Tag Archives: medicine

Generic and Branded Drugs

This is an interesting case that the Supreme Court will hear today.  Does a branded drug maker, faced with a potential competitor who makes generic drugs, act illegally if it pays money to the competitor in a deal that postpones the sale of the generic drug for a period of years?

The FTC says it is unlawful, while the generic and branded drug makers disagree.

So why does this matter?  Everyone knows that generic drugs are cheaper than branded drugs.  As the NY Times reported, “73 percent of consumer spending” is spent on branded drugs.  When a generic drug, which costs about 15% of the branded drug cost, enters the market, branded drug makers lose about 90% of their profits.

In FTC v. Actavis, Inc., the 11th Circuit Court of Appeals held companies holding the patent to the branded drug could make those payments to the generic drug maker.  In this case, the generic drug maker challenged the patent of the branded drug maker in court.  Both drug makers came to a settlement, whereby the generic would get some payment as long as the branded drug maker could continue to sell its branded drug exclusively for a time period.

In sum, the 11th Circuit reasoned, “absent sham litigation or fraud” when the anticompetitive effects of a patent fell within that scope, there is no antitrust claim. Further, since there was a settlement, the 11th Circuit stated that it would be hard to predict what the effect would have been.  And since the settlement was with one generic drug maker, this did not impact other generic drug makers from selling the generic version of the drug.

Now, the Supreme Court has to decide on this issue.

via Generic-Brand Name Drug Case Goes to Supreme Court – NYTimes.com.

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Failure-to-warn not preempted by federal law

The Ninth Circuit (en banc) held that a state-law failure-to-warn was not preempted by the Medical Device Amendments to the Food, Drug, and Cosmetic Act.  The Ninth Circuit explained that the Amendments parallels the state-law claim, and therefore does not preempt, either expressly or impliedly.

What does this mean?  The federal court of appeals made a decision whether a federal court or a state court had jurisdiction over the failure-to-warn claims.  The failure-to-warn state-law claims arise when a medical manufacturer fails to warn the patients or its physicians of known-dangers of the medical device.

The arguments in the lawsuit were rooted on the MDA explicit preemption clause – which provided that federal courts had the power to hear the case exclusively.

So why was that preemption clause irrelevant to this situation?  The Supreme Court had previously ruled, in 3 preemption cases under the MDA, that the MDA does not preempt a state-law claim for violating a state-law duty that parallels a federal-law duty under the MDA.

 

If anything else, this is a very interesting read if you are interested in preemption rationales – express, field, and conflict.

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VA Can’t Refuse To Treat Medical Conditions Of Inmates

The District Court for the Western District of Virginia refused to dismiss a class action alleging that a womens prison in Virginia fails to treat medical conditions as a way to cut costs.

Five prisoners at Fluvanna Correction Center for Women FCCW in Troy, Va., are leading the charge against the Virginia Department of Corrections VDOC, which they say routinely violates Eighth Amendment rights and shows deliberate indifference to medical needs.

U.S. District Judge Norman Moon denied the states motion to dismiss Tuesday.

“Plaintiffs allege that, as a result of cost-saving concerns, medical personnel at FCCW have failed, or refused, to invest the time or effort required to acknowledge, examine, diagnose and treat them with respect to existing or potentially serious medical problems and concerns,” he wrote. “Indeed, the complaint is replete with specific examples of how Plaintiffs have been adversely affected as a result of this concern.”

The decision states that officials with the Virginia Department of Corrections allegedly received hundreds of grievances, which should have notified them of a continuing problem at the prison facility.  Consequently, Judge Moon held that the class may proceed.

“Given that plaintiffs have alleged that the VDOC defendants remained inactive despite personal knowledge of information disclosing alleged ongoing deficiencies in medical care, plaintiffs Eighth Amendment claim may proceed against them directly.”

The complaint alleges the prison refused to treat medical conditions in the following examples of the putative class representatives.

  • The prison failed to give the proper dosage of medication prescribed to Cynthia Scott after she was diagnosed with sarcoidosis, a disease that formed nodules in her lungs, spleen and liver. Scott also allegedly developed a blood clot in her leg that was left untreated until it traveled to her lungs.
  • Bobinette Fearce, a second named plaintiff, says she has degenerative disc disease, causing her chronic pain. The prison doctors allegedly refused to give her enough Tylenol to alleviate her pain. She also claims to suffer from incontinence and must wear a diaper at all times, but an FCCW doctor said she is “too old to be afforded the surgery that would correct her bladder condition.”
  • Patricia Knight says that a stroke caused her to lose grip strength and made walking difficult. Because her conditions allegedly prevent her from performing any prison job, Knight says she cannot afford the $5 “co-pay” for prison medical visits and therefore gets little medical care.
  • Marguerite Richardson says she visited the medical staff when she developed a number of boils on her leg. A test found that she had a highly contagious antibiotic-resistant infection, but the prison waited five months to give her medication to treat the infection, the complaint states.
  • Rebecca Scott, the fifth plaintiff, allegedly suffers from recurring tonsillitis. She says an FCCW doctor told her he “does not believe in removal of tonsils by surgery,” that the prison has rejected her requests to see an outside specialist.

via Courthouse News Service.

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