January 2nd, 2007

Spitzer Advocates for Judicial Reform in New York

In the world of New York and the law, there is really only one story in today’s paper: Crusading former attorney general Eliot Spitzer being sworn in as Governor, with vows to reform the state and improve the troubling ethical issues that he sees in Albany. And to pick better judges, (a subject overlooked by most of the media).

In making his reforms immediately by executive orders, he stopped government staffers from using state-owned cars, computers or other property for their personal business. This was the issue that brought down Comptroller Alan Hevesi.

Spitzer also prohibited state officials from starring in taxpayer-paid advertisements. This was a favorite activity of outgoing Gov. George Pataki that effectively acted as free advertising for him.

Spitzer also, thankfully, set up new procedures to ensure those seeking state judgeships are qualified. A copy of his executive order with respect to new judicial screening committees can be found here. It includes folks from the judiciary and the attorney general’s office, and from both majority and minority political parties.

The screening committees seem designed to find judges based more on core competence than political ideology. And that would be a very good thing.

[Addendum: On January 3rd, the New York Law Journal did a major front page story on judges Gov. Pataki elevated to appellate posts and their lack of diversity, which I posted about here.]

December 12th, 2006

Fighting Fake Drugs: NYT Editorial

The New York Times today jumps into the fray regarding the dangers of counterfeit drugs in an editorial. They do so from the perspective of those buying drugs over the Internet:

Tempted to buy cheap medicines from a pharmacy Web site? Think twice. If the Web site shows no verifiable street address for the pharmacy, there is a 50 percent chance the drugs are counterfeit.

In rich countries, fake medicines mainly come from virtual stores. Elsewhere, they are on the pharmacy shelves. In much of the former Soviet Union, 20 percent of the drugs on sale are fakes. In parts of Africa, Asia and Latin America, 30 percent are counterfeit. The culprits range from mom-and-pop operations processing chalk in their garages to organized-crime networks that buy the complicity of regulators, customs officials and pharmacists.

The editorial goes on to the deaths from counterfeits and the ways developing countries have been fighting it, and otherwise serves to further sound the alarm of buying medication when you don’t know its origins.

As those in the pharmaceutical drug trade know, the issue of counterfeits has been a hot topic before the FDA in recent years. It is also, most certainly, not confined to foreign counterfeits as we have purely domestic counterfeiting going on.

After identifying the problem, the Times makes its pitch for action, writing:

An international convention is also needed to establish stiffer penalties for counterfeiting drugs, and marshal more funds and support to fight this deadly crime.

That’s a great idea. And we can start right here at home with legislation currently stuck in congressional committees. The pending legislation before both the House and the Senate comes in the form of Tim Fagan’s Law, named for one of my clients.

For more on the issues, you can visit my own Counterfeit Drug Resource Page, and read more about the problem by clicking on the Counterfeit Crugs label on your left and seeing other posts on the subject.

December 10th, 2006

Lawyers Push For Greater Workplace and Product Safety

Business oriented Bloomberg News did a piece this week on the changing landscape for tort “reform” given the election results. A few snippets from the article:

Trial lawyers, who say they were demonized during 12 years of Republican congressional rule, are seeking vindication with the Democrats’ return to power…Their plans include pushing tougher enforcement of workplace-safety rules and enhanced patients’ rights.

They say the shift in power also signals an end to the so- called tort reform backed by President George W. Bush, which was aimed at limiting awards in personal-injury lawsuits against doctors and U.S. corporations.

“The Republicans had a hell of a chance for the last couple of years and really didn’t get that far,” said John Coale, a trial attorney at the Coale Cooley firm in Washington. “And now it’s over.”
…

Businesses are girding for a fight in Congress over workplace safety and such other issues as making it a federal crime for chief executive officers and other company officials to knowingly introduce defective products that kill or severely injure consumers.
….
Bush’s major victory in limiting lawsuits was 2005 legislation requiring the biggest class-action suits to be filed in federal court rather than state courts, which have been more sympathetic to plaintiffs.

The Republican-controlled Congress failed to pass proposals to place caps on medical-malpractice awards and to create a $140 billion fund for asbestos-exposure victims.

…
Linda Lipsen, chief lobbyist for the [The Association of Trial Lawyers of America] would like to see Congress strip the insurance industry of its exemption from antitrust laws, a move that would pave the way for suits against insurers. She also suggested there might be congressional hearings one day on “why there are 98,000 deaths per year” in the medical industry.

Trial attorneys will “alert the Congress to areas where they can encourage safety,” including “cars, airplanes, the environment, clean air and water, medical procedures, hospitals,” Lipsen said. “Our job is to make sure these industries are accountable.”

November 27th, 2006

New York Counterfeit Drug Bill Affected by Election?

The recent election seems destined to play a role in the counterfeit drug bill pending in New York. While last week I wrote about Tim Fagan’s Law pending in Washington, that is not the only proposed legislation designed to bring greater safety to our drug distribution system. In Albany, Assemblywoman Amy Paulin (D-Scarsdale) introduced her own bill to track drugs and increase pharmaceutical safety. From the press release:

This legislation requires drug manufacturers to establish a pedigree for each prescription drug, requires every wholesaler to submit a bond of $100,000, punishes manufacturers and wholesalers who intentionally package, sell, transfer, distribute or deliver a counterfeit drug with a class D Felony, establishes a fine of up to two thousand dollars per violation for offending drug manufacturers, and authorizes criminal background checks for manufacturers and wholesalers.

But two things happened in the election. First on the negative side, Paulin’s Republican co-sponsor lost his Senate seat. Nick Spano (R-Yonkers) had hung on to re-election by a mere 18 votes in 2004, but this time lost. Paulin was bold to reach across the aisle to ask Spano to co-sponsor this bill — both pictured with me here after the press conference annoucing the legislation — especially given the vulnerability of his seat. But sound public policy comes first for this bill she cares passionately about. She now needs a new sponsor on the Senate side.

And second, on the far more positive side, Eliot Spitzer blew away his opponent to win the governorship. Since Spitzer as Attorney General started an investigation into drug distribution practices in New York, it is presumably a matter he knows and cares much about. One of the subpoenas he dropped in this investigation was on my firm, for the records that I have for representing Tim Fagan and investigating the problem of counterfeit drugs.

This bill is one of many in state legislatures across the country that have popped up give the extraordinary risks from counterfeit drugs that exists due to our leaky drug supply chain. Hopefully the holes can be plugged before more people are injured.

November 22nd, 2006

Counterfeit Drugs: How the election helps consumers

Counterfeit drugs fly beneath the usual political radar of war, deficits, gay rights, and other issues that Washington often deals with. But to Kevin Fagan, the problem of pharmaceutical fakery is a real problem: Tim, his then 16 year old son, had been injected with counterfeits after a life-saving liver transplant in 2002.

Kevin’s crusade to help clean up our leaky drug distribution system — which all too often allows fake drugs to slip into the legitimate supply chain through shady secondary wholesalers — brought him to Washington, where Representative Steve Israel introduced Tim Fagan’s Law in 2005. The bill, and the significant problems with the distribution system that allows this to happen, are detailed more fully on my Counterfeit Drug Resource Page. Since I represent the Fagan family, it is a matter of some interest to me.

The problem with the proposed law doesn’t seem to be self-evident since it is non-partisan legislation that does the following:

Increases criminal penalties. The current federal law is three years in prison. Israel’s bill increases penalties and includes up to life in prison.

Mandates that a manufacturer must alert the FDA of a counterfeited drug in 2 days. Currently, there is no mandate. The pharmaceutical industry has said that it would voluntarily tell the FDA about counterfeited drugs within 5 business days.

Provides the FDA with the authority to require companies to use anti-counterfeiting technology, as the technology becomes feasible and available.

Mandates that the FDA implement the paper pedigree rule that was mandated in 1988 and has been postponed for 17 years. It also closes the “authorized wholesaler” loophole and includes manufacturers as needed to start the pedigree.

Authorizes $60 million for spot-checking for counterfeits for each year between fiscal years 2006 and 2010.

Authorizes $5 million for each year between fiscal years 2006 and 2010 for educating the public and health care professionals on how to identify counterfeit drugs.

Provides recall authority to the FDA for prescription drugs. Currently, the FDA can only recall equipment and can only encourage private companies to recall their drugs.

Authorizes the FDA to issue subpoenas with respect to preventing threats to public health.

So why would a bill that has no partisan agenda languish in a committee despite it being sound public policy? The answer, I’m afraid, is that it languishes simply because it came from the minority party. Israel, who is the Fagans’ congressman, happens to be a Democrat. So too is New York Senator Chuck Schumer, who introduced a counterfeit drug bill in the Senate.

With the Democrats taking control of Congress, it is hoped that this bill can now move out of the committees where it is stuck and out on to the floor for debate and voting.