The Dallas-based law firm Fears Nachawati has been retained by the Calvert County Board of County Commissioners in Maryland to pursue a lawsuit against opioid manufacturers and distributors over their role in the epidemic of addiction to these painkillers, the firm said in a release.

Representing the southern Maryland county is a legal consortium that features Matthew McCarley and Jonathan Novak of Fears Nachawati, along with attorneys from Ferrer, Poirot & Wansbrough in Dallas; Motley Rice in Washington, D.C.; and The Kane Law Group and McNamee, Hosea, Jernigan, Kim Greenan & Lynch in Maryland.

Just southeast of the Washington, D.C., metropolitan area, Calvert County has seen its public resources overburdened by the societal, health and public safety demands created by the reckless proliferation of prescription opioids, plaintiffs say.

“The opioid epidemic has continued at a horrifying pace, taking a tremendous human toll and creating intense financial and social services pressures on local governments such as Calvert County,” said McCarley. “There is no single, simple solution, but recovery cannot begin until those who knowingly created the problem are held responsible for their actions.”

Fears Nachawati currently represents 61 counties, cities and hospital systems in Texas, Florida, Kentucky, Maryland, Mississippi, New Mexico and North Dakota in lawsuits seeking to hold 30 of the nation’s largest pharmaceutical manufacturers and distributors liable for their role in the opioid addiction crisis that resulted from deceptive and illegal marketing schemes.

“While we fight to recover some of the financial costs related to the public health emergency caused by the overuse of prescription opioids, this is also about stopping these illegal and unethical practices,” said Novak.

Fears Nachawati trial lawyer Jonathan Novak will be a featured speaker at a continuing legal education conference in Austin exploring legal issues surrounding the opioid epidemic.

The May 8 Opioid Litigation Conference, hosted by HarrisMartin Publishing, is titled “The State Court Case Against the PBMs, Retailers and Distributors.” Novak is scheduled to present the 11:15 a.m. seminar “Roadmap for Applying DEA Retail Pharmacy Regulation Strategy to State Claims,” a general discussion on distributor liability theories in the opioid litigation.

A former litigator with the U.S. Department of Justice, Novak’s work focused on controlled substance regulation, policy and compliance, including prosecuting opioid cases and working with the federal ARCOS database, which collects information on controlled substances transactions involving manufacturers and distributors, the firm said in a release.

At the Austin Opioid Litigation Conference, Novak also will participate in the 1:30 p.m. roundtable discussion on ARCOS data.

Novak played a role in an investigation detailing how opioid distributors worked with a handful of lawmakers to push through a law that stripped the Drug Enforcement Administration of its authority. After leaving the DEA, he took part in a high-profile opioid investigation that exposed the slowdown of DEA enforcement and the influence of pharmaceutical companies over agency investigations and prosecutions. His work was featured on “60 Minutes” and in The Washington Post.

Dallas attorney Jeffrey Simon says U.S. Surgeon General Jerome Adams’ call for more Americans to carry the opioid antidote naloxone is one that could save countless lives, and play a key role in addiction recovery.

“Naloxone should be widely available and at the ready for emergency medical personnel, people who are opioid addicts, or people who live with opioid addicts. I equate having naloxone at the ready to having a CPR kit at the ready — both can save lives as emergency care if administered in time,” says Simon of Simon Greenstone Panatier Bartlett, P.C.

“Unfortunately, it’s easy for anyone to overdose on opioids, so we are not just talking about saving the lives of addicts. But when we speak of opioid addicts, we need to remember that addiction is a disease. We want addicts to get into recovery, and if they die from an overdose, that can’t happen. Keeping them alive long enough for them to make headway with addiction treatment is crucial, and naloxone is often a key component to achieving that goal,” he says.

Simon Greenstone and co-counsel collectively represent more than 40 counties in Texas as well as other states in opioid litigation.

Compliancy Group will present a webinar on HIPAA compliance. The event will be Tuesday, Oct. 17, at 2 p.m. EDT.

“Through the years of helping the Healthcare industry become HIPAA compliant and pass their HIPAA audits, we continually run into the same HIPAA compliance issues and questions,” the company says on its website. “In this webinar we will run through a HIPAA compliance checklist of what needs to be done for your organization to meet the Federal Requirements. All attendees will receive a FREE personal walk through of their organization and to answer all their questions, concerns and to focus you on what your organization needs.”

