drug

Nation’s Largest Drug Distributor to Pay $150M in Settlement

Drug distributor McKesson Corporation will pay a $150 million fine.

Regulators have alleged that McKesson Corporation, a drug distributor, failed to report suspicious orders of painkillers that have been linked to the opioid addiction epidemic.drug

The company has agreed to pay a $150 million fine after they allegedly failed to detect and report suspicious orders of prescription pain pills, according to federal prosecutors. This has arguably led to the growing heroin crisis.

For example, more than 1.6 million orders for controlled substances were filled by McKesson in Colorado between June 2008 through May 2013. However,  just 16 of them from a single customer as suspicious, the Justice Department said.

In a statement from the White House last summer, federal fears related to pain killer and opioid addictions were made clear:

“President [Obama] has made [it] clear that addressing this epidemic is a priority for his Administration.  While Federal agencies have been using their authority to take every available action they can, Congress needs to take action on what is most urgently needed now – additional funding to make lifesaving treatment available to everyone who seeks it. The President has called for $1.1 billion in new funding to help Americans who want treatment get it wherever they live.”

Those addicted to opioid painkillers are most likely to form a heroin addiction according to the Centers for Disease and prevention.

McKesson, the nation’s largest drug distributor,  was accused of failing  to create an effective system to detect suspicious pharmacy orders. This was argued to be a violation of the Controlled Substances Act.

In 2008, McKesson agreed to a $13.25 million civil penalty for actions including failing to report suspicious sales of their drugs on “internet pharmacies.”

 

In a statement, McKesson said it settled “in the interest of moving beyond disagreements about whether McKesson was complying with the controlled substance regulations … and to instead focus on the company’s partnership with regulators and others to help stem the opioid epidemic in this country.”

Coca-cola

Consumer Group Suing Coca-Cola Due to Sugary Soda Risks

Lawsuit claims Coca-Cola misled consumers on sugary soda health risks.

The consumer-advocacy group, Center for Science in the Public Interest (CSPI) asserts that Coca-Cola has misled consumers about the health risks of sugary drinks such as soda. Coca-Cola

In 2015, it was revealed that the corporate giant had heavily funded and been involved in the operation of the research group Global Energy Balance Network. Coca-Cola aimed to help establish the group as a “reputable scientific source to counter “public health extremists.” The company has starkly tried to avoid claims that their products are unhealthy.

It is based on these findings that the lawsuit claims that, “for years, [the] defendants have engaged in a pattern of deception to mislead and confuse the public (and governmental entities that bear responsibility for the public health) about the scientific consensus that consumption of sugar-sweetened beverages is linked to obesity, type 2 diabetes, and cardiovascular disease.”

The industry group, American Beverage Association (ABA) is the co-defendant in the lawsuit. The ABA continues to argue that obesity is a “complex condition.” Further asserting that as obesity and diabetes rates continue to rise, that soda consumption is dropping.

CSPI wants the ABA and Coca-Cola to make some changes. They want marketing to disclose the health risks of sugary drinks, while stopping ads directed at children. They also want the groups to disclose file “indicating the potential health implications.” Plus, the CSPI would like for Coca-Cola and the ABA to fund a public health campaign.

The ABA said in a statement that “America’s beverage companies know we have an important role to play in addressing our nation’s health challenges. That’s why we’re engaging with health groups and community organizations to drive a reduction in the sugar and calories Americans get from beverages.”

Coca-Cola has called the suit “legally and factually meritless.”

Infuse bone graft

Infuse Bone Graft Lawsuit Gets New Life

A lawsuit accusing Medtronics of covering up negative side effects of its Infuse bone graft has been revived by an appeals court.

A lawsuit accusing Medtronic of misleading shareholders by concealing the adverse effects of its Infuse bone graft, has been revived by the The 8th U.S. Circuit Court of Appeals in St. Paul, Minnesota.

The Infuse bone graft has been used in more than 1 million surgeries. In 2002, the FDA approved the Infuse bone graft for use in specific types of spinal fusion surgeries. The Infuse bone grafts variety are “synthetic, concentrated proteins…mixed with collagen from cows and injected into the spine to alleviate pain.”

The Spine Journal found, in 2011, that the risks of the product had been understated by medical professionals.

In 2012, the U.S. Senate Finance Committee stated that Medtronic, Inc., the manufacturer of the Infuse bone graft, had paid doctors hundreds of millions of dollars to write favorable articles and manipulate studies on the popular product.

In 2013, Medtronic shareholders sued the company claiming that the company’s stock had been inflated due to these unethical activities. As the truth about the product emerged, they have alleged hundreds of millions of dollars in losses.

In 2014, Medtronic agreed to settle its Infuse bone graft lawsuit for $22 million that involves 950 people. Around 2,300 surgeons had used Medtronic products in the US prior to any serious side effects being reported.

An earlier decision in the case judged that shareholders had waited too long before seeking legal action. As 2016 came to a close an appeals court found that the case could still be brought forward.

