Current Federal drug rules list marijuana as a Schedule I drug, along with LSD and heroin. Meanwhile, 14 states have laws that permit people with medical conditions like cancer and chronic pain to possess and use marijuana without fear of prosecution.

This confusing situation turns chaotic when it comes to the field of employment law. For example, the Supreme Courts in Oregon, California and Montana—states with permissive laws about possession and use of cannabis—have allowed employers to fire medical-marijuana patients for using the drug. In other states like Maine and Rhode Island, medical-marijuana laws proscribe such behavior.

A pending lawsuit in Michigan might clarify matters. In that case, Joseph Casias, a Michigan resident who uses the drug to control pain associated with a brain tumor, has sued Wal-Mart, his employer, after the retailer fired him for failing a drug test on the job.

Casias claims he uses marijuana legally according to Michigan law. He takes the drug at night and has never come to work high. The drug test was administered per company policy after he strained his knee one day at work.

A Wal-Mart spokesman told the Wall Street Journal that Casias’ case was “unfortunate,” adding that “as more states allow this treatment, employers are left without any guidelines except the federal standard. Until further guidance is available, we will default to what we believe is the safest environment for our associates and customers.”

No one suggests that workers should be permitted to use marijuana on the job. But advocacy groups suggest that if employees show no clear signs of impairment, employers should assume those with valid medical-marijuana registration cards are taking the drug responsibly.

That doesn’t sit well with some employers, who cite statistics showing that cannabis is implicated more frequently than any other drug in workplace accidents causing injury or property damage. Time to fix this, fellas.

The jury in a Boston-based US District court case has found that Pfizer, the world’s largest drug maker, violated federal antiracketeering laws by promoting Neurontin for off-label uses. Neurontin is FDA-approved for the treatment of epilepsy, but the jury found Pfizer guilty of marketing it for migraine headaches and bipolar disorder.

The jury set damages at $47 million. This amount is tripled under the Racketeer Influenced and Corrupt Organizations Act, meaning that Pfizer must pay damages equaling $141 million.

The case was brought by Kaiser Foundation Health Plan and Kaiser Foundation Hospitals. Kaiser alleged that it overpaid for Neurontin as a result of Pfizer’s illegal marketing tactics.

Physicians are free to prescribe drugs for non-FDA approved uses, but drug makers cannot market their products for such purposes.

Kaiser said in a statement that “that justice has been achieved for our members and the physicians, pharmacists and staff who care for them.”

Pfizer claimed that Neurontin did work in some cases, and that Kaiser still allows its physicians to prescribe the drug off-label. “We are disappointed with the verdict and will pursue… an appeal,” said Pfizer spokesman Christopher Loder.

In an unrelated case in 2004, Pfizer plead guilty to similar charges and agreed to pay $430 million to settle the matter.

Two years ago, unsealed documents from yet another case revealed that Pfizer executives suppressed the results of a 1999 trial showing that Neurontin didn’t work for chronic nerve pain at the same time the company was promoting the drug for that purpose.

Pfizer’s Neurontin marketing campaign transformed the underperforming epilepsy drug into a $2 billion per year blockbuster before generic versions became available in 2004.

Last week, a federal judge threw out patents on BRCA1 and BRCA2, genes whose mutations are linked to breast and ovarian cancer. The decision casts doubt on patents covering thousands of human genes.

In his decision, US District Court Judge Robert Sweet  ruled the patents were “improperly granted” since they involved a “law of nature.” He rejected the notion that isolating a gene made it patentable, calling that “a ‘lawyer’s trick’” which circumvents the “prohibition on the direct patenting of the DNA in our bodies but which, in practice, reaches the same result.”

The case had been brought by patients and medical organizations last May. They argued that genes, as products of nature, are discoverable and hence fall outside of the universe of things that can be patented. They also argued that patents drive up testing costs and stifle biomedical innovation.

Myriad Genetics is the company that held the BRCA patents. It markets a $3,000 test that scans for mutations in the genes which are associated with a high risk of breast and ovarian cancer.

Nearly 20% of all human genes have been patented. Enormous industries have been created around the intellectual property rights granted by these patents.

If the decision withstands a likely appeal, it might become difficult for companies to raise venture capital to support genomics research. “The industry is going to have to get more creative about how to retain exclusivity and attract capital in the face of potentially weaker patent protection,” said Kenneth Chahine, a law professor who filed an amicus brief for Myriad.

In that instance, “the government is going to become the funder for content discovery because it’s going to be hard to justify it outside of academia,” venture capitalist Bryan Roberts told the New York Times.

Jon Basso, owner of the Heart Attack Grill in Chandler, Florida and proud creator of the quadruple bypass burger (see picture) is suing his counterpart, who recently started a similarly-themed establishment, the Heart Stoppers Sports Grill, in nearby Delray Beach.

The Heart Attack Grill has been around for years. Heart Stoppers began serving it’s artery-clogging, stomach-expanding fare in the past few months.

