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Does Off-Label Promotion Settlement Signal Change in FDA Policy?

Policy & Legislation
STAT | May 5, 2016

FDA Issues Warning Over Ability and Compulsive Gambling, Other Behaviors

“We decided that a warning would be warranted,” said Sandy Walsh, a spokesperson for the FDA.


The warning comes amid pending class-action lawsuits against the drug’s manufacturer, Otsuka America Pharmaceutical, which allege that the company didn’t properly warn patients about the possible impulse-control issues. Otsuka partners with Bristol-Myers Squibb to manufacture the drug.


Policy & Legislation
Bloomberg | Apr 29, 2016

Increased Competition Pits Lawyers v Lawyers in TV Ads

When trial lawyer Geoffrey Fieger takes to the airwaves in Detroit, he doesn’t just tout his courtroom prowess, he also chides his competition. “Every day, people are forced to settle for less than they need or deserve. Why? Because their lawyer doesn’t really try cases; they only advertise on TV.” Another Fieger ad shows darkened silhouettes labeled with the names of competitors as a deep voice asks, “You think you know them, or do you?”


The rise of such ads is tied to a slowdown in legal services and increasing competition among plaintiffs’ firms, big and small. Many national legal practices, which have seen revenue growth slow since 2008, are going after potential clients they previously left to small, local law firms. The competition is so fierce in Detroit, for example, that the share of TV ads run by legal services firms has increased 181 percent since 2006, says Kantar Media’s Campaign Media Analysis Group.


Policy & Legislation
The Washington Post | Apr 27, 2016
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Law Enforcement Avarice and Another Civil Asset Forfeiture Horror Story

Civil asset forfeiture comes from a relatively obscure corner of the law that allows authorities to seize cash and property from people they suspect of a crime. In most states, and under federal law, authorities get to keep the proceeds regardless of whether the person is ever convicted, or even charged, with criminal wrongdoing.


Under civil forfeiture, the burden of proof is on the property owner to prove their innocence to get their stuff back. This turns the common criminal-law principle on its head: When it comes to civil forfeiture, you are guilty until proven innocent.


Policy & Legislation
ABA Journal | Apr 25, 2016
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ABA Issues Opinion on Fee Splitting Between Lawyers

Under ABA Model Rule 1.5(3), lawyers may refer cases to lawyers in other firms and receive a fee, as long as the referring lawyer performs legal services or assumes joint responsibility for the case. Comment 7 to Rule 1.5 explains that these arrangements most often occur between a referring lawyer and a trial lawyer.


The opinion notes in a footnote that state adoptions of Model Rule 1.5(e) vary dramatically. Some states only require client consent and a total reasonable fee. A few states prohibit referral fees altogether. Other states mandate joint responsibility or joint financial responsibility.


Clients must consent to such an arrangement and be fully informed of the agreement regarding the division of fees before or within a reasonable time after the start of the representation. Lawyers often cannot receive a referral fee or assume responsibility for the case, however, if they have a concurrent conflict of interest. A lawyer cannot be involved in the case if there is a concurrent conflict of interest unless the lawyer meets the requirements of Model Rule 1.7(b), which includes having each affected client giving informed consent.

Policy & Legislation
American Constitution Society for Law and Policy | Apr 22, 2016
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Not Just The Supreme Court – GOP Shirking Its Duty to Confirm Judges At All Levels of the Federal Judiciary

Since January 2015, Senate Republicans have confirmed only 17 judicial nominees.


In comparison, from January 2007 to April 2008, Senate Democrats confirmed 45 of President Bush’s judicial nominees.


The difference is even starker when you consider the circuit courts—the level of our federal courts just below the Supreme Court.

Policy & Legislation
Chicago Tribune | Apr 20, 2016

Congressman Wants to Improve Medical Device Safety – Industry Expected to Oppose

Antibiotic-resistant superbugs spread by tainted endoscopes, those flexible devices used to peer into your body, have sickened hundreds and killed more than a few. Outbreaks at hospitals in Los Angeles, Seattle, and elsewhere have triggered regulatory warnings, litigation, and even a recall.


Now one California congressman wants to change a law governing medical device makers to prevent future infections: He wants them to tell the FDA when they make a design change.


"There are loopholes in the law that need to be closed," said Rep. Ted Lieu, D. Right now, it's up to manufacturers to decide whether a change is significant enough to tell the regulator. "I don't think it's appropriate for device manufacturers to make the decision," Lieu said.

Policy & Legislation
Rueters | Apr 15, 2016

Following Reports That Medtronic Hid Infuse Bone Graft Injuries, U.S. Senator Begins Inquiry

U.S. Senator Al Franken asked federal regulators and Medtronic Inc for detailed information about injuries associated with the company's bone graft Infuse following a newspaper report that Medtronic hid thousands of adverse events linked to the product. The Minneapolis Star Tribune reported on Sunday that Medtronic studied the outcomes of 3,600 patients who received Infuse between 2002, when the product was approved, and 2006. Doctors reported more than 1,000 adverse events. But, instead of reporting the events to the U.S. Food and Drug Administration, within 30 days of discovering them, as required by law, Medtronic hid them, the Star Tribune said. Medtronic officials told the Star Tribune that the database of adverse events was misfiled internally and was reported to the FDA after it was rediscovered more than five years later. It said no patients were hurt by the delay. Medtronic's operational headquarters is in Minneapolis.



Policy & Legislation
Scientific American | Apr 15, 2016

Claim: Exxon Knew About Climate Change 40 Years Ago, Spent Millions on ‘Misinformation’

A new investigation shows the oil company understood the science before it became a public issue and spent millions to promote misinformation


Exxon was aware of climate change, as early as 1977, 11 years before it became a public issue, according to a recent investigation from InsideClimate News. This knowledge did not prevent the company (now ExxonMobil and the world’s largest oil and gas company) from spending decades refusing to publicly acknowledge climate change and even promoting climate misinformation—an approach many have likened to the lies spread by the tobacco industry regarding the health risks of smoking. Both industries were conscious that their products wouldn’t stay profitable once the world understood the risks, so much so that they used the same consultants to develop strategies on how to communicate with the public.

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