Category Archives: News

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…

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The Manufacturer Made Me Do It – One Claim By Negligent Surgeon Survives

California certainly breeds interesting cases. In the Chao case, available here, recently decided by a federal judge in the Southern District of California, the plaintiff was not an injured person. He was an orthopedic surgeon found to be negligent in his treatment of a patient by an arbitration panel, which awarded in excess of $2 million to the patient. The surgery was a hip replacement surgery during which the surgeon lacerated the patient’s femoral artery. Following the award, the orthopedic surgeon brought an indemnity action…

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This Week’s Life Science Headlines

        Litigation

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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…

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Last Week’s Important Headlines

Here are some other notable decisions and developments from last week in the Life Science area: Litigation

Regulatory

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Congress to Codify FDA Recent Decision Not to Seek Enforcement of Low Risk Mobile Medical Apps

On September 25, the FDA released a guidance document related to Mobile Medical Applications (“MMAs”), which provided critical industry guidance as to which MMAs will be considered medical devices and subject to regulation by the FDA.  On September 30 we reported on these new rules (click here) and on October 23 we also presented a webinar entitled “Mobile Medical Apps: FDA Regulation and Product Liability Implications” which was recorded and is available here.  In particular, the FDA exercised its discretion not to enforce…

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MMA: No Longer Just An Acronym for Mixed Martial Arts, Mobile Medical Apps May Own That Sooner Rather Than Later

Mobile device software (apps) that give nursing home doctors access to drug reference databases help prevent serious and potentially life-threatening medication errors. That was one of the findings of a recent study published in the Journal of the American Medical Director’s Association (JAMDA), which also found that use of the drug reference apps was fairly routine for the physicians with access to them. The researchers found that nursing home physicians who used drug reference apps were more aware and less likely to give medications…

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Generic Drug Manufacturer Loses Battle on Preemption, But Wins War on Causation

Are state law claims against a generic drug manufacturer preempted where labeling of the generic drug differs from the brand name drug labeling?  In a recent drug liability case decided in the federal district court in Arizona, the court said no and held that the plaintiff’s claims were not preempted.  Nevertheless, the court concluded that the plaintiff’s physicians did not read or rely on the labeling and, therefore, Arizona law required dismissal of the plaintiff’s claim.  The case is Carter v. APP Pharmaceuticals and can…

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Are (Legally) Imported Prescription Drugs a Thing of the Future: Maine Thinks So

Maine has passed a law that takes effect today which permits the direct purchase of prescription drugs from certain foreign pharmacies. More specifically, the law exempts foreign pharmaceutical vendors from state pharmaceutical licensing laws. The law, which is noted to be the first of its kind, has come under attack from the pharmaceutical industry. Drug makers argue that consumer safety will be lost if the purchase of drugs from foreign pharmacies is allowed and that FDA oversight is impinged upon by the new law. The…

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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…

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