Both establishments feature Hooter’s-like “nurses” as waitresses and a cardiovascular-catastrophe themed ambiance, which prompted the lawyer representing the Heart Attack Grill to plead his case thusly to the South Florida Sun Sentinel:

“Heart Attack Grill is the originator of the medically themed hamburger grill and restaurant. … It sells high-calorie food products and we have had very extensive media coverage, including numerous shows on the Travel Channel and the Food Network. In my mind, we are just as well known as McDonald’s.”

According to the WSJ Health Blog, the Heart Stoppers folks were negotiating for a Heart Attack Grill franchise before cutting and running. The Heart Stoppers theme “is completely different,” says the lawyer for the upstart. “They didn’t steal the same trademarked Single Bypass, Double Bypass burger”

And Heart Stoppers offers food for vegetarians as well, claimed Iggy Lena, the owner.

Should companies be allowed to patent genes? They are right now, and an HHS-advisory committee has warned that such practices threaten medical progress and could drive critical bio-medical research overseas in search of friendlier legal environments.

The HHS Advisory Committee on Genetics, Health, and Society also said in a report dated February 5 that the cost of genetic analysis has plummeted recently to a point where there is substantial potential to improve health using gene-based technologies.

But existing patent laws pose serious obstacles to “the promise of these developments,” according to the report. As evidence for this assertion, the report cites several labs that run multiplex gene testing but do not report the results regarding patent-protected genes to patients or clinicians, because they worry about being sued.

The Committee recommended that the US should create broad exemptions from liability for infringement of patent claims on genes used in diagnostic testing for patients, as well as in the use of patent-protected genes in research.

The Committee also recommended that guidelines be established to promote non-exclusive licensing for genomic and diagnostic genetic technologies, improved transparency in licensing, and creation of an advisory board focused on gene patenting and licensing practices and their impact on health.

The report was ordered by HHS Secretary Sebelius at a time when a bevy of lawsuits have put judges in the position of deciding whether gene patents are enforceable.

 “Patenting has moved upstream; instead of covering only commercial products, patents can now control foundational research discoveries, claiming the purified form of genes. Fragmented ownership of these patents on genes by multiple competing entities substantially threatens clinical and research use,” according to the report. “Fragmented ownership may create problems such as patent thickets, blocking patents, high transaction costs, royalty stacking, and holdouts.” (more…)

The Massachusetts anesthesiologist accused of cooking up data for use in trials of pain medications has agreed to plead guilty to criminal charges in a deal with federal prosecutors.

Scott Reuben, who had been among the nation’s most respected investigators on the subject, had been charged with one count of healthcare fraud.

Reuben’s trouble began last year, when an internal audit conducted by Baystate Medical Center in Springfield, Mass., revealed he fabricated data for 21 studies he had conducted during the last 15 years.

The criminal charge had focused on one of these, a trial of Celebrex as part of a “multimodal” pain regimen for knee surgery. The study showed the drug was effective and was published in 2007 in Anesthesia & Analgesia.

“In fact,” the prosecution wrote in a court filing, “Reuben had not enrolled any patients into that study, and the results reported…to Anesthesia & Analgesia were wholly made up by Reuben .”

Had he not copped a plea, Reuben could have spent 10 years behind bars and been fined $250,000. The plea convinced prosecutors to recommend lighter penalties.

After Baystate spilled the beans, journals that had published his tainted articles retracted them.

Baystate terminated its contract with Reuben last spring. At the same time, he reportedly agreed to suspend his practice and was stripped of a professorship at Tufts.

Several widely accepted medical beliefs need to be re-examined in light of the scandal. Topping the list are the effect of COX-2 inhibitors on bone healing and the role of multimodal analgesic regimens in managing chronic pain.

With respect to the former, Reuben’s studies suggested the drugs had no effect on bone fusion, a finding that was contrary to the results of several animal studies.

A federal judge has told the FDA to quit blocking the importation of electronic cigarettes from China and ruled the devices should be regulated like tobacco products rather than as drugs or medical devices.

Judge Richard Leon of Federal District Court in Washington issued the order in a lawsuit brought by e-cigarette distributors.

e-Cigarettes are battery-powered tubes that heat liquid nicotine into a vapor which is subsequently inhaled. The devices also add ingredients that give the vapor a taste and smell just like cigarette smoke.

According to e-cigarette distributors, the inhaled mix does not contain cancer-causing chemicals. The FDA argues they have not been proven safe.

Judge Leon ruled that last year’s tobacco legislation gave the FDA power to regulate the contents and marketing claims of e-cigarettes just like traditional tobacco products, but not to ban them.

The FDA released a statement in response: “The public health issues surrounding electronic cigarettes are of serious concern to the FDA. The agency is reviewing Judge Leon’s opinion and will decide the appropriate action to take.”

Ray Story, a VP at Smoking Everywhere, the plaintiff in the suit, claimed the ruling was a victory for people who want a safer cigarette. “The public will have a less harmful alternative to tobacco products,” Story said. “Wherever they’re sold, we are going to be sold.”

Matthew Myers, president of the antismoking advocacy group Campaign for Tobacco-Free Kids, decried the ruling. “These products could serve as a pathway to nicotine addiction for children,” Meyers told the New York Times.

People have estimated e-cigarettes could grow to become a $100 million business nationwide. Traditional cigarette makers are not involved in the e-cigarette business.

The Obama administration has announced a new policy that makes it harder for the government to claim “state secrets”—a phrase we thought had become George W. Bush’s middle name—in an effort to hide shady national security tactics like rendition and warrantless wiretapping from the public. 

The new policy requires the CIA, FBI, NSA and the US military to convince the attorney general and a team of lawyers at Justice that the release of information regarding such tactics presents a significant risk to “national defense or foreign relations,” according to the Washington Post.

The legislation raises the standard for “state secrets” to instances when the release of material “would be reasonably likely to cause significant harm to the national defense or the diplomatic relations of the United States.”

Under Bush, a claim of “state secrets” required approval of a mid-level official using a much lower standard of proof that disclosure would harm national security.

Bush asserted “state secrets” dozens of times, according to legal scholars.

“What we’re trying to do is . . . improve public confidence that this privilege is invoked very rarely and only when it’s well supported,” a senior department official confided to the Post. “We’re not following a ‘just trust us’ approach.”

Gary Bass, executive director of OMB Watch, a nonprofit that promotes government transparency welcomed the change. It is “enormously consistent with open-government recommendations” that he and other advocates have made for years.

Last February, in anticipation of the policy shift, Justice began reviewing about a dozen cases in which “state secrets” had been invoked.

Surprisingly, it reversed course in just one instance—a bizarre case in which a former DEA operative has accused the CIA and the State Department of wiretapping his home.

Boston Scientific Corp. has agreed to cut a $716 million check to Johnson & Johnson to settle more than a dozen patent infringement lawsuits, including one in which a judge had already ruled in favor of J&J.

The settlement wraps up all but 3 stent-related lawsuits involving the two companies. Stents are cage-like metal struts that prop open partially blocked arteries.

Stents are most frequently used in the coronary arteries, but they can be used in other arteries as well.

The market for cardiac stents now exceeds $4 billion. Boston Scientific leads the pack in this field, but J&J owns the original patents on the medical devices after acquiring them from Julio Palmaz, the radiologist who invented them.

Nine years ago, a judge ruled that a Boston Scientific stent known as the NIR infringed on one of J&J’s patents. Boston Scientific appealed, but announced last year that it expected to fork over more than $700 million to settle the claim. That includes interest dating from the original verdict.

Boston Scientific announced it will pay the settlement from cash holdings, which amounted to $1.2 billion as of last June.

The market for stents has leveled off in recent years after studies showed they weren’t that effective in many instances, and other studies raised concerns about bleeding from the anti-platelet therapy that is normally prescribed after stents are placed.

The J&J settlement comes shortly after Boston Scientific settled separate stent-related claims with Medtronic. For its part, Medtronic recently paid $400 million to Abbott Laboratories to settle a patent infringement case regarding…you guessed it, stents.

Last June, Internet radio host Hal Turner disagreed with a decision by 3 Chicago-based federal judges, in which they rejected the National Rifle Association’s lawsuit designed to overturn a pair of bans on handguns.

So he shared his opinions on his blog. “Let me be the first to say this plainly: these judges deserve to be killed,” he wrote. “Their blood will replenish the tree of liberty. A small price to pay to assure freedom for millions.”

A day later, Turner posted photos of the judges and a map showing routes to the courthouse where they presided.

He appended details regarding the location of “anti-truck bomb barriers” in front of the courthouse.

Not too long thereafter, US Attorney Patrick Fitzgerald charged Turner, whose blog is followed by white supremacists, with threatening the lives of the judges. Turner was sent to prison, and his bail request was denied.

Turner’s attorney, Michael Orozco claims the Feds overreacted. “He gave an opinion. He did not say go out and kill,” he told the Washington Post. “This is political hyperbole, nothing more. He’s a shock jock.”

Turner’s blog has been taken down. On it, Turner called the judges, who are generally felt to be conservative, “unpatriotic, deceitful scum.” He added that the only thing preventing judges and “the government” from achieving ultimate power “is the fact that We The People have guns. Now, that is very much in jeopardy.”

Turner then quoted Thomas Jefferson: “The tree of liberty must be replenished from time to time with the blood of tyrants and patriots.” To this, Turner added an exhortation of his own: “It is time to replenish the tree!”

Timothy McVeigh, the Oklahoma City bomber, was wearing a T-shirt emblazoned with that very Jefferson quote when he was nabbed.

According to First Amendment scholar Martin Redish, most of Turner’s rants are protected by the Constitution, including his statements that the judges should be cut down.

But Turner probably crossed the line by printing information about the judges’ whereabouts and a map of the courthouse.

“I would give very strong odds that once he said that stuff, it takes it out of any kind of hyperbole range,” Redish told the Post.