[The following is adapted from a guest post by Brian Mahany. The original post was published by the Pharmaceutical Integrity Coalition. ]
Pharmaceutical companies spend more on lobbyists than any other industry in America. According to one recent study, 90% of all House members and 97 out 100 senators have accepted campaign contributions from big pharma. In the last decade, the amount spent on campaign contributions and lobbying expenses exceeds $2.5 billion.
Pharma spends so much money that there are two lobbyists for every Senator and House member. Dr. Raeford Brown, the chair of one the FDA’s powerful committees, bluntly stated that “Congress is owned by pharma”.
In the first 6 months of 2019, Senators Chris Coons (D- Delaware) and Thom Tillis (R- North Carolina) accepted $103,000 and $102,000 respectively from the pharmaceutical industry. The two sponsored legislation to protect patents issued to the drug companies. Patents have been a way that big pharma keeps out lower priced generics off the market.
Even with all that money flowing into Congress, most legislators now agree that something needs to be done about the high cost of prescription drugs. Both Republicans and Democrats are beginning to agree on price reform and that has pharma in a cold sweat. It’s about time.
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.
A battle that played out last week in a Philadelphia courtroom isn’t helping pharma win new friends. U.S. District Court Judge Cynthia Rufe refused to block the release and publication of an email in which a Heritage Pharmaceutical lawyer told Congress that it could go f@*k itself.
According to the court, 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.
We certainly understand why the company didn’t want anyone to see the email. The pharmaceutical companies wanted to sanction the Connecticut Attorney General’s Office and claw back the email. They claim it is protected by the attorney client privilege.
How Does the Attorney – Client Privilege Work
As lawyers, we understand the importance of the attorney – client privilege. Although not directly referenced in the Constitution, courts say the Constitution’s 5th Amendment right against incrimination and the 6th amendment right to counsel protect the attorney – client privilege. That privilege isn’t absolute, however.
One common exception is the crime fraud exception. A client can’t protect a communication with her lawyer if the communication is made with the intention of committing a crime or fraud. You can tell your lawyer after the fact that you robbed a bank but you better not tell your lawyer you are about to kill your spouse. One statement is protected, the other is not.
Aa a general rule, 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 means there is no privilege when 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.”
How much did the industry want to hide this email? We counted the lawyers appearing in the case on behalf of the pharmaceutical industry. They hired 16 of the biggest and best law firms to protect their interests. It’s obvious that big pharma didn’t want Congress or the public to know what it really thinks about Congress.
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 f-u email 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.
Whether or not there are other smoking gun emails in circulation isn’t the main issue. The real issue is the attitude of pharmaceutical companies towards the American people and their elected leaders.
Who can forget the ridiculous smirk of “pharma bro” Martin Shkreli and his pleading the 5th when asked to testify before the House Oversight and Government Reform Committee? (We have attached the YouTube video at the end of this post.) Many just shrugged off Shkreli as a spoiled brat but the Heritage f-u email shows that the contempt runs much deeper.
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.
Call for Pharmaceutical Whistleblowers
Pharmaceutical executives, compliance workers and others in the industry play a critical role in the battle against greed and corruption. These folks are the eyes and ears of the Justice Department and the FDA. Brave pharmaceutical whistleblowers have helped taxpayers save billions of dollars and have certainly helped thousands of Americans struggling to get lifesaving medications.
Why blow the whistle? Obviously, it is the right thing to do. Congress has made it easier and safer than ever. Robust whistleblower protection provisions prohibit retaliation. Under the False Claims Act, workers suffering retaliation can receive double lost wages, future wages, out-of-pocket damages and attorney’s fees. The SEC’s whistleblower program offers similar protections.
Another incentive are the cash rewards. The 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
- Back room price fixing deals
- Recommending drugs for improper off label uses
- 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
- Paying kickbacks to physicians or hospitals for using their products
To learn more, visit our pharmaceutical fraud whistleblower page. Ready to see if you qualify for a reward? Contact us online, by email brian@mahanylaw.com or by phone at 414.704.6731 (direct). All inquiries are protected by the attorney – client privilege and kept confidential.
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