07/21/2013 // New York, NY, USA // jcreiterlaw // Jonathan C. Reiter // (press release)
A class of drugs for acid reflux, and gastro-esophageal reflux disease (‘GERD’) may lead to heart disease and heart attacks, according to new research published on July 12, 2013, reports Jonathan C. Reiter, a New York City medical malpractice attorney who is also experienced in product liability cases. The drugs include a class known as proton pump inhibitors (PPI) and include brand names, Prilosec, Nexium and Prevacid. Millions of people in this country, and around the world, have been prescribed these drugs for treatment of GERD.
The recommended treatment time is 8-12 weeks on this medication, but many people stay on these drugs for life. Dr. John Cooke, of University of Houston Methodist Hospital, where he is a professor and chairman of the Department of Cardiovascular Medicine, reported the research. He performed the research on both mouse and human tissue.
The results of the research showed that the use of PPI’s caused a constriction in blood vessels, and blood flow, by suppressing the production of a chemical messenger, which relaxes the blood vessels and protects the artery walls. Dr. Cooke recommended that the general population, who is prescribed this drug, should discuss the risks with their physicians, and consider switching to taking non-PPI medications. He called for large-scale studies, stating that the risks that were clearly shown in his study were based on a joint Canadian-British study in 2011 that found the same risk of heart disease and heart attacks in connection with taking PPI drugs.
Jonathan C. Reiter, a New York injury attorney, whose office is located in the Empire State Building, specializes in the field of medical malpractice and products liability, has handled many cases involving drugs that were marketed and sold to the general population that had unintended, severe side effects. Mr. Reiter stated, as follows: “A dangerous or defective drug poses significant health risks to the population taking the drug. This is one of the most complex areas of law because of the science involved in proving a case. The standard for determining if there is a case is whether the drug caused severe and adverse side effects, the seriousness of which outweighs the intended benefits of the drug.
In the case of PPI drugs, having a heart attack, or damage to your cardiovascular system resulting in hypertension is serious and severe, and most likely outweighs the benefit of curing GERD, which is a severe form of heartburn, especially when there are alternative therapies available, including non-PPI drugs such as Zantac or Pepcid.”
Mr. Reiter went on to discuss the legal theories involved in a products liability case for a defective drug as follows: “There are three possible legal theories upon which to base a lawsuit against a drug manufacturer:
1. A Design Defect in the Drug Itself
Presently, a warning regarding increased risk of heart disease is not contained in the packaging of these drugs. It is possible that the manufacture did not know of the risks, or it is also possible that they knew, and somehow ignored and suppressed the evidence of risks, in order to get a popular drug on the market, a situation that has happened time and again in our history. One must only consider the drugs ‘fen-phen,’ which caused heart damage and death, or thalidomide, which caused severe birth defects when taken by pregnant women.
2. A Manufacturing Defect
There is also the possibility of a manufacturing defect, but is probably irrelevant in this instance, where the drug itself is having unintended, severe side effects, and manufacturing issues have not arisen in the research yet.
3. A Failure to Warn of the Adverse Effects.
And the third theory is that of failure to warn, which simply means that a person taking the drug should receive warning printed on the packaging of the drug, of the known risks of this drug, especially when they can be severe and life-threatening.”
Mr. Reiter went on to discuss the role of the government in the marketing of drugs that are new to the market, as follows: “The Federal Drug Administration is the agency of the US government which is responsible for testing and approving new drugs that are submitted by the drug manufacturers. A sub-agency within the FDA is the Center for Drug Evaluation and Research (‘CDER’), which is responsible for weighing the evidence submitted in an application by the manufacturer of the drug. Many times, drugs have been approved by the FDA, only to be withdrawn from the market in what is known as an FDA recall.”
The results of Dr. Cooke’s research, along with prior research out of Britain and Canada, have led to calls for a larger research project, to determine whether PPI’s should be recalled. At the present time, Dr. Cooke recommends that a patient should discuss the risks with their doctor before taking this medication, and consider taking a non-PPI drug for treatment of the GERD symptoms until a final conclusion is drawn, which could be years away.
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