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Reuben Guttman wants us all to be concerned about what’s in our medicine cabinets. A Washington lawyer who specializes in prosecuting pharmaceutical fraud, Guttman has gone after Pfizer, Abbott, GlaxoSmithKline, and several other top drug makers — and he usually wins big, recouping billions of dollars for federal and state governments...STAT talked with Guttman about bad behavior in the drug industry, and whom he trusts for his own medical care.

• The lawsuits you’ve won often center on unlawful marketing and kickback schemes. How widespread are these practices?
• How does your work as a lawyer impact the health care system?
• And the consequence for patients?
• Is there anything patients can do to protect themselves?
• Knowing what you know, do you avoid doctors and hospitals?
• What’s the next big pharma scam?
• What do you do in your spare time?
• Are you an athlete yourself?
• When you were a kid, did you fantasize about being a whistleblower attorney?

U.S. regulators have backed off an attempt to limit Pacira Pharmaceuticals Inc.’s promotion of its pain drug, striking an agreement that’s likely to fan the flames of debate over free speech and drug marketing...After the drugmaker filed suit citing its constitutional rights to free speech, the Food and Drug Administration agreed to let Pacira broadly promote the medication Exparel (bupivacaine), rather than limiting its sales team to talking only about its use after bunion and hemorrhoid surgeries...The painkiller, a non-narcotic shot, hadn’t been studied for use with other surgeries, such as dental or orthopedic procedures. While its FDA-approved label notes that fact, it doesn’t explicitly say the medication can only be used for surgeries that have been studied. Pacira argued that meant it could market the treatment for broader use...FDA has faced difficulty in its efforts to police drug marketing. In August, a court ruled the agency couldn’t bar Amarin Corp. from talking to doctors about unapproved uses of its fish-oil pill. While doctors are already allowed to prescribe drugs off-label, drugmakers have been restricted on promoting such uses...Drugmakers are able to give doctors information about unapproved uses if doctors specifically request it. The Amarin ruling allows pharmaceutical companies to hand out the information more widely without a request…

More than a year after denying allegations it surreptitiously attempted to boost its stock price, Galena Biopharma has agreed to pay $20 million to settle a shareholder lawsuit that accused the drug maker of a misleading marketing campaign and insider trading…The settlement resolves an unusual episode that raised questions about the extent to which some biotech companies may have been aggressively promoting their prospects during a bull market in biopharma stocks. However, we should note that Galena and its executives and directors did not admit any wrongdoing…Galena said it “believes the claims are without merit, but is settling the lawsuits to avoid potentially lengthy, costly, distracting, and time-consuming litigation.” Of the $20 million payment, $16.7 million will be paid by the company’s insurers and $3.3 million will be paid by Galena — $2.3 million in cash and $1 million in stock. This represents less than 1 percent of its outstanding shares.

A father’s bid to keep his 20-year-old daughter on life-support at a Reno hospital after doctors declared her brain-dead is pending before a Nevada state court judge. Beyond the family attorney’s claim on Wednesday that the cost of caring for Aden Hailu (AY’-dehn HEHL’-oo) is driving hospital efforts to pull the plug, the case raises key questions about Nevada’s interpretation of national end-of-life guidelines.

• What’s the issue?
• What’s the Nevada law?
• What’s the Uniform Determination of Death Act?
• What did the Uniform Determination of Death Act do?
• How many states follow the act?
• What tests are recommended to determine brain death?
• Have there been cases similar to Hailu’s in other states?

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An Australian court ordered Reckitt Benckiser to pull several of its Nurofen pain relief products from the market, saying...the British firm had misled consumers by marketing identical products for different types of pain...The Federal Court ruled that the Nurofen Back Pain, Period Pain, Migraine Pain and Tension Headache products were identical and that Reckitt Benckiser had "engaged in misleading conduct" by labeling them for different ailments...We have known for years that they are all the same,"..."We have been advising our customers to go for the standard painkiller which is cheaper."...Nurofen specific-pain relief products were sold at almost double the price of Nurofen's standard painkiller...Patty O'Hayer, a spokeswoman for Nurofen's UK-based parent Reckitt Benckiser, said had agreed to amend its Australian packaging to show the specific-pain relief products were effective against other types of pain as well, adding this was to prevent any confusion over dosing...

Uruguayans will be able to choose from three varieties of state-sanctioned cannabis when marijuana starts being sold in pharmacies in the small South American country next year…Each variety will have different levels of...tetrahydrocannabinol and cannabidiol..."There will be three options with indications about the effects of each that point beginners toward starting with the lowest level" of THC...Uruguay became the first country to legalize the cultivation and distribution of marijuana in late 2013, aiming to wrest control of the trade from gangs while regulating and taxing its consumption…Authorities have developed traceable, genetically-distinct plants to ensure they do not leave Uruguay's borders or end up on the black market…The government estimates registered marijuana users will be able to buy the drug from pharmacies in mid-2016, when the country's two licensed producers start selling their first commercial load of about four tonnes…Authorities are also working with companies interested in exploring the possibility of exporting medical marijuana to the United States and Europe...

Martin Shkreli, the pharmaceuticals entrepreneur vilified for jacking up the price of a life-saving AIDS drug, said on Saturday that unrelated securities fraud allegations that resulted in his arrest this week were "baseless and without merit."…Federal prosecutors have alleged that Shkreli was running a Ponzi-like scheme at his former hedge fund and a company he headed before he took the helm of Turing Pharmaceuticals Inc, where he created an uproar in September when the company raised the price of the drug Daraprim from $13.50 to $750 a tablet…"I am confident I will prevail," Shkreli wrote on Twitter on Saturday… The allegations have amplified the public outrage over the brash, boyish-looking Shkreli, who has become the poster child for the issue of soaring prices for prescription medications.

In an unusual move, Takeda Pharmaceuticals asked a federal appeals court to rule that a Native American tribal court does not have jurisdiction over a lawsuit which could expose the company to enormous liability...The effort marks the first time that a drug maker has taken such a step...underscores the risks facing the pharmaceutical industry amid a proliferation of lawsuits filed by patients who claim they were harmed by medicines...The case against...Takeda...was filed...by a member of the Blackfeet tribe who claims he developed bladder cancer after taking the Actos diabetes drug for several years...At issue is whether Native American tribal courts have jurisdiction over civil lawsuits filed against those who are not Native American. This matters to Takeda because in the US state and federal court system, a company that loses a case has the right to seek an appeal. But if a company loses a case in tribal court, it cannot appeal to a federal court. In other words, Takeda has no recourse if it loses the case…Indian tribes are independent sovereigns and not subject to federal court review, except on the huge question of whether they have legal jurisdiction in the first place...

...drug disposal is expensive — the Nebraska program spends $10 per pound to ship and destroy medication — and some states and municipalities want drug companies to pick up the tab…Six municipalities in California require drugmakers to pay for take-backs. Nine states...have considered similar measures...Proponents say these laws, which are similar to programs that require manufacturers to pay for electronics recycling, would make it easier for patients to dispose of prescriptions. But drugmakers oppose the local mandates and warn that disposal costs could be passed on to patients through higher drug prices…Alameda County in California was the first jurisdiction to pass a law requiring manufacturers to pay for take-backs, in 2012, though the industry was quick to file suit, arguing it violated the interstate commerce clause of the U.S. Constitution. The Alameda law was upheld this year when the Supreme Court refused to hear the industry’s appeal…Drugmakers would rather lead their own take-back programs than comply with local or state mandates, said Priscilla VanderVeer, of the Pharmaceutical Research and Manufacturers of America...Because drugmakers sell across the country, meeting the customized disposal requirements of local programs is complicated...There are also more effective ways to get rid of the medicines, she said, like at-home disposal or returning unwanted drugs using special envelopes with carbon lining…“That’s just a financial and logistical nightmare for something that’s not necessarily going to be effective, or secure or environmentally helpful,” she said.