Questions discussed include:

• What do I need to do to become HIPAA compliant?
• I’ve done my Security Risk Assessment, now what?
• Is there a such thing as overkill when it comes to HIPAA?
• Can you automate HIPAA compliance completely?
• Is group or individual training sufficient?

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In a new article, Covington’s global cross-practice Digital Health team considers some key questions that companies across the life sciences, technology, and communications industries should be asking as they seek to fit together the regulatory and commercial pieces of the complex digital health puzzle.

In this installment in the three-part series, Covington’s team discusses the questions:

1. Will you own or have rights to use the data that is collected and generated, and any insights, models, and algorithms that are developed?

2. Do you have commitments from your suppliers to provide functions at service levels suitable for the health sector and designed to maintain patient/user trust?

3. When you are structuring strategic collaborations to develop and deliver a digital health service, have you taken into account uncertainties as to the ultimate composition of the service, its customers, and its reimbursement model?

Read the article.

Compliancy Group will present a free webinar on HIPAA compliance, titled “The 30-Minute Guide to Understanding Compliance.”

The event will be Tuesday, June 27, at 2 p.m. EDT.

In this webinar, the goal is to break down HIPAA compliance by walking you through the Regulation since the moment it was enacted in 1996, Compliancy Group says on its website.

“Through the years HIPAA regulation has undergone significant change, and the need to understand the Regulation has as well.

“Though it was once just another regulation, HIPAA has become a cultural issue for health care organizations of all kinds, affecting how to run a practice and the means of doing business. Join us through this timeline of HIPAA compliance and a how it pertains to you as a Covered Entity or Business Associate,” the site adds.

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A recent decision of the Arizona Court of Appeals provides guidance for evaluation of the enforceability of arbitration agreements in the health care field, reports Snell & Wilmer in its Health Law Checkup blog.

Andrew Sniegowski explains that Gullett v. Kindred Nursing Centers West, LLC arose out of the plaintiff’s claims that a rehabilitation center had abused and neglected his father, who lived there for the last month of his life. The plaintiff argued that the arbitration agreement was substantively and procedurally unconscionable.

The court determined that the agreement was substantively valid, but it remanded the case for further proceedings in the trial court limited to the issue of procedural unconscionability.

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Healthlaw Publishing announces the upcoming release of Healthcare and the False Claims Act, 2016 Survey. Registration is available now for free downloading of the survey report.

Healthcare and the False Claims Act, 2016 Survey summarizes the important laws, regulations, pronouncements, and cases of the past year, to inform healthcare providers and healthcare attorneys on this crucial statute in the healthcare industry.

On Dec. 14, 2016, the United States Department of Justice announced the recovery of more than $4.7 billion in False Claims Act (“FCA”) settlements and judgments. It was the third-highest total in history, and more than $2.5 billion came from the healthcare industry. During the eight years of the Obama Administration, the Department of Justice recovered more than $31 billion in FCA settlements and judgments, taking more than $19.3 billion from healthcare providers and other participants in the healthcare industry.

2016 was a pivotal year for the FCA. It was the year of a tremendously important Supreme Court decision that could expose healthcare providers to whole new areas of FCA liability based upon state and federal regulations. The penalties were more than doubled to a minimum of more than $11,000 per claim and a maximum of more than $22,000 per claim, massively increasing both the risk of litigation and the likelihood of settling FCA cases even in the absence of wrongdoing. And it saw a new focus on the investigation and even the criminal indictment of individuals involved with entities sued under the FCA. 2016 also saw new regulations and new court interpretations of laws first put in place in 2009 and 2010 to turbocharge the FCA and encourage greater participation by whistleblowers.

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In 2016, two federal juries in Dallas delivered significant verdicts on behalf of the victims of serious medical complications caused by defective metal-on-metal hip implants made by Johnson & Johnson and its subsidiary DePuy Orthopaedics Inc., according to a post by the plaintiffs’ legal counsel, The Lanier Law Firm.

Although the court has reduced the amount of punitive damages awarded by the juries in each case, and those judgments are under appeal by The Lanier Law Firm, the two verdicts still total almost $700 million in actual and punitive damages assessed against Johnson & Johnson and DePuy.

In the post, the firm said these verdicts marked the second and third bellwether trials among thousands of similar lawsuits nationwide that have been consolidated in multidistrict litigation (MDL 3:11-md-0244) in the U.S. District Court for the Northern District of Texas. A bellwether trial is one that is typically representative of all the issues involved in the litigation of a mass tort case.

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NBC News is reporting that about 18 million people would lose or drop their health insurance in the first year after Obamacare is repealed, the Congressional Budget Office reported Tuesday.

