Concussions or head injuries, also known as MTBIs, are a serious problem across the country but especially for NFL players.
We have reported on issues related to mild traumatic brain injuries previously here on Legal Blog – see posts here and here.
As reported by ESPN, the NFL Players Association is looking into the procedures that were followed when Cleveland Browns quarterback Colt McCoy suffered a concussion in Sunday’s game against the Pittsburgh Steelers.
The NFL has been criticised in the past for a lack of action and procedures regarding concussion-related issues. The question that the Players Association is looking into is whether proper procedures were followed when McCoy was latter sent back into the game after suffering such a hard hit to the head. Many players, however, feel that the issue is less about whether procedures were followed, and more about the procedures, or return-to-play guidelines, and concussion-related injuries.
The Browns’ coach has asserted that he was given the clear by the teams’ medical staff to put McCoy back in the game. Many critics feel that the current medical staff used by NFL teams is inadequate to evaluate players when they suffer a possible MTBI.
As the process by the Players’ Association continues some believe this incident may lead to the placement of an independent neurologist at each game in the 2012 season.
As reported by ESPN, Former NFL players have filed a lawsuit complaining of the NFL’s policies regarding concussions (mild traumatic brain injuries) as well as the pre-game use of an anti-inflammatory that could increase certain risks for someone with a head injury.
Here on Legal Blog we have written extensively about MTBI, have a brain injury resource page, and written previously about the NFL’s policies regarding brain injuries and players.
Specifically, the players have complained about the pre-game use of Toradol. Toradol is a painkiller and anti-inflammatory drug. The players experts have asserted that this drug can have serious risks for someone who suffers a brain injury or concussion.
In their complaint, the players have also complained that the league disregarded independent studies that contradicted the committee’s findings (the NFL previously established the Mild Traumatic Brain Injury Committee to study head injuries, concussions and post-concussion syndrome in NFL players) failed to acknowledge a correlation between concussions and brain injuries, failed to acknowledge a link between playing football and long-term brain injuries, misled players about the dangers associated with concussions and playing immediately afterwards and failed to change league policies.
According to ESPN, NFL spokesman Greg Aiello stated in an email to The Associated Press: “The NFL has long made player safety a priority and continues to do so. Any allegation that the NFL intentionally sought to mislead players has no merit. It stands in contrast to the league’s actions to better protect players and advance the science and medical understanding of the management and treatment of concussions.”
Many hip implant devices- weather a metal-on-metal design as with DePuy’s ASR system or a ceramic-on-ceramic design as with Stryker Corporation’s Trident system – are defective. There are currently numerous product liability lawsuits across the country involving these Class III medical devices. And, traditionally federal preemption has played a central role in litigating these cases.
After the Supreme Court’s decision in Riegel there were two critical questions left unaddressed regarding preemption that impact both sides in medical device litigation. First, the Court in Riegel did not specify whether a violation of any federal regulation can give rise to a parallel claim (a simultaneous violation of a state tort duty and federal requirement) or if the violation must be of a device-specific requirement. Second, the Court in Riegel said nothing about implied preemption and parallel claims – in other words, would such a claim survive implied preemption even if it made it past express preemption.
The Supreme Court seems to have allowed the Seventh Circuit to answer both of these questions by its denial of cert this Fall in Stryker Corporation v. Bausch.
Bausch involved federal preemption of a plaintiff’s claim that she had been injured by a hip replacement system in violation of federal law.
After Riegel there had been a split in the circuits regarding which violations of federal law (device-specific or general) would survive preemption as a parallel claim. The plaintiff’s claims in Bausch were based on common law negligence and strict liability for a defective product. The plaintiff asserted that the Trident hip system was “adulterated” and that the company’s manufacturing process failed to comply with federal standards (QSRs).
The court in Bausch took a liberal or broad approach emphasizing the phrase “any requirement” in 21 U.S.C. Section 360k. The court saw little basis for the distinction adopted by some courts and urged by defendants between device-specific and general requirements. The court noted that the FDA regulations possess many requirements that are not device-specific, but which are vital to producing safe and effective medical devices.
