Posts Tagged “Lawsuit”

Lawmakers accuse drugmakers Mylan, Teva of ‘coordinated obstruction’

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Lawmakers accuse drugmakers Mylan, Teva of ‘coordinated obstruction’

U.S. lawmakers on Wednesday accused three major pharmaceutical companies of “coordinated obstruction” and “apparent efforts to stonewall” an investigation on generic drug prices launched in 2014. Chairman of the House Committee on Oversight, Elijah Cummings, D-Md., along with Sen. Bernie Sanders, I-Vt., sent letters to Mylan, Teva Pharmaceutical and Heritage Pharmaceuticals asking them to turn over documents, according to a joint statement Wednesday. The lawmakers said they decided to open an investigation following findings in a lawsuit filed by 44 states in May that accused the drugmakers and others of inflating drug prices and stifling competition for generic drug versions.

“Not only did your company’s apparent obstruction undermine our investigation, but it may have caused further harm to patients and health care providers by delaying the discovery of evidence about the companies’ price-fixing,” Cummings and Sanders wrote in each of the letters, dated August 13. Shares of Mylan and Teva Pharmaceutical were each down roughly 8% on Wednesday. A spokesperson for Mylan said the company, with the help of outside counsel, is investigation the allegations made in the states’ lawsuit.

“We have not found any evidence to corroborate the allegations. We are prepared to make our case in a court…

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Opioid epidemic: Prescription pills were made and sold ‘like Doritos’

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Opioid epidemic: Prescription pills were made and sold ‘like Doritos’

Much of the responsibility for the opioid epidemic has been directed at Purdue Pharma, and not without good reason. Purdue introduced OxyContin in the mid-1990s and marketed it aggressively. Its sales representatives lied about its addictive qualities. Its executives downplayed reports of abuse. Its owners grew rich while thousands of people died and countless families were shattered. But documents pried loose last month, thanks to legal action by The Washington Post and the Charleston Gazette-Mail, confirm that there is plenty of blame to go around for the opioid crisis , much of it falling on other drugmakers and distributors.

The data, compiled in the Drug Enforcement Administration’s Automation of Reports and Consolidated Orders System database , shows that from 2006 to 2012 America was saturated with an astonishing 76 billion prescription opioid pills — about 230 for every adult and child in the country. Even as more people became addicted and deaths involving opioids skyrocketed (from 8,048 in 1999 to 18,515 in 2007 to 47,600 in 2017), more companies ramped up the business of making, distributing and dispensing generic forms of powerful painkillers such as oxycodone and hydrocodone. Among drugmakers, Purdue actually ranked fourth (2.5 billion pills) in the ARCOS…

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USA: Purdue Pharma Executives Discussed Expanding Into the Addiction Treatment Market

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USA: Purdue Pharma Executives Discussed Expanding Into the Addiction Treatment Market

Not content with billions of dollars in profits from the potent painkiller OxyContin, its maker explored expanding into an “attractive market” fueled by the drug’s popularity—treatment of opioid addiction, according to previously secret passages in a court document filed by the state of Massachusetts.

In internal correspondence beginning in 2014, Purdue Pharma executives discussed how the sale of opioids and the treatment of opioid addiction are “naturally linked” and that the company should expand across “the pain and addiction spectrum,” according to redacted sections of the lawsuit by the Massachusetts attorney general. A member of the billionaire Sackler family, which founded and controls the privately held company, joined in those discussions and urged staff in an email to give “immediate attention” to this business opportunity, the complaint alleges.

ProPublica reviewed the scores of redacted paragraphs in Massachusetts’ 274-page civil complaint against Purdue, eight Sackler family members, company directors, and current and former executives, which alleges that they created the opioid epidemic through illegal deceit. These passages remain blacked out at the company’s request after the rest of the complaint was made public on January 15th. A Massachusetts Superior Court judge on Monday ordered that the entire document be released, but…

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USA: Kaleo increases naloxone price by 600% over 4 years.

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USA: Kaleo increases naloxone price by 600% over 4 years.

In the midst of an unprecedented opioid epidemic, the price of one company’s version of a life-saving drug, naloxone, which can reverse the effects of an opioid overdose, has skyrocketed.

