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OIG Issues Rare Special Fraud Alert Targeting Pharmaceutical and Medical Device Speaker Programs

The U.S. Department of Health and Human Services’ Office of Inspector General (OIG) issued a Special Fraud Alert on fraud and abuse risks “associated with the offer, payment, solicitation, or receipt of remuneration relating to speaker programs by pharmaceutical and medical device companies.” The OIG generally defines speaker programs as company-sponsored events at which a physician or other health care professional (HCP) “makes a speech or presentation to other HCPs about a drug or device product or a disease state” on behalf of a manufacturer.…  

FDA Approves First COVID-19 Drug: Veklury

The Food and Drug Administration (FDA) approved the first drug for the treatment of COVID-19. The antiviral drug Veklury (remdesivir), manufactured by Gilead Sciences Inc., is approved for use in hospitalized adult and pediatric patients 12 years of age and older. Veklury was previously issued as an emergency use authorization (EUA) in May 2020 following the National Institutes of Health’s clinical trial, which showed promising results in battling COVID-19. Under the Federal Food, Drug, and Cosmetic Act, approval of a new drug product requires substantial…  

FDA Issues Warning Letter for Off-Label Promotion of Drug to Treat COVID-19

The Food and Drug Administration (FDA) recently issued a warning letter to the manufacturer of an approved prescription drug for an off-label use to treat COVID-19 symptoms. Off-label use is defined as an approved prescription drug for unapproved conditions, patient groups, or dosages. While the FDA has previously pursued hundreds of fraudulent COVID-19 products, this appears to be the first warning letter addressing the unapproved use of an FDA-approved drug to treat patients with COVID-19. Currently, there are no FDA-approved COVID-19 products on the…  

State Law Negligence COVID-19-Related Claims Do Not Fall within PREPA’s Preemptive Scope; Do Not Mandate a Federal Forum

A New Jersey District Court has held that state law claims such as negligence, wrongful death, and medical malpractice are not preempted by the Public Readiness and Emergency Preparedness Act (PREPA) and does not create a basis for federal jurisdiction―resulting in a remand of two cases back to a New Jersey state court. We previously wrote about PREPA and the scope of the March 17, 2020, declaration by the Secretary of Health and Human Services providing civil liability immunity to manufacturers, distributors, and state-licensed health…  

GOP Introduces Bill Creating Broad Civil Immunity for COVID-19 Lawsuits

We previously discussed whether Senate Republicans would propose federal liability immunity in the next COVID-19 relief bill. On July 27, 2020, Sen. John Cornyn (R- TX), introduced the SAFE TO WORK (Safeguarding America’s Frontline Employees to Offer Work Opportunities Required to Kickstart the Economy) Act, Section 4317, which would provide broad liability immunity for businesses, health care workers and facilities, educational institutions, and local governments. Sen. Cornyn claims that this bill “would protect those acting in good faith from being sued into oblivion while…  

FDA Moves to Stop Subpar KN95 Respirators from Being Sold in the U.S.

The Food and Drug Administration (FDA) is warning health care workers and other medical first responders about defective KN95 respirators imported from China for failing to meet a minimum particulate filtration efficiency of 95 percent in National Institute for Occupational Safety and Health (NIOSH) testing. This move is a part of the broader effort by the FDA to combat the sale of fraudulent COVID-19 products. The FDA first allowed the import of Chinese-made KN95 respirators on April 3, 2020, by issuing an emergency use  

FDA’s Efforts to Monitor Manufacturers of COVID-19 Products

The Food and Drug Administration (FDA) provided an update on its efforts to combat the sale of fraudulent products during the COVID-19 pandemic through written testimony before the U.S. Senate Subcommittee on Manufacturing, Trade, and Consumer Protection on July 21, 2020. The FDA has uncovered more than 780 fraudulent COVID-19 products, including substandard personal protective equipment (PPE), diagnostic tests, and purported vaccines being offered for sale. The FDA found that the Internet is the primary mechanism for the sale of fraudulent COVID-19-related products, which presents…  

FDA Authorizes First COVID-19 At-Home Sample Collection Kit Authorized For Use With Multiple Tests

Diagnostic testing for SARS-CoV-2 is a key tool in the combat against the COVID-19 pandemic. Since the Secretary of Health and Human Services declared a public emergency on January 31, 2020, calling for the entire country to aid in response to the COVID-19 outbreak, the U.S. has had low diagnostic testing rates due to a lack of testing capabilities. In order to improve access to testing, the U.S. Food and Drug Administration (FDA) recently granted an emergency use authorization to Everlywell, Inc. for an at-home…  

Will Lawmakers Provide Immunity to Businesses from COVID-19 Lawsuits?