Federal law, the court stated, is clear: “for manufacturers of Class III medical devices, the Quality System Regulations and Current Good Manufacturing Practices adopted by the FDA under its delegated regulatory authority are legally binding requirements.”
The court then addressed implied preemption finding that plaintiff’s claims were tantamount to the breach of a recognized state law duty owed to her by manufacturers: the duty to use due care in manufacturing a medical device. Therefore, plaintiff’s claims were not impliedly preempted.
With a clear split between the circuits, one would think that Bausch was the perfect case for the Supreme Court to take if any problems existed in the Seventh Circuit’s preemption analysis. But with cert denied, it is clear that alleged violations of either device-specific or industry-wide requirements under federal law can form the basis of parallel claims against manufacturers. And that these claims, if based on traditional tort duties and state law, will survive implied preemption as well.
This is good news to plaintiffs in hip implant lawsuits and medical device litigation across the country.
As reported by USA Today, Honda Motor has announced a recall of 304,000 vehicles due to a problem with the air-bags, which may inflate with too much pressure during a crash.
The recall covers vehicles manufactured in 2001 and 2002 across the globe. There have been 20 reported related accidents, including two fatalities in the U.S. and this is an expansion of 2008 and 2009 recalls for the same issue.
As reported by the San Francisco Chronicle, Pacific Gas & Electric Co. has agreed to pay $38 million “for a string of safety violations that led up to a” 2008 explosion near Sacramento, killing one.
This is the largest fine “ever imposed in California for gas safety violations – after an administrative law judge rejected a $26 million settlement as too low.”
The decision could mean much higher fines for a similar incident under investigation from 2010 in San Bruno, resulting in 8 fatalities and the destruction of 38 homes.
According to a new study, and as reported by MedPage Today, the new metal-on-metal designed hip implants, like DePuy’s ASR hip implant system, are no more effective than the older designs.
Art Sedrakyan, MD, PhD, of Weill Cornell Medical College in New York City, and colleagues studied the safety and effectiveness of different types of bearing surfaces for hip implants. Their study included 3,139 patients (and 3,404 hips) enrolled in 18 randomized trials or comparative observational studies, and more than 830,000 operations in national registries.
What they found was that functional outcomes and quality-of-life scores either did not differ between implant types, or showed an advantage for metal-on-polyethylene over metal-on-metal implants.
As we have reported here on Legal Blog, problems with hip implant metal-on-metal designs have included the accumulation of metal ions in patients’ tissue and resulted in product liability lawsuits throughout the country.
Since DePuy’s recall of its ASR hip replacement system, thousands of product liability lawsuits have been filed against the company.
These claims are based on design defects and state tort laws and have been filed by personal injury attorneys on behalf of victims and patients. The defense would like nothing better than to assert that these claims are preempted by federal law. That is, that federal law supersedes and trumps any state law claims asserted by the plaintiffs. But this is simply not the case. And, though we have addressed this issue before here on Legal BLog (see DePuy Hip Replacement Lawsuits, Preemption, And Pliva, Inc. v. Mensing), it’s worth a second, though brief, take.
Preemption is a legal doctrine whereby federal law displaces overlapping or related state law. Preemption can be either express or implied. In the context of a Class III medical device (DePuy’s hip replacement system) the applicable federal law is the Medical Device Amendments of 1976 to the federal Food, Drug, and Cosmetic Act. 21 U.S.C. Sec. 360 et seq.
DePuy took advantage of the 501(k) process under this law to market its hip replacement system to the public (See DePuy Hip Implant Defects & The 510(k) Process). As the Supreme Court in its majority decision as well as the dissent made clear in Medtronic v. Lohr, and was confirmed by the majority in Riegel v. Medtronic, Inc., the 510(k) process does not place “requirements” on a device; “substantial equivalence” is not a safety requirement but an exemption from it.
Without a federal requirement there can be no preemption of state law tort claims. The “sameness” analysis that was employed in Pliva, Inc. v. Mensing does not apply because, besides the fact that drugs and devices and the jurisprudence that governs them are very different, the requirement that a generic drug and a brand name drug be the same is a “requirement” under the FDCA regarding safety and “substantial equivalence” is not.