According to a new investigative report by Senators Rob Portman (R-OD) and Tom Carper (D-DE), drug company Kaleo has increased the price of its version of the drug (brand name: EVZIO) a whopping 600 percent, from $575 to $4,100, during the last four years. The drug can treat a narcotic overdose in an emergency situation.

The report’s executive summary states that Kaleo hiked the price of the drug in February 2016 and “launched its new distribution model planning to ‘capitalize on the opportunity’ of ‘opioid overdose at epidemic levels’ and a ‘well established public health crisis.’”

More than 70,000 people died due to drug-related overdoses in 2017, according to data from the US Centers of Disease Control and Prevention (CDC). At least two-thirds of those deaths were linked to opioid misuse.

In addition, the report states that the company’s sales force pressured doctors’ offices to sign paperwork (known as prior authorizations) in order to fill and cover EVZIO prescriptions, rather than prescribe generic versions of naloxone, which could be cheaper.

“This included paperwork indicating that EVZIO was medically necessary, which ensured the drug would be covered by government programs like Medicare and Medicaid for the Wholesale Acquisition…

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US probes pharma firms accused of aiding Iraqi militia that killed Americans

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US probes pharma firms accused of aiding Iraqi militia that killed Americans

Michael Chand was working in south-east Iraq as a civilian contractor for American reconstruction efforts when his convoy was attacked in 2007 by forces believed to be loyal to then firebrand Shia cleric Moqtada Al Sadr.

At first, his family were told he was shot and killed. They later learned he was being held hostage at a time when militant attacks on American forces were at their bloodiest.

His body was returned three years later, bearing the hallmarks of torture.

Now his widow is one of the dozens of bereaved relatives who accuse big international pharmaceutical companies of helping bankroll the Mahdi Army in its campaign of violence through kickbacks of medicine and supplies given to the Iraqi ministry of health which was then under Mr Al Sadr’s control.

For Washington, Mr Al Sadr has been the most vocal opponent of the American war. His militias were blamed for deadly attacks on a US-backed political opponent and soldiers, triggering an arrest warrant for murder that was never executed. But in recent years he has moved away from his openly anti-US stance and the position in Washington has softened.

The five pharmaceutical companies deny the allegations but this week it emerged…

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Big Pharma abandons lawsuit over Nevada’s insulin pricing transparency law

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Big Pharma abandons lawsuit over Nevada’s insulin pricing transparency law

Two national drug lobbying organizations dropped a lawsuit Thursday challenging the constitutionality of Nevada’s first-in-the-nation insulin pricing transparency law a little less than a month after the state approved regulations allowing drug companies to protect certain information they turn over to the state from public disclosure.

Attorneys representing two associations and the state agreed in a joint court filing that the newly adopted regulations resolve drug companies’ concerns that the new law would require manufacturers of diabetes drugs to disclose trade secret-protected information in conflict with federal law and in violation of the U.S. Constitution. The decision to abandon a legal fight comes nine months after the Pharmaceutical Researchers and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) challenged the law in U.S. District Court.

PhRMA’s Executive Vice President and General Counsel James Stansel said in a statement Thursday that the regulations addressed the “most significant legal flaw” in the legislation and that it had agreed to drop its lawsuit “given the changes to the interpretation and implementation of the law.” However, he noted that the association was doing so while “specifically reserving rights to reinstitute the litigation in the future.”

In the joint filing, both sides agreed…

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Massachusetts Sues OxyContin Maker Purdue Pharma, Saying It ‘Peddled Falsehoods’

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Massachusetts Sues OxyContin Maker Purdue Pharma, Saying It ‘Peddled Falsehoods’

The state of Massachusetts is taking a new step in the fight against the opioid epidemic, filing a lawsuit against Purdue Pharma that also names the OxyContin maker’s executives. The suit alleges the company and 16 of its current and former directors misled doctors and patients about the risks of its opioid-based pain medications.

“Their strategy was simple: The more drugs they sold, the more money they made — and the more people died,” the state’s attorney general, Maura Healey, said at a news conference on Tuesday, flanked by Gov. Charlie Baker and law enforcement officials.