As state and local governments take steps toward reopening the economy, business owners are rallying around the issue of liability immunity from COVID-19 lawsuits and organizing efforts aimed at pressuring federal and state lawmakers to enact legislation limiting liability from lawsuits filed by workers and customers infected by COVID-19. The stakes are high. Because the complete clinical picture regarding COVID-19 is not fully understood, big and small businesses alike are targets for opportunistic lawsuits. When symptoms may not develop for days after the fact, just…  

PREPA Extends Liability Immunity to Manufacturers of Component Parts and Suppliers of Raw Material Suppliers Used in COVID-19 Countermeasures

With the COVID-19 outbreak spreading across the globe, there is a shortage of critical medical supplies such as ventilators, test kits, and personal protective equipment (PPE). Component part manufacturers and raw material suppliers have scaled up production to help medical device and pharmaceutical manufacturers eliminate critical shortages. Components and raw materials are also being supplied to non-medical companies like General Motors, Tesla, and Dyson, who have repurposed their factories to make unfamiliar products like ventilators and face shields. To head off the inevitable wave of…  

Liability Immunity Now Extended to Manufacturers of Any NIOSH-Approved Respirator Used as a COVID-19 Countermeasure, Including Those Not Intended for Medical Applications

As the COVID-19 pandemic stresses the U.S. health care system, personal protective equipment such as personal respirators are in desperately short supply. Healthcare providers are repurposing respirators originally designed for non-medical use to combat the COVID-19 pandemic. This practice raises the question as to whether manufacturers of non-medical respirators qualify for liability immunity under the Public Readiness and Emergency Preparedness Act (PREPA). We previously wrote about PREPA and the March 17, 2020 declaration by the Secretary of Health and Human Services providing liability immunity to…  

The Shifting Landscape of Marijuana Law

Trial attorneys are somewhat like first responders, meaning that it is frequently only after a lawsuit has been filed and litigated that lawmakers step in to enact statutes and regulations governing the subject activity or conduct. This is apparent in the nascent cannabis industry. A prime example is the recent line of cases dealing with competing land use rights of marijuana growers and their neighbors. In Momtazi Family, LLC v. Wagner, Et Al.[i],  pending in the Eastern District of Oregon, the parties are…  

CBD, THC, and the Hazy Boundaries of Product Labeling in the Cannabis Industry

Cannabis is a dynamic plant with tens of thousands of known applications, from clothing and paper to food and medicine. While cannabis has been cultivated for many purposes over thousands of years, much of the recent attention has been on the chemical compounds that are predominant within certain species of the genus, most notably Δ-9-tetrahydrocannabinol (THC) and cannabidiol (CBD). Of course, THC is known for producing the high that users experience when they smoke cannabis. CBD, on the other hand, does not produce a high…  

Big Cannabis, Priority Applicants, and Social Equity in the Budding Marijuana Industry

The city of Cambridge, Massachusetts recently passed an ordinance prohibiting existing medical marijuana dispensaries from engaging in the sale of recreational marijuana for two years.[1] Specifically, the ordinance gives priority to economic empowerment applicants, defined under the state’s Cannabis Control Commission as businesses that are owned by, serve, or reside in areas disproportionately impacted by high amounts of drug-related arrests, including businesses owned by individuals of Black, African American, Hispanic, and Latino descent.[2] For the first two years after the Cambridge ordinance’s enactment,…  

