[Guest post by Brian Mahany, Esq.]
There has always been tension between big pharma and Congress. Pharmaceutical companies spend more on lobbying than any other industry. They also contribute heavily to political campaigns. Over the last decade, drug companies contributed $2.5 billion in political contributions and Congressional lobbying efforts.
Nine out ten House members and all but three senators have accepted campaign money from pharmaceutical companies. What do the drug companies get in return? Plenty! One example is the higher drug prices found here than in most other countries.
The chair of the Food and Drug Administration’s (FDA) Committee on Analgesics and Anesthetics, Dr. Raeford Brown, openly claims that “Congress is owned by pharma.”
Until the opioid crisis and Congressional hearings on high drug prices, most people had no idea of the cozy relationship between Congress and the pharmaceutical industry. Slowly things are changing. Finally, even billions spent in lobbying efforts doesn’t seem to be working as well for big pharma. So what’s next? One pharmaceutical company has apparently declared open war on Congress.
A federal judge last week refused to block release of an internal email by an industry group that discussed their planned “f-u” response to Congress. Heritage Pharmaceutical claimed the email was protected by attorney – client privilege because a lawyer wrote it. The Court disagreed.
The email at issue says, “Spoke with my colleague [redacted] in DC, who is doing the response letter for Mylan. Her husband works for [redacted] and he is doing the response for Teva. They have both been in contact with GPhA [lobbying group] on coordinating a response — and the consensus at this point is that the response will be ‘polite f-u’ letters.” The response being discussed was concerning a Congressional inquiry. Apparently, some pharmaceutical companies believe they are above the law.
How Does the Attorney – Client Privilege Work
The attorney-client privilege serves an important role in our legal system. Courts and the Constitution recognize the privilege because it allows clients and their lawyers to have open and frank discussions. The privilege isn’t absolute, however.
The general rule is that the privilege applies to communications to or from an attorney in confidence for the purpose of obtaining or providing legal assistance for the client. The privilege does not extend to communications where the lawyer provides non-legal business advice. It also does not apply when an attorney is simply repeating the substance of what a third party has conveyed.
According to Judge Cynthia Rufe, the email from the attorney conveys information from third parties and was not providing legal advice. “The record does not show that Heritage, Mylan, and Teva (the companies referenced in the final email) shared a sufficiently common legal interest in responding to the congressional inquiries, and the communications extended beyond individual companies to an industry trade association (the GPhA), as stated in the final email. The Court, therefore, concludes that the final email is not privileged.”
In this battle, the pharmaceutical companies were represented by 16 top-dollar law firms. Clearly, big pharma doesn’t want the public to know what it really thinks about Congress. They were so desperate to block the release of the email that they brought a sanctions action against the Connecticut Attorney General’s Office for releasing the memo. They even sought a court order trying to claw back the memo. (Both efforts failed.)
Millions of Americans are struggling to pay for prescription drugs. Let’s take insulin as an example. In 1996 a vial of insulin cost $21. In 2001, that same vial cost $35. Today the cost is $275, an increase of 1200%! (Some insulin such as Novalog is over $500 per vial.) The price of insulin in Canada? $30.
Pharmaceutical companies are entitled to a profit. But there are limits. An industry that tries to stifle competition, bar genetics, and engages in pay-to-delay tactics is ripe for more regulation.
Memos such as the one written by Heritage’s counsel are rare. From our many conversations with pharma executives and compliance professionals, we know that employees are instructed not to put certain things in writing. Pharmaceutical companies don’t want a paper trail.
We believe that the only reason we are seeing the Heritage f-u email is simply because everyone assumed that since it was written by a lawyer it would never see the light of day.
Whether or not there are other smoking gun emails in circulation isn’t the issue. (We think those emails are few and far between.) The real issue is the attitude of pharmaceutical companies towards the American people and their elected leaders.
How can we fight back? Hopefully, Congress is beginning to listen more to the public and less to lobbyists. Polls universally show that an overwhelming percentage of the public – Republicans and Democrats – favor lowering drug prices. It is probably the only source of agreement between President Donald Trump and Sen. Bernie Sanders.
Pharmaceutical executives, compliance workers, and others in the industry also have a critical role. Individual workers can make a difference. Pharmaceutical whistleblowers have helped taxpayers save billions of dollars and have certainly helped thousands of Americans struggling to get life-saving medications.
Obviously, blowing the whistle is the right thing to do. Congress has made it easier and safer. First, retaliation against whistleblowers is illegal. Both Congress and most states have strict laws against retaliation. These laws typically pay double lost wages and attorney’s fees as well.
The Federal False Claims Act pays cash rewards to whistleblowers. Anyone with inside information about fraud involving pharmaceutical companies can receive up to 30% of whatever the government collects from wrongdoers.
Typical whistleblower reward scenarios involving pharmaceutical companies include:
- Pay to delay schemes that delay release of generics
- Backroom price-fixing deals
- cGMP violations that impact the safety and potency of pharmaceuticals sold in the US
- Payment of bribes to foreign government officials
- Improper books and records
- Lying to or misleading the FDA
The world needs more whistleblowers. They are America’s new unsung heroes. Let’s clean up the pharmaceutical industry and keep it at the forefront of patient safety and medical innovation.
About the author. Brian Mahany is a bestselling author and prominent whistleblower lawyer. The views expressed in this post are his and not that of the Coalition.
We connect potential whistleblowers with the necessary experts and qualified lawyers required to maximize cash awards and protection from retaliation. There is no fee for our services. The Pharmaceutical Integrity Coalition (PIC) is an independent Advocacy Group, with no ties to the Pharma industry.
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