Lauren Stevens of Durham, N.C., an attorney for a major pharmaceutical company was charged with obstruction and making false statements  She was charged with one count of obstructing an official proceeding, one count of concealing and falsifying documents to influence a federal agency, and four counts of making false statements to the Food and Drug Administration (FDA).

The indictment states that in October 2002, the FDA asked for information about the company’s promotion of a prescription drug, as part of an inquiry into whether the drug was being promoted for uses that had not been approved by the FDA. Data demonstrating a drug’s safety and efficacy for a particular use is required for FDA approval. Federal law prohibits the marketing or promotion of drugs for unapproved – or "off-label" – uses.

The indictment alleges that, in response to the FDA’s inquiry, Stevens signed and sent a series of letters from the company to the FDA that falsely denied that the company had promoted the drug for off-label uses, even though she knew, among other things, that the company had sponsored numerous programs where the drug was promoted for unapproved uses. The indictment alleges that Stevens knew that the company had paid numerous physicians to give promotional talks to other physicians that included information about unapproved uses of the drug. According to the indictment, the company paid one such physician to speak at 511 promotional events in 2001-2002 and another physician to speak at 488 such events during that time period.
The indictment also alleges that Stevens did not provide the FDA with slide sets used by the physicians who were paid by the company to promote the drug, even though the FDA had asked for the slide sets and Stevens had previously promised to obtain and provide the FDA with such materials. The indictment alleges that a memorandum was prepared for Stevens that set forth the "pros" and "cons" of producing the slide sets to the FDA. One of the "cons" was that the slide sets would provide "incriminating evidence about potential off-label promotion of [the drug] that may be used against [the company] in this or in a future investigation." Instead of providing the requested slide sets to the government, Stevens represented that the company’s responses to the FDA’s requests was "final" and "complete."

" This indictment demonstrates that those who purposely subvert the regulatory functions of the FDA through false statements and misleading information will be held accountable for their deception," stated Dara Corrigan, FDA’s Associate Commissioner for Regulatory Affairs.

Each of the obstruction charges carries a maximum penalty of 20 years in prison. Each of the false statement counts carry a maximum penalty of five years in prison. 
 

Numerous media outlets have been discussing the ongoing problems with Indiana’s oversight of nursing homes including The Indianapolis Star and The Journal Gazette,   Over the past five years, the Health Department has passed along about 300 inspection reports to the attorney general in accordance with a federal law that says health inspectors must report major problems to licensing officials. At some homes, inspectors found such problems year after year. Complaints against nursing home administrators in Indiana are less likely to reach the Indiana State Board of Health Facility Administrators—that state’s nursing home regulatory body—than in other states.  Most states take a broader approach to complaints against nursing home administrators, and will file complaints based not just on personal responsibility, but on facility wide or systemic issues.

But from those 300 reports, an Indianapolis Star investigation found, the attorney general brought the board a grand total of six complaints.  None since 2009.  The Indiana state attorney general’s office has said it only files complaints with the board if it finds the administrator was personally responsible for the infraction.   In forwarding a complaint to the state board, the attorney general simply calls for a review. It becomes the state board’s responsibility to follow through and determine if action is warranted.

 

The connection between Indiana’s abysmal record for nursing home performance and what appears to be lax oversight can’t be a coincidence. The Centers for Medicare and Medicaid Services reported that in 2007, nearly 90 percent of Indiana nursing homes were cited for violations of federal standards. Thirty-five percent of the facilities – almost twice the national average – were cited for causing actual harm or placing patients in jeopardy.

It wasn’t always like this in Indiana.  Here is the history:

In 2000 alone, Indiana Attorney General Karen Freeman-Wilson reviewed 300 inspection reports of nursing homes and forwarded 92 of them to a state board for review. At least 40 of the reviews resulted in a fine, reprimand or other discipline.

In November of 2000, nursing home owners and trade groups representing them contributed at least $11,000 to her Republican opponent, Steve Carter. He was elected, and the number of reports resulting in complaints fell dramatically. Of 463 reports forwarded by health officials during his two terms, Carter filed only 38 with the Indiana State Board of Health Facility Administrators.

Greg Zoeller, who served as Carter’s chief deputy and succeeded him in 2009, received 40 inspection reports last year. Not a single report resulted in a review by the state.

Numerous incidents over the last few years show an atmosphere of lax oversight. In June 2008, health officials and police investigated a rape at a Marion nursing home and learned that the administrator knew that the resident accused was a sex offender on parole. The administrator did not convey the history and make sure nurses and aides knew that history and developed no plan to protect other residents. When the attorney general’s office received the report from health officials, it could have filed a complaint, triggering a review by the state board. No complaint was filed; no review of the case was made; no disciplinary action has been taken against the administrator.

In another case, health officials forwarded a report on an Indianapolis nursing home where emergency call lights were disabled for 11 days, leaving residents with no way to summon help. Six residents suffered falls in the meantime. No complaint was filed by the attorney general.

At a Muncie nursing home in January 2009, inadequate heating units in 26 rooms left residents shivering in temperatures in the mid-50s. The inspection report found the administrator was aware of the problem. Again, no complaint.

 

 

The Ithaca Journal had an interesting article related to the increase in Medicaid fraud convictions.  As my earlier blog mentioned, Attorney General Andrew Cuomo is doing a great and courageous job protecting tax payers and vulnerable nursing home residents.  His office recovered more than $283 million and obtained a record 148 criminal convictions last year.  The unit has recovered some $660 million in taxpayer funds in the past three years. That includes 103 convictions and $113.8 million in restitutions ordered in 2007 and 144 convictions and $264.5 million in restitutions in 2008.

Cases, settlements, convictions and achievements are detailed in the article.

 See related article from the Times Union here.

 

There is a new website called www.laws.com. The website is free for users to use and is a great source of information for the general public regarding legal information. The following are points of information listed on the website:

* Listings of licensed legal professionals
* Blogging information
* Legal news around the country
* Additional resources for the users to take advantage of.

Many need the advice of lawyers but are not sure where to find one.  Websites like NewLawyer are helpful and can assist consumers and victims of malfeasance in finding the right lawyer for a specific problem or case.
 

Here is a sample Power of Attorney that anyone can print and use as long as it is notarized and signed properly.  This power of attorney does not authorize the POA to sign an arbitration agreement and prohibts the POA from waiving the signatory’s right to a jury trial.  This should help combat the hidden arbitration clauses that the nursing home industry hides in their admissions paperwork.