FDA and FTC Continue to Warn CBD Companies about Unlawful Marketing Claims

Last week, the United States Food and Drug Administration (FDA), in conjunction with the Federal Trade Commission (FTC), issued a warning letter to Rooted Apothecary, LLC in Florida for unlawfully marketing products containing cannabidiol (CBD). The warning letter specifically addresses unsubstantiated claims that the company’s products treat teething pain, ear aches in infants, autism, attention deficit disorders, and Parkinson’s and Alzheimer’s disease. Despite the FDA’s promises to explore potential pathways for the lawful marketing of various CBD products, it has yet to publish any specific…  

Kenney v. Helix TCS, Inc.: Leveling the Playing Field in the Marijuana Industry and Beyond

Are employers in the marijuana industry excused from complying with federal law because their business practices are federally prohibited? In the recent case of Robert Kenney v. Helix TCS, Inc.[i], the U.S. Court of Appeals for the Tenth Circuit answered that question with an unequivocal “no.” The plaintiff in that case, Robert Kenney, was a former security guard for the defendant, Helix TCS, Inc., a private company that provides security services to businesses in Colorado’s state-sanctioned marijuana industry. Kenney alleged that he…  

Ketamine: Another Pandora’s Box or Viable Treatment for Pain?

In the wake of the opioid crisis, some physicians are seeking to utilize ketamine, a highly addictive drug, to treat chronic pain and depression. Ketamine is a generic name for Ketalar (ketamine hydrochloride) and belongs to a class of drugs known as dissociate anesthetics. Ketamine’s FDA label warns of the potential emergence of psychological issues with potentially dangerous drug interactions with barbiturates and narcotics. Ketamine has already proven its high potential for abuse and is well-known as a “recreational drug,” “club drug,,” and “date rape…  

DEA Breaks Silence on Marijuana Grower Applications

We previously reported on a unique lawsuit filed this summer by Scottsdale Research Institute, LLC (SRI) against the Drug Enforcement Administration (DEA). By filing a petition for writ of mandamus, SRI sought to compel the DEA to take action on its application to grow cannabis for clinical research, which was filed in 2016. With a deadline to respond to SRI’s petition looming just two days away, the DEA announced on Monday that it is “providing notice of pending applications from entities applying to be…  

DEA Court Ordered to Address Silence on Marijuana Research Applications

In 2016, the Drug Enforcement Administration (DEA) announced that it would be adopting a new policy designed to increase the number of entities that could manufacture marijuana for the use in federally approved research. However, despite receiving at least two dozen applications to grow research marijuana since that announcement, to date the University of Mississippi still holds the only license to manufacture marijuana for research in the United States. Although, that may finally be about to change. Last month, the Scottsdale Research Institute, LLC (SRI)…  

Alcoholic Beverages with CBD Will Have to Wait

The passage of the 2018 Farm Bill modified the Controlled Substances Act to exclude hemp from the definition of marijuana. With the deschedulization of hemp, cannabidiol (CBD), which is derived from hemp, has had quite the boom. CBD infused products seem to be popping up everywhere and are a hot commodity in the wellness industry in particular. However, with the recent guidance from the Alcohol and Tobacco Tax and Trade Bureau (TTB), it appears producers of alcoholic beverages are still going to have to wait…  

Edible Cannabis: Coming to a Dispensary Near You in Florida

Medical marijuana continues its eventful 2019 in the Sunshine State. Mere weeks after Governor Ron DeSantis signed a bill ending Florida’s ban on smokable medical marijuana, the Florida Legislature pushed back on the industry. A February house bill that sought to legalize recreational cannabis died without a hearing or a vote, the House Appropriations Committee rejected an amendment that would have allowed medical marijuana to treat opioid addiction, and, despite the lack of public support, the Legislature proposed a bill that would place caps on…  

A Potential Rise in Toxic Tort Litigation: Pesticide Use on Cannabis

As more states enact medicinal and adult recreational cannabis laws each year, we are likely to see growing litigation in the toxic torts arena. Health officials have warned about the potential hazards to consumers’ health from cannabis that has been treated with chemical pesticides. The risks may vary depending on how the product is consumed, whether eaten, smoked, vaped, or dermally applied. So far, given the federal ban on marijuana, there are no pesticide products that have been approved on the federal level specific to…  

