HEALTH Act Archives - Shopfloor

Bilbray: Who Can I Sue? Litigation Denies Access to Needed Drugs

By | Briefly Legal, General, Health Care | One Comment

During the two days of committee discussion last week on the House’s medical liability reform bill,
H.R. 5, the Help Efficient, Accessible, Low-cost, Timely Healthcare (HEALTH) Act of 2011, Rep. Henry Waxman (D-CA) and several fellow committee members defended litigation and trial lawyers from the (well-founded) accusations that lawsuits increase health care costs and detract from medical treatment.

Litigation actually works to improve quality, supplementing the work of the Food and Drug Administration in the regulatory approval of drugs, they argued. Uh huh. The term is “regulation through litigation,” and it’s an inefficient, expensive and counterproductive system of dual regulation, in which trial lawyers and juries of laymen replace scientific experts and testing in determining which drugs are allowable.

At one point, an apparently frustrated Rep. Brian Bilbray (R-CA) reminded the committee members of the real-world consequences of this kind of litigation: Lawsuits force drugs off the market that help people. People really suffer because of the cash-seeking litigation by trial lawyers.

Bilbray spoke passionately about the loss of Benedictin, an anti-morning sickness medication, taken off the market after The National Enquirer published an alarmist article, “New Thalidomide Scandal-Experts Reveal,” and thousands of lawsuits followed. As a consequence, his wife was deprived of a safe and widely prescribed drug she had used in previous pregnancies. She wound up in intensive care.

Rep. Bilbray:

This is one issue you don’t talk about. You had a treatment, Benedictin, that was used all over the country. There was a National Enquirer story in ’79. It ended up being lawsuit after lawsuit after lawsuit, with no scientific data, according to the FDA, to take it off the market. But sheerly by the harassment of litigation this product is no longer available to women across this country.

And my wife was one of those that went into intensive care, while she was in the first trimester of pregnancy, because the litigation drove that product off the market and denied her access to that product. And you know what physicians do now? … They prescribe the chief components of Benedictin separately, because the private sector cannot provide it because it was driven off the market through litigation, not through science.

So this does have an effect. It has an effect on what’s available for consumers. And I say this…Who do I get to sue? Who do I get to take to trial for those who drove this product off the market. Who do I get to point the finger at? Which lawyers do I get to litigate with who drove it off the market, because my wife didn’t a product that she had in her previous pregnancies, she didn’t have the ability to get the medication that is essential to not only her, but to her unborn baby. Who do I get to have justice with because this product was driven off? Read More

Medical Devices, Liability Reform, and Defensive Medicine

By | Briefly Legal, Health Care, Innovation, Regulations | No Comments

The House Energy and Commerce holds a hearing this morning, “Impact of Medical Device Regulation on Jobs and Patients,” to examine the state of the medical device industry and the impact of regulations on job creation and patient access.

It’s a timely topic. Working on H.R. 5, the medical liability reform bill, the House Judiciary Committee rejected an amendment (Amdt. 15) sponsored by Rep. Mike Quiqley (D-IL) to strike the “safe harbor” provisions that would preclude punitive damages in litigation against FDA-approved medical devices and drugs. We discussed the importance of that language in a post Wednesday, “Why Medical Liability Matters to Manufacturers.”

Elsewhere in the world of medical liability, a new study provides further documentation that the threat of lawsuits drives doctors to conduct unnecessary and expensive tests, driving up health care cost. From the American Academy of Orthopaedic Surgeons, “Healthcare Spending: Study Shows High Imaging Costs for Defensive Purposes“:

Nearly 35 percent of all the imaging costs ordered for 2,068 orthopaedic patient encounters in Pennsylvania were ordered for defensive purposes, according to a new study presented today at the 2011 Annual Meeting of the American Academy of Orthopaedic Surgeons (AAOS).

For many years now, some physicians have ordered specific diagnostic procedures that are of little or no benefit to a patient, largely to protect themselves from a lawsuit. Until now, however, efforts to actually measure defensive medicine practices have been limited primarily to surveys sent to physicians. Such surveys would simply ask whether or not that individual actually practiced defensive medicine.

