Category: Daily News

Four U.S. senators – two Democrats and two Republicans – introduced a bill on Tuesday aimed at preventing big pharmaceutical companies from using safety rules to prevent generic drugs from coming to market.

Top leaders on the Senate Judiciary Committee led by Ranking Member Patrick Leahy (D-Vt.) introduced the new legislation to combat anticompetitive practices by brand-name drug companies that delay entry of lower-priced generic drugs. The issue will also be the subject of a Senate committee hearing next week.

The Creating and Restoring Equal Access to Equivalent Samples (CREATES) Act would deter pharmaceutical companies from blocking cheaper generic alternatives from entering the marketplace. The bill is cosponsored by Chairman Chuck Grassley (R-Iowa), and Senators Amy Klobuchar (D-Minn.) and Mike Lee (R-Utah), leaders of the Subcommittee on Antitrust, Competition Policy and Consumer Rights.

Leahy said: “the high cost of prescription drugs is preventing access to necessary medical care, and I share their concern that many pharmaceutical products are simply too expensive for consumers. Pharmaceutical companies should be compensated for their important work developing life-saving treatments, but predatory practices at the expense of consumers are unacceptable. Drug affordability is a bipartisan issue that affects each and every one of us.”

The CREATES Act targets abusive delay tactics that are being used to block entry of affordable generic drugs. The first delay tactic addressed by the CREATES Act occurs when brand- name drug companies prevent potential generic competitors from obtaining samples of the branded product, so the generic company cannot perform the testing necessary to show that its product is equivalent to the brand-name product, a prerequisite for FDA approval.

The second delay tactic addressed by the CREATES Act occurs when brand-name manufacturers whose products require a distribution safety protocol (known as a Risk Evaluation Mitigation Strategy with Elements to Assure Safe Use, or “REMS with ETASU” ) refuse to allow generic competitors to participate in that safety protocol, again undermining the generic’s ability to gain FDA approval.

The CREATES Act allows a generic drug manufacturer facing one of these delay tactics to bring an action in federal court for injunctive relief (i.e. to obtain the sample it needs, or to enter court- supervised negotiations for a shared safety protocol). The bill also authorizes a judge to award damages to deter future delaying conduct.

The CREATES Act is intended to provide an efficient, tailored path for generic drug manufacturers to obtain relief so they can continue working to bring their lower-cost product to market. The Congressional Budget Office has estimated that similar legislation would save the government over $2 billion in direct savings over 10 years. The savings to consumers and private insurance companies would likely be far greater.

There is a similar bill in the House of Representatives which addresses the same issue but uses a different strategy. For example, it requires the generic company seeking a REMS drug to get FDA authorization to obtain the sample.

As an example of one of the REMS disputes which is public, Mylan Pharmaceuticals filed a lawsuit in 2014 against Celgene Corp, accusing it of using REMS to prevent generic copies of Thalomid and Revlimid to market.

The Senate Judiciary Committee’s antitrust panel will hold a hearing on its bill on June 21.The Pharmaceutical Research and Manufacturers of America, or PhRMA, which counts major drugmakers among its members, said it had no immediate comment. The Generic Pharmaceutical Association was pleased to see the bill introduced.

Famous criminal defense lawyer Mark Geragos who has defended Michael Jackson, actress Winona Ryder, politician Gary Condit, Susan McDougal and Scott Peterson was likely bluffing last week when media sources quoted him as proclaiming that a plea agreement for his client, former State Senator Ron Calderon, was not being discussed and expected the case would proceed to trial. Within a week of this proclamation, Ron Calderon’s criminal plea agreement was signed by both of them and filed in federal court.

According to the signed document, Ron Calderon admitted that it must be true that he (1) “knowingly devised or participated in a scheme to defraud the public of its right to the honest services of the public official through bribery or kickbacks; (2) defendant did so knowingly and with an intent to defraud; (3) the scheme or artifice to defraud involved a material misrepresentation, false statement, false pretense, or concealment of fact; and (5) in advancing, or furthering, or carrying out the scheme to defraud, the defendant used, or caused someone to use, the mails to carry out or to attempt to carry out the scheme.”

Ron Calderon also agreed to a “statement of facts” recited in the agreement that included the following factual admission that are in part sufficient to support his pleas of guilty.

“In 2006, defendant was elected California State Senator for the 30th Senate District and held that office until in or around November 2014. As a public official, defendant owed a duty of honest services to his constituents as well as the citizens of California.”

“Defendant’s brother, defendant THOMAS M. CALDERON, served as a California State Assemblyman for the 58th Assembly District until in or around 2002. Shortly after leaving office, defendant THOMAS M. CALDERON founded the Calderon Group Incorporated (“the Calderon Group”) in the Central District of California, a political consulting company, and.also became an Executive Officer of Californians for Diversity (“CFD”), a tax exempt public benefits corporation under Title 26, United States Code, Section 501 (1) (c) (4), in or around 2008.”