The case will now be returned to the lower court for further proceedings.

Powdered medical gloves

Powdered Medical Gloves Banned By the FDA

The use of most powdered medical gloves has been banned by the FDA.

For only the second time in history the FDA has banned a medical device. Powdered medical gloves seem to pose adverse risks.Powdered medical gloves

The Food and Drug Administration (FDA) has found that powdered medical gloves (powdered surgeon’s gloves, powdered patient examination gloves, and absorbable powder for lubricating a surgeon’s glove) “present an unreasonable and substantial risk of illness or injury.” This has led to a new rule banning these products from use, effective January 18, 2017.

One group has called the ban “18 years too late.” Nearly 20 years ago, in 1998, the advocacy group Public Citizen, filed the first of several citizen’s petition calling on FDA to ban powdered gloves.

After the ban was proposed by the FDA, Public Citizen responded saying that “when a medical product, drug or, in this case device, has unique serious risks but no unique benefit, it should be banned. The FDA’s statement that “we … only take this action when we feel it’s necessary to protect the public health” ignores overwhelming evidence going back almost two decades about the necessity to do so.”

Back in March of 2016, the FDA had prosed the powdered medical gloves citing evidence that they were a  danger to  patients, risks included airway and wound inflammation, post-surgical adhesions and allergic reactions.

Powdered gloves aim to make the removal of gloves easier for medical professionals. So, the FDA had to determine whether the ease of use outweighed the risks.

The rules not that powder is fine when used in the manufacturing process, but should not be a part of the finished product. The rule from the FDA “encourages manufacturers to ensure finished non-powdered gloves have as little powder as possible.”

 

If you believe that you or a loved one might have suffered from the medical use of powdered gloves, let the Medical Claim Legal Team help.

Johnson & Johnson Faces More Legal Trouble Over Hip Products

Johnson and Johnson is facing more legal trouble related to their hip products.

There are currently more than 8,000 suits for the DePuy Orthopaedics products manufactured by Johnson & Johnson.

In the past, the company has lost one trial involving the device and won another where the courts ruled in the manufacturer’s favor.

In the new case, the victim claims to have “suffered substantial injuries and damages” from the Johnson & Johnson subsidiary manufactured hip implant.

This comes less than a month after a federal jury in Dallas ordered Johnson & Johnson and its DePuy Orthopaedics unit to pay more than $1 billion to plaintiffs who claimed they were injured by Pinnacle hip implants.

The Indiana man filed the lawsuit in Middlesex County Superior Court on Dec. 9, the new suit alleges that the metal-on-metal version of the product is defective. As a result of defects,  metal particles move into a recipient’s bloodstream and tissue after wear and tear.

If you have suffered pain or suffering due a faulty Johnson & Johnson hip replacement product, you could be entitled to compensation.

Kia Faces Minivan Recall

KiaAutomobile manufacturer Kia, is recalling nearly 100,000 of the company’s Sedona minivans with model years spanning from 2006 to 2012. The recall is in place due to some suspension parts that are susceptible to rust damage when they come into contact with salt used on icy roads in the winter.

The recall will effect drivers in the following cold-weather states: Alaska, Connecticut, Delaware, Illinois, Indiana, Iowa, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, Nebraska, New Hampshire, New Jersey, New York, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota, Utah, Vermont, West Virginia, Wisconsin and Washington, D.C.

According to a Chron article, the same recall problem was addressed in 2013.  2006 and 2007 model year vehicles will have their suspension parts replaced by the company, while the remaining vehicles will receive an anti-rust coating on the parts to protect them from any further damage.

Kia will reportedly inform consumers of their recall on July 25th.

Opioid Overdose Claims a Legend

opioidReports have been released showing legendary pop star Prince, died of an overdose of the painkiller Fentanyl. The drug, which can be found on the black market, is more than 100 times more potent than morphine, making it the strongest opioid available.

“Fentanyl is a very dangerous opioid, whether you’re taking it as a prescription or you’re mixing it with black-market heroin,” said addiction specialist Andrew Kolodny, executive director of Physicians for Responsible Opioid Prescribing, in a USA Today article.

“Celebrity overdoses are just the tip of the iceberg of an epidemic,” Kolodny said. “Many of these deaths are occurring in people who are not your typical drug abuser. They are suffering from chronic pain and they are becoming addicted to legitimately prescribed medication.”

Prince’s death is just one in an increasing trend of opioid-related fatalities in America. According to a CDC report, Since 2000, the rate of deaths from drug overdoses has increased 137%, including a 200% increase in the rate of overdose deaths involving opioids. The alarming growth of opioid addictions and deaths has even been a topic in the presidential race, and continues to be a major topic in politics as a whole.

One startling point made in a Washington Post article is that so many people are dying of drug overdoses that it’s easing the shortage of donated organs. While there are many factors, whether accidental or intentional, that contribute to the number of overdoses in this country, there must be more effort put in to stop this growing epidemic.

In the past year, google searches containing the word “opioid” have increased continuously, and they grew even more when Prince’s death was linked to the painkillers. The awareness of the problem has grown across the country, however a solution has not been found. Hopefully there can be a solution to rehabilitate addicts, and prevent future overdoses from occurring.

 

Purdue Pharma Under Pressure

PurduePurdue Pharma, makers of OxyContin, are facing some increased scrutiny from the FDA over their marketing of the popular painkiller. Since the release of OxyContin, the packaging has always said “12-hour relief” however in some patients the effects of the drug begin to wear off after about eight hours. This leads to many patients having to take more pills each day than what they were originally prescribed. Opioid addiction is increasing across the country and Purdue is being blamed as one of the leading causes.

In a large-scale investigation of the pharmaceutical company by the LA Times, it was revealed that they knew the effects of OxyContin did not always last 12 hours. The main reasoning for the company’s false advertising was because the 12-hour relief claim gave the drug a large competitive advantage over other, less expensive drugs. In the late 1990’s, doctors began prescribing OxyContin at shorter intervals so Purdue sent a team of sales executives all across the country to convince doctors to stick with the 12-hour doses. According to the LA Times report, More than half of long-term OxyContin users are on doses that public health officials consider dangerously high, according to an analysis of nationwide prescription data conducted for The Times.

In a statement released by Purdue the company had this to say, “Nearly a decade ago, the FDA cited a lack of clinical evidence when it formally rejected the ‘fundamental premise’ that patients receiving OxyContin at intervals more frequent than twice-daily are at increased risk of ‘side effects and serious adverse reactions.’ In doing so, the agency reinforced the twice-daily labeling for OxyContin. The LAT omitted the findings of this report from its story.”

This story will be one that continues to develop and as news comes out, lawsuits may follow. The entire medical world will be following these developments as it could change the market for painkillers in the United States and other countries as well.

Addicts Suing Doctors

Addiction to painkillers, and other opioid drugs, is a serious problem in the state of West Virginia. According to a CBS News report, West Virginia has the highest rate of overdose deaths in the nation. Each year doctors write the equivalent of one painkiller prescription for every man, woman and child in this state of 1.8 million people. The painkiller problem has become so severe that state legislature has stepped in to make changes, and has led to the addicts suing doctors.

More than 30 addicts have sued their doctors for enabling their addiction. Many of these patients suffered from work related injuries and had to rely on painkillers in order to continue working.

Addicts suing doctorsPatients are not the only ones filing lawsuits regarding this subject. West Virginia Attorney General Patrick Morrisey has filed a lawsuit against McKesson Corporation, a prescription drug distributor, for allegedly failing to identify, detect, report and help stop the flood of suspicious drug orders into the state.

According to a CBS San Francisco article, The DEA, along with six states, sued McKesson (a San Francisco based company) in 2008 for supplying hundreds of suspicious hydrocodone orders to rogue pharmacies. McKesson settled, paying more than $13 million in fines and agreeing to closely monitor their pill supply.

In research of McKesson’s involvement in West Virginia, it shows that more than 100 million doses of opioids to a state where the population is 1.8 million. This egregious amount of drugs being sent to a state that has the most overdose related deaths in the country is what has put the company in hot water. McKesson could face tens of millions in legal fees, but for a company that makes over a billion dollars that is simply pocket change.

Hopefully the changes made by the legislation in West Virginia can help the addicts recover and find the treatment they need.

 

 

Pelvic Mesh Lawsuit

Pelvic mesh lawsuit
Johnson & Johnson faces a massive pelvic mesh lawsuit

Johnson & Johnson is back in the news, although it is not they type of news they would like to hear. The company is entrenched in a pelvic mesh lawsuit that has already seen over 100 cases settled in the past year, and faces over 30,000 more cases that have yet to be heard. While the exact settlement numbers have not been released by Johnson & Johnson, it is speculated that the company could lose millions.

What is the Reason for the Lawsuits?

The pelvic mesh lawsuits are flooding in from patients all over the country who have experienced severe side effects from the mesh. The claims are being made that Johnson & Johnson did not properly market the products, failing to cite the side effects that were caused by the product.

In a report by the Associated Press, Attorneys General Bob Ferguson of Washington and Kamala Harris of California accused the New Jersey-based health care giant of neglecting to tell patients and doctors about the risks and occurrences of dire, sometimes irreversible complications. Those include urinary dysfunction, loss of sexual function, constipation and severe pain. These side effects can make everyday activities such as walking up and down stairs, laying down, or exercising extremely painful.

In a Reuters article, it is stated that Johnson & Johnson sold more than 787,000 pelvic mesh devices in the United States from 2008 until 2014, including more than 42,000 in California. Also in that article, the Food and Drug Administration said it was reclassifying mesh used to treat pelvic organ prolapse trans-vaginally from class II, or moderate risk, to class III, for high-risk devices, which will require manufacturers to submit extensive data to establish the devices’ safety. Hopefully this increased scrutiny by the FDA will prevent something like this from happening again in the future.