Matthew Mombrea

All articles by Matthew Mombrea

 

Former Drug Executives Criminally Charged in Ongoing Opioid Crisis Fight

The former chief executive and former chief compliance officer of the Rochester Drug Co-Operative were recently charged in a criminal case for conspiracy to distribute controlled substances, conspiracy to defraud the United States, and willingly failing to file suspicious order reports with the DEA. The Rochester Drug Co-Operative is also being charged with conspiracy to violate narcotics laws. This prosecution represents the first time executives of a pharmaceutical company and the company itself were charged with drug trafficking. According to the suite, Rochester Drug Co-Operative…  

Two Bills Pending Before Maryland Legislature Potentially Place Employers/Insurers in a No-Win Situation

As the 2019 Maryland legislative session winds down, two bills pending before the Maryland legislature are positioned to create significant changes and additional uncertainty, within  Maryland’s Workers’ Compensation framework. Committee Chair Sen. Bobby Zirkin (D-Baltimore County) is the lead sponsor of Senate Bills 854 and 863, two bills specifying the use of medical cannabis in the context of workers’ compensation cases. Background Senate Bill 854 states that a covered employee or dependent is not entitled to workers’ compensation or associated benefits if the accidental injury…  

Crisis in Construction: Increased Risk of Opioid Abuse in the Construction Industry

The Centers for Disease Control and Prevention (CDC) states that, on average, 130 Americans die every day from an opioid overdose. The construction industry, in particular, has been disproportionately impacted by the opioid epidemic. According to North America’s Building Trades Union, the overdose rate for workers in the construction industry is seven times that of the general population. But why? The work is physically intensive and the risk of suffering a work-related injury is higher than the national average in other occupations. Laborers tend to…  

“Medicine Chest of the World” Joins Fight Against Opioid Epidemic

New Jersey has joined the long – and growing – company of states and local municipalities in the fight against the opioid epidemic.  The New Jersey attorney general filed suit against Janssen Pharmaceuticals, alleging that the company misled consumers on how addictive the long term use of their opioid products were. The lawsuit by New Jersey represents a new frontier in the opioid epidemic as the state brings legal action against one of its biggest employers.  New Jersey has a deep relationship with the pharmaceutical…  

FDA Cracks Down on Promotional Claims Made on Facebook

In this day and age nearly everyone has a Facebook page, including companies which often use Facebook pages to promote their products and services. Given that Facebook is quite an informal marketing medium, companies may not always scrutinize everything they post as highly as they would more organized or targeted media. But that doesn’t mean the Food and Drug Administration isn’t scrutinizing every wall post and status update. On March 12, 2014, the FDA posted an untitled letter to a Switzerland-based international drug maker, noting…  

Pennsylvania Supreme Court Holds Plaintiffs May Assert Negligent Design Claims Against Drug Companies

The Pennsylvania Supreme Court in Lance v. Wyeth (2014 Pa.LEXIS 205) recently ruled that pharmaceutical companies can be held liable for negligent design, testing, marketing, and distribution of drugs regulated by the FDA. This decision alters the landscape of Pennsylvania law because pharmaceutical companies previously succeeded in having similar claims dismissed based upon the learned intermediary doctrine. Under this doctrine, the manufacturer of prescription medications discharges its duty to warn users of the risks associated with its products by warning the prescribing physician of…  

Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…  

Drug Quality and Security Act

In October of 2012, a meningitis outbreak that caused the death of sixty-four people was traced to tainted steroids purchased from a Compounding Center in New England.  In response to this outbreak, last November President Barack Obama signed the Drug Quality and Security Act into law, which overhauls the FDA’s regulation of Compounding Pharmacies by establishing a system to trace the supply chain of prescription drugs. (See the bill here). Furthermore, under this bill, the FDA is given more authority to regulate and monitor…  

Pennsylvania Superior Court Upholds Dismissal of Suit Claiming Paxil Caused Birth Defects

The Pennsylvania Superior Court recently upheld the trial court’s ruling in Thomas v. SmithKline Beecham Corp., 27 Pa.D.&C. 5th 279 (Pa.Commw. Ct. 2012).  Thomas dismissed plaintiff’s wrongful death and survival claims based on her use of the antidepressant drug Paxil during pregnancy as time barred.  She ingested Paxil during her pregnancy and she was subsequently informed in 2001 that a fetal echocardiogram revealed that her fetus had congenital heart defects.  Three days later she chose to undergo a therapeutic abortion at less than…  

United States Supreme Court to Determine Whether It Should Hear Lupron Labeling Suit

The United States Supreme Court has been asked to determine whether a drug manufacturer’s older labeling is admissible to establish its failure to warn consumers of a product’s dangerous side effects.  See the Petition for Writ of Certiorari here.   In Klein v. TAP Pharmaceutical, 518 Fed.Appx. 583 (9th Cir. May 14, 2013), the plaintiff alleged a drug manufactured and marketed by TAP Pharmaceuticals, in a joint venture with Abbott Laboratories, did not contain adequate warnings regarding the dangerous side effects associated with Lupron…  

D.C. Circuit to Determine if FDA can Regulate Stem Cell Treatments

The intersection of what is the practice of medicine and what is a regulated drug or biologic is an interesting place with constitutional and regulatory implications. These issues have come to the forefront in a significant case involving an autologous stem cell procedure used by an orthopedic group in Colorado.  In United States of America v. Regenerative Sciences, LLC, 878 F. Supp. 2d. 248 (D.D.C. 2012), available here,  a D.C. district court judge issued an opinion addressing many of these constitutional and regulatory issues, which…  

FDA Requires Drug Company to Address Quality Control Issues

Earlier this month, the United States Food and Drug Administration (FDA) sent a warning letter to Posh Chemicals Pvt. Ltd. (Posh), an Indian drug manufacturing company, to improve its documentation regarding its quality control and testing systems. The drug company was warned that its failure to correct these issues would result in the FDA refusing admission of its products into the United States. Last March, the FDA inspected Posh and found it lacked the ability to protect data concerning its products from becoming altered or…  

Congress’ Concern with Heparin Supply

The United States Food and Drug Administration has determined more than 90 deaths were caused by contaminated Heparin imported from China in 2008.  Heparin is widely used as an injectable anticoagulant during heart surgery and kidney dialysis.  Last week, concern was raised in the United States House of Representatives regarding Shanghui International Holdings Ltd’s pending $4.7 acquisition of Smithfield Food Inc., which is a supplier of raw heparin.  House Republicans believe this business transaction could threaten the safety and availability of the drug.  Apparently, concerns…  

New Jersey Appellate Court Takes Bite Out Of Zometa Cases

The drug Zometa, which is manufactured by Novartis Pharmaceuticals Corporation, is used to prevent skeletal fractures in patients with various cancers.  Novartis has been hit with some plaintiff’s verdicts recently where it was alleged that it failed to disclose dead jaw bone risks associated with Zometa.  However, two recent appellate rulings in New Jersey have clarified any ambiguity associated with the application of that state’s statute of limitations for similar cases.  Under New Jersey law, the statute of limitations in product liability actions…