was instructed and encouraged to do a lot, if not all, of the work for physicians in getting their patients approved for Enbrel by health insurance carriers. This meant spending blocks of time in physicians' offices, going through patient files, filling out prior authorization requests, then calling their insurance companies as though on the doctor's staff to follow up on the prior authorization requests. This began in 2004, and continued at least into 2007.

... Engelman and other reps would then put a letter together for the physician to sign and copy, address the envelopes from the addresses in the patient records, stuff the envelopes and pay for the postage.

Amgen instructed its employees, including Claimant, to review the files of patients in the offices of physicians who were prescribing Enbrel, contrary to HIPPA, and extract insurance
information; and to then encourage the physicians to write to those carriers to urge them to
approve payment for the Enbrel prescription.

Additionally, numerous current and former Amgen employees, including recently some executive vice presidents and other officers of the Company, have received grand jury subpoenas to provide testimony on a wide variety of subjects.

In a mid-July filing, Amgen asked that the Moke case be dismissed. The cases of the two sales reps are stuck in arbititration.

Related:

• When Is a Kickback Not a Kickback? In Amgen Case, It's When You Filled Out Paperwork to Get It
• Aranesp Suit: What Did Amgen CEO Sharer Know (and Did He Read It in His Company's PowerPoint Slides)?
  
• Suit: Amgen Under-Reported Adverse Events to FDA on All Products
• Amgen Accused of Falsifying Medical Records, Lying to Patient in Enbrel Trial