“MICHAEL D. DROBOT (“DROBOT”) was one of defendant THOMAS M. CALDERON’s political consulting clients. DROBOT owned and operated the Pacific Hospital of Long Beach (“PHLB”) and other affiliated companies from in or around 1997 until in or around October 2013. One of the political issues for which defendant THOMAS M. CALDERON was providing consulting services to DROBOT had to do with “spinal pass-through” legislation in California. Specifically, DROBOT wanted to preserve the spinal pass-through legislation in California because it enabled DROBOT and his companies to make substantial amounts of money performing spinal implant surgeries on worker’s compensation patients. Defendant knew that DROBOT wanted to preserve the spinal pass-through legislation in California.”

“In or around June 2010, defendant told DROBOT that his son would be attending college and asked DROBOT to hire his son as a summer employee of PHLB while his son was in college. Defendant told DROBOT that his son would need to earn $10,000 per summer in order to pay his college tuition each year. DROBOT agreed to hire defendant’s son as a summer file clerk at one of his companies and to pay him $10,000 (take-home or net) per summer while defendant’s son was in college. Defendant accepted DROBOT’s offer to hire his son and to pay him $10,000 per summer knowing that as a result of those payments DROBOT expected defendant to perform official acts that benefited DROBOT, like voting against legislation that would eliminate the spinal (pass) through and supporting legislation that preserved it, and intending to perform those official acts in return, which defendant did. For example, defendant asked a fellow Senator to introduce SB 896, legislation favorable to DROBOT and the spinal pass-through, and voted against SB 863, legislation unfavorable to DROBOT and the spinal pass-through. DROBOT employed defendant’s son for the first three summers he was in college (2010, 2011, and 2012) and paid his son a total of approximately $30,000.”

Ron Calderon also agreed that he “understands that the statutory maximum sentence that the Court can impose for a violation of Title 18, United States 4 Code, Sections 1341 and 1346, is: 20 years imprisonment; a three-year period of supervised release; a fine of $250,000 or twice the gross gain or gross loss resulting from the offense, whichever is greatest; and a mandatory special assessment of $100.”

A new study summarized in Reuters Health says that doctors in states that track painkiller prescriptions were nearly one-third less likely to offer patients dangerously addicting opioids. The launch of drug-monitoring programs in 24 states led to an immediate 30 percent drop in prescriptions for Schedule II opioids, the most addictive, in patients with pain complaints, the study showed.

California is among the states that have such a monitoring program. CURES 2.0 (Controlled Substance Utilization Review and Evaluation System) is a database of Schedule II, III and IV controlled substance prescriptions dispensed in California serving the public health, regulatory oversight agencies, and law enforcement. California law (Health and Safety Code Section 11165.1) requires all California licensed prescribers authorized to prescribe scheduled drugs to register for access to CURES 2.0 by July 1, 2016 or upon issuance of a Drug Enforcement Administration Controlled Substance Registration Certificate, whichever occurs later. California licensed pharmacists must register for access to CURES 2.0 by July 1, 2016, or upon issuance of a Board of Pharmacy Pharmacist License, whichever occurs later.

Lead author Yuhua Bao, a health economist at Weill Cornell Medical College in New York, and colleagues analyzed 26,275 office visits for pain in 24 states that implemented prescription drug-monitoring programs from 2001 to 2010. As reported in Health Affairs, in these states the probability of a doctor prescribing a Schedule II opioid dropped from 5.5 percent to 3.7 percent – a more than 30 percent reduction. The results were immediate and held for three years.

The study confirmed Bao’s hypothesis that physician drug-monitoring programs, which have been implemented in a wide variety of forms in every state except Missouri, are an effective tool to combat the opioid drug epidemic. But she stressed the need for other means as well.

“There are no magic bullets here,” said Dr. Caleb Alexander, who directs the Johns Hopkins Center for Drug Safety and Effectiveness in Baltimore, in a phone interview. “The interventions are needed along the continuum here – from manufacturers to end-users. This is important to keep in mind given the magnitude of addiction, injuries and deaths,” said Alexander, who was not involved in the current study.

Overdose deaths, along with sales of prescription opioids, have quadrupled since 1999, the CDC estimates. More than 165,000 Americans died from overdoses related to prescription opioids from 1999 to 2014. Some of these deaths might have been avoided if doctors had been able to check a prescription drug-monitoring database, Alexander said.

A database could show when patients are obtaining opioids under their own name from multiple doctors, which might assist in identifying potential abuse and dependency, he noted.

Drug-monitoring databases may make doctors think twice before prescribing pain medications for a variety of reasons in addition to uncovering “doctor shopping” by patients, the study authors write. Knowing that they’re being watched may serve as a deterrent, and the programs may generally increase awareness of the dangers of prescribing opioids, they say.

Primary-care doctors treating adults for chronic pain write nearly half of opioid prescriptions, the CDC said. The new guidelines recommend non-opioids like acetaminophen and ibuprofen as the first line of pain treatment.

The Ventura County District Attorney announced that 49 year old Linda Boggess of Ventura was convicted by a jury of four felony counts of workers compensation insurance fraud. Boggess was employed by the Ventura County Human Services Agency.

In March, 2007 she filed a workers compensation claim alleging she experienced “paralyzing pain.”

She received medical treatment and temporary disability payments until November 2011, when she was cleared to return to work without restrictions. Shortly thereafter, Boggess provided new work restrictions from a separate doctor which limited her to lifting no more than five pounds.

In January, 2012, Ventura County, which is self-insured for workers compensation claims, opened an investigation of the claim.

Video surveillance taken of Boggess in a parking lot revealed she was able to lift car tires mounted on wheels, each weighing 45 pounds, and carry them for a distance of approximately 50 feet.

In March, 2012, Boggess testified at her deposition that she was unable to lift and move anything heavier than a gallon of milk.

Boggess will be sentenced on July 26, 2016, at 8:30 a.m. in Ventura Superior Court Department 26. She faces a maximum possible sentence of 8 years in local custody and a $150,000 fine.

The District Attorneys’ office said that workers compensation insurance fraud is not a victimless crime. It affects every law abiding insured employers in California. In the United States, workers compensation insurance fraud costs insured employers $2 billion annually. The District Attorney’s Office is committed to vigorous prosecution of all those who choose to victimize the public in this manner.

Jack Tuttle slipped and fell down 22 steps at an office complex where his employer, Lincare, leased space. He and his wife, Megan Tuttle, sued a number of entities connected with the complex, but not his employer Lincare. The Tuttles settled with many of them: Ceramic Tile World, Inc. paid $35,000; Selberg Associates paid $500,000 ($430,000 allocated to Jack Tuttle); and in a “global settlement,” other defendants paid a total of $2.2 million ($1.9 million allocated to Jack Tuttle).

The Tuttles went to trial against the lone remaining defendant, Medical Center, on the issue of damages. The parties entered into a stipulation on liability that was read to the jury and provided in pertinent part: Medical Center “was negligent in its use and maintenance” of the office complex and “caused . . . Jack Tuttle’s fall;” “neither Jack Tuttle [n]or any other individual or entity bears any comparative fault for Mr. Tuttle’s fall;” and Medical Center was “only contesting the full extent of Mr. Tuttle’s claimed injuries and damages.”

When discussing the stipulation with the trial court, Medical Center’s counsel alerted the court and plaintiffs that Medical Center would likely be seeking “setoffs” or “credits” for the settlements once the jury put a number on damages. Counsel also repeatedly sought assurance the language of the stipulation would not be understood as foreclosing Medical Center from seeking such setoffs or credits. The trial court sympathized, telling the Tuttles’s counsel “I’m not going to allow you to have your so-called cake and eat it, too.” The Tuttles’s counsel then responded he was willing to “go along with it.”

The jury found Jack Tuttle sustained total damages of $2,476,378.86 and Megan Tuttle sustained $150,000 in damages for lack of consortium. Following the verdict, the trial court instructed the clerk to record it and asked counsel if there was “anything further at the moment,” to which all replied there was not. The court then entered judgment in accordance with the verdict.

Shortly thereafter, Medical Center filed a motion under section 663 to vacate the judgment and enter a new judgment reflecting setoffs and credits for the pretrial settlements and workers’ compensation benefits paid by the insurance carrier for Jack Tuttle’s employer. Medical Center had purchased the carrier’s workers’ compensation lien. The trial court ordered setoff and reduced the judgment by the portion of the settlements attributable to economic damages ($1,074,843.40) and by the workers’ compensation benefits minus attorney fees ($375,312.41). Tuttle appealed. The Court of Appeal sustained the judgment in the unpublished case of Tuttle v Ukiah Adventist Hospital.

CCP section 877 provides that a judgment in favor of a tort plaintiff shall be offset by the amount of pretrial settlements the plaintiff obtains from other defendants allegedly liable for the tort.The purpose of the statute is to assure equitable sharing of damages and to assure a plaintiff will not be enriched unjustly by a double recovery, collecting part of his total claim from one joint tortfeasor and all of his claim from another.

“The obvious purpose of the parties’ stipulation concerning liability was to frame the issue to be tried for the jury (i.e., damages only), to prevent the jury from engaging in any speculation about the liability of other parties, and to foreclose the jury from making any apportionment of damages based on such speculation. The stipulation, in short, had nothing to do with setoff and did not constitute a knowing relinquishment by Medical Center of its right to setoff under section 877.”