Monday, October 27, 2014

Evidence of the Problems with Office Use Compounded Medications and Drugs: Consumers of Compounded Medications in Texas Need to Be Aware of Compounders' Position on their very limited liabilty if a patient is injured by bad compounded drugs--the Texas Supreme Court Will Decide This Critical Issue for consumers of compounded medications and compounding pharmacists.

 Petitioners,  v. Stacey Miller and Randy Miller, No. 13-1014, is a major case in the compounding
industry in Texas.

In this case Stacey Miller was diagnosed with Hepatitis C. Her physician
began administering weekly injections of the antioxidant supplement lipoic acid.
After nine weeks of injections, Stacey Miller had violent nausea and
vomiting when her physician administered an injection of lipoic acid.

Stacey Miller is now blind in both eyes.  She contends that administration of lipoic acid by her physician, caused her blindness. She sued the compounding pharmacists
from which her physician obtained the lipoic acid, alleging that the pharmacists
manufactured, distributed, and sold a defective product, and breached warranties
with regard to that product.

At the trial level, Randol Mills Pharmacy filed a  motion to dismiss and supplemental motion to dismiss which claimed that the allegations against petitioners were
“inextricably intertwined” with the claims against the physician and that as
pharmacists they were therefore healthcare providers falling within the
ambit of the Texas Medical Liability Act (“TMLA”). The Millers, relying on
TEX. CIV. PRAC. REM. CODE 74.001(a)(22), asserted that this was nothing
more than a common law cause of action for the sale of a mishandled or
defective product. The Millers's position is that the compounding pharmacy provided
a physician—not a patient—with the dietary supplement lipoic acid in injectable form without a prescription.  Under TEX. CIV. PRAC. REM. CODE § 74.001(a)(22) a
pharmacist is a “healthcare provider” for purposes of the
Texas Medical Liablity Act only when dispensing prescription medications.

The trial court agreed with the Millers and denied the Randol Mill Pharmacy's Motion to dismiss. The Honorable Sue Walker of the 2nd Court of Appeals of Texas affirmed the trial court in 02-12-00519-CV.  The Texas Supreme Court recently set for a the case for oral argument on January 14, 2015, at 9 a.m.

The Millers state that the issue is this:

Did the court of appeals
correctly hold that a pharmacist’s act of filling a bulk phone
order placed by a doctor for over twenty 30–milliliter vials
of a nonprescription injectable form of the antioxidant
supplement lipoic acid for use in the doctor's office did not
constitute dispensing a prescription medicine as required
for the pharmacist to qualify as a health care provider
under the Texas Medical Liability Act?

In amicus briefs (friends of the court usually requiring permission to file from individuals or groups that are not parties to the litigation, a who-who in the Texas Compounding world has filed briefs, evidencing how critical this issue is to them.  Those filing amicus briefs are Texas Pharmacy Association, IACP, PCCA, Unique Pharmaceutical, Alliance of Independent Texas Pharmacists, and the Southwest Pharmacy Solutions d/b/a AMERICAN PHARMACIES.  This case, if not, overrulled by the Texas Supreme Court, is devastating for the compounding industry in Texas because it exposes them to huge liability claims for bad compounds.  The panic in the compounding industry on this issue can be found in the amicus briefs filed:

The court of appeals erred in holding that the plaintiffs’ claims in this case
are not governed by the TMLA. Its holding will limit the ability of Texans to
obtain necessary health care.

See Amicus Brief field by  IACP, PCCA, Unique Pharmaceutical, Alliance of Independent Texas Pharmacists.

Some additional questions to ask are these:  Did Randol Mill Pharmacy report the adverse event to the Texas Board of Pharmacy?  to the FDA?  Did the Texas Board of pharmacy investigate?  Did it discipline the pharmacy?  If it hasn't shouldn't it invetigate?  Doesn't this make a strong agrument to Congress to leave the DQSA in place because it points out the huge dangers of office use compounding and if liability is going to eventually be limited by compounding pharmacies and pharmacist who don't want to be legally responsible for the adverse events they may cause in this area, don't we need to offer the upmost protection for American consumers' health and safety?

This is definitely a case to follow.  For folks in Texas taking or considering taking compounded medications, you need to be aware of the position of compounding pharamacists and pharmacies when adverse reactions occur from taking bad compounded preparations.

No comments: