Texas Court Holds that Compounding Pharmacies are Subject to Requirements of the Texas Medical Liability Act

On April 24, 2015, in a significant win for pharmacies in the State of Texas, the Texas Supreme Court dismissed a plaintiff’s product liability action that alleged that the lipoic acid treatment she received caused her to go blind. The court held that the defendant compounding pharmacy that provided the supplement was entitled to protection under the Texas Medical Liability Act (TMLA) and dismissed the case. The decision is available here. In 2011, Ms. Miller was undergoing weekly injections of lipoic acid with her…
Continue reading...

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…
Continue reading...

The US Food & Drug Administration is Looking into Whether Morning-After Emergency Contraceptive Pills Fail to Work in Women Over a Certain Weight

The FDA quickly addressed a recent report that European health regulators have ordered a label change on an emergency contraceptive product sold by French drugmaker HRA Pharma under the brand name Norlevo(levonorgestrel). The European authorities now require the drug’s labeling to address the potential that there is diminishing effectiveness of the pill depending upon the weight of the user. According to HRA, the emergency contraceptive begins to lose its effectivness for wormn who weigh more than 165 pounds and is completely ineffective for women…
Continue reading...

Its Flu Season – Remember the National Childhood Vaccine Injury Act

It is getting to be flu season – with the annual barrage of public-service announcements about the importance of getting this year’s flu vaccine.  Vaccines were also in the news recently on reports of a polio outbreak in Syria. Vaccines also end up the subject of lawsuits, including the recent decision from the United States Court of Appeals for the Federal Circuit in Tembenis v. Sec’y Health & Human Servs., (October 28, 2013), available here, which ruled that future lost earnings cannot be awarded…
Continue reading...

McIntyre Prevails Again – Contacts with the U.S. Are Insufficient to Establish Jurisdiction in Arkansas

In keeping with McIntyre, the Eastern District of Arkansas has ruled that the foreign manufacturer of the pharmaceutical metronidazole is not subject to jurisdiction.  In the Woods and Brinker matters the plaintiffs alleged that they were injured by contaminated metronidazole and they made claim under the Arkansas Product Liability Act.  The decision is available, click here.  The metronidazole was manufactured in India by Claris Lifesciences Limited (Claris India) pursuant to a supply agreement with Pfizer. Pfizer then sold the drug as its own with a…
Continue reading...

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…
Continue reading...

FDA Largely Shutdown

With the Federal Government on shutdown, the FDA is largely shutdown as well. The FDA’s official announcement regarding the shutdown states that in the absence of either a 2014 fiscal year appropriation or an FDA specific Continuing Resolution, the FDA’s activities going forward will be limited to the following;
  • emergency work involving the safety of human life or protection of property;
  • criminal law enforcement work; and
  • activities funded by carryover user fees under certain acts such as the Prescription Drug User Fee Act.
Until an…
Continue reading...

European Union’s Proposed Regulations Governing Medical Devices Raise Multiple Concerns for US Manufacturers

On September 25, 2013, the European Parliament Committee on the Environment, Public Health and Food Safety (“ENVI”) voted on draft Regulations including a proposal concerning high risk medical devices, raising concerns among US manufacturers. Expectations that a more restricted process in Europe could undermine the development of domestic medical devices appear increasingly well-founded, but the entire story has yet to be played out overseas. At issue is an attempt by the European Union (“EU”) to close loopholes that allowed breast implants made with industrial-grade silicone…
Continue reading...

Voluntary Recall of Millions of Glucose Test Strips

On July 31, 2013, the FDA announced a voluntary recall of Nova Max Glucose Test Strips.  It is estimated that approximately 62 million strips may be affected and are marketed under the brand names Nova Max Blood Glucose Test Strips and Nova Max Plus Glucose Meter Kits.  The test strips, manufactured between December 2011 and April 2013, were contaminated with a chemical during the manufacturing process.  This chemical causes false readings indicating a false, abnormally high blood glucose level.  This could result in an insulin…
Continue reading...

Preemption Defense Not Completely Dead for Branded Drugs

As all who follow drug and device law know full-well, the 2009 decision from the United States Supreme Court in Wyeth v. Levine represented a significant setback for brand-name drug manufacturers seeking to defend failure-to-warn claims on preemption grounds.  In Levine, the court held that state law failure-to-warn claims involving brand-name drugs are not preempted, unless there is “clear evidence” that the Food and Drug Administration (FDA)  would not have approved whatever labeling change forms the basis for the failure-to-warn claim.  Such a standard…
Continue reading...