Big Pharma News
Big Pharma: Indictment Reveals Kickbacks to Doctors
Five prominent New York doctors each have been charged with multiple felonies involving fraud and violations of the state’s Anti-Kickback Statute, according to an indictment unsealed March 16. The charges relate to the doctors’ allegedly accepting bribes and other benefits in exchange for prescribing the powerful pain medication Subsys, which contains fentanyl.
Each defendant faces up to 30 years behind bars if convicted. All five reportedly have pleaded not guilty.
The indictment alleges that the doctors accepted tens of thousands of dollars in “speaking fees” from the drug company Infosys in exchange for their prescribing Subsys to their patients. With a single prescription of Subsys costing as much as thousands of dollars per month, Infosys—Subsys’ maker—was highly motivated to get doctors to write as many prescriptions as possible. For example, Infosys is alleged to have paid Dr. Gordon Freedman over $300,000 in speaker fees, while the doctor wrote approximately $1.1 million in Subsys prescriptions.
Subsys was developed as a fentanyl-based spray to treat cancer pain. It was approved by the United States Food and Drug Administration (FDA) in January 2012, but it’s key ingredient—fentanyl—since has played a central role in the national opioid crisis, having been associated with many overdose deaths, often by users who were not aware that the drug they were taking contained fentanyl.
Insys itself has recently been subject to a flood of enforcement actions relating to its marketing practices, which are alleged to include kickbacks of the kind described in the five doctors’ felony indictment. Attorneys general from a number of states already have brought suits against Insys, including criminal charges against company executives such as founder John Kapoor.
Four of the five doctors—with the exception being Freedman—have also been charged with violating the Health Insurance Portability and Accountability Act by unlawfully disclosing patient information to Insys sales representatives. According to the indictment, in at least one instance, the private patient information provided to the Insys rep was provided for the purpose of obtaining prior authorization for a Subsys prescription from a patient’s insurance company.
Big Pharma: News and Updates
Big Pharma: Brand Name Drug Makers Can Be Liable For Generic Labels
In a victory for those seeking to hold Big Pharma accountable for the effects of its drugs—even in generic form—the Massachusetts Supreme Judicial Court ruled on March 16 that pharmaceutical companies can be held liable for labeling problems in the generic equivalents of their drugs.
Although the ruling provides an opening for plaintiffs, the Court did set a high legal hurdle for them to overcome, requiring that plaintiffs demonstrate that a drug maker acted recklessly—a more difficult standard to meet than negligence—in passing information about the drug onto makers of the generic equivalent. Although only applicable within Massachusetts, the ruling is particularly significant because the state houses the biggest bio-pharmaceutical hub in America.
The decision was opposed vigorously by pharmaceutical giant Merck & Co. as well as a number of drug-industry advocacy groups because it opens drug makers to liability not only from their own customers but from consumers of generic equivalents, as well. Meanwhile, consumer- and patient-rights advocates hailed the Supreme Judicial Court ruling as a step forward in holding drug makers fully accountable for the ill effects of their drugs even beyond terms of their exclusive patents, saying that the ruling will incentivize drug makers to fully disclose all available information about their drugs to generic makers.
Some legal observers have interpreted the Court’s decision at least in part as a response to the United States Supreme Court’s 2011 ruling in Pliva Inc. v. Mensing, which held that the makers of generic equivalents were essentially shielded from liability over labeling claims because federal law required the makers of generic equivalents to copy exactly the labels of the brand-name drug. Because the Court in its ruling did not also shift liability onto the maker of the brand-name drug, it created a legal gap for patients seeking recourse for harms caused by generic drugs. The Massachusetts Supreme Judicial Court decision fills this void somewhat, but while establishing the higher recklessness standard.
The instant case involved a plaintiff who claimed to have suffered erectile dysfunction, hypogonadism, and testosterone deficiency as a result of his taking a generic equivalent of Merck’s drug Proscar. The Supreme Judicial Court ruling reverses a lower court decision that had dismissed the case, which alleged that Merck had failed to warn via the copycat generic label.
Big Pharma: Profits Over People - Drug Patents
MDL’s have been formed on Eliquis, Ethicion’s Phyiomesh, the Stryker coCR V40 femoral heads and proton pump inhibitors Prilosec, Nexium, Protonix and Dexilant.
The attorneys at ThelawFirm.com have written many times about the lengths that Big Pharma will go to in order to protect their profits. It is our belief that these corporations consistently and frequently place their profits over the people that they are trying to ‘help’. This belief is not only backed up by our experience with these corporations but by the numbers. Some estimate that 2,000,000 to 4,000,000 people a year are injured in mass tort cases. There are approximately 230 MDL dockets in the US today with about 123,000 actions pending in 50 US District Courts. New MDL’s are created constantly. Recently, MDL’s have been formed on Eliquis, Ethicion’s Phyiomesh, the Stryker coCR V40 femoral heads and proton pump inhibitors Prilosec, Nexium, Protonix and Dexilant.