Florida Seeks to End Ban on Smoking Medical Marijuana

On Tuesday, February 12, 2019, the Florida House’s Health and Human Services Committee considered a new bill that would allow medical marijuana patients to receive their prescription in smokable form.  The Committee voted in favor of the bill, with only two votes in opposition, and it will now head to the appropriations committee as it moves closer to a vote. After Florida voted to legalize medical marijuana in 2016, then Governor Rick Scott signed the bill into law while putting into place a ban on…  

Litigation is the Pits – Claim Dismissed for Injuries Caused by Natural Food Substance

“A lady bit down on a pit in an olive …” may sound like the opening line to a bad joke, but the defendant she sued for her injuries with the help of an injury lawyer from https://www.braininjurylawyersorangecounty.com/ appears to have had the last laugh. The plaintiff filed a personal injury claim with the help of a personal injury attorney from www.kwdllp.com/workplace-accidents/ against the defendant in California state court for products liability and pursued theories of strict liability, negligence and breach of an express written…  

Michael Hamilton to Speak at Perrin Conferences on Opioid Litigation

Join Goldberg Segalla’s Michael A. Hamilton at Perrin Conferences Opioid Litigation Conference in Dallas, TX on Thursday June 28, 2018. This one-day conference covers medical perspectives on opioid prescription practices, opioid-related litigation across state courts, and more. Register here. 

Third Circuit Affirms Summary Judgment for Pfizer in Zoloft MDL

A Third Circuit Court of Appeals panel recently upheld a lower court’s decision to dismiss plaintiffs’ claims at summary judgment in a multi-district litigation involving Zoloft, an anti-depressant manufactured by Pfizer. The MDL involved 315 plaintiffs alleging that Zoloft causes cardiac birth defects when taken during early pregnancy. The decision, which upheld an earlier ruling by the U.S. District Court for the Eastern District of Pennsylvania, has both good and bad aspects for defendants facing pharmaceutical product liability claims. The plaintiffs introduced several expert witnesses…  

Plaintiffs’ Product Case Trumped by the Learned Intermediary Doctrine

A large pharmaceutical manufacturer recently won a fundamentally important victory both within the mass tort it is facing and for all life science companies needing to rely upon the learned intermediary doctrine. In the consolidated litigation proceeding in New Jersey state court, the plaintiffs’ claim the manufacturer failed to properly warn its users of known gastro-intestinal complications associated with the drug. Relying on the learned intermediary doctrine, the judge granted the manufacturer summary judgment in some cases because the treating physicians testified they prescribed the…  

Illinois Federal Court Considers Whether Plaintiff Expert’s Methodologies Were Sufficiently Reliable under Daubert in a Pharmaceutical Case

GlaxoSmithKline has attempted to knock out the plaintiff’s experts in Dolin v. GlaxoSmithKline, in its latest round of Daubert motions. Wendy Dolin is suing GSK after the suicide death of her prominent lawyer husband, who had been taking the generic form of Paxil, paroxetine, an antidepressant.  This case made national news just a year ago when Judge Zagel of the Northern District of Illinois held that GSK could be liable for Dolin’s death under a negligence theory, not a product liability theory, even though…  

Drug Promotion on Social Media By Consumers: Can It Be Regulated?

Kim Kardashian recently used social media to promote the use of a prescription drug. In her Instagram post, Ms. Kardashian told her followers that a physician recommended use of the drug Diclegis to alleviate her symptoms of morning sickness. Ms. Kardashian is not the only public figure to recently deal with morning sickness as the Duchess of Cambridge also dealt with this issue, reported here. Having experienced positive results following the use of this drug, Ms. Kardashian posted her intent to pair with the  

Recent Philadelphia Verdict Highlights Need to Combat Punitive Damages

In the Philadelphia Court of Common Pleas, a jury recently awarded the plaintiff $2.3 million in compensatory damages for injuries he alleged arose from his use of a diabetes treatment drug.  The plaintiff claimed that the drug company failed to properly warn that its use was linked to a higher incidence of bladder cancer, a condition he subsequently developed.  In addition to awarding a compensatory sum, the jury awarded $1.3 million in punitive damages, apparently based upon evidence that the company’s pharmaceutical reps were instructed…  

