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Mark Bello
Mark Bello
Attorney • (877) 377-7848

Generic Drug Immunity High Risk for Patient Safety

3 comments

The US Supreme Court was asked to decide whether or not a generic drug maker, which has complied with federal requirements to provide labeling similar to a brand-name drugs, should be liable for inadequate warnings on its product labels. Last week, a 5-4 decision in Pliva vs Mensing, effectively granted the generic drug industry immunity when failing to warn the public of its’ drugs’ possible side-effects. The high Court stated that makers of generic drugs cannot be sued for failing to warn consumers of the possible dangers and side effects of their products if they copy the exact warnings on the brand-name equivalents of the medicines. Justice Clarence Thomas said because the Federal Food and Drug Administration must approve changes in the warning labels, the generic makers may not be sued under state liability laws for failing to warn patients of new dangers.

The case involved a lawsuit by two women who alleged that Metoclopramide (the generic drug for Reglan) gave them a severe neurological movement disorder called tardive dyskinesia, but none of the generic drug’s manufacturers and distributors made any effort to include warnings on the label. Pliva and other generic drug manufacturers argued that it is not their legal responsibility to request label changes, and that lawsuits filed in state courts over the content of labels improperly infringe on the FDA. Reglan provided a warning about tardive dyskinesia when the two women were taking the drug.

The District Court of Minnesota decided that the state tort claims were pre-empted by federal law; Pliva could not have changed labeling on its drug due to the federal drug labeling requirement that the generic drug must be labeled the same as its name-brand counterpart. The 8th US Court of Appeals overturned the ruling stating that the generic drug manufacturer more should have been done to warn consumers about possible risks; they could have proposed a label change to the FDA. Pliva filed an appeal arguing that the Circuit Court of Appeals decision was unrealistic.

Have we become an “everything for business and/or commerce and nothing for safety” society? This decision is absurd! Did Congress intend to create a market in which consumers can only sue name-brand product manufacturers? If that is true, why would anyone use generic drugs? The Supreme Court has, again, granted effective immunity to large corporations and to the detriment of consumers. What incentive does a generic drug manufacturer have to provide the most current safety information (at considerable cost) to the FDA?

Although active ingredients are the same, inactive ingredients may be different. Under the Supreme Court’s interpretation, if warnings on a drug label are inadequate – as in cases like generic versions of Accutane, Darvocet, Zocor, and Yaz – a patient who is injured after using a generic version has no claim for those injuries. Yet, if the same patient suffered the same injury while taking the brand name of the same drug filled by the same pharmacy, a claim can be filed. Granting immunity to generic drug manufacturers shows a lack of concern for patient safety. Consumers need adequate warning labels to make informed decisions about their healthcare.

This decision could affect millions of Americans; generic drugs make up 75 percent of the prescription drugs dispensed in the United States. Because many insurance companies require that generic drugs be used whenever possible, patients have two choices – risk generic prescriptions that may lack full disclosure of all side effects or pay the costs of name-brand drugs. Obviously, no one wants to take a gamble with their health. Shouldn’t we hold all drug manufacturers to the same standards? What do you think?

  • Should the same laws for name-brand drugs apply to lower-cost generic prescriptions?
  • Should generic drug makers be liable for not disclosing potentially dangerous side effects?
  • Knowing you have zero recourse, does this decision change your mind about using generic drugs?

Hopefully, Congress will consider patient safety and act to amend existing law and render moot, this atrocious decision. Until then, Lawsuit Financial suggests that when your doctor prescribes a generic, ask him/her what the brand name equivalent is. Ask about potential side effects and obtain the warnings contained on the brand name medication. Learn what potential side effects of both, including those not listed on the labels; make an informed choice. Additionally, talk to your pharmacist when filling prescriptions or purchasing over-the-counter medication. For a brand-generic combination identifier, click here. Thanks to our Republican appointed conservative Supreme Court majority, we are on our own when it comes to education about the dangerous side effects of generic medication. Looking for reasons to vote for President Obama? The health and safety of yourself and your family might be the number one reason to do so.

Mark Bello has thirty-three years experience as a trial lawyer and twelve years as an underwriter and situational analyst in the lawsuit funding industry. He is the owner and founder of Lawsuit Financial Corporation which helps provide legal finance cash flow solutions and consulting when necessities of life litigation funding is needed by plaintiffs involved in pending, personal injury litigation. Bello is a Justice Pac member of the American Association for Justice, Sustaining and Justice Pac member of the Michigan Association for Justice, Business Associate of the Florida, Tennessee, and Colorado Associations for Justice, a member of the American Bar Association as well as their ABA Advisory Committee, the State Bar of Michigan and the Injury Board.

3 Comments

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  1. sara cole says:
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    Its time to recall Supreme Court Justices. The Supreme Court has been bought by Corporate America and it is time for the citizens of our nation to take back the courts.

  2. Mark Bello says:
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    Amen Sarah; if only we could. Supreme Court appointments are lifetime appointments, made only by a sitting President. Some people, obviously, forget that when they go to the polls. If you elect pro-business, anti-citizen Presidents like George Bush, you get anti-citizen, pro-business Justices like Roberts, Scalia, Thomas, Alito,and, to a lesser degree, Kennedy. This is a possibility that the next President may have an opportunity to appoint one, maybe two, Supreme Court Justices. If not in the next six years, replacements are probable in the eight years following. Who is President for the purpose of Supreme Court appointments is a vital issue for the citizens of this country in their battle (yes, I mean BATTLE, MORTAL COMBAT) for simple justice against corporate interests. Decision after decision, usually divided 5-4, have eroded citizen justice in favor of corporate interests. Recent decisions in pharmaceutical industry liability, employment discrimination, campaign finance, environmental protections and a host of other key issues have been decided in favor of corporate interests and against citizens by this conservative majority. If you want to “recall” this majority, you must vote for a President who puts citizens first. You have one in President Obama, who, thankfully, has been able to appoint two new Justices. We need to retain him for four more years and elect a pro-citizen candidate to follow him when his eight years are up. The make-up of the Supreme Court is one of the most important issues of our time; it is a shame that justice can now be bought and sold in political elections, but that is how polarized our politics have become.

  3. Candice Kelleher says:
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    My son was given the generic version of Accutane and developed Chrohn’s disease. We did not know he was given the generic (insurance substituted it automatically). There were no warnings regarding developing Chrohn’s disease on taking Accutane. Accutane is no longer on the market. My son must take a drug infusion of Remicade for his Chrohn’s disease every 8 weeks at a cost of $11,000.00!! We were in the process of filing suit against the generic drugs…now what!