But there is another important way that Big Pharma makes money. That is through patenting drugs. These companies fight hard to keep these patents. However, there are also many companies that want to make a generic version. The law in the US has a process for sorting out who gets to make the drug. Recently, for example, the U.S. Patent Trial and Appeal Board ruled that a patent for Johnson & Johnson’s Zytiga prostate cancer drug described an ‘obvious process’. This ruling invalidated the last remaining patent blocking Argentum Pharmaceuticals LLC from making a generic version of Zytiga. Zytiga made over $2.2 billion in sales in 2016.
The Board said that the patent that covers Zytiga’s chemical combination for fighting prostate cancer could have been developed using prior patents. The Board said that anyone experienced in pharmaceutical research could have figured out how to combine the chemicals to make it work.
Johnson & Johnson argued that Zytiga’s success in the market and the failure of others to match that success was evidence the drug could not have been obviously developed by just anyone.
The amount of money at stake shows exactly why, in our opinion, Big Pharma is willing to do whatever it takes to get drugs onto the market and keep them there. Drug companies fighting among themselves for the profits is only way that the concept of ‘profits over people’ manifests itself.
Big News In The Fight Against Big Pharma
On December 21, 2017 the Supreme court of California in T.H. v. Novartis Pharmaceuticals Corporation ruled that consumers can file lawsuits against makers of brand-name pharmaceutical products when it is alleged that generic versions of the drugs manufactured by other companies are what caused injuries to the Plaintiff. The lawsuit centered on two twin children who were diagnosed with developmental delays and autism after their mother took a generic version of Brethine to suppress premature labor.
This is significant news regarding the ability to hold Big Pharma accountable. After all, generics are based on the formula and the research and development done in Big Pharma labs. Since they created the pharmaceutical, why should they not be responsible for any injury or death caused by the progeny of the drug?
This decision is the only one in the United Sates where a state’s top court has ruled in favor of consumers who were prescribed generic drugs, and have legally been prevented from filing suit against generic drug makers for not warning about their products’ risks.
Thus, the ruling has probably created massive exposure for brand-name drug makers who can now be sued in California for failing to warn users about the risks of cheaper, generic versions of their drugs. The attorneys at TheLawFirm.com see this decision as a huge victory for public health and safety.
The defendant in the case, Novartis, said it disagrees with the court’s decision to potentially hold it responsible for an injury caused by a different company’s product. This has been the primary defense of Big Pharma when defending themselves from legal claims against generic makers of the products that Big Pharma brought to the marketplace originally.
Indeed, Novartis argued its duty to warn consumers did not cover those taking generics and that a contrary ruling would effectively make it the market’s insurer.
The court disagreed. Justice Mariano-Florentino Cuéllar wrote that brand-name manufacturers are the only entities with the ability to strengthen a warning label. The Court stated that we “find that brand-name drug manufacturers have a duty to use ordinary care in warning about the safety risks of their drugs, regardless of whether the injured party (in reliance on the brand-name manufacturer’s warning) was dispensed the brand-name or generic version of the drug. We also conclude that a brand-name manufacturer’s sale of the rights to a drug does not, as a matter of law, terminate its liability for injuries foreseeably and proximately caused by deficiencies present in the warning label prior to the sale.
As California based attorneys with a nation-wide practice focusing on bad drugs and defective medical devices, we applaud this decision. We will continue to try and hold big Pharma accountable when they injured innocent Americans.
Doctors Given More Than $8 Billion by Drug and Medical Device Companies
The federal government’s Open Payments initiative has revealed that the makers of drugs and medical devices paid $8.2 billion in 2016 to doctors and teaching hospitals for the marketing and research of their products. The sum includes more than $2 billion in disputed payments.
$2.8 billion went to speaker fees, consulting, travel, meals, and gifts; $4.4 billion for research payments; and $1 billion was paid in the form of ownership interests (e.g., shares of stock) in the companies.
Almost 1500 companies made payments, though the great majority was from just a few dozen corporations. Pharmaceutical and medical-devices giants such as Genentech ($534 million), Novartis ($471 million), Pfizer ($475 million), AstraZeneca ($270 million), Merck ($302 million), and AbbVie ($171 million) led the pack in spending.
Recipients of the money included more than 600,000 physicians and more than 1100 teaching hospitals.
The goal of the Open Payments initiative, an arm of the Affordable Care Act, is to make transparent the agreements between doctors and drug/device manufacturers.
If you believe that your health has been compromised by the dealings between doctors and drug and device manufacturers, TheLawFirm.com wants to help you.