“We found that Purdue engaged in a multibillion-dollar enterprise to mislead us about their drugs,” she added. “Purdue pushed prescribers to give higher doses to keep patients on drugs for longer periods of time, without regard to the very real risks of addiction, overdose and death.”

Across nearly 80 pages, the civil suit filed in Suffolk Superior Court lists Purdue’s alleged wrongdoing and its effects on people in Massachusetts in painstaking detail.

Citing the Massachusetts Department of Public Health, the complaint notes that more than 11,000 of the state’s residents have died of opioid-related overdoses in the past decade — nearly 2,000 of whom…

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Yale Professors Highlight New Trend In Pharma

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Yale Professors Highlight New Trend In Pharma

Just when it seems like progress may be on the horizon for lowering pharmaceutical drug prices, something else undermines it.

Yale School of Management Professors Song Ma and Florian Ederer and London Business School’s Colleen Cunningham authored a paper, which found more drugs would be available each year if not for “killer acquisitions.”

They refer to “killer acquisitions” as mergers used to terminate development of the target’s innovations to pre-empt future competition.

The professors admit it’s a “novel” but potentially concerning trend in the industry.

Connecticut State Comptroller Kevin Lembo, who is in charge of the state’s health insurance contract and has been a proponent of lowering drug prices, said it’s a concerning new trend that needs to be investigated.

“These killer acquisitions – pharmaceutical corporations that acquire competitors in order to block new potentially life-saving or life-changing medications from entering the market – demand immediate investigation and legal action by the state and federal investigators,” Lembo said. “When it comes to prescription drugs, killing innovation has the potential to kill lives as well when drug research is suppressed and prices senselessly skyrocket.”

Earlier this year the Connecticut General Assembly passed legislation that will increase transparency in drug pricing. It’s…

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Pfizer takes Apotex to court over generic cancer drug

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Pfizer takes Apotex to court over generic cancer drug

Pfizer has sued Canadian pharmaceutical company Apotex over its plan to make and sell a generic version of Pfizer’s Inlyta (axitinib) tablets.

Pfizer accused Apotex of infringing US patent number 8,791,140 in a filing at the US District Court for the District of Delaware on Friday, May 25.

Pfizer is the holder of New Drug Application number 202324, approved by the US Food and Drug Administration (FDA) for the treatment of advanced renal cell carcinoma after the failure of one systemic therapy.

Apotex allegedly submitted an Abbreviated New Drug Application (ANDA) to the FDA seeking approval to manufacture and sell a generic version of the cancer drug earlier this year, and informed Pfizer of the filing in April.

According to the lawsuit, Apotex’s notice letter purported to include an offer of confidential access to Pfizer to the ANDA.

“In an exchange of correspondence, counsel for defendants and counsel for Pfizer discussed the terms of Apotex’s offer of confidential access. The parties were unable to agree on terms under which Pfizer could review Apotex’s ANDA 211650, and defendants refused to produce other internal documents, samples, and data relevant to infringement,” said the claim.

Pfizer is seeking a judgment that Apotex has…

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The Fourth Circuit Was Right to Reject Price Controls for Generic Drugs

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The Fourth Circuit Was Right to Reject Price Controls for Generic Drugs

The United States Court of Appeals for the Fourth Circuit ruled in a 2 to 1 decision that Maryland’s generic drug pricing “gouging” law was unconstitutional because it violates the Commerce Clause.  This prudent decision will send a strong message to other state legislatures across the country not to pursue similar legislation.

The judges called the Maryland law what it was, a price-control measure, filled with ambiguities such as “price gouging,” “an unconscionable increase” that is “excessive” and “not justified.”  Maryland taxpayers should view this as a good decision, as there are better ways to drive down drug costs.

The Association for Accessible Medicines (AAM), the trade group for generic drugs, filed their lawsuit against the Maryland law on July 6, 2017, in U.S District Court, seeking an injunction to stop state officials from enforcing it on the grounds that it violated the Commerce Clause, was vague, and gave the attorney general arbitrary enforcement powers by allowing him to substitute his judgment for the free market.  AAM appealed when the district court ruled in favor of the state and argued its case before the Fourth Circuit on January 24, 2018.

The Circuit Court agreed with AAM’s arguments and stated the…

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