We could go on regarding the inapplicable nature and just plain rottenness of preemption in the DePuy hip replacement lawsuits, but we won’t. Here is hoping everyone enjoys Thanksgiving as much as we will and that the University of Texas beats the hell out of A&M.
Hook ‘em!
The DePuy Hip Implant ASR system and the product liability problems associated with it didn’t just appear magically. DePuy’s Hip Replacement system is a medical device approved for physician use by the FDA.
But if DePuy’s ASR is indeed defective and causing the myriad of injuries asserted by personal injury attorneys across the country, how did this product ever get to the public?
The answer resided with a 35 year old ineffective regulatory system known as the 510(k) process.
The 510(k) process refers to the section of the 1976 Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act (an even older law). Under this law there are essentially two methods for a medical device to make it to market; the premarket approval process and section 510(k). The ASR was cleared through the 510(k) process.
Under this process clinical data is not required. The device must simply be found to be “substantially equivalent” to a preexisting device known as a “predicate” device. However, the predict may have also been approved through section 510(k), which can mean that neither the new device nor the predicate were evaluated for safety.
The importance of this last point cannot be overstated. The 510(k) process is not an evaluation for safety but only one of substantial equivalence to a predicate device.
DePuy’s ASR Hip Implant was built with a metal-on-metal design. This design was not without it’s critics. But DePuy convinced the FDA that it was substantially equivalent to a preexisting device. The only data regarding it’s safety was obtained by bench testing. This means testing in a laboratory not clinical trials, which was inadequate to evaluate how it would perform in patients.
The disastrous results and product liability lawsuits that ensued because of DePuy’s hip replacement system should be evidence enough of 510(k)’s inadequacies. The FDA, however, turned to the Institute of Medicine (IOM) to evaluate the 510(k) process and answer two essential questions: (1) Does the 510(k) process protect patients and promote innovations? (2) If it does not, what changes need to take place?
In July of 2011 the IOM released it’s findings in a report. The IOM concluded that the 510(k) process does not assure safety or effectiveness because it does not evaluate safety or effectiveness. The IOM recommended that the 510(k) process be eliminated entirely and replaced with a system that in fact evaluates safety and effectiveness.
The IOM also recommended that the FDA develop a premarket and aftermarket evaluation process that collects and analyzes medical device safety and performance information. And in order to achieve these goals the FDA’s regulatory powers should be strengthened and updated.
Congress should adopt the IOM’s recommendations and work immediately to ensure the safety of patients and consumers from dangerous products like DePuy’s ASR.
In our next post we look at federal law that is often used to prevent personal injury and product liability attorneys from helping consumers who have been harmed by products like DePuy’s hip replacement implants.
In 2010, DePuy recalled its ASR hip replacement systems due to product defects. The injuries and problems associated with this product may ultimately impact tens of thousands of patients. It is a product liability disaster.
As large as it is, however, it is only one aspect of a much larger problem plaguing the healthcare system in the United States: how medical devices and drugs are brought to market and the influence of money from drug and medical device manufacturers on physicians.
This week on Legal Blog we’ll take a closer look at both the influence of money and how dangerous drugs and defective products, like DePuy’s ASR hip replacements, make it to market.
First, the money.
ProPublica has complied an excellent data base illustrating how much money hospitals and physicians have received from drug and medical device companies for various activities like speaking and consulting – $761.3 million based on disclosures. These same drug and device manufacturers have been hit recently with numerous whistle-blower lawsuits and Justice Department actions for illegally promoting their products.
For example, Johnson & Johnson incorporates some 250 divisions or corporate units, including DePuy, as well as Ortho-McNeil and Ortho-McNeil-Janssen. The latter two agreed to pay $81 million in April 2010 to settle civil and criminal charges of illegally promoting the epilepsy drug Topamax. GlaxoSmithKline stated earlier this year that it was setting aside $3.4 billion to settle government investigations and product liability lawsuits related to its diabetes drug Avandia. And then of course their is Merck. In 2008, the company agreed to pay more than $650 million to settle allegations that it didn’t pay proper rebates to government health programs and illegally paid health care providers as inducements to prescribe the company’s products.
And how much have these companies paid to health care providers for speaking, consulting, meals, travel, and other activities? In 2010, Johnson & Johnson reported $17,900,346; Glaxo – $85,263,683; and Merck – $20,365,446.
Currently, only 12 pharmaceutical companies disclose their payments to health care providers publicly. All such corporations will be required to report and disclose these payments in 2013, however.
Much more light is needed on this subject; patients should know if drug or device companies are paying their doctors and for what those payments are being made.
Next post, how medical devices that are defective, like DePuy’s hip replacement system, make it to an unsuspecting public.
Will DePuy Hip Replacement lawsuit plaintiffs face implied preemption challenges based on the Supreme Court’s ruling in Mensing?
This year the Supreme Court handed down several product liability decisions involving preemption making life more difficult for plaintiffs. Pliva, Inc. v. Mensing was one of those decisions.
Mensing was a drug case involving implied preemption and the manufacturer of a generic drug. The plaintiffs sued the drug manufacturer on failure to warn claims. The defendant moved to dismiss those claims asserting implied preemption of the state law causes of action based on impossibility. In other words, the defense argued that it would be impossible to comply with both state and federal requirements under the law.
The Court, per Justice Thomas, sided with the drug company in finding preemption. The central question was whether the defendant could independently change it’s label under the federal law. The Court found that it could not; hence preemption. And the Court distinguished its decision from Wyeth v. Levine (see previous analysis of Wyeth here), in which preemption was not found, on the basis that the FDA regulations provide for a brand name manufacturer’s ability to unilaterally change its label when required by state law.
Mensing is problematic for a litany of reasons – too many to detail in this post. But the real threat of Mensing resides in its potential use by defendants and business friendly courts in asserting preemption of state law causes of action in medical device litigation.
The folks at Drug and Device Law Blog present that the same logic that resulted in preemption in Mensing, a drug case, can rescue medical device manufacturers who face state product liability claims on devices approved through the 510(k) process, which would include DePuy hip replacement lawsuits.
Their argument in an extreme nutshell works like this: Part of the analysis in Mensing focused on the requirement that the generic drug be the “same” or identical to the brand name equivalent (this is how a drug qualifies as a generic form of a brand name). This in turn brings the drug under the FDA regulations as a generic form forcing its compliance with federal law, which in turn leads to preemption of state law failure to warn claims due to impossibility.
The folks at Drug and Device then ask: “Is there an analogous “sameness” requirement applicable to 510k medical devices? If a plaintiff argued that a defendant’s medical device should have been drastically re-designed to make it safer, would that purported state-law duty conflict with the terms of the device’s clearance?” In other words, is the “substantial equivalence” procedure under the 510(k) process similar enough to the “sameness” issues in Mensing to warrant preemption?
They answer their own question – Yes. Thus state law claims should be preempted.
But they are wrong for several reasons. First, and most importantly, as one commenter noted, drugs and devices are very different. Generic drugs are identical in their chemical nature. This is the essence of a generic drug. A predicate device and a device introduced through the 510(k) process can be very different, only substantial similarity is required. And this can mean significant design differences between the two devices, as is the case with the DePuy ASR Modular Acetabular Cup System and earlier devices.
Second, Mensing involves drug-specific requirements (the drugs must be the same). The Court in Medtronic v. Lohr rejected the contention that the substantial-equivalence review under the 510(k) process imposed device-specific requirements. The focus for the approval process for a brand name drug under the FDCA is safety, just as the focus for approval of a device under the MDA’s premarket approval process (PMA) is safety. The focus under 510(k) is not safety but substantial-equivalence. And because the 510(k) process does not involve a safety review, it is not implicated by the preemption provision under the MDA.
And third, the touchstone of federal pre-emption is always the intent of Congress. Had Congress wanted drug and device pre-emption to be alike it could have applied the pre-emption clause under the MDA to the entire FDCA, it did not. What Congress did was write a pre-emption provision that applies only to medical devices.
And that’s just for starters…