“This is the first study we know of that looked at the actual practice decisions of physicians regarding defensive imaging in real time — prospectively done,” says John Flynn, MD.

And here’s the agenda for the summer convention in New York City of the American Association for Justice, the trial lawyers’ lobby. You’ll see that AAJ’s members are very interested in suing doctors, drug makers and medical device manufacturers.

Why Medical Liability Reform Matters to Manufacturers

By | Briefly Legal, Health Care | 2 Comments

The House Judiciary Committee continues to work on H.R. 5, the medical liability reform package, today in an afternoon mark-up session. We wish them well on the effort. Liability reform will help control the rising costs of health care, and this specific piece of legislation — called the HEALTH Act — contains important protections for drugmakers and medical device manufacturers. The language reflects the understanding that drugs and devices are sold into interstate commerce, approved and regulated by the federal Food and Drug Administration, and once demonstrated as safe should not be subject to trial lawyers’ efforts to use state courts to play litigation lottery.

Section 7 of the legislation, Punitive Damages, sets guidelines on punitive damage awards in health care lawsuits, including limits so punitive damages awards do not exceed the greater of $250,000 or twice economic damages.

Manufacturers of drugs and medical devices are most interested in paragraph (c), “No Punitive Damages for Products That Comply With FDA Standards.


(A) No punitive damages may be awarded against the manufacturer or distributor of a medical product, or a supplier of any component or raw material of such medical product, based on a claim that such product caused the claimant’s harm where–

(i)(I) such medical product was subject to premarket approval, clearance, or licensure by the Food and Drug Administration with respect to the safety of the formulation or performance of the aspect of such medical product which caused the claimant’s harm or the adequacy of the packaging or labeling of such medical product; and

(II) such medical product was so approved, cleared, or licensed; or

(ii) such medical product is generally recognized among qualified experts as safe and effective pursuant to conditions established by the Food and Drug Administration and applicable Food and Drug Administration regulations, including without limitation those related to packaging and labeling, unless the Food and Drug Administration has determined that such medical product was not manufactured or distributed in substantial compliance with applicable Food and Drug Administration statutes and regulations.

Trial lawyers have long sought to bring suits against drug and device makers into state courts, seeking venues and judges that favor the plaintiffs and huge damage awards. In the 2008 decision in Riegel v. Medtronic, the U.S. Supreme Court limited such state suits against manufacturers of medical devices that had received pre-market approval from the FDA. The court ruled that Congress had specifically preempted the devices from state regulation under § 360k(a) of the Medical Device Amendments to the Food, Drug and Cosmetic Act.

This decision was critical in affirming the principle of federal preemption, which provides effective protections for public health and safety. Congress has determined that the FDA is the proper authority with the available resources to regulate drugs and devices in interstate commerce.  Lawsuits in state courts in effect create a 50-state system of regulation for these devices and drugs, full of inconsistencies, capricious enforcement and unjustified damage awards. (No wonder the American Association for Justice and other trial lawyer lobbyists sought to reverse the Riegel decision last Congress with the so-called Medical Device Safety Act. Thankfully, they failed.)

The language in H.R. 5, Section 7, paragraph(c) draws on that general principle of preemption for its “safe harbor” language. It holds that companies that manufacture drugs and devices recognized as safe by the FDA have by definition gone through the careful development, testing and approval — the due diligence — that demonstrate the companies did not behave in a way to justify punitive damages. The legislation provides a measure of protection for companies so they can manufacture effective drugs and devices. It’s exactly the kind of medical liability reform that will reduce costs while ensuring a dynamic market that innovates and creates live-saving products.

UPDATE (4:50 p.m.): The House Judiciary Committee just voted 16-20 to defeat an amendment offered by Reps. Mike Quigley (D-IL) and Sheila Jackson-Lee (D-TX) to strike  Section 7. Rep. Franks (R-AZ) successfully opposed against the amendment, making a similar case as argued above.