“The nonpartisan federal agency also found that health insurance premiums would spike another 20 to 25 percent, according to the new report. Within 10 years, 32 million more people would be without health insurance, the CBO projects,” writes Maggie Fox.

The report’s projections are based on the repeal law passed in the House of Representatives last year, using a budget-based process called reconciliation, the same process that Congress is working on now.

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A federal jury in Dallas ordered Johnson & Johnson and one of its subsidiaries to pay more than $1 billion in damages Thursday for “despicable and vile conduct” in selling Pinnacle metal-on-metal hip implants that they knew were seriously defective, reports The Dallas Morning News.

The New Jersey pharmaceutical and medical device maker and its DePuy Orthopaedics subsidiary must pay damages to six California plaintiffs who say they suffered serious chronic and painful medical problems caused by the device.

“The trial was the third in a series of bellwether cases being held by U.S. District Judge Ed Kinkeade,” reports Mark Curriden of Texas Lawbook for The Morning News. “More than 8,900 cases against Johnson & Johnson and DePuy have been filed across the U.S. The lawsuits have been consolidated in what is known as multi-district litigation.”

Read The Morning News article.

U.S. prosecutors are bearing down on generic pharmaceutical companies in a sweeping criminal investigation into suspected price collusion, a fresh challenge for an industry that’s already reeling from public outrage over the spiraling costs of some medicines, reports Bloomberg.

David McLaughlin and Caroline Chen write that the antitrust investigation by the Justice Department spans more than a dozen companies and about two dozen drugs. A grand jury is examining whether some executives agreed with one another to raise prices, and the first charges could emerge by the end of the year, sources told the reporters.

“Among the drugmakers to have received subpoenas are industry giants Mylan NV and Teva Pharmaceutical Industries Ltd. Other companies include Actavis, which Teva bought from Allergan Plc in August, Lannett Co., Impax Laboratories Inc., Covis Pharma Holdings Sarl, Sun Pharmaceutical Industries Ltd., Mayne Pharma Group Ltd., Endo International Plc’s subsidiary Par Pharmaceutical Holdings and Taro Pharmaceutical Industries Ltd.,” according to the report.

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A law firm in Montgomery, Ala., says it received nearly 26,000 phone calls from people inquiring about a possible link between talcum powder and ovarian cancer after its clients won a total of $127 million in two verdicts earlier this year, reports AL.com.

Beasley, Allen, Crow, Methvin, Portis & Miles, P.C. reported 12,221 open cases from the 25,916 calls it had received as of Thursday. In a statement, the firm said it now has 867 cases filed nationwide against Johnson & Johnson regarding talcum powder products, which plaintiffs have claimed are linked to cases of ovarian cancer.

“In February a City of St. Louis Circuit Court jury awarded the family of Jacqueline Fox $72 million, finding Johnson & Johnson liable for her ovarian cancer that led to her death,” reports Kent Faulk of AL.com. “In May another jury in St. Louis found Johnson & Johnson liable for ovarian cancer linked to genital use of its talcum powder products and awarded a South Dakota woman, Gloria Ristesund, $55 million.”

“Though it’s been discussed as a hypothesis and carefully studied for decades, there is no proven linkage between talc and ovarian cancer,” Gene Williams, outside counsel for Johnson & Johnson, told Legal NewsLine.

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Elizabeth Holmes

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Fox Business is reporting that Theranos Inc. has withdrawn its request for emergency clearance of a Zika-virus blood test after federal regulators found that the company didn’t include proper patient safeguards in a study of the new test.

“The move is another setback for the Palo Alto, Calif., company as it tries to recover from crippling regulatory sanctions that followed revelations by The Wall Street Journal of shortcomings in Theranos’s technology and operations,” Fox Business reports. “Theranos has said it is appealing.”

Elizabeth Holmes, founder of the troubled company, recently announced development of a new blood-testing device that she said was designed for use outside a clinical laboratory and could run accurate tests from a few drops of blood.

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Two former executives of Acclarent Inc, a medical device company bought by Johnson & Johnson in 2010, were convicted on Wednesday by a U.S. jury on charges of promoting a product for an unapproved use, Reuters is reporting.

Prosecutors said former Acclarent Chief Executive William Facteau and former Vice President of Sales Patrick Fabian were found guilty in federal court in Boston of 10 misdemeanor counts of violating the U.S. Food, Drug and Cosmetic Act. The counts each carry a maximum prison sentence of one year.

But the jury acquitted the two defendants of felony charges of wire fraud and conspiracy, finding they did not act with intent to defraud or mislead.

“In an indictment unsealed last April, federal prosecutors said that beginning in 2006 or earlier, Facteau, 47, and Fabian, 49, promoted Acclarent’s Relieva Stratus Microflow Spacer device to deliver steroid medications to patients’ sinuses, though it was only approved by the U.S. Food and Drug Administration for keeping sinuses open,” reports Brendan Pierson for Reuters.

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The U.S. Department of Justice has filed lawsuits to block the proposed mergers of four of the nation’s five biggest health insurers, reports The New York Times.

The proposed mergers involve Aetna and Humana, and Anthem and Cigna.

U.S. Attorney General Loretta E. Lynch said the proposed mergers “would leave much of the multitrillion-dollar health insurance industry in the hands of three mammoth insurance companies.”

“If these mergers were to take place, the competition among insurers that has pushed them to provide lower premiums, higher-quality care and better benefits would be eliminated,” she said.

“The companies responded by vowing, in varying degrees, to fight the government’s challenge,” report Leslie Picker and Reed Abelson. “Aetna, which had hoped to gain an advantage by being the first to reach a deal, aggressively defended its proposed merger, which it contended was different from the larger Anthem-Cigna deal that followed.”

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Theranos Inc.’s Chief Executive Officer Elizabeth Holmes was banned for two years from owning or operating laboratories by U.S. regulators, a major blow against the controversial blood-testing startup that’s come under scrutiny for risking patient harm with unreliable tests, reports Doni Bloomfield for Bloomberg Technology.

“The once high-flying Silicon Valley company was also penalized for an undisclosed amount and lost its eligibility to get payments from federal health insurance programs for lab services, according to a statement late Thursday from Theranos, citing a notice it received from the Centers for Medicare and Medicaid Services,” the report says. “The closely-held firm is shutting down its Newark, California, lab and plans to rebuild it, Holmes said.”

The company founded by Holmes at one time had a $9 billion private valuation, based on technology that it said would allow for cheap, less-painful blood tests processed with breakthrough analyzers. Regulators soon stepped in, citing violations that put patients’ health and safety at risk.

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Atlanta-based LabMD was a successful company that tested blood, urine, and tissue samples for urologists, and had about 30 employees and $4 million in annual sales. Then one day in 2008, the company’s general manager received a phone call from a man who claimed to be in possession of a file containing LabMD patient information, including more than 9,000 Social Security numbers, reports Bloomberg.

Then came the sales pitch: His company, Tiversa, offered an investigative service that could identify the source and severity of the breach that had exposed this data and stop any further spread of sensitive information — at a cost of about $38,000. After some back-and-forth, LabMD told Tiversa to direct all communication through its lawyers. Then the Federal Trade Commission came calling.

LabMD’s woes could end up finishing off the once-promising business.

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Elizabeth Holmes
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Federal prosecutors have launched a criminal investigation into whether Theranos Inc. misled investors about the state of its technology and operations, according to people familiar with the matter, The Wall Street Journal is reporting.

Walgreens Boots Alliance Inc. and the New York State Department of Health have received subpoenas in recent weeks seeking documents and testimony about representations made to them by the Palo Alto, Calif., blood-testing company, some of the people said.

Theranos once claimed it had made “breakthrough advancements” that made it possible to run “the full range” of lab tests on a few drops of blood pricked from a finger. But some regulators and former employees have voiced doubt about the tests.

“Theranos was valued at $9 billion in a funding round in 2014 and the majority stake of Elizabeth Holmes, the startup’s founder and chief executive, at more than half that,” The Journal reports.

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Abbott Laboratories didn’t cause medical providers to submit false payment claims to Medicare for unapproved stents, a Texas jury ruled, thwarting a whistle-blower’s lawsuit seeking as much as $1 billion, reports Bloomberg.

A former salesman for Abbott’s predecessor Guidant claimed the company pushed bile duct stents that were intended for short-term purposes for more complex vascular use. His 2006 lawsuit on behalf of the U.S. government accused the company of encouraging doctors and hospitals to code bills to Medicare falsely.

“Abbott, which acquired Guidant’s stent business in 2006, denied during the trial in Dallas federal court that it induced anyone to submit false claims to Medicare. Its lawyers told jurors the use of biliary stents for peripheral vascular or arterial disease was accepted medical practice and Medicare knowingly approved payments,” Bloomberg reports.

Read the article.