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By Ron Kaplan, Managing Editor©
The case against Rite Aid had been sealed for over three years. Now that it's been opened it seems that Judge Bartle is in a hurry to dispose of it, or at least keep it on a fast track until its conclusion.
Just a week after his decision to throw out Rite Aid's motion for a dismissal, the judge has sent a notice to all the lawyers involved to be prepared for a scheduling conference in his chambers on June 27th.
The notice, dated June 12th, came complete with forms to be completed and a set of rules for the game that is about to be played out. It said, "All participants must be present and prepared to discuss the following: …" What followed is pretty standard stuff in these cases, except for one item. Along with jurisdictional disputes, alternative dispute resolution, time limitation, etc., was a line that said, "the possibility of an amicable settlement," it was even underlined.
"I've never seen that on a form like this," said Ross Begelman the qui tam's (whistle blower) attorney. He's not quite sure what to make of it. He has repeatedly told the Record that he expected a long period for discovery and a long trial. Other attorneys that we contacted were also surprised by this line; suggesting the judge wants to get rid of this case quickly. Eric Sitarchuk, the defendant's attorney, of course had, "No comment" for the record, but we had a nice chat anyway.
If it is true that the judge is looking for a quick disposition of this case, can all the questions that the case has raised be answered? If it is only about the money, and it is a tremendous amount that is involved, it
wouldn't be as important, but serious allegations have been made that raise very serious questions about the health and welfare of the general public. These allegations must be either proved or disproved. If these questions are left unanswered by some settlement we all get shortchanged.
No matter what the final disposition of this particular case is many questions will most likely go unanswered. The most important of which is -- "Who is minding the store?" What agency, federal or state is responsible for looking out for our welfare in the case of prescription drugs?
The FDA has told the Record that if the allegations of mixing drugs from one lot to another are proved, that is definitely a violation of federal law. Legally the new lot is adulterated and misbranded. If expired drugs are mixed in with newer ones they all become contaminated. It is a violation of the Federal Food, Drug & Cosmetic Act. If the FDA recalls drugs from specific lots and individual pharmacies don't respond, that too is a violation of federal law. But the FDA was also quick to inform us that, "Again, in the pharmacy setting, this would have to be enforced by that State's Board of Pharmacy"-- but not in Pennsylvania.
Jasmine Bucher is the Deputy Press Secretary of the state Bureau of Professional and Occupational Affairs. The State Board of Pharmacy is one of sixteen state boards that are subdivisions of this bureau. They run the gamut from dogcatchers to physicians. Ms. Bucher has informed us that their sole purpose is that of licensing, not enforcement and oversight. She did say that if someone were to make a specific complaint to them about a specific pharmacist they would investigate that charge and possibly revoke or suspend his or her license if deemed appropriate. But they do not investigate FDA recalls or regulations…not them.
Richard McGarvey, the Press Secretary at the State Health Department wasn't quite as friendly as he had been before. "I remember talking to you. That's a federal issue and we don't have anything to do with it, this is a state agency." I didn't even get a chance to ask him a new question.
Barbara Petito, Deputy Press Secretary to Attorney General Mike Fisher, tried to help. She listened very carefully to the questions and agreed about the seriousness of this whole issue about who is looking out for us. There must be some agency in place that checks these things. Yes, there must, but apparently there isn't. She did say she would bring it up to the Attorney General. If there wasn't something there already maybe they could start something.
She called back later to refer me to an association called PHARMA, a lobbying group for the drug manufacturers in Washington DC. They never answered their phone.
Calls to Glaxo-SmithKline, didn't get anywhere either, after being switched from one division to another and then yet another, they finally just disconnected.
Most of the people involved have tried to underplay the safety issue involved here. Several different sources within the medical establishment have said they don't think anyone is actually dying over this, however it is true that they may not be getting better like they should. If people aren't getting better like they should; whose to say they aren't dying.
Some agency somewhere, either federal or state should be monitoring pharmacies, after all they monitor everything else. When industries are left to monitor themselves the door to corruption is left wide open. This is an industry that we all take for granted, but we shouldn't, because it's an industry that could kill us.
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