Pennsylvania Supreme Court Overrules Azzarello But Declines Opportunity To Adopt Restatement Third of Torts

On November 19, 2014, the Pennsylvania Supreme Court issued its much-anticipated decision in  Tincher v. Omega Flex, Inc.Having originally granted allowance of appeal to decide whether to replace the strict liability analysis of Section 402A of the Restatement Second, Pennsylvania’s highest court declined the opportunity and instead overruled  its 1978 ruling in Azzarello vs. Black Brothers, 391 A.2d 1020 (Pa. 1978). The four justice majority opinion (available here), written by Chief Justice Ronald D. Castille, held that Pennsylvania will continue to apply…  

Alabama Supreme Court Decision Lends Support to Plaintiffs’ Innovator Liability Theory

It is a bedrock principle of the American legal system that a product manufacturer is typically not held responsible for an injury to a plaintiff when that manufacturer’s product was not used.  In other words, if a plaintiff was injured while using Product A, the manufacturer of Product B cannot be responsible. This common-sense rule has been challenged over the years by various plaintiffs’ theories, and one of those efforts – the so-called “innovator liability” theory – recently gained a bit more traction in a…  

Drug Decision Discusses Learned Intermediary Doctrine and Failure to Warn Claims

On July 28, 2014, Judge Mark R. Hornak of the Western District of Pennsylvania granted Novartis partial summary judgment on product liability claims for Zometa in Rowland v. Novartis Pharmaceuticals Corp., 12-cv-1474.  These plaintiffs brought claims in strict liability, negligence and breach of warranty arising out of their use of Zometa, a prescription bisphosphonate medication for metastatic bone cancer. The plaintiffs claimed that the use of Zometa caused osteonecrosis of the jaw bone. Novartis moved for summary judgment arguing that the plaintiffs’ claims were not…  

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Keep Us Posted: FDA Updates Rules On Changes To Medical Devices

The U.S. Food and Drug Administration has updated its rules regarding how manufacturers of medical devices disclose manufacturing and design changes to previously approved medical devices. The focus of the FDA’s update is on annual reports for Class III devices which are subject to premarket approval. Under the FDA’s updated guidelines, manufacturers are to disclose in their annual report all changes made to either the manufacturing or design of the device and the underlying rationale and scientific basis for the change. For more significant and…  

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Pennsylvania Supreme Court Opens Door for Negligent Design Claims Against Pharmaceutical Manufacturers

In a decision with significant potential ramifications, the Pennsylvania Supreme Court has issued a ruling that pharmaceutical companies can be held liable for negligence in the design and marketing of drugs, regardless of claims that the drugs had been properly labeled and tested, as well as approved by the U.S. Food and Drug Administration. The ruling, announced January 22nd, upholds an intermediate appellate court decision against a Pfizer, Inc. subsidiary in a wrongful death action involving the diet drug Redux. In its 4-2 decision, the…  

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Claims Regarding Post-FDA Approval Problems Not Preempted

While Medical Device Amendments of 1976, 21 U.S.C. § 360k(a) provides protection to manufacturers for medical devices approved by the FDA, certain post-FDA approval activities may still give rise to claims.  In this recent case, the defendant St. Jude Medical, Inc. moved to dismiss the complaints against it for injuries allegedly resulting from St. Jude Riata leads on implantable cardiac defibrillators where the insulation failed and caused unnecessary shocks in the body.  The product was removed from the market in 2010, a warning letter was…  

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FDA Addresses Antibacterial Soaps and Body Washes and Opens Its Proposal to Public Comment

In December 2013, the U.S. Food and Drug Administration (“FDA”) issued a proposed rule that would require manufacturers of antibacterial hand soaps and body washes to provide substantial data to demonstrate that “their products are safe for long-term daily use and more effective than plain soap and water in preventing illness and the spread of certain infections.” Under this proposed rule, if companies do not demonstrate such safety and effectiveness, these products would need to be reformulated or relabelled to remain